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Recall Archives 27
FDA Recalls
July 7 - December 29, 2010
- Recalls as of December 29, 2010
- Recalls as of December 22, 2010
- Recalls as of December 15, 2010
- Recalls as of December 08, 2010
- Recalls as of December 01, 2010
- Recalls as of
October 27, 2010
- Recalls as of
October 20, 2010
- Recalls as of
October 13, 2010
- Recalls as of
October 6, 2010
- Recalls as of
September 29, 2010
- Recalls as of
September 22, 2010
- Recalls as of
September 15, 2010
- Recalls as of
September 8, 2010
- Recalls as of
September 1, 2010
- Recalls as of
August 25, 2010
- Recalls as of
August 18, 2010
- Recalls as of
August 11, 2010
- Recalls as of
August 8, 2010
- Recalls as of July 28, 2010
- Recalls as of
July 21, 2010
- Recalls as of
July 14, 2010
- Recalls as of
July 7, 2010
July 2010 - December 2010
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of December 29, 2010.
CLASS I
PRODUCT:
1) AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical
systems, Magellan, Cannula Tip, Catalog Number AMS600-B,Sterilized by
Ethylene Oxide, Rx Only. Arteriocyte Medical systems, Magellan, Cannula
Tip, Catalog Number AMS700-B,Sterilized by Ethylene Oxide, Rx Only.
Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm),
Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx
Only. Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip,
Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx
Only. Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678,
Micromedics, Sterilized by Ethylene Oxide, Rx Only. Recall #
Z-0345-2011
2) ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous
Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene
Oxide, Rx Only. LP-AP-M0001, LifeSeal SLR Applicator Sterilized by
Ethylene Oxide. Recall # Z-0346-2011;
3) SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal
Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide.
Nasal Products, Catalog Number SP-78105, Nasal Septal Button Oversize
(5cm), Rx Only, Sterilized by Ethylene Oxide. Recall # Z-0347-2011;
4) VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50,
Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene
Oxide, Rx Only. VT-0204-01 Otological Ventilation Tubes, Catalog Number
VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene
Oxide, Rx Only. VT-0406-01 Otological Ventilation Tubes, Catalog Number
VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene
Oxide, Rx Only. VT-0503-01 Otological Ventilation Tubes, Catalog Number
VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized
by Ethylene Oxide, Rx Only. VT-0503-50 Otological Ventilation Tubes,
Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen,
Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only. VT-0507-01
Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong
Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only.
VT0508-50 Otological Ventilation Tubes, Catalog Number VT-0508-50,
Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by
Ethylene Oxide, Rx Only. VT-1002-50 Otological Ventilation Tubes,
Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone,
Sterilized by Ethylene Oxide, Rx Only. VT-1035-01 Otological Ventilation
Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium,
Sterilized by Ethylene Oxide, Rx Only. VT1204-01 Otological Ventilation
Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL
Sterilized by Ethylene Oxide, Rx Only. VT-1421-01 Otological Ventilation
Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI,
Sterilized by Ethylene Oxide, Rx Only. ET-ABGDT-45 Distributed By API
Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP
Sterilized by Ethylene Oxide, Rx Only. Otological Ventilation Tubes.
ET-GTST-45-12, Distributed By API Anthony products, Inc., ET-GTST-45-12,
T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx
Only, Otological Ventilation Tubes. ET-SPDT-40T, Distributed By API
Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI,
Sterilized by Ethylene Oxide, Rx Only. Otological Ventilation Tubes.
ET-TBDT-45 Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter
Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx
Only, Otological Ventilation Tubes. Recall # Z-0348-2011
MANUFACTURER: Micromedics, Inc., Eagan, MN, by letter dated March 15,
2010. Firm initiated recall is ongoing.
REASON: Micromedics, Inc is conducting a product recall on a number of
medical device products because of weak seals of the sterile pouches,
potentially resulting in a non-sterile product which may cause
transmission of disease or infection.
PRODUCT:
Penumbra System Reperfusion Catheter 032, catalog number PSC032. Recall
# Z-0428-2011
MANUFACTURER: Penumbra Inc., Alameda, CA, by letter dated October 28,
2010. Firm initiated recall is ongoing.
REASON: Reperfusion catheter may fail at the mid-shaft joint and may
break off. If the segment cannot be removed, it may result in blocked
blood flow, requiring emergency medical treatment.Italy, Norway,
Slovenia, Spain, and the United Kingdom
CLASS II
PRODUCT:
Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040.
For use with Boston Scientific CHILLI Cooled Ablation Catheters and
Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide.
Contents: peristaltic pump fluid delivery extension tube set. Tubing Set
(model 2104) for use with Boston Scientific Cooled Ablation System.
Recall # Z-0170-2011
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter, dated September 27, 2010, Manufacturers: Boston Scientific
Corp., San Jose, CA;Central Admixture Pharmacy Inc., Bethlehem, PA. Firm
initiated recall is ongoing.
REASON: Boston Scientific is conducting a Recall on CircuCool? Tubing
Sets used with the Chilli II? Cooled Ablation System because there may
be a potential for a sterile barrier breach which could compromise
device sterility and potentially the sterile field. Even though there
have been no reported complaints.
PRODUCT:
Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System,
x-ray, mobile. Model numbers 1818363 and 1818454. Recall # Z-0171-2011
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter on October 4, 2010.Manufacturer: Siemens Medical
Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is
ongoing.
REASON: Units not equipped with protective plastic cover over
electronics.
PRODUCT:
1) REALIZE? Adjustable Gastric Band, Injection Port and Applier Product
Code: RLZB22, RLZB22D, RLZB22DG. Recall # Z-0289-2011;
2) REALIZE? Adjustable Gastric Band Pak with 15mm XCEL" trocar Product
Code RLZB22T. Recall # Z-0290-2011;
3) REALIZE? Adjustable Gastric Band Pak with Endoscopic Dissector
Product Code RLZB22D1. Recall # Z-0291-2011;
4) REALIZE? Adjustable Gastric Band Pak with Endoscopic Dissector and
15mm XCEL" trocar Product Code RLZB22DT.Recall # Z-0292-2011;
5) REALIZE? Adjustable Gastric Band Pak with Endoscopic Dissector and
Calibration Tube Product Code RLZB22DG1. Recall # Z-0293-2011;
6) REALIZE? Adjustable Gastric Band Pak with Endoscopic Dissector,
Calibration Tube and 15mm XCEL" trocar Product Code RLZB22DGT. Recall #
Z-0294-2011;
7) REALIZE? Adjustable Gastric Band-C Product Code RLZB32. Recall #
Z-0295-2011;
8) REALIZE? Adjustable Gastric Band-C Pak with 15mm XCEL" trocar Product
Code RLZB32T. Recall # Z-0296-2011;
9) REALIZE? Adjustable Gastric Band-C Pak with Endoscopic Dissector and
15mm XCEL" trocar. Product Code RLZB32DT. Recall # Z-0297-2011;
10) REALIZE? Adjustable Gastric Band-C Pak with Endoscopic Dissector and
calibration tube. Product Code RLZB32DG1. Recall # Z-0298-2011;
11) REALIZE? Adjustable Gastric Band-C Pak with Endoscopic Dissector,
Calibration Tube and 15mm XCEL" trocar. Product Code RLZB32DGT. Recall #
Z-0299-2011;
12) REALIZE? Adjustable Gastric Band-C with Endoscopic Dissector.
Product Code RLZB32D1. Recall # Z-0300-2011;
13) REALIZE? Injection Port and Applier. Product Code RLZPT2. Recall #
Z-0301-2011;
14) SAGB QuickClose Swedish Adjustable Gastric Band including Velocity"
Injection Port and Applier. Product Code BD2XV. Recall # Z-0302-2011;
15) SAGB VC Swedish Adjustable Gastric Band including Velocity"
Injection Port Applier Product Code BD3XV, Product Code BD2XV. Recall #
Z-0303-2011;
16) Velocity" Injection Port and Applier Product Code PT2XV. Recall #
Z-0304-2011
MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH,
by letter dated October 8, 2010.Manufacturer: Obtech Medical Sarl, Le
Locle, Switzerland. Firm initiated recall is ongoing.
REASON: The Tubing Strain Relief component of the Injection Port may
detach from the Locking Connector, and migrate from its original
position on the Locking Connector. This may result in: Tubing Strain
Relief migrating on the Tubing; Kinking of the Tubing resulting in
difficulty/inability to adjust the fluid volume within the Band; or a
free foreign body in the abdominal wall or abdominal (peritoneal)
cavity.
PRODUCT:
Smith&Nephew Ezcare Negative Pressure Wound Therapy pumps manufactured
between July 17, 2007 and December 13, 2007 and distributed between July
18, 2007 and January 14, 2010. Affected products codes are 66800187,
66800322, 66800323, 66800324, and 66800325. Rx only. 100-240 V 12 V
50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a
suction device particularly as the device may promote healing when used
with accessory wound sealing kits. Made in USA. Recall # Z-0310-2011
MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Saint Petersburg, FL,
by letter dated January 27, 2010.Manufacturer: Blue Sky Medical Group
Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON: Devices subject to this recall have exhibited inconsistent
battery performance and may after repeated battery charging cycles,
experience battery failure due to overheating.
PRODUCT:
HeartStart MRx Defibrillator/Monitor Models: M3535A / M3536A / M3536J /
M3536MC The HeartStart MRx is for use for the termination of ventricular
tachycardia and ventricular fibrillation. The device is for use by
qualified medical personnel trained in the operation of the device and
qualified by training in basic life support, advanced cardiac support,
or defibrillation. It must be used by or on the order of a physician.
Recall # Z-0322-2011
MANUFACTURER: Philips Healthcare Inc., Andover, MA, by letter on July
20, 2010. Firm initiated recall is ongoing.
REASON: Updated Instructions for Use- HeartStart MRx
monitor/defibrillator. The update provides more detailed information on:
" Default ECG Lead Behavior " Synchronized Cardioversion using External
Paddles
PRODUCT:
Stryker M1 Ambulance cot, Model 6100. Recall # Z-0328-2011
MANUFACTURER: Stryker Medical Div. of Stryker Corp., Portage, MI, by
letter dated May 15, 2010. Firm initiated recall is ongoing.
REASON: The firm has received 42 complaints regarding the head end lock
rod, head end slide tube, brushing, and upper cross tube failures.
PRODUCT
Titan XL Handpiece Infrared Therapeutic Heating Lamp, Infrared
therapeutic heating lamp, intended to emit energy in the infrared
spectrum to provide topical heating for the purpose of elevating tissue
temperature for the temporary relief of minor muscle and joint pain and
stiffness. Recall # Z-0329-2011
MANUFACTURER: Cutera Inc., Brisbane, CA, by letters on May 8, 2010. Firm
initiated recall is ongoing.
REASON: Risk of burns-- under certain conditions, devices containing a
gold plated end block could produce energy above what is stated on the
device setting.
PRODUCT:
1) External Compression Device; 1 unit per package. Active
Apposition/compression is achieved by threading the External Compression
Device into the Nail holding Screw. While being threaded into the Nail
Holding Screw the tip of the External Compression Device will contact
the (shaft screw (cross screw) and will push the screw in distal
direction. As the cross screw is screwed into the bone of the patient,
the bone fragment will be moved too in distal direction. Finally both
sides of the bone fracture will be pressed together - compression is now
applied to the fracture side. Catalog Number: 1806-1601. Recall #
Z-0330-2011;2) Nail Holding Screw; 1 unit per package Stryker Trauma
GmbH; The nail holding Screw is used to assemble the nail to the target
device. The Nail holding Screw is the mating part (inner thread) of the
External Compression Device as the instruments needs to be threaded into
the Nail holding Screw in order to achieve Compression at the fracture
side. Catalog Number: 1806-1602. Recall # Z-0331-2011
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letters on September 9, 2010 and September 10, 2010.Manufacturer:
Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is
ongoing.
REASON: Variations in the outer diameter of the shaft of the External
Compression Device and the inner diameter of the Nail Holding Screw may
make assembly of these 2 instruments not possible.
PRODUCT:
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, CD45 recognizes
members of the T200 family of human leucocyte antigens with molecular
mass of 180 to 220 kilodaltons (kDa). Model/Catalog number 641408,
Recall # Z-0397-2011
MANUFACTURER: BD Biosciences, Systems & Reagents, San Jose, CA, by
letter, dated November 2009. Firm initiated recall is complete.
REASON: Incorrect expiration date: product with an expiration date of
03/31/2010 was marked with an incorrect expiration date of 06/30/2010.
PRODUCT
Baxter Interlink System, Micro-Infusion Manifold; and Interlink
Manifold. An Rx sterile device with 3 injection sites, volume per
injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product
code 2N3410 and A2N3410; Intended for use with a vascular access device
for blood sampling and the administration of multiple drugs and
solutions. Recall # Z-0502-2011
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
by letter dated October 20, 2010.Manufacturers: Baxter Healthcare Corp.
of Puerto Rico S.A., Aibonito, PR;Baxter Healthcare Corp., Singapore,
Singapore. Firm initiated recall is ongoing.
REASON: If the manifolds are connected in series, there may be a risk of
the manifolds loosening or disconnecting at the luer connection between
them.
PRODUCT:
1) Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00.
Recall # Z-0550-2011;
2) Dixtal Handheld Pulse Oximetry, Model 512, Catalog Number: 9100-00.
Recall # Z-0551-2011
MANUFACTURER: Dixtal Medical, Inc., Wallingford, CT, by email and
letter, dated September 27, 2010. Firm initiated recall is ongoing.
REASON: Unit may overestimate Sp02 levels in a high humidity
environment.
PRODUCT:
1) Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer
locking syringe containing Heparin Lock Flush Solution, USP, a sterile
non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush
Syringe contains 100 units of heparin sodium derived from porcine
intestinal mucosa and 9 mg of sodium chloride in water for injection.
The pre-filled syringes were packed as 60 syringes per dispenser box, 16
boxes per shipping carton in the following syringe configurations: a)
NDC# 64253-333-33, catalog # MIH-3333: 3 mL fill in 12 mL syringe; b)
NDC# 64253-333-35, catalog # MIH-3335: 5 mL fill in 12 mL syringe.
Recall # Z-0599-2011;
2) Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer
locking syringe containing Heparin Lock Flush Solution, USP, a sterile
non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush
Syringe contains 10 units of heparin sodium derived from porcine
intestinal mucosa and 9 mg of sodium chloride in water for injection.
The pre-filled syringes were packed as 60 syringes per dispenser box, 16
boxes per shipping carton in the following syringe configurations: a)
NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b)
NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c)
NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe.
Recall # Z-0600-2011;
3) Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer
locking syringe containing Heparin Lock Flush Solution, USP, a sterile
non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush
Syringe contains 1 units of heparin sodium derived from porcine
intestinal mucosa and 9 mg of sodium chloride in water for injection;
The pre-filled syringes were packed as 60 syringes per dispenser box, 16
boxes per shipping carton in the following syringe configurations: a)
NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b)
NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe. Recall
# Z-0601-2011
MANUFACTURER: Medefil, Inc. Glendale Heights, IL. by email and letter
dated November 1, 2010. Firm initiated recall is ongoing.
REASON: The heparin lock flush solution was manufactured with
contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).
PRODUCT:
1) Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO
Surgical.
Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024,
804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030,
804-05-031, 804-05-032, 804-05-033, 804-05-034, 804-05-035, 804-05-036,
804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042,
804-05-043, 804-05-044, 804-05-045. Recall # Z-0798-2011;
2) Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO
Surgical.
Part number 804-15-000, and 804-15-001. Recall # Z-0799-2011;
3) Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid,
DJO Surgical,.
Part number 804-25-006, 804-25-007, 804-25-008, 804-25-009, 804-25-010.
Recall # Z-0800-2011;
4) Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill
Guide, DJO Surgical, Part number 804-25-024, and 804-25-025. Recall #
Z-0801-2011
MANUFACTURER: Encore Medical, LP, Austin, TX, by letter on November
5/2010. Firm initiated recall is ongoing.
REASON: Complaints of fracturing were reported for affected trial
products.
CLASS III
PRODUCT:
Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46
Intended for use as a drilling guide to prepare a site for placement of
a dental implant into the dental implant site. Recall # Z-0320-2011
MANUFACTURER: Recalling Firm: Straumann Manufacturing Inc., Andover, MA,
by telephone on June 4, 2009, and letter dated, June 8,
2009.Manufacturer: Institut Straumann AG, Basel, Switzerland. Firm
initiated recall is complete.
REASON: Incorrect Inner diameter of the T-sleeve .
The following is condensed list of
medical devices involved in recalls listed by the FDA Enforcement Report
as of December 22, 2010.
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CLASS I
PRODUCT:
1) VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For
In Vitro Diagnostic Use, 20 cards/box. The firm names on the label.
Cards that are intended for use with the Vitek 2 Systems in clinical
laboratories as an in vitro test to determine the susceptibility of
clinically significant aerobic/anaerobic gram-negative bacilli to
antimicrobial agents. Recall # Z-0172-2011;
2) VITEK 2 Gram Negative Susceptibility Card, AST-GN23, REF 22 228, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0173-2011;
3) VITEK 2 Gram Negative Susceptibility Card, AST-GN24, REF 22 229, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0174-2011;
4) VITEK 2 Gram Negative Susceptibility Card, AST-GN25, REF 22 230, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0175-2011;
5) VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall #
Z-0176-2011;
6) VITEK 2 Gram Negative Susceptibility Card, AST-GN27, REF 22 245, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0177-2011;
7) VITEK 2 Gram Negative Susceptibility Card, AST-GN28, REF 22 254, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0178-2011;
8) VITEK 2 Gram Negative Susceptibility Card, AST-GN29, REF 22 266, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0179-2011;
9) VITEK 2 Gram Negative Susceptibility Card, AST-GN30, REF 22 267, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0180-2011;
10) VITEK 2 Gram Negative Susceptibility Card, AST-GN31, REF 22 268, For
In Vitro Diagnostic Use, 20 cards/box. The firm names on the label.
Cards that are intended for use with the Vitek 2 Systems in clinical
laboratories as an in vitro test to determine the susceptibility of
clinically significant aerobic/anaerobic gram-negative bacilli to
antimicrobial agents. Recall # Z-0181-2011;
11) VITEK 2 Gram Negative Susceptibility Card, AST-GN32, REF 22 269, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0182-2011;
12) VITEK 2 Gram Negative Susceptibility Card, AST-GN33, REF 22 270, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0183-2011;
13) VITEK 2 Gram Negative Susceptibility Card, AST-GN34, REF 22 271, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0184-2011;
14) VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0185-2011;
15) VITEK 2 Gram Negative Susceptibility Card, AST-GN36, REF 22 300, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0186-2011;
16) VITEK 2 Gram Negative Susceptibility Card, AST-GN37, REF 22 312, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0187-2011;
17) VITEK 2 Gram Negative Susceptibility Card, AST-GN39, REF 22 337, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0188-2011;
18) VITEK 2 Gram Negative Susceptibility Card, AST-GN41, REF 410 757,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0189-2011;
19) VITEK 2 Gram Negative Susceptibility Card, AST-GN42, REF 410 758,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0190-2011;
20) VITEK 2 Gram Negative Susceptibility Card, AST-N080, REF 22 214, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0191-2011;
21) VITEK 2 Gram Negative Susceptibility Card, AST-N081, REF 22 215, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0192-2011;
22) VITEK 2 Gram Negative Susceptibility Card, AST-N082, REF 22 217, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0193-2011;
23) VITEK 2 Gram Negative Susceptibility Card, AST-N084, REF 22 224, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0194-2011;
24) VITEK 2 Gram Negative Susceptibility Card, AST-N085, REF 22 225, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0195-2011;
25) VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0196-2011;
26) VITEK 2 Gram Negative Susceptibility Card, AST-N087, REF 22 235, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0197-2011;
27) VITEK 2 Gram Negative Susceptibility Card, AST-N088, REF 22 236,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0198-2011;
28) VITEK 2 Gram Negative Susceptibility Card, AST-N089, REF 22 237, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall #
Z-0199-2011;
29) VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0200-2011;
30) VITEK 2 Gram Negative Susceptibility Card, AST-N091, REF 22 241, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0201-2011;
31) VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 243, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0202-2011;
32) VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 246, For
In Vitro Diagnostic Use, 20 cards/box.Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0203-2011;
33) VITEK 2 Gram Negative Susceptibility Card, AST-N094, REF 22 247, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0204-2011;
34) VITEK 2 Gram Negative Susceptibility Card, AST-N095, REF 22 249, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0205-2011;
35) VITEK 2 Gram Negative Susceptibility Card, AST-N096, REF 22 250, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0206-2011;
36) VITEK 2 Gram Negative Susceptibility Card, AST-N097, REF 22 251, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0207-2011;
37) VITEK 2 Gram Negative Susceptibility Card, AST-N098, REF 22 253, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0208-2011;
38) VITEK 2 Gram Negative Susceptibility Card, AST-N100, REF 22 256, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0209-2011;
39) VITEK 2 Gram Negative Susceptibility Card, AST-N103, REF 22 259, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0210-2011;
40) VITEK 2 Gram Negative Susceptibility Card, AST-N104, REF 22 261, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0211-2011;
41) VITEK 2 Gram Negative Susceptibility Card, AST-N105, REF 22 262, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0212-2011;
42) VITEK 2 Gram Negative Susceptibility Card, AST-N106, REF 22 264, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0213-2011;
43) VITEK 2 Gram Negative Susceptibility Card, AST-N108, REF 22 272, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0214-2011;
44) VITEK 2 Gram Negative Susceptibility Card, AST-N109, REF 22 273, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0215-2011;
45) VITEK 2 Gram Negative Susceptibility Card, AST-N110, REF 22 274, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0216-2011;
46) VITEK 2 Gram Negative Susceptibility Card, AST-N111, REF 22 275, For
In Vitro Diagnostic Use, 20 cards/box.
Recall # Z-0217-2011;
47) VITEK 2 Gram Negative Susceptibility Card, AST-N112, REF 22 281, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0218-2011;
48) VITEK 2 Gram Negative Susceptibility Card, AST-N114, REF 22 283, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0219-2011;
49) VITEK 2 Gram Negative Susceptibility Card, AST-N115, REF 22 285, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0220-2011;
50) VITEK 2 Gram Negative Susceptibility Card, AST-N116, REF 22 289, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0221-2011;
51) VITEK 2 Gram Negative Susceptibility Card, AST-N117, REF 22 290, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0222-2011;
52) VITEK 2 Gram Negative Susceptibility Card, AST-N118, REF 22 291, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0223-2011;
53) VITEK 2 Gram Negative Susceptibility Card, AST-N120, REF 22 293, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0224-2011;
54) VITEK 2 Gram Negative Susceptibility Card, AST-N121, REF 22 295, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0225-2011;
55) VITEK 2 Gram Negative Susceptibility Card, AST-N122, REF 22 299, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0226-2011;
56) VITEK 2 Gram Negative Susceptibility Card, AST-N123, REF 22 301, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0227-2011;
57) VITEK 2 Gram Negative Susceptibility Card, AST-N124, REF 22 303, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0228-2011;
58) VITEK 2 Gram Negative Susceptibility Card, AST-N127, REF 22 308, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0229-2011;
59) VITEK 2 Gram Negative Susceptibility Card, AST-N128, REF 22 309, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0230-2011;
60) VITEK 2 Gram Negative Susceptibility Card, AST-N129, REF 22 310, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0231-2011;
61) VITEK 2 Gram Negative Susceptibility Card, AST-N130, REF 22 311, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0232-2011;
62) VITEK 2 Gram Negative Susceptibility Card, AST-N131, REF 22 315, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0233-2011;
63) VITEK 2 Gram Negative Susceptibility Card, AST-N132, REF 22 316, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0234-2011;
64) VITEK 2 Gram Negative Susceptibility Card, AST-N133, REF 22 318, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0235-2011;
65) VITEK 2 Gram Negative Susceptibility Card, AST-N134, REF 22 319, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0236-2011;
66) VITEK 2 Gram Negative Susceptibility Card, AST-N135, REF 22 322, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0237-2011;
67) VITEK 2 Gram Negative Susceptibility Card, AST-N136, REF 22 323, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0238-2011;
68) VITEK 2 Gram Negative Susceptibility Card, AST-N137, REF 22 324, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0239-2011;
69) VITEK 2 Gram Negative Susceptibility Card, AST-N138, REF 22 326, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0240-2011;
70) VITEK 2 Gram Negative Susceptibility Card, AST-N139, REF 22 327, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0241-2011;
71) VITEK 2 Gram Negative Susceptibility Card, AST-N140, REF 22 328, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0242-2011;
72) VITEK 2 Gram Negative Susceptibility Card, AST-N141, REF 22 329, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0243-2011;
73) VITEK 2 Gram Negative Susceptibility Card, AST-N142, REF 22 332, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0244-2011;
74) VITEK 2 Gram Negative Susceptibility Card, AST-N143, REF 22 333, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0245-2011;
75) VITEK 2 Gram Negative Susceptibility Card, AST-N144, REF 22 334, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0246-2011;
76) VITEK 2 Gram Negative Susceptibility Card, AST-N145, REF 22 338, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0247-2011;
77) VITEK 2 Gram Negative Susceptibility Card, AST-N146, REF 22 341, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0248-2011;
78) VITEK 2 Gram Negative Susceptibility Card, AST-N147, REF 22 342, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0249-2011;
79) VITEK 2 Gram Negative Susceptibility Card, AST-N148, REF 22 343, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0250-2011;
80) VITEK 2 Gram Negative Susceptibility Card, AST-N149, REF 22 344, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0251-2011;
81) VITEK 2 Gram Negative Susceptibility Card, AST-N150, REF 22 345, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0252-2011;
82) VITEK 2 Gram Negative Susceptibility Card, AST-N151, REF 22 346, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0253-2011;
83) VITEK 2 Gram Negative Susceptibility Card, AST-N152, REF 22 347, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0254-2011;
84) VITEK 2 Gram Negative Susceptibility Card, AST-N153, REF 22 348, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0255-2011;
85) VITEK 2 Gram Negative Susceptibility Card, AST-N155, REF 22 352, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0256-2011;
86) VITEK 2 Gram Negative Susceptibility Card, AST-N156, REF 22 353, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0257-2011;
87) VITEK 2 Gram Negative Susceptibility Card, AST-N157, REF 22 354, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0258-2011:
88) VITEK 2 Gram Negative Susceptibility Card, AST-N158, REF 22 355, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0259-2011;
89) VITEK 2 Gram Negative Susceptibility Card, AST-N159, REF 22 356, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0260-2011;
90) VITEK 2 Gram Negative Susceptibility Card, AST-N160, REF 22 357, For
In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for use
with the Vitek 2 Systems in clinical laboratories as an in vitro test to
determine the susceptibility of clinically significant aerobic/anaerobic
gram-negative bacilli to antimicrobial agents. Recall # Z-0261-2011;
91) VITEK 2 Gram Negative Susceptibility Card, AST-N161, REF 410 026,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0262-2011;
92) VITEK 2 Gram Negative Susceptibility Card, AST-N162, REF 410 023,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0263-2011;
93) VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0264-2011;
94) VITEK 2 Gram Negative Susceptibility Card, AST-N164, REF 410 101,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0265-2011;
95) VITEK 2 Gram Negative Susceptibility Card, AST-N165, REF 410 102,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0266-2011;
96) VITEK 2 Gram Negative Susceptibility Card, AST-N166, REF 410 136,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0267-2011;
97) VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0268-2011;
98) VITEK 2 Gram Negative Susceptibility Card, AST-N168, REF 410 139,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0269-2011;
99) VITEK 2 Gram Negative Susceptibility Card, AST-N170, REF 410 222,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0270-2011;
100) VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0271-2011;
101) VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0272-2011;
102) VITEK 2 Gram Negative Susceptibility Card, AST-N174, REF 410 404,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0273-2011;
103) VITEK 2 Gram Negative Susceptibility Card, AST-N175, REF 410 403,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0274-2011;
104) VITEK 2 Gram Negative Susceptibility Card, AST-N176, REF 410 402,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0275-2011;
105) VITEK 2 Gram Negative Susceptibility Card, AST-N177, REF 410 392,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0276-2011;
106) VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0277-2011;
107) VITEK 2 Gram Negative Susceptibility Card, AST-N179, REF 410 640,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0278-2011;
108) VITEK 2 Gram Negative Susceptibility Card, AST-N180, REF 410 771,
For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label
are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280
Marcy-l'Etoile France. Cards that are intended for use with the Vitek 2
Systems in clinical laboratories as an in vitro test to determine the
susceptibility of clinically significant aerobic/anaerobic gram-negative
bacilli to antimicrobial agents. Recall # Z-0279-2011;
109) VITEK 2 Gram Negative Susceptibility Card, AST-N181, REF 410 803,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0280-2011;
110) VITEK 2 Gram Negative Susceptibility Card, AST-N182, REF 410 804,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0281-2011;
111) VITEK 2 Gram Negative Susceptibility Card, AST-GN40, REF 410 756,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0282-2011;
112) VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0283-2011;
113) VITEK 2 Gram Negative Susceptibility Card, AST-GN44, REF 410 805,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0284-2011;
114) VITEK 2 Gram Negative Susceptibility Card, AST-N107, REF 22 265,
For In Vitro Diagnostic Use, 20 cards/box. Cards that are intended for
use with the Vitek 2 Systems in clinical laboratories as an in vitro
test to determine the susceptibility of clinically significant
aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall
# Z-0285-2011
MANUFACTURER: BioMerieux Inc, Hazelwood, MO, by letter dated September
13, 2010. Firm initiated recall is ongoing.
REASON: The piperacillin/tazobactam drug on the antimicrobial
susceptibility cards is providing false susceptibility and false
resistance results for E. coli; and the same drug is providing false
susceptibility results for Klebsiella.
PRODUCT:
SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16.
Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15
Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured &
Distributed 08/22/2008. Used in a medical research or clinical
laboratory setting by knowledgeable, trained and experienced personnel.
Recall # Z-0344-2011
MANUFACTURER: SCC Soft Computer, Clearwater, FL, by the proprietary
communication software on February 16, 2010. Firm initiated recall is
ongoing.
REASON: When a test is being verified, the wrong (expired) ranges may be
associated to that test result, causing an incorrect flag to be posted
for that test result.
CLASS II
PRODUCT
Elekta Synergy XVI Intended use: Radiation therapy treatment of
malignant neoplastic diseases, as determined by a licensed medical
practitioner. Recall # Z-0350-2011
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter
dated September 1, 2010.Manufacturer: Elekta Oncology Systems (Fmrl
Philipps), West Sussex, UK. Firm initiated recall is ongoing.
REASON: It is possible to do couch corrections twice if both Couch Move
Assistant in MOSAIQ and Remote Automatic Table in XVI are configured
when in SYNERGISTIQ mode.
PRODUCT:
SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data
Drive Clearwater, FL 33760. SoftID.NET is to be used in a medical or
clinical laboratory setting by knowledgeable, trained, and experienced
professionals. SoftID.NET supports bedside collection of patient
specimens used in diagnostic testing. This product is integrated with
Soft Computer's SoftLab, SoftScape and can also interface with all other
SCC laboratory systems and Hospital Information Systems (HIS). Recall #
Z-0360-2011
MANUFACTURER: SCC Soft Computer, Clearwater, FL, by letter on August 28,
2009. Firm initiated recall is ongoing.
REASON: When using the Cancel functionality, if the collection list
refreshes during the transaction and changes the position of the patient
on the list, the wrong patient order can be cancelled.
PRODUCT
SoftBank Versions 23.1.2.x, 23.2.0.x, and 25.0.0.x with SoftReports.
23.1:BK040048 23.2:BK080020 25.0:BK090017 The SoftBank II application,
using SoftScape user interface, is a decision support software device
that requires knowledgeable user intervention to document steps and
events in a transfusion service. The application provides single and
multiple site facilities the ability to manage their transfusion service
by integrating patient and unit information. SoftBank uses an SCC
proprietary interface called SoftScape that facilitates access to the
application. Recall # Z-0362-2011
MANUFACTURER: SCC Soft Computer, Clearwater, FL, via the proprietary
communication software entitled "Risk-to-Health Notification Task
Verbiage" dated June 11, 2010. Firm initiated recall is ongoing.
REASON: Functionality issue - For clients generating patient history
reports using Patient>Reports>Batch Reports>History Report option in
SoftBank with SoftReports activated for patient reports, when the report
is generated for more than one patient ALL of the results for the
qualified patients are displayed under each patient's header.
PRODUCT:
SA BASE with SoftLab Version 3.1.4.x. Manufactured 03/2003. Intends to
provide clients with an interface that links all clinical laboratory
departments throughout the enterprise. Recall # Z-0364-2011
MANUFACTURER: SCC Soft Computer, Clearwater, FL, on June 1, 2010. Firm
initiated recall is ongoing.
REASON: Functionality issue: For clients using the instrument to
generate results on the interface menu, two different result records
could be displayed under the same order and sequence numbers. This could
cause incorrect results to be populated to a patient record.
PRODUCT:
SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 -
4.0.3.13, and 4.0.4.0 - 4.0.4.5. Manufacture/Distribution Dates: 4.0.1.0
- 08/06/04, 4.0.1.4 - 10/18/04, 4.0.1.5 - 01/18/04, 4.0.1.6 - 12/15/04,
4.0.1.7 - 01/10/05, 4.0.1.8 - 03/29/05, 4.0.1.9 - 05/06/05, 4.0.1.13 -
01/25/06, 4.0.1.14 - 03/26/07 4.0.1.15 - 05/02/07, 4.0.1.16 - 08/22/08,
4.0.2.0 - 04/08/05, 4.0.2.1 - 08/13/08, 4.0.2.2 - 06/06/05, 4.0.2.3 -
09/19/05, 4.0.2.4 - 09/19/05, 4.0.2.5 - 09/19/05, 4.0.2.7 - 02/13/06,
4.0.2.8 - 12/12/06, 4.0.2.9 - 02/20/08, 04.2.10 - 08/13/08, 4.0.3.2 -
05/17/06, 4.0.3.3 - 09/18/06, 4.0.3.4 - 09/27/06, 4.0.3.5 - 11/29/06,
4.0.3.6 - 06/22/07, 4.0.3.7 - 03/28/07, 4.0.3.8 - 06/22/07, 4.0.3.9 -
08/03/07, 4.0.3.10 - 08/24/07, 4.0.3.11 - 09/24/07, 4.0.3.12 - 03/07/08,
4.0.3.13 - 06/13/08, 4.0.4.2 - 02/22/08, 4.0.4.3 - 05/22/08, 4.0.4.4 -
07/28/08, 4.0.4.5 - 05/04/09. Intends to provide clients with an
interface that links all clinical laboratory departments throughout the
enterprise. Recall # Z-0365-2011
MANUFACTURER: SCC Soft Computer, Clearwater, Fl, via the proprietary
communication software on June 1, 2009. Firm initiated recall is
ongoing.
REASON: Clients using Patient Maintenance to perform Moves of Stays may
send the wrong billing number during an ADT update to SoftWeb, SoftPath
or SoftMedia. The wrong billing number can come from a different patient
in Order Entry. Only Moves of Stays are affected.
PRODUCT:
1) GE LightSpeed VCT Scanner System, models: a) 5212920-300, b)
5212920-310, c) 5311595-10. Composed of a gantry, patient table,
operator console, computer, and PDU and includes image acquisition
hardware, image acquisition and reconstruction software, associated
accessories and connections/interfaces to accessories. Is intended to
produce cross-sectional images of the body by computer reconstruction of
x-ray transmission data taken at different angles and planes, including
Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.
Recall # Z-0368-2011;
2) GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System,
models a) 2377708-560, b) 5377708-540, c) 5377708-560. Composed of a
gantry, patient table, operator console, computer, and PDU and includes
image acquisition hardware, image acquisition and reconstruction
software, associated accessories and connections/interfaces to
accessories. Is intended to produce cross-sectional images of the body
by computer reconstruction of x-ray transmission data taken at different
angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac,
and Gated acquisitions. Recall # Z-0369-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letters dated September 2, 2010 and September 24, 2010.Manufacturers:
Yokogawa Medical Systems, Ltd., Hino-Shi, Tokyo, Japan;Ge Hangwei
Medical Systems Co., Ltd. Beijing, China;GE Healthcare, LLC,
Waukesha, WI. Firm initiated recall is ongoing.
REASON: GE has become aware of a potential set of circumstances that
could cause x-ray continuation during an unexpected table stop on
certain LightSpeed VCT and BrightSpeed systems.
PRODUCT:
1) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0370-2011;
2) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0371-2011;
3) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0372-2011;
4) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0373-2011;
5) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0374-2011;
6) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0375-2011;
7) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0376-2011;
8) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0377-2011;
9) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0378-2011;
10) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0379-2011;
11) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0380-2011;
12) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0381-2011;
13) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0382-2011;
14) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0383-2011;
15) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0384-2011;
16) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0385-2011;
17) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000,
Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0386-2011;
18) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0387-2011;
19) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0388-2011;
20) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0389-2011;
21) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0390-2011;
22) Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800,
Indicated for use in surgical procedures requiring extracorporeal
support for periods of up to six hours. Recall # Z-0391-2011
MANUFACTURER: Sorin Group USA, Inc., Arvada, CO, letter dated October 7,
2010. Firm initiated recall is ongoing.
REASON: Defective product packaging may compromise product sterility.
PRODUCT:
10 Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare,
Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a
vascular or cardiac table, an X-ray system and a digital detector) The
Innova systems are indicated for use in generating fluoroscopic images
of human anatomy for vascular angiography, diagnostic and interventional
procedures, and optionally, rotational imaging procedures. They are also
indicated for generating fluoroscopic images of human anatomy for
cardiology, diagnostic and interventional procedures. They are intended
to replace fluoroscopic images obtained through image intensifier
technology. Those devices are not intended for mammography applications.
Recall # Z-0392-2011;
2) Innova 2000 The principle system components include a C-arm, image
acquisition, processing and archiving capabilities. The Innova systems
are indicated for use in generating fluoroscopic images of human anatomy
for diagnostic and interventional cardiac angiography procedures. These
system can be operated in a mobile or fixed site environment. Recall #
Z-0393-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated July 9, 2009. Manufacturer: GE Medical Systems, SCSBuc
Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential video splitter
failure with certain Innova 2000 and 4100 X-ray systems that may impact
patient safety. A potential video splitter failure inside the GE
equipment cabinet could occur with no advance warning and thereby
prevent x-ray image display. Should this occur, the system cannot be
recovered without service intervention. GE Healthcare has observed 1
failure out of 30000 exams. To date, no injury has been reported related
to this condition.
PRODUCT:
1) CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile
extension for use with Universal Couchtop. For use to support and aid in
positioning a patient during radiologic and other medical procedures.
Recall # Z-0394-2011;
2) CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension
for use with Universal Couchtop. For use to support and aid in
positioning a patient during radiologic and other medical procedures.
Recall # Z-0395-2011;
3) CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension
for use with the Universal Couchtop. For use to support and aid in
positioning a patient during radiologic and other medical procedures.
Recall # Z-0396-2011
MANUFACTURER: Med Tec Inc., Orange City, IA, by letters dated June 15,
2010 and July 20, and by telephone on July 22, 2010. Firm initiated
recall is ongoing.
REASON: Under certain conditions, the extensions can become detached
from the main body of the couch.
PRODUCT:
SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma
Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model
number 4535 602 20381. Intended to produce images depicting the
anatomical distributions of single photon and positron emitting
radioisotopes within the human body for interpretation by medical
personnel. Recall # Z-0398-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems, San Jose, CA, by
letter dated November 3, 2010.Manufacturer: Philips Medical Systems
(Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.
REASON: Detector arm assembly may slide to hardware limit, potentially
causing impact.
PRODUCT:
1) i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor
moderate and high-level heparin therapy through analysis of arterial and
venous whole blood samples. List numbers: 07G01-01, 07G01-02,.
600-9006-25. Recall # Z-0399-2011;
2) i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses
fresh whole blood to monitor high-dose heparin anticoagulation
frequently associated with cardiovascular surgery. List numbers:
07G81-01, 07G81-02. Recall # Z-0400-2011
MANUFACTURER: Abbott Point Of Care Inc., Princeton, NJ, by letter dated
September 2010. Firm initiated recall is ongoing.
REASON: Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may
be difficult to fill or will not fill when attempting to transfer blood
to the sample entry port of the cartridge.
PRODUCT
1) Innova 2121-IQ/3131--1Q Biplane Cardiovascular Imaging System. The
Innova Biplane systems are the first and only digital flat panel biplane
systems with a full sized lateral plane to cover lateral anatomy without
requiring multiple contrast injections and radiation exposures. The
Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are
indicated for use in generating fluoroscopic images of human anatomy for
vascular angiography, diagnostic and interventional procedures, and
optionally, rotational angiography procedures. They are also indicated
for generating fluoroscopic images of human anatomy for cardiology,
diagnostic, and interventional procedures. They are intended to replace
fluoroscopic images obtained through image intensifier technology. These
devices are not intended for mammography applications. Recall #
Z-0407-2011;
2) Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an
a monoplane positioner, a vascular or cardiac table, an X-ray system and
a digital detector) The Innova systems are indicated for use in
generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. They are also indicated for generating
fluoroscopic images of human anatomy for cardiology, diagnostic and
interventional procedures. They are intended to replace fluoroscopic
images obtained through image intensifier technology. Those devices are
not intended for mammography applications. Recall #: Z-0408-2011;
3) Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging
System. (The system consists of an a monoplane positioner, a vascular or
cardiac table, an X-ray system and a digital detector) The Innova
systems are indicated for use in generating fluoroscopic images of human
anatomy for vascular angiography, diagnostic and interventional
procedures, and optionally, rotational imaging procedures. They are also
indicated for generating fluoroscopic images of human anatomy for
cardiology, diagnostic and interventional procedures. They are intended
to replace fluoroscopic images obtained through image intensifier
technology. Those devices are not intended for mammography applications.
Recall # Z-0409-2011;
4) Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. ( The system consists of
an a monoplane positioner, a vascular or cardiac table, an X-ray system
and a digital detector). The Innova systems are indicated for use in
generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. They are also indicated for generating
fluoroscopic images of human anatomy for cardiology, diagnostic and
interventional procedures. They are intended to replace fluoroscopic
images obtained through image intensifier technology. Those devices are
not intended for mammography applications. Recall # Z-0410-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated August 4, 2009.Manufacturer: GE Medical Systems, SCS, Buc
Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential issue regarding
Innova systems with GE Fluoro UPS 20KVA that may impact patient safety.
GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain
fluoroscopy availability for approximately 5 minutes should there be a
main power failure. Once power is restored, the equipment power will be
returned to the main hospital power. UPS fluoro battery degradation
could occur due to long storage conditions impacting the life expectancy
of sealed cell batteries. The fluoro UPS could be potentially
unavailable if it is not periodically maintained as prescribed in the
service documentation and Operator Manual delivered with the Innova
system.
PRODUCT:
Smith & Nephew TRIGEN SURESHOT Distal Targeting System, Trauma
Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an
intraoperative image-guided localization system. It is a
computer-assisted orthopedic surgery tool to aid the surgeon with drill
positioning for screws during intramedullary nail implantation. Recall #
Z-0411-2011
MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter dated October
4, 2010. Firm initiated recall is ongoing.
REASON
Targeting software has been found to provide erroneous targeting when
used with the 13 mm TAN/FAN Left nails.
PRODUCT
Philips EasyVision MM workstation with software R10.2 and R11.1 The
EasyVision MM Workstation is intended for the manipulation and display
of medical images, including mammograms. It can show images from
different modalities and interfaces to various image storage and
printing devices using DICOM or similar interface standards. Device
options enable mammography reading, teleradiology, fast demonstration,
3D, etc. Device accessories enable orthopedic pre-operative planning;
angiography/cardiology imaging capabilities; and bone densitometry
capabilities. Typical users are trained professionals such as
physicians, radiologists, nurses, medical technicians and assistants.
Recall # Z-0412-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letter dated January 30, 2009. Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is complete.
REASON: Review by firm of Philips EasyVision MM workstations found that
to assure compliance with 21 CFR 900.12(c)(5) corrected software was
needed so that all sites are in compliance.
PRODUCT
LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS
PRT II KIT (0-10CC) US), B-2106 (ACCESS PRT II KIT (0-14CC) US), B-2210
(LP-BND SYS, 9.75, STER, US), B-2215 (LAP-BAND 9.75 W/ACC PRT II US),
B-2220 (LP-BND SYS, 10.0, STER, US), B-2225 (LAP-BND 10.0,ACCESS PORT
II,US), B-2255 (LAP-BAND VG W/ACS PORT II (US), B-2260 (LP-BND AP
STANDARD SYS, W ACC PRT II), B-2265 (LP-BND AP LG SYS, W/ACC PRT II);
The Lap-Band System is a long-term implantable device intended to induce
weight loss in morbidly obese patients by limiting food consumption
restrictive and satiating, rather than malabsorptive). The device is
surgically implanted, using either a laparoscopic or open procedure, to
create a restricted opening (stoma) and a small gastric pouch to limit
food consumption and induce early satiety. The main components of the
device are the silicone elastomer band, access port. and kink-resistant
tubing used to connect the other two components. The inner surface of
the silicone band, which is placed around the stomach, is inflatable and
connected by the tubing to the access port (a remote injection site. The
access port is implanted on, or attached to, the rectus muscle to permit
non-surgical, percutaneous adjustments to the band and thus, the stoma
diameter, using sterile saline. Recall # Z-0418-2011
MANUFACTURER: Recalling Firm: Allergan, Goleta, CA, by letter dated
September 15, 2010.Manufacturer: Allergan Costa Rica, S.A., La Aurora De
He, Costa Rica. Firm initiated recall is ongoing.
REASON: The recall was initiated after Allergan received reports which
have been attributed to damage to the port caused by insertion of the
needle into the septum of the port at an oblique angle. Allergan issued
the notice to emphasize that when performing a LAP-BAND System
adjustment, failure to inject the needle perpendicular to the access
port septum, as described in Directions for Use, may lead to port damage
which may result in subsequent port leakage. Port leakage results in
deflation of the LAP-BAND System to its widest, open position and the
need for a procedure to replace the port. This is most often diagnosed
through discussions between the patient and clinician, based on symptoms
of reduced satiety and increased appetite. Stalling of weight loss or
even weight gain may also be seen.
PRODUCT
1) Smith & Nephew Fast Fix 360, Straight Needle, Catalog Number;
72202467. Intended for use as a suture retention device to facilitate
percutaneous or endoscopic soft tissue procedures such as shoulder
stabilization (Bankart Repair), rotator cuff repair, meniscal repair,
and gastrostomy. Recall # Z-0419-2011;
2) Smith & Nephew Fast Fix 360, Curved Needle Catalog Number; 72202468.
Intended for use as a suture retention device to facilitate percutaneous
or endoscopic soft tissue procedures such as shoulder stabilization
(Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.
Recall # Z-0420-2011;
3) Smith & Nephew Fast Fix 360, Reverse Curved Needle, Catalog Number;
72202469. Intended for use as a suture retention device to facilitate
percutaneous or endoscopic soft tissue procedures such as shoulder
stabilization (Bankart Repair), rotator cuff repair, meniscal repair,
and gastrostomy. Recall # Z-0421-2011
MANUFACTURER: Recalling Firm: Smith & Nephew, Inc. Endoscopy Division,
Andover, MA, by letter on October 14, 2010.Manufacturer: Smith & Nephew,
Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is
ongoing.
REASON: FasT-Fix 360 Needle Delivery System may not allow the T-2
(anchor) to advance for implantation.
PRODUCT:
1) BARD? Ventrio? Small Oval Hernia Patch 3.1" x 4.7" Product Code:
0010211 Indicated for use in the reconstruction of soft tissue
deficiencies such as for the repair of hernias. Recall # Z-0422-2011;
2) BARD? Ventrio? Large Oval Hernia Patch 5.4" x 7.0" Product Code:
0010212 Indicated for use in the reconstruction of soft tissue
deficiencies such as for the repair of hernias. Recall # Z-0423-2011;
3) BARD? Ventrio? Small Circle Hernia Patch 3.0" Product Code: 0010213
Indicated for use in the reconstruction of soft tissue deficiencies such
as for the repair of hernias. Recall # Z-0424-2011
MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc.,
Warwick, RI, by letter on October 15, 2010. Manufacturer: Bard Shannon
Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON: Mislabeled: Hernia Patch may be a different size than on the
product label.
PRODUCT:
1) Signa OpenSpeed, 0.7T MR Systems (HFO3-5). Recall # Z-0425-2011;
2) Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a
diagnostic imaging device to produce transverse, sagittal, coronal and
oblique images of the musculoskeletal, vascular, cardiac, and neuro
systems. Recall # Z-0426-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated August 20, 2010.Manufacturer: Yokogawa Medical Systems,
Ltd., Hino-Shi, Tokyo, Japan. Firm initiated recall is ongoing.
REASON: If the lateral table adjustment crank handle breaks off, it has
sufficient attractive force to the magnet and may result in patient
injury
PRODUCT
diaDexus PLAC Test ELISA Kit; Model Part Number: 90123 The diaDexusPLAC
Test ELISA Kit is an enzyme Immunoassay for the quantitative
determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in
human plasma and serum, to be used in conjunction with clinical
evaluation and patient risk assessment as an aid in predicting risk for
coronary hear disease, and ischemic stroke associated with
atherosclerosis. Product Code NOE. Recall # Z-0429-2011
MANUFACTURER: DiaDexus, Inc., South San Francisco, CA, by telephone
beginning on March 15, 2010. Firm initiated recall is ongoing.
REASON: Real Time Stability Test program showed the kit lot failed
stability prior to expiration, affecting samples with results> 500
ng/ml. Results up to 500 ng/ml exhibit passing stability results and are
not impacted by this issue
PRODUCT:
Sex Hormone Binding Globulin (SHBG) Reagent for use on Access
Immunoassay Systems, Part number(s): A48617 The Access SHBG assay is a
paramagnetic particle, chemiluminescent immunoassay for the quantitative
determination of Sex Hormone Binding Globulin levels in human serum and
plasma using the Access Immunoassay Systems. Recall # Z-0431-2011
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
dated July 30, 2010.Manufacturer: Beckman Coulter, Inc., Chaska, MN.
Firm initiated recall is ongoing.
REASON: The recall was initiated because the Instruction for Use (IFU)
for Access SHBG does not specify the units of measure to be used when
calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values
and Access Testosterone (ng/mL) values are reported in different default
units. The testosterone value (when reported in ng/mL) requires
conversion to nmol/L before the FAI % can be calculated. Use of
different units of measure for SHBG and Testosterone when calculating
FAI % will result in an incorrect FAI %.
PRODUCT:
1) The Ascension PyroHemiSphere (aka NuGrip), Model #30-L NUG-443-30L,
Catalog #NUG-443-30L, is a single-use uncemented, one-component
prosthesis for the basal thumb joint. The NuGrip is intended to replace
the proximal end of the first metacarpal. Recall # Z-0437-2011;
2) The Ascension PyroHemiSphere (aka NuGrip), Model #40-M NUG-443-40M,
Catalog #NUG-443-40M, is a single-use uncemented, one-component
prosthesis for the basal thumb joint. The NuGrip is intended to replace
the proximal end of the first metacarpal. Recall # Z-0438-2011
MANUFACTURER: Ascension Orthopedics, Inc., Austin, TX, by telephone on
June 25, 2010 and letter dated July 22, 2010. Firm initiated recall is
ongoing.
REASON: Two different product lots were found to be incorrectly labeled
and placed into the incorrect box.
PRODUCT:
1) Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set,
Catalog Number 12-712. Assayed quality control material for use with the
Cholestech LDX System. Recall # Z-0439-2011;
2) Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set,
Catalog Number 12-713. Assayed quality control material for use with the
Cholestech LDX System. Recall # Z-0440-2011;
3) Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog
Number 10-982. Assayed quality control material for use with the
Cholestech LDX System. Recall # Z-0441-2011;
4) Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog
Number 10-983. Assayed quality control material for use with the
Cholestech LDX System. Recall # Z-0442-2011;
5) Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number
11-255. To be used for verifying the reportable range of tests on the
Cholestech LDX System. Z-0443-2011
MANUFACTURER: Biosite Inc., Dba Innovacon Inc., San Diego, CA, by
letter, fax, email or direct mail beginning on October 6, 2010. Firm
initiated recall is ongoing.
REASON: The recall was initiated because results were being reported as
being out of range. Firm is reassigning ranges for HDL cholesterol in
product.
PRODUCT
BARD? Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700
Intended use: Bard Pre-shaped mesh is a pre-shaped mesh constructed of
knitted polypropylene monofilaments. It is indicated for the repair of
inguinal hernia defects. Recall # Z-0446-2011
MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc.,
Warwick, RI, by letter on October 15, 2010.Manufacturer: Bard Shannon
Limited, Humacao, PR. Firm initiated recall is ongoing.
REASON: Mislabeled: The labeled BARD? Mesh Pre-shaped product code
0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD? Mesh
Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
PRODUCT:
Medtronic Navigation O-Arm Imaging System, Door Assembly (BI-700-00006)
used in Product Catalog Numbers: 9732719,9733346,81-700-00027,
81-700-00027R, 81700- 00027-100, 81-700-00027-1 OOR, 81-700-00027-120,
81-700-00027-120R, 81700-00027-230, 81-700-00027-230R, 81-700-00027GER,
81-700-00027GERR Intended use: Designed for 2D fluoroscopic and 3D
imaging and is intended to be used by a physician benefits from 2D and
3D information of anatomic structures with high x-ray attenuation such
as bony and metallic objects. Recall # Z-0447-2011
MANUFACTURER: Medtronic Navigation, Inc., Littleton, MA, by letter dated
October 15, 2010. Firm initiated recall is ongoing.
REASON: Safety Notice: Door Cable Periodic Maintenance Schedule and
Cable Wear for the O-ARM® Imaging System Breakage of the door cable
during opening and closing may occur and cause physical harm or delay of
therapy.
PRODUCT:
Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use:
The Access Estradiol assay is a paramagnetic particle, chemiluminescent
immunoassay for the quantitative determination of Estradiol levels in
human serum and plasma using the Access Immunoassay systems. Recall #
Z-0448-2011
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
dated March 17, 2010.Manufacturer: Beckman Coulter, Inc., Chaska, MN.
Firm initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter confirmed that
three lots of Access Estradiol reagent (REF 33540) contains an incorrect
raw material which may produce incorrect patient results.
PRODUCT
Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in
combination with the Flat Panel, Part No. 8139789. To deliver x-ray
radiation for therapeutic treatment of cancer. Recall # Z-0449-2011
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter, fax, telephone on January 27, 2010. Firm initiated recall is
ongoing.
REASON: The robotic lift armature shaft may break and allow the Flat
Panel Positioner with the digital flat panel imager to fall into the
Flat Panel cradle. If the positioner is over a patient, there is a
potential for injury.
PRODUCT:
1) DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non
Pyrogenic; Rx only; DuraGen XS is indicated as a dural substitute for
repair of dura matter. Catalog number DXM1022. Recall # Z-0450-2011;
2) DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non
Pyrogenic; Rx only; DuraGen XS is indicated as a dural substitute
for repair of dura matter. Catalog number DXM1033. Recall #
Z-0451-2011;
3) DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non
Pyrogenic; Rx only; DuraGen XS is indicated as a dural substitute for
repair of dura matter. Catalog number DXM1045. Recall # Z-0452-2011;
4) DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non
Pyrogenic; Rx only; DuraGen XS is indicated as a dural substitute for
repair of dura matter. Catalog number DXM1057. Recall # Z-0453-2011;
5) DuraGen XS Dural Regeneration Matrix: 1 inch x 3 inches. Non
Pyrogenic; Rx only; DuraGen XS is indicated as a dural substitute for
repair of dura matter. Catalog number DXM1013, Recall # Z-0454-2011
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp.,
Plainsboro, NJ, by telephone, e-mail and letters dated September 29,
2010 and by letters and e-mail on October 1, 2010.Manufacturers Integra
LifeSciences Corp., Plainsboro, NJ;Integra Neurosciences PR, Inc.,
Anasco, PR. Firm initiated recall is ongoing.
REASON: Test results no longer support a 3 year shelf life.
PRODUCT:
1) The Dimension FT4L Flex reagent cartridge (Free Thyroxin). Recall #
Z-0458-2011;
2) The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating
Hormone). Recall # Z-0459-2011;
3) The Dimension TNI Flex reagent cartridge (Cardiac Troponin). Recall #
Z-0460-2011;
4) The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro-
Brain Natriuretic Peptide and N-Terminal Pro brain Natriuretic Peptide
(low volume). Recall # Z-0461-2011
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated April 2010. Firm initiated recall is ongoing.
REASON: Some LOCI cartridges have sub-optimal seal of the lidstock that
can cause rupture of the package at high elevations, causing the
cartridge to leak. Use of leaking cartridges may result in inaccurate
test results.
PRODUCT:
Signa? Excite" 1.5 T Magnetic Resonance Systems. Recall # Z-0462-2011
MANUFACTURER: GE Medical Systems LLC, Waukesha, WI, by letter dated
April 21, 2009. Firm initiated recall is ongoing.
REASON: Signa? MR Excite" 1.5T system containing 11.1_M4_0818.a
software, associated with 2D Fast Spin Echo based pulse sequences (2D
FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may
experience an image flip along the phase encode direction and incorrect
annotation, which may result in incorrect localization of anatomy in
oblique axial images with the pulse sequences.
PRODUCT
1) CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge. Recall #
Z-0466-2011;
2) CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge. Recall #
Z-0467-2011;
3) CSS-059-40-4 Modified 4.0mm Modified Depth Gauge. Recall #
Z-0468-2011
MANUFACTURER: Recalling Firm: Orthohelix Surgical Designs Inc., Medina,
OH, by letter dated October 15, 2010. Manufacturer: Troy Innovative
Instruments, Inc., Middlefield, OH. Firm initiated recall is ongoing.
REASON: The print for modified CSS depth gauges has inaccurate
definition of the etched screw length. The error results in a length
reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases
of the 5.5 and 4.0) than the actual length of the buried guide wire
segment and even longer (10 mm in the case of the 7.0 and 8mm in the
cases of the 5.5 and 4.0) than the design intention readings. This error
applies to all screw length applicable to these depth gauges. Use of the
affected device may result in soft tissue, vascular, or nerve damage, or
encroachment of an articular surface.
PRODUCT
The product's marketing brochure states: "1.5T coils and
accessories...Philips Achieva and Intera 1.5T MR systems". The
Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on
the driver box. The 12nc of the affected system is labeled as
4522-131-6656x. Recall # Z-0469-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letters dated May 1, 2009 and October 14,
2009 Manufacturer: Philips Medical Systems Nederlands, Best,
Netherlands. Firm initiated recall is ongoing.
REASON: Combined use of the Synergy Flex-M / Shoulder Coil 1.5T
increases the chance of RF interaction and heating up of the coil. This
may result in possible burns of the patient.
PRODUCT:
1) HeartStart FR2+ automated external defibrillator (AED) Model M3860:
Philips brand; configurable ECG on screen; configurable manual charge in
advance mode. Recall # Z-0470-2011;
2) HeartStart FR2+ automated external defibrillator (AED) model: M3840:
LAERDAL brand; configurable ECG on screen; configurable manual charge in
advance mode. Recall # Z-0471-2011;
3) HeartStart FR2+ automated external defibrillator (AED) model: M3861:
PHILIPS brand; text prompts only on screen (NO ECG); no configurable
manual charge. Recall # Z-0472-2011;
4) HeartStart FR2+ automated external defibrillator (AED) model: M3841:
LAERDAL brand; text prompts only on screen (NO ECG); no configurable
manual charge. Recall # Z-0473-2011
MANUFACTURER: Philips Medical Systems, Seattle, WA, by letter dated May
28, 2010. Firm initiated recall is ongoing.
REASON: Failure of the voltage detector, U8 may cause the AED battery to
drain more rapidly than normal or make the AED unusable.
PRODUCT:
1) Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting,
tripolar, screw-in, ventricular lead with RV defibrillation coil
electrode. Contents Sterile. Recall # Z-0474-2011;
2) Medtronic Sprint Quattro Secure, model 6947. Steroid eluting,
quadripolar, screw-in, ventricular lead with Right Ventricular (RV) and
superior vena cava (SVC) defibrillation coil electrodes. Contents
Sterile. Recall # Z-0475-2011
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease
Management, Saint Paul, MN, by letter, dated October 2010.Manufacturer:
Medtronic Puerto Rico Operations Co., Villalba, PR. Firm initiated
recall is ongoing.
REASON: Over-retraction of the helix during initial implant or
subsequent repositioning may result in the inability to extend the
helix. This does not impact acute or chronic performance of successfully
implanted leads.
PRODUCT
1) GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1. Recall
# Z-0476-2011;
2) GE Healthcare IDI Mammo Workstation. Recall # Z-0477-2011
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letters dated August 28, 2009 and August 31, 2009.Manufacturers: GE
Medical Systems, SCS, Buc Cedex, FranceImage Diagnost International
GMBH, Munich, Germany. Firm initiated recall is ongoing.
REASON: The measurement values provided by the GE Workstation may be
incorrect when applied to magnification images acquired on non-GE
digital mammography systems. If not noticed by the caregiver, this could
lead to an overestimate of the size of the breast lesion that may impact
patient treatment and safety. The measurement values for GE images are
not affected.
PRODUCT
"Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS". Recall
# Z-0479-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letters dated January 27, 2009.Manufacturer:
Philips Medical Systems Gmbh, DMC, Hamburg. Germany. Firm initiated
recall is ongoing.
REASON: Patient and image data can be exchanged when a patient is
selected in the patient list and the examination tab is pressed with
background query running at the same time. There is a risk that the data
may then be linked to the incorrect patient, which may adversely affect
diagnosis and treatment.
PRODUCT:
GasPak" EZ Large Incubation Container, a component of the GasPak" EZ Gas
Generating Container System, catalog # 260672. Recall # Z-0480-2011
MANUFACTURER: Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD,
on Manufacturer: Thermo Fisher Scientific – Monterrey, Apodaca, Mexico.
Firm initiated recall is complete.
REASON: In vitro diagnostic reagent containers may be defective and
could cause incorrect test results in patient samples.
PRODUCT:
CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000
Hematology Analyzers; CELL-DYN Sapphire Vent Head Assembly, List Number:
08H53-02, CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01,
CELL-DYN 4000 Vent Needle, List Number: 02H61-01, CELL-DYN 4000
Accessory Kit, List Number: 01H20-01, CELL-DYN 4000 Vent Needle Upgrade
Kit, List Number: 9130576, CELL-DYN 4000 Vent Head Assembly, List
Number: 8921187101, CELL-DYN 4000 Sample Processor Assembly, List
Number: 8921198201. Recall # Z-0489-2011
MANUFACTURER: Recalling Firm: Abbott Diagnostics Division, Santa Clara,
CA, by letter dated July 23, 2010.Manufacturer: Abbott Laboratories,
Santa Clara, CA. Firm initiated recall is ongoing.
REASON: The Vent Needle, which is built into the Vent Head Assembly on
the CELL-DYN Sapphire Instrument and which is used directly on the
CELL-DYN 4000 Instrument, may be defective, which may result in an
undetected short sample, generating incorrect low results, or which may
bend, preventing aspiration of the sample.
PRODUCT:
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for
the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number:
KT007. Recall # Z-0490-2011
MANUFACTURER: Recalling Firm: AdvanDx, Inc., Woburn, MA, by letter dated
October 6, 2010.Manufacturer: Oxoid Ely Ltd, United Kingdom. Firm
initiated recall is ongoing.
REASON: Strains of Acinetobacter radioresistens cross-react with both
E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce
a false positive red signal.
PRODUCT:
AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for
identification of E. coli and/or K. pneumoniae and P. aeruginosa
bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa
PNA FISH is a multicolor, qualitative nucleic acid hybridization assay
intended for identification of Escherichia coli and/or Klebsiella
pneumoniae and Pseudomonas aeruginosa on smears made from positive blood
cultures containing Gram-negative rods. Recall # Z-0491-2011
MANUFACTURER: AdvanDx, Inc., Woburn, MA, by letter dated October 6, 2010
and e-mail on October 8, 2010. Firm initiated recall is ongoing.
REASON: Strains of Acinetobacter radioresistens cross-react with both E.
coli/P. aeruginosa PNA FISH and EK /P. aeruginosa PNA FISH to produce a
false positive red signal.
PRODUCT
1) Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch,
Item # 00-1179-021-00. Intended to temporarily reduce pelvic fractures
for fixation during reconstructive surgery. Recall # Z-0493-2011;
2) Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch,
Item # 00-1179-022-00. Intended to temporarily reduce pelvic fractures
for fixation during reconstructive surgery. Recall # Z-0494-2011;
3) Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch,
Item # 00-1179-023-00. Intended to temporarily reduce pelvic fractures
for fixation during reconstructive surgery. Recall # Z-0495-2011;
4) Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm
Screw Tine, Item # 00-1179-024-00. Intended to temporarily reduce pelvic
fractures for fixation during reconstructive surgery. Recall #
Z-0496-2011;
5) Zimmer Reconstruction System Tenaculum Standard 9 inch, Item #
00-1179-025-00. Intended to temporarily reduce pelvic fractures for
fixation during reconstructive surgery. Recall # Z-0497-2011;
6) Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item #
00-1179-026-00. Intended to temporarily reduce pelvic fractures for
fixation during reconstructive surgery. Recall # Z-0498-2011;
7) Zimmer Reconstruction System Offset Clamp Tips Inline, Item #
00-1179-028-01. Intended to temporarily reduce pelvic fractures for
fixation during reconstructive surgery. Recall # Z-0499-2011;
8) Zimmer Reconstruction System Offset Clamp Tips 3.5 cm Offset, Item #
00-1179-028-02. Intended to temporarily reduce pelvic fractures for
fixation during reconstructive surgery. Recall # Z-0500-2011;
9) Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item #
00-1179-028-03. Intended to temporarily reduce pelvic fractures for
fixation during reconstructive surgery. Recall # Z-0501-2011
MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated February 16,
2010. Firm initiated recall is ongoing.
REASON: The firm determined that the recalled instruments were
manufactured using the wrong grade of material. As manufactured, the
instruments are more brittle, increasing the potential for fracture.
PRODUCT:
1) VacLok Syringe, 10ml, REF: VAC110, Sterile EO, Single Use. Recall #
Z-0503-2011;
2) VacLok Syringe, 20ml, REF: VAC120E, Sterile EO, Single Use. Recall #
Z-0504-2011;
3) Merit MEDALLION Syringe, 10ml, REF: MSSW11-R, Sterile EO, Single Use.
Recall # Z-0505-2011;
4) Merit MEDALLION Syringe, 10ml, REF: MSSW11-Y, Sterile EO, Single Use.
Recall # Z-0506-2011
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by
telephone, letter and/or fax on October 22, 2010. Firm initiated recall
is ongoing.
REASON: Packaging for syringes may have holes which would compromise the
sterility of the package contents.
PRODUCT:
1) Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog
Number: 96AN. Recall # Z-0539-2011;
2) Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog
Number: 576AN. Recall # Z-0540-2011
MANUFACTURER: Bio-Rad Laboratories Inc., Hercules, CA, by letter dated
March 1, 2010. Firm initiated recall is ongoing.
REASON: The ANA Screening kit generates a high percentage of false
positive results, associated with a low check control reading.
PRODUCT
A-dec Decade Plus 1221 Dental Chair This chair is used for positioning
dental patient prior to and during dental treatment. Recall #
Z-0541-2011
MANUFACTURER: A-Dec Inc., Newberg, OR, by letter dated March 23, 2009.
Firm initiated recall is ongoing.
REASON: The design of the Decade Plus 1221 chair backrest creates a
possible pinch-point between the chair backrest and the underside of the
armrests.
PRODUCT
1) Edwards Protection Cannulae - Monitoring and Infusion Set, Model
ISP3147, Sterile EO. Recall # Z-0542-2011;
2) Edwards Protection Cannulae - Monitoring and Infusion Set, Model
MIS004, Sterile EO. Recall # Z-0543-2011
MANUFACTURER: Edwards LifeSciences LLC, Draper, UT, by letter dated
October 13, 2010. Firm initiated recall is ongoing.
REASON: Monitoring and Infusion Set connectors may break during
manipulation.
PRODUCT:
1) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H.
Recall # Z-0552-2011;
2) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872P, Revision H.
Recall # Z-0553-2011;
3) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B.
Recall # Z-0554-2011;
4) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A.
Recall # Z-0555-2011;
5) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B.
Z-0556-2011;
6) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815. Recall #
Z-0557-2011;
7) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573. Recall #
Z-0558-2011;
8) Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A.
Recall # Z-0559-2011
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter
dated October 25, 2010. Firm initiated recall is ongoing.
REASON: Defective custom kits may draw in air during use which may
compromise patient safety and affect treatment. The valve's fixed luer
may be over- or under-tightened, causing leaking at the bond joint.
PRODUCT:
1) Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine
console, 115V, Catalog No 16402. The system 8000 is indicated for use in
extracorporeal circulation of blood for arterial perfusion, reginal
perfusion and cardiopulmonary bypass procedures. Recall # Z-0562-2011;
2)) Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine
console, 220V, Catalog No 16407, (not distributed in the US). The system
8000 is indicated for use in extracorporeal circulation of blood for
arterial perfusion, reginal perfusion and cardiopulmonary bypass
procedures. Recall # Z-0563-2011
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
letter dated November 2, 2010. Firm initiated recall is ongoing
REASON: The system 8000 roller pumps may fail resulting in a persistent
pump stop.
PRODUCT:
1) Baxter Three-Way Large Bore Stopcock with Rotating Male Luer Lock
Adapter; a sterile, nonpyrogenic fluid pathway; product code 2C6201.
Intended use: For the administration of drugs and solutions to a
patient's vascular system through a vascular access device. The stopcock
was sold alone and as a component of the following I.V. Administration
Sets: a) product code 1C8471, Baxter Interlink System Large Bore 3-Way
Stopcock with Rotating Male Luer Lock Extension Set, 44", Vol. 5.9 mL;
b) product code 2N5600, Baxter Interlink System Large Bore 3-Way
Stopcock with Rotating Male Luer Lock, Vol. 0.7 mL; c) product code
3C0114, Baxter Interlink System Continu-Flo Solution Set, 66", 2-Port
Manifold with Check Valves, and Large Bore 3-Way Stopcock with Rotating
Male Luer Lock Extension Set, 40", Vol. 5.6 mL; d) product code 3C0180,
Baxter Clearlink System Non-DEHP Continu-Flo Solution Set, 108", Large
Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set, 30",
Vol. 3.9 mL, and Extension Set, 7", 0.9 mL; e) product code 3C0021,
Baxter Interlink System Continu-Flo Solution Set, 65" with Large Bore
3-Way Stopcock with Rotating Male Luer Lock Extension Set, 61", Vol. 9.1
mL; f) product code 3C0174, Baxter Interlink System Buretrol Solution
Set, 58", Large Bore 3-Way Stopcock with Rotating Male Luer Lock
Extension Set, 43", Vol. 6.1 mL, and Minivolume Extension Set, 6", 0.6
mL; g) product code 3C0098, Baxter Interlink System Solution Set, 30",
Extension Set, 44", Large Bore 3-Way Stopcock with Rotating Male Luer
Lock Extension Set, 29", Vol. 3.9 mL, 3-Port Manifold with Check Valves
and Extension Set, 7"; h) product code 3C0090, Baxter Interlink System
Continu-Flo Solution Set, 107" with Large Bore 3-Way Stopcock with
Rotating Male Luer Lock Extension Set, 38", Vol. 5.8 mL; i) product code
3C0175, Baxter Interlink System Buretrol Solution Set, 56", Two Large
Bore 3-Way Stopcocks with Rotating Male Luer Lock Minivolume Extension
Set, 53", 1.5 mL. Recall # Z-0586-2011;
2) Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile,
nonpyrogenic fluid pathway; product code 2C6202. Intended use: For the
administration of drugs and solutions to a patient's vascular system
through a vascular access device. Recall # Z-0587-2011
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
by letters dated October 28, 2010.Manufacturer: Baxter Healthcare
Corporation of Puerto Rico S.A., Aibonito, PR. Firm initiated recall is
ongoing.
REASON: Rotating the handle on the 3-Way Large Bore Stopcock past the
stop can cause the stopcock to leak. A leak can lead to under-infusion
or interruption of critical life-sustaining therapy.
CLASS III
PRODUCT:
1) LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 20 strips
Catalog Number: 1102-20 Intended to be placed on the patient's skin to
assist during imaging procedures by serving as an internal frame of
reference. Recall # Z-0433-2011;
2) LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips
Catalog Number: 1102-00 Intended to be placed on the patient's skin to
assist during imaging procedures by serving as an internal frame of
reference. Recall # Z-0434-2011;
3) LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 30cm Tape, 100
strips Catalog Number: 1100-00 Intended to be placed on the patient's
skin to assist during imaging procedures by serving as an internal frame
of reference. Recall # Z-0435-2011;
4) LeMaitre VascuTape Radiopaque Tape, Glow 'N Tell 55cm Tape 20 strips
Catalog Number: 1108-20 Intended to be placed on the patient's skin to
assist during imaging procedures by serving as an internal frame of
reference. Recall # Z-0436-2011
MANUFACTURER: Lemaitre Vascular, Inc., Burlington, MA, by letter
on October 22, 2010. Firm initiated recall is ongoing.
REASON: Box label (Top Part). Lot and Expiration Date information were
switched.
PRODUCT:
3M ESPE Stainless Steel Primary Molar Crowns, Made in USA. Unitek"
Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223
(Refill), 900213 (Refill), 902150 (Kit). Recall # Z-0463-2011
MANUFACTURER: 3M Company / Medical Division, Saint Paul, MN, by letter
dated October 6, 2010. Firm initiated recall is ongoing.
REASON: Unitek Stainless Steel Permanent Crowns with product Codes
902150, 900213, and 900223, is mislabeled. The crown contained within
the package is incorrectly labeled; series UL3 crowns are labeled series
UR3 and vice versa. The lid of the package correctly identified the
product number and lot. This mislabeling could result in placement on
the right side of a crown intended for use on the left, and vice versa.
PRODUCT:
Bard Rectal Tubes, 22 French, 20 Long (51 cm), X-Ray Opaque Rubber with
Funnel end, Open Tip, One Eye , Non sterile, 12 Each. Catalog Number:
8006370. Recall # Z-0465-2011
MANUFACTURER: Recalling Firm: C.R. Bard, Inc., Urological Division,
Covington, GA, letter dated October 28, 2010 Manufacturer: C.R. Bard
Inc. - Glen Falls Technology Center, Queensbury, NY. Firm initiated
recall is ongoing.
REASON: The product is misbranded. The product is labeled as 22 French,
however the product is actually 20 French.
PRODUCT
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5).
The software is used with the SonoSite NanoMaxx ultrasound system. Part
code: P11111-35. Recall # Z-0478-2011
MANUFACTURER: Sonosite, Inc., Bothell, WA, by letters dated August 9,
2010. Firm initiated recall is ongoing.
REASON: Software ARM version 60.80.101.025 (referred to as Nano1.0.5) on
the NanoMaxx ultrasound system results in errors when the "print"
command is selected. As a result, the displayed MI or TI values may be
incorrect.
The following is condensed list of
medical devices involved in recalls listed by the FDA Enforcement Report
as of December 15, 2010.
CLASS I
PRODUCT:
Sigma Spectrum Volumetric Infusion Pump, with or without Master Drug
Library, Part Number 35700 -- Common/Classification Name: Infusion Pump
--Class 2 medical device -- Shipping box label: Infusion Pump SIGMA
Model 35700 (with accessories), ** Serial Number: XXXXXX. To be used in
a healthcare facility in an IV pole mounted configuration or carried by
the user in an ambulatory manner. Recall # Z-0146-2011
MANUFACTURER: Sigma International General Medical Apparatus, LLC,
Medina, NY, by letters dated September 14, 2010. FDA initiated recall is
ongoing.
REASON: The infusion pumps have the potential to fail causing inaccurate
flow conditions during use. These conditions range from back flow to
free flow, which could result in over-infusion.
PRODUCT:
1) B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50
units per bag with 4 bags per shipping box) Intended for use in a
pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a
20 mm drug vial for reconstituting or mixing the drug in the vial with
the solution in the bag. Recall # Z-0305-2011;2) B. Braun addEASE Binary
Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per
shipping box) Intended for use in a pharmacy setting to connect a B.
Braun 250 mL Excel IV solution bag to a 20 mm drug vial for
reconstituting or mixing the drug in the vial with the solution in the
bag. Recall # Z-0306-2011
MANUFACTURER: B. Braun Medical Inc., Irvine, CA, by letter, dated June
28, 2010. Firm initiated recall is ongoing.
REASON: During this insertion, fragmentation of the PAB container
stopper may occur resulting in a small amount of visible particulates in
the solution.
PRODUCT
WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for
delivering infusions of medications, as well as providing total
parenteral nutrition, and patient control analgesia. Recall #
Z-0307-2011
MANUFACTURER: Recalling Firm: WalkMed Infusion LLC, Centennial, CO, by
letter on June 17, 2010, Manufacturer: WalkMed Infusion, LLC,
Englewood, CO. Firm initiated recall is ongoing.
REASON: Pump door may be in a near shut position, but unlatched, and the
"Door Open" alarm may not sound.
CLASS II
PRODUCT:
1) HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand,
configurable manual charge in advance mode. The label of the device
states: "HEARTSTART...FR2+ Automated External Defibrillator. Recall #
Z-0483-2011;2) HeartStart FR2+ AED with Text Display (No ECG), Model
M3861, Philips brand, no configurable manual charge. The label of the
device states: "HEARTSTART...FR2+ Automated External Defibrillator.
Recall # Z-0484-2011;3) HeartStart FR2+ AED with ECG Display, Model
3840, Laerdal brand, configurable manual charge in advance mode. The
label of the device states: "HEARTSTART...FR2+ Automated External
Defibrillator. Recall # Z-0485-2011;4) HeartStart FR2+ AED with Text
Display (No ECG), Model 3841, Laerdal brand, no configurable manual
charge. The label of the device states: "HEARTSTART...FR2+ Automated
External Defibrillator. Recall # Z-0486-2011;5) HeartStart FR2+ AED with
ECG Display, Model 989803148601. This product is G2005 Update according
to the American Heart Association 2005 Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care (ECC). The label of the
device states: "HEARTSTART...FR2+ Automated External Defibrillator.
Recall # Z-0487-2011;6) HeartStart FR2+ AED with Text Display, Model
989803148611. This product is G2005 Update in accordance with the
American Heart Association 2005 Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care (ECC). The label of the
device states: "HEARTSTART...FR2+ Automated External Defibrillator.
Recall # Z-0488-2011
MANUFACTURER: Philips Medical Systems, Seattle, WA, by letters beginning
October 5, 2010. Firm initiated recall is ongoing.
REASON: A flash memory component in the HeartStart FR2+ and Automated
External Defibrillator was improperly relabeled by a third party.
Therefore the component could not be identified by its source, quality,
and date of manufacture.
Please visit our websites at www.mdiconsultants.com for more
information on mdi’s services, staff and items of interest.
The following is condensed list of
medical devices involved in recalls listed by the FDA Enforcement Report
as of December 08, 2010.
CLASS I
PRODUCT:
1) Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq
One-Channel Infuser, List Number Configurations:
16026-04-01/03/04,51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90,
16026-13-25/26, 53/54. Recall # Z-0127-20112) Hospira brand Symbiq
Two-Channel Infuser, List No. 16027 Symbiq Two-Channel Infuser, List
Number Configurations: 16027-04-01/03/04, 51/52, 53/54,
79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90,
16027-13-25/26,53/54. Recall # Z-0128-2011
MANUFACTURER: Hospira Inc., Morgan Hill, CA, by letters dated February
22, 2010 and October 4, 2010. Firm initiated recall is ongoing.
REASON: Motor encoder failures in the Symbiq pumping mechanism that
causes the infuser to cease operation during infusion therapy, resulting
in delay or interruption of infusion therapy.
PRODUCT:
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus
Nuvo Tissue Stabilizer is a disposable tissue stabilization system
consisting of a rigid shaft, detachable tissue stabilizer headlink and a
flexible articulating arm. The device is assembled within the thoracic
cavity. Sterilized using ethylene oxide, non pyrogenic, disposable,
single use only. The product is intended to stabilize and minimize the
motion of selected areas of the beating heart during minimally invasive
cardiac surgery procedures under direct visualization through a
thoracotomy. Recall # Z-0134-2011
MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn
Park, MN, by letter dated September 14, 2010.Manufacturer: Atek Medical
Manufacturing, Grand Rapids, MI. Firm initiated recall is ongoing
REASON: Medtronic has received reports regarding the Octopus Nuvo Tissue
Stabilizer stating that during use, the collet (a component of the
device that stabilizes the head link) fractured, thereby causing
immediate separation of the head link from the shaft of the device. The
resulting potential hazards are that fragments of the collet could fall
into the patient's chest cavity and/or damage the heart tissue.
Medtronic is requesting removal of all unused Octopus Nuvo devices from
the field
CLASS II
PRODUCT:
EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink
Informatics System is classified as a data calculator and processing
module for use with In-vitro diagnostic devices. The EasyLink is
included with the Dimension Vista System (K051087), and may be used with
other Siemens analyzers, as a communications and connectivity
workstation for integration with laboratory information system (LIS)
networks. Part # 1000034805. Recall # Z-0121-2011
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated July 2010. Firm initiated recall is ongoing.
REASON: The EasyLink QCFIRST custom rule does not operate as intended.
PRODUCT:
in2it (I) and (II) System A1c Test cartridges and in2it Self Test System
A1c Test Cartridges, for use with the in2it (I) and (II) self test
system analyzer. The in2it (I) and (II) is an affinity chromatography
method and is intended for the in-vitro quantitative determination of
A1c in capillary blood taken from a finger prick. The test is indicated
for monitoring the time averaged blood Glucose levels of known
diabetics, for professional use as an indicator of overall glycemic
control. The in2it (I) assay is intended for use in a
physicians/doctors' office, the in2it (II) is intended for home use. The
in2it Self Test system in intended for testing blood taken from a
fingerstick. The test system is for self testing and for in-vitro
diagnostic use only (not to be swallowed). The system shows how good
glucose control has been over a two to three month period. The test
system is the same as the test that has been CE marked for use in a
clinical laboratory. The instructions for use have been changed with
suggestions from people with diabetes. A patient study was conducted
where untrained users ran their own blood tests and produced results
which were as accurate as results obtained by trained users. Catalog
numbers 281-0001EX, 281-0001, and 281-0001ST. Recall # Z-0122-2011
MANUFACTURER: Recalling Firm: Bio-Rad Laboratories Inc., Hercules, CA,
by letter, dated July 26, 2010. Manufacturer: Bio Rad Laboratories
Deeside, Flintshire, UK. Firm initiated recall is ongoing.
REASON: Inaccurate results with high bias-- Inaccurate results may be
read by the machine, creating the risk for untreated hypoglycemia at
elevated altitudes.
PRODUCT:
1) Allura Xper FD10 Monoplane X-ray system. Intended for use in
cardiovascular and vascular x-ray imaging applications, including
diagnostic, interventional procedures (such as PTCA and stent placement
and atherectomies), pacemaker implantations and electrophysiology. It is
compatible with specified magnetic navigation systems. Recall #
Z-0124-2011;
2) Allura Xper FD10/10 Biplane X-ray system. Intended for use in
cardiovascular and vascular x-ray imaging applications, including
diagnostic, interventional procedures (such as PTCA and stent placement
and atherectomies), pacemaker implantations and electrophysiology. It is
compatible with specified magnetic navigation systems. Recall #
Z-0125-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letter dated September 15, 2010.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands.
Firm initiated recall is ongoing.
REASON: Potential for table and stand not to move due to a software
error.
PRODUCT:
EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and
7.2.1825.5. Recall # Z-0126-2011
MANUFACTURER: Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter
dated July 23, 2010.Manufacturer: MD Scientific LLC, Charlotte, NC. Firm
initiated recall is ongoing.
REASON: The EndoTool software did not always provide an audible alert
when a blood glucose measurement was due. This could result in a patient
not receiving an appropriate dose of insulin.
PRODUCT:
1) AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code:
93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml). Cleans rinses,
disinfects, and stores all soft contact lenses and helps keep your eyes
protected from dryness and irritation throughout the day. Recall #
Z-0129-20112) AMO Total Care (1) Contact Lens Solution, Formula: 8772x;
Product Code: 90275 (240 ml). Relieves the dryness, irritation, and
discomfort that may be associated with contact lens wear. Recall #
Z-0130-2011
MANUFACTURER: Recalling Firm: Abbott Medical Optics Inc (AMO), Santa
Ana, CA, by letter on July 28, 2010. Manufacturer: Advanced Medical
Optics Manufacturing Spain, S.L., Alcobendas (Madrid), Spain. Firm
initiated recall is ongoing.
REASON: The recall was initiated after AMO determined, through internal
testing, that a limited number of the flip top caps used during
production of these solutions may leak and, although unlikely, the
sterility of the product may be compromised. Products that are
non-sterile have the potential to cause eye infections, which may be
sight threatening.
PRODUCT:
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile.
Part number: 94672. Recall # Z-0131-2011
MANUFACTURER: Ebi, LLC, Parsippany, NJ, by letter dated September 16,
2010. Firm initiated recall is ongoing.
REASON: One of the two connector ends of the medium cross connector may
not be fully secured to the rod after tightening. This may not be
readily apparent to the operating surgeon, resulting in inadequate
torsional stability.
PRODUCT:
PD Access Vascular Access Device: a) Model 78050 18 Gauge GA Doppler
Guided Bare Needle Assembly, 2 3/4 in Length, 0.038 in guidewire,
Sterile EO, PD Access Vascular Access Device. b) Model 78060 Extended 18
Gauge Doppler Guided Bare Needle Assembly, 3 ½ in Length, 0.038 in
Guidewire, Sterile EO, PD Access Vascular Access Device, c) Model 75010
18 Gauge 2 3/4 in Length, 0.038 in guidewire, Sterile EO, SmartNeedle
Vascular Access Devices. Expiration Dates Between May-2010 and
March-2015. Recall # Z-0132-2011
MANUFACTURER: Escalon Medical Corp., New Berlin, WI, by letter dated May
5, 2010. Firm initiated recall is ongoing.
REASON: The packaging of the vascular access device may potentially
become damaged, compromising the sterility of the product. Use of a
non-sterile product increases risk of patient infection.
PRODUCT:
Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Produce
cross-sectional images of the body by computer reconstruction of x-ray
transmission data taken at different angles and planes. Recall #
Z-0133-2011
MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH,
by letters dated July 29, 2010 and August 23, 2010. Firm initiated
recall is ongoing.
REASON: Philips Healthcare has decided to recall the Computed Tomography
X-Ray System MX 8000 IDT due to the fact that the software upgrade for
the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of
4x4.5 (18mm). If the customer does not verify the increment and
thickness coincide with the newly selected collimation suggested by the
conversion report, there is potential for a 6mm gap to appear in axial
images.
PRODUCT:
1) ACL TOP (Base) PN 000280000 Bench top, fully automated, random access
analyzer designed specifically for in vitro diagnostic clinical use in
the hemostasis laboratory for coagulation and/or fibrinolysis testing in
the assessment of thrombosis and/or hemostasis. The systems provide
results for both direct hemostasis measurements and calculated
parameters. Recall # Z-0135-2011; 2) ACL TOP 500 CTS PN 000280040 Bench
top, fully automated, random access analyzer designed specifically for
in vitro diagnostic clinical use in the hemostasis laboratory for
coagulation and/or fibrinolysis testing in the assessment of thrombosis
and/or hemostasis. The systems provide results for both direct
hemostasis measurements and calculated parameters. Recall #
Z-0136-2011;3) ACL TOP 700 LAS PN 000280030 Bench top, fully automated,
random access analyzer designed specifically for in vitro diagnostic
clinical use in the hemostasis laboratory for coagulation and/or
fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The systems provide results for both direct hemostasis measurements and
calculated parameters. Recall # Z-0137-2011;4) ACL TOP CTS PN 000280020
Bench top, fully automated, random access analyzer designed specifically
for in vitro diagnostic clinical use in the hemostasis laboratory for
coagulation and/or fibrinolysis testing in the assessment of thrombosis
and/or hemostasis. The systems provide results for both direct
hemostasis measurements and calculated parameters. Recall # Z-0138-2011
MANUFACTURER: Instrumentation Laboratory Co., Bedford, MA, by letter on
August 13, 2010. Firm initiated recall is ongoing.
REASON: Software: New data check, "Multiple Threshold Check", was added
to identify and fail abnormal (bimodal) clot curves.
PRODUCT:
Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration
of Na+/K+/Cl- on the Dimension vista System. Recall # Z-0139-2011
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated August 2010. Firm initiated recall is complete.
REASON: High potassium content in the affected lots results in the
potential for low potassium recovery for Dilution Check, QC and patient
samples when run on the Dimension Vista System.
PRODUCT:
Detachol adhesive remover, 4 fl oz (118 mL). Recall # Z-0142-2011
MANUFACTURER: Ferndale Laboratories, Inc., Ferndale, MI, by letter
dated July 7, 2010. Firm initiated recall is ongoing.
REASON: There is a defect on the neck surface of the bottles, causing
bottles to leak. Bottle defect may potentially cause contamination of
solvent stored in bottles.
PRODUCT:
The label (which is affixed to ScanPoint Communications Cradle) states:
VERATHON ScanPoint Docking Station...Part No. 0570-0168. Recall #
Z-0143-2011
MANUFACTURER: Verathon, Inc., Bothell, WA, by letter dated September 20,
2010. Firm initiated recall is ongoing.
REASON: Incorrect programming causes QuickPrint to fail to recognize the
communication Cradles. As a result, ScanPoint Communications Cradles
could not communicate with ScanPoint Online Tool while using the
QuickPrint interface. This will affect the transfer of exams and device
calibration through QuickPrint interface.
PRODUCT:
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model
Numbers: 5904433, 5904649, 5904466, 5904441, 5904656, 7728350, and
7007755 Angiographic X-ray System. Recall # Z-0144-2011
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter on September 9, 2011. Manufacturer: Siemens
Medical Solutions Inc., Germany. Firm initiated recall is ongoing.
REASON: Sporadic system crash while Perivision is performed.
PRODUCT:
The Care Cliner chair is a multi position recliner with a steel frame
used primarily in clinics, hospitals and treatment centers for recovery,
dialysis, oncology, examination, infusion. Recalled chairs include the
following: Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care
Cliner, XL Elite Care Cliner. Model Numbers 653N, 654N, 655N, 657N,
690N, 691N, 694N, 695N, 6530, 6540, 6550, 6570, 6900, 6910, 6940, 6950.
Recalled chairs include the following: 2008 Model Numbers: 653N - Care
Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL
Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care
Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual
Swing-Arm Elite Care Cliner. 2009 Model Numbers: 6530 - Care Cliner,
6540 - XL Care Cliner, 6550 - Drop Arm Care Cliner, 6570- XL Drop Arm
Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940
- Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care
Cliner. Recalled model numbers are as follows: 6530-02, 6530-03,
6530-03-TB, 6530-04, 6530-06, 6530-07, 6530-08, 6530-08-TB-00-PB,
6530-14, 6530-15, 6530-15-00-00-00-00-LC, 6530-15-00-00-PB, 6530-16,
6530-17, 6530-17-TB, 6530-25, 65302N, 65302NT, 6530-30, 6530-31,
6530-33, 6530-37-00-00-PB, 6530-39, 6530-39-00-00-PB, 65303N, 65303N,
65304N, 65304NH, 65304NHT, 65304NT, 6530-63, 6530-63-TB, 65306N,
65306NH, 65307N, 65307NT, 65308N, 65308NT, 65314N, 65314NH, 65314NT,
65315N, 65316N, 65317N, 65317NT, 65330N, 65333NT, 65337N, 65341N,
65344N, 65360N, 65361N, 65362N, 65362NT, 65363N, 65363NT, 6540-02,
6540-03, 6540-04, 6540-04-00-HM, 6540-06, 6540-07, 6540-08, 6540-14,
6540-16-TB, 6540-17, 6540-17-TB, 65402N, 65402NT, 6540-30-00-00-PB,
6540-37, 6540-39, 6540-39-00-00-PB, 65403N, 65403NT, 65404N, 65404NH,
65404NHT, 6540-60, 6540-63-TB, 65406N, 65406NH, 65407N, 65408N, 65414N,
65414NT, 65415N, 65416N, 65417N, 65417NT, 65430N, 65437N, 65441N,
65442N, 65461NH, 65462N, 65465N, 6550-02, 6550-03, 6550-03-00-HM,
6550-04, 6550-06, 6550-13, 6550-14, 6550-14-00-00-PB, 6550-14-00-HM,
6550-16, 6550-17, 65502N, 6550-30-00-HM, 6550-34-00-00-PB, 6550-37,
6550-39-00-HM, 65503N, 65503NH, 65504N, 65504NL, 65504NT, 65504NT-DART,
65506N, 65506NH, 65507N, 65507NH, 65508N, 65514N, 65514NH, 65514NL,
65514NW, 65515N, 65516N, 65516NH, 65516NT, 65517N, 65517NCE, 65517NH,
65517NHT, 65525N, 65527N, 65527NH, 65528NH, 65530NH, 65532N, 65532NH,
65533N, 65537N, 65539N, 65539NH, 65541NL, 65544NW, 65561NL, 65562NH,
65562NL, 65567N, 65567NH, 6570-02, 6570-03, 6570-03-00-HM, 6570-07,
6570-14, 6570-14-00-00-PB, 6570-14-00-HM, 6570-17, 6570-17-00-00-PB,
6570-17-00-00-PC, 6570-17-TB, 65702N, 65702NT, 6570-39-00-HM, 65703N,
65703NH, 6570-41, 65704N, 65704NT, 6570-62, 6570-63-TB, 65706N ,
65706NH, 65707N, 65707NH, 65708N, 65708NT, 65714N, 65714NH, 65714NL,
65714NT, 65714NW, 65715N, 65716NH, 65717N, 65717NCE, 65717NH, 65725N,
65727NH, 65728NH, 65730N, 65730NH, 65732N, 65732NH, 65733N, 65737N,
65739N, 65739NH, 65741NH, 65741NL, 65761N, 65762N, 65762NH, 65762NL,
65763NH, 65766N, 65767NH, 6900-02, 6900-03, 6900-04, 6900-17, 69002N ,
6900-30, 6900-39 , 69003N, 69003NH, 6900-41, 69004N, 6900-60, 6900-61,
6900-62, 6900-63, 6900-63-00-HM, 6900-63-TB, 69006N, 69007N, 69008N,
69008NH, 69014N, 69014NT, 69014NW, 69015N, 69016N, 69016NT, 69017N,
69017NH, 69026N, 69027N, 69028N, 69030N, 69030NH, 69031N, 69032N,
69033N, 69034N, 69037N, 69039N, 69041N, 69041NH, 69060N, 69062N, 69063N,
69063NH, 69063NT, 69065NT, 69066N, 69066NT, 69067N, 6910-03, 6910-06,
6910-17, 6910-32, 6910-33-00-HM, 6910-37-00-00-PB, 6910-37-TB, 6910-39,
69103N, 69104N, 6910-60, 6910-61, 6910-62, 6910-63, 69106N, 69107NT,
69114N, 69114NW, 69117N, 69117NH, 69117NT, 69127N, 69133N, 69133NT,
69134N, 69137N, 69162N, 69163N, 69167N, 6940-03, 6940-03-00-HT,
6940-04-TB-HT, 6940-06, 6940-06-TB-HM, 6940-07-TB, 6940-14, 6940-14-TB,
6940-15, 6940-15-00-HM, 6940-16, 6940-16-TB-HM, 6940-17, 6940-17-00-HM,
6940-17-TB-HM, 6940-19-TB-HM, 6940-26-TB, 6940-26-TB-HM, 6940-27-TB-HM,
69402N, 69402NT, 6940-30, 6940-32, 6940-32-TB, 6940-33-TB-HM, 69403N,
69403NH, 69403NT, 69403NW, 6940-41-TB-HM, 69404N, 69404NDH, 69404NH,
69404NHT, 69404NT, 69404NWT, 6940-60-TB-HT, 6940-62, 6940-62-TB,
6940-62-TB-HM, 6940-62-TB-HT, 6940-63-TB, 69406N, 69406NH, 69407N ,
69407NT, 69414N, 69414NH, 69414NT, 69415N, 69415NH, 69415NHT, 69416N,
69416NHT, 69416NT, 69417N, 69417NHT, 69417NT, 69417NW, 69419NHT,
69427NHT, 69429NT, 69430NH, 69432N, 69432NT, 69433N, 69433NH, 69433NHT,
69433NT, 69434N, 69434NHT, 69437NH, 69437NHT, 69441NHT, 69444ND,
69444NDH, 69460N, 69460NHT, 69460NWT, 69461NH, 69462N, 69462NHT,
69462NT, 69463N, 69463NH, 69463NT, 69463NWT, 69466NWT, 69467N, 6950-03,
6950-03-00-HT, 6950-04-00-HM, 6950-04-TB-HT, 6950-06-TB-HM, 6950-15,
6950-16-TB-HM, 6950-19-TB-HM, 6950-19-TB-HT, 6950-26-TB-HM,
6950-27-TB-HM, 69502NH, 6950-33, 6950-33-TB-HM, 6950-39-00-HM, 69503N,
69503N, 69503NH, 69503NT, 6950-41-00-HT, 69504N, 69504NH, 69504NW,
6950-60, 6950-60-TB-HT, 6950-62-00-00-PB, 6950-62-TB-HT, 69506NHT,
69514N, 69514NH, 69514NHT, 69514NT, 69515N, 69515NH, 69516N, 69516NHT,
69516NT, 69517N, 69517NH, 69517NHT, 69517NT, 69519NHT, 69527NHT,
69529NT, 69530NH, 69532N, 69532NT, 69533N, 69533NH, 69533NHT, 69534N,
69541NHT, 69544ND, 69560N, 69560NHT, 69560NWT, 69561N, 69561NH, 69562N,
69562NHT, 69563NH, 69563NWT. Recall # Z-0147-2011
MANUFACTURER: Winco, Inc., Ocala, FL, by letter dated October 1,
2010. Firm initiated recall is ongoing.
REASON: Winco Mfg., is recalling their Care Cliner due to malfunctioning
axles which become lose from the caster assembly.
PRODUCT:
Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen +
ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref
CC1.P1 combined Oxygen & Temperature probe; Contains sterile and
non-pyrogenic if package is unopened and undamaged. Recall # Z-0161-2011
REASON: Incorrect expiration date - The outer boxes of the IP2P Licox
Complete Kit for Cerebral Pressure, Temperature and ICP Monitoring
Probes, Lot 250210A are labeled with an incorrect shelf life date (10
months too long).
PRODUCT:
Leksell Gamma Knife Perfexion with EXTEND Frame System. Model #1009633.
Recall # Z-0163-2011
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter
dated September 17, 2010, Manufacturer: Elekta Instrument AB,
Stockholm, Sweden. Firm initiated recall is ongoing.
REASON: The anterior fixation bar of the EXTEND mouthpiece frontpiece
may separate from the dental impression tray. This may result in reduced
treatment accuracy.
PRODUCT:
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers
435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall #
Z-0168-2011
MANUFACTURER: Volcano Corp., Rancho Cordova, CA, by letter dated June
30, 2010. Firm initiated recall is ongoing.
REASON: Software defect results in improper image brightness, which may
result in introduction of artifacts, which may cause misclassification
of results and affect classification of tissue types. This may result in
misdiagnosis and inappropriate treatment.
PRODUCT:
Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The
product is delivered in a syringe which is packaged in an
aluminum-backed polyethylene pouch and is distributed one (1) pouch per
box. The product affected by this recall was distributed by the
recalling firm under six (6) different names. They are: Form-Putty;
SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product
is indicated for use in filling the gaps or voids of osseous defects
surgically created or resulting from trauma and are intended for
treatment of osseous defects not intrinsic to the stability of the bone
structure. The products are intended for use in defects of the skeletal
system (i. e. the extremities, spine and pelvis). The products are
identified with the following Model Numbers and Trade Names: FormPutty -
Model #50-07-0050 FormPutty - Model #-50-07-0100 SBvFShape - Model
#-725-7010 SBvFShape - Model #-725-7025 SBvFShape - Model #-725-7050
SBvF Shape - Model #-725-7100 SynFlow - Model #-05-7100-010 SynFlow -
Model #-05-7100-025 SynFlow - Model #-05-7100- 050 SynFlow - Model
#-05-7100-100 TheriGraft TCP Putty - Model #107010 TheriGraft TCP Putty
- Model #107025 TheriGraft TCP Putty - Model #107050 TheriGraft TCP
Putty - Model #107100 Valeo BP - Model #817010 Valeo BP - Model #817025
Valeo BP - Model #817050 Valeo B - Model #817100 X-Putty - Model #TS0005
X-Putty - Model #TS0006. Recall # Z-0169-2011
MANUFACTURER: Theken Spine LLC, Akron, OH, by letters dated August 26,
2010. Firm initiated recall is ongoing.
REASON: The firm's quality control testing determined that a separation
was occurring between the flowable carrier and the B-TriCalcium
Phosphate within some of the product syringes.
PRODUCT:
enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar
(labeled as Unipolar) Connector, , REF 511212. 54 cm. Contents in
unopened, undamaged package have been sterilized by ethylene oxide gas.
Recall # Z-0287-2011
MANUFACTURERz: Greatbatch Medical, Minneapolis, MN, by letter dated May
13, 2010. Firm initiated recall is ongoing.
REASON: The Myopore Bipolar Epicardial Leads packaging is labeled as
unipolar leads. The lead body itself is correctly labeled as bipolar.
This could result in a bipolar lead being implanted with a pulse
generator operating in unipolar mode.
PRODUCT:
Panta Support Device Panta? Arthrodesis Nail Instrumentation Tray. One
unit per package. The PANTA(R) Nail is intended for use in
tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot
and distal tibia. Catalog number 519110. Recall # Z-0308-2011
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Cincinnati,
OH, by letters dated March 1, 2010.Manufacturer: NewDeal SA, Lyon,
France. Firm initiated recall is ongoing.
REASON: Inability to properly align the calcaneal screw placement on
a consistent basis, due to a manufacturing defect of the targeting frame
(Panta Support Device).
VOLUME OF PRODUCT IN COMMERCE108 units
PRODUCT:
3.5mm LCP Periarticular Proximal Humerus Plates Indicated for fractures
and fracture dislocations, osteotomies, and nonunions of the proximal
humerus, particularly for patients with osteopenic bone. Catalog/model
numbers: 02.123.020, 02.123.020S, 02.123..021, 02.123.021S, 02.123.022,
02.123.022S, 02.123.023, 02.123.023S, 02.123.024, 02.123.024S,
02.123.025, 02.123.025S, 02.123.026, 02.123.026S, 02.123.027,
02.123.027S, 02.123.028, 02.123.028S, 02.123.029, 02.123.029S,
02.123.030, 02.123.030S, 02.123.031, 02.123.031S, 02.123.032,
02.123.032S, 02.123.033, 02.123.033S, 02.123.040, 02.123.040S,
02.123.041, 02.123.041S, 02.123.042, 02.123.042S, 02.123.043, and
02.123.043S. Recall # Z-0309-2011
MANUFACTURER: Recalling Firm; Synthes USA (HQ), Inc., West Chester, PA,
by letter dated September 27, 2010.Manufacturer: Synthes (USA),
Horseheads, NY. Firm initiated recall is ongoing.
REASON: Screw can pass through plate hole.
PRODUCT:
1) microTargeting Drive System with Mounted Accessories Catalog numbers
: 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) Product is the FHC DBS Depth
Stop Adapter, a component of the microTargeting Drive and the STar
Drive. The Drives are intended to be used with commercially available
stereotactic systems for neurosurgical procedures which require the
accurate positioning of microelectrodes, stimulating electrodes, or
other instruments in the brain or nervous system. Recall #
Z-0311-2011;2) STar Drive System, Catalog numbers: ST-DS-MA, ST-DS-ME,
70-ZD-ME Product is the FHC DBS Depth Stop Adapter, a component of the
microTargeting Drive and the STar Drive. The Drives are intended to be
used with commercially available stereotactic systems for neurosurgical
procedures which require the accurate positioning of microelectrodes,
stimulating electrodes, or other instruments in the brain or nervous
system. Recall # Z-0312-2011; 3) microTargeting Drive DBS Lead Holder
66-CN-DB Product is the FHC DBS Depth Stop Adapter, a component of the
microTargeting Drive and the STar Drive. The Drives are intended to be
used with commercially available stereotactic systems for neurosurgical
procedures which require the accurate positioning of microelectrodes,
stimulating electrodes, or other instruments in the brain or nervous
system. Recall # Z-0313-2011;4) Depth Stop Adapter 66-AC-DS(1.8),
E6-01-.5 used with the microTargeting and STar Drives Product is the FHC
DBS Depth Stop Adapter, a component of the microTargeting Drive and the
STar Drive. The Drives are intended to be used with commercially
available stereotactic systems for neurosurgical procedures which
require the accurate positioning of microelectrodes, stimulating
electrodes, or other instruments in the brain or nervous system. Recall
# Z-0314-2011
MANUFACTURER: FHC, Inc., Bowdoinham, ME, by letter dated March 29, 2010.
Firm initiated recall is complete.
REASON: Fixation thumbscrew on the DBS depth stop adapter may be over
tightened and damage the implantable lead.
PRODUCT:
Distal Centralizer 10 mm. Recall # Z-0315-2011; 0051535; 0054967;
0055667; 0060372; 0061102; 0061769; 0062929; 0063395
MANUFACTURER: Ortho Development Corp., Draper, UT, by Memo dated July
28, 2010. Firm initiated recall is ongoing.
REASON: The hip stem did not fit the distal centralizer because the hole
was not drilled with the appropriate taper.
PRODUCT:
BD FACS Sample Prep Assistant III; (BD SPA III). The intended use for
the BD FACS Sample Prep Assistant is to prepare human whole blood
samples for flow cytometry analysis. Model/Catalog No. 647205. Sample
Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769.
Recall # Z-0316-2011
MANUFACTURER: BD Biosciences, Systems & Reagents, San Jose, Ca, by
letters dated February 2010 and July 2010. Firm initiated recall is
ongoing.
REASON: Due to inaccurate sample dispense, use of product may result in
getting incorrect results on samples prepared using the device. Having a
piece of the lid partially or fully clogging the Probe during piercing a
hole in the lid of tube may cause inaccurate sample dispense, resulting
in incorrect test results. The piece of the lid clogging the Probe can
be in the processed sample tube. It has the possibility to partially or
fully block the flow of patient sample (prepared cells) presented to the
flow cytometers through the sample introduction tube.
PRODUCT:
Single-stage 3.5mm Healing Abutment, 4 mm, REF SYHA40, Rx Only, STERILE
R, gamma irradiated, expires 2014-44, CE 0473. Endosseous dental implant
healing abutment. Recall #Z- 0321-2011
MANUFACTURER: BioHorizons Implant Systems Inc., Birmingham AL, by letter
on September 7, 2010. Firm initiated recall is complete.
REASON: Healing abutment may not fully seat on the implant.
PRODUCT
1) Allura Xper FD Systems with Velara Generator X-ray imaging system
intended uses: Dedicated vascular and neurovascular imaging
applications, including diagnostic and interventional procedures;
Cardiac imaging applications including diagnostic and interventional
procedures; and Non-vascular interventions such as drainages, biopsies
and vertebroplasties procedures. Angiographic X-ray systems with a solid
state x-ray imaging device for cardiovascular and vascular diagnostic
and interventional procedures (such as PTCA, stent placement, and
atherectomies), pacemaker implantations and ElectroPhysiology (EP).
Recall # Z-0324-2011;2) Allura Integris Systems with OMCP Generator
Intended Use: X-ray imaging system intended for peripheral abdominal,
cerebral, diagnostic and interventional angiography, neuron
applications, cardiac applications and non-vascular interventions.
Recall # Z-0325-2011;3) MultiDiagnost-Eleva Systems Intended Use: X-ray
imaging system. Recall # Z-0326-2011;4) OmniDiagnost-Eleva Imaging
Systems Intended Use: X-ray imaging system. Recall # Z-0327-2011
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, letter dated October 14, 2010. Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is ongoing.
REASON: A wire in the connector of the Generator Grid Switch Supervisor
box might short circuit between the 12 volt power and ground. If a short
circuit occurs it may cause the system to break down. If the system
fails during a critical interventional case it may cause risk to
patients. (No Fluoro is available.)
PRODUCT: 1) Excel Care Bariatric Bed, P 610A.
Intended Use: The Excel Care Bariatric Bed is for bariatric patients
with varying medical and physical conditions. The bed supports patients
between 250 and 1000 pounds. Recall # Z-0332-20112) Excel Care ES
Bariatric Bed, P 610B. Intended use: The Excel Care Bariatric Bed is for
bariatric patients with varying medical and physical conditions. The bed
has an expandable surface and supports patients between 250 and 1000
pounds. Recall # Z-0333-2011
MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated March 5,
2010. Firm initiated recall is ongoing
REASON: The firm received complaints regarding the siderails not
operating correctly or becoming inoperable. The siderails could
experience false latching, unintentional lowering or become inoperable.
There have been reports of 5 patient falls and 2 injuries to caregivers.
PRODUCT:
1) Medtronic Intrathecal Catheter, 8731SC with sutureless connector.
Method of Sterilization: Ethylene Oxide. The implantable Medtronic Model
8731SC intrathecal catheter is part of an infusion system that stores
and delivers parenteral drugs to the intrathecal space. The implanted
infusion system components consist of a Medtronic pump and a Model
8731SC catheter. The catheter connects to the pump at the catheter port.
To deliver parenteral drugs to the intrathecal space. The needle is used
to facilitate the placement of the catheter. The needle is inserted
percutaneously into the intrathecal. The needle stylet is then removed
to confirm the needle placement through observing backflow of
cerebrospinal fluid (CSF) through the needle. The needle stylet prevents
tissue coring and also minimizes loss of CSF. The spinal segment tip of
the catheter is inserted through the needle until the catheter is
advanced to the desired location. Once the catheter position is verified
through fluoroscopy, the needle is carefully removed and discarded.
Recall # Z-0334-2011;2) Medtronic Intrathecal Catheter Spinal Segment
Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. The
Medtronic Model 8598A Spinal Segment Revision Kit is used when a
revision to the spinal segment of a Model 8731 or Model 8731SC catheter
is required. The catheter is part of an infusion system that stores and
delivers parenteral drugs to the intrathecal space. The implanted
infusion system components consist of a Medtronic pump and a Model 8731
or Model 8731SC catheter. The catheter connects to the pump at the
catheter port. To deliver parenteral drugs to the intrathecal space. The
needle is used to facilitate the placement of the catheter. The needle
is inserted percutaneously into the intrathecal. The needle stylet is
then removed to confirm the needle placement through observing backflow
of cerebrospinal fluid (CSF) through the needle. The needle stylet
prevents tissue coring and also minimizes loss of CSF. The spinal
segment tip of the catheter is inserted through the needle until the
catheter is advanced to the desired location. Once the catheter position
is verified through fluoroscopy, the needle is carefully removed and
discarded. Recall # Z-0335-2011
MANUFACTURER: Medtronic, Inc. – Neuromodulation, Minneapolis, MN, by
letter, dated September 2010, was sent beginning September 29, 2010.
Firm initiated recall is ongoing
REASON: Medtronic is recalling specific lots of Model 8731SC intrathecal
catheter kits and Model 8598A intrathecal catheter spinal revision kits
because there is the potential that the 11.4 cm introducer needles
within these kits may exceed USP requirements for bacterial endotoxin.
PRODUCT: Zimmer Dental, Drill stop kit, REF DSKIT,
for use with dental implants. Recall # Z-0444-2011
REASON: The instructions for use contain pre-vacuum sterilization
instructions that may lead to compromised sterility at the lid-kit
interface location.
PRODUCT:
Lumen Biomedical Xtract Aspiration Catheter system, consisting of One
Catheter, Two 30 mL Syringes, One Extension Tube with Stopcock, and One
40 um Cell Strainer. Single-user, 0.014" guidewire compatible
intravascular extraction and aspiration catheter, Part number 1450-0001
size 4.2F, and part number 1451-003 size 5.8F. Part number 1450-001 size
4.2F and 1451-003 size 5.8F. Recall # Z-0445-2011
MANUFACTURER: Recalling Firm: Volcano Corp., Rancho Cordova, CA, by
letters on November 3, 2010, and November 4, 2010. Manufacturer:
Lumen Biomedical, Inc., Plymouth, MN. Firm initiated recall is ongoing.
REASON: Potential for product failure. Packaging/Storage issue results
in compromised integrity and potential product failure during use,
leading to potential patient injury.
PRODUCT:
Alaris PC unit Model 8000 only when used with Alaris Pump module or
Alaris Syringe module. Recall # Z-0492-2011
MANUFACTURER: CareFusion Corp., San Diego, CA, beginning August 24,
2010. Firm initiated recall is ongoing.
REASON: Issue: PC Unit model 8000, when used with Pump or Syringe
modules, may under certain conditions display an incorrect total dose
when programmed to deliver a bolus dose. The Pump or Syringe module
delivers the actual programmed bolus dose (and associated volume to be
infused) regardless of the displayed total bolus dose. Potential Risk:
If the display of an incorrect total dose is detected, it has a
potential to confuse clinicians and may lead to a delay in therapy or
over- or underinfusion of a therapy, which may result in serious injury
and/or death.
PRODUCT:
1) Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G
Left, sterile, REF 00-5996-017-01. Recall # Z-0528-2011;2) Zimmer,
NexGen Complete Knee Solution LPS Femoral Component, Size G Right,
sterile, REF 00-5996-017-02. Recall # Z-0529-2011;3) Zimmer, NexGen
Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF
00-5996-016-01. Recall # Z-0530-2011;4) Zimmer, NexGen Complete Knee
Solution LPS Femoral Component, Size F Right, sterile, REF
00-5996-016-02. Recall # Z-0531-2011;5) Zimmer, NexGen Complete Knee
Solution LPS Femoral Component, Size E Right, sterile, REF
00-5996-015-02. Recall # Z-0532-2011;6) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF
00-5764-017-51. Recall # Z-0533-2011;7) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF
00-5764-016-52. Recall # Z-0534-2011;8) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF
00-5764-015-51. Recall # Z-0535-2011;9) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF
00-5764-015-52. Recall # Z-0536-2011
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letters dated
September 15, 2010.Manufacturer: Zimmer Orthopedic Mfg LTD, Shannon,
Ireland. Firm initiated recall is ongoing.
REASON: Products exhibit a nonconforming internal CAM radius. The
condition is intermittent and not all devices have nonconforming
geometry.
CLASS III
PRODUCT:
1) LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size
Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06
Medium size 1 Pack. Recall # Z-0164-2011;2) LeMaitre Vascular AnastoClip
GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack
4008-03 Large size 10 Pack 4007-07 Large size 1 Pack. Recall #
Z-0165-2011
MANUFACTURER: LeMaitre Vascular, Inc., Burlington, MA, by letter dated
September 28, 2010. Firm initiated recall is ongoing.
REASON: Mislabeled size on external packaging: The contents section
listed on the Tyvek lid labels of the Medium and Large sizes incorrectly
identified the size of the clip as XL, while the device inside was
either a Medium or Large size.
MANUFACTURER: CareFusion Corp., San Diego, CA, beginning August 24,
2010. Firm initiated recall is ongoing.
REASON: Issue: PC Unit model 8000, when used with Pump or Syringe
modules, may under certain conditions display an incorrect total dose
when programmed to deliver a bolus dose. The Pump or Syringe module
delivers the actual programmed bolus dose (and associated volume to be
infused) regardless of the displayed total bolus dose. Potential Risk:
If the display of an incorrect total dose is detected, it has a
potential to confuse clinicians and may lead to a delay in therapy or
over- or underinfusion of a therapy, which may result in serious injury
and/or death.
PRODUCT:
1) Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G
Left, sterile, REF 00-5996-017-01. Recall # Z-0528-2011;2) Zimmer,
NexGen Complete Knee Solution LPS Femoral Component, Size G Right,
sterile, REF 00-5996-017-02. Recall # Z-0529-2011;3) Zimmer, NexGen
Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF
00-5996-016-01. Recall # Z-0530-2011;4) Zimmer, NexGen Complete Knee
Solution LPS Femoral Component, Size F Right, sterile, REF
00-5996-016-02. Recall # Z-0531-2011;5) Zimmer, NexGen Complete Knee
Solution LPS Femoral Component, Size E Right, sterile, REF
00-5996-015-02. Recall # Z-0532-2011;6) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF
00-5764-017-51. Recall # Z-0533-2011;7) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF
00-5764-016-52. Recall # Z-0534-2011;8) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF
00-5764-015-51. Recall # Z-0535-2011;9) Zimmer, NexGen Complete Knee
Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF
00-5764-015-52. Recall # Z-0536-2011
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letters dated
September 15, 2010.Manufacturer: Zimmer Orthopedic Mfg LTD, Shannon,
Ireland. Firm initiated recall is ongoing.
REASON: Products exhibit a nonconforming internal CAM radius. The
condition is intermittent and not all devices have nonconforming
geometry.
CLASS III
PRODUCT:
1) LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size
Models: 4007-02 Medium size 3 Pack 4008-02 Medium size 10 Pack 4007-06
Medium size 1 Pack. Recall # Z-0164-2011;2) LeMaitre Vascular AnastoClip
GC Vessel Closure System-Large Size Models: 4007-03 Large size 3 Pack
4008-03 Large size 10 Pack 4007-07 Large size 1 Pack. Recall #
Z-0165-2011
MANUFACTURER: LeMaitre Vascular, Inc., Burlington, MA, by letter dated
September 28, 2010. Firm initiated recall is ongoing.
REASON: Mislabeled size on external packaging: The contents section
listed on the Tyvek lid labels of the Medium and Large sizes incorrectly
identified the size of the clip as XL, while the device inside was
either a Medium or Large size.
The following is condensed list of
medical devices involved in recalls listed by the FDA Enforcement Report
as of December 1, 2010.
CLASS II
PRODUCT:
NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No.
V71-3001, Rx only, NON-STERILE. Most commonly used during medical
medical emergencies and surgery to remove fluid and secretions from a
patient. Recall # Z-0101-2011
MANUFACTURER: Recalling Firm: DeRoyal Industries Inc., Powell, TN, by
letter dated July 1, 2010.Manufacturer: Royal Precision Plastics,
Powell, TN. Firm initiated recall is ongoing.
REASON: Suction canisters may crack during use.
PRODUCT:
SoftPath GUI version 4.2.3.4 2008-06-30 (Manuf Date). SoftPath GUI
version 4.2.4.1 2008-09-30 (Manuf Date). SoftPath GUI version 4.3.0.3,
2008-07-23 (Manuf Date). SoftPath GUI version 4.3.0.4 2008-09-16 (Manuf
Date). Recall # Z-0102-2011
MANUFACTURER: SCC Soft Computer, Clearwater, FL, by a Risk-to-Health
notification on January 26, 2009. Firm initiated recall is ongoing.
REASON: The Previous Patient History and some QA Management reports
may have missing or incorrect diagnosis text. However, the patient final
report, HIS resulting and Query display are all correct.
PRODUCT:
1) LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with
stay safe connectors (Dual Patient Connector) PIN: 050-87212. Recall #
Z-0103-2011;2) LIBERTY Automated Peritoneal Dialysis System Line Cycler
Set with stay safe connectors (Single Patient Connector) PIN: 050-87215.
Recall # Z-0104-2011;3) LIBERTY Automated Peritoneal Dialysis System
lntegrated Cycler Set with single stay safe patient connector and
extended drain line PIN: 050-87216. Recall # Z-0105-2011
MANUFACTURER: Recalling Firm: Fresenius Medical Care Holdings, Inc.,
Waltham, MA, by letter on September 3, 2010.Manufacturer: Fresenius
Medical Care, Tamulipas, Mexico. Firm initiated recall is ongoing.
REASON: Cycle set cassettes may leak due to holes/scratches in the
film, contaminating dialysate and potentially resulting in peritonitis.
PRODUCT:
Varian brand TrueBeam and TrueBeam STx, Model Number: TMX- H19. Recall #
Z-0106-2011
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA,
by letter dated May 24, 2010. Firm initiated recall is ongoing.
REASON: Due to a software anomaly, guidance-based couch shift values
may not be applied as expected when the operator selects "Apply Shift"
and presses Motion Enable buttons. This can result in the actual patient
position differing from that position indicated by the imaging
application affecting position accuracy and precision.
PRODUCT:
Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number:
DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent
Assay (ELISA) Kit provides materials for the quantitative measurement of
I-PTH in serum or plasma. This assay is intended for in vitro diagnostic
use as an aid in the diagnosis of hyperparathyroidism. Recall #
Z-0107-2011
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA,
by Manufacturer: Diagnostic System Laboratories Inc., Webster, TX. Firm
initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter confirmed that
the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be
achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers
listed above passed the stability testing performed at 6 months, but
failed the testing performed at 12 months. Therefore the affected I-PTH
ELISA kit lots may produce falsely elevated patient results. These lots
may also produce elevated results on quality control materials provided
by other manufacturers. Internal stability testing showed an average 57%
elevation.
PRODUCT:
2.0/1.0 4 hole long plate (titanium plate).Lot 120150. Product labeling
reads: (1.) REF: 01-9205, Lot 999999, "2.0MM" SYSTEM PLATE 4 HOLE PLATE,
STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0
MM Titanium, (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE,
STRAIGHT, LONG, 1.0 MM, CE 0086. Recall # Z-0108-2011
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letter
dated August 31, 2010. Firm initiated recall is ongoing.
REASON: Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is
labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package
contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).
PRODUCT:
in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c
Test Cartridges (Catalog 281-0001). The in2it (I) is for Physician use,
the (II) is for prescription home use. The products are medical devices
used in affinity chromatography method, intended for the in-vitro
quantitative determination of A1c (HbA1C) in capillary blood taken from
a finger prick. The test is indicated for monitoring the time averaged
blood glucose levels of known diabetics, for professional use as an
indicator of overall glycemic control. Recall # Z-0109-2011
MANUFACTURER: Recalling Firm: Bio-Rad Laboratories Inc., Hercules,
CA, by letter dated September 7, 2010. Manufacturer: Bio-Rad
Laboratories Deeside, Flintshire, United Kingdom. Firm initiated recall
is ongoing.
REASON: Test Cartridges may leak and have the potential to generate
error messages and biased inaccurate results.
PRODUCT:
1) Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not
available in the US. Digital implantable cardioverter defibrillator with
cardiac resynchronization therapy (DDE-DDR). Sterilized using ethylene
oxide. The Dual chamber implantable cardioverter defibrillator with
cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac
device that monitors and regulates the patient's heart rate by providing
single or dual chamber rate-responsive bradycardia pacing, sequential
biventricular pacing, ventricular tachyarrhythmia therapies, and atrial
tachyarrhythmia therapies. The device automatically detects ventricular
tachyarrhythmias (VT/VF) and provides treatment with defibrillation,
cardioversion, and antitachycardia pacing therapies. The device also
automatically detects atrial tachyarrhythmias (AT/AF) and provides
treatment with cardioversion and antitachycardia pacing therapies.
Simultaneous or sequential biventricular pacing is used to provide
patients with cardiac resynchronization therapy. The device responds to
bradyarrhythmias by providing bradycardia pacing therapies. Recall #
Z-0110-2011;2) Medtronic Consulta CRT-D, model D224TRK and Model D234TRK
not available in the US. Digital implantable cardioverter defibrillator
with cardiac resynchronization therapy (DDE-DDDR). Sterilized using
ethylene oxide. The Dual chamber implantable cardioverter defibrillator
with cardiac resynchronization therapy (CRT-D) is a multiprogrammable
cardiac device that monitors and regulates the patient's heart rate by
providing single or dual chamber rate-responsive bradycardia pacing,
sequential biventricular pacing, ventricular tachyarrhythmia therapies,
and atrial tachyarrhythmia therapies. The device automatically detects
ventricular tachyarrhythmias (VT/VF) and provides treatment with
defibrillation, cardioversion, and antitachycardia pacing therapies. The
device also automatically detects atrial tachyarrhythmias (AT/AF) and
provides treatment with cardioversion and antitachycardia pacing
therapies. Simultaneous or sequential biventricular pacing is used to
provide patients with cardiac resynchronization therapy. The device
responds to bradyarrhythmias by providing bradycardia pacing therapies.
Recall #Z-0111-2011;3) Medtronic Maximo II CRT-D, model D284TRK. Digital
implantable cardioverter defibrillator with cardiac resynchronization
therapy (VVE-DDDR). Sterilized using ethylene oxide. The Dual chamber
implantable cardioverter defibrillator with cardiac resynchronization
therapy (CRT-D) is a multiprogrammable cardiac device that monitors and
regulates the patient's heart rate by providing single or dual chamber
rate-responsive bradycardia pacing, sequential biventricular pacing, and
ventricular tachyarrhythmia therapies. The device automatically detects
ventricular tachyarrhythmias (VT/VF) and provides treatment with
defibrillation, cardioversion, and antitachycardia pacing therapies. The
device also automatically detects atrial tachyarrhythmias (AT/AF).
Simultaneous or sequential biventricular pacing is used to provide
patients with cardiac resynchronization therapy. The device responds to
bradyarrhythmias by providing bradycardia pacing therapies. Recall #
Z-0112-2011;4) Medtronic Maximo II DR, model D284DRG. Digital dual
chamber implantable cardioverter defibrillator (VVE-DDDR). Sterilized
using ethylene oxide. The Dual chamber implantable cardioverter
defibrillator (ICD) is a multiprogrammable cardiac device that monitors
and regulates the patient's heart rate by providing single or dual
chamber rate-responsive bradycardia pacing, and ventricular
tachyarrhythmia therapies. The device automatically detects ventricular
tachyarrhythmias (VT/VF) and provides treatment with defibrillation,
cardioversion, and antitachycardia pacing therapies. The device also
automatically detects atrial tachyarrhythmias (AT/AF). The device
responds to bradyarrhythmias by providing bradycardia pacing therapies.
Recall # Z-0113-2011;5) Medtronic Maximo II VR, model D284VRC. Digital
single chamber implantable cardioverter defibrillator (VVE-VVIR).
Sterilized using ethylene oxide. The Single chamber implantable
cardioverter defibrillator (ICD) is a multiprogrammable cardiac device
that monitors and regulates the patient's heart rate by providing single
chamber rate-responsive bradycardia pacing, and ventricular
tachyarrhythmia therapies. The device automatically detects ventricular
tachyarrhythmias (VT/VF) and provides treatment with defibrillation,
cardioversion, and antitachycardia pacing therapies. The device responds
to bradyarrhythmias by providing bradycardia pacing therapy. Recall #
Z-0114-2011;6) Medtronic Secura DR, model D224DRG, and model D234DRG not
available in the U.S.. Digital Dual chamber implantable cardioverter
defibrillator (DDE-DDDR). Sterilized using ethylene oxide. The Dual
chamber implantable cardioverter defibrillator (ICD) is a
multiprogrammable cardiac device that monitors and regulates the
patient's heart rate by providing single or dual chamber rate-responsive
bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial
tachyarrhythmia therapies. The device automatically detects ventricular
tachyarrhythmias (VT/VF) and provides treatment with defibrillation,
cardioversion, and antitachycardia pacing therapies. The device also
automatically detects atrial tachyarrhythmias (AT/AF) and provides
treatment with cardioversion and antitachycardia pacing therapies. The
device responds to bradyarrhythmias by providing bradycardia pacing
therapy. Recall #Z-0115-2011;7) Medtronic Secura VR, model D224VRC, and
model D234VRC not available in the U.S.. Digital single chamber
implantable cardioverter defibrillator (VVE-VVIR). Sterilized using
ethylene oxide. The Dual chamber implantable cardioverter defibrillator
(ICD) is a multiprogrammable cardiac device that monitors and regulates
the patient's heart rate by providing single or dual chamber
rate-responsive bradycardia pacing, ventricular tachyarrhythmia
therapies, and atrial tachyarrhythmia therapies. The device
automatically detects ventricular tachyarrhythmias (VT/VF) and provides
treatment with defibrillation, cardioversion, and antitachycardia pacing
therapies. The device also automatically detects atrial tachyarrhythmias
(AT/AF) and provides treatment with cardioversion and antitachycardia
pacing therapies. The device responds to bradyarrhythmias by providing
bradycardia pacing therapy. Recall # Z-0116-2011;8) Medtronic Virtuoso
DR, model D274DRG, and model D294DRG not available in the U.S.. Digital
Dual chamber implantable cardioverter defibrillator (DDE-DDDR).
Sterilized using ethylene oxide. The Dual chamber implantable
cardioverter defibrillator (ICD) is a multiprogrammable cardiac device
that monitors and regulates the patient's heart rate by providing single
or dual chamber rate-responsive bradycardia pacing, ventricular
tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The
device automatically detects ventricular tachyarrhythmias (VT/VF) and
provides treatment with defibrillation, cardioversion, and
antitachycardia pacing therapies. The device also automatically detects
atrial tachyarrhythmias (AT/AF) and provides treatment with
cardioversion and antitachycardia pacing therapies. The device responds
to bradyarrhythmias by providing bradycardia pacing therapy. Recall #
Z-0117-2011;9) Medtronic Virtuoso VR, model D274VRC, and model D294VRC
not available in the U.S. Digital Single chamber implantable
cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide.
The Single chamber implantable cardioverter defibrillator (ICD) is a
multiprogrammable cardiac device that monitors and regulates the
patient's heart rate by providing single chamber rate-responsive
bradycardia pacing, and ventricular tachyarrhythmia therapies. The
device automatically detects ventricular tachyarrhythmias (VT/VF) and
provides treatment with defibrillation, cardioversion, and
antitachycardia pacing therapies. The device responds to
bradyarrhythmias by providing bradycardia pacing therapy. Recall #
Z-0118-2011
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease
Management, Saint Paul, MN, by letter dated May 2010 beginning May 05,
2010.Manufacturer: Medtronic Puerto Rico Operations Co., Juncos,
PR;Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland. Firm
initiated recall is ongoing.
REASON: Medtronic is informing you of a rare device software issue in
certain ICD and CRT-D devices. A software update will be available to
correct his issue. There have been 5 reports of this issue occurring
with no reported patient injuries or deaths. Medtronic has identified
the root cause to be a rare and specific sequence of events that must
occur within a few milliseconds of each other. In the unlikely event
that this sequence occurs, all subsequent high voltage therapies will
experience prolonged charge time or loss of high voltage therapy (due to
a charge circuit timeout). Device alerts are nominally ON and will
notify patients to seek medical attention should either of these alert
conditions occur.
PRODUCT:
GE Centricity Laboratory Instrument Interface software. The intended
use: the Centricity Laboratory is used to facilitate the general
clinical, anatomic pathology and cytology laboratory workflow such as
order entry, results entry, instrument interfacing, results reporting
and patient record retrieval. Recall # Z-0123-2011
MANUFACTURER: Recalling Firm: GE Healthcare IT, Barrington, IL, by
letters dated August 27, 2010. Manufacturer: Triple G Systems Group,
Inc., Markham Ontario, Canada. Firm initiated recall is ongoing.
REASON: Instrument may incorrectly report the result of an
antimicrobial sensitivity test.
PRODUCT:
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a
Medtronic Computer-Assisted Surgery System to help assist with screw
placement during spine procedures. Recall # Z-0145-2011
MANUFACTURER: Medtronic Navigation, Inc., Louisville, CO, by letter
dated September 22, 2010. Firm initiated recall is complete.
REASON: Drill guide handle may detach unintentionally during use.
PRODUCT :
1) Baxter Clearlink System Non-DEHP Y-Type Catheter Extension Set, 6.5"
(16.5 cm), Vol 1.2 mL, Luer Activated Valve for I.V. Access, Male Luer
Lock Adapter with Retractable Collar; an Rx sterile device; product
2N8377 For the administration of drugs and solutions to a patient's
vascular system through a vascular access device. Recall #Z-0148-2011;2)
Baxter Non-DEHP Y-Type Catheter Extension Set, 5.3" (13.5 cm), 1.0 mL,
Male Luer Lock Adapter with Retractable Collar; a sterile Rx device;
product 2N1196 For the administration of drugs and solutions to a
patient's vascular system through a vascular access device. Recall #
Z-0149-2011;3) Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL,
2 Luer Activated Valves for IV Access, Male Luer Lock Adapter; a sterile
Rx device; product 2N8334 For the administration of drugs and solutions
to a patient's vascular system through a vascular access device. Recall
#Z-0150-2011;4) Baxter Interlink System Non-DHEP Extension Set; 8.3"
(21.0 cm), Volume 1.4 mL, Large Bore 3-Way Stopcock with Rotating Male
Luer Lock, Injection Site, Male Luer Lock Adapter with Retractable
Collar; an Rx sterile device; product 2N5602 For the administration of
drugs and solutions to a patient's vascular system through a vascular
access device. Recall # Z-0151-2011;5) Baxter Micro-Volume Infusion Set,
with 27 G x 0.6" (1.5 cm) Needle, 25" (64 cm), 0.18 mL; an Rx sterile
device; product 1M8450 For the administration of drugs and solutions to
a patient's vascular system through a vascular access device. Recall #
Z-0152-2011;6) Baxter Micro-Volume Infusion Set, with 27 G x 0.6" (1.5
cm) Needle, 43" (64 cm), 0.24 mL; an Rx sterile device; product 1M8451
For the administration of drugs and solutions to a patient's vascular
system through a vascular access device.Recall # Z-0153-2011;7) Baxter
Non-DEHP I.V. Catheter Extension Set, 8.2" (20.9 cm), 0.3 mL, PosiFlow
Positive Displacement Access Device for I.V. Access, Male Luer Lock
Adapter; an Rx sterile device; product 2N9051 For the administration of
drugs and solutions to a patient's vascular system through a vascular
access device. Recall # Z-0154-2011;8) Baxter Non-DEHP I.V. Catheter
Extension Set, 6.0" (15.2 cm), 0.5 mL, PosiFlow Positive Displacement
Access Device for I.V. Access, Male Luer Lock Adapter with Retractable
Collar; an Rx sterile device; product 2N9053 For the administration of
drugs and solutions to a patient's vascular system through a vascular
access device. Recall #Z-0155-2011;9) Baxter Non-DEHP Y-Type Catheter
Extension Set, 6.6" (16.8 cm)., 1.1 mL, PosiFlow Positive Displacement
Access Device for I.V. Access, Male Luer Lock Adapter with Retractable
Collar; an Rx sterile device; product 2N9054 For the administration of
drugs tears and pinholes in Chevron-style pouches for certain infusion
disposable products. The pinholes and tears could compromise the sterile
barrier properties of the pouch. and solutions to a patient's vascular
system through a vascular access device. Recall # Z-0156-2011;10) Baxter
Non-DEHP I.V. Catheter T-Connector Extension Set, 6.5" (16.5 cm), 0.5
mL, PosiFlow Positive Displacement Access Device for I.V. Access, Male
Luer Lock Adapter with Retractable Collar; an Rx sterile device; product
2N9057 For the administration of drugs and solutions to a patient's
vascular system through a vascular access device. Recall #
Z-0157-2011;11) Baxter Catheter Extension Set, Luer Activated Valve for
I.V. Access, Male Luer Lock Adapter, Volume 1.0 mL, Length 6" (15 cm);
an Rx sterile device; product 2N9191 For the administration of drugs and
solutions to a patient's vascular system through a vascular access
device. Recall # Z-0158-2011
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round
Lake, IL, by letter on Manufacturer: Baxter Healthcare Corp., of Puerto
Rico S.A., Aibonito, PR;Baxter Productos Medicos Ltda., Parque
Industrial - De Cartago, Cartago Costa Rica. Firm initiated recall is
ongoing.
REASON: During packaging testing, Baxter observed tears and pinholes
in Chevron-style pouches for certain infusion disposable products. The
pinholes and tears could compromise the sterile barrier properties of
the pouch.
PRODUCT:
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, The
intended use of Sequencer (generically referred to as a verification
system) is to assist in the process of process of patient treatment on a
radiotherapy treatment machine. Recall # Z-0159-2011
MANUFACTURER: Impac Medical Systems Inc., Sunnyvale, CA, by letter
dated February 19, 2010. Firm initiated recall is ongoing.
REASON: Mistreatment-- The database conversion utility used during
the upgrade errantly changes the start gantry angle to zero. Any
affected treatment fields, if not already treated, would start
delivering from zero instead of the original prescribed value.
PRODUCT:
Edwards' MHANM8 Pressure Slave Cable, Part Number: 693657001 The Edwards
Lifesciences Analog Slave Cable is used to transfer monitoring output
from patient monitors to the analog input ports of the Vigileo Monitor
series or compatible Edwards monitoring systems. This cable has
instrument specific connectors. Recall # Z-0160-2011
MANUFACTURER: Edwards Lifesciences, LLC, Irvine, CA, by telephone on
June 22, 2010. Firm initiated recall is ongoing.
REASON: The recall was initiated because the Edwards' MHANM8
Pressure Slave Cable was wired incorrectly, thus will not work as
stated.
PRODUCT:
Siemens brand 550 TxT Patient Table, Part No. 7346534. Recall #
Z-0166-2011
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Concord, CA, by letter on March 31, 2010. Manufacturer: Siemens Ag
Medical Solutions, Kemnath, Germany. Firm initiated recall is ongoing.
REASON: An increase in voltage may cause a short circuit of a power
transistor that may cause a smoldering and smoking effect of the
electrical wiring and also an unexpected lowering of the Table. Both
issues present the potential for injury to a patient or the operator.
PRODUCT:
Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec
item number 5430-2130. Recall # Z-0167-2011
MANUFACTURER: Capintec Inc., Pittsburgh, PA, by letter on September
20, 2010. Firm initiated recall is ongoing.
REASON: The spring arm on portable stand may have been over tightened
during assembly, which may result in failure. If the spring arm fails,
it will not balance the collimator weight, and the arm will drop to the
lowest position.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
October 27, 2010.
CLASS II
PRODUCT:
iBOT 4000 Mobility System Battery pack. Recall # Z-1775-2010
MANUFACTURER: Independence Technology LLC, Warren, NJ, by letters on
February 22, 2010. Firm initiated recall is complete.
REASON: A thermal breaker in the battery pack has the potential to open
due to overheating and disable one third of the cells in the affected
battery pack.
PRODUCT:
1) i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for
use in the in vitro quantification of packed red blood cell volume in
arterial, venous, or capillary whole blood. Hematocrit is a key
indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1791-2010;2) i-STAT CG8+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1792-2010; 3) i-STAT EG7+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1793-2010; 4) i-STAT EG6+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1794-2010;5) i-STAT EC8+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1795-2010; 6) i-STAT 6+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1796-2010; 7) i-STAT EC4+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1797-2010; 8) i-STAT E3+ cartridges The i-stat Hematocrit (Hct) is
intended for use in the in vitro quantification of packed red blood cell
volume in arterial, venous, or capillary whole blood. Hematocrit is a
key indicator of the body's state of hydration, anemia, or severe blood
loss, as well as the blood's ability to transport oxygen. Recall #
Z-1798-2010
MANUFACTURER: Abbott Point of Care Inc., Princeton, NJ, by letters dated
January 2010 and February 5, 2010. Firm initiated recall is ongoing.
REASON: Abbott has determined that there is a dependence of the i-STAT
Hct assay on the vertical pitch angle of the i-STAT Analyzer during the
blood analysis cycle.
PRODUCT:
GE Healthcare, CARESCAPE" Monitor B850, Software version 1.0.1.13 and
1.0.2.1 The CARESCAPE " Monitor B850 is a multi-parameter high acuity
patient monitor intended for use in multiple areas within a professional
healthcare facility. The CARESCAPE Monitor B850 is intended for use on
adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor B850 system is indicated for monitoring of
Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG
Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive
Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance
Respiration and SvO2 (Mixed Venous Oxygen Saturation)), Airway Gases (Fi/Et
C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02
Consumption (VO2), C02 production (VCO2), energy expenditure (EE), and
respiratory quotient (RQ)) and neurophysiological (including
electroencephalography (EEG), Entropy, Bispectral Index (BIS) and
Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE
Monitor B850 provides alarms, trends, snapshots and events, and
calculations and can be connected to displays, printers and recording
devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or
interfaced to other devices. It can also be connected to other monitors
for bed to bed viewing and to data management software devices via a
network. The CARESCAPE Monitor B850 is intended for use under the direct
supervision of a licensed healthcare practitioner, or by personnel
trained in proper use of the equipment in a professional healthcare
facility. In addition to the healthcare practitioner, the CARESCAPE
Monitor B850 is designed to provide configuration and troubleshooting
capabilities to qualified service personnel. The CARESCAPE Monitor B850
is not intended for use during MRI. Recall # Z-1801-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLLC, Waukesha, WI, letter
dated April 22, 2010.Manufacturer: General Electric Medical Systems
Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a safety issue associated with
the CARESCAPE" Monitor B850 when monitoring ECG. The safety issue
includes the potential for a delay in treatment.
PRODUCT:
i-STAT PT/INR Cartridge. Catalog numbers: 04J50-01, 04J50-02. Recall #
Z-1996-2010
MANUFACTURER: Abbott Point of Care Inc., Princeton, NJ, by letters on
May 13 2010. Firm initiated recall is ongoing.
REASON: A high mean bias (12-16%) was documented in 8 lots of i-STAT
PT/INR cartridges. This may lead a clinician to believe that a patient
is adequately anticoagulated when they are not. Inadequate
anticoagluation therapy may be given and issues with clotting and/or
thrombosis could occur. No reports of injury have been received.
PRODUCT:
PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG
Ultrasound Systems. Recall # Z-1997-2010
MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc.,
Tustin, CA, by letter on January 5, 2010.Manufacturer: Toshiba Medical
Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON: Toshiba America Medical Systems is initiating a field correction
on the PVT-681MV Endocavitary Transducer used with the Aplio XG and
Xario XG Ultrasound Systems due to an incorrect sweep direction setting.
Images acquired using the endo-cavitary transducer PVT-681MV and
cross-sectional images created from these volume images are reversed
horizontally on the Aplio XG (SSA-790A) and the Xario XG (SSA- 680A)
diagnostic ultrasound systems.
PRODUCT
1) Microstream O2/CO2 NASAL FILTERLINE ADULT 25UN Part Number: 006912.
Recall # Z-1999-2010;2) Microstream NIVLINE ADULT 25UN Part Number:
008174. Recall # Z-2000-2010; 3) Microstream CAPNOLINE H ADULT 25UN Part
Number: 008177. Recall # Z-2001-2010; 4) Microstream CAPNOLINE H O2
ADULT 25UN Part Number: 008180. Recall # Z-2002-2010; 5) Microstream
SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion
3012176-011 Physio Control. Recall # Z-2003-2010; 6) Microstream SMART
CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012
Physio Control. Recall # Z-2004-2010; 7) Microstream SMART CAPNOLINE
PLUS O2 LONG ADU/INT 25UN Part Number: 009826. Recall # Z-2005-2010; 8)
Microstream SMART CAPNOLINE PLUS 100 UN Part Number: 010209 Oridion
3012176-111 Physio Control. Recall # Z-2006-2010; 9) Microstream SMART
CAPNOLINE PLUS O2 100UN Part Number: 010210 Oridion 3012176-112 Physio
Control. Recall # Z-2007-2010; 10) Microstream SMART CAPNOLINE H PLUS O2
ADU/INT 25UN Part Number: 010433. Recall # Z-2008-2010; 11) Microstream
SCP H PLUS O2 ADU/INT 100UN Part Number: 010625. Recall # Z-2009-2010;
12) Microstream FILTERLINE SET ADULT/PEDIATRIC 100 UN Part Number:
010579-01. Recall # Z-2010-2010; 13) Microstream FILTERLINE H SET
ADULT/PEDIATRIC 100 UN Part Number: 010580-01. Recall # Z-2011-2010; 14)
Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion
XS04661 Physio Control. Recall # Z-2012-2010; 15) Microstream SMART
CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number:
10341. Recall # Z-2013-2010; 16) Microstream O2/CO2 NASAL FILTERLINE
ADULT LONG O2 CONN 100UN Part Number: 010343 010341 Part Number: 10341.
Recall # Z-2014-2010
MANUFACTURER: Oridion Medical 1987 Ltd., Jerusalem, Israel, by letter on
May 26, 2010. Firm initiated recall is ongoing.
REASON: The Microstream Filterline may not be recognized by the monitor
when connected. No CO2 readings will be displayed and no alarms may
sound for unmonitored patients. Replacing the filterline may delay
treatment.
PRODUCT:
Advantage Turbo 2-Button Shaver. Rx Only, Made In USA, Non Sterile.
Catalog Number D9924. This issue has been isolated to products
manufactured between June 7, 2004 and June 1, 2006. Recall # Z-2026-2010
MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter
on October 29, 2009. Firm initiated recall is ongoing.
REASON: These products may self-activate due to moisture intrusion into
the housing body.
PRODUCT:
1) GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert:
IVD. 15/pk. 06260061600. Intended to be used to perform quality control
assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable
Coagulation Laboratory. Recall # Z-2107-2010; 2) GEM Check Coag CNTRL
Abnormal APTT Whole Blood Controls Package Insert; IVD. 06260060100.
15/pk. Intended to be used to perform quality control assays using GEM
test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation
Laboratory. Recall # Z-2108-2010
MANUFACTURER: Recalling Firm: International Technidyne, Corp.,
Piscataway, NJ, by letters dated July 1, 2010.Manufacturer:
International Technidyne, Corp., Edison, NJ. Firm initiated recall is
ongoing.
REASON: Certain lots of GEM Check Coag Whole Blood Controls contain an
error in the package insert where the incorrect Acceptable Performance
Ranges were published.
PRODUCT:
IMPAX CV Results Manager/Results Manager Administration Tool. Model No.
L9M2100. Recall # Z-2112-2010
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter on
June 11, 2010.Manufacturer: AGFA Healthcare Corp., Westerly, RI. Firm
initiated recall is ongoing.
REASON: Agfa Service technician had incorrectly modified a report
template at one site resulting in erroneous anatomic segment locators.
PRODUCT:
BleaseSirius Anaesthesia System, gas machine. Blease Beech House,
Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England Intended
for use in the hospital environment and operating room. Recall #
Z-2113-2010
MANUFACTURER: Recalling Firm: Spacelabs Healthcare, LLC, Issaquah, WA,
by letter on June 24, 2010.
Manufacturer: Blease Beech House Chiltern Court, Chesham, United
Kingdom. Firm initiated recall is ongoing.
REASON: Potential for the touch screen on the ventilator portion of the
device to go blank when touched. Possibility that this failure may also
cause mechanical ventilation to stop.
PRODUCT:
IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650.
Recall # Z-2195-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc. Brea, CA, by letter
beginning April 19, 2010.Manufacturer: Beckman Coulter Inc., Carlsbad,
CA. Firm initiated recall is ongoing.
REASON: Beckman Coulter is initiating a recall of IMMAGE Immunochemistry
Systems Buffer 1 (BUF1) due to received reports of increased recovery of
control and patient samples using the lots of IMMAGE BUF1. Some lots of
BUF1 have been reported to cause high shifts in recovery of control or
patient samples. Quality Control failures may result after replacing
BUF1 with a different lot.
PRODUCT:
1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST, REF 71163006, Qty:
(6), Sterile R, CE 008, 2020/07, Usage: Bone fracture fixation. Recall #
Z-2197-2010; 2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST, REF
71163008, Qty: (6), Sterile R, CE 008, 2020/07, Usage: Bone fracture
fixation. Recall # Z-2198-2010; 3) PERI-LOC, 2.0 MM X 228 MM, K-WIRE
W/TROCAR POINT, CO-CR, REF 71173361, Qty: (6), Sterile FR, CE 0123,
2015/04, Usage: Bone fracture fixation. Recall # Z-2199-2010
MANUFACTURER: Recalling Firm: Smith & Nephew Inc., Memphis, TN, by
letter, email and telephone on January 23, 2009. Firm initiated recall
is ongoing.
REASON: Plastic trays which encase these products have burrs on the
hinged packaging which can puncture the single barrier sterile pouch,
compromising sterility.
PRODUCT:
Motorized Height Ceiling Suspensions (MCS) and motorized height movement
(actuator) for X-ray systems. Usage: Ceiling suspension unit with an
actuator to hold monitors and X-ray shields. Recall # Z-2210-2010
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips
Bothell, WA, by letter on July 2, 2008.Manufacturer: Philips Medical
Systems Nederlands, Best, Netherlands. Firm initiated recall is
complete.
REASON: Monitor ceiling carriage may separate from the monitor ceiling
suspension.
PRODUCT:
Toshiba Aquilion ONE CT SystemTSX-301 A/2D. Recall # Z-2339-2010
MANUFACTURER: Recalling Firm: Toshiba American Medical Systems Inc.,
Tustin, CA, by letter dated January 14, 2009.Manufacturer: Toshiba
Medical Systems, Co., Tochigi-Ken, Japan. Firm initiated recall is
ongoing.
REASON: ECG Gated Dynamic Volume Prospective scan may stop if preset
eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure
control PWB.
PRODUCT:
Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers:
PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52. Recall #
Z-2399-2010
MANUFACTURER: Peregrine Surgical LTD, New Britain, PA, by letter on July
19, 2010. Firm initiated recall is complete.
REASON: Product did not have proper 510(k) clearance.
PRODUCT:
Sonopet Ultrasonic Surgical System, Model UST-2001. Recall # Z-2640-2010
MANUFACTURER: Recalling Firm: Stryker Instruments, Division of Stryker
Corp., Kalamazoo, MI, by letters dated July 15, 2010.Manufacturer:
Stryker Medtech, Tokyo, Japan. Firm initiated recall is ongoing.
REASON: Stryker determined that the Sonopet consode did not meet the
IEC-60601-1 standard. Stryker decided to recall the Sonopet consode. #
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
October 20, 2010.
CLASS II
PRODUCT
1) MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C,
Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura
12-15 Monoplane. The Monoplane system has one C-arm and it could be
mounted on a ceiling or on the floor stand. Recall # Z-2448-2010; 2)
BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10,
FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. The BIPLANE
system has two C-arms and it allows the operator to image in two planes:
Lateral and Frontal. It has a C-arm on the stand and C-arm suspended
from the ceiling. Recall # Z-2449-2010
MANUFACTURER: Recalling Firm: Philips Medical Systems – North America
Co. Phillips, Bothell, WA, by letters on February 4, 2010.Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is ongoing.
REASON: A lock-up might occur inside the Velara Generator due to
intermittent shorts inside the system. The problem could only resolved
by a warm or cold system restart. In exceptional cases the power
converters of the KVmA unit in the generator are damaged and the system
can not be restarted.
PRODUCT
1) MAC Two-Lumen Central Venous Access kit with Integral Hemostasis
Valve for use with 7 - 8 Fr. Catheters. Product # AK-11142-B. Recall #
Z-2488-2010; 2) Two-Lumen Central Venous Catheterization kit with Blue
FlexTip Catheter (Sharps Safety Features). Product # AK-12702-SP. Recall
# Z-2489-2010; 3) Multi-Lumen Central Venous Catheterization kit with
Blue FlexTip Catheter (Sharps Safety Features). Product # AK-15703-BCDC.
Recall # Z-2490-2010; 4) Multi-Lumen Pressure Injectable Central Venous
Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue PLUS
Catheter and Sharps Safety Features. Product # ASK-42703-PSBM. Recall #
Z-2491-2010; 5) Two-Lumen Central Venous Catheterization kit with Blue
FlexTip Catheter, ARROW g+ard Blue Catheter. Product # CA-22702. Recall
# Z-2492-2010; 6) Two-Lumen Central Venous Catheterization kit with Blue
FlexTip ARROW g+ard Blue PLUS Catheter, Sharps Safety Features, and
Maximal Barrier Precautions. Product # CDC-45802-B1A. Recall #
Z-2493-2010; 7) Arterial Catheterization Set. Product # CK-04018. Recall
# Z-2494-2010; 8) Femoral Artery Catheterization Set. Product #
GH-04150. Recall # Z-2495-2010; 9) Two-Lumen Central Venous
Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter. Product
# NR-22802-B. Recall # Z-2496-2010
MANUFACTURER: Arrow International, Inc., Reading, PA, by letter dated
July 23, 2010. Firm initiated recall is ongoing.
REASON: Incorrectly assembled 18 Ga x 2 ½ Introducer Needle.
PRODUCT
1) Bond Ready-To-Use Primary Antibody Thyroid Transcription Factor-1
(SPT24); 7 mL vial; an in vitro diagnostic reagent for the qualitative
identification by light microscopy of human thyroid transcription
factor-1 in formalin-fixed, paraffin- embedded tissue by
immunohistochemical staining using the automated Bond system; Catalog
No.: PA0364. Recall # Z-2497-2010; 2) Lyophilized Mouse Monoclonal
Antibody Thyroid Transcription Factor-1; 0.1 mL and 1 mL lyophilized
tissue culture supernatant in vials; an in vitro diagnostic reagent for
the qualitative identification by light microscopy of thyroid
transcription factor-1 molecules in paraffin-embedded tissue by
immunohistochemical staining; Catalog No.: NCL-TTF-1. Recall #
Z-2498-2010; 3) Liquid Mouse Monoclonal Antibody Thyroid Transcription
Factor-1; 1 mL liquid tissue culture supernatant in a 1 mL vial; an in
vitro diagnostic reagent for the qualitative identification by light
microscopy of thyroid transcription factor-1 molecules in
paraffin-embedded tissue by immunohistochemical staining; Catalog No.:
NCL-L-TTF-1. Recall # Z-2499-2010
MANUFACTURER: Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL,
by letter dated July 28, 2010.Manufacturer: Leica Biosystems Newcastle
Ltd., Newcastle Upon Tyne, UK. Firm initiated recall is ongoing.
REASON: In combination with a sensitive polymer detection system, the
TTF-1 antibodies may stain additional tumor types other than is
currently indicated on the instructions for use.
PRODUCT
GreenLight HPS fiber optics, Model Number 10-2090. Potentially
Mislabeled as GreenLight PV 10-2079. Recall # Z-2502-2010
MANUFACTURER: AMS Innovative Center – San Jose, San Jose, CA, by letter
on January 12, 2010. Firm initiated recall is ongoing.
REASON: Product may be packed with incorrect external or internal labels
and/or missing product insert.
PRODUCT
GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only. Recall #
Z-2503-2010
MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letter,
e-mail, Fax beginning August 5, 2010. Firm initiated recall is ongoing.
REASON: Breech in the sterile barrier.
PRODUCT
1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600. Recall #
Z-2504-2010; 2) Modular Microplasty Cup impactor 1/4" - 28 thread
insert, REF 31-400605. Recall # Z-2505-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters on July 28, 2010.
Firm initiated recall is ongoing.
REASON: There was a clerical error in order entry which resulted in the
recalling firm receiving spring components from a supplier made of
"music wire" The recalling firm conducted tests to determine the effects
of the change in materials. The testing showed that the wire would
oxidize and there would be early failure of the device.
PRODUCT
Concept Grafix Tendon Stripper. REF TS8850. 7.0MM, Qty 1. Rx Only,
Non-Sterile, Made In USA. Recall # Z-2585-2010
MANUFACTURER: Linvatec Corp. dba ConMed Linvatec, Largo, FL, by letters
on January 29, 2010. Firm initiated recall is ongoing.
REASON: There is a possibility that the device may exhibit Hydrogen
Embrittlement in the material and are subject to potential breakage.
PRODUCT
Engenex Non Acute Care Suction Cup for use with Engenex Negative
Pressure Wound Therapy. 1) Product Order Number: #446600 (post acute);
2) Product Order Number: 446610 (acute); 3) Product Order Number: 446620
(demo unit). Recall # Z-2609-2010
MANUFACTURER: Recalling Firm: Convatec, Inc., Skillman, NJ, by letters
on July 9, 2010.Manufacturer: Boehringer Wound Systems, LLC, Norristown,
PA. Firm initiated recall is ongoing.
REASON: Reduced vacuum capacity has been reported with a small number of
units caused by electrostatic discharge (ESD) or static electricity.
PRODUCT
1) AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:
6066. Recall # Z-2656-2010;2) Sterile Impad Rigid Sole Foot Cover, Left
Foot Product Code: 6067. Recall # Z-2657-2010
MANUFACTURER: Recalling Firm: Covidien LP, Mansfield, MA, by letter
beginning August 11, 2010.Manufacturer: Arrow Medical Limited,
Herefordshire, UK. Firm initiated recall is ongoing.
REASON: Covidien issued an Urgent Product Recall of the Sterile ImPad
Rigid Sole Foot Cover. The product is indicated for prevention of blood
pooling in the limb. 120 cases of each Lot code 6066 (right foot) and
6067 (left foot) were shipped to the distributor before sterilization.
PRODUCT
Access Immunoassay Systems Free T4, Part Number: 33880. Recall #
Z-2658-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, letter was
sent on March 24, 2010.Manufacturer: Beckman Coulter, Inc., Chaska, MN.
Firm initiated recall is ongoing.
REASON: Kit boxes for Access Free T4 reagent (REF 33880), lot number
916293 may contain reagent packs labeled as Access Vitamin B12, (REF
33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot
916277, filled with Access Free T4 reagents may generate incorrect
patient results.
CLASS III
PRODUCT
1) UCG Slide Test; Rapid latex agglutination inhibition slide test for
the detection of hCG in urine. Used in the diagnosis of pregnancy.
Recall # Z-2500-2010; 2) UCG Beta Slide Monoclonal II is a latex
agglutination inhibition slide test for the detection of hCG in urine.
This test is used for the diagnosis of pregnancy. Recall # Z-2501-2010
MANUFACTURER: Recalling Firm: Inverness Medical Professional
Diagnostics, Princeton, NJ, by letters on February 12,
2010.Manufacturer: NERL Diagnostics Corp., East Providence, RI. Firm
initiated recall is ongoing.
REASON: Specific lots no longer meet their stated limit of detection
claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the
UCG-Beta Slide Monoclonal II test.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
October 13, 2010
CLASS II
PRODUCT
Medtronic StealthStation S7 System. Recall # Z-2029-2010
MANUFACTURER: Medtronic Navigation, Inc., Louisville, CO, by letter on
Jun 14, 2010. Firm initiated recall is ongoing.
REASON: Excessive wear at the power cord retractor or incorrect assembly
of the power plug may cause sparking, intermittent loss of power, or
electrical shock.
PRODUCT
1) DePuy ASR 100 Acetabular Implant, 44 mm, 999800744, non-sterile.
Recall # Z-2031-2010;
2) DePuy ASR 100 Acetabular Implant, 46 mm, 999800746, non-sterile.
Recall # Z-2032-2010;3) DePuy ASR 100 Acetabular Implant, 48 mm,
999800748, non-sterile. Recall # Z-2033-2010; 4) DePuy ASR 100
Acetabular Implant, 50 mm, 999800750, non-sterile. Recall # Z-2034-2010;
5) DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, non-sterile.
Recall # Z-2035-2010; 6) DePuy ASR 100 Acetabular Implant, 54 mm,
999800754, non-sterile. Recall # Z-2036-2010;7) DePuy ASR 100 Acetabular
Implant, 56 mm, 999800756, non-sterile. Recall # Z-2037-2010; 8) DePuy
ASR 100 Acetabular Implant, 57 mm, 999890157, non-sterile. Recall #
Z-2038-2010;9) DePuy ASR 100 Acetabular Implant, 58 mm, 999800758,
non-sterile. Recall # Z-2039-2010; 10) DePuy ASR 100 Acetabular Implant,
66 mm, 999805966, non-sterile. Recall # Z-2040-2010; 11) DePuy ASR 100
Acetabular Implant, 60 mm, 999800760, non-sterile. Recall # Z-2041-2010;
12) DePuy ASR 100 Acetabular Implant, 62 mm, 999800762, non-sterile.
Recall # Z-2042-2010; 13) DePuy ASR 100 Acetabular Implant, 64 mm,
999805764, non-sterile. Recall # Z-2043-2010; 14) DePuy ASR 100
Acetabular Implant, 68 mm, 999806168, non-sterile. Recall # Z-2044-2010;
15) DePuy ASR 100 Acetabular Implant, 70 mm, 999806370, non-sterile.
Recall # Z-2045-2010; 16) DePuy ASR 300 Acetabular Implant, 44 mm,
999830744, non-sterile. Recall # Z-2046-2010; 17) DePuy ASR 300
Acetabular Implant, 46 mm, 999830746, non-sterile. Recall # Z-2047-2010;
18) DePuy ASR 300 Acetabular Implant, 48 mm, 999830748, non-sterile.
Recall # Z-2048-2010; 19) DePuy ASR 300 Acetabular Implant, 50 mm,
999830750, non-sterile. Recall # Z-2049-2010; 20) DePuy ASR 300
Acetabular Implant, 52 mm, 999830752, non-sterile. Recall #Z-2050-2010;
21) DePuy ASR 300 Acetabular Implant, 54 mm, 999830754, non-sterile.
Recall # Z-2051-2010; 22) DePuy ASR 300 Acetabular Implant, 56 mm,
999830756, non-sterile. Recall # Z-2052-2010; 23) DePuy ASR 300
Acetabular Implant, 58 mm, 999830758, non-sterile. Recall #
Z-2053-2010;24) DePuy ASR 300 Acetabular Implant, 60 mm, 999830760,
non-sterile. Recall # Z-2054-2010;25) DePuy ASR 300 Acetabular Implant,
62 mm, 999830762, non-sterile. Recall # 2055-2010;26) DePuy ASR 300
Acetabular Implant, 64 mm, 999830764, non-sterile. Recall #
Z-2056-2010;27) DePuy ASR 300 Acetabular Implant, 66 mm, 999830766,
non-sterile. Recall # Z-2057-2010;28) DePuy ASR 300 Acetabular Implant,
68 mm, 999830768, non-sterile. Recall # Z-2058-2010;29) DePuy ASR 300
Acetabular Implant, 70 mm, 999830770, non-sterile. Recall # Z-2059-2010
MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by
letter on October 29, 2009Manufacturer: Depuy International Ltd., Leeds,
United Kingdom. Firm initiated recall is ongoing.
REASON: Notification to clinicians of new revision rate data/information
regarding the use of the device. As part of the post-market
surveillance, DePuy is continually evaluating data from a variety of
sources including national joint replacement registries, published
literature, company sponsored clinical trials, internal complaints data
and unpublished clinical research reports. As part of the post-market
surveillance activities, the firm recently received and analyzed new
data regarding the ASR platform which suggests a higher than expected
revision rate for the ASR XL Monoblock Metal-on-Metal (MoM) System
linked to usage of monoblock MoM cups with corresponding head sizes
below 50mm in diameter. As a result of the findings, DePuy Orthopaedics
issued a Field Safety Notice to share the new data with the surgeons and
reiterate the importance of correct implant positioning and patient
selection in achieving optimal implant performance and survivorship.
Reasons for revision are typical for the class of large diameter MoM
monoblock cups and includes component loosening, component malalignment,
infection, pain, fracture, dislocation and metal sensitivity.
PRODUCT
One Touch Ultra Test Strips, Part Number 020-245-32, Manufactured
between September 10, 2009 and September 24, 2009, distributed between
September 30, 2009 and October 27, 2009. Recall # Z-2639-2010
MANUFACTURER: Lifescan, Inc., Milpitas, CA, by letter during the first
week of February 2010. Firm initiated recall is ongoing.
REASON: One Touch Ultra Test Strip products may actually contain a
different product, One Touch Select strips.
PRODUCT
Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1D-F08E (designed to
be used with Olympus endoscopic equipment). Recall # Z-2642-2010
MANUFACTURER: Recalling Firm: Olympus America Inc., enter Valley, PA, by
letter August 20, 2010.Manufacturer: Shirakawa Olympus Co., Ltd.,
Nishishirakawa –Gun. Firm initiated recall is ongoing.
REASON: Mislabeled. Endoscopic body-type camera heads labeled as
cardiac-type.
CLASS III
PRODUCT
Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL
glass vials. Recall # Z-2025-2010
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., BD Diagnostic
Systems, Sparks, MD, by fax and e-mail on May 19, 2010.Manufacturer:
Becton Dickinson, Grayson, GA. Firm initiated recall is ongoing
REASON: In vitro diagnostic reagent to aid in the diagnosis of
Salmonellosis may exhibit decreased or no reactivity. If proper controls
are run with the lot in question, it would become apparent that the
antigen is non reactive and patient specimen results should not be
reported. If control testing is not performed a salmonella-infected
patient could go undiagnosed, with possible adverse effects.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
October 06, 2010.
CLASS I
PRODUCT
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx
only, single use, latex free: Catalog number: 7CBD10. Recall #
Z-2425-2010
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro,
NJ, by fax, e-mail and letter on July 2, 2010. Manufacturer: Integra
Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated
recall is ongoing.
REASON: Certain NeuroBalloon Catheters have the potential to improperly
inflate or deflate under certain conditions.
CLASS II
PRODUCT
Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent
Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack.
Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and
3000T instruments within the Product Effect. Recall # Z-2423-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter in May 2010. Firm initiated recall is ongoing.
REASON: Defective batteries used in the Alpha Pinnacle P10 UPS External
Battery Pack may overheat and cause a strong sulfuric odor to be
released and a corrosive sulfuric acid solution leak to occur.
PRODUCT
NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4),
immunochemistry Reagent and Kit, For In Vitro Diagnostic use. Catalog
number RM-910. Recall # Z-2424-2010
MANUFACTURER: Lab Vision Corp., Fremont, CA, by letter dated March 5,
2010. Firm initiated recall is ongoing.
REASON: Two lots may be contaminated with Ki-67 antibody, which could
cause abnormal staining patterns, and produce false positive results.
PRODUCT
Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator
Tampons, UPC #0-57800-23314-5. Recall # Z-2466-2010
MANUFACTURER: First Quality Hygienic Inc., Elhattan, PA, via telephone
and letter on March 25, 2010. Firm initiated recall is ongoing.
REASON: Life Brand Regular Absorbency 40 Count Unscented Plastic
Applicator Tampons package contained Super Plus Unscented Plastic
Applicator Tampons.
PRODUCT
Driver Star #8 Cannulated Dart-Fire (TM), Compression Screw, Size: #8,
REF: DSDS-0008, 1 Each, Rx only Non-Sterile, EC REP. Recall #
Z-2470-2010
MANUFACTURER: Recalling Firm: Wright Medical Technology Inc., Arlington,
TN, by letter on August 26, 2010. Manufacturer: Southeastern Technology
Inc., Murfreesboro, TN. Firm initiated recall is ongoing.
REASON: After autoclaving, the epoxy identifier (colored) band bled and
there is concern that it may flake.
PRODUCT
1) 7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727,
Sterile. Usage: Bone Coring Device used in ACL and PCL procedures.
Recall # Z-2597-2010;2) 8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION
SLEEVE, REF 900728, Sterile. Usage: Bone Coring Device used in ACL and
PCL procedures. Recall # Z-2598-2010;3) 9 MM DISPOSABLE CORING TREPHINE
WITH PROTECTION SLEEVE, REF 900729, Sterile. Usage: Bone Coring Device
used in ACL and PCL procedures. Recall # Z-2599-2010;4) 10 MM DISPOSABLE
CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile. Usage: Bone
Coring Device used in ACL and PCL procedures. Recall # Z-2600-2010;5) 7
MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737,
Sterile. Usage: Bone Coring Device used in ACL and PCL procedures.
Recall # Z-2601-2010;6) 8 MM
DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738,
Sterile. Usage: Bone Coring Device used in ACL and PCL procedures.
Recall # Z-2602-2010;7) 9 MM DISPOSABLE DOWEL HARVEST TUBE WITH
PROTECTION SLEEVE, REF 900739, Sterile. Usage: Bone Coring Device used
in ACL and PCL procedures. Recall # Z-2603-2010;8) 10 MM DISPOSABLE
DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile. Usage:
Bone Coring Device used in ACL and PCL procedures. Recall #
Z-2604-2010;9) 8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH
PROTECTION SLEEVE, REF 900788, Sterile. Usage: Bone Coring Device used
in ACL and PCL procedures. Recall # Z-2605-2010
MANUFACTURER: Biomet, Inc. Warsaw, IN, by letters dated July 1, 2010 and
July 15, 2010. Firm initiated recall is ongoing.
REASON: The affected instruments are discolored and/or have a sticky
residue on the end.
PRODUCT
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered
Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028,
CEOT032; and as single sterile units with product codes CV-164275,
164275 and 164275X. CV-164275 is an item number for product that is sold
to foreign affiliate. Usage: The Sarns Centrifugal Pump (with X-Coating)
is indicated as an extracorporeal blood pump for use in cardiopulmonary
bypass procedures. Recall # Z-2606-2010
MANUFACTURER: Terumo Cardiovascular Corp., Elkton, MD, by telephone,
fax, email and mail on March 15, 2010 and May 17, 2010. Firm initiated
recall is ongoing.
REASON: Medical device component may malfunction and require user
intervention during surgical bypass procedures.
PRODUCT
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage:
The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides
materials for the quantitative measurement of IGFBP-3 in serum. This
assay is intended for in vitro diagnostic use. Recall # Z-2607-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
on August 09, 2010.Manufacturer: Diagnostic System Laboratories Inc.,
Webster, TX, Firm initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter confirmed
customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF
DSL-6600) lots identified above may result in IGFBP-3 levels that are
not in agreement with simultaneously measured levels of IGF-1. The
investigation confirmed that above mentioned lots of IGFBP-3 kit provide
results elevated by 84% on average. Erroneously elevated IGFBP-3
results, when not reviewed in the light of additional tests (e.g.,
IGF-1) and the patient's clinical status and history, may affect
clinical decisions and patient safety, leading to inadequate
administration of growth hormone.
PRODUCT
Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, 110 cm
length. Recall # Z-2608-2010
MANUFACTURER: Vascular Solutions, Inc., Maple Grove, MN, letter dated
September 1, 2010. Firm initiated recall is ongoing.
REASON: Recently, it was reported that pouches containing Langston
Pigtail catheter (Model 5540) were missing a seal, posing a risk of
product contamination. It is possible that a compromised sterile barrier
could go unnoticed and the contaminated product could be used on a
patient. Use of contaminated product could lead to an infection possibly
requiring medication, hospitalization and/or medical intervention.
Although there have been no reports of adverse patient events related to
this problem considering the potential for harm, Vascular Solutions will
remove and replace the affected Langston catheters.
PRODUCT
Access Immunoassay Systems Free T4, Part Number: 33880. Recall #
Z-2658-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
on March 24, 2010. Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm
initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter determined that
kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may
contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot
916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled
with Access Free T4 reagents may generate incorrect patient results.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of recalls as of
September 29, 2010
CLASS II
PRODUCT:
1) Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to
monitor vital signs of neonatal, pediatric, and adult patients for
bedside and transport applications. Catalog Number: MS18597. Recall #
Z-2283-20102) Infinity Delta/Gamma X XL Patient Monitor. Portable
monitor used to monitor vital signs of neonatal, pediatric, and adult
patients for bedside and transport applications. Catalog Number:
MS18852. Recall # Z-2284-2010
MANUFACTURER: Draeger Medical Systems, Inc., Telford, PA, by letters on
June 4, 2010. Firm initiated recall is ongoing.
REASON : Monitor keys may become inoperative or activate spontaneously.
This may cause a membrane switch panel malfunction, which could result
in the monitor discharging a patient automatically.
PRODUCT:
1) Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG
BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus
Synthetic Absorbable Surgical Sutures intended uses are in general
surgical procedures where general soft tissue approximation and/or
ligation are performed, including use in ophthalmic procedures, but not
for use in cardiovascular and neurological procedures. Catalog Number:
EP4084N. Recall # Z-2286-2010;2) Deknatel Bondek Plus Polyglycolic
Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex
Medical. Catalog Number: EP1081P. Recall # Z-2287-2010
MANUFACTURER: Recalling Firm: Telefelx Medical, Durham, NC, by letter
dated February 1, 2010. Manufacturer: Teleflex Medical, Nueva Laredo,
Mexico. Firm initiated recall is ongoing.
REASON : Labeling error; The Bondek Suture product inside the box are of
a different catalog number than labeled on the outer box.
PRODUCT:
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table
used on patients for massage and chiropractic treatment. Recall #
Z-2288-2010
MANUFACTURER: Recalling Firm: MDC Acquisition Co., Rancho Cucamonga, CA,
by letters in April 2010.Manufacturer: Huangshan City Shexian Comfort
Massanage Applia, Huangshan, China. Firm initiated recall is ongoing.
REASON : Two complaints were received of the vinyl-covered, padded,
plywood table surface breaking near the foot end.
PRODUCT:
Zimmer ITST" Intertrochanteric/Subtrochanteric Fixation Locking Bolt
Extractor - Nonsterile. The ITST Intertrochanteric/Subtrochanteric
Fixation Locking Bolt Extractor instrument is a reusable surgical
instrument used to separate the femoral nail from the locking bolt after
nail implantation/fixation in trauma surgeries. Catalog No.
00-2258-051-01. Recall # Z-2289-2010
MANUFACTURER: Zimmer Inc., Warsaw, IN, by letters dated July 8, 2010.
Firm initiated recall is ongoing.
REASON : Instruments were manufactured with the incorrect grade of
steel, increasing the potential for fracture during use.
PRODUCT:
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal
Monitoring Electrode #V2560, used for ECG monitoring. Recall #
Z-2383-2010
MANUFACTURER: Recalling Firm: 3M Company, Medical Division, Saint Paul,
MN, by letters dated July 29, 2010.Manufacturer: 3M Canada Co., Morden
Manitoba, Canada. Firm initiated recall is ongoing
REASON : The sensing element of the 3M Red Dot Monitoring Electrode,
Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may
have corrosion. In an emergency situation where defibrillation is
necessary and electrodes are already in use, the electrodes may
malfunction and provide a delayed or no trace response.
PRODUCT:
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N-
acetylprocainamide reagent. Recall # Z-2386-2010
MANUFACTURER: Roche Diagnostics Operations, Inc., Indianapolis, IN, by
letter dated February 2010. Firm initiated recall is ongoing.
REASON : The N-acetylprocainamide reagent lot 14456200 shows an
incorrect expiration date of 7/31/2011. The correct expiration date for
the lot is 1/31/2011.
PRODUCT:
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part
Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel
DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel
DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ). Recall
# Z-2388-2010
MANUFACTURER: Beckman Coulter Inc., Brea, CA, by letter dated April
2010. Firm initiated recall is ongoing.
REASON : UniCel DxC and Synchron LX instruments produced inaccurate
(low) GLUCm results. False low results could affect or delay diagnosis
or treatment.
PRODUCT:
1) Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq
One-Channel Infuser, List Number Configurations: 16026-04-01/03/04,
51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26,
53/54. Recall # Z-2390-2010;2) Hospira brand Symbiq Two-Channel Infuser,
LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations:
16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90
16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54. Recall #
Z-2391-2010
MANUFACTURER: Hospira, Inc. Morgan Hill, CA, by letter dated February
22, 2010. Firm initiated recall is ongoing.
REASON : The clamp may not secure to the IV pole and the pump may slip
or fall off. The pump may fall on a person or pull the tubing out of the
IV container.
PRODUCT:
BIOMET MICROFIXATION REF: 02-0461 Rees Insulated Forceps, 21CM, (8.25")
(L), Stainless steel, nylon, ***Non-Sterile Product***. The Rees
Insulated Forceps are used during surgery to grasp, dissect and
coagulate selected tissue. Recall # Z-2392-2010
MANUFACTURER: Recalling Firm: Biomet Microfixation, Inc., Jacksonville,
FL, by letter dated July 2010.Manufacturer: Egon Faulhaber Pinzetten,
Frittlingen, Germany. Firm initiated recall is ongoing
REASON : The forceps insulation may have cracks or breaks in the
insulation that may cause burns to patients when used.
PRODUCT:
Clinical Chemistry Phosphorus assay. Recall # Z-2398-2010
MANUFACTURER: Abbott Laboratories Inc., South Pasadena, CA, by letter
dated May 4, 2010. Firm initiated recall is ongoing.
REASON : Product may give inaccurate results and aspiration errors with
reagent configuration, including results outside of linear range &
calibration failure.
PRODUCT:
The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of
specimens while minimizing contamination of the abdominal cavity or
wound tract. The system contains one (1) Sac and one (1) obturator in a
sterile, ready -to -use, single- use procedure tray. Recall #
Z-2436-2010
MANUFACTURER: Recalling Firm: Gyrus Acmi, Inc., Southborough, MA, by
telephone on August 3, 2010.Manufacturer: Gyrus Medical, Inc., Osseo,
MN. Firm initiated recall is ongoing.
REASON : A manufacturing error in the production of the trays used in
this lot, it is possible that a crack could form that would compromise
the package integrity, and possibly the sterility of the packaged
device.
PRODUCT :
1) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner
Diameter: 5 mm (3/16"), Length: 1.8 m (6 ft.); Sterile, for single use
only, 50 tubes per case; Made in Mexico; catalog N56A and NEX56A
(European label). Recall # Z-2450-2010;2) Medi-Vac Non-Conductive
Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"),
Length: 3.0 m (10 ft.); Sterile, for single use only, 50 tubes per case;
Made in Mexico; catalog N510 and NEX510 (European label). Recall #
Z-2451-2010;3) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip
Connectors, Inner Diameter: 5 mm (3/16"), Length: 3.6 m (12 ft.);
Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog
N512 and NEX512 (European label). Recall # Z-2452-20104) Medi-Vac
Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6
mm (1/4"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes
per case; Made in Mexico; catalog CN6 and NEX (European label). Recall #
Z-2453-2010;5) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip
Connectors, Inner Diameter: 6 mm (1/4"), Length: 3.0 m (10 ft.);
Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog
N610 and NEX610 (European label). Recall # Z-2454-2010;6) Medi-Vac
Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6
mm (1/4"), Length: 3.6 m (12 ft.); Sterile, for single use only, 50
tubes per case; Made in Mexico; catalog N612 and NEX612 (European
label). Recall # Z-2455-2010;7) Medi-Vac Non-Conductive Suction Tube
with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m
(6 ft.); Sterile, for single use only, 50 tubes per case; Made in
Mexico; catalog N76A and NEX76A (European label). Recall #
Z-2456-2010;8) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip
Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.0 m (10 ft.);
Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog
N710 and NEX710 (European label). Recall # Z-2457-2010;9) Medi-Vac
Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7
mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Made
in Mexico; catalog N712 and NEX712 (European label). Recall #
Z-2458-201010) All Presource Kits that contain Medi-Vac Non-Conductive
Suction Tube with Maxi-Grip Connectors; Sterile, for single use only;
Presource Kits are custom packaged kits that contain various products as
requested by specific hospital it’s made for. All work orders
manufactured with the affected Medi-Vac Non-Conductive Tubing (all lots
prior to Y10K) of the following Presource Kit Catalog numbers:
AD4410346A, ADPVT0137A, AN1440132G, AN1BC8765K, AN1HD00401, AN1HD00402,
AN1HD00403, AN1HD0040A, AN1HD0040D, AN1HD0040E, AN1HD0040F, AN1VB8550A,
AN1W11505D, AN2BC87651, AN2BC8765G, ANE228891D, ANE336899B, ANE336899C,
ANE337178H, ANE411105A, ANE445297A, ANE451348E, ANE451348F, ANECG3266B,
ANEHD0040B, ANEHD0040D, ANEHD0040E, ANEHD0040F, ANEVF0839B, ANEVM0722I,
ANEVM0722J, ANEVM0722K, ANEVP6706A, ANEVP6706B, BA1BC87651, BA1BC87652,
BA1BC8765P, BA1BC8765Q, BA1BC8765T, BA1VT3436K, BA1VT3436M, BA1VT3436N,
BA1VT3436P, BA1VT3436R, BABV85615A, BABV85615B, CA1732289D, CA1734322B,
CAN10-I962, CAN213585A, CAN410130A, CAN410130B, CAN481521B, CAN482677A,
CAN485373A, CAN733718D, CANOC3718A, ENTVP6706A, MA1MH5297A, MAT955327B,
MAT955327C, MATCG0045A, MATV16666C, MATV16666D, OM4410346A, OMSCG3091A,
OMSOC0110A, OR1CN0084A, OR1CN0084B, OR1CN0084C, ORCHF5342A, OREVM0726A,
OREVM0726B, OREVM0726C, ORP593693A, ORPCN0084A, ORPCN0084B, ORPCN0084C,
ORPCN0084D, ORPHF5342A, ORPHF5342B, ORPHF5342E, ORPHF5342G, ORPVM0726F,
ORPVM0726G, ORPVM0726H, OUTHF5342A, OVC241104I, OVC241104J, OVC241104K,
OVC241104L, OVC241104M, OVC336813A, OVCHF1259A, OVCHF1259B, OVCHF1259C,
OVCHF1259D, OVCHF1259E, PAJVGAME1, PAJVGAMEO, PAJVGAMEP, PAJVPAMMJ,
PAMHAAFBC, PAMHAAFBD, PAMHGAMCF, PAMHGAMCG, PB12ABWCJ, PB12ABWCK,
PB12ABWCL, PB12DCWCG, PB12DCWCH, PB12PEWCJ, PB12PEWCK, PB23LASMD,
PB23LASMF, PB23LASMG, PB23LASMH, PB23LASMI, PB23MGWOE, PB23TASAA,
PB23TASAB, PB23TASAC, PB23TASAD, PB23TASAE, PB23VHGMA, PB24GLGMG,
PB24HYGMH, PB24LIGML, PB24LISMC, PB24LISMD, PB24LISME, PB24LISMF,
PB24LISMG, PB24LSSMD, PB24LSSME, PB24LSSMF, PB24MLSMC, PB24MLSMD,
PB24MLSME, PB24MLSMG, PB2GLSPHC, PB2GOTPHB, PB30GYPRA, PB30GYPRB,
PB30GYPRC, PB30MGPR1, PB30MGPRA, PB30MGPRB, PB33OTMWA, PB35DCSTA,
PB35LSPH1, PB35LSPHA, PB35LSPHB, PB35OTPHA, PB41LSCNA, PB41MJCN1,
PB41MJCNA, PB41THNRH, PB46CSSHC, PB46CSSHD, PB46CSSHF, PB46CSSHG,
PB46CSSHH, PB46CSSHJ, PB54JVREE, PB54LSREC, PB60DCLHJ, PB60LSLH5,
PB60LSLHV, PB60LSLHW, PB69ABEHB, PB69CSEHC, PB69CSEHD, PB69MAEHB,
PB69VGEHD, PB73GLSJN, PB73GLSJO, PB73LSUHR, PB73LTUHS, PB73MJSBK,
PB73MJSBL, PB73MJSBM, PB73MJSBN, PB73MJSBO, PB73MJSBP, PB73MJSBQ,
PB7CDCYNA, PB7CDCYNB, PB7CDCYND, PB7CLVAS1, PB7CLVASA, PB7CLVASB,
PBCGCSCD3, PBCGCSCD4, PBCGCSCDL, PBCGCSCDN, PBCGCSCDO, PBCGCSCDP,
PBCGCSCDR, PBCGDCMJH, PBCGDCMJI, PBCGDCMJJ, PBCGGAMRB, PBCGGAMRC,
PBCGGAMRD, PBCGGAMRE, PBCGHYMRB, PBCGHYMRC, PBCGHYMRD, PBCGLSMJL,
PBCGLSMJM, PBCGLSMJN, PBCGLSMJO, PBCGLSMJP, PBCGLVMHC, PBCGLVMHF,
PBCGLVMHG, PBCGLVMHH, PBCGLVMHI, PBCGMJMRB, PBCGMJMRC, PBCGMJMRD,
PBCGMJMRE, PBCGMLMRB, PBCGMLMRC, PBCGMLMRD, PBCGMLMRE, PBHDHSCHB,
PBHDHSCHC, PBHDJVSUI, PBHDMAWAF, PBHFCSLR5, PBHFCSLRG, PBHFCSLRH,
PBHFCSLRI, PBHFCSLRJ, PBHFCSLRK, PBJVAD001, PBJVAD00J, PBMHAHESG,
PBMHCSESF, PBMHCSESG, PBMHCSESH, PBMHCSESI, PBMHCSESJ, PBMHCSESK,
PBMHCSESL, PBMHCSESN, PBMHCSWD1, PBMHCSWDF, PBMHCSWN3, PBMHCSWN4,
PBMHCSWND, PBMHCSWNE, PBMHCSWNG, PBMHCSWNH, PBMHCSWNI, PBMHDCFBF,
PBMHHSBHD, PBMHVDESB, PBMHVDESC, PBMHVDESE, PBMHVDESF, PBMHVDESG,
PBMHVDFBE, PBMHVDMH1, PBMHVDMHD, PBMHVDMHE, PBMHVDMHF, PBMHVDMHG,
PBOCCSVBH, PBOCCSVBI, PBOCCSVBJ, PBOCCSVBK, PBOCCSVBM, PBOCCSVBL,
PBOCCSVBN, PBOCCSVBO, PBOCCSVBP, PBOCCSVBQ, PBOCLSSNM, PBOCLSSNN,
PBOCLSSNO, PBOCOTANS1, PBOCOTANSH, PBOCOTHOQ, PBOCOTHOR, PBOCOTHOS,
PBOCOTHOU, PBV1ABFSS, PBV1DCFSJ, PBV1VHFSH, PBV8DCVAT, PBV8DCVAU,
PBV8LSVAT, PBV8LSVAU, PBV8LSVAV, PBVBSCNMD, PBVBSCNME, PBVBSCNMF,
PBVBSCNMG, PBVBSCNMH, PBVBSCNMI, PBVBSCNMJ, PBVZOTMBH, PBW1LSOMS,
PC12MCWCK, PC12MCWCL, PC12OHWCP, PC12OHWCQ, PC12OHWCR, PC12OHWCS,
PC12OHWCT, PC12OHWCU, PC12OHWCV, PC12OVWCQ, PC12OVWCS, PC12OVWCT,
PC12OVWCU, PC12OVWCV, PC12VAWCL, PC12VAWCM, PC13OH60B, PC13OHCA1,
PC13OHCAC, PC13OHCAD, PC13OHCAE, PC13OHEM6, PC13OHEMS, PC13OHEMU,
PC13OHEMX, PC13OHEMY, PC13OHEMZ, PC13OPEME, PC13OPEMF, PC13OPEMG,
PC13OPEMJ, PC13OPEMK, PC21AOUHA, PC21CGUHA, PC22HEMCH, PC22HTHCC,
PC22HTHCD, PC22HTHCE, PC22HTHCG, PC22HTHCH, PC22HTHCI, PC23CACVG,
PC23HSSM1, PC23HSSMG, PC23HSSMH, PC23HSSMI, PC23HSSMJ, PC23HSSMK,
PC23HSSML, PC23HSSMM, PC23HSSMN, PC23OHCV1, PC23OHCVB, PC23OHCVF,
PC23OHCVG, PC23OHCVH, PC23OHCVI, PC23OHCVJ, PC23OHCVK, PC23OHCVL,
PC23OHCVM, PC23OHCVN, PC23VSCV1, PC23VSCV2, PC23VSCVJ, PC24FPBP2,
PC24FPBPK, PC24FPBPL, PC24FPBPN, PC24FPBPP, PC24FPBPQ, PC24FPBPR,
PC24MVWRN, PC24OHBPT, PC24OHBPW, PC2GOHPH1, PC2GOHPHD, PC35OHPHA,
PC35OHPHB, PC35OHPHC, PC36MVCRB, PC36MVCRC, PC36MVCRD, PC36MVCRE,
PC36MVCRF, PC36OHCRB, PC36OHCRC, PC36OHCRD, PC13OPEMH, PC36OHCRE,
PC36OHCRF, PC36OHCRG, PC36OHRH1, PC36OHRHA, PC36OHRHB, PC36OHRHC,
PC41CBTQ1, PC41CBTQB, PC41CBTQC, PC41CBTQD, PC41CBTQE, PC41CG117,
PC41CG118, PC41CG119, PC41CG16L, PC41CG16M, PC41CG16N, PC41CG16O,
PC41CG16P, PC41CG16Q, PC41CG16R, PC41CSTCB, PC41CSTCC, PC41CSTCD,
PC41CVHCS, PC41CVHCT, PC41CVHCU, PC41CVHCV, PC41CVHCW, PC41CVHCX,
PC41CVHCY, PC41CVHCZ, PC41OHCN1, PC41OHCNA, PC41OHCNC, PC41OHCND,
PC41OHCNF, PC43CGNOH, PC43CGNOI, PC43CGNOJ, PC43CGSPS, PC43OTLGH,
PC43OTLGI, PC43OTLGJ, PC48OH04A, PC48OH04B, PC48OH04C, PC48OHNB5,
PC48OHNB6, PC48OHNB7, PC48OHNBP, PC48OHNBQ, PC48OHNBR, PC48OHNBU,
PC48OHNBV, PC48OHNBW, PC48OHNBZ, PC48PBNBG, PC48PBNBI, PC48PBNBJ,
PC48PBNBK, PC48PBNBL, PC48PBNBM, PC48TYNBI, PC48TYNBJ, PC48TYNBK,
PC48TYNBL, PC48TYNBM, PC48TYNBN, PC48TYNBO, PC48TYNBP, PC55OHSCO,
PC55OHSCP, PC55OHSCQ, PC55OHSCR, PC55OHSCS, PC55OHSCT, PC55OHSCU,
PC55OHSCV, PC55OHSCW, PC57CG80H, PC57CG80I, PC57CG80J, PC57CG80K,
PC57CG80L, PC57OHLGA, PC57OHLGB, PC57OHLGC, PC57OHLGD, PC57VLSHJ,
PC57VLSHK, PC57VLSHL, PC57VLSHM, PC57VLSHN, PC5FCGGSB, PC5FCGGSC,
PC60OHANBE, PC60OHANBF, PC60OHANBG, PC60OHANBH, PC60OHANBI, PC63ODHAC,
PC63ODHAD, PC69OHKSC, PC69OHKSD, PC69OHKSE, PC69OHKSF, PC69OHRMA,
PC69OHRMB, PC69OHRMC, PC69OHRMD, PC73AOUHV, PC73MJ816, PC73MJ817,
PC73MJ818, PC73MJ81F, PC73OH81L, PC73OHCM1, PC73OHCM2, PC73OHCM3,
PC73OHCM4, PC73OHCMB, PC73OHCMC, PC73OHCMD, PC73OHCME, PC73OHCMF,
PC73OHLUQ, PC73OHLUR, PC73OHLUS, PC73OHLUT, PC73OHLUU, PC73OHLUW,
PCCGAAMJL, PCCGAAMJM, PCCGAAMJN, PCCGAAMJP, PCCGAAMJQ, PCCGAAMJR,
PCCGLVMJ1, PCCGLVMJG, PCCGLVMJI, PCCGLVMJK, PCCGOHABK, PCCGOHABS,
PCCGOHMJ5, PCCGOHMJ6, PCCGOHMJ7, PCCGOHMJ8, PCCGOHMJ9, PCCGOHMJJ,
PCCGOHMJL, PCCGOHMJN, PCCGOHMJO, PCCGOHMJP, PCCGOHMJQ, PCCGOHMJR,
PCCGOHMJT, PCCGOHMJU, PCCGOHMJV, PCCGOTMJM, PCCGOTMJN, PCCGOTMJO,
PCCGOTMJP, PCCGOTMJQ, PCCGOTMJS, PCCNOHLTF, PCCNOHLTG, PCCZABFLH,
PCHBH2BRH, PCHBMJVAG, PCHDOHACHB, PCHDOHACHC, PCHDOHACHD, PCHDOHACHE,
PCHDOHACHF, PCHFBCBFA, PCMHPMBHA, PCMHPMBHB, PCOCMJSNS, PCOCOTSNN,
PCOCOTSNP, PCOCPMSNN, PCRMOTAMUG, PCRMOTAMUH, PCRMOTMUI, PCRMOTMUJ,
PCRMOTMUK, PCV1MVUMF, PCV2CCCPS, PCVAHCSJA, PCVAHCSJB, PCVMAOBJ2,
PCVMAOBJQ, PCVMAOBJR, PCVMAOBJS, PCVMAOBJU, PCVMAOBJV, PCVMAOBJW,
PCVMAOBJX, PCVMOTACRM, PCVMOTACRN, PCVNCG50N, PCVNCGASJU, PCVNOH09A,
PCVNOH09D, PCVTAASWT, PCVTCGNM2, PCVTCGNMR, PCVTCGNMS, PCVTCGNMT,
PDHDKTWCG, PDHDKTWCH, PDHDKTWCI, PDHFLVLUH, PE12BTAKDM, PE12CLLOM,
PE12EA33D, PE12EAKDN, PE12EAKDO, PE12EAWCP, PE12EAWCQ, PE12HN33B,
PE12HNWCI, PE12HNWCJ, PE12MIWCI, PE12MIWCJ, PE12MJWCJ, PE12MJWCK,
PE12NSWCH, PE12NSWCI, PE12TPWCK, PE12TPWCL,PE12TPWCM, PE21HNUHA,
PE21TAHAK, PE23ETWMB, PE23NAXFD, PE23THSM1, PE23THSMB, PE23THSMC,
PE23THSMD, PE24MJSMC, PE24MJSMD, PE24MJSME, PE24MJSMF, PE24TAAACB,
PE24TABMJ, PE24TABMK, PE24TASMB, PE36DNCRB, PE36DNCRC, PE36TACRA,
PE36TACRB, PE36TACRC, PE36TMCH2, PE36TMCHM, PE36TMCHN, PE36TMCHO,
PE43NSNOL, PE46TASPD, PE46TASPE, PE46TAUHJ, PE4ETMCHP, PE54HNYRK,
PE54HNYRL, PE54HNYRM, PE54HNYRN, PE63EMGHA, PE69EAKSA, PE69EAKSB,
PE69EAKSC, PE73NSUH6, PE73NSUHU, PE82EATC2, PE82EATCR, PECGDRMRB,
PECGDRMRC, PECGDRMRD, PECGDRMRE, PECGHNMRB, PECGHNMRC, PECGHNMRD,
PECGHNMRE, PECGNSMRB, PECGNSMRC, PECGNSMRD, PECGNSMRE, PECGTAMRB,
PECGTAMRC, PECGTAMRD, PEHBHNVAH, PEHDETCHA, PEHDETCHB, PEHDNSSUJ,
PEOCNSSHG, PEOCNSSNN, PEOCNSSNP, PERMHNMUQ, PEV1HNFSJ, PEV1NSHHF,
PEV1TAFSJ, PEV1TAFSK, PEV8HNVAA, PEV8HNVAB, PEV8HNVAT, PEV8HNVAU,
PEV8TAVAQ, PEVMNABWB, PEVNSDBGA, PEVZTAMBE, PEW1HNMC1, PEW1HNMCF,
PEW1HNMCG, PEW1HNMCH, PG11GUTMC, PG12BRWCJ, PG12BRWCK, PG12CBWCJ,
PG12CBWCK, PG12COLOC, PG12EGLOD, PG12LGWCA, PG12LGWCB, PG12LGWCC,
PG12LSWCK, PG12LSWCL, PG12LSWCM, PG12MAWCK, PG12MAWCL, PG12MDWCI,
PG12MNWCK, PG12MNWCL, PG12OBSHD, PG12OMWCJ, PG12OMWCK, PG12RCWCJ,
PG12RCWCK, PG15GSFCF, PG15GSFCG, PG15GSFCH, PG15GSFCI, PG15GSFCK,
PG15GSFCL, PG15GSFCM, PG15GSFCN, PG21BBUHA, PG21LBUHA, PG21LGUHA,
PG21MJUHA, PG21OTAUHA, PG21RCHAI, PG23LBSM1, PG23LBSM2, PG23LBSMD,
PG23LBSME, PG23LBSMF, PG23LBSMG, PG23LBSMH, PG23LGSM1, PG23LGSM2,
PG23LGSM3, PG23LGSM4, PG23LGSME, PG23LGSMF, PG23LGSMH, PG23LGSMI,
PG23LGSMJ, PG23LPSME, PG23LPSMG, PG23LPSMH, PG23LPSMI, PG23LPSMJ,
PG23MAGMB, PG23MAGMD, PG23MASAF, PG23MASAH, PG23MBGMB, PG23MBTUL,
PG23MNMPM, PG23MNSMF, PG23MNSMG, PG23MNSMH, PG23MNSMI, PG23MNSMJ,
PG23MNSMK, PG23MNSML, PG23MNSMM, PG23MNSMN, PG24LCBPQ, PG24LGSMD,
PG24LGSME, PG24MAWRR, PG24MNJMP, PG24MNJMT, PG24MPSMD, PG24MPSME,
PG24MPSMF, PG2GLBPHC, PG2GLPPHC, PG30MAPR1, PG30MAPR2, PG30MAPR3,
PG30MAPR4, PG30MAPRA, PG30MAPRB, PG30MAPRC, PG30MJPR1, PG30MJPR2,
PG30MJPR3, PG30MJPRA, PG30MJPRB, PG33LCRVI, PG35LBPHA, PG35LBPHB,
PG35LPPHA, PG35LPPHB, PG40MFDOF, PG41ABHCN, PG41BACN1, PG41BACNA,
PG41ENHMH, PG41ENHMI, PG41ENHMJ, PG41LCHC6, PG41LCHC7, PG41LCHC8,
PG41LCHCR, PG41LCHCS, PG41LCHCT, PG41LCHCU, PG41LCHCV, PG41MANRF,
PG41MNHCB, PG41OTIRA, PG45HNPHK, PG46LBSRH, PG46MASPG, PG46MASPH,
PG46MASPI, PG46MBSPG, PG46MBSPH, PG46MBSPI, PG46MNSPF, PG46MNSPG,
PG46MNSPH, PG46OTSPF, PG46OTSPG, PG46OTUHO, PG47ENSFJ, PG47ENSFK,
PG47ENSFL, PG47ENSFM, PG48AMMIH, PG48BRLSD, PG48BRLSF, PG48LPLSC,
PG4FGSCFB, PG54BKWB2, PG54HNDSD, PG54HNDSE, PG54LCREH, PG54MAREE,
PG54MNDSE, PG54MNRED, PG55LCACMK, PG55LCACML, PG55LCACMM, PG55LCACMN,
PG55LCACMO,PG60MJSMK, PG63BRRV1, PG63BRRVA, PG63BRRVC, G63BRRVD,
PG63BRRVE, PG63GBRVG, PG63LPGHA, PG63MJDHH, PG69LYVCP, PG73BJLUI,
PG73BJLUL, PG73BJLUN, PG73BJLUO, PG73BNLU1, PG73BNLUI, PG73BNLUK,
PG73BNLUL, PG73BNLUM, PG73BNLUN, PG73BNLUO, PG73BNLUP, PG73LPUHU,
PG73MAAUHQ, PG73MASB1, PG73MASBJ, PG73MASBK, PG73MASBL, PG73MASBN,
PG73MASBO, PG73MASBP, PG73MASJT, PG73MNUHR, PG73MPLUE, PG73MPLUF,
PG73MPLUG, PG73MPLUH, PG73MPLUI, PG73OTALU1, PG73OTALUI, PG73OTALUJ,
PG73OTALUK, PG73OTALUL, PG73OTAUHR, PG73PCLUH, PG73PCLUJ, PG73PCLUL,
PG73PCLUN, PG73TGUHT, PG92KDHRA, PG92KDHRB, PG92KDHRC, PGCGBDABD,
PGCGBRMRB, PGCGBRMRC, PGCGBRMRD, PGCGGAMR1, PGCGGAMR2, PGCGGAMR3,
PGCGGAMR4, PGCGGAMR5, PGCGGAMR6, PGCGGAMRB, PGCGGAMRC, PGCGGAMRD,
PGCGGAMRE, PGCGGLMR1, PGCGGLMRB, PGCGGLMRC, PGCGGLMRD, PGCGLBAUC,
PGCGLBMJJ, PGCGLBMJK, PGCGLBMJL, PGCGLBMJM, PGCGLBMJN, PGCGLBMJO,
PGCGLBMJP, PGCGLBMJQ, PGCGLCMRB, PGCGLCMRC, PGCGMAABL, PGCGMAMJI,
PGCGMAMJJ, PGCGMAMJK, PGCGMAMJL, PGCGMAMJM, PGCGMAMJN, PGCGMIMRB,
PGCGMIMRC, PGCGMIMRD, PGCGMJMRB, PGCGMJMRC, PGCGMJMRD, PGCGMNMJJ,
PGCGMNMJL, PGCGMNMJM, PGCGMNMJN, PGCGMNMJO, PGCGMNMJP, PGCGMNMJQ,
PGCGMNMJR, PGCGOTMJJ, PGCGOTMJK, PGCGOTMJL, PGCGOTMJM, PGCGOTMJN,
PGCGOTMJO, PGCGOTMJP, PGCGOTUIB, PGCGOTUIC, PGCGOTUID, PGCGOTUIF,
PGCGOTUIG, PGCGOTUIH, PGCGRLMJA, PGCGRLMJC, PGCNENPAB, PGCNOTPAB,
PGHBMAVAM, PGHBMNVAI, PGHDMASUI, PGHDMASUJ, PGHDMAWAH, PGHDMJCHA,
PGHDMJCHB, PGHDMJCHC, PGHDMJCHD, PGHDMNCHA, PGHDMNCHB, PGHDMNCHC,
PGMHMAESI, PGMHSUWNF, PGOCLSSNP, PGOCLSSNR, PGOCMASNQ, PGOCMJJOB,
PGSVGSHMA, PGSVGSHMB, PGSVGSHMC, PGSVGSHMD, PGSVGSHME, PGSVGSHMF,
PGV1MPFSL, PGV8BCVC1, PGV8BCVC2, PGV8BCVCC, PGV8BCVCE, PGV8BCVCG,
PGV8EN17A, PGV8EN17B, PGV8EN17C, PGV8EN17D, PGV8MAVCT, PGV8MAVCU,
PGV8MAVCW, PGV8OTZNM, PGV8OTZNN, PGVFNLAGG, PGVFNLAGH, PGVHENHHH,
PGVMTOBLK, PGVNBPBGA, PGVNGL09M, PGVNMN09I, PGVTMNSWU, PGVZAHMBB,
PGVZMNMBF, PGVZOTMBG, PH12TCGUX, PH21BRUHA, PH21BRUHB, PH21BRUHC,
PH21TCUHA, PH22TCMH1, PH22TCMH2, PH22TCMHD, PH22TCMHE, PH22TCMHF,
PH22TCMHG, PH22TCMHI, PH22TCMHJ, PH22TCMHL, PH2GTCPHC, PH35TCPHA,
PH35TCPHB, PH41TCCN1, PH41TCCNA, PH41TCCNB, PH41TCCNC, PH41TCCND,
PH41TCCNE, PH41TCCNF, PH41TCCNG, PH44TCSEJ, PH6ETHRVA, PH6ETHRVB,
PH76TCMDP, PH76TSMDP, PH76TSMDQ, PH76TSMDR, PH95BRSEC, PHCGTHAUB,
PHCGTHAUC, PHCGTTMRB, PHCGTTMRC, PHCGTTMRD, PHCGTTMRE, PHHDTCCHE,
PHHDTCCHF, PHJVBRMMA, PHJVBRMMB, PHJVBRMMC, PHMHTCMHG, PHOCTCMMD,
PHOCTCMME, PHOCTCMMF, PHOCTCNSP, PHOCTSMMF, PHOCTSMMH, PHOCTSMMI,
PHOCTSMML, PJ12BDWCG, PJ12BDWCH, PJ12BDWCI, PL08CSDWD, PL08CSDWE,
PL08CSDWF, PL08CSDWG, PL08CSDWH, PL23CPSAE, PL23CSMPM, PL23CSWMH,
PL23CSWOD, PL24CSBMW, PL24CSBMX, PL24CSBMY, PL24CSBMZ, PL29CSAHC4,
PL29CSAHC5, PL29CSAHCM, PL29CSAHCN, PL29CSAHCO, PL29CSLW1, PL29CSLWF,
PL29CSLWG, PL29CSLWH, PL29CSLWI, PL29CSLWJ, PL29CSLWK, PL29CSLWL,
PL29VDAHC3, PL29VDAHCQ,PL29VDAHCR, PL33CSLMA, PL33CSLMB, PL33VALM1,
PL33VALMA, PL33VALMC, PL33VALMD, PL41CSCCM, PL41CSCCN, PL41CSTQB,
PL41CSTQC, PL41CSTQD, PL41CSTQE, PL41CSTQG, PL41VDTQB, PL42CSOMY,
PL44CSSEK, PL44SESJ6, PL44SESJE, PL45CS581, PL45CS58A, PL45CS58B,
PL45CS58C, PL45CSDHW, PL45CSDHX, PL45CSDHY, PL45CSDHZ, PL46SHVD1,
PL46SHVD2, PL46SHVDD, PL46SHVDG, PL46SHVDH, PL46SHVDI, PL54CSSVM,
PL54CSSVO, PL54CSSVP, PL54CSSVQ, PL54VDASV1, PL54VDASV2, PL54VDASVF,
PL54VDASVG, PL54VDASVI, PL54VDASVJ, PL54VDASVK, PL60LR07G, PL60LR07H,
PL60LR07I, PL60LR07J, PL73BPNVA, PL73BPNVB, PL82CS173, PL82CS174,
PL82CS175, PL82CS176, PL82CS17R, PLCGCSMJO, PLHDCSAGI, PLHDCSCHA,
PLHDCSCHB, PLHDCSCHC, PLHDCSCHE, PLHDCSCHF, PLHDCSHC1, PLHDCSHC2,
PLHDCSHC3, PLHDCSHCK, PLHDCSHCL, PLHDCSHCM, PLHDCSHCO, PLHDCSWAG,
PLHDCSWAH, PLHDCSWAI, PLHDCSWAJ, PLHDVDHC1, PLHDVDHC2, PLHDVDHC3,
PLHDVDHCL, PLHDVDHCM, PLHDVDHCN, PLHDVDHCO, PLHDVDHCQ, PLMHCSMHD,
PLMHCSMHE, PLMHCSMHG, PLMHCSMHH, PLMHCSMHI, PLMHCSMHJ, PLMHCSMHK,
PLMHCSMHL, PLOCLRNS3, PLOCLRNSF, PLOCLRNSG, PLOCLRNSH, PLOCLRNSI,
PLOCOTNSG, PLRLLTMMV, PLV8VDVCV, PLV8VDVCW, PLV8VDVCX, PLVHCSSMA,
PLVMCSBJJ, PLVMCSBJK, PLVMCSBJL, PLVMCSBJM, PLVTCSMMV, PLW1CSBL1,
PLW1CSBL2, PLW1CSBL3, PLW1CSBL4, PLW1CSBLM, PLW1CSBLN, PLW1CSBLO,
PLW1CSBLP, PLW1CSBLQ, PLW1CSBLR, PLW1CSBLS, PLW1CSBLT, PLW1CSBLU,
PLW1CSBLV, PLW1CSBLW, PLW1CSBLX, PLW1CSBLY, PMRMMM05I, PN12ACGUM,
PN12ACWCJ, PN12ACWCK, PN12CYWCO, PN12CYWCP, PN12CYWCQ, PN12OTGUZ,
PN12SHGUO, PN12SPDPG, PN12VPWCN, PN12VPWCO, PN12VPWCP, PN21CRUH1,
PN21CRUH2, PN21CRUH3, PN21CRUHB, PN21CRUHC, PN23CRGMB, PN23CRSMF,
PN23CRSMG, PN23CRSMH, PN23CRSMI, PN23CRSMJ, PN23LMGMA, PN23LMSMH,
PN23LMSMI, PN23LMSMJ, PN23LMSMK, PN23LMSML, PN23LMSMM, PN23LMSMN,
PN23PSXFE, PN23SPMCM, PN23SPROE, PN24CRACA, PN24CRACB, PN24CRACC,
PN24CRACD, PN24CYBP1, PN24CYBP2, PN24CYBPO, PN24CYBPP, PN24CYBPS,
PN24CYBPT, PN24LMJML, PN24LMWR6, PN24LMWR7, PN24LMWR8, PN24LMWR9,
PN24LMWRO, PN24LMWRP, PN24LMWRQ, PN24NSASC, PN24SPBPQ, PN24SPBPR,
PN24SPBPS, PN24SPBPT, PN24SPBPV, PN24SPBPW, PN29CYHCN, PN29CYHCO,
PN29CYHCP, PN29CYHCQ, PN41CRCNA,PN41ND79A, PN41NDHC6, PN41NDHCU,
PN41NDHCV, PN41NDHCW, PN41NDHCX, PN41NDHCY, PN41NDHCZ, PN41NJCNA,
PN41OT791, PN41OT792, PN41OT79A, PN41OTHCW, PN41OTHCX, PN41OTHCY,
PN41OTHCZ, PN41SPCNA, PN47CY79A, PN47CYHMW, PN47CYHMX, PN47CYHMY,
PN47CYHMZ, PN54CRRED, PN60SPLHI, PN60SPLHJ, PN60SPLHK, PN60SPLHL,
PN69CRKSA, PN69CRKSB, PN69NJKSA, PN73CR111, PN73CR112, PN73CR113,
PN73CR11A, PN73CR11B, PN73CR11C, PN73CRLU2, PN73CRLUT, PN73CRLUW,
PN73CRLUX, PN73CRLUY, PN73CRLUZ, PN73CRUHY, PN73CRUHZ, PN73CYSBW,
PN73LMSB1, PN73LMSB3, PN73LMSB4, PN73LMSBP, PN73LMSBQ, PN73LMSBR,
PN73LMSBS, PN73LMSBT, PN73LMSBU, PN73LMSBV, PN73NDSJU, PN73NDSJV,
PN73NNUHS, PN73NNUHT, PN73OTSB2, PN73OTSBM, PN73OTSBN, PN73OTSBO,
PN73OTSBP, PN73SPLU2, PN73SPLU3, PN73SPLUL, PN73SPLUN, PN73SPLUO,
PN73SPLUP, PN73SPLUQ, PN73VPLUL, PN73VPLUO, PN73VPLUP, PN73VPLUQ,
PN73VPLUR, PN73VPLUS, PNCGCNAUB, PNCGCNAUC, PNCGCRABT, PNCGCRMJ7,
PNCGCRMJM, PNCGCRMJN, PNCGCRMJQ, PNCGCRMJR, PNCGCRMRB, PNCGCRMRC,
PNCGCRMRD, PNCGNJMJ2, PNCGNJMJ3, PNCGNJMJ4, PNCGNJMJL, PNCGNJMJM,
PNCGNJMJN, PNCGNJMJO, PNCGNJMJP, PNCGNLMRB, PNCGNLMRC, PNCGNLMRD,
PNCGNSMRB, PNCGSPMR1, PNCGSPMRB, PNCGSPMRC, PNCGSPMRD, PNCGSPMRE,
PNHDNDAGC, PNHDNDAGG, PNHDNNCHC, PNOCCYORS, PNOCCYORT, PNOCCYORU,
PNOCCYORV, PNOCCYSNS, PNOCNUJOG, PNOCSPSCA, PNOCSPSCB, PNOCSPSNU,
PNV1CSFSG, PNV1CSFSH, PNV1CSFSI, PNV1CSFSJ, PNV1CSFSK, PNV1CSFSL,
PNV1CSFSM, PNV1CSFSN, PNV1LSFSG, PNV1LSFSH, PNV1LSFSJ, PNV1MNFSI,
PNV1MNFSJ, PNV1MNFSK, PNV1MNFSL, PNV1MNFSN, PNV1MNFSO, PNV1SPGSF,
PNV8LMVCT, PNV8LMVCU, PNV8LMVCV, PNV8LMVCX, PNVMSPBWR, PNVNAS09N,
PNVNVP09L, PNVPNDSJO, PNVTLLSWV, PNVTOTNMP, PO12AKSUF, PO12AR33A,
PO12AR33B, PO12AR33C, PO12ARGUY, PO12ARGUZ, PO12EXWCN, PO12EXWCO,
PO12EXWCP, PO12FTWCP, PO12FTWCQ, PO12FTWCR, PO12HFWCL, PO12HFWCM,
PO12KNWCJ, PO12KNWCK, PO12LELOO, PO12MEWCL, PO12MEWCM, PO12MEWCN,
PO12SHSUF, PO12SHWCM, PO12SHWCN, PO12SHWCO, PO12SPWCM, PO12SPWCN,
PO12SPWCO, PO12SPWCP, PO12THWCP, PO12THWCR, PO12THWCS, PO12TK33F,
PO12TKWC1, PO12TKWCQ, PO12TKWCR, PO12TKWCS, PO12TKWCT, PO12TRWCK,
PO12TRWCL, PO12TRWCM, PO18TKNDD, PO1DAKUNA, PO1DAKUNB, PO1DKRUNA,
PO1DKRUNB, PO1DKRUNC, PO1DKRUND, PO21AKUHA, PO21APUH1, PO21APUH2,
PO21APUH3, PO21APUHA, PO21APUHB, PO21EXUHA, PO21LEHAN, PO21LMUHA,
PO21TJUHA, PO23ARSMA, PO23ARSMC, PO23ARSMD, PO23ARSME, PO23ARSMF,
PO23ARWML, PO23ARWMM, PO23BOGMD, PO23FAGMB, PO23GHGMA, PO23GOWOD,
PO23HPMPI, PO23KDSFH, PO23LEAMT, PO23SHAHCE, PO23SHAML, PO23SSSM1,
PO23SSSMI, PO23THAFE, PO23THAWMJ, PO23TKAEG, PO23UDSFG, PO23UEMPI,
PO24AASM3, PO24AASM4, PO24AASM5, PO24AASM6, PO24AASMD, PO24AASME,
PO24AASMF, PO24AASMG, PO24AASMH, PO24AASMI, PO24ARBMO, PO24HPSMF,
PO24LESMB, PO24LESMC, PO24LESMD, PO24LESME, PO24LESMF, PO24LESMG,
PO24OTJMK, PO24SHASD, PO24SHBMF, PO24SHBMG, PO24SHBMH, PO24SHBMI,
PO24SHSMC, PO24SHSMD, PO24SHSMF, PO24SHSMG, PO24SHSMH, PO24SHSMI,
PO24TH041, PO24TH042, PO24TH043, PO24TH044, PO24TH04A, PO24TH04B,
PO24TH04C, PO24THBPW, PO24THBPX, PO24THBPZ, PO24THGMD, PO24THGMF,
PO24THSM2, PO24THSM3, PO24THSM4, PO24THSME, PO24THSMF, PO24THSMG,
PO24THSMH, PO24THSMI, PO24THWRK, PO24TKB04A, PO24TKB04B, PO24TKBP3,
PO24TKBP4, PO24TKBPU, PO24TKBPV, PO24TKBPW, PO24TKBPX, PO24TKBPY,
PO24TKBPZ, PO24TKGMD, PO24TKGMF, PO24TKSM1, PO24TKSM2, PO24TKSM3,
PO24TKSME, PO24TKSMF, PO24TKSMG, PO24TKSMH, PO24TKSMI, PO24TKWRN,
PO24UEBMP, PO24UEBMT, PO29EXFGG, PO29EXFGH, PO29EXFGI, PO29EXFGJ,
PO29EXFGL, PO29KASUB, PO29KASUC, PO29KASUD, PO29KASUE, PO29KASUF,
PO29KASUG, PO29KASUH, PO29SHSUAB, PO29SHSUC, PO29SHSUD, PO29SHSUE,
PO29SHSUF, PO29SHSUG, PO29SSMHK, PO29SSMHL, PO2GHPPHC, PO2GTHPH1,
PO2GTHPH2, PO2GTHPH3, PO2GTHPH4, PO2GTHPH5, PO2GTHPH6, PO2GTHPH7,
PO2GTHPH8, PO2GTHPHD, PO2GTHPHE, PO2GTHPHF, PO2GTKPH1, PO2GTKPH2,
PO2GTKPH3, PO2GTKPH4, PO2GTKPH5, PO2GTKPHD, PO2GTKPHE, PO30AYPR1,
PO30AYPRA, PO30AYPRB, PO30AYPRC, PO30AYPRE, PO30AYPRF, PO30KAPRA,
PO30KAPRB, PO30KAPRC, PO30KEPRA, PO30KEPRB, PO30KEPRC, PO30THHRA,
PO30THHRB, PO30THHRC, PO30THHRD, PO35HPPHA, PO35HPPHB, PO35THPH1,
PO35THPHA, PO35THPHB, PO35THPHC, PO35TKPH1, PO35TKPHA, PO35TKPHB,
PO35TKPHC, PO36LXSMD, PO36TKSMD, PO36TKSME, PO41ANVAD, PO41ARHCT,
PO41HPHBH, PO41HPHBK, PO41LEVAC, PO41OTHBJ, PO41SHHBI, PO41THCNA,
PO41TK10A, PO41TKCNA, PO41TKHBO, PO41TKMTZ, PO45ARPHI, PO46ARSPF,
PO46ARSPG, PO46ARSPH, PO46ARSPI, PO46ARSPJ, PO46HFSPE, PO46HFSPF,
PO46HFSPG, PO46HFSPH, PO46LESPH, PO46LESPI, PO46SHSPD, PO46SHSPE,
PO46SHSPF, PO46SHSPG, PO46SHSPH, PO46TKSRJ, PO48ARLSC, PO48LELSC,
PO48OSLSC, PO48OSLSD, PO48SALSC, PO48SALSD, PO48SPLSD, PO48SPLSE,
PO48THLSC, PO48TJWMA, PO48TJWMB, PO48TKLSC, PO4ATKHCA, PO54BKRED,
PO54KAWBE, PO54LXRED, PO54OTREE, PO54SAWBC, PO54SAWBD, PO54SAWBE,
PO54TKRE2, PO54UERED, PO55ARTAB, PO60LXSMH, PO60UESMH, PO63LMGHA,
PO69THEHE, PO69TKEHE, PO73AKUHQ, PO73AKUHR, PO73ARSJN, PO73ARSJO,
PO73HNUHS, PO73HPSBU, PO73LSSB1, PO73LSSBR, PO73LSSBS, PO73LSSBT,
PO73LSSBV, PO73LSSBW, PO73LSSBX, PO73LSSBY, PO73LSSBZ, PO73LXUHT,
PO73LXUHU, PO73MJSBT, PO73OTSBM, PO73OTSBN, PO73OTSBO, PO73OTSBP,
PO73OTSBQ, PO73OTSBR, PO73OTSJP, PO73OTSJQ, PO73OTSJR, PO73THSJK,
PO73THSJL, PO73TJUHT, PO73TJUHU, PO92OPDRC, PO94TJSET, POCGACABI,
POCGAKABH, POCGFTMRB, POCGFTMRC, POCGFTMRD, POCGHPABH, POCGHPABL,
POCGKAMRB, POCGKAMRC, POCGKAMRD, POCGLXABK, POCGLXMRB, POCGLXMRC,
POCGLXMRD, POCGSHMRB, POCGSSMJH, POCGSSMJI, POCGSSMJJ, POCGSSMJK,
POCGSSMJL, POCGSSMJM, POCGSSMJN, POCGTHABP, POCGTHMR1, POCGTHMRB,
POCGTHMRC, POCGTHMRD, POCGTHMRE, POCGTKABQ, POCGTKMRB, POCGTKMRC,
POCGTKMRD, POCGTKMRE, POCGTKUCL, POHBAAVAD, POHBTHVAF, POHDAKCHA,
POHDAKCHB, POHDAKCHC, POHDEXCHA, POHDEXCHC, POHDEXCHD, POHDEXCHE,
POHDSHCHA, POHDSHCHB, POHDSHCHC, POHDSHCHD, POHDTHSUJ, POHDTKCHA,
POHDTKCHB, POHDTKCHD, POHDTKCHE, POHDTKCHF, POHDTKSUI, POHDTKSUK,
POHFASLUF, POHFEXLUE, POHFTHBFB, POMHINBHG, POMHKAESI, POMHTHMHH,
POMHTKBHF, POMHTKWDE, POOCARSNL, POOCARSNM, POOCARSNN, POOCARSNO,
POOCEXSNM, POOCFSVBH, POOCFTSCI, POOCFTSCJ, POOCSHSNO, POOCSHSNP,
POOCSHSNQ, POOCSHSNR, POOCSLPUD, POOCSLPUE, POOCSLPUF, POOCSLPUG,
POOCSLPUJ, POOCSLPUK, POOCSLPUL, POOCSLPUM, POOCTHSNR, PORMFTOHD,
POV1AKFSM, POV1ASGSG, POV2HNWCH, POV2HNWCI, POV2HNWCJ, POV2HNWCK,
POV2MJWCH, POV2SHWC1, POV2SHWCB, POV2SHWCC, POV2SHWCE, POV2SHWCF,
POV8AHVCA, POV8AHVCC, POV8ARVAT, POV8ARVAU, POV8HPVCN, POV8LEVCR,
POV8LEVCS, POV8LEVCT, POV8SH17A, POV8SH17B, POV8SH17C, POV8SUVAA,
POV8SUVAB, POV8THVCX, POV8THVCY, POV8TK17A, POV8TKVCY, POV8TKVCZ,
POV8UEVAU, POV8UEVAV, POVAOHSJA, POVAOHSJB, POVAOHSJC, POVAOHSJD,
POVAOHSJE, POVMARBJL, POVMEXBJC, POVMHNBJK, POVMHNBJL, POVMHNBJM,
POVMHNBJN, POVMSH22A, POVMTK22H, POVNAABGN, POVNEXBGK, POVNTH92A,
POVTEXSWH, POVTOTNMR, POVTTKSAP, POW1ARCCJ, POW1ARCCK, POW1ARCCL,
POW1ARCCM, POW1ARCCN, POW1ARCCO, POW1ARMC1, POW1ARMCM, POW1ARMCN,
POW1ARMCO, POW1ARMCP, POW1ARMCQ, POW1ARMCR, POW1ARMCS, POW1AROCF,
POW1AROCG, POW1AROCH, POW1AROCI, POW1AROCJ, POW1FTOM2, POW1FTOMT,
POW1FTOMU, POW1FTOMW, POW1FTOMX, POW1SHAMGI, POW1SHOMR, POW1SHOMS,
POW1SHOMT, POW1SHOMU, POW1SHOMV, POW1SHOMW, POW1SHSPD, POW1SHWSH,
POW1SSOLE, POW1SSOLF, POW1SSOLG, POW1SSOLH, POW1THOMP, POW1THOMQ,
POW1THOMS, POW1THOMT, POW1THOMU, POW1THOMV, POW1TKOMR, POW1TKOMS,
POW1TKOMT, POW1TKOMU, PP82OTWMT, PPVTOHSW2, PPVTOHSWT, PPVTOHSWU,
PPVTOHSWX, PPVTOHSWY, PQ18OPSJA, PQ18OPSJB, PQ18OPSJC, PQ73EYLU1,
PQ73EYLU2, PQ73EYLUH, PQ73EYLUI, PQ73EYLUJ, PQ73EYLUK, PQ73EYLUL,
PQ73OTLUI, PQ73OTLUJ, PQ73OTLUK, PQ73OTLUL, PQHBBEVAF, PQMHEEESI,
PQMHEEESJ, PSDKOTAOB, PSDKOTAOC, PU12OTKDC, PU12OTKDF, PU24CCBLR,
PU41PYCNA, PU73CYSJM, PU73OTSB4, PU73OTSBP, PU92BCHRD, PU92BCHRE,
PU92RDHRD, PU92RDHRE, PU92RDHRF, PU92RDHRG, PU92RDHRH, PUCGCYMRB,
PUCGCYMRC, PUCGRPAUC, PUCGRPAUD, PUCGRPAUE, PUW1RPMMQ, PUW1RPMMR,
PUW1RPMMS, PUW1RPMMT, PUW1RPMMU, PUW1RPMMW, PUW1RPMMX, PUW1RPMMY,
PV08CDGHH, PV08CDGHI, PV08CDGHJ, PV08CDGHK, PV08CDGHL, PV08CDGHM,
PV08VLGHI, PV08VLGHJ, PV08VLGHK, PV08VLGHL, PV08VLGHM, PV08VLGHN,
PV12CAGUV, PV12CVUMT, PV12OTGUX, PV13AVXEK, PV21CAUHA, PV21CAUHB,
PV21MJUHA, PV21PVUHA, PV21PVUHB, PV23AVSMH, PV23AVSMI, PV23CASMM,
PV24AABP1, PV24AABPN, PV24AABPP, PV24AABPQ, PV24AABPR, PV24AABPS,
PV24AABPT, PV24CABP1, PV24CABP2, PV24CABPH, PV24CABPI, PV24CABPJ,
PV24CABPM, PV24CABPN, PV24CABPO, PV26PVSAB, PV2GAAPHC, PV35AAPHA,
PV35AAPHB, PV41LVCNA, PV4FOYCFC, PV60MNSMI, PV73AVLUG, PV73AVLUI,
PV73AVLUJ, PV73AVLUK, PV73AVLUL, PV73AVSB1, PV73AVSBK, PV73AVSBL,
PV73AVSBN, PV73AVSBP, PV73AVSBQ, PV73AVSBR, PV73AVUHS, PV73OTBSN,
PV73OTBSO, PV73OTBSQ, PV73OTBSS, PV73OTBST, PV73OTBSU, PV73OTBSV,
PV73VUSJP, PVCGAVMRB, PVCGCVMRB, PVCGCVMRD, PVCGMJABJ, PVCGVAMRB,
PVCGVAMRC, PVCGVAMRD, PVCGVAMRE, PVCGVLMRB, PVCGVLMRC, PVCGVLMRD,
PVCGVLMRE, PVHDPVSUH, PVMHAVMHK, PVMHPKESA, PVSVAVTME, PVV1CEFSI,
PVVAVS60E, PVVNVABGK, PVVNVLBSJR, PW12BSGUW, PW12BSGUX, PW23BJXFG,
PW23HETUA, PW23OSWOF, PW30PSPRA, PW30PSPRB, PW67BSMDN, PW73PLUHV,
PWCGPLMJF, PWCGPLMJG, PWCGPLMJH, PWCGPLMJJ, PWCGPLMJK, PWCGPLMJL,
PWCGPLMJM, PWHDPLSUH, PWOCOTMHJ, PWVNHN09K, PWVTFLSWE, PZ12ADUMA,
PZ12ADUME, PZ12ADUMF, PZ12ADUMG, PZ23ANAMUG, PZ23ANBUB, PZ23ANBUC,
PZ33ADHRI, PZ33ADHRJ, PZ33ADHRK, PZ35ANPHA, PZ36ANAVC, PZ36ANAVD,
PZ36ANAVE, PZ36ANAVF, PZ41ESTNA, PZ41FCHCJ, PZ41FCHCK, PZ41FCHCL,
PZ41GSHMF, PZ41GSHMG, PZ41GSHMH, PZ45OTNCF, PZ45OTNCG, PZ45OTNCH,
PZ54FCSMD, PZ55ENSF2, PZ55ENSFF, PZ55ENSFG, PZ55ENSFH, PZ55ENSFI,
PZ55OTSFB, PZ55OTSFC, PZ63OTMCG, PZ73MNCRB, PZ73OTCRA, PZCGTHAGEG,
PZMHADFB1, PZMHADFB2, PZMHADFBA, PZMHADFBB, PZMHADFBC, PZMHADFBD,
PZMHADFBE, PZMHADFBF, PZMHLAWN2, PZMHLAWN3, PZMHLAWN4, PZMHLAWNC,
PZMHLAWND, PZMHLAWNE, PZMHLAWNF, PZRMANBMUI, PZRMANMUK, PZV8ANVAL,
PZVBOTANM2, PZVBOTANM3, PZVBOTANMK, PZVBOTANML, PZVBOTANMM, PZVBOTANMN,
PZVBOTANMO, PZVBOTANMP, PZVBOTANMQ, PZVBOTANMR, PZVBOTANMS, PZVMANBLH,
PZVMANBLI, PZVMANBLJ, PZVMANJWH, PZVMANJWI, PZVMANJWJ, PZVMANJWK,
PZVMANJWL, PZVMOTCHG, RE7363573A, RESVM0726A, RESW11505C, RESW1505B,
RPD239008A, SP1411105C, SP1421926B, SP1421926C, SP1691807A, SP1CG7271C,
SP1CG7271D, SP1CG7271E, SP1CG7317K, SP1CG7317L, SP1HF5342E, SP1HF5342F,
SP1HF5342G, SP1HF5342H, SP2534859G, SP2534859I, SP2534859J, SP2HF5342C,
SP2HF5342D, SP5HF5342D, SP5HF5342E, SP5HF5342F, SP5HF5342G, SP5HF5342H,
SPK224490A, SPK224716C, SPK224716D, SPK224716E, SPK370130A, SPK422677B,
SPK483772A, SPK6918071, SPK691807A, SPK691807B, SPK691807C, SPK691807D,
SPK765210C, SPK765210D, SPK765210E, SPKCN5570C, SPKCN5570D, SPKCN5570E,
SPKCN5570F, SPKCN5570G, SPKDH9501A, SPKHD8398B, SPKOC0110A, SPKOC7731F,
SPKOC7731H, SPKRM2105A, SPKVB0149N, SPKVM0726B, SPKVM0726C, SPKVM0726D,
SRIET0513L, UCV69OHK11, UEN69TMKSD, UNE69SPKSD, UOP30KAPRB, UOP30KAPRE,
UOP30KAPRF, UOP30OGPRB, UOP30OGPRC, UOP30OGPRD and UOP63BKGSF. Recall #
Z-2459-2010
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by
letter dated August 16, 2010. Manufacturer: Productos Urologos De Mexico
S.A, Mercurio Mexicali, Mexico. Firm initiated recall is ongoing.
REASON : The packaging seals may not be intact, resulting in compromised
sterility for the listed Medi-Vac Non-Conductive Tubing.
PRODUCT:
Nuclear Magnetic Resonance Imaging System (MRI). Trace item
9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x.
Recall # Z-2461-2010
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letter dated September 30, 2008.Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is complete.
REASON : The cables of the coil may become too hot and cause burns when
placed too close to the patient. While using the 1.5T Sense XL Torso
coil, unwanted radiofrequencies (RF) interaction with the patient can
occur. Especially in combination with high SAR levels and when the RF
cables of the coil are too close to the patient, this RF interaction has
resulted in RF burns to patients.
PRODUCT:
Philips BV Pulsera Mobile X-Ray system with the extended rotation
option. Recall # Z-2463-2010;2) Philips BV Endura Mobile X-Ray system
with the extended rotation option. Recall # Z-2464-2010
MANUFACTURER: Recalling Firm: Philips Medical Systems, North America Co.
Phillips, Bothell, WA, by letter dated September 30, 2008.Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is ongoing.
REASON : The C-arm rotation brake does not always function properly, and
may not hold the C-arm position if the C-arm is not positioned in its
maximum rotation and if it is accidentally bumped by medical staff or
patients. Unwanted C-arm movement may cause the C-arm to collide with a
patient. The brakes function properly if the C-arm is rotated to its
maximum positions.
PRODUCT:
Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix.
Model number: 9000031. Recall # Z-2465-2010
MANUFACTURER: TransEnterix, Inc., Durham, NC, by letter dated June 22,
2010. Firm initiated recall is ongoing.
REASON : The hook end effecter from a monopolar device may become
dislodged and fall into the patient when in use during laparoscopic
surgery. Retrieval from the patient may involve extended anesthesia
time.
PRODUCT:
1) 1) Terumo Advanced Perfusion System 1, Catalog number 801763,
100/120V System 1 base. Recall # Z-2480-2010;2) Terumo Advanced
Perfusion System 1, Catalog number 801764, 220/240V System 1 base. (This
product is not distributed in the US). Recall # Z-2481-2010
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
letter dated September 10, 2010. Firm initiated recall is ongoing.
REASON : The design document states that the oxygen sensor would operate
for 300,000 hours but the supplier of the oxygen sensor indicated that
it has a 100,000 hour warranty. The oxygen sensor is a consumable part
that slowly depletes over time. At the end of its service life, a
depleted oxygen sensor results in a gas system calibration failure or a
message to the user prompting service for the gas system. If the user
does not recognize that the gas system has failed calibration, and
attempts to use the system normally, the FiO2 readings may be
inaccurate. The firm received seven complaints related to the oxygen
sensor.
PRODUCT:
1) Sterile double breast personal accessory convenience kit for the
Symphony Breast pump; the kit connects to a hospital grade breast pump
for the removal, collection, and storage of mother's breast milk;
Article # 67099S. Recall # Z-2483-2010;2) Sterile double breast personal
accessory convenience kit for the Symphony or Lactina Breast pumps; the
kit connects to a hospital grade breast pump for the removal,
collection, and storage of mother's breast milk; Article # 67116S.
Recall # Z-2484-2010;3) Sterile single/double breast personal accessory
convenience kit for single or double pumping with a Classic Breast pump;
the kit connects to a hospital grade breast pump for the removal,
collection, and storage of mother's breast milk; Article # 67093S.
Recall # Z-2485-2010;4) Sterile single/double breast personal accessory
convenience kit for the Lactina Breast pump; the kit connects to a
hospital grade breast pump for the removal, collection, and storage of
mother's breast milk; Article # 67094S. Recall # Z-2486-2010
MANUFACTURER: Medela Inc., McHenry, IL, by letters dated August 6, 2010.
Firm initiated recall is ongoing.
REASON : The product sterility may be compromised due to possible
pinholes in the rigid tray of the package.
PRODUCT:
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model
8770. Recall # Z-2579-2010
MANUFACTURER: Recalling Firm: ela Medical LLC, Plymouth, MN, by letter
dated June 7, 2010. Manufacturer: Sorin Biomedica C.R.M., S.r.l.,
Saluggia, VC, Italy. Firm initiated recall is ongoing.
REASON : The Paradym CRT 8750 and CRT sonR 8770 device models have a
software anomaly, which will cause the device to lose the ability to
sense/pace and to deliver further therapy. The software anomaly could
only occur under a specific sequence of events.
PRODUCT:
1) Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and
coagulation device, Model Number 01-242208. Recall # Z-2580-2010.2)
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and
coagulation device, Model Number 01-242208. Recall # Z-2581-2010
MANUFACTURER: Cardima Inc., Fremont, CA, by letter dated May 18, 2010.
Firm initiated recall is ongoing.
REASON : Sterility compromised-- The sterile pouch in which the product
is packaged may be compromised, which could result in patient infection.
PRODUCT:
Integra Suction Reservoir Kit for use with Integra NeuroSciences
Subdural Drainage Catheter; Sterile, Rx only. This product is
distributed by Integra NeuroSciences under, a) catalog number 910-500
and in Suction Valve Reservoir Kits under b) catalog number 31223 and c)
31253. Recall # Z-2588-2010
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro,
NJ, by letters dated May 7, 2010. Manufacturer: Integra Neurosciences
Implants S.A., Sophia Antipolis, France. Firm initiated recall is
ongoing.
REASON : The sterility of the product may be compromised. The product's
sterility may be affected by a sterilization issue discovered by the
supplier.
CLASS III
PRODUCT:
Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on
the Dimension system is an in vitro diagnostic test intended to
quantitatively measure Total Iron Binding capacity in human serum and
plasma. Catalog number df84. Recall # Z-2385-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated December 2009. Firm initiated recall is complete.
REASON : Test produces falsely elevated IBCT results and Abnormal
Reaction test report messages on heparinized plasma samples.
PRODUCT:
The Provent Nasal Cannula is a nasal appliance device placed in both
nostrils intended to be used for transmission of respiratory airflow
signals between the Provent Professional Sleep Apnea Therapy device and
physiologic recorders. Catalog Number: MRS0208. Recall # Z-2435-2010
MANUFACTURER: Ventus Medical, Inc., Belmont, CA, by letter on December
3, 2009. Firm initiated recall is complete.
REASON : The catalog number printed on two Nasal Cannula Diagnostic Kits
(MRS0231) was different that the catalog number printed on the bulk pack
shipper box and the other Nasal Cannula Kits in the same shipper
(MRS0208). No devices were used on any patient.
PRODUCT :
Primary (inner) Package Label: Acuvue Oasys Brand Contact Lenses for
Astigmatism with Hydraclear Plus (senofilcon A) Johnson & Johnson Vision
Care, Inc. Rx Only, Sterile. Lot B006WBS1 -9.00D -1.25 CYL 80, 2013/05
AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot
B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not
For Sale Consumer Note: This product has been provided free of charge to
your Eye Care professional to aid in proper fitting. The sale of this
product is prohibited. You should not have been charged money for this
product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005%
methyl ether cellulose. Recall # Z-2445-2010
MANUFACTURER: Vistakon, Jacksonville, FL, by letters dated July 28,
2010. Firm initiated recall is ongoing.
REASON : ACUVUE OASYS Brand Contact Lenses for Astigmatism may be
mislabeled on the outer (secondary) packaging carton. The outer
(secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis
may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl.
80 Axis. The inner (primary) package labeling is correct. Product was
only distributed to Eye Care Professionals for use in proper fitting of
patients and labeled as "Not For Sale".
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of recalls as of
September 22, 2010
CLASS II
PRODUCT:
1) FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO. The
Flexima Biliary Stent System is intended for delivery of the stent to
the biliary tract for drainage of the bile ducts, for splinting of a
bile duct during healing, or for providing bile duct patency in a
stricture or past a stone. Recall # Z-1975-2010;2) FLEXIMA Biliary Stent
System, 7Fr-7cm, M00539210, Sterile EO. The Flexima Biliary Stent System
is intended for delivery of the stent to the biliary tract for drainage
of the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1976-2010;3) FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1977-2010;4) FLEXIMA
Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1978-2010; 5) FLEXIMA Biliary Stent System,
7Fr-15cm, M00539240, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1979-2010;6) FLEXIMA Biliary Stent System, 8.5Fr-5cm, M00539250,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1980-2010;7) FLEXIMA
Biliary Stent System, 8.5Fr-7cm, M00539260, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1981-2010;8) FLEXIMA Biliary Stent System,
8.5Fr-10cm, M00539270, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1982-2010;9) FLEXIMA Biliary Stent System, 8.5Fr-12cm, M00539280,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1983-2010;10) FLEXIMA
Biliary Stent System, 8.5Fr-15cm, M00539290, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1984-2010;11) FLEXIMA Biliary Stent System,
10Fr-5cm, M00539300, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1985-2010;12) FLEXIMA Biliary Stent System, 10Fr-7cm, M00539310,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1986-2010;13) FLEXIMA
Biliary Stent System, 10Fr-10cm, M00539320, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1987-2010;14) FLEXIMA Biliary Stent System,
10Fr-12cm, M00539330, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1988-2010;15) FLEXIMA Biliary Stent System, 10Fr-15cm, M00539340,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1989-2010;16) FLEXIMA
Biliary Stent System, 11.5Fr-5cm, M00539350, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1990-201017) FLEXIMA Biliary Stent System,
11.5Fr-7cm, M00539360, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1991-2010;18) FLEXIMA Biliary Stent System, 11.5Fr-10cm, M00539370,
Sterile EO. The Flexima Biliary Stent System is intended for delivery of
the stent to the biliary tract for drainage of the bile ducts, for
splinting of a bile duct during healing, or for providing bile duct
patency in a stricture or past a stone. Recall # Z-1992-2010;19) FLEXIMA
Biliary Stent System, 11.5Fr-12cm, M00539380, Sterile EO. The Flexima
Biliary Stent System is intended for delivery of the stent to the
biliary tract for drainage of the bile ducts, for splinting of a bile
duct during healing, or for providing bile duct patency in a stricture
or past a stone. Recall # Z-1993-2010;20) FLEXIMA Biliary Stent System,
11.5Fr-15cm, M00539390, Sterile EO. The Flexima Biliary Stent System is
intended for delivery of the stent to the biliary tract for drainage of
the bile ducts, for splinting of a bile duct during healing, or for
providing bile duct patency in a stricture or past a stone. Recall #
Z-1994-2010
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Quincy, MA, by
letter dated April 27, 2010.
Manufacturer: Boston Scientific Corp., Spencer, IN. Firm initiated
recall is ongoing.
REASON : Flexima Biliary Stent System Devices were packaged with Tyvek
tray lids that had incorrect adhesive, resulting in sterile barrier seal
defects. The breach of the sterility barrier could lead to the device
being non-sterile.
PRODUCT:
The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and
23C Model numbers 102-137D allow the surgeon to position the distal jaws
of the instrument around the region of tissue to be cut/cauterized. The
surgeon squeezes the handle and depresses the switch, heating elements
activates in the jaws. The heat is conducted to the tissue between the
jaws to provide cutting/cauterization. For the simultaneous cutting and
cauterization of soft tissue during surgery. Cutting of natural or
synthetic, non-metallic, sutures during surgery. Recall # Z-2239-2010
MANUFACTURER: Starion Instruments, Sunnyvale, CA, by letter dated March
9, 2010. Firm initiated recall is ongoing.
REASON : The Starion Instruments Thermal Ligating Shears (STLS) 35C and
the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on
without the finger button being depressed. The devices may also work
intermittently, incorrectly indicating the device is 'on".
PRODUCT:
CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm)
polyethylene telescopically-folded cover with attached (6cm) NeoGuard
tip. The latex-free surgi tipped covers are utilized to cover ultrasound
transducers and prevent cross-contamination from occurring with
equipment and patients. Recall # Z-2242-2010
MANUFACTURER: Civco Medical Instruments, Inc., Kalona, IA, by letter
date July 19, 2010. Firm initiated recall is ongoing.
REASON : Polyethylene material did not have proper treatment applied
during manufacturing. Untreated polyethylene material does not maintain
a secure seal with the adhesive tape used to secure the tip to the
cover.
PRODUCT:
Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST
KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker.
Enzyme Immunoassay for the quantitative determination of Human Cardiac
Fatty Acid-Binding Protein (H-FABP) concentration in serum,
citrate-plasma, EDTA-plasma, and heparin-plasma. Catalog #/Product #
BC-1123. Recall # Z-2243-2010
MANUFACTURER: BioCheck, Inc., Foster City, CA, by letter dated July 15,
2010. Firm initiated recall is ongoing.
REASON : Products were marketed without 510 (k) for diagnostic use.
Unapproved device.
PRODUCT:
1) Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds.
Recall # Z-2263-2010;2) Philips M1019A IntelliVue G5 Anesthesia Gas
Modules with manifolds. Recall # Z-2264-2010;3) Philips M1026B
IntelliVue Anesthesia Gas Modules with manifolds. Recall #
Z-2265-2010;4) Philips M1026BT Gas Modules with manifolds. Recall #
Z-2266-2010
MANUFACTURER: Recalling Firm: Philips Healthcare Inc., Andover MA,
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard
Strasse 2, Boblingen, Germany. Firm initiated recall is ongoing.
REASON : The manifold seal in the Philips M1657B Water Trap used on the
Philips M1013A IntelliVue G1, M1019A, IntelliVue G5, and Anesthesia Gas
Modules M1026B/BT may be unintentionally removed when changing the
traps. A missing seal may result in leakage and may cause incorrect
monitor readings of inspiratory or expiratory gas levels.
PRODUCT :
Dimension Tacrolimus Flex Reagent Cartridge. Recall # Z-2407-2010
2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp
12/14/10)
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letters dated June 2010. Firm initiated recall is ongoing.
REASON : Low patient sample recovery results in all affected lots, with
possibility of inappropriate increase in tacrolimus dosage based on
false low result.
PRODUCT:
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in
vitro diagnostic test for the quantitative measurement of creatinine in
human serum, plasma and urine on the Dimension Vista System. Creatinine
measurements are used in the diagnosis and treatment of renal diseases
in monitoring renal dialysis, and as a calculation basis for other urine
analytes. Catalog number K1270. Recall # Z-2419-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated February 2010. Firm initiated recall is ongoing.
REASON : The ECREA test results may be falsely elevated or depressed.
PRODUCT :
CELL-DYN Sapphire Probe Detector PCB Assembly (also called the
Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology
Analyzer. Recall # Z-2421-2010
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, initiated a field
correction on April 5, 2010. Firm initiated recall is ongoing.
REASON: Under certain conditions in closed mode of operations, the
Aspiration Probe Detector PCB assembly may fail to operate properly and
provide inaccurate results.
PRODUCT:
DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using
Digital Solid State Imaging Detector. It is identified with Part Number
4512 201 04752 Software Version 1.5.1 and Part Number 4512 201 04753
Software Version 1.5.2. Recall # Z-2422-2010
MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips,
Bothell, WA, by letter dated March 10, 2008.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and
Manufacturing Ctr. Hamburg, Germany. Firm initiated recall is complete.
REASON : When using DICOM print functionality, the printed images may
contain data for the wrong patient.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of recalls as of
September 15, 2010
CLASS I
PRODUCT:
Hospira Inc. Symbiq One- and Two- Channel Infuser. Recall # Z-2381-2010
MANUFACTURER: Recalling Firm: Hospira, Inc., Morgan Hill, CA, by letter
on March 26, 2010.Manufacturer: Hospira Holdings de, Costa Rica Ltd., La
Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON : If the administrator set is removed prior to the cassette
carriage fully opening without closing the slide/roller clamp,
unrestricted flow and delivery may result.
CLASS II
PRODUCT:
Microwave Ovens, Model Number DG-2. Recall # Z-2114-2010
MANUFACTURER: Duke Manufacturing Co., Saint Louis, MO, by letter on May
12, 2010. Firm initiated recall is ongoing.
REASON: The oven did not meet Federal Performance Standard for certain
requirements.
PRODUCT:
1) SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up,
Qty. 1. Sterile. Part number 904008. Used to pass suture through tissue.
Recall # Z-2228-2010;2) SpeedPass Disposable Suture Lariat with Nitinol
Wire 25 Degree Left, Qty. 1. Sterile. Part number 904010. Used to pass
suture through tissue. Recall # Z-2229-2010;3) SpeedPass Disposable
Suture Lariat with Nitinol Wire 25 Degree Right, Qty. 1. Sterile. Part
number 904012. Used to pass suture through tissue. Recall #
Z-2230-2010;4) Suture Lariat 30 Degree Up, Qty. 1. Sterile. Part number
904022. Used to pass suture through tissue. Recall # Z-2231-2010;5)
Suture Lariat 45 Degree Dog Leg Up, Qty. 1. Sterile. Part number 904025.
Used to pass suture through tissue. Recall # Z-2232-2010
MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter on June 18, 2010. Firm
initiated recall is ongoing.
REASON: The nitinol wire may be fractured or may have the potential to
fracture making the suture lariat unusable and possibly delaying
surgery.
PRODUCT:
Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole
clamp bracket to attach to the IV pole with the infusion pump; part
number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG Accessory
power pack used for use with medical devices. Recall # Z-2234-2010
MANUFACTURER: Recalling Firm: Hospira Inc., Lake Forest, IL, by letters
dated July 1, 2010. Manufacturer: Modo Inc., Beaverton, OR. Firm
initiated recall is ongoing.
REASON: The Power Pack Accessory is not certified to UL 60601 standard
or Subject 1363A for relocatable power taps intended for use with
medical equipment. Potential problems could include electrical shock,
electrical short or electrical fire.
PRODUCT:
1) External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P,
LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. External
Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have
a Part Number 3009166-XX (XX symbolized any 2 numbers). External
Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a
Part Number 804507-XX (XX symbolizes any 2 numbers). Recall #
Z-2311-2010;2) Pediatric Paddles attachments used with LIFEPAK 9,
LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors. The
product has the Part Number 800418-XX (XX symbolize any 2 numbers).
Recall # Z-2312-2010
MANUFACTURER: Physio Control, Inc., Redmond, WA, letter on November 14,
2008. Firm initiated recall is complete.
REASON : Sterilization efficacy could not be confirmed for sterilization
methods on External Sterilizable Paddles and Pediatric Paddle
attachments.
PRODUCT:
Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD,
non-sterile; Ref. 1160-2. Usage: The screwdriver is intended to mate to
the hexalobular feature of a PathFinder open polyaxial screw and threads
onto the head to hold it in on-axis for implanting. Recall # Z-2335-2010
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter on
April 6, 2010. Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm
initiated recall is ongoing.
REASON : The screwdriver may fracture, resulting in surgical delays
and/or fragments going into the surgical site.
PRODUCT:
Mayfield Infinity XR2 Base Unit, model A-2079. The MAYFIELD Infinity XR2
Base Unit (A-2079) is an operating room table accessory intended to be
used to support a patient during diagnostic examination and/or surgical
procedures where a rigid support between surgical table and headrest, or
skull clamp is necessary, positional freedom is required and where x-ray
imaging modalities will be used. Recall # Z-2336-2010
MANUFACTURER: Integra LifeSciences Corp., Cincinnati, OH, by telephone
and letter on May 10, 2010. Firm initiated recall is ongoing.
REASON : Storage case incorrectly labeled. The labels were for the
Infinity XR2 Skull Clamp storage containers but were inadvertently
placed on the Infinity XR2 Base Unit storage cases.
PRODUCT:
1) Eye surgery stretcher with crank fowler, model 1069. Intended use: A
stretcher used for eye surgery. Recall # Z-2341-2010; 2) Eye surgery
stretcher with crank fowler, model 1079. Intended Use: A stretcher used
for eye surgery. Recall # Z-2342-20103) Service parts for Crank Screw
Assembly (PN1069-042-010S and 1069-042110S). Intended use: Service parts
are replacement parts for the eye surgery stretcher. Recall #
Z-2343-2010
MANUFACTURER: Stryker Medical Division of Stryker Corp., Portage, MI, by
letter dated February 26, 2010. Firm initiated recall is ongoing.
REASON : The fowler of the bed is raised by a crank. The crank consists
of a steel screw that moves through a brass nut. Over time the screw can
wear the threads on the brass nut. The screw and the nut can become
misaligned, causing a loud squealing noise when the screw comes in
contact with the drive tube. In addition the fowler can become
inoperable over time with excessive wear of the brass nut. This may
delay care for a patient who requires the fowler to be raised.
PRODUCT:
1) TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are
intended to provide immobilization and stabilization of spinal segments
as an adjunct to fusion in the treatment of acute and chronic
instabilities or deformities of the spine. Catalog number
04.600.715.02S. Recall # Z-2344-2010;2)
2) N-Hance System 150mm The Synthes N-Hance and NFix II rods are
intended to provide immobilization and stabilization of spinal segments
as an adjunct to fusion in the treatment of acute and chronic
instabilities or deformities of the spine. Catalog number NH60150-1.
Recall # Z-2345-2010;3)
3) NFix II System 150mm The Synthes N-Hance and NFix II rods are
intended to provide immobilization and stabilization of spinal segments
as an adjunct to fusion in the treatment of acute and chronic
instabilities or deformities of the spine. Catalog number NX60150-1.
Recall # Z-2346-2010;4) NFlex Straight monosegmental L 150mm The Synthes
N-Hance and NFix II rods are intended to provide immobilization and
stabilization of spinal segments as an adjunct to fusion in the
treatment of acute and chronic instabilities or deformities of the
spine. Catalog number 04.600.716.02S. Recall # Z-2347-2010;5) NFlex
Stabilization System 150mm The Synthes N-Hance and NFix II rods are
intended to provide immobilization and stabilization of spinal segments
as an adjunct to fusion in the treatment of acute and chronic
instabilities or deformities of the spine. Catalog number NF60150-1.
Recall # Z-2348-2010Lot number: P07M01;
MANUFACTURER: Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA,
by letters dated February 9, 2009, February 12, 2009, March 11, 2009 and
April 9, 2009. Manufacturer: Synthes (USA), Monument, CO. Firm initiated
recall is complete.
REASON : Package integrity compromised.
PRODUCT:
Picasso/Picasso Lite lasers Intended use: Dentistry. Recall #
Z-2349-2010
MANUFACTURER: AMD Lasers, LLC, Indianapolis, IN, by letters, dated April
30, 2010. Firm initiated recall is ongoing.
REASON : Product is noncompliant with the Federal laser product
performance standard in certain requirements. The ON/OFF key on some of
the Picasso/Picasso Lite lasers could be removed with force while the
key was in the ON position.
PRODUCT:
Impella 5.0 Circulatory Support System Catalog number: 004840 The
Impella 5.0 System is intended for circulatory support using an
extracorporeal bypass control unit, for periods up to 6 hours. Recall #
Z-2382-2010
MANUFACTURER: Recalling Firm: Abiomed, Inc, Danvers, MA, by letter on
July 5, 2010.Manufacturer: Abiomed Europe Gmbh, Aachen, Germany. Firm
initiated recall is complete.
REASON : Pump may separate at the motor housing while device is
expanded.
PRODUCT:
SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number:
472525 Systems AQUA CAL 1 and 2 is intended for the quantitative
determination of creatinine concentration in human serum, plasma or
urine. CREm reagent, when used in conjunction with SYNCHRON LX
System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2,
is intended for the quantitative determination of creatinine
concentration in human serum, plasma or urine. Recall # Z-2389-2010
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc, Brea, CA, by letter
dated August 3, 2010.Manufacturer: Beckman Coulter, Inc, Carlsbad, CA.
Firm initiated recall is ongoing.
REASON : The recall was initiated after Beckman Coulter confirmed
reports that black / brown particulates were observed in some bottles of
the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in
modular Creatinine (CREm) reagent kit lots M911428 and M911519. Beckman
Coulter has had reports of erroneous results when using the lots of
Creatinine Alkaline Buffer listed above. Single creatinine
determinations are used to predict end-stage renal failure (estimate
glomerular filtration rate, or eGFR), to monitor renal transplant
patients, and to dose medications and intravenous radiopaque dyes.
Erroneous creatinine results corresponding to eGFR >60 mL/min/1.73 m2,
when the true value is below these clinical thresholds, may result in
serious harm. Creatinine values in the 0.5 to 2.5 mg/dL (45 to 220
micromol/L) range are important for drug dose adjustments. Low or high
erroneous results in this range may result in inappropriate dosing of
medication or chemotherapy.
PRODUCT
Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490
IVC. Recall # Z-2393-2010
MANUFACTURER:
Invacare Corp., Sanford, FL, by letter on October 18, 2006. Firm
initiated recall is ongoing.
REASON : Invacare Corporation issued a device correction in October 2006
for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890
IVC and 5490 IVC. The actuators were not in the fully extended position
and could not be mounted onto the beds. All affected consignees were
notified of this correction in October 2006.
PRODUCT:
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated April 2010. Firm initiated recall is ongoing.
REASON : False elevated Stratus CS CTNI results
PRODUCT:
Maquet HLM Tubing Pack; Bioline Coating. Product number BEQ-TOP 14801.
Recall # Z-2401-2010
MANUFACTURER: Recalling Firm: Maquet Inc., Wayne, NJ, by letters and
e-mail on July 13, 2010.Manufacturer: Maquet Cardiopulmonary Ag,
Hirrlingen, Germany. Firm initiated recall is ongoing.
REASON : The color of the tape on the arterial and the venous line were
placed incorrectly, causing the connection of the arterial and the
venous lines to be interchanged.
PRODUCT
CareGuard Mattress Models CG10180 and CG10180A used with IVC and
ValueCare Series of manual, semi-electric and electric beds. Mattresses
can be identified by looking on the law label tag for the following
information: Model # CG10180 or CG10180CA and a BLACK date code with the
corresponding month and year of manufacture (i.e. September 2006.
October 2006...August 2007). Affected bed packages are model numbers:
BED24IVC, BED25IVC, BED24CA or BED25CA. Recall # Z-2402-2010
MANUFACTURER: Invacare Corp., Sanford, FL, by letter dated October 15,
2007. Firm initiated recall is ongoing.
REASON : The mattresses when used in combination with the IVC and
ValueCare Series of manual, semi-electric and electric beds and
associated bed rails do not meet some of the requirements of the
voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to
Reduce Entrapment, as intended. Use of these particular mattresses in
combination with Invacare beds and bed rails may put users at increased
risk of entrapment.
PRODUCT
Mattress Model 5185 and 5185XL. Mattress Model 5185 and 5185XL were
packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633,
BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR
VCPKGIVC2-1633. In September 2007 Invacare Corporation recalled the
innerspring mattresses associated with Invacare's IVC Bed Series Full
Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed
Series Semi Electric Bed. These mattresses were manufactured between
June 28, 2007 and July 12, 2007. Recall # Z-2403-2010
MANUFACTURER: Invacare Corp., Sanford, FL, by letter dated September 5,
2007. Firm initiated recall is ongoing.
REASON : These mattresses when used in combination with the IVC and
ValueCare Series of manual, semi-electric and electric beds and
associated bed rails, do not meet some of the requirements of the
voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to
Reduce Entrapment. Use of these particular mattresses in combination
with Invacare beds and bed rails may put users at increased risk of
entrapment.
PRODUCT
Stryker Bur Guard REF 2296-301. The Impaction Bur Guard is intended to
be used with the Impaction Drill. The drill is used for surgical
procedures involving precision drilling and cutting of bone and hard
tissue. The bur guard covers the nose of the handpiece and the shaft of
the cutting accessory to prevent exposure to heat and moving parts, as
well as minimize bur whip and handpiece vibration. Recall # Z-2420-2010
MANUFACTURER: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI,
by letter dated June 10, 2010. Firm initiated recall is ongoing.
REASON : The reason for the field action is that the inner diameter of
the Bur Guards may be out of specification. If there is excess material
on the inside of the Bur Guard at the location where the guard tapers,
it may come into contact with the Nose Cone of the drill. This could
result in an injury or burn to the patient and/or user.
CLASS III
PRODUCT:
Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to
calibrate Phosphate, Salicylate, and Triglycerides methods on the
Dimension Vista system. Recall # Z-2387-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated February 2010. Firm initiated recall is ongoing.
REASON : There is incorrect barcode information, which can potentially
cause the Alert Message "Calibrator Insert Missing" to be displayed.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of recalls as of
September 8, 2010
CLASS I
PRODUCT:
AngioSculpt Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheter, cutting/scoring, Easy Exchange (EX) delivery system. Catheter
is for use in the treatment of hemodynamically significant coronary
artery stenosis, including in-stent restenosis and complex type C
lesions, for improving myocardial perfusion. The devices are available
in balloon diameters of 2.0-3.5 mm in 0.5 mm increments, and in scoring
balloon lengths of 10 to 15 nm. Catheter length is 139 cm and is
compatible with 0.014 inch guide wires and 6F guide catheters. The EX
catheter is supplied sterile and intended for single use. Recall #
Z-2218-2010
MANUFACTURER: AngioScore Inc., Fremont, CA, by letter dated December 4,
2009. Firm initiated recall is ongoing.
REASON: Separations of the PTCA catheter shaft at the guide wire exit
port have occurred during treatment of coronary artery stenosis.
Fragments of the catheter may become lodged in coronary arteries, which
resulting in serious patient outcome and require emergency coronary
bypass surgery and medical intervention to remove the retained device
fragments.
CLASS II
PRODUCT:
Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx
Only. Usage: Temporary pacing of open hearts: used with External Pacing
Generators (EPGs). Recall # Z-2223-2010
MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by letter on/about
May 19, 2010. Firm initiated recall is ongoing.
REASON: The Safe Connect component may separate from the cable, causing
the cable to become unplugged from the EPG.
PRODUCT:
medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low Profile CT Port with
Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit. Catalog
#MRCTI66841. Recall # Z-2235-2010
MANUFACTURER: Medical Components, Inc dba MedComp, Harleysville, PA, by
email on July 1, 2010.
REASON: Recalled product was packaged with the incorrect port and does
not match the label. The kit is labeled as a 6.6F "Dignity" Low Profile
CT Port. The kit contains a 6.6F "Pro-Fuse" Low Profile CT Port.
PRODUCT:
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1,
SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube
model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to
electrosurgically resect tissue within the digestive tract. Recall #
Z-2236-2010, K0303, K0305, K0308, K0309, K0310, K0311, K0312, K0315, and
K0316
MANUFACTURER: Recalling Firm: Olympus America Inc., Center Valley, PA,
by letter on May 4, 2010.Manufacturer: Amori Olympus Co., Ltd., Kuroisha-Shi,
Aomori-Ken, Japan. Firm initiated recall is ongoing.
REASON: An investigation of consumer complaints revealed the inability
of the snare wire to be retracted into the snare tube after deployment
of the snare.
PRODUCT:
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray
System. Part Number: 989605651321. Intended to produce cross-section
images of head and body by computer reconstruction of X-ray transmission
data taken at different angles. Recall # Z-2237-2010
MANUFACTURER: Recalling Firm: Neuisys, LLC, Greensboro, NC, by letter on
July 21, 2008.Manufacturer: Philips and Neusoft Medical Systems Co.,
Ltd., Shenyang, Liaoning, China. Firm initiated recall is complete
REASON: The reference lines for image generated for a Surview scan may
appear in the incorrect position in the "FILM" display mode.
PRODUCT :
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001,
1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006,
1000093-007. Sterilized using Ethylene Oxide. The OptiSeal Valved PTFE
Peelable Introducer is designed to reduce blood loss and air intake by
providing hemostatic sealing at venous pressures. The device is offered
in two configurations, one without a sideport and one with a sideport
attached to a segment of extension tubing terminating in a 3-way
stopcock. Recall # Z-2294-2010
MANUFACTURER: Greatbatch Medical, Minneapolis, MN, by letter dated July
12, 2010. Firm initiated recall is ongoing.
REASON: The outer sterile barrier (pouch) packaging for the 12 Fr device
is not intact. No breaches in the inner sterile barrier (tray/tyvek lid)
have been identified. The OptiSeal introducer and accessories sealed in
the tray are sterile. Infection may result if a sterile field is
contaminated by the outer surface of the inner tray.
PRODUCT:
VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test
card is packaged into a foil pouch with 20 pouches per box. This is an
Export Only test kit that is not marketed in the U.S. Recall #
Z-2295-2010
MANUFACTURER: Biomerieux Inc., Hazelwood, MO, by letter dated July 29,
2010. Firm initiated recall is ongoing.
REASON: Foil pouch was punctured by drug susceptibility cards during
packaging, allowing moisture into pouch, resulting in inaccurate and/or
incorrect drug susceptibility results.
PRODUCT:
V. Mueller Peanut Sponges, Catalog number 23275-470, Sterile, For Single
Use Only, Size: 3/8, X-Ray Detectable In Holders. There are various uses
including as gauze/sponge internal, x-ray detectable and as dissectors.
Recall # Z-2296-2010
MANUFACTURER: Recalling Firm: He, Inc., Martinez, GA, by letter dated
March 1, 2010.Manufacturer: G3 Medical, Asheville, NC. Firm initiated
recall is ongoing.
REASON: Sterile product packaging contains weak seals, which may result
in compromised product sterility.
PRODUCT:
VP 2000 Processor Heated Reagent Basins; automated slide stainer; The
basins are sold under the following part numbers: a) list 02J11-013,
part number 30-144152 (replacement basins); b) list 02J11-060, part
number 30-144100 (as a component of the 100 volt VP 2000 Processor); c)
list 02J11-001, part number 30-144101 (as a component of the 117 volt VP
2000 Processor); d) list 02J11-004, part number 30-144102 (as a
component of the 230 volt VP 2000 Processor); Designed to automate and
standardize FISH slide specimen processing and routine slide staining
for the laboratory. Recall # Z-2313-2010
MANUFACTURER: Recalling Firm: Abbott Molecular, Des Plaines, IL, by
letters dated July 20, 2010. Manufacturer: U.S. Machine and Tool, Round
Lake, IL; Pcm, Co., Camden, NJ. Firm initiated recall is ongoing.
REASON: The VP2000 Processor Heated Reagent Basins crack along the
bottom seam, have non-uniform coating of interior corners, may be
warped, and some may have incorrect dimensions.
PRODUCT:
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 Hole, Right -
148 MM, REF 71800710, Qty: (1), Sterile R, CE 0086. Adult and pediatric
patients, as indicated for pelvic, small, and long bone fracture
fixation. Recall # Z-2314-2010
MANUFACTURER: Smith & Nephew Inc., Memphis, TN, by letter dated July 20,
2010. Firm initiated recall is ongoing.
REASON: Inner packaging of sterile product was not sealed. Lack of
sterility assurance.
PRODUCT:
1) Boston Scientific Ultraflex Uncovered Esophageal Stent System -
Distal Release (18/23/15) Material/Catalog Number: M00513720. Recall #
Z-2316-2010;
2) Boston Scientific Ultraflex Covered Esophageal Stent System - Distal
Release Distal Release (18/23/12/9) Material/UPN/Catalog Number:
M00513740. Recall # Z-2317-2010;
3) Boston Scientific Ultraflex Uncovered Esophageal Stent System -
Proximal Release (18/23/7) Material/UPN/Catalog Number: M00513800.
Recall # Z-2318-2010;
4) Boston Scientific Ultraflex Covered Esophageal Stent System -
Proximal Release (18/23/10/7) Material/UPN/Catalog Number: M00513840.
Recall # Z-2319-2010;
5) Boston Scientific Ultraflex Covered Esophageal Stent System -
Proximal Release (18/23/12/9) Material/UPN/Catalog Number: M00513850.
Recall # Z-2320-2010;
6) Boston Scientific Ultraflex Covered Esophageal Stent System -
Proximal Release (18/23/15/12) Material/UPN/Catalog Number: M00513860.
Recall # Z-2321-2010;
7) Boston Scientific Ultraflex Covered large Esophageal Stent System -
Distal Release (23/28/10/7) Material/UPN/Catalog Number: M00514200.
Recall # Z-2322-2010;
8) Boston Scientific Ultraflex Uncovered Large Esophageal Stent System -
Distal Release (23/28/12) Material/UPN/Catalog Number: M00514230. Recall
# Z-2323-2010;
9) Boston Scientific Ultraflex Covered Large Esophageal Stent System -
Proximal Release (23/28/12/9) Material/UPN/Catalog Number: M00514250.
Recall # Z-2324-2010;
10) Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System
- Proximal Release (10/4) Material/UPN/Catalog Number: M00564670. Recall
# Z-2325-2010;
11) Boston Scientific Ultraflex Covered Tracheobronchial Stent System --
Distal Release (10/4/2.5) Material/UPN/Catalog Number: M00564760. Recall
# Z-2326-2010;
12) Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (14/4/2.5) Material/UPN/Catalog Number: M00564800. Recall
# Z-2327-2010;
13) Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (16/6/4.5) Material/UPN/Catalog Number: M00564840. Recall
# Z-2328-2010;
14) Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (18/4/2.5) Material/UPN/Catalog Number: MOO564860. Recall
# Z-2329-2010; 15) Boston Scientific Ultraflex Covered Tracheobronchial
Stent System - Distal Release (20/6/4.5) Material/UPN/Catalog Number:
M00564900. Recall # Z-2330-2010;16) Boston Scientific Ultraflex
Precision Colonic Stent System Material/UPN/Catalog Number: M00557360.
Recall # Z-2331-2010
MANUFACTURER: Recalling Firm: Boston Scientific, Corp., Marlborough, MA,
by letters dated July 15, 2010.Manufacturer: Boston Scientific Ireland,
Ltd., Galway, Ireland. Firm initiated recall is ongoing
REASON: Units have excessive fraying of the deployment suture thread; as
a result, these devices may experience a suture break during deployment.
PRODUCT:
Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI
Alloy, Implant; Catalog number 3225-0360S. Intended for temporary
fixation, correction, or stabilization of the right femur. Recall #
Z-2340-2010Lot code K248963; Expiration: 8/14/2014
MANUFACTURER: Recalling Firm:Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letters on July 23, 2010 and July 26, 2010.Manufacturer: Stryker
Worldwide, Kiel, Germany. Firm initiated recall is ongoing.
REASON: The nail has no thread for the set screw hindering insertion.
PRODUCT:
1) CELL-DYN 3200 CS and SL, Hematology Analyzer. Waste Reservoir
Assembly Part number 8921174802. Recall # Z-2350-2010 2) CELL-DYN 3700
CS and SL, Hematology Analyzer. Waste Reservoir Assembly Part number
8921174802. Recall # Z-2351-201; 3) CELL-DYN Ruby, Hematology Analyzer.
Waste Reservoir Assembly Part number 8921174802. Recall # Z-2352-2010;
4) CELL-DYN Sapphire, Hematology Analyzer. Waste Reservoir Assembly Part
number 8921174802. Recall # Z-2353-2010
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on April
16/2010. Firm initiated recall is complete.
REASON: Epoxy holding the two parts of the waste reservoir together
fails, potentially resulting in biohazardous fluid leaks.
PRODUCT:
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number:
A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use
is for the quantitative determination of thyroglobulin antibody levels
in human serum and plasma using the Access Immunoassay Systems. Recall #
Z-2355-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
dated June 29, 2010.Manufacturer: Beckman Coulter, Inc., Chaska, MN.
Firm initiated recall is ongoing.
REASON: The affected Access Thyroglobulin Antibody II reagent may
produce inaccurate results due to a change in the thyroglobulin that was
used in the kits.
PRODUCT:
1) Stryker Pain Pump 2 Luer Cap, REF 525-401, Rx, Sterile. Recall #
Z-2356-2010;
2) Stryker Sheath 17 gage 12 inch for use with Stryker Pain Pump, REF
540-428, Rx, Sterile. Recall # Z-2357-2010;
3) Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF
540-482, Rx, Sterile. Recall # Z-2358-2010;
4) Stryker Sheath 11 gage 8 inch for use with Stryker Pain Pump, REF
540-482, Rx, Sterile.Recall # Z-2359-2010;
5) Poly Stim II Nerve Stimulator 8 inch for use with Stryker Pain Pump,
REF 550-100, Rx, and Sterile.Recall # Z-2360-2010;
6) 21G x 90mm/20 Bevel Single Shot Needle, REF 55-021-090, Rx, Sterile.
Recall # Z-2361-2010;
7) 22G x 50m/20 bevel Single Shot Needle, REF 552-022-050, Rx, and
Sterile.Recall # Z-2362-2010;
8) 21G x 150m/20 bevel Single Shot Needle, REF 552-021-150, Rx, and
Sterile. Recall # Z-2363-2010;
9) 22G x 70mm/20 bevel Single Shot Needle, REF 552-022-70, Rx, and
Sterile. Recall # Z-2364-2010;
10) 24G x 25mm/20 bevel Single Shot Needle, REF 552-024-025, Rx,
Sterile. Recall # Z-2365-2010;
11) 18G x 50mm/20 Tuohy Catheter Kit, REF 553-118-050, Rx, Sterile.
Recall # Z-2366-2010;
12) 18G x 90mm/20 Tuohy Catheter Kit, REF 553-118-090, Rx, Sterile.
Recall # Z-2367-2010;
13) 18G x 150m Tuohy Catheter Kit, REF 553-118-150, Rx, Sterile. Recall
# Z-2368-2010
14) 17G x 50m Tuohy Catheter Kit, REF 553-218-50, Rx, Sterile. Recall #
Z-2369-2010;
15) 17G x 90m Tuohy Stimulation Catheter Kit, REF 553-218-90, Rx,
Sterile. Recall # Z-2370-2010;
16) 17G x 150mm Tuohy Stimulation Catheter Kit, REF 553-218-150, Rx,
Sterile. Recall # Z-2371-2010;
17) 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF
553-318-050, Rx, Sterile. Recall # Z-2372-2010;
18) 17G x 90mm Stimulation Catheter Continuous Nerve Block Tray, REF
553-318-090, Rx, Sterile. Recall # Z-2373-2010;
19) 17G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF
553-318-150, Rx, Sterile. Recall # Z-2374-2010;
20) 21G x 90mm/45 Bevel Single Shot Needle, REF 554-021-090, Rx,
Sterile. Recall # Z-2375-2010;
21) 21G x 150mm Stimulation Catheter Continuous Nerve Block Tray, REF
554-021-150, Rx, Sterile. Recall # Z-2376-2010;
22) 22G x 50mm/45 Bevel Single Shot Needle, REF 554-022-050, Rx,
Sterile. Recall # Z-2377-2010;
23) 22G x 70mm/45 Bevel Single Shot Needle, REF 554-022-070, Rx,
Sterile. Recall # Z-2378-2010;
24) 24G x 25mm/45 Bevel Single Shot Needle, REF 554-024-025, Rx,
Sterile. Recall # Z-2379-2010
MANUFACTURER: Recalling Firm: Stryker Instruments Div. of Stryker Corp.,
Kalamazoo, MI, by letter on February 2, 2010.Manufacturers: Imed Ireland
Limited, Donegal, Ireland; Integra Life Sciences Corp., Salt Lake City,
UT; Te Me Na Sas, Carrieres Sur Seine, France. Firm initiated recall is
ongoing.
REASON: Defects include, but not limited to: Not sterile, not properly
labeled, drugs and swabs may be ineffective, and catheter tips may break
in patients.
PRODUCT:
Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge.
Medical point-of-care device designed to warm blood and IV fluids. Model
numbers: 9800200, 9800202, 9800200EU, 9800202EU, 9100020010, 9100020210,
91000153, 91000154, 91000156. Recall # Z-2380-2010
MANUFACTURER: Vital Signs Inc., Totowa, NJ, by letter, dated July 15,
2010. Firm initiated recall is ongoing.
REASON: The enFlow Disposable IV Fluid/Blood Warmer Cartridge's male
luer-lock fitting may be oversized and may not fit properly with
standard female luer fittings.
CLASS III
PRODUCT:
1) COULTER LH 500 Series System. Recall # Z-2337-2010;2) Unicel DxH 800
Coulter Cellular Analysis System. Recall # Z-2338-2010
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by
letters beginning the week of February 15, 2010.Manufacturer: Beckman
Coulter, Inc., Miami, FL. Firm initiated recall is complete.
REASON: The recall was initiated after Beckman Coulter identified four
(4) issues with the COULTER LH 500 Series System and the Unicel DxH 800
Coulter Cellular Analysis System: Issue 1: There is a potential for
misidentification to occur when the system is configured in languages
other than English or Chinese. The characters #, @, [, \ , ], `,{, |, }
or ~ are substituted or omitted in other languages. The issue affects
the LH500 and DxH 800. Issue 2: Independent of language, the DxH 800
omits the characters *?” when used as part of the selected demographics
including Speciman ID and Patient ID. Issue 3: In the DxH 800, space (s)
used as leading character (s) in a Patient or Specimen ID, can cause
random insertion of extra character (s) within that identifier. Issue 4:
The LH500 instrument omits the tilde character (~) from the barcode when
read by the primary mode (automatic aspiration) scanner. This is
independent of language configuration on system.
PRODUCT:
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free. Part
number 262261. Recall # Z-2354-2010
MANUFACTURER: Dental EZ Stardental Division, Lancaster, PA, by letter on
August 11, 2010. Firm initiated recall is ongoing.
REASON: The housing of 5K motor is labeled as a 20K motor.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of recalls as of
September 1, 2010
CLASS II
PRODUCT:
1) Fresenius 2008H Dialysate Delivery Machine, Catalog numbers 501228,
R190188 (Refurbished), R501228, RTLR501228 (Refurbished). Recall #
Z-2224-2010;2) Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis
Machines, Catalog numbers: 2008K: 190300, 190303, 190305, 190336,
190371, 190372, 190373, 190517, R190305 (Refurbished), R190371
(Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished),
RTLR190371 (Refurbished), RTLR190373 (Refurbished). Recall #
Z-2225-2010;3) Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and
Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101,
Catalog Numbers G047-80101 and RTLG047-80101. Recall # Z-2226-2010;4)
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for
hemodialysis machines and Granuflo 1 mixers. Catalog Numbers 190011 (60
Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC
power cord assembly -hemodialysis machine) and 160089 (AC power cord
assembly, Granuflo 1 mixers). Recall # Z-2227-2010
MANUFACTURER: Recalling Firm: Fresenius Medical Care North America,
Waltham, MA, by letter on June 28, 2010. Manufacturer: Fresenius USA,
Inc., Walnut Creek, CA. Firm initiated recall is ongoing.
REASON : Power cords may fail if the prongs crack or fail at the plug,
and may become a fire/burn/shock hazard or delay/interrupt therapy.
PRODUCT:
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray
system. Model numbers: 10094139, 5904466, 7555365. Recall # Z-2233-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter on July 13, 2010. Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON : The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm
gearbox can become damaged. If the gearbox is damaged, the C-arm may
tilt away when being repositioned and collide with nearby objects in its
range of motion.
PRODUCT :
3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8, Left, Part #
333-01-108. Recall # Z-2244-2010
MANUFACTURER: ore Medical, LP, Austin, TX, by letter on June 28, 2010.
Firm initiated recall is ongoing.
REASON : lot of product has an incorrect color label. The color label is
a secondary visual indicator of sizing.
PRODUCT:
1) Medtronic Everest 20 Disposable Inflation Device, AC2200. Used to
inflate/deflate balloon catheters as well as to monitor pressure within
the balloon. Recall # Z-2271-2010;2) Medtronic Everest 30 Disposable
Inflation Device, AC3200. Used to inflate/deflate balloon catheters as
well as to monitor pressure within the balloon. Recall # Z-2272-2010;3)
Medtronic Everest 30 Disposable Inflation Device, AC3205P. Used to
inflate/deflate balloon catheters as well as to monitor pressure within
the balloon. Recall # Z-2273-2010
MANUFACTURER : calling Firm: Medtronic, Inc., Danvers, MA, by letter on
July 15, 2010.Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm
initiated recall is ongoing.
REASON : Product sterility may be compromised due to breach of package
seal integrity.
PRODUCT:
Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis
Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801.
Recall # Z-2274-2010
MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by
letter on June 7, 2010.Manufacturer: Arrow International Inc., Asheboro,
NC. Firm initiated recall is ongoing.
REASON : Sterility not assured. The stopcock handle position was
inadvertently changed from an open to a closed position, which prevents
sterilization of the closed portion of the device. Sterility of the
affected product cannot be guaranteed.
PRODUCT :
Carescape Monitor B850 Usage: The Carescape TM Monitor B850 is a
multi-parameter high acuity patient monitor intended for use in multiple
areas within a professional healthcare facility. Recall # Z-2275-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated July 12, 2010.Manufacturer: General Electric Medical
Systems Information Technology,
Milwaukee, WI. Firm initiated recall is ongoing.
REASON : GE Healthcare has become aware of four potential safety issues
associated with the CARESCAPE" Monitor B850: 1. Loss of user input when
using certain displays or the USB remote control. 2. Potential for a
delay in treatment or missed alarm when the alarm light is used as a
primary alarm source and audible alarms are turned down or off. 3. The
CARESCAPE Monitor B850 will not use user entered hemoglobin values when
calculating SvO2 values, which could result in incorrect treatment of a
patient. 4. When CARESCAPE B850 is used in conjunction with Tram, the HR
Alarm Limits may revert back to default settings, which could result in
a missed alarm. There were no reported patient injuries or illnesses.
PRODUCT:
ABC Bend-A-Beam Handpiece REF 134003 Handcontrol Malleable Handpiece, 3"
(7.6 cm) qty: 1 Sterile (pouch label) ABC Bend-A-Beam Handpiece REF
134003 Handcontrol Malleable Handpiece, 3" (7.6 cm) qty: 10 Sterile
(case label) Usage: Electrosurgical handpiece for use as monopolar
electrosurgical accessory in conjunction with CONMED electrosurgical
units equipped with argon beam coagulation. Recall # Z-2276-2010;2) ABC
Bend-A-Beam Handpiece REF 134006 Handcontrol Malleable Handpiece, 6"
(15.2 cm) qty: 1 Sterile, (Pouch label); ABC Bend-A-Beam Handpiece REF
134006 Handcontrol Malleable Handpiece, 6" (15.2 cm) qty: 10 Sterile,
(case label) Usage: Electrosurgical handpiece for use as monopolar
electrosurgical accessory in conjunction with Conmed electrosurgical
units equipped with argon beam coagulation. Recall # Z-2277-2010;3) ABC
Bend-A-Beam Handpiece REF 134009 Handcontrol Malleable Handpiece, 9"
(22.8 cm) qty: 1 Sterile, (Pouch label); ABC Bend-A-Beam Handpiece REF
134006 Handcontrol Malleable Handpiece, 9" (22.8 cm) qty: 10 Sterile
(Case label) Usage: Electrosurgical handpiece for use as monopolar
electrosurgical accessory in conjunction with Conmed electrosurgical
units equipped with argon beam coagulation. Recall # Z-2278-2010;4) ABC
Probe REF 160656 5 mm Handswitching Probe, 28 cm qty: 1 Sterile; ABC
Probe REF 160656 5 mm Handswitching Probe, 28 cm qty: 10 Sterile. Usage:
Electrosurgical handpiece for use as monopolar electrosurgical accessory
in conjunction with Conmed electrosurgical units equipped with argon
beam coagulation. Recall # Z-2279-2010;5) ABC Probe REF 160636 5 mm
Handswitching Probe, 36 cm qty: 1 Sterile; ABC Probe REF 160636 5 mm
Handswitching Probe, 36 cm qty: 10 Sterile Usage: Electrosurgical
handpiece for use as monopolar electrosurgical accessory in conjunction
with Conmed electrosurgical units equipped with argon beam coagulation.
Recall # Z-2280-2010;6) ABC Probe REF 160644 5 mm Handswitching Probe,
44 cm Qty: 1 Sterile, ABC Probe REF 160636 5 mm Handswitching Probe, 44
cm, qty: 10 Sterile, Usage: Electrosurgical handpiece for use as
monopolar electrosurgical accessory in conjunction with Conmed
electrosurgical units equipped with argon beam coagulation. Recall #
Z-2281-2010;7) ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1
STERILE ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 10 STERILE;
Usage: Electrosurgical handpiece for use as monopolar electrosurgical
accessory in conjunction with CONMED electrosurgical units equipped with
argon beam coagulation. Recall # Z-2282-2010
MANUFACTURER: Recalling Firm: ConMed Electrosurgery, Centennial, CO, by
letter on December 18, 2008.Manufacturer: Seisa Medical, Chih, Mexico.
Firm initiated recall is ongoing.
REASON : The internal electrode can protrude in front of ceramic
insulator at the tip of the ABC Handpiece used with Conmed
Electrosurgical units.
PRODUCT:
Genzyme Biosurgery Essentials Kit, Item Number 82004. Recall #
Z-2310-2010
MANUFACTURER: Genzyme Corp., Cambridge, MA, letter on July 13, 2010.
Firm initiated recall is ongoing.
REASON : Revised Labeling of Carticel Essentials Kit clarifies the
non-sterile packaging of the outer clear plastic tray which should not
be opened in the sterile field.
PRODUCT:
E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No.
KT003) is a multicolor, qualitative nucleic acid hybridization assay
intended for identification of Enterococcus faecalis and selected other
enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides
rapid identification of E. faecalis and selected other enterococci (OE)
on smears made from positive blood cultures and is compatible with all
major blood culture media. Recall # Z-2315-2010
MANUFACTURER : AdvanDx, Inc., Woburn, MA, by letter dated June 8, 2010,
and email notification on June 11, 2010. Firm initiated recall is
ongoing.
REASON : Some strains of streptococcus anginosus cross-reach with E.
faecalis/OE PNA FISH to produce a false positive green signal.
CLASS III
PRODUCT:
Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer. Recall #
Z-2292-2010
MANUFACTURER: Recalling Firm: Integrated Orbital Implants Inc., San
Diego, CA, by telephone and email beginning June 7, 2010.Manufacturer:
Interpore Cross International LLC, Irvine, CA. Firm initiated recall is
ongoing.
REASON : Integrated Orbital Implants, Inc. has initiated a recall of its
Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a
labeling issue in which the expiration date of the product was omitted.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
August 31, 2010
CLASS II
PRODUCT
19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD
Arm Agfa's Computed Radiography Systems with NX2.X software are
indicated for use in providing diagnostic quality images to aid the
physician with diagnosis. Recall # Z-2100-2010
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter
dated June 30, 2010.Manufacturer: Agfa Healthcare Corp., Carlstadt, NJ.
Firm initiated recall is ongoing.
REASON: Monitor fell from the mounting bracket used to support the
monitor
PRODUCT
1) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT
No: LWSTDA35180, 180cm, Sterile EO. Intended to facilitate the placement
of devices during diagnostic and interventional procedures. Recall #
Z-2101-2010;
2) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In
Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO. Intended to facilitate
the placement of devices during diagnostic and interventional
procedures. Recall # Z-2102-2010;
3) Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT
No: LWSTFS35180, 180cm, Sterile EO. Intended to facilitate the placement
of devices during diagnostic and interventional procedures. Recall #
Z-2103-2010;
4) Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT
No: LWSTDA35260EX, 260cm, Sterile EO. Intended to facilitate the
placement of devices during diagnostic and interventional procedures.
Recall # Z-2104-2010;
5) Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In
Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO. Intended to
facilitate the placement of devices during diagnostic and interventional
procedures. Recall # Z-2105-2010
6) Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in
Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO. Intended to
facilitate the placement of devices during diagnostic and interventional
procedures. Recall # Z-2106-2010
MANUFACTURER: Recalling Firm: Merit Medical Systems, Inc., South Jordan,
UT, by e-mail on June 28, 2010. Manufacturer: Merit Medical Ireland
Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON: Guidewires have decreased lubricity at the proximal end,
inhibiting proper operation.
PRODUCT
RQCHRT HRT Control Level 1 & 2; Whole Blood controls for use with
Hemochron Kaolin and Celite HRT Test Tubes. 20 vials Whole Blood -
2.0mL; dried 20 vials Diluent - 4.0 mL The Hemochron HRT Whole Blood
Quality Controls are intended to be used to perform quality control
assays using the Hemochron HRT test tubes. Recall # Z-2110-2010
MANUFACTURER: International Technidyne Corp., Edison, NJ, by letters
dated June 24, 2010. Firm initiated recall is ongoing.
REASON: An ingredient in the RQCHRT Whole Blood Controls for use with
Hemochron Kaolin and Celite HRT Test tubes may become less potent over
time and result in excessive High LQC Failures.
PRODUCT
Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle
(20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for
single use only sets, 5 sets per case; Made in Dominican Republic; REF
CCH2220 For use in soft tissue aspiration such as breast, kidney, liver,
lung, thyroid, lymph nodes and other various soft tissue masses. It is
not intended for use in the bone. Recall # Z-2111-2010
MANUFACTURER: Recalling Firm: Carefusion 2200 Inc., Waukegan, IL, by
telephone and letter on June 15, 2010.Manufacturer: Cardinal Health,
Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON: The introducer needle is only 10 cm in length instead of the
required 15 cm.
PRODUCT
International Technidyne Corporation (ITC) directCheck Whole Blood
Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N;
in vitro diagnostic 15 vials For performance of Level 1 quality control
ACT-LR test curettes’ on the Hemochron Microcoagulation Systems. Recall
# Z-2200-2010
MANUFACTURER: International Technidyne Corp., Edison, NJ, by letters on
June 25, 2010. Firm initiated recall is ongoing.
REASON: The package insert for the direct Check Microcoagulation Quality
Control contains an incorrect acceptable performance range regarding
ACT-LR curettes’.
PRODUCT
1) Philips Intellivue Patient Monitor Model MP60 (M8005A). Recall #
Z-2201-2010;2) Philips Intellivue Patient Monitor Model MP70 (M8007A).
Recall # Z-2202-2010
MANUFACTURER: Recalling Firm: Philips Healthcare Inc., Andover, MA,
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen,
Germany. Firm initiated recall is ongoing.
REASON: Additional Instruction for Use for Intellivue MP60/MP70 to
prevent monitors from becoming loose and detaching from the mounting
arm.
PRODUCT
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022,
Knee prosthesis component. Recall # Z-2204-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on April 13, 14 and
15, and by letter dated April 20, 2010. Firm initiated recall is
ongoing.
REASON: A knee implant labeled as left was opened and the package
actually contained a right knee implant.
PRODUCT
Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT
5/Pkg. These circuits are intended for use with the MR Conditional LTV
1200 System with the ventilator utilizing an external exhalation valve,
as single patient use (SPU) only patient circuits for adult and
pediatric patients. The LTV 1200 ventilator is intended to provide
continuous or intermittent ventilator support for the care of
individuals who require mechanical ventilation. The ventilator is
suitable for use in institutional, home and transport settings, and is
applicable for adult and pediatric patients weighing at least 5 kg (11
lbs.), who require the following types of ventilator support: -Positive
Pressure Ventilation, delivered invasively (via ET tube) or
non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of
ventilation. -Breath types including Volume, Pressure Control and
Pressure Support. Recall # Z-2205-2010
MANUFACTURER: Recalling Firm: CareFusion 203, Inc., Minneapolis, MN, by
letter dated July 2, 1010. Manufacturer: Productos Urologos de Mexico
S.A. de C.V., Mexicali, Baja California, Mexico. Firm initiated recall
is ongoing.
REASON: CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU
W/O PEEP 15ft) because some of the circuit sense lines may have been
reversed during the manufacturing process. If the sense lines have been
reversed, immediately upon connection of the patient circuit to the
ventilator and turning the ventilator on, the ventilator will begin to
autocycle (with increased pressure delivered) with both audible and
visual alarm indicators to alert the Health Care Professional to provide
alternative ventilation as required.
PRODUCT
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor
Model 2490C is designed to automatically gather information from the
implanted heart device. This automatic wireless communication between
the heart device and the monitor takes place at times scheduled by the
doctor or clinic. The gathered heart device information is sent over a
telephone line to the clinic using a toll-free number. The monitor can
also send wireless heart device alerts to the clinic automatically.
Z-2209-2010
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease
Management, Saint Paul, MN, by letters dated 6/10/2010. Manufacturer:
Plexus Manufacturing Sdn. Bhd., Penang, Malaysia. Firm initiated recall
is ongoing.
REASON: Medtronic has identified that a subset of 2490C CareLink
Monitors recently received an incorrect software update. Patients
reported that their monitor was making a "ticking sound" and they were
unable to transmit device data via CareLink. These monitors are now
non-functional. No patient injuries have been reported as a result of
this issue.
PRODUCT
1) Trabecular Metal acetabular revision system buttress augment size,
54, 00-4898-001-54, sterile. Usage: Implantable devices that are used to
address bony deficiencies of the pelvic antebulum in revision total hip
arthroplasty surgery. Recall # Z-2214-2010;2) Trabecular Metal
acetabular revision system buttress augment size, 58, 00-4898-001-58,
sterile. Usage: Implantable devices that are used to address bony
deficiencies of the pelvic antebulum in revision total hip arthroplasty
surgery. Recall # Z-2215-2010;3) Trabecular Metal acetabular revision
system column buttress left posterior/right anterior, 00-4894-300-00,
sterile. Usage: Implantable devices that are used to address bony
deficiencies of the pelvic antebulum in revision total hip arthroplasty
surgery. Recall # Z-2216-2010;4) Trabecular Metal acetabular revision
system column buttress right posterior/left anterior, 00-4894-400-00,
sterile. Recall # Z-2217-2010;
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated
4/6/2010.
Manufacturer: Zimmer Trabecular Metal Technology, Inc., Parsippany, NJ.
Firm initiated recall is ongoing.
REASON: The firm has determined that some of the packages could develop
a breach of the seal in the sterile barrier pouches.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
August 18, 2010
CLASS I
PRODUCT:
Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal
Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number
1570. The Aqua+ Flex is a passive humidifier indicated for use on
patients under anesthesia and intensive care to effectively warm and
humidify the inspired air. Recall # Z-1634-2010
MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, by letter on
March 22, 2010. Manufacturer: Teleflex Medical, Perak, Malaysia. Firm
initiated recall is ongoing.
REASON: The patient end of the 22 cm connector on the flex tube may not
fit securely within the endotracheal tube (ET) connector and therefore
disconnect from the endotracheal tube. A disconnect in ventilator
dependent patients without prompt response to the alarm could lead to
hypoxia, organ failure, or cardio-respiratory arrest.
PRODUCT:
Ikaria INOMAX DS Drug Delivery System, model 10003. The INOMAX DS
Delivery System delivers INOMAX (nitric oxide for inhalation) therapy
gas into the aspiratory limb of the patient breathing circuit in a way
that provides a constant concentration of nitric oxide (NO), as set by
the user, to the patient throughout the inspired breath. It uses a
specially designed injector module, which enables tracking of the
ventilator waveforms and the delivery of a synchronized and proportional
dose of NO. It may be used with most ventilators. The INOMAX DS provides
continuous integrated monitoring of inspired O2, NO2, and NO, and a
comprehensive alarm system. Recall # Z-2176-2010
MANUFACTURER: Recalling Firm: Ikaria Holdings, Clinton, NJ, by letter
dated July 21, 2010.Manufacturer: INO Therapeutics, Middleton, WI. Firm
initiated recall is ongoing.
REASON: The pressure switch in the INOMAX DS drug-delivery system may
fail, which may interrupt or delay the administration of INOMAX (nitric
oxide) for inhalation to patients.
PRODUCT :
1) Engage" TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max
Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. Recall #
Z-2178-2010;
2) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max
Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. Recall #
Z-2179-2010;
3) Engage" TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max
Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. Recall #
Z-2180-2010;
4) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max
Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. Recall #
Z-2181-2010;
5) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max
Guidewire O.D., Rx, Sterile EO, REF C408507,100017564. Recall #
Z-2182-2010
MANUFACTURER: St. Jude Medical Cardiovascular Division, Minnetonka, MN,
by letter dated June 24, 2010. Firm initiated recall is ongoing.
REASON: St Jude Medical Cardiovascular Division is performing a
voluntary recall of certain batches of the 6 Fr. Engage" Introducer
produced during the time period of 27 April to 03 June 2010. They have
identified that a very small percentage of devices in the affected
batches have the potential for a partial or complete separation of the
Shaft (sheath) from the hub or a material break in the hub assembly just
distal to the hemostasis seal. If either of these were to occur during
use, it is likely that fluids would leak around the Introducer hub and
strain relief. To date, no adverse events related to this issue have
been reported.
LASS II
PRODUCT :
MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal
femur as a guide for making the anterior, posterior and both chamfer
cuts. Model/Catalog Numbers: 800-01-368/370; 800-02-343/345; Specials
that are affected: S1028, S1046, S1130, S1135, S1305, S1366, S1373,
S1374, S1375, S1403, S1468, S1469, S1470, S1511, S1512, S1513. Recall #
Z-2164-2010
MANUFACTURER: Encore Medical, LP, Austin, TX, by letter dated May 20,
2010. Firm initiated recall is ongoing.
REASON: A crack or complete fracture in the anterior chamfer cut slot
may occur on the size 8, 10, and 12 MIKA Speedblocks.
PRODUCT:
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL)
Anti-Sirolimus Antibody Coated Micro particles, 1 bottle (9.7 mL)
Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL)
4-Methylumbelliferyl Phosphate, 1.2 mM; list 5C91-21. The IMx Sirolimus
assay is an in vitro reagent system for the quantitative determination
of sirolimus in human whole blood as an aid in the management of renal
transplantpatients receiving sirolimus therapy. Recall # Z-2171-2010
MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by
letter dated April 30, 2010, Manufacturer: Axis-Shield Diagnostics,
Ltd., Dundee, UK. Firm initiated recall is ongoing.
REASON: IMx Sirolimus reagent lot 802873106 has exhibited an increased
frequency of calibration errors.
PRODUCT :
Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0
mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus
Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL)
Assay Diluent containing saline; list 01L76-25. The Architect Sirolimus
assay is chemiluminescent microparticle immunoassay (CMIA) for the
quantitative determination of sirolimus in human whole blood on the
Architect i System, as an aid in the management of renal transplant
patients receiving sirolimus therapy. Recall # Z-2172-2010
MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by
letter dated May 27, 2010.Manufacturer: Fujirebio Diagnostics, Inc.,
Malvern, PA. Firm initiated recall is ongoing.
REASON: The Architect Sirolimus assay lot 80162M100 is exhibiting higher
than normal reports of barcode read errors.
PRODUCT:
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01,
Sterile R, Working Length 145cm, for embolus and thrombus removal from
arterial vessels. Recall # Z-2190-2010
MANUFACTURER: Spectranetics Corp., Colorado Springs, CO, by letter on
July 1, 2010. Firm initiated recall is complete.
REASON: Guidewire lumen may be occluded, preventing guidewire insertion
into the catheter.
PRODUCT :
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer". The TEE/8-3
MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave
(PW) Doppler and continuous wave (CW) Doppler by applying ultrasound
energy through the esophagus or stomach of the patient into the heart.
The TEE transducer is intended to be used on adults only. Backscattered
ultrasound energy from the patient's heart is used to form images of the
heart to detect abnormalities in structure or motion, to evaluate the
velocity of blood flowing within the heart, and to obtain a color
depiction of the velocities of blood flowing in the heart. Part number
P05813 and P06841. Recall # Z-2191-2010
MANUFACTURER: Sonosite, Inc., Bothell, WA, by telephone and by letter
on August 21, 2008. Firm initiated recall is complete.
REASON: The TEE transesophageal transducer, when connected to a Sonosite
M-Turbo Ultrasound System, may exhibit erratic operation of the
Scanplane Orientation Indicator on the system display. The indicator may
move erratically and not accurately represent the orientation of the TEE
transducer array.
PRODUCT :
REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy
Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set
with any Small Joint Cannula System. Made in USA. The 87K Arthroscopy
Tubing Set is designed for use with the 87K Arthroscopy Pump System.
This system can be used in arthroscopic procedures using fluid
irrigation for joint distension. This system may be used where gravity
systems are currently in use such as knee, shoulder, ankle and elbow
arthroscopy. Recall # Z-2192-2010
MANUFACTURER: Recalling Firm: Linvatec Corp., dba ConMed Linvatec,
Largo, FL, by letter dated July 6, 2010. Manufacturer: ConMed Corp.,
Utica, NY. Firm initiated recall is ongoing.
REASON: Product may have a breach in the seal that could potentially
compromise the sterility of the contents.
PRODUCT :
Crossfire Console, model number 475-000-000, Manufactured by Stryker
Endoscopy
Jose Medical device indicated for use in orthopedic and arthroscopic
procedures for the knee, shoulder, ankle, elbow, wrist and hip. The
system provides abrasion, resection, debridement, and removal of bone
and soft tissue through its shaver blade and ablation and coagulation of
soft tissue, as well as hemostasis of blood vessels through its
electrosurgical probe. Examples of use include resection, ablation and
coagulation of torn knee cartilage, subacromial decompression and
resection of synovial tissue in other joints. The probe is
contraindicated for use in procedures where a nonconductive irrigant is
used or with patients having cardiac pacemakers or other electronic
implants. Recall # Z-2193-2010
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by letters dated June 28,
2010 and July 9, 2010. Firm initiated recall is ongoing.
REASON: RF energy or powered shaver handpieces may continue to operate
when not intended when used with the iSwitch Wireless Foot switch.
PRODUCT
Dynasty A-Class Poly Liner, REF DLXP-LD36, 1 each, Rx only, Sterile EO,
Group D, I.D. 36 mm, LIP 15o, Liner STD. Product is used in total hip
arthroplasty. Recall # Z-2212-2010
MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letter
on June 28, 2010. Firm initiated recall is ongoing.
REASON: The inner and outer product packaging was missing the following
information: shelf life, translations, manufacturing date, CE marking
and also listed the incorrect sterilization method.
PRODUCT :
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal
Video Scope Hookup (DSD-110-HU0109) only when used with the DSD
automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.
Recall # Z-2213-2010
MANUFACTURER: Minntech, Corp., Plymouth, MN, by letter dated June l7,
2010. Firm initiated recall is ongoing.
REASON: The DSD hook up Application Guide incorrectly recommends use of
the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax
EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor
or Medivators Scope Buddy Endoscope Flushing Aid. This may result in
inadequate disinfection during reprocessing, and subsequent infection
risk to the patient. The recall was due to the misprinted DSD hook up
Application Guide (M04-0001 revision M).
CLASS III
PRODUCT :
Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC
is intended for monitoring system performance of immunoenzymatic
procedures for the quantitative measurement of alpha-fetoprotein (AFP)
using the Access Immunoassay Systems. Recall # -2208-2010
MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on the week of
April 19, 2010. Firm initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter confirmed an
issue with the Access AFP QC kits (REF 33219) which contain three levels
of control material identified as QC1, QC2, and QC3, Beckman Coulter has
confirmed that vials of QC1 in the kit lots identified above contain
microbial contamination. Customers may see that the results from a
contaminated vial of QC1 are within the established reference range, but
are elevated and statistically different than results from an
uncontaminated control lot. Elevated CV's may also be observed with the
contaminated vials.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
August 11, 2010
CLASS I
PRODUCT:
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15
monitor/defibrillator is a complete acute cardiac care response system
designed for basic life support (BLS) and advanced life support (ALS)
patient protocols. Product part numbers: V15-2-000xxxxxx. Recall #
Z-1410-2010
MANUFACTURER:..Physio Control, Inc., Redmond, WA, by letter dated March
2010. Firm initiated recall is ongoing.
REASON: Potential for the device to power off then on by itself, or to
power off by itself and requiring the operator to turn it back on, or
the device doesn't turn off.
PRODUCT:
Cardiac Science, Automated External Defibrillator (AED) under the
following brand names (with respective model numbers): Powerheart AED
G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and
92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and
2023440. Indicated for emergency treatment of victims exhibiting
symptoms of sudden cardiac arrest who are unresponsive and not
breathing. The affected devices were manufactured between October 29,
2003 and February 10, 2009. Recall # Z-1424-2010
MANUFACTURER
Recalling Firm: Cardiac Science Corp., Bothell, WA, by letters dated
October 2009.
Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated
recall is ongoing.
REASON: Certain models of Powerheart G3 AEDs may not have received
adequate electrical safety testing prior to being shipped from the
factory.
CLASS II
PRODUCT:
1) DigitalDiagnost General radiographic examinations and applications
wherever a solid state X-ray imaging device can be used. 2.x systems.
Recall # Z-0847-2010;
2) BuckyDiagnost General Radiography and Tomography examination of
patients in supine, seated, or standing positions. Recall # Z-0848-2010;
3)EasyDiagnost Multi-functional R/F systems used for general R/F,
Fluoroscopy, Radiography and Angiography examinations. Recall #
Z-0849-2010
MANUFACTURER: Philips Medical Systems North America Co. Phillips,
Bothell, WA, by letters dated January 20 & 21, 2010. Firm initiated
recall is ongoing.
REASON: Device failed to display appropriate labels indicating Radiation
Symbol along with the required wording.
PRODUCT:
1) AC power cords manufactured by Electri-Cord with tall bridge design.
Used across all Philips product lines, as well as Respironics/Philips
products, Dixtel owned products and Dixtal (formerly Novametrix or
Respironics/Novametrix products. Philips HeartStart MRx
Defibrillator/Monitor model number M3535A. For use for the termination
of ventricular tachycardia and ventricular fibrillation. Recall #
Z-1257-2010;
2) HeartStart MRx Defibrillator/Monitor. For use for the termination of
ventricular tachycardia and ventricular fibrillation. Recall #
Z-1258-2010;
3) HeartStart MRx- AC power module kit. For use for the termination of
ventricular tachycardia and ventricular fibrillation. Model # M3539A.
Recall # Z-1259-2010;
4) DeviceLink Connectivity Hardware. Supports Philips specified
manufacturers' devices including urimeters, ventilators, oximeters,
patient monitors, infusion pumps and anesthesia machines. Recall #
Z-1260-2010;
5) Evaluation Kit, Capnostat 5, Respironics/Philips Product. Intended
use of the Capnostat 5 CO2 sensor is to provide carbon dioxide
monitoring to a host monitoring system. Recall # Z-1261-2010;
6) NICO2, Model 7600 Respironics/Philips Product. Intended use is
cardiac output monitoring via the method of partial rebreathing in adult
patients receiving mechanical ventilation. Recall # Z-1262-2010;
7) Sharn TidalGuard SP 710V, Respironics/Philips product. Intended use
of the monitors is to provide short term monitoring of carbon dioxide
and oxygen saturation during anesthesia/recovery, in the intensive care
unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
Recall # Z-1263-2010;
8) C5 LOFLO Evaluation Kit, Respironics/Philips product. Intended use of
the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring. Recall
# Z-1264-2010;
9) Evaluation Kit, LOFLO Engine, Respironics/Philips product. Intended
use of the LoFlo C5 CO2 sensor is to provide carbon dioxide monitoring.
Recall # Z-1265-2010;
10) 100-120V Capnogard 1265, Respironics/Philips product. Intended to be
used for monitoring end tidal CO2 and respiration rate in all critical
monitoring environments. Recall # Z-1266-2010;
11) Spanish Capnogard 1265, Respironics/Philips product. Intended to be
used for monitoring end tidal CO2 and respiration rate in all critical
monitoring environments. Recall # Z-1267-2010;
12) Cosmo - Model 7100 SP02 & ETC02 Monitor, Respironics./Philips
product. Intended to be used for monitoring end tidal CO2, respiration
rate, oxygen saturation and pulse rate in critical monitoring
environments. Recall # Z-1268-2010;
13) Spanish 100-120V Cosmo - 7100 Capnograp, Respironics/Philips
products. Intended to be used for monitoring end tidal CO2, respiration
rate, oxygen saturation and pulse rate in critical monitoring
environments. Recall # Z-1269-2010;
14) Transcutaneous C02 & O2 Monitor - 860, Respironics/Philips product.
Used for trending O2 and CO2 tension at the skin surface for neonates
and adults as an adjunct to arterial O2 and CO2 measurements. Recall #
Z-1270-2010;
15) French 100-120V 860 TC C02 & 02 Monitor, Respironics/Philips
product. Used for trending O2 and CO2 tension at the skin surface for
neonates and adults as an adjunct to arterial O2 and CO2 measurements.
Recall # Z-1271-201;
16) Spanish 100-120V TCOM-860, Respironics/Philips product. Used for
trending O2 and CO2 tension at the skin surface for neonates and adults
as an adjunct to arterial O2 and CO2 measurements. Recall # Z-1272-2010;
17) Tidal wave, Model 610, Respironics/Philips product. Intended use of
the monitors is to provide short term monitoring of carbon dioxide and
oxygen saturation during anesthesia/recovery, in the intensive care unit
(ICU), and in Emergency Medicine/transport of Respiratory Care. Recall #
Z-1273-2010;
18) Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used
to provide spirometric, carbon dioxide and pulse oximetry monitoring.
Recall # Z-1274-2010;
19) Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used
to provide spirometric, carbon dioxide and pulse oximetry monitoring.
Recall # Z-1275-2010;
20) TidalWave SP 710, Respironics/Philips product. Intended use of the
monitors is to provide short term monitoring of carbon dioxide and
oxygen saturation during anesthesia/recovery, in the intensive care unit
(ICU), and in Emergency Medicine/transport of Respiratory Care. Recall #
Z-1276-2010;
21) Japanese TidalWave SP 710, Respironics/Philips product. Intended use
of the monitors is to provide short term monitoring of carbon dioxide
and oxygen saturation during anesthesia/recovery, in the intensive care
unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
Recall # Z-1277-2010;
22) Tidal Wave Sp Model 715, Respironics/Philips product. Intended use
of the monitors is to provide short term monitoring of carbon dioxide
and oxygen saturation during anesthesia/recovery, in the intensive care
unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
Recall # Z-1278-2010
23) Japanese TidalWave SP 715, Respironics/Philips product. Intended use
of the monitors is to provide short term monitoring of carbon dioxide
and oxygen saturation during anesthesia/recovery, in the intensive care
unit (ICU), and in Emergency Medicine/transport of Respiratory Care.
Recall # Z-1279-201;
24) 100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product.
Intended use is cardiac output monitoring via the method of partial
rebreathing in adult patients receiving mechanical ventilation during
general anesthesia and in the ICU; spirometric and carbon dioxide
monitoring in neonatal, pediatric and adult patients during general
anesthesia and in the ICU and emergency department. Recall #
Z-1280-2010;
25) French 100-120V NICO 7300, Respironics/Philips product. Intended use
is: cardiac output monitoring via the method of partial rebreathing in
adult patients receiving mechanical ventilation during general
anesthesia and in the ICU ; spirometric and carbon dioxide monitoring in
neonatal, pediatric and adult patients during general anesthesia and in
the ICU and emergency department. Recall # Z-1281-2010;
26) Spanish 100-120V NICO 7300, Respironics/Philips product. Intended
use is cardiac output monitoring via the method of partial rebreathing
in adult patients receiving mechanical ventilation during general
anesthesia and in the ICU; spirometric and carbon dioxide monitoring in
neonatal, pediatric and adult patients during general anesthesia and in
the ICU and emergency department. Recall # Z-1282-2010;
27) Tidal Wave Model 615, Respironics/Philips product. Intended use of
the monitors is to provide short term monitoring of carbon dioxide and
oxygen saturation during anesthesia/recovery, in the intensive care unit
(ICU), and in Emergency Medicine/transport of Respiratory Care. Recall #
Z-1283-2010;
28) NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended
use is cardiac output monitoring via the method of partial rebreathing
in adult patients receiving mechanical ventilation during general
anesthesia and in the ICU;spirometric and carbon dioxide monitoring in
neonatal, pediatric and adult patients during general anesthesia and in
the ICU and emergency department. Recall # Z-1284-2010
29) NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended
use is cardiac output monitoring via the method of partial rebreathing
in adult patients receiving mechanical ventilation during general
anesthesia and in the ICU; spirometric and carbon dioxide monitoring in
neonatal, pediatric and adult patients during general anesthesia and in
the ICU and emergency department. Recall # Z-1285-2010;
30) 100-120V Capnogard 1265, Refurbished, Respironics/Philips product.
Intended to be used for monitoring end tidal CO2 and respiration rate in
all critical monitoring environments in ventilator support, patient
support and anesthesia. Recall # Z-1286-2010;
31) Cosmo Model 7100 SP02 & ETC02 Monitor, Refurbished,
Respironics/Philips product. Intended to be used for monitoring end
tidal CO2, respiration rate, oxygen saturation and pulse rate in
critical monitoring environments including ventilator support and
anesthesia. Recall # Z-1287-2010;
32) Transcutaneous C02 & 02 Monitor - 860, Refurbished,
Respironics/Philips product. Used for trending O2 and CO2 tension at the
skin surface for neonates and adults as an adjunct to arterial O2 and
CO2 measurements. Recall # Z-1288-2010;
33) Tidal Wave 610, Refurbished, Respironics/Philips product. Intended
use of the monitors is to provide short term monitoring of carbon
dioxide and oxygen saturation during anesthesia/recovery, in the
intensive care unit (ICU), and in Emergency Medicine/transport of
Respiratory Care. Recall # Z-1289-2010;
34) Resp Profile Monitor, 8100 Cosmo+, Refurbished, Respironics/Philips
product. Used to provide spirometric, carbon dioxide and pulse oximetry
monitoring during general anesthesia and in the intensive care unit
(ICU) and the emergency department (ED). Recall # Z-1290-2010;
35) Refurbished Tidal Wave SP 710, Refurbished, Respironics/Philips
product. Intended use of the monitors is to provide short term
monitoring of carbon dioxide and oxygen saturation during
anesthesia/recovery, in the intensive care unit (ICU), and in Emergency
Medicine/transport of Respiratory Care. Recall # Z-1291-2010
36) Refurbished Tidal Wave SP 715, Refurbished, Respironics/Philips
product. Intended use of the monitors is to provide short term
monitoring of carbon dioxide and oxygen saturation during
anesthesia/recovery, in the intensive care unit (ICU), and in Emergency
Medicine/transport of Respiratory Care. Intended use of the monitors is
to provide short term monitoring of carbon dioxide and oxygen saturation
during anesthesia/recovery, in the intensive care unit (ICU), and in
Emergency Medicine/transport of Respiratory Care. Recall # Z-1292-2010;
37) 100-200V NICO, 7300 Cardio Mgt System, Refurbished,
Respironics/Philips product. The intended use is cardiac output
monitoring via the method of partial rebreathing in adult patients
receiving mechanical ventilation during general anesthesia and in the
ICU; spirometric and carbon dioxide monitoring in neonatal, pediatric
and adult patients during general anesthesia and in the ICU and
emergency department. Recall # Z-1293-2010;
38) Tidal Wave - 615, Refurbished, Respironics/Philips product. Intended
use of the monitors is to provide short term monitoring of carbon
dioxide and oxygen saturation during anesthesia/recovery, in the
intensive care unit (ICU), and in Emergency Medicine/transport of
Respiratory Care. Recall # Z-1294-2010;
39) 100-120V Oxypleth - 520A Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1295-2010;
40) Japanese 100-120V Oxypleth - 520A Pulse Oximeter- Dixtal owned
product. Intended use is to provide continuous, non-invasive monitoring
of functional saturation (SpO2) and pulse rate. Recall # Z-1296-2010;
41) Span 100-120V 520A - OxyPleth Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1297-2010;
42) 515B Pulse Oximeter - Dixtal owned product. Intended use is to
provide continuous, non-invasive monitoring of functional saturation
(SpO2) and pulse rate. Recall Z-1298-2010;
43) French 100-120V 515B Pulse Oximeter - Dixtal owned product. Intended
use is to provide continuous, non-invasive monitoring of functional
saturation (SpO2) and pulse rate. Recall Z-1299-2010;
44) 100-120V 515B with RS-232 Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1300-2010;
45) Spanish 100-120V 515B Pulse Oximeter - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1301-2010;
46) 100-120V 2001 Pulse Oximeter with Mars - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1302-2010;
47) 100-120V 2001 Pulse Oximeter with Mars Nurse Call - Dixtal owned
product. Intended use is to provide continuous, non-invasive monitoring
of functional saturation (SpO2) and pulse rate. Recall # Z-1303-2010;
48) Spanish 100-120V 2001 Pulse Oximeter WI - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1304-2010;
49) 100-120V Oxypleth - 520A Pulse Oximeter, Refurbished - Dixtal owned
product. Intended use is to provide continuous, non-invasive monitoring
of functional saturation (SpO2) and pulse rate. Recall # Z-1305-2010;
50) 515B Pulse Oximeter, Refurbished - Dixtal owned product. Intended
use is to provide continuous, non-invasive monitoring of functional
saturation (SpO2) and pulse rate. Recall # Z-1306-2010;
51) 515B Pulse Oximeter, RS232, Refurbished - Dixtal owned product.
Intended use is to provide continuous, non-invasive monitoring of
functional saturation (SpO2) and pulse rate. Recall # Z-1307-2010;
52) 100-120V 2001 Pulse Oximeter with Mars, Refurbished - Dixtal owned
product. Intended use is to provide continuous, non-invasive monitoring
of functional saturation (SpO2) and pulse rate. Recall # Z-1308-2010;
53) 100-120V 2001 Pulse Oximeter with Mars Nurse Call, Refurbished -
Dixtal owned product. Intended use is to provide continuous,
non-invasive monitoring of functional saturation (SpO2) and pulse rate.
Recall # Z-1309-2010
MANUFACTURER: Philips Healthcare Inc., Andover, MA, by telephone
beginning November 20, 2009. Firm initiated recall is ongoing.
REASON : Power cords’ prongs may crack or fail – Philips was notified
that FDA is investigating whether certain types of Electric-Cord
Manufacturing Co power cords used with medical devices may be defective
in that the power cord’s prongs may crack and fail at/or inside the
plug. Potential for burns or electrical shock.
PRODUCT:
1) GE Centricity PACS-IW software. Device that receives stores and
communicates medical images and data from various imaging sources.
Recall # Z-1402-201;
2)GE Centricity Web Diagnostic (WebDX) software; Device that receives
stores and communicates medical images and data from various imaging
sources. Recall # Z-1403-2010
MANUFACTURER: Recalling Firm: GE Healthcare It, Barrington, IL, by
letter dated February 11, 2010. Manufacturer: Dynamic Imaging, LLC,
Allendale, NJ. Firm initiated recall is ongoing.
REASON: There is a potential safety issue associated with the use of GE
Centricity PACS-IW and PACS Web Diagnostic software when
dragging-and-dropping images from the Navigator causing flipping of the
images that may impact patient safety.
PRODUCT:
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0
and R4.2. Intended for use as a radiation therapy treatment of malignant
neo-plastic diseases, as determined by a licensed medical practitioner.
Recall # Z-1405-2010
MANUFACTURER: Recalling Firm: Elekta, Inc., Norcross, GA, by letter
dated December 12, 2008. Manufacturer: Elekta Oncology Systems (Fmrl
Philipps), West Sussex, United Kingdom. Firm initiated recall is
ongoing.
REASON : It is possible that two (or more) CT reference data sets are
necessary for one patient, for example, if you have to scan a patient
during breath hold and then again during free breathing.
PRODUCT:
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro
Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Indicated
for daily wear for the correction of refractive ametropia in aphakic
and/or not-aphakic persons with non-diseased eyes. Recall # Z-1705-2010
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc, Rochester, NY, by
letter dated April 20, 2010.Manufacturer: Bausch & Lomb Inc, Wilmington,
MA. Firm initiated recall is ongoing.
REASON: The amount of D&C #6 Dye added to the formulation exceeded
specified amounts.
PRODUCT:
AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. Toric
lenses approved for daily wear and extended wear up to 6 nights. a)
Label Power: -0.50, Cylinder: -1.75, Axis: 180; b) Label Power: -2.50,
Cylinder -1.75, Axis 180. Recall # Z-1706-2010
MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter
beginning April 15, 2010.Manufacturer: Pt Ciba Vision Batam, Batam
Island, Indonesia. Firm initiated recall is ongoing.
REASON:
The lenses inside the package do not match the prescription information
for power labeled on the primary package.
PRODUCT:
PulseSpray Infusion System, 90 cm x 20 cm infusion length, Catalog
No/Ref 12500402, Sterile, EO. Infusion Catheter. Recall # Z-1707-2010
MANUFACTURER: Angiodynamics, Inc., Queensbury, NY, by letter dated May
11, 2010. Firm initiated recall is ongoing.
REASON: This lot was packaged with the wrong occluding ball guidewire.
The PulseSpray Catheter is 90 cm in length and requires a 109 cm
occluding ball guidewire; however this lot was packaged with a 60 cm
occluding ball guidewire.
PRODUCT:
Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF
Pigtail, Performa, Sterile EO. Designed to be used for delivering
radiopaque media to selected sites in the vascular system in conjunction
with routine diagnostic procedures. Recall # Z-1731-2010
MANUFACTURER: Recalling Firm: Merit Medical Systems, Inc., South Jordan,
UT, by telephone beginning May 5, 2010.Manufacturer: Merit Medical
Systems, Inc., Angleton, TX. Firm initiated recall is complete.
REASON: Marker bands on angiographic catheters may not be properly
attached, allowing movement of the bands.
PRODUCT:
Axiom Artis systems with Motor Controller Unit. Intended for x-ray,
angiographic use.
Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142,
10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365,
7555373, 7727717 and 7728392. Recall # Z-1732-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter on April 12, 2010.Manufacturer: Siemens Medical
Solutions Inc., D-91056 Erlangen, Germany. Firm initiated recall is
ongoing.
REASON: Sporadic malfunctions of the Artis Systems with Motor Controller
caused by tolerances on electronic parts that might increase during the
lifetime of the system.
PRODUCT:
1) Angiodynamics Benephit (TM) XT Infusion System, 35 cm, Targeted Renal
Therapy Infusion system, Model/REF Number 70035, Sterile, EO, Intended
for Single Use Only. Recall # Z-1733-2010;2) Angiodynamics Benephit (TM)
CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system,
Catalog/Model/REF Number 60035, Sterile, EO, Intended for Single Use
Only. Recall # Z-1734-20102) Batch number: P909231
MANUFACTURER: Angiodynamics, Inc., Queensbury, NY, by letter dated April
28, 2010. Firm initiated recall is ongoing.
REASON: Benephit Infusion Catheters may exhibit a hole or tear in the
primary sterile barrier packaging. The product is intended to be
sterile. Breaches in the sterile packaging may result in non-sterile
product, which could potentially cause a patient infection which is a
serious medical condition.
PRODUCT:
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color
contact lens immersed in buffered isotonic saline solution, Size: B.C.
8.6mm DIA. 14.5mm. a) Includes models Amber, Amethyst, Blueberry Crush,
BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble
Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21,
HL22, HL23, HL24, HL26, Fierce Fandango and Holiday Green; b) inlcudes
models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and Natural Hazel; c)
includes models Aquamist, Artic Blue, Deep Ocean Blue, HJ35, HJ36 and
HW26; d) includes models HJ33, HJ34, HW23, HW24, Lavender, Lazer Green,
Sour Apple Green and Vibrant Violet; and e) includes models 011, 015,
024, 029, 032, 033, 035, 043-1, 044, 046, 047, 049, 055, 063-1, 064,
071, 079, 085 and 088. Recall # Z-1756-2010
MANUFACTURER: Recalling Firm: Kim's Trading Inc., Bethlehem, PA, by
telephone on May 12, 2010. Manufacturer: Dreamcon Co., Yangsan City,
Republic Of (South), Korea. Firm initiated recall is ongoing.
REASON: Recall is being conducted because the recalled color cosmetic
contact lenses are unapproved medical devices.
PRODUCT:
Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Intended for
in vitro diagnostic use by health care professionals and for
Point-Of-Care usage for the quantitative measurement of glucose in
capillary, venous, arterial and neonate whole blood. Recall #
Z-1783-2010
MANUFACTURER: Nova Biomedical Corp., Waltham, MA, by telephone and
follow up by email and/or fax dated February 12, 2010. Firm initiated
recall is ongoing.
REASON: Glucose strips report low glucose results.
PRODUCT:
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22.
Intended as a guide to normal healing and are not intended to replace
normal body structure or bear the weight of the body in the presence of
incomplete bone healing. Recall # Z-1784-2010
MANUFACTURER: Recalling Firm: Orthohelix Surgical Designs Inc., Medina,
OH, by letter dated March 23, 2010. Manufacturer: 3d-Machining, Riviera
Beach, FL. Firm initiated recall is ongoing.
REASON: The recalling firm packaged MFT-021-35-24 Screws from lot
0964092 as MFT-021-35-22 lot 0964081.
PRODUCT:
Passport V Monitor: Mindray, North America. Mindray DS USA. Intended for
intra hospital use under the direct supervision of a healthcare
practitioner for the monitoring of various human physiological
parameters. Part Number 6100F. Recall # Z-1785-2010
MANUFACTURER: Mindray DS USA, Inc., dba Datascope Patient Monitoring,
Mahwah, NJ, by letters beginning April 28, 2010. Firm initiated recall
is ongoing.
REASON: An issue with the Passport V Monitor has been identified where
the Arrhythmia Analysis, ST Analysis and Invasive Blood Pressure
functions are not operational.
PRODUCT:
Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Designed for single
use acute and chronic hemodialysis. Recall # Z-1951-2010
MANUFACTURER: Recalling Firm: Fresenius Medical Care North America,
Waltham, MA, by telephone script beginning May 14, 2010 and follow up
letter. Manufacturer: Fresenius Medical Care North America, Ogden, UT.
Firm initiated recall is ongoing.
REASON: Hemodialyzer may leak at the header/end cap.
RODUCT:
Microtek Medical, Inc, Stackhouse Laser Resistant Suction Probe, Size:
1/4" x 9" (0.64cm x 22.9cm), REF 24014, qty 10 ea, Sterile EO, 2015-05.
Manufactured in the U.S.A. Suction probe for a smoke evacuation device.
Recall # Z-2109-2010
MANUFACTURER: Microtek Medical, Inc., Columbus, MS, by telephone on May
25, 2010 followed with a letter dated June 3, 2010. Firm initiated
recall is complete.
REASON: Product labeled as sterile was distributed with sterilization.
PRODUCT:
Medfusion Syringe Infusion Pumps, Models 3010 and 3010a with Software
Versions 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are
designed for use in critical care areas for the administration of fluids
requiring precisely controlled infusion rates. Recall # Z-2121-2010
MANUFACTURER: Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated
June 11, 2010. Firm initiated recall is ongoing.
REASON
Smiths Medical has found that pumps with obsolete software may continue
to run past the set volume limit. This can result in an over-delivery if
the syringe is over-filled. Smiths Medical has received no reports of
serious patient injury or death related to this issue.
PRODUCT
Claw Hex Screw Charlotte " F&A System Contents: 1 each Foot and Ankle
Screw ... Implant Material: Stainless Steel Ref: 4013-3520 ... Size
3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-Sterile. Implantation:
used in Food and Ankle surgeries. Item # 40133520. Recall # Z-2188-2010
MANUFACTURER: Wright Medical Technology Inc., Arlington, TN via
telephone on June 7, 2010 and followed with a letter dated June 15, 2010
and June 29, 2010. Firm initiated recall is ongoing.
REASON: One lot of CLAW Hex Foot and Ankle Screws was incorrectly
packaged containing Multi-use Compression Screws.
PRODUCT:
Ascent Healthcare Solutions. Reprocessed Femoral Compression Device,
Model 11165. Recall # Z-2196-2010
MANUFACTURER: Ascent Healthcare Solutions, Inc., Lakeland, FL, by letter
on June 25, 2010. Firm initiated recall is ongoing.
REASON: The FemoStop Devices may fail to inflate or hold pressure. A
separation between the dome and arch base prevents the device from
maintaining pressure when inflated.
CLASS III
PRODUCT:
BD Visitec EdgeAhead MVR Knife. Intended for use in cataract surgery to
create self-sealing stab incisions through the cornea or sclera. Also
used in retinal surgery for sclerotomy incisions. Model # 585230. Recall
# Z-1597-2010
MANUFACTURER: Recalling Firm: Becton Dickinson and Co, Waltham, MA, by
letter dated April 6, 2010. Manufacturer: Becton Dickinson Ophthalmic
Systems, Warwickshire, UK. Firm initiated recall is ongoing.
REASON: A field action was initiated due to a recent customer complaint
from Japan there is a labeling mixup and that some of the BD Visitec
EdgeAhead MVR Knife 0.90mm (20G), REF 585230, shelf packs may contain BD
Visitec EdgeAhead Slit Knife 2.3mm (40 degree), REF 8009918.
PRODUCT:
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Intended to display
mammographic images. Recall # Z-1799-2010
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter
dated April 22, 2010. Manufacturer: Agfa Materials Corp., Goose Creek,
SC. Firm initiated recall is ongoing.
REASON: The RF tags on the white protection sheets of the media stacks
were incorrect.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
August 8, 2010
CLASS I
PRODUCT:
1) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTIS-100-A-HC-PERC8, G12403. Recall # Z-2076-2010;
2) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTISY-100-A-HC-PERC8, G12566. Recall # Z-2077-2010;
3) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTIS-100-HC-PERC6, G13165. Recall # Z-2078-2010;
4) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTIS-100-HC-PERC6-CA, G36037. Recall # Z-2079-2010;
5) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTISY-100-HC-PERC6, G13166. Recall # Z-2080-2010;
6) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTIS-100-HC-PERC8, G12523. Recall # Z-2081-2010;
7) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038. Recall # Z-2082-2010;
8) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTISY-100-HC-PERC8, G12565. Recall # Z-2083-2010;
9) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy
Introducer Set, C-PTISY-100-HC-G-PERC6, G53178. Recall # Z-2084-2010;
10) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous
Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC6, G53169. Recall #
Z-2085-2010;
11) Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous
Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC8, G53170. Recall #
Z-2086-2010;
12) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G36116, C-PTBS-2600-PERC6. Recall # Z-2087-2010;
13) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G36118, C-PTBSY-2600-PERC6. Recall # Z-2088-2010;
14) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G51971, C-PTBSYJC-2600-PERC6. Recall # Z-2089-201;
15) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G36117, C-PTBS-2800-PERC8. Recall # Z-2090-2010;
16) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G49507, C-PTBSY-2800-PERC8. Recall # Z-2091-2010;
17) Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy
Introducer Tray, G51972, C-PTBSYJC-2800-PERC8. Recall # Z-2092-2010
MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated April 21,
2010. Firm initiated recall is ongoing.
REASON: The set and/or tray products are being recalled because they
include a Covidien Shiley 6PERC or Covidien Shiley 8PERC tracheotomy
tube component that has been associated with cuff leakage as a result of
the pilot balloon inflation assembly.
CLASS II
PRODUCT :
1) Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle,
Sterile, REF 904755. Intended for soft tissue to bone fixation. Recall #
Z-1952-2010;
2) Toggleloc Artificial ligament fixation device ZIPLOOP Technology
Implant Kit, Sterile, REF 909848. Intended for soft tissue to bone
fixation. Recall # Z-1953-2010
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters dated March 31, and
June 2, 2010. Firm initiated recall is ongoing.
REASON: The firm has received complaints that the saddle is too long.
The saddle is supposed to be between 7/8 and 1 1/8 inches long. The
saddle in the complaints was up to 1.9 inches long.
PRODUCT :
Howmedica Osteonics Corp, Stryker Orthopedics Passport A.R. Knee
Instrumentation Distal Guide Stand; Catalog number 7650-5005. Recall #
Z-2118-2010
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters
dated April 8, 2010. Firm initiated recall is ongoing.
REASON: There is the potential for the posts on the Distal Resection
Guide Stand to disassociate from the main body part.
PRODUCT :
X-Celerate Instrumentation Punch Thru Tibial Base Plate, Catalog
numbers: 3750-0003. 3750-0004, 3750-0005, 3740-0006, 3750-0007,
3750-0009, 3750-0011, 3750-0013; Stryker Howmedica Osteonics Corp
Scorpio Total Knee System. Recall # Z-2119-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
dated April 5, 2010. Firm initiated recall is ongoing.
REASON: The locating pins on the Punch Thru Tibial Baseplates could
break or disassociate from the main body of the instrument.
PRODUCT :
Howmedica Osteonics Corp., Stryker Orthopedics Passport A.R. Knee
Instrumentation Anterior Skim Guide; Catalog Number 7650-5003. Recall #
Z-2120-2010
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
dated April 5, 2010. Firm initiated recall is ongoing.
REASON: One of the two posts on the Anterior Resection Guide could
disassociate from the main body of the part which has been determined to
be caused by a fracture weld.
PRODUCT :
1) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135412. Recall # Z-2122-2010;
2) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135415. Recall # Z-2123-2010;
3) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135417. Recall # Z-2124-2010;
4) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135420. Recall # Z-2125-2010;
5) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135512. Recall # Z-2126-2010;
6) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135515. Recall # Z-2127-2010;
7) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135517. Recall # Z-2128-2010
8) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135520. Recall # Z-2129-2010;
9) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135612. Recall # Z-2130-2010;
10) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135615. Recall # Z-2131-2010;
11) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135620. Recall # Z-2132-2010;
12) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135712. Recall # Z-2133-2010;
13) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135715. Recall # Z-2134-2010;
14) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135717. Recall # Z-2135-2010
15) BARD DORADO PTA BALLOON DILATATION CATHETERS, Product Code #
DR135720. Recall # Z-2136-2010
MANUFACTURER: Bard Peripheral Vascular Inc., Tempe, AZ, by letter
beginning May 7, 2010. Firm initiated recall is ongoing.
REASON: The affected DORADO PTA Balloon Dilatation catheters contain
catheter materials that, under certain conditions, are subject to
premature breakage allowing the balloon to partially or completely
separate from the catheter shaft.
PRODUCT :
1) Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137.
Recall # Z-2137-2010;
2) Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138.
Recall # Z-2138-2010;
3) Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139.
Recall # Z-2139-2010;
4) Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140.
Recall # Z-2140-2010;
5) Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141.
Recall # Z-2141-2010;
6) Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142.
Recall # Z-2142-2010;
7) Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143.
Recall # Z-2143-2010;
8) Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500
mL upper chamber, Order No. REF: 341. Recall # Z-2144-2010;
9) Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250
mL Reorder No. H938 371 3. Recall # Z-2145-2010;
10) Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL,
Order No. REF: 724. Recall # Z-2146-2010;
11) Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit
w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order
No. REF 706.Recall # Z-2147-2010;
12) Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag,
Fluid Path is sterile and non-pyrogenic in unopened, undamaged package,
250 mL, Order No. REF: 706D. Recall # Z-2148-2010
MANUFACTURER: Recalling Firm: Baxa Corp., Englewood, CO, by letter on
May 26, 2010. Manufacturer: AVAILMED S.A. DE C.V., Tijuana, Mexico. Firm
initiated recall is ongoing.
REASON: Fill port cap on TPN bags may become detached prior to use, thus
compromising the sterility of the fluid pathway.
PRODUCT :
1) Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N
64937. Recall # Z-2149-2010;
2) Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4
CRYSTALLOID CARDIOPLEGIA P/N 65246. Recall # Z-2150-2010;
3) Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF,
W/RECIRC, COND / PUMP & TABLE PACK P/N 65503/70881-02. Recall #
Z-2151-2010;
4) Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N
70608-01. Recall # Z-2152-2010;
5) Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE
PACK P/N 71544-01. Recall # Z-2153-2010;
6) Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01.
Recall # Z-2154-2010;
7) Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N
71733. Recall # Z-2155-2010;
8) Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG
FRAMEPACK P/N 71766PP. Recall # Z-2156-2010;
9) Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK
P/N 71934. Recall # Z-2157-2010;
10) Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE
PACK W/8:1 CARDIOPLEGIA P/N 72642. Recall # Z-2158-2010;
11) Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N
72790. Recall # Z-2159-2010;
12) Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N
72846. Recall # Z-2160-2010;
13) Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N:
131351-02. Recall # Z-2161-2010;
14) Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG
PACK P/N: 70608-01. Recall # Z-2162-2010;
15) Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO
RECIRC. DOUBLE SPIKE P/N: 71032. Recall # Z-2163-2010
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ashland, MA, by
telephone, fax, and email on June 8, 2010 and letter on June 9, 2010.
Firm initiated recall is ongoing.
REASON: Vent port maybe occluded and prevent delivery of fluid.
CLASS III
PRODUCT :
Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels,
catalog number KS855. For in vitro diagnostic use. Recall # Z-2117-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Newark, DE, by
letter dated March 2010. Firm initiated recall is complete.
REASON: Vessel pick up errors and vessel jams when the vessel is being
loaded. The error halts the instrument and disrupts processing. Vessel
flange is thin.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
July 28, 2010
CLASS I
PRODUCT:
1) Lifeline AED DDU-100 semiautomatic external defibrillator used with
the DBP-2800 Battery Pack. The DBP-2800 battery pack is an accessory to
the AED and does not have its own intended use. The AED is intended for
use on victims of sudden cardiac arrest when the patient is unconscious,
unresponsive and not breathing. Recall # Z-1781-2010;
2) ReviveR AED semiautomatic external defibrillator used with the
DBP-2800 Battery Pack. The DBP-2800 battery pack is an accessory to the
AED and does not have its own intended use. The AED is intended for use
on victims of sudden cardiac arrest when the patient is unconscious,
unresponsive and not breathing. Recall # Z-1782-2010
MANUFACTURER: Defibtech LLC, Seymour, CT, by letter dated May 20, 2010.
Firm initiated recall is ongoing.
REASON: The AED when used with an affected battery pack, may falsely
detect an error condition, cancel charge and not provide therapy.
RODUCT:
1) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium
Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm),
REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY,
For Single Use Only --- Implantable Vascular Access System with PASV(TM)
Valve Technology - (kit contains Huber needle) -- previously distributed
by Boston Scientific Corporation. Indicated for use in patients who
require long-term access to the central venous system for administration
of fluids, including but not limited to, hydration fluids, antibiotics,
chemotherapy analgesics, nutritional therapy and blood products. The
device is also indicated for blood specimen withdrawal. Recall #
Z-1874-2010;
2) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium
Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm),
REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY,
For Single Use Only --- Implantable Vascular Access System with PASV(TM)
Valve Technology (kit contains Huber needle) -- previously distributed
by Boston Scientific Corporation. Indicated for use in patients who
require long-term access to the central venous system for administration
of fluids, including but not limited to, hydration fluids, antibiotics,
chemotherapy analgesics, nutritional therapy and blood products. The
device is also indicated for blood specimen withdrawal. Recall #
Z-1875-2010;
3) Navilyst Medical, Inc., Vaxcel (TM) Port with PASV(TM) Titanium
Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF
Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For
single use only --- Implantable Vascular Access System with PASV(TM)
Valve Technology --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated for use in
patients who require long-term access to the central venous system for
administration of fluids, including but not limited to, hydration
fluids, antibiotics, chemotherapy analgesics, nutritional therapy and
blood products. The device is also indicated for blood specimen
withdrawal. Recall # Z-1876-2010;
4) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium
Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6
mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx
ONLY, For single use only --- Implantable Vascular Access System with
PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated for use in
patients who require long-term access to the central venous system for
administration of fluids, including but not limited to, hydration
fluids, antibiotics, chemotherapy analgesics, nutritional therapy and
blood products. The device is also indicated for blood specimen
withdrawal. Recall # Z-1877-2010;
5) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium
Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm),
REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only,
For single use only --- Common Name: Implantable Vascular Access System
with PASV(TM) Valve Technology --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated for
use in patients who require long-term access to the central venous
system for administration of fluids, including but not limited to,
hydration fluids, antibiotics, chemotherapy analgesics, nutritional
therapy and blood products. The device is also indicated for blood
specimen withdrawal. Recall # Z-1878-2010;
6) Navilyst Medical, Inc., Vaxcel(TM) Port w PASV(TM) Plastic Standard
Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF
Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For
single use only --- Implantable Vascular Access System with PASV(TM)
Valve Technology --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated for use in
patients who require long-term access to the central venous system for
administration of fluids, including but not limited to, hydration
fluids, antibiotics, chemotherapy analgesics, nutritional therapy and
blood products. The device is also indicated for blood specimen
withdrawal. Recall # Z-1879-2010;
7) Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic
Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm),
REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY,
For Single Use Only --- Implantable Vascular Access System with PASV(TM)
Valve Technology. --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated for use in
patients who require long-term access to the central venous system for
administration of fluids, including but not limited to, hydration
fluids, antibiotics, chemotherapy analgesics, nutritional therapy and
blood products. The device is also indicated for blood specimen
withdrawal. Recall # Z-1880-2010;
8) Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F
Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN
Product No. M001453030, STERILE, Rx ONLY, For single use only ---
Implantable Vascular Access System --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated
whenever patient therapy requires repeated intravascular injection or
continuous infusion of fluids, medications, antibiotics, nutritionals
and the withdrawals of venous blood samples. Recall # Z-1881-2010;
9) Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F
Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN
Product No. M001453050, STERILE, Rx ONLY, For single use only ---
Implantable Vascular Access System --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated
whenever patient therapy requires repeated intravascular injection or
continuous infusion of fluids, medications, antibiotics, nutritionals
and the withdrawals of venous blood samples. Recall # Z-1882-2010;
10) Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F
Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product
No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable
Vascular Access System --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated whenever patient
therapy requires repeated intravascular injection or continuous infusion
of fluids, medications, antibiotics, nutritionals and the withdrawals of
venous blood samples. Recall # Z-1883-2010;
11) Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with
9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN
Product No. M001453150, STERILE, Rx ONLY, For single use only ---
Implantable Vascular Access System --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated
whenever patient therapy requires repeated intravascular injection or
continuous infusion of fluids, medications, antibiotics, nutritionals
and the withdrawals of venous blood samples. Recall # Z-1884-2010;
12) Navilyst Medical, Inc. Vaxcel (TM) Port Titanium Standard Port with
8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # -
M001453200, STERILE, Rx ONLY, For single use only --- Implantable
Vascular Access System --- (kit contains Huber needle) -- previously
distributed by Boston Scientific Corporation. Indicated whenever patient
therapy requires repeated intravascular injection or continuous infusion
of fluids, medications, antibiotics, nutritionals and the withdrawals of
venous blood samples. Ecall Z-1885-2010;
13) Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with
8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-340, UPN
Product No. M001453400, STERILE, Rx ONLY, For single use only ---
Implantable Vascular Access System --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated
whenever patient therapy requires repeated intravascular injection or
continuous infusion of fluids, medications, antibiotics, nutritionals
and the withdrawals of venous blood samples. Recall # Z-1886-2010;
14) Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with
9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN
Product No. M001453600, STERILE, Rx ONLY, For single use only ---
Implantable Vascular Access System --- (kit contains Huber needle) --
previously distributed by Boston Scientific Corporation. Indicated for
use in patients who require long-term access to the central venous
system for administration of fluids, including but not limited to,
hydration fluids, antibiotics, chemotherapy analgesics, nutritional
therapy and blood products. The device is also indicated for blood
specimen withdrawal. Recall # Z-1887-2010
MANUFACTURER: Recalling Firm: Navilyst Medical, Inc., Glens Falls, NY,
by letters on May 13, 2010, May 14, 2010 and June 3, 2010.Manufacturers:
Navilyst Medical, Inc., Glens Falls, NY; Multi-Med, Inc., Homestead
Mills Complex, Keene, NH. Firm initiated recall is ongoing.
REASON : FDA testing determined that non-coring needles included in the
Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and
resulting septum damage which could lead to patient injury.
PRODUCT:
1) 22ga x 1" Straight Huber Needle, Model number 10600218. This product
is a small gauge needle intended for single use hypodermic access to
implanted ports. Recall # Z-1888-2010;
2) 22ga x 1" Right Angle Huber Needle, Model number 10600219. This
product is a small gauge needle intended for single use hypodermic
access to implanted ports. Recall # Z-1889-2010
MANUFACTURER: Recalling Firm: Multi-Med, Inc., West Swanzey, NH, by
letter dated May 26, 2010.Manufacturer: Multi-Med, Inc., Keene, NH. Firm
initiated recall is ongoing.
REASON: FDA sample determined the needles to be coring.
PRODUCT :
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx
System. Medical device, qualitative in vitro diagnostic test intended
for the detection of Staphylococcus aureus and methicillin-resistant
Staphylococcus aures DNA directly from patient positive blood cultures.
It is not intended to monitor treatment for MRSA/SA infections. Sub
culturing of positive blood cultures is necessary to recover organisms
for susceptibility testing or for epidemiological typing. Product codes:
a) GXMRSA/SA-BC-10 and b) GXMRSA/SA-BC-CE-10. Recall # Z-1898-2010
MANUFACTURER: Cepheid, Sunnyvale, CA, by letter on April 5, 2010 and
April 9, 2010. Firm initiated recall is ongoing.
REASON: The firm is receiving reports of inaccurate results, which may
result in delay of care for seriously ill patients.
PRODUCT :
1) Constellation Vision System, Model: Constellation Vision System
w/Laser, Catalogue Number: 8065751145 The Constellation Vision System is
an ophthalmic microsurgical system that is indicated for both anterior
segment (i.e. phacoemulsification and removal of cataracts) and
posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition
to the indications included with the optional Next Generation laser.
Recall # Z-1924-2010;
2) Constellation Vision System, Model: Constellation Vision System w/o
Laser, Catalogue Number: 8065751147 The Constellation Vision System is
an ophthalmic microsurgical system that is indicated for both anterior
segment (i.e. phacoemulsification and removal of cataracts) and
posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition
to the indications included with the optional Next Generation laser.
Recall # Z-1925-2010;
3) Constellation Vision System, Model: Constellation Tabletop, Catalogue
Number: 8065751150 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1926-2010;
4) Constellation Vision System, Model: Constellation XT, Catalogue
Number: 8065751548 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1927-2010;
5) Constellation Vision System, Model: Constellation LT, Catalogue
Number: 8065751549 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1928-2010;
6) Constellation Vision System, Model: Constellation LXT, Catalogue
Number: 8065751550 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1929-2010;
7) Constellation Vision System, Model: Constellation LX, Catalogue
Number: 8065751551 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1930-2010;
8) Constellation Vision System, Model: Constellation B, Catalogue
Number: 8065751552 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1931-201;
9) Constellation Vision System, Model: Constellation X, Catalogue
Number: 8065751553 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1932-2010;
10) Constellation Vision System, Model: Constellation L, Catalogue
Number: 8065751554 The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1933-2010;
11) Constellation Vision System, Model: Constellation T, Catalogue
Number: 8065751558. The Constellation Vision System is an ophthalmic
microsurgical system that is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment
(i.e., vitreoretinal) ophthalmic surgery in addition to the indications
included with the optional Next Generation laser. Recall # Z-1934-2010
MANUFACTURER: Alcon Research LTD dba Alcon Laboratories, Inc., Irvine,
CA, by letter dated July 2, 2010. Firm initiated recall is ongoing.
REASON: The recall was initiated after Alcon identified both system
performance and machine settings that may impact the infusion
performance of the CONSTELLATION Vision System.
CLASS II
PRODUCT :
1) Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile; Part
# 10-1500-021. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0339-2010;
2) Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile; Part
# 10-1500-022. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-034-2010;
3) Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile; Part
# 10-1500-023. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0341-2010;
4) Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile; Part
# 10-1500-024. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0342-2010;
5) Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile; Part #
10-1500-025. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0343-2010;
6) Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile; Part
# 10-1500-026. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0344-2010;
7) Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile; Part
# 10-1500-031. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0345-2010;
8) Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile; Part
# 10-1500-032. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0346-2010;
9) Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile; Part
# 10-1500-033. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0347-2010;
10) Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile; Part
# 10-1500-034. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0348-2010;
11) Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile; Part
# 10-1500-035. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0349-2010;
12) Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile; Part
# 10-1500-036. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0350-2010;
13) Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile; Part
# 10-1500-037. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0351-2010;
14) Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile; Part
# 10-1500-071. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0352-2010;
15) Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile; Part
# 10-1500-072. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0353-2010;
16) Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile; Part
# 10-1500-073. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0354-2010;
17) Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile; Part
# 10-1500-074. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0355-2010;
18) Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile; Part
# 10-1500-075. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0356-2010;
19) Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile; Part
# 10-1500-076. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0357-2010;
20) Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile; Part
# 10-1500-081. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0358-2010;
21) Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile; Part
# 10-1500-082. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0359-2010;
22) Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile; Part
# 10-1500-083. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0360-2010;
23) Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile; Part
# 10-1500-084. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0361-2010;
24) Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile; Part
# 10-1500-085. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0362-2010;
25) Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile; Part
# 10-1500-086. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0363-2010;
26) Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile; Part
# 10-1500-087. The system is used for pediatric and small stature adult
patients to stabilize fractures of the femoral shaft, subtrochanteric
fractures, ipsilateral neck/shaft fractures, prophylactic nailing of
impending pathologic fractures, nonunions and malunions, fixation of
femurs that have been surgically prepared for correction of deformity.
Recall # Z-0364-2010
MANUFACTURER: Recalling Firm: Orthopediatrics Corp., Warsaw, IN, by
email dated July 28, 2009. Manufacturers: Orthopediatrics Corp., Warsaw,
IN; C & A Tool Engineering Inc., Churubusco, IN. Firm initiated recall
is ongoing.
REASON: The potential exists for the nails to fracture during insertion
of the nail.
PRODUCT :
1) DigitalDiagnost General radiographic examinations and applications
wherever a solid state X-ray imaging device can be used. 2.x systems.
Recall # Z-0847-2010;
2) BuckyDiagnost General Radiography and Tomography examination of
patients in supine, seated, or standing positions. Recall # Z-0848-2010;
3) EasyDiagnost Multi-functional R/F systems used for general R/F,
Fluoroscopy, Radiography and Angiography examinations. Recall #
Z-0849-2010
MANUFACTURER: Philips Medical Systems North America Co. Phillips,
Bothell, WA, by letters, dated January 20 & 21, 2010. Firm initiated
recall is complete.
REASON: Device failed to display appropriate labels indicating Radiation
Symbol along with the required wording.
PRODUCT :
UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i,
860i, 660i, and 680i SYNCHRON Access Clinical Systems with DxI System
Software versions 4.2 or 4.2.1. In vitro diagnostic device used for the
quantitative, semi-quantitive or qualitative determination of various
analyte concentrations found in human body fluids. For labeling see
UniCel DxI Operator's Guide. Part Number: 387262G. Recall # Z-0856-2010
MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter dated October
28, 2009. Firm initiated recall is ongoing.
REASON: This recall was initiated because of software issue was
identified in System Software 4.2 and 4.2.1, which may result in the
incorrect handling of a wash arm dispense plate motion failure. Instead
of generating a red warning event and stopping sample processing, the
system will post a yellow caution event and continue to operate with the
dispense plate in an elevated position until the instrument is
reinitialized. Potentially affected results are not flagged.
CLASS III
PRODUCT :
BD FACSCount Controls Kit, An Automated Differential Cell Counter,
Model/Catalog Number: P/N: 340166. The reagents are for in vitro
diagnostic use on a BD FACSCount instrument. Recall # Z-1007-2010
MANUFACTURER: BD Biosciences, Systems & Reagents, San Jose, CA, by
letters on January 29, 2009. Firm initiated recall is complete.
REASON: The product is mislabeled, in that, zero/low controls were
mislabeled as medium/high, and the medium/high controls were labeled
zero/low.
PRODUCT :
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. a) 115 stacks and 65 stacks;
Intended to display mammographic images. Recall # Z-1799-2010
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter
dated April 22, 2010. Manufacturer: Agfa Materials Corp., Goose Creek,
SC. Firm initiated recall is ongoing.
REASON: The RF tags on the white protection sheets of the media stacks
were incorrect.
PRODUCT :
Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL
glass vials. Recall # Z-2025-2010
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., BD Diagnostic
Systems, Sparks, MD, by fax and e-mail on May 19, 2010. Manufacturer:
Becton Dickinson, Grayson, GA. Firm initiated recall is ongoing.
REASON: In vitro diagnostic reagent to aid in the diagnosis of
Salmonellosis may exhibit decreased or no reactivity. If proper controls
are run with the lot in question, it would become apparent that the
antigen is non reactive and patient specimen results should not be
reported. If control testing is not performed a salmonella-infected
patient could go undiagnosed, with possible adverse effects.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of
July 21, 2010
CLASS II
PRODUCT :
1) Triage Total Controls 5, Level 1: Five 0.25 mL tubes. Storage Temp
<-20C. Intended use: Assayed materials used with the Triage Profiler
S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer
Test and Triage Meters to assist in monitoring test performance. Model
88753. Z-1788-2010;
2) Triage Total Controls 5, Level 2: Five 0.25 mL tubes. Storage Temp
<-20C. Intended use: Assayed materials used with the Triage Profiler
S.O.B. Panel, Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer
Test and Triage Meters to assist in monitoring test performance. Model
88754. Recall # Z-1789-2010;
3) Triage Total Controls Calibration Verification 5: Two - 0.25 mL tubes
for each of five different levels (A,B,C,D,E). Storage Temp <-20C.
Intended use: Materials used with the Triage Profiler S.O.B. Panel,
Triage CardioProfilER Panel, Triage BNP Test, Triage D-Dimer Test and
Triage Meters to verify the calibration of the Test Devices throughout
the measurable range. Model 88755. Recall # Z-1790-2010
MANUFACTURER: Biosite Inc., San Diego, CA, by letter dated February 6,
2009. Firm initiated recall is complete.
REASON: Incidence of low recovery results has exceeded post market
surveillance thresholds of customer complaints in the field.
PRODUCT :
CaviBleach Wipes; a disinfectant medical device, active ingredient
Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened
with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly
foil pouch, 50 wipes per dispenser box, 8 boxes per case. General
purpose disinfectant wipe for hard, non-porous surfaces, patient care
equipment and point of care equipment. Reorder No. 10-1155. Recall #
Z-1815-2010
MANUFACTURER: Medtrol, Inc., Niles, IL, by telephone on December 2, 2009
and by letters dated December 3, 2009. Firm initiated recall is
complete.
REASON: The disinfectant wipes were found out of specifications for the
disinfectant activity prior to the expiration date.
PRODUCT
1) Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog
Number: M00568920. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1817-2010;
2) Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog
Number: M00568930. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1818-2010;
3) Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog
Number: M00568940. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1819-2010;
4) Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog
Number: M00568950. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1820-2010;
5) Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog
Number: M00568960. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1821-2010;
6) Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog
Number: M00568970. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1822-2010;
7) Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog
Number: M00568980. Single Use, Rx only. Boston Scientific, Natick, MA
01760. Indicated for the use in the treatment of tracheobronchial
structures produced by malignant neoplasms. Z-1823-2010;
8) Ultraflex Tracheobronchial Stent System. Uncovered - 14/80 Catalog
Number: M00569000. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1824-2010;
9) Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog
Number: M00569040. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1825-2010;
10) Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog
Number: M00569050. Single Use, Rx only. Boston Scientific, Natick, MA
01760. Indicated for the use in the treatment of tracheobronchial
structures produced by malignant neoplasms.
Recall # Z-1826-2010;
11) Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog
Number: M00569060. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant neoplasms.
Recall # Z-1827-2010;
12) Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog
Number: M00569070. Indicated for the use in the treatment of
tracheobronchial structures produced by malignant neoplasms. Recall #
Z-1828-2010;
13) Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog
Number: M00569080. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1829-2010;
14) Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog
Number: M00569090. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1830-2010;
15) Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog
Number: M00569230. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1831-2010;
16) Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog
Number: M00569240. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1832-2010;
17) Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog
Number: M00569250. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1833-2010;
18) Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog
Number: M00569260. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1834-2010;
19) Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog
Number: M00569270. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1835-2010;
20) Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog
Number: M00569280. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1836-2010;
21) Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog
Number: M00569290. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1837-2010;
22) Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog
Number: M00569300. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1838-2010;
23) Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog
Number: M00569310. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1839-201;
24) Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog
Number: M00569410. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1840-2010;
25) Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog
Number: M00569430. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1841-2010;
26) Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog
Number: M00569450. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1842-2010;
27) Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog
Number: M00569480. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1843-2010;
28) Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog
Number: M00569490. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1844-2010;
29) Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog
Number: M00569500. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1845-2010;
30) Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog
Number: M00569510. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1846-2010;
31) Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog
Number: M00569520. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1847-2010;
32) Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog
Number: M00569530. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1848-2010;
33) Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog
Number: M00569540. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1849-2010;
34) Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog
Number: M00569550. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1850-2010
35) Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog
Number: M00569560. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1851-2010;
36) Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog
Number: M00569570. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1852-2010;
37) Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog
Number: M00569580. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1853-2010;
38) Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog
Number: M00569590. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1854-2010;
39) Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog
Number: M00569920. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1855-2010;
40) Ultraflex Tracheobronchial Stent System. Covered - 14/60. Catalog
Number: M00569930. Single Use, Rx only. Indicated for the use in the
treatment of tracheobronchial structures produced by malignant
neoplasms. Recall # Z-1856-2010;
41) Ultraflex Esophageal Stent System. Uncovered – Distal Release –
18/23/7. Catalog Number: M00513700. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1858-2010;
42) Ultraflex Esophageal Stent System. Uncovered - Distal Release -
18/23/10. Catalog Number M00513710. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1859-2010;
43) Ultraflex Esophageal Stent System. Uncovered - Distal Release -
18/23/15. Catalog Number M00513720. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1860-2010;
44) Ultraflex Esophageal Stent System. Covered - Distal Release -
18/23/10/7. Catalog Number M00513730. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1861-2010;
45) Ultraflex Esophageal Stent System. Covered - Distal Release -
18/23/12/9. Catalog Number M00513740. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1862-2010;
46) Ultraflex Esophageal Stent System. Covered - Distal Release -
18/23/15/12. Catalog Number M00513750. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1863-2010;
47) Ultraflex Esophageal Stent System. Uncovered - Proximal Release -
18/23/7. Catalog Number M00513800. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1864-2010;
48) Ultraflex Esophageal Stent System. Uncovered - Proximal Release -
18/23/10. Catalog Number M00513810. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1865-2010;
49) Ultraflex Esophageal Stent System. Uncovered - Proximal Release -
18/23/15. Catalog Number M00513830. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1866-2010;
50) Ultraflex Esophageal Stent System. Covered - Proximal Release -
18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1867-2010
51) Ultraflex Esophageal Stent System. Covered - Proximal Release -
18/23/12/9. Catalog Number M00513850. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1868-2010;
52) Ultraflex Esophageal Stent System. Covered - Proximal Release -
18/23/15/12. Catalog Number M00513860. Single Use, Rx only. Intended for
maintaining esophageal luminal patency in esophageal structures caused
by intrinsic and/or extrinsic malignant tumors only and occlusion of
concurrent esophageal fistulas. Recall # Z-1869-2010
53) Ultraflex Esophageal Stent System. Covered - Large - Distal Release
- 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Intended
for maintaining esophageal luminal patency in esophageal structures
caused by intrinsic and/or extrinsic malignant tumors only and occlusion
of concurrent esophageal fistulas. Recall # Z-1870-2010;
54) Ultraflex Esophageal Stent System. Covered - Large - Distal Release
- 23/28/12/9. Catalog Number M00514210. Single Use, Rx only. Intended
for maintaining esophageal luminal patency in esophageal structures
caused by intrinsic and/or extrinsic malignant tumors only and occlusion
of concurrent esophageal fistulas. Recall # Z-1871-2010;
55) Ultraflex Esophageal Stent System. Covered - Large - Proximal
Release - 23/28/10/7. Catalog Number M00514240. Single Use, Rx only.
Intended for maintaining esophageal luminal patency in esophageal
structures caused by intrinsic and/or extrinsic malignant tumors only
and occlusion of concurrent esophageal fistulas. Recall # Z-1872-2010;
56) Ultraflex Esophageal Stent System. Covered - Large - Proximal
Release - 23/28/12/9. Catalog Number M00514250. Single Use, Rx only.
Intended for maintaining esophageal luminal patency in esophageal
structures caused by intrinsic and/or extrinsic malignant tumors only
and occlusion of concurrent esophageal fistulas. Recall # Z-1873-2010
MANUFACTURER: Boston Scientific Corp., Marlborough, MA, by letter dated
May 17, 2010. Firm initiated recall is ongoing.
REASON: Suture related device failures during deployment and
repositioning of the stent.
PRODUCT :
IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the
routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
Recall # Z-1891-2010
MANUFACTURER: Siemens Healthcare Diagnostics, Inc., Los Angeles, CA, by
letter dated May 2009. Firm initiated recall is ongoing.
REASON: These substrate lots have shown a tendency to introduce a shift
in both control and patient results with multiple methods.
PRODUCT :
Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
Material number 10014063. Recall # Z-1892-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, by letter dated April 6, 2010. Manufacturer: Siemens Medical
Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Siemens has become aware of a potential malfunction and hazard
to patients when using Syngo Imaging version lines VB20, VB30, VB35A in
combination with a RIS that is violating DICOM Standard by creating
non-unique study instance UIDs.
PRODUCT :
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260
(Domestic). Provides continuous or intermittent ventilatory support for
the care of individuals who require mechanical ventilation. Recall #
Z-1896-2010
MANUFACTURER: Respironics, Inc., Murrysville, PA, by telephone beginning
June 10, 2010. Firm initiated recall is ongoing.
REASON: It is possible that the battery could electrically short,
resulting in a potential for fire or a thermal event.
PRODUCT :
Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. Used for obtaining
ocular measurements and performing calculations to assist in
determination of the appropriate power and type of Intraocular Lens for
implantation after removal of the natural crystalline lens following
cataract removal. Recall # Z-1897-2010
MANUFACTURER: Recalling Firm: Haag-Streit USA Inc., Mason, OH, by
letters beginning May 19, 2010. Manufacturer: Haag Streit Ag, Koeniz,
Switzerland. Firm initiated recall is ongoing.
REASON: During the creation of the Lenstar LS 900 software, the ability
to perform a manual adjustment of the retinal thickness measurement was
not disabled for products targeted for US distribution. The current
software installed allows the user to manually alter the retinal
thickness measurement, which could modify the automatic axial eye length
measurement resulting in the selection of an incorrect intra-ocular lens
(IOL).
PRODUCT :
Genesis II Tibial Drill Guide, REF 71440238, Size 5, Qty (1),
Non-Sterile. Drill guide used as manual surgical instrument during knee
replacement surgeries. Recall # Z-1900-2010
MANUFACTURER: Smith and Nephew, Inc., Memphis, TN, by letter dated April
16, 2010 and by e-mail on April 20, 2010. Firm initiated recall is
ongoing.
REASON: Markings for the drill guides are on the incorrect side: left is
printed on right side and right is printed on the left side.
PRODUCT :
1) VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version
3.5; Model Number: 270-2000; Provides an integrated method for sample
preparation, separation and determination of the relative percent of
specific hemoglobin in whole blood. Recall # Z-1901-2010;2) VARIANT II
TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5;
Model Number: 270-2600; Provides an integrated method for sample
preparation, separation and the percent determination of percent
hemoglobin A1C in EDTA human whole blood. Recall # Z-1902-2010
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated
January 22, 2009 followed by telephone calls. Firm initiated recall is
ongoing.
REASON: Sample test results for the first run appears to be correct but
all subsequent results during that run were assigned incorrect barcode
and tube position.
PRODUCT :
Hydradjust IV DR Urological Table Sedecal Generator ( a) p/n 750732 -
64W generator & b) p/n 750733 80W generator). Facilitates digital
radiologic and/or fluoroscopic procedures requiring a beam of diagnostic
quality radiation and a flat imaging table. Recall # Z-1904-2010
MANUFACTURER: Recalling Firm: Mallinckrodt, Inc., Cincinnati, OH, by
letter dated June 14, 2010.Manufacturers: Sedecal USA, Inc., Arlington
Heights, IL; Sedecal S.A., Algete, Spain. Firm initiated recall is
ongoing
REASON: Covidien received complaints of the Sedecal Generator failing
and producing smoke at customer sites. The failure modes are located in
different parts of the generator and will lead to the generator becoming
inoperative.
PRODUCT :
GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test
kit), CA-1553 (500 test kit). Indicated for the quantitative
determination of plasma renin activity (PRA) by the radioimmunoassay of
generated angiotension I. Recall # Z-1914-2010
MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letter dated October
21, 2009. Firm initiated recall is ongoing.
REASON: The kit control provided with the GammaCoat Plasma Renin
Activity kit was labeled with the incorrect range.
PRODUCT Z:
1) Automated External Defibrillator (AED) of brand name "Philips
HeartStart FRx" (Model number 861304). Device is designed for use on a
person in sudden cardiac arrest who is unresponsive when shaken and not
breathing normally. Recall # Z-1915-2010;
2) Automated External Defibrillator (AED) of brand name "Philips
HeartStart HS1 OnSite" (Model number M5066A). Device is designed for use
on a person in sudden cardiac arrest who is unresponsive when shaken and
not breathing normally. Recall # Z-1916-2010;
3) Automated External Defibrillator (AED) of brand name "Philips
HeartStart HS1 Home" (Model Number M5068A). Device is designed for use
on a person in sudden cardiac arrest who is unresponsive when shaken and
not breathing normally. Recall # Z-1917-2010
MANUFACTURER: Philips Medical Systems, Seattle, WA, by telephone,
e-mail, and website posting on April 30, 2010 and by letter dated April
29, 2010. Firm initiated recall is ongoing.
REASON: Seventeen AEDs failed production line testing (Final Acceptance
Test).
PRODUCT :
1) MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for
the destruction of tumors. Recall # Z-1918-2010;
2) MIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for
the destruction of tumors. Recall # Z-1919-2010;
3) MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended
for the destruction of tumors. Recall # Z-1920-2010
MANUFACTURER: Mira, Inc., Uxbridge, MA, by e-mail between April 8, 2010
and May 21, 2010. Firm initiated recall is ongoing.
REASON: Devices distributed without an approved 510(k).
PRODUCT :
1) Innova 2100IQ system with InnovaIQ Table Option Indicated for use in
generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1921-2010;
2) Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for
use in generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1922-2010;
3) Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for
use in generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1923-2010
MANUFACTURER: Philips Medical Systems, Seattle, WA, by telephone,
e-mail, and website posting on April 30, 2010 and by letter dated April
29, 2010. Firm initiated recall is ongoing.
REASON: Seventeen AEDs failed production line testing (Final Acceptance
Test).
PRODUCT :
1) MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for
the destruction of tumors. Recall # Z-1918-2010;
2) MIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for
the destruction of tumors. Recall # Z-1919-2010;
3) MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended
for the destruction of tumors. Recall # Z-1920-2010
MANUFACTURER: Mira, Inc., Uxbridge, MA, by e-mail between April 8, 2010
and May 21, 2010. Firm initiated recall is ongoing.
REASON: Devices distributed without an approved 510(k).
PRODUCT :
1) Innova 2100IQ system with InnovaIQ Table Option Indicated for use in
generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1921-2010;
2) Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for
use in generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1922-2010;
3) Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for
use in generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Recall # Z-1923-2010
MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by
letter dated May 12, 2010. Manufacturer: GE Medical Systems, SCS, Buc
Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential loss of gantry and
table motions affecting Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ
systems with InnovaIQ Table that may impact patient safety.
PRODUCT
Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the
CERSR Electromyography System and Electrode Array; the system consists
of two devices. The first is a system of capital equipment referred to
as CERSR Electromyography System, which includes a cart. The second
device is disposable electrodes arrays, which are single use devices,
used with the capital equipment that is adhered to the patient for
monitoring the bioelectric signals produced by the muscles. Model
Number(s): a) AM-0001-08-0 (CERSR) and b) 02003 (Electrode Array). The
disposable is referred to as the Electrode Array. CERSR Electromyography
System is packaged in a reusable crate maintained by SMI. The Electrode
Array is packaged in a sealed foil pouch. Both devices are non-sterile
and the packaging is for protection from damage during shipping. Recall
# Z-1935-2010
MANUFACTURER: SpineMatrix, Inc., Akron, OH, by letter and telephone on
January 29, 2010. Firm initiated recall is ongoing.
REASON: A full design review of the CERSR system was conducted in
7/2009. The audit revealed numerous design verification tests that
either did not pass or did not meet the design input requirement. One
requirement found that it was possible for the physician to think they
were reviewing one patients scan, but were actually reviewing a scan
from a different patient. This event did not happen; however, the
possibility was there, which resulted in this recall.
PRODUCT :
1) Dialysis On/Off Kit, DT11300, Sterile, Micropore Surgical Tape,
Single Use Rolls, Port Access Dressing Change Tray. Recall #
Z-1936-2010;
2) C.A.P.D. Tubing Exchange Tray, HT80, Sterile, Micropore Surgical
Tape, Single Use Rolls. Recall # Z-1937-2010;
3) Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use
Rolls. Recall # Z-1938-2010
MANUFACTURER: Recalling Firm: Centurion Medical Products, Howell MI, by
letter dated March 16, 2010. Manufacturer: Centurion Medical Products
Corp., Yuma, AZ. Firm initiated recall is ongoing.
REASON: The 3M micropore tape is under recall due to the tape not
performing and needles becoming loose and dislodged.
PRODUCT
1) Tabs Professional Monitor, includes one wall bracket, Model 25022.
Recall # Z-1944-2010;
2) Tabs Professional Monitor without Wall Bracket, Model 25023. Recall #
Z-1945-2010;
3) Tabs Professional Monitor without Pull Cord or wall bracket, Model
25025. Recall # Z-1946-2010;
4) Tabs Professional Monitor with Wire Bracket and Push Button Reset,
Model 25223. Recall # Z-1947-2010
MANUFACTURER: Stanley Security Solutions, Inc., Lincoln, NB, by letters
dated March 25, 2010 and by telephone beginning March 26, 2010. Firm
initiated recall is ongoing.
REASON: Product might not indicate low battery alarms or exit alarms
when powered by a DC power supply.
PRODUCT
1) Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Intended
for use in the thoraco-lumbar spine. Recall # Z-1957-2010;
2) Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408. Intended
for use in the thoraco-lumbar spine. Recall # Z-1958-2010;
3) Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Intended
for use in the thoraco-lumbar spine. Recall # Z-1959-201;
4) Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Intended
for use in the thoraco-lumbar spine. Recall # Z-1960-2010;
5) Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Intended
for use in the thoraco-lumbar spine. Recall # Z-1961-2010;
6) Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412. Intended
for use in the thoraco-lumbar spine. Recall # Z-1962-2010;
7) Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. Intended
for use in the thoraco-lumbar spine. Recall # Z-1963-2010;
8) Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414. Intended
for use in the thoraco-lumbar spine. Recall # Z-1964-2010;
9) Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415. Intended
for use in the thoraco-lumbar spine. Recall # Z-1965-2010;
10) Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416.
Intended for use in the thoraco-lumbar spine. Recall # Z-1966-2010;
11) Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417.
Intended for use in the thoraco-lumbar spine. Recall # Z-1967-2010;
12) Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418.
Intended for use in the thoraco-lumbar spine. Recall # Z-1968-2010
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters
dated June 1, 2010. Manufacturer: Stryker Spine, Cestas, Aquitane,
France. Firm initiated recall is ongoing.
REASON: Stryker Spine has received reports of breakage of the distal end
of the AVS TL Spacer Trial during the trialing step of the AVS TL
procedure.
CLASS III
PRODUCT
Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM
Anti-HBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219... For the
qualitative detection of antibody to Hepatitis B Surface Antigen
(anti-HBs) in Human Serum and EDTA or citrated plasma. Recall #
Z-1620-2010
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letter on August 11,
2008. Firm initiated recall is ongoing.
REASON: The package insert provided with this kit contains a
typographical error, giving incorrect directions to prepare a Working
Conjugate Solution. If these directions are followed, it would result in
a 1:6 dilution and invalidate the assay.
PRODUCT :
Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum
ESR Tubes. Single Use. Product Number: EX-I0552. Slider allows a larger
label to be applied to the ESR tube. Recall # Z-1816-2010
MANUFACTURER: Recalling Firm: Vital Diagnostics, Inc., Lincoln, RI, by
letter dated April 14, 2010. Manufacturer: Wilden Ag, Regensburg,
Germany. Firm initiated recall is ongoing.
REASON: The tube may fall out or separate from the Slider adapter.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of
Recalls as of July 14, 2010
CLASS II
PRODUCT:
Treadmill models TM55, TM65, and CR60 (brand names include Quinton,
Burdick, and Cardiac Science). Recall # Z-0985-2005
MANUFACTURER: Recalling Firm: Cardiac Science Corp., Bothell, WA, by
letter on April 3, 2009 and via FedEx. Manufacturer: Cardiac Science
Corp., Deerfield, WI. Firm initiated recall is ongoing.
REASON: 28 stress and rehab treadmills manufactured between September
2006 and January 2009 may not have received adequate electrical safety
testing prior to being shipped from the factory. If these components
break down in the field, a patient or operator could be exposed to
excess touch currents on the surface of the product. The risk is
electric shock.
PRODUCT :
EVA 450 Patient Lift Battery Charger. Recall # Z-1736-2010
MANUFACTURER: Recalling Firm: Romedic, Inc., Ephrata, PA, by letter
April 28, 2010.
Manufacturer: Romedic AB, Jarfalla, Sweden. Firm initiated recall is
ongoing.
REASON: Incorrect battery chargers were supplied with the EVA 450
Patient Lifts. Charger unit stops working and will not charge lift. New
chargers were supplied to customers.
PRODUCT :
1) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
90107, 100 test kit. Recall # Z-1748-2010;
2) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
90110, 100 test kit (obsolete). Recall # Z-1749-2010;
3) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
90112, 50 test kit. Recall # Z-1750-2010;
4) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
90115, Beckman test kit. Recall # Z-1751-2010;
5) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
90116, 250 test kit. Recall # Z-1752-2010;
6) PLAC Test Reagent Kit, immuno-turbidimetric method, Part Number
10-112, 10-0113, and 10-115 Advia test kit. Recall # Z-1753-2010
MANUFACTURER: DiaDexus, Inc., South San Francisco, CA, by letter on
October 29, 2009. Firm initiated recall is ongoing.
REASON: Inaccurate results-- some samples may return with falsely
elevated results potentially as a result of an interfering substance.
Some patients may be subjected to additional lifestyle changes or
intensified pharmaceutical therapy; such as statins, as a result of the
falsely elevated result.
PRODUCT :
Treadmill models TM55, TM65, and CR60 (brand names include Quinton,
Burdick, and Cardiac Science). Recall # Z-1757-2010
MANUFACTURER: Recalling Firm: Cardiac Science Corp., Bothell, WA, by
letter on April 3, 2009. Manufacturer: Cardiac Science Corp., Deerfield,
WI. Firm initiated recall is ongoing.
REASON: 28 stress and rehab treadmills manufactured between September
2006 and January 2009 may not have received adequate electrical safety
testing prior to being shipped from the factory. If these components
break down in the field, a patient or operator could be exposed to
excess touch currents on the surface of the product. Because safety
testing may not have allowed for complete evaluation of the electrical
isolation of the treadmill, there is a remote chance a shock hazard
could exist.
PRODUCT L:
1) COULTER PrepPlus, Part Number: 286600. Recall # Z-1758-2010;
2) COULTER PrepPlus 2, Part Number: 378600. Recall # Z-1759-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
on January 25, 2010. Manufacturer: Beckman Coulter, Inc., Miami, FL.
Firm initiated recall is ongoing.
REASONL: The recall was initiated after Beckman Coulter confirmed
reports of potential dilution of reagent vials loaded onto the PrepPIus
or PrepPlus 2 systems. Affected systems have a syringe pump with part
number A46748 (see illustrations below) which cause the probe to
prematurely dispense Isoflow prior to arriving at the wash station. This
condition only occurs with worklist panels which include both antibody
reagents along with specimen pipetted via blood rocker. The open vial
position is not affected by this issue or any instances where the blood
rocker is not in use. This problem could result in dilution of affected
antibody vials which may diminish cellular fluorescence staining and
present a risk of erroneously low results.
PRODUCT :
directCHECK Whole Blood Control; for Hemochron J. Microcoagulation
Systems.
Catalog number. Code number: DCJPT-A. Recall # Z-1786-2010
MANUFACTURER: International Technidyne Corp., Edison, NJ, letters on
April 15, 2010. Firm initiated recall is ongoing.
REASON: The acceptable performance range published in the directCHECK
Microcoagulation Quality Control package insert is incorrect.
PRODUCT :
InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile.
Group #1: a) Catalog number: 100002, b) Catalog number: 100017, c)
Catalog number: 100018, d) Catalog number: 100019, e) Catalog number:
100032, and f) Catalog number: 100034; Group #2: a) Catalog number:
100019, b) Catalog number: 100032, c) Catalog number: 100038, d) Catalog
number: 100047, e) Catalog number: 100055. Recall # Z-1800-2010
MANUFACTURER: Recalling Firm: Inviro Medical Devices, Inc.,
Lawrenceville, GA, by letter on/about May 10, 2010.Manufacturer:
Safegard Medical (Hungary) Kft, Farkaslyuk, Hungary. Firm initiated
recall is ongoing.
REASON: Syringe Defects. Group 1 syringes: The plunger pull out force
was below specification. Group 2 syringes: The needle length is out of
specification.
PRODUCT :
Synthes Medullary Tubes; Catalog number 355.01. Recall # Z-1804-2010
MANUFACTURER: Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA,
by letter dated April 9, 2010. Manufacturer: Synthes, USA, Monument, CO.
Firm initiated recall is ongoing.
REASON: After repeated sterilizations product may become discolored and
break including while in the medullary canal. Synthes has determined
that the Medullary Tube will be a single use item that is to be
discarded after one sterilization cycle.
PRODUCT
1) Calcium Sulfate Hemihydrate 0.5 gram kits; Product Code #5052002.
Recall # Z-1805-2010;
2) Calcium Sulfate Hemihydrate 1.0 gram kits; Product Code #5052001.
Recall # Z-1806-2010
MANUFACTURER: Ace Surgical Supply Co., Inc., Brockton, MA, by telephone
on May 14, 2010. Firm initiated recall is ongoing.
REASON: Fast set 4% potassium sulfate solution may not be sterile. For
customers who have used the Calcium Sulfate Hemihydrate kit without the
Fast Set solution, and then the potential risks identified do not apply.
Risks of adverse health consequences with the Fast Set 4% potassium
sulfate solution include tissue inflammation and infection.
PRODUCT :
Cardiac Science Powerheart 9390A automated external defibrillator. This
fully automatic model does not require the user to press a shock button
in order for the device to deliver therapy (when appropriate). Intended
for use in either in-hospital or out-of-hospital settings for emergency
treatment of victims exhibiting symptoms of sudden cardiac arrest who
are unresponsive and not breathing. Recall # Z-1810-2010
MANUFACTURER: Recalling Firm: Cardiac Science Corp., Bothell, WA, by
letters between December 18 and December 23, 2009. Manufacturer: Cardiac
Science Corp., Deerfield, WI. Firm initiated recall is ongoing.
REASON: The K302 relay switch of the G3 series AED product line may
experience an early failure. If the K302 contacts are open at the time
of rescue, there is a possible delay in therapy or failure to deliver
therapy.
PRODUCT :
1) CS100 Intra-Aortic Balloon Pump; Product number 0998-00-3023-XX.
Recall # Z-1811-2010;2) CS300 Intra-Aortic Balloon Pump; Product number
0998-00-3013-XX. Recall # Z-1812-2010;3) System 98XT/98 Intra-Aortic
Balloon Pump; Product number 0998-00-0446-XX and 0998-00-0479-XX. This
product was only distributed in India and Hong Kong/China. Recall #
Z-1813-2010
MANUFACTURER: Recalling Firm: Datascope Corp., Fairfield, NJ, by letters
beginning May 10, 2010. Manufacturer: Maquet Datascope Corp - Cardiac
Assist Division, Mahwah, NJ. Firm initiated recall is ongoing.
REASON: Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have
the potential to experience display related issues. Although the IABP
continues to deliver therapy to the patient, display related issues may
cause the user to be unable to view the IABP on the information screen.
PRODUCT :
Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029.
Recall # Z-1905-2010
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
beginning on July 29, 2009. Manufacturer: Beckman Coulter, Inc., Miami,
FL. Firm initiated recall is ongoing.
REASON: The recall was initiated after Beckman Coulter confirmed an
issue with the UniCel DxH 800 during in-house testing. It was determined
that there is a potential for a false increase in platelet results, due
to micro-bubbles. This situation could present a risk of falsely
increased platelet results in patient samples as diluent containers are
depleted.
PRODUCT :
FemSoft Insert, Female Urethral Insert, Sterile (R), Rx Only. Assorted
Sizes Multi-Pack, REF 70200. The FSSTDSUP product is a Clinician Supply
Pack that is provided directly to clinics. The Clinician Supply Pack is
a package containing 2 multi-pack boxes of product. The corresponding
retail box label for this product (FSSTDSUP) is the REF 70200. The
Multi-pack products contains 28 devices of the following: -8 of size 1
Standard; -4 of size 2 Standard; -4 of size 3 Standard; -4 of size 1
Long; -4 of size 2 Long; and -4 of size 3 Long. Recall # Z-1913-2010
MANUFACTURER: Rochester Medical Corp., Stewartville, MN, by telephone on
May 3, 2010 and letter dated April 26, 2010. Firm initiated recall is
ongoing.
REASON: Rochester Medical is voluntarily recalling specific lots of
FemSoft urethral inserts manufactured and distributed in 2009 and 2010.
Testing has revealed a small number of packages which contain a small
void in the package seal, and it has been determined that product
sterility cannot be guaranteed. If product sterility has been
compromised, there is a potential for increased risk of urinary tract
infection.
PRODUCT
1) Coseal Surgical Sealant 2mL, Product Codes: 934070 & 934073.
Indicated for use in vascular reconstructions to achieve adjunctive
hemostasis. Recall # Z-1948-2010;
2) Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074.
Indicated for use in vascular reconstructions to achieve adjunctive
hemostasis. Recall # Z-1949-2010;
3) Coseal Surgical Sealant 8mL, Product Codes: 934072 & 934075.
Indicated for use in vascular reconstructions to achieve adjunctive
hemostasis. Recall # Z-1950-2010
MANUFACTURER: Recalling Firm: Baxter Bioscience, Westlake Village, CA,
by letter on January 14, 2010. Manufacturer: Baxter Healthcare Corp.,
Hayward, CA. Firm initiated recall is ongoing.
REASON: The recall is being conducted as a precautionary measure due to
out of specification results at the 18 month and 21 month time points
(out of the 24 month licensed shelf life to expiration) for the percent
thiol substitution during a Coseal Stability study. The parameter that
is out of specification is an indicator of possible failure for the
product to gel appropriately.
PRODUCT
Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and
SDS-CTP-SPK. Recall # Z-1954-2010
MANUFACTURER: Recalling Firm: Medrad Inc., Warrendale, PA, by letter on
May 24, 2010. Manufacturer: Medrad Inc., Indianola, PA. Firm initiated
recall is ongoing.
REASON: Kits contain a T connector that may be susceptible to cracking
or breaking or leaking.
PRODUCT :
SSH-880CV Aplio Artida System. Recall # Z-1955-2010
MANUFACTURER: Toshiba American Medical Systems Inc., Tustin, CA, by
letter September 16, 2009. Firm initiated recall is ongoing.
REASON: Problem related to a wrong measurement value display in using
with DICOM viewer. When an image is transferred from this system in
DICOM transfer and a measurement is performed on a Doppler image in the
DICOM viewer, measured values such as VTI (Velocity Time Integral) and
PI/RI (Pulsatility Index I Resistance Index) will frequently be
displayed incorrectly. In the worse case, misdiagnosis may result. This
was discovered during company review; no complaints or other reports
have been received.
PRODUCT :
Biomet 3i GS300 Gold Slotted Screw-3mm, Sterile, Rx Only. Made in USA.
Recall # Z-1956-2010
MANUFACTURER: Biomet 3i, LLC, Palm Beach Gardens, FL, by telephone,
faxed letter and e-mail. Firm initiated recall is ongoing.
REASON: Product is Out Of Specification - product was manufactured with
a material not specified for use in this product.
PRODUCT :
1) biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In
Vitro Diagnostic test for Herpes Simplex Virus 2. Recall # Z-1970-2010;
2) Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In
Vitro Diagnostic test for Herpes Simplex Virus 2. Recall # Z-1971-2010
MANUFACTURER: Recalling Firm: Biokit U.S.A. Inc., Bedford, MA, by fax on
February 18, 2010. Manufacturer: Bio Diagnostics Ltd, Upton-Upon-Severn,
United Kingdom. Firm initiated recall is complete.
REASON: Negative serum was giving a positive result Herpes Simplex Type
2 (HSV-2). It is possible that misdiagnosis (i.e., positive) could be
made.
CLASS III
PRODUCT :
Difco (TM) Decarboxylase Base Moeller, packaged in 500 gm bottles,
labeled in part. Recall # Z-1787-2010
MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by letter on December
9, 2009. Firm initiated recall is complete.
REASON: Diagnostic test reagents may not meet quality control
specifications.
The following is condensed list of medical devices involved
in recalls listed by the FDA Enforcement Report as of Recalls as of
July 7, 2010
CLASS II
PRODUCT :
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro
Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Indicated
for daily wear for the correction of refractive ametropia in aphakic
and/or not-aphakic persons with non-diseased eyes. Recall # Z-1705-2010
MANUFACTURER: Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by
letter dated April 20, 2010.Manufacturer: Bausch & Lomb, Inc.,
Wilmington, MA. Firm initiated recall is ongoing.
REASON: The amount of D&C #6 Dye added to the formulation exceeded
specified amounts.
PRODUCT :
AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. a) Label
Power: -0.50, Cylinder: -1.75, Axis: 180; b) Label Power: -2.50,
Cylinder -1.75, Axis 180. Toric lenses approved for daily wear and
extended wear up to 6 nights. Recall # Z-1706-2010
MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter
beginning April 15, 2010.Manufacturer: Pt Ciba Vision Batam, Batam
Island, Indonesia. Firm initiated recall is ongoing.
REASON: The lenses inside the package do not match the prescription
information for power labeled on the primary package.
PRODUCT :
PulseSpray Infusion System, 90 cm x 20 cm infusion length, Catalog
No./Ref 12500402, Sterile, EO; Infusion Catheter. Recall # Z-1707-2010
MANUFACTURER: Angiodynamics, Inc., Queensbury, NY, by letter dated May
11, 2010. Firm initiated recall is ongoing.
REASON: This lot was packaged with the wrong occluding ball guidewire.
The PulseSpray Catheter is 90 cm in length and requires a 109 cm
occluding ball guidewire; however this lot was packaged with a 60 cm
occluding ball guidewire.
PRODUCT :
Axiom Artis systems with Motor Controller Unit. Intended for x-ray,
angiographic use. Model Numbers: 10094135, 10094137, 10094139, 10094141,
10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357,
7555365, 7555373, 7727717 and 7728392. Recall # Z-1732-2010
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter April 12, 2010.Manufacturer: Siemens Medical
Solutions, Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON: Sporadic malfunctions of the Artis Systems with Motor Controller
caused by tolerances on electronic parts that might increase during the
lifetime of the system.
PRODUCT :
1) ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal
Therapy Infusion system, Model/REF Number 70035, Sterile, EO, Intended
for Single Use Only. Recall # Z-1733-2010;2) ANGIODYNAMICS BENEPHIT(TM)
CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system,
Catalog/Model/REF Number 60035, Sterile, EO, Intended for Single Use
Only. Recall # Z-1734-2010
MANUFACTURER: Angiodynamics, Inc., Queensbury, NY, by letter dated April
28, 2010. Firm initiated recall is ongoing.
REASON: Benephit Infusion Catheters may exhibit a hole or tear in the
primary sterile barrier packaging. The product is intended to be
sterile. Breaches in the sterile packaging may result in non-sterile
product, which could potentially cause a patient infection which is a
serious medical condition.
PRODUCT :
1) ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO.
194284 Labeled Sterile, Rx. Recall # Z-1737-2010;2) CATHETER INTRODUCER
KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx. Recall
# Z-1738-2010;3) CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT
REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Recall #
Z-1739-20104) ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE
USE, Rx. Recall # Z-1740-2010;5) ARTERIAL LINE KIT REF/REORDER NO.
498410B DISPOSABLE, SINGLE USE, Rx. Recall # Z-1741-2010;6) ARTERIAL
LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Recall #
Z-1742-2010;7) ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE
SINGLE USE, Rx. Recall # Z-1743-2010;8) ARTERIAL LINE KIT, Custom
Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Recall #
Z-1744-2010;9) ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO.
498447 DISPOSABLE SINGLE USE, Rx. Recall # Z-1745-2010
MANUFACTURER: Argon Medical Devices, Inc., Athens, TX, letters dated
March 29, 2010. Firm initiated recall is ongoing.
REASON: There are 1-2 places on some of the multi-purpose kit
blisters/trays in which there are holes and/or the material is so thin
that holes are easily created. This would potentially cause the
sterility of the products to be compromised.
PRODUCT :
Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by
Electri-Cord Manufacturing Co. beginning in February 2003. The cords are
a detachable unit, supplied with the instruments listed below: Medtronic
Bio-Console 550 centrifugal pump console, Model #95180, Catalogue #
95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump
consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic
autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R.
Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E,
SEQ1000R. Recall # Z-1939-2010
MANUFACTURER: Medtronic Cardiovascular Revascularization & Surgical
Therapy, Brooklyn Park, MN, by letter dated April 19, 2010. Firm
initiated recall is ongoing.
REASON: The power cord's prongs may crack and fail at/or inside the
plug.
PRODUCT :
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample
preparer for flow cytometry analysis. Sample Probe Catalog Numbers
337170, 333494, 333485, 339118, 647768, 647769. Recall # Z-1940-2010
MANUFACTURER: BD Biosciences, Systems and Reagents, San Jose, CA, by
letter of February 2010. Firm initiated recall is ongoing.
REASON: Samples prepared on the BD SPA II, SN T0076 produced inaccurate
sample results due to inaccurate sample dispensed as a result of the cap
piercing probe.
PRODUCT :
STERIS 4085, 5085 & 5085SRT Surgical Tables. Model #: 4085, 5085 &
5085SRT. Recall # Z-1941-2010
MANUFACTURER: Recalling Firm: Steris Corporation, Mentor, OH, by letters
on May 14, 2010.Manufacturer: Steris Corporation, Montgomery, AL. Firm
initiated recall is ongoing.
REASON: STERIS has learned that a limited quantity of manifold
assemblies were manufactured by our supplier with incorrect washers and
springs in the valves of the manifold. This supplier error has the
potential to cause: a) an inability to articulate/move a table section
when commanded by the operator; b) two different articulations occurring
when a single articulation is commanded, or c) that the table sections
move slowly or drift without prompting by an operator.
CLASS III
PRODUCT :
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex
EIA Kit, Part#: MK021. Recall # Z-1942-2010
MANUFACTURER: Recalling Firm: Inova Diagnostics Inc., San Diego, CA, by
letters on October 30, 2009. Manufacturer: The Binding Site, Ltd.,
Birmingham, United Kingdom. Firm initiated recall is complete.
REASON: The affected Bindazyme Human C1q binding Circulating Immune
Complex EIA Kits may contain an ELISA plate labeled as "tissue
Transglutaminase Coated Wells" instead of "C1q Coated Wells".
PRODUCT :
Biomet Microfixation Ref: 91-6103 "1.5MM" System High Torque (HT), SD,
X-DR, Screw 1.5MM X 3.5MM (WXL) Titanium, Non Sterile Product. Bone
screws used along with implantable bone plates for oral, cranio-maxillofacial
procedures. Recall # Z-1943-2010
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by e-mail
and fax on October 5, 2009. Firm initiated recall is complete.
REASON: Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD
X-drive screw Lot Number 829760. This package may contain 91-6704
1.5x4mm ThinFlap SD X-drive screw.
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