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Recall Archives 23
FDA Recalls
July 2008 - December 2008
- Recalls as of December 31, 2008:
- Recalls as of
December 24,
2008:
- Recalls as of
December 17,
2008:
- Recalls as of
December 10,
2008:
- Recalls as of
December 3, 2008:
- Recalls as of
November 26, 2008
- Recalls as of
November 19,
2008
- Recalls as of
November 12,
2008
- Recalls as of
November 5, 2008
- Recalls as of October 29, 2008
- Recalls as of October 22, 2008
- Recalls as of
October 15, 2008
- Recalls as of October 8, 2008
- Recalls as of
October 1, 2008
- Recalls as of
September 24,
2008
- Recalls as of
September 17,
2008
- Recalls as of
September 10,
2008
- Recalls as of
September 3,
2008
- Recalls as of
August 27, 2008
- Recalls as of
August 20, 2008
- Recalls as of
August 13, 2008
- Recalls as of
August 6, 2008
- Recalls as of
July 23, 2008
- Recalls as of
July 16, 2008
- Recalls as of
July 9, 2008
- Recalls as of
July 2, 2008
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
December 31, 2008
CLASS I
PRODUCT:
Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic
Green System Handles, Sterile Disposable. Contents 20, Recall #
Z-0459-2009
MANUFACTURER: Recalling Firm: Sun Med, Inc., Largo , FL, by letter on
April 27, 2007 and by press release on December 12, 2008. Manufacturer:
Medical Devices (Pvt) Ltd., Sialkot , Pakistan . Firm initiated recall
is ongoing.
REASON: A breakage problem of the acrylic bundles at both distal and
proximal ends of the light tube for the MD Laryngoscope Blade GreenLine
D Mac 3 has been detected.
PRODUCT:
a) Stryker Custom Cranial Implant Kit, small. Catalog # 54-00101. Custom
cranial implant designed individually for each patient to correct trauma
and or defects in mandibular, maxillofacial or craniofacial bone, Recall
# Z-0509-2009;
b) Stryker Custom Cranial Implant Kit, medium. Catalog # 54-00102.
Custom cranial implant designed individually for each patient to correct
trauma and or defects in mandibular, maxillofacial or craniofacial bone,
Recall # Z-0510-2009;
c) Stryker Custom Cranial Implant Kit, large. Catalog #: 54-00103.
Custom cranial implant designed individually for each patient to correct
trauma and or defects in mandibular, maxillofacial or craniofacial bone,
Recall # Z-0511-2009;
d) Stryker Custom Cranial Implant Kit, extra large. Catalog #: 54-00104.
Custom cranial implant designed individually for each patient to correct
trauma and or defects in mandibular, maxillofacial or craniofacial bone,
Recall # Z-0512-2009;
MANUFACTURER: Recalling Firm: Stryker Leibinger USA , Portage , MI , by
letter dated October 24, 2008. Manufacturer: Contract Medical
Manufacturing, Oxford , CT. Firm initiated recall is ongoing.
REASON: Lack of assurance of sterility.
CLASS II
PRODUCT:
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit
breaker), 50/60 Hz (20A power source required) base; Model 801763,
Recall # Z-0445-2009;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker),
50/60 Hz (10A power source required) base; Model 801764 (Not distributed
within the United States ), Recall # Z-0446-2009
MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor , MI , by
letter dated April 17, 2008. Firm initiated recall is ongoing.
REASON: The power supply may fail to charge the batteries due to various
hardware malfunctions.
PRODUCT: Hodogic, Inc., 10 Year Fracture Risk
Questionnaire Option for QDR X-Ray Bone Densitometers Software, Recall #
Z-0449-2009
MANUFACTURER: Hologic, Inc., Bedford , MA , by telephone on September
23-24, 2008 and by letter on September 25, 2008. Firm initiated recall
is complete.
REASON: Software error may lead to a high estimate of major fracture
probability.
PRODUCT:
a) CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve.
Model: 903TGA. It is designed for use in rapid infusion, invasive
pressure monitoring and with auto-transfusion devices, Recall #
Z-0461-2009;
b) CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model:
803FGA. It is designed for use in rapid infusion, invasive pressure
monitoring and with auto-transfusion devices, Recall # Z-0462-2009;
c) CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model:
A803SGA. The letter A refers to a special quantity designator for a
particular customer. The product is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices, Recall #
Z-0463-2009;
d) CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve
Model: 2803SGA. It is designed for use in rapid infusion, invasive
pressure monitoring and with auto-transfusion devices, Recall #
Z-0464-2009;
e) CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model:
803SGA. It is designed for use in rapid infusion, invasive pressure
monitoring and with auto-transfusion devices, Recall # Z-0465-2009;
f) CASMED 500cc Unifusor Classic with piston gauge and stopcock valve.
Model: A903SGA. The letter A refers to a special quantity designator for
a particular customer. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices, Recall #
Z-0466-2009;
g) CASMED 500cc Unifusor Classic with piston gauge and stopcock valve
Model: 903SGA. It is designed for use in rapid infusion, invasive
pressure monitoring and with auto-transfusion devices, Recall #
Z-0467-2009;
h) CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve
Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK . It is
designed for use in rapid infusion, invasive pressure monitoring and
with auto-transfusion devices, Recall # Z-0468-2009;
i) CASMED 500cc Unifusor with a short tub. Private labeled for King
Systems. Model: P500BAG. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices, Recall #
Z-0469-2009;
j) CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve.
Private labeled for Transmed in Germany . Model: T2803SGA. It is
designed for use in rapid infusion, invasive pressure monitoring and
with auto-transfusion devices, Recall # Z-0470-2009;
k) CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel
valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany .
It is designed for use in rapid infusion, invasive pressure monitoring
and with auto-transfusion devices, Recall # Z-0471-2009
MANUFACTURER: Recalling Firm: CAS Medical Systems, Inc., Branford , CT ,
by letter dated September 19, 2008. Manufacturer: Statcorp, Inc.,
Jacksonville , FL. Firm initiated recall is ongoing.
REASON: Leaks: Infusion Cuffs may exhibit air leakage at the union of
the tube and bag, and not maintain pressure.
PRODUCT: VASOVIEW 4 Endoscopic Vessel Harvesting System
with VASOVIEW Flexible Endoscopic Tools in the following configuration:
a) VH-10242: Uniport plus dissection cannula, short port blunt tip
trocar, flexible endoscopic scissors; and b) VH-10243: Uniport plus
dissection cannula, short port blunt tip trocar, flexible endoscopic
bisector, Recall # Z-0476-2009
MANUFACTURER: CTS, Inc., dba Guidant Cardiac Surgery, San Jose, CA, by
letter on September 9, 2008. Firm initiated recall is ongoing.
REASON: Packaging unsealed: Sterility of product may be compromised due
to packaging issue.
PRODUCT: Insure® Quik Fit™ Developer Kit, Product Numbers:
30025 (InSure Quik Fit Developer Kit) and 50025 (Insure® Quik Fit™
containing Developer Kit and Patient Collection Kits. Product Number
30025 - InSure® Quik Fit™ Developer Kit (1 Box). Each box contains: 25
InSure® Quik Fit™ Test Strips (1 per foil pack), 1 InSure® Quik Fit™
Conjugate Solution, I InSure® Quik Fit™ Run Buffer, and 1 InSure® Quik
Fit™ Product Instructions. Product 50025 - InSure® Quik Fit™ contains 25
Patient Kits & 1 Developer Kit, Recall # Z-0480-2009
MANUFACTURER: Enterix, Inc., Edison , NJ , by letters on October 3,
2008. Firm initiated recall is ongoing.
REASON: False readings: Reduced sensitivity could affect the test line
area and/or control line on the test strips, which may lead to
inaccurate results.
PRODUCT: FHC microTargeting Platform DBS Measuring
Fixture, a component of the micro-targeting Drive System, Catalog #
66-FA-SF. The device is a stereotactic instrument used for the placement
of recording and stimulating electrodes in the brain, Recall #
Z-0486-2009
MANUFACTURER: FHC, Inc., Bowdoinham , ME , by letter on October 8, 2008.
Firm initiated recall is ongoing.
REASON: Measuring fixture is incorrectly graduated.
PRODUCT: Thoratec HeartMate II Left Ventricular Assist
System (LVAS). Model/Catalog Number 1355 and Model/Catalog Number
102139. The HM II LVAS is intended to provide hemodynamic support in
patients with end-stage, refractory left ventricular heart failure;
either for temporary support, such as a bridge to cardiac
transplantation or myocardial recovery, or as permanent destination
therapy. The HeartMate II is intended for use inside or outside the
hospital, Recall # Z-0496-2009
MANUFACTURER: Thoratec Corp., Pleasanton , CA , by letter dated October
21, 2008. Firm initiated recall is ongoing.
REASON: Over time, wear and fatigue of the percutaneous lead connecting
the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump
with external system controller may result in damage that has the
potential to interrupt pump function and may require a reoperation to
replace the pump.
PRODUCT: FastPack(R) Total PSA Immunoassay; Catalog #:
25000001 Is a paramagnetic particle immunoassay for the in vitro
quantitative determination of prostate-specific antigen (PSA) in human
serum and plasma as an aid in the management of patients with prostate
cancer. The FastPack(R) Total PSA immunoassay is designed for use with
the FastPack (R) System, Recall # Z-0500-2009
MANUFACTURER: Qualigen, Inc., Carlsbad , CA , by letter dated September
29, 2008 and by telephone beginning September 30, 2008. Firm initiated
recall is ongoing.
REASON: Product was not meeting product performance expectations.
PRODUCT: IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000
Analyzers - for the quantitative measurement of progesterone in serum,
as an aid in the diagnosis and treatment of disorders of the ovaries or
placenta, Recall # Z-0524-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions Diagnostics,
Deerfield , IL , by letter on July 22, 2008. Manufacturer: Siemens
Medical Solutions Diagnostics, Los Angeles , CA. Firm initiated recall
is ongoing.
REASON: Siemens Healthcare Diagnostics has confirmed a long-standing
high bias with LKPG 1, 5. (The bias is approximately 25% at 10 - 20 ng/mL
as opposed to approximately 3% at 1-3 ng/mL).
PRODUCT: Wallace Oocyte Recovery Needles, Oocyte Recovery
sets, 750mm tube with flushing connector, Product Number: ONS1633LL-750,
and ONS1733LL-750. Retrieval of Oocytes, Recall # Z-0593-2009
MANUFACTURER: Recalling Firm: Irvine Scientific Sales Co., Inc., Santa
Ana , CA , by letter dated October 22, 2008. Manufacturer: Smiths
Medical, Hythe , Kent , UK . Firm initiated recall is ongoing.
REASON: Certain lots of Wallace Oocyte Recovery Sets have a damaged
needle tip.
PRODUCT: Flextome Cutting Balloon Device Over-the-Wire
Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery
System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland . The
Flextome Cutting Balloon Device consists of a balloon with 3 or 4
atherotomes (microsurgical blades) mounted longitudinally on its outer
surface. When the Flextome Cutting Balloon Device is inflated, the
atherotomes score the plaque, creating initiation sites for crack
propagation. This process, referred to as Atherotomy, allows dilation of
the target lesion with less pressure. Indicated for dilatation of
stenoses in coronary arteries for the purpose of improving myocardial
perfusion in those circumstances where a high pressure balloon resistant
lesion is encountered, Recall # Z-0621-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove , MN
, by letter dated November 21, 2008. Manufacturer: Interventional
Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny,
County Donegal, Republic of Ireland. Firm initiated recall is ongoing.
REASON: An incorrect compliance chart was packaged inside the sterile
pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a
3.5mm diameter Flextome Cutting Balloon device. This labeling
discrepancy could create a procedural delay as users seek to explain the
discrepancy and/or obtain a replacement unit.
PRODUCT: Genicon 5mm Pyramidal Trocar, Sterile, Only.
Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made for
positioning the laparoscopic cannula or ports, Recall # Z-0622-2009
MANUFACTURER: Recalling Firm: Genico, Inc., dba Genicon, Winter Park,
FL, by letter dated September 19, 2008 and by e-mail and fax on
September 25, 2008. Manufacturer: Unimax Medical Systems, Taipei ,
Taiwan . Firm initiated recall is ongoing.
REASON: The stainless steel tips on the Genicon 5mm Pyramidal Trocar
exhibited contamination that resembled rust and there was also pitting
on the tip of the trocar.
CLASS III
PRODUCT:
a) Micro Plate EIA Oral Fluid Positive Control which is a component of
the Intercept Micro Plate EIA kit. Product number 61456, Recall #
Z-0477-2009;
b) Micro Plate EIA Oral Fluid Negative Control which is a component of
the Intercept Micro Plate EIA kit. Product Number 61452, Recall #
Z-0478-2009;
c) Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of
the Intercept Micro Plate EIA kit. Product number 61454, Recall #
Z-0479-2009
MANUFACTURER: OraSure Technologies, Inc., Bethlehem , PA , by letter
dated September 8, 2008. Firm initiated recall is ongoing.
REASON: Results, false-positive test: low % displacement result of 36.0%
(spec 39-60%).
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
December 24, 2008
CLASS II
PRODUCT: Boston Scientific iLab Ultrasound Imaging System, models 120INS
and 240INS. Its intended use is for ultrasound examination of
intravascular pathology, Recall # Z-0338-2009
MANUFACTURER: Boston Scientific Corporation, Fremont , CA , by letters
on September 5, 2008. Firm initiated recall is ongoing.
REASON: Computer malware: Products may be infected with a worm (computer
malware) which could infect a computer network to which it may be
connected.
PRODUCT:
a) Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A
Non-AC-Powered Patient Lift. Model KM560101, and Model KM560001 - Maxi
500 with 2-Point Spreader Bar, if it was equipped with the optional
scale kit 700.05505. The Maxi 500 is a mobile passive lifter, intended
to be used for lifting and transferring of patients in hospitals,
nursing homes of other health care facilities, Recall # Z-0412-2009;
b) Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic
Positioning System) and Scale. A Non-AC-Powered Patient Lift. Model
KM560181 and Model KM560081 - Maxi 500 with 4-Point Spreader Bar, if it
was equipped with the optional scale kit 700.19251, Recall # Z-0413-2009
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle , IL , by letter dated
October 29, 2008. Manufacturer: B. H. M. Medical, Inc., Magog , Canada .
Firm initiated recall is ongoing.
REASON: If the spring pin is not properly reinstalled after maintenance,
the pivot bolt could unscrew by itself within a limited period of time,
resulting in a hanger bar detachment.
PRODUCT
Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version
1.0.41, Recall # Z-0454-2009
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea , CA , by
telephone and letter on September 11, 2007. Manufacturer: Beckman
Coulter Inc., Fullerton , CA. Firm initiated recall is ongoing.
REASON: Incorrect results: under certain circumstances, when transfer
volume is not within the set range, the Vidiera NsP software does not
report sample exclusion and does not flag the excluded sample in the
"Run Results" report.
PRODUCT: ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent,
EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c)
Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c)
Assay. For in vitro diagnostic use only. ACE EZA1c Reagent is intended
for the quantitative determination of stable hemoglobin A1c in human
whole blood samples using the ACE and Ace Alera clinical chemistry
systems. Measurement of hemoglobin A1c is a viable indicator for
long-term diabetic control. a) EZA1c Reagent ACI-30, and b) EZA1c
Reagent ACI-30. The following EZA1c control and calibrator kits were
included in the customer notification instructing them to discard the
product. There is no use for these products without the reagent, (EZA1c
Controls C2-82, and EZA1c Calibrators S2-82), Recall # Z-0482-2009
MANUFACTURER: Alfa Wassermann, Inc., Caldwell , NJ , by letters dated
August 22, 2008 and September 18, 2008. Firm initiated recall is
ongoing.
REASON: Internal studies observed occasional unexpected outlier results
in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent
on the ACE or ACE Alera clinical chemistry systems.
PRODUCT:
a) FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in
intra-operative recording of single unit neuronal activity or
intra-operative stimulation of neural elements in the brain, Recall #
Z-0497-2009;
b) FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and
Nexdrive. REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2
electrodes each) Intended for use in intra-operative recording of single
unit neuronal activity or intra-operative stimulation of neural elements
in the brain, Recall # Z-0498-2009;
c) FC400SP MicroTargeting StimPilot Single Procedure Kit, Ref:
FHC4000SP. Intended for use in intra-operative recording of single unit
neuronal activity or intra-operative stimulation of neural elements in
the brain, Recall # Z-0498-2009
MANUFACTURER: FHC, Inc., Bowdoinham , ME , by letter dated October 20,
2008. Firm initiated recall is ongoing.
REASON: Mislabeled: May contain an electrode longer than labeled size.
PRODUCT:
a) STA Neoplastine CI 10; Product Catalogue Number: 0666, Recall #
Z-0501-2009;
b) STA Neoplastine CI Plus 10; Product Catalogue Number: 0667, Recall #
Z-0502-2009
MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany , NJ ,
by letters on October 20, 2008. Manufacturer: Diagnostica Stago -
Taverny Site, Taverny, France . Firm initiated recall is ongoing.
REASON: Internal investigation has determined the potential lack of
homogeneity between product vials.
PRODUCT: Maxi Move, Model NDA0200-20 Batteries Pack. The
equipment is intended to be used in Hospitals, nursing homes, or other
health care facilities by trained caregivers for the transfer of
patients. This battery pack was solely supplied with Maxi Move floor
lift model numbers starting with KCxxx or sold separately as replacement
parts, Recall # Z-0503-2009
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle , IL ,
by Field Safety Notice dated October 31, and letter dated November 5,
2008. Manufacturer: B. H.M. Medical, Inc., Magog , Canada . Firm
initiated recall is ongoing.
REASON: The battery pack has a defective connector that could lead to
the inability of the battery pack to recharge and/or short circuit,
resulting in smoke emission.
PRODUCT: Single-use sterile puncture attachment UA1256-U
used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro
Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic
Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667
Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer
8667 performing ultrasound guided biopsies of the prostate, Recall #
Z-0504-2009
MANUFACTURER: Recalling Firm: Bk Medical, Lierlev , Denmark , by letter
dated September 3, 2008. Manufacturer: Mepy Systems, Saint Jean , France
. Firm initiated recall is complete.
REASON: No 510k approved.
CLASS III
PRODUCT: Cannabinoids Intercept Micro Plate EIA 100 plate kit; Product
number 11181C, Recall # Z-0481-2009
MANUFACTURER: OraSure Technologies, Inc., Bethlehem , PA , by telephone
on September 8, 2008 and by letter dated September 11, 2008. Firm
initiated recall is complete.
REASON: Readings , high: intermittent high absorbance readings.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
December 17, 2008
CLASS I
PRODUCT: AMO Healon D Ophthalmic Viscosurgical Device, Product Code:
10204011, 30 mg/mL fill size, Recall # Z-0343-2009
MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana ,
CA , by letters on October 30, 2008. Manufacturer: Pharmacia Diagnostics
AB, Uppsala , Sweden . Firm initiated recall is ongoing.
REASON: Endotoxin levels above specifications have been noted in some
syringes tested for lot number UD30654 of the AMO Healon D Ophthalmic
Viscosurgical Device. Endotoxin levels above the maximum USP level may
be potential causes of an inflammatory response and/or TASS in patients
following surgery.
PRODUCT: Gravity Compensating Accessory; High Pressure
Range , Sterile, Single Use, Rx only. CSF shunt accessory. The GCA is an
implantable device designed to be used in conjunction with implanted
systems which. shunt cerebrospinal fluid CSF from the cerebral
ventricles to an appropriate drainage site a) Catalog number: 903-430,
b) Catalog Number 903-435, c) Catalog Number 903-440, Recall #
Z-0458-2009
MANUFACTURER: Recalling Firm: Integra LifeSciences Corp., Plainsboro ,
NJ , by letters dated October 3, 2008. Manufacturer: Integra
Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated
recall is ongoing.
REASON: Product has the potential for CSF leakage under certain
conditions.
CLASS II
PRODUCT: Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced
Perfusion System I, Perfusion System 800 and Perfusion System 900. REF
195240. Level Sensor pads are used to attach the level sensor to the
sides of a rigid reservoir, Recall # Z-0311-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by
letter dated February 13, 2008. Firm initiated recall is ongoing.
REASON: The level sensor holder may detach from the adhesive pad causing
the sensor to lose contact with the venous reservoir, which may result
in a detached sensor indication or false alarm.
PRODUCT:
a) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump;
Model 801040). Extracorporeal circulation of blood for arterial
perfusion, regional perfusion, and cardiopulmonary bypass procedures,
Recall # Z-0354-2009;
b) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump;
Model 801041). Extracorporeal circulation of blood for arterial
perfusion, regional perfusion, and cardiopulmonary bypass procedures,
Recall # Z-0355-2009;
c) Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump,
Gray; Model 816570). Extracorporeal circulation of blood for arterial
perfusion, regional perfusion, and cardiopulmonary bypass procedures,
Recall # Z-0356-2009;
d) Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump,
Gray; Model 816571). Extracorporeal circulation of blood for arterial
perfusion, regional perfusion, and cardiopulmonary bypass procedures,
Recall # Z-0357-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by
letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON: Overspeed and underspeed errors, erratic pump behavior, jerky
operation at low RPMs, pump instability, pump slowdowns and pump stops
due to overspeed max events may occur due to a grease leak onto the
motor speed encoder disk.
PRODUCT: a) Mentor Aseptic Transfer Set, Cat. #350-8400,
b) contains BD 60mL Luer-Lok Syringe, Reorder Number: 309653, Recall #
Z-0407-2009
MANUFACTURER: Recalling Firm: Mentor Texas, Inc., Irving , TX , by
letter on August 18, 2008. Manufacturer: Becton Dickinson & Company,
Franklin Lakes , NJ. Firm initiated recall is ongoing.
REASON: The Mentor Aseptic Transfer Set contains a component, the BD
60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to
a package integrity issue.
PRODUCT: Fisher & Paykel Healthcare RT240 Adult Breathing
Circuit Kit. Intended Use: The dual heated adult respiratory ventilator
circuits are intended as conduits of breathing gas for ventilation of
patients, and to maintain the temperature of the humidified gas, to
reduce condensation, Recall # Z-0414-2009
MANUFACTURER: Recalling Firm: Fisher & Paykel Healthcare Inc.,
Huntington Beach , CA , by letters dated October 8, 2008. Manufacturer:
Fisher & Paykel Electronics, Ltd, Auckland , New Zealand . Firm
initiated recall is ongoing.
REASON: The recall was initiated because certain lot dates of the RT240
Adult Breathing Circuit Kits manufactured on or before June 27, 2008
include a heated breathing circuit that may be more susceptible to
damage when used in excess of the specified seven-day maximum duration
of use, which may increase the risk of malfunction or fire.
PRODUCT
a) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00200W, 16F, 1.2cm, 10cc, Sterile EO. Dual Port Wizard Low Profile
Replacement Gastrostomy Device is a silicone low-profile balloon-type
device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged
in a kit which also includes two tubes, two gauze pads, and a syringe.
The Wizard anti-reflux valve is a component of the Dual Port Wizard
Gastrostomy Device. The inserted device is used for enteral feeding,
Recall # Z-0416-2009;
b) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00201W, 16F, 1.7cm, 10cc, Sterile EO. Dual Port Wizard Low Profile
Replacement Gastrostomy Device is a silicone low-profile balloon-type
device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged
in a kit which also includes two tubes, two gauze pads, and a syringe.
The Wizard anti-reflux valve is a component of the Dual Port Wizard
Gastrostomy Device. The inserted device is used for internal feeding,
Recall # Z-0417-2009;
c) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00202W, 16F, 2.4cm, 10cc, Sterile EO. Dual Port Wizard Low Profile
Replacement Gastrostomy Device is a silicone low-profile balloon-type
device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged
in a kit which also includes two tubes, two gauze pads, and a syringe.
The Wizard anti-reflux valve is a component of the Dual Port Wizard
Gastrostomy Device. The inserted device is used for enteral feeding,
Recall # Z-0418-2009;
d) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00203W, 20F, 1.2cm, 10cc, Sterile EO. Dual Port Wizard Low Profile
Replacement Gastrostomy Device is a silicone low-profile balloon-type
device designed for percutaneous insertion through an established,
appropriately sized stoma tract. The Dual Port Wizard Device is packaged
in a kit which also includes two tubes, two gauze pads, and a syringe.
The Wizard anti-reflux valve is a component of the Dual Port Wizard
Gastrostomy Device. The inserted device is used for enteral feeding,
Recall # Z-0419-2009;
e) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00204W, 20F, 1.7cm, 10cc, Sterile EO, Recall # Z-0420-2009;
f) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00205W, 20F, 2.4cm, 10cc, Sterile EO, Recall # Z-0421-2009;
g) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00206W, 20F, 3.4cm, 10cc, Sterile EO, Recall # Z-0422-2009;
h) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00207W, 20F, 4.4cm, 10cc, Sterile EO, Recall # Z-0423-2009;
i) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00209W, 16F, 1.7cm, 20cc, Sterile EO, Recall # Z-0424-2009;
j) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00210W, 16F, 2.4cm, 20cc, Sterile EO, Recall # Z-0425-2009;
k) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00212W, 20F, 1.7cm, 20cc, Sterile EO, Recall # Z-0426-2009;
l) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00213W, 20F, 2.4cm, 20cc, Sterile EO, Recall # Z-0427-2009;
m) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00214W, 20F, 3.4cm, 20cc, Sterile EO, Recall # Z-0428-2009;
n) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00215W, 20F, 4.4cm, 20cc, Sterile EO, Recall # Z-0429-2009;
o) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00216W, 24F, 1.7cm, 20cc, Sterile EO, Recall # Z-0430-2009;
p) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00217W, 24F, 2.4cm, 20cc, Sterile EO, Recall # Z-0431-2009;
q) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00218W, 24F, 3.4cm, 20cc, Sterile EO, Recall # Z-0432-2009;
r) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00219W, 24F, 4.4cm, 20cc, Sterile EO, Recall # Z-0433-2009;
s) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00221W, 18F, 1.2cm, 10cc, Sterile EO, Recall # Z-0434-2009;
t) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00222W, 18F, 1.7cm, 10cc, Sterile EO, Recall # Z-0435-2009;
u) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00223W, 18F, 2.4cm, 10cc, Sterile EO, Recall # Z-0436-2009;
v) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00224W, 18F, 3.4cm, 10cc, Sterile EO, Recall # Z-0437-2009;
w) Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code
00225W, 18F, 4.4cm, 10cc, Sterile EO, Recall # Z-0438-2009
MANUFACTURER: Recalling Firm: C R Bard Inc., Salt Lake City , UT , by
letter on September 23, 2008. Manufacturer: Bard Puerto Rico, Humacao,
Puerto Rico . Firm initiated recall is ongoing.
REASON: Gastrostomy device anti-reflux valve may allow leakage from the
stomach.
PRODUCT: Modular Shoulder Body Assembly, 15mm, Left
(SH-1540L-S) and Modular Shoulder Body Assembly, 15mm, Right
(SH-1540R-S). Product labeled in part, Recall # Z-0447-2009
MANUFACTURER: Acumed LLC, Hillsboro , OR , by letter on May 13, 2008.
Firm initiated recall is ongoing.
REASON: The packages for Modular Shoulder Body Assembly Left
(SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may
contain assemblies for the opposite side as indicated.
PRODUCT: GE Centricity PACS RA1000 Workstation (for
diagnostic image analysis). The Centricity" PACS Workstation is intended
for use as a primary diagnostic and analysis tool for diagnostic images
by trained healthcare professionals. It is also intended for use as a
clinical review workstation throughout the healthcare facility. The
workstation interface provides the user with a means to display,
manipulate, archive, print, and export images when connected with the
Centricity" PACS infrastructure, Recall # Z-0460-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington , IL ,
by letter dated September 25, 2008. Firm initiated recall is ongoing.
REASON: Software anomalies result in patient safety issues involving
patient jacket content intermittently becoming unintentionally out of
synchronization with the images being displayed, and involving Default
Display Protocols (DDPs) which are used to layout images when displaying
a study. If the user does not check the Study Date Time of the exam on
the image title bar, then they may interpret the current exam as a
historical study and vice versa.
PRODUCT: RNAgents® Total RNA Isolation System (Cat. #
Z5110). Kit Box label/Box drawer label. For Laboratory Use. Bottle
Label: Phenol: Chloroform: Isoamyl Alcohol (Cat. # Z5112). Part Two of
Two of Z5110. Size 100ml. For laboratory Use. A component of the
RNAgents® Total RNA Isolation System. The RNAgents® Total RNA Isolation
System provides a scalable method for RNA isolation from 6 grams of
tissue or 6 x 10 (eighth power) cultured cells. The system reduces the
level of chromosomal DNA, a major advantage when the downstream
application of amplification and analysis of RNA transcripts is desired.
Isolated RNA can be resuspended in any volume, making the system ideal
for microarrays, Recall # Z-0483-2009
MANUFACTURER: Promega Corporation, Madison , WI , by email on May 29,
2008 and letter dated June 9, 2008. Firm initiated recall is ongoing.
REASON: Reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol,
Promega product Z5112 is a mixture of phenol, chloroform and isoamyl
alcohol. If phenol contacts skin, it can cause burns and poisoning. The
fumes of this product are also harmful.
PRODUCT: Dimension Enzymatic Creatinine Flex reagent
cartridge, DF270. The ECRE method is an in vitro diagnostic test for the
quantitative measurement of creatinine in human serum, plasma, and urine
on the clinical chemistry 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 analyses, Recall #
Z-0485-2009
MANUFACTURER: Dade Behring, Inc., Newark , DE , by telephone and letter
dated September 29, 2008. Firm initiated recall is ongoing.
REASON: Reagent may exhibit unflagged inaccurate patient sample results.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
December 10, 2008
The following is condensed list of medical devices
involved in recalls listed by the FDA Enforcement Report as of December
10, 2008:
CLASS II
PRODUCT: GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part
or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and
2001-9725. The GSI Audera is used as part of an audiometric test
battery. It can be used to assess cochlear function, enable estimation
of behavioral hearing thresholds by evoking auditory brainstem or steady
state brainstem response and to aid in detection of lesions in the
auditory pathway on neonates through adults, Recall # Z-0195-2009
MANUFACTURER: Cardinal Health, Inc., Madison , WI , by letter dated
September 16, 2008, September 22, and September 26, 2008, Firm initiated
recall is ongoing.
REASON:
GSI Audera systems require a system software update due to issues with
the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP)
functions. A. Split Screen Field Correction: GSI Audera units with
version 2.6 software may mislabel Auditory Evoked Potential (AEP)
waveform responses with respect to the identification of the stimulus
ear. When using 2.6 software in split-screen mode, and switching data
acquisition from right ear to the left ear, if the audiologist clicks
back on the right ear to annotate or mark it, the data acquisition from
the left ear is then assigned to the record of the right ear. The
waveform is labeled as a right ear response even though the left ear was
stimulated and vice versa. Mislabeling of the results could lead to a
decision to fit a hearing aid on the incorrect ear and result in
excessive hearing aid amplification and possible damage to the
misdiagnosed ear. B. VEMP Marketing Correction: The US Food and Drug
Administration is requiring the removal of the Vestibular Evoked
Myogenic Potential (VEMP) function from the GSI Audera products in the
field until this function has been granted FDA's clearance.
PRODUCT: Posey Synthetic Leather and Biothane Waist and
Wrist Restraints, Catalog Numbers: 2217SL and 2217B, Recall #
Z-0286-2009
MANUFACTURER: J T Posey Co., Arcadia , CA , by letters on July 29, 2008.
Firm initiated recall is ongoing.
REASON: Failure to restrain.
PRODUCT:
a) AXIOM Artis System dFC using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures.
Model number 7412807, Recall # Z-0312-2009;
b) AXIOM Artis System dBA using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures.
Model number 7555357;
Recall # Z-0313-2009;
c) AXIOM Artis System dFA using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures.
Model number 7555373. Recall # Z-0314-2009;
d) AXIOM Artis System dTC using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures.
Model number 7413078; Recall # Z-0315-2009;
e) AXIOM Artis System dTA using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures.
Model number 7008605; Recall # Z-0316-2009;
f) AXIOM Artis System dMP using software version VB31D with 30x40 cm2
flat detectors. ˙AXIOM Artis is a angiography system developed for
single and biplane diagnostic imaging and interventional procedures;
Model number 7555365; Recall # Z-0317-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern , PA , by letter dated August 20, 2008. Manufacturer: Siemens
AG, Medical Solution, Forchheim , Germany . Firm initiated recall is
ongoing.
REASON: System may switch to emergency fluoroscopy mode.
PRODUCT: AS3000 Anesthesia Delivery System. Datascope
Patient Monitoring; A Mindray Global Company. The AS3000 is a device
used to administer to a patient, continuously or intermittently, a
general inhalation anesthetic and to maintain a patient's ventilation;
Recall # Z-0319-2009
MANUFACTURER: Mindray DS USA, Inc., dba Datascope Patient Monitoring,
Mahwah , NJ , by letters on October 7, 2008. Firm initiated recall is
ongoing.
REASON: Two issues have been identified with the AS3000 unit. 1. The
threadlocker of the caster (wheels) may not have been utilized, which
may allow the caster to loosen and possibly separate from the unit. 2.
The use of select brands of pre-pack absorber in the absorber canister
of the AS3000 has been associated, in some cases, with gas leakage
around the pre-pack, rather than through the absorber material.
PRODUCT: syngo MultiModality WorkPlace (MM WP). Software
product (Model Number 10140720). The product is intended for use in
picture archiving and communications system; Recall # Z-0324-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern , PA , by visit beginning September 12, 2008. Manufacturer:
Siemens Medical Solutions Inc., Erlangen , Germany . Firm initiated
recall is ongoing.
REASON: Values derived from Dynamic CT data sets may be incorrect. The
corresponding images are not affected.
PRODUCT:
a) Terumo Sarns Sternal Saw II System Power Unit, 115 V; Catalog #
15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw
II system consists of a disposable blade, saw, flexible drive shaft,
motor and foot control; Recall # Z-0358-2009;
b) Terumo Sarns Sternal Saw II System Power Unit, 220/240 V; Catalog #
7084. Note: This product was not sold in the U.S. Indicated for use in
medial sternotomies. The Sarns Sternal Saw II system consists of a
disposable blade, saw, flexible drive shaft, motor and foot control;
Recall # Z-0359-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor , MI , by
letter dated February 14, 2008. Firm initiated recall is ongoing.
REASON: The drive power cable cannot be fully inserted into the power
unit or can only be inserted with difficulty, resulting in the device
not being operational.
PRODUCT:
a) 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set Ref: 050A11
Percutaneous catheter introducer sets, including sheath, dilator, guide
wire and needle, are used to facilitate placing a catheter through the
skin into a vein or artery. Percutaneous introducers are recommended for
initial percutaneous introduction or the exchange of intravascular
devices. Guide wire introducer needles are used for percutaneous
puncture and insertion into the blood vessel. The guide wire is then
inserted through the cannula of the introducer needle at the puncture
site. The cannula is then removed to allow insertion of the percutaneous
catheter introducer following removal of the guide wire introducer
needle, Recall # Z-0441-2009;
b) 6 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 060A11
Percutaneous catheter introducer sets, including sheath, dilator, guide
wire and needle, are used to facilitate placing a catheter through the
skin into a vein or artery. Percutaneous introducers are recommended for
initial percutaneous introduction or the exchange of intravascular
devices. Guide wire introducer needles are used for percutaneous
puncture and insertion into the blood vessel. The guide wire is then
inserted through the cannula of the introducer needle at the puncture
site. The cannula is then removed to allow insertion of the percutaneous
catheter introducer following removal of the guide wire introducer
needle, Recall # Z-0442-2009;
c) 7 F BardSelect 11cm Percutaneous Catheter Introducer Set Ref: 070A11
Percutaneous catheter introducer sets, including sheath, dilator, guide
wire and needle, are used to facilitate placing a catheter through the
skin into a vein or artery. Percutaneous introducers are recommended for
initial percutaneous introduction or the exchange of intravascular
devices. Guide wire introducer needles are used for percutaneous
puncture and insertion into the blood vessel. The guide wire is then
inserted through the cannula of the introducer needle at the puncture
site. The cannula is then removed to allow insertion of the percutaneous
catheter introducer following removal of the guide wire introducer
needle; Recall # Z-0443-2009;
d) Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous catheter
introducer sets, including sheath, dilator, guide wire and needle, are
used to facilitate placing a catheter through the skin into a vein or
artery. Percutaneous introducers are recommended for initial
percutaneous introduction or the exchange of intravascular devices.
Guide wire introducer needles are used for percutaneous puncture and
insertion into the blood vessel. The guide wire is then inserted through
the cannula of the introducer needle at the puncture site. The cannula
is then removed to allow insertion of the percutaneous catheter
introducer following removal of the guide wire introducer needle, Recall
# Z-0444-2009
MANUFACTURER: Recalling Firm: Medtronic, Inc, Danvers , MA , by letter
on October 7, 2008. Manufacturer: Thomas Medical Products, Inc., Malvern
, PA. Firm initiated recall is ongoing.
REASON: Failure to insert the guidewire through the 18 gauge introducer
needle.
PRODUCT: GE Healthcare Centricity Perinatal (formerly
Quantitative Sentinel) System - Alert and Reminder software; automatic
patient data management providing clinical information at the bedside in
Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE
Healthcare Integrated IT Solutions, Barrington, IL 60010 Intended for
use as a clinical data management system; Recall # -0456-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington , IL ,
by letter dated August 29, 2008. Firm initiated recall is complete.
REASON: Software anomalies in the Alert and Reminder feature could
result in a delay of treatment. When attempting to select the last
visible alert or reminder choice, the next choice on the list below the
desired choice is selected, and an inconsistent color may be displayed
for the same clinical element across a set of work stations.
PRODUCT: Calibration 1 Solution for the ABL700 series. P/N
S1720, 944-024 Intended for in vitro testing of samples of whole blood
for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride,
glucose, lactate, total bilirubin, and co-oximetry parameters (total
hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb,
FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of
expired air for the parameters pO2 and pCO2. P/N S1720, 944-024; Recall
# Z-0457-2009
MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake , OH ,
by letters on September 2, 2008. Manufacturer: Radiometer Medical ApS,
Bronshoj , Denmark . Firm initiated recall is ongoing.
REASON: For this particular lot the barcode, used for entering the
characteristics of CAL1 Solution into the analyzer, does not reflect the
actual values of the solution. As a consequence, the calibration curves
for these parameters and thereby the measured results for patient
samples and quality controls will be biased.
PRODUCT: STERRAD NX Sterilizer, Product Code 10033 Low
temperature sterilizers that use hydrogen peroxide gas plasma to
inactivate microorganisms on a broad range of medical and surgical
instruments; Recall # Z-0484-2009
MANUFACTURER Advanced Sterilization Products, Irvine , CA , by letter
dated October 6, 2008. Firm initiated recall is ongoing.
REASON: ASP has discovered a component defect in some of the UV lamp
power supplies used in certain STERRAD NX Sterilizers. This defect can
potentially cause the Hydrogen Peroxide Monitor to give inaccurate
readings.
CLASS III
PRODUCT:Toddler Chair Hip Strap (Belt). The hip belt is made with nylon
webbing and a plastic buckle. 510(k) exempt, Medical Device Listing #
R061877. The product is used as a hip strap chair for children, Recall #
Z-0318-2009
MANUFACTURER: Recalling Firm: Community Products, LLC, Rifton , NY , by
telephone on September 12, 2008. Manufacturer: Community Products, LLC,
Elka Park , NY . Firm initiated recall is ongoing.
REASON: Some hip straps were assembled incorrectly by threading the
buckle on the strap upside down. If a child were left unattended in
spite of the warnings on the product and in the manual, a defective hip
strap could loosen, allowing the child to slip down in the chair and
this could create a choking hazard.
PRODUCT:
a) PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with
Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch
(4.85mm) x 23cm. NOTE: Both the "sport pack" and "kit" package
configurations include the catheter, Venetrac insertion stylets, pull
apart sheath, and other accessories necessary for placement. The
Venetrac insertion stylet is an optional accessory. The 510k for the
Venetrac accessory is K051584. The 510k for the catheter is K060509,
Recall # Z-0408-2009;
b) PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with
Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch
(4.85mm) x 28cm. NOTE: Both the "sport pack" and "kit" package
configurations include the catheter, Venetrac insertion stylets, pull
apart sheath, and other accessories necessary for placement. The
Venetrac insertion stylet is an optional accessory. The 510k for the
Venetrac accessory is K051584. The 510k for the catheter is K060509;
Recall # Z-0409-2009;
c) PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved
Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm.
NOTE: Both the "sport pack" and "kit" package configurations include the
catheter, Venetrac insertion stylets, pull apart sheath, and other
accessories necessary for placement. The kit includes additional
components that would also be available at the hospital, such as a
scalpel, wound dressing, etc. The Venetrac insertion stylet is an
optional accessory. The 510k for the Venetrac accessory is K051584. The
510k for the catheter is K060509, Recall # Z-0410-2009;
d) PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed
Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm.
NOTE: Both the "sport pack" and "kit" package configurations include the
catheter, Venetrac insertion stylets, pull apart sheath, and other
accessories necessary for placement. The kit includes additional
components that would also be available at the hospital, such as a
scalpel, wound dressing, etc. The Venetrac insertion stylet is an
optional accessory. The 510k for the Venetrac accessory is K051584. The
510k for the catheter is K060509, Recall # Z-0411-2009
MANUFACTURER: Covidien, Argyle, NY, by visit beginning September 19,
2008. Firm initiated recall is complete.
REASON: Incorrect size of the Venetrac stylets (an optional accessory).
They are too short and cannot be used.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
December 3, 2008:
CLASS II
PRODUCT:
a) Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model
number 7412807, Recall # Z-0120-2009;
b) Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System,
Model number 5917054, Recall # Z-0121-2009;
c) Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model
number 7008605, Recall # Z-0122-2009;
d) Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model
number 7413078, Recall # Z-0123-2009;
e) Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model
number 7555357, Recall # Z-0124-2009;
f) Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System,
Model number 7727717, Recall # Z-0125-2009;
g) Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model
number 7555373, Recall # Z-0126-2009;
h) Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model
number 7555365, Recall # Z-0127-2009;
i) Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model
number 7728392., Recall # Z-0128-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter dated August 29, 2008. Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Incorrect contour finding: Image may be calibrated to the wrong
size catheter.
PRODUCT:
1) PREMISE, Part No. 32650, 10 PACK UNIDOSE PREMISE A1, dental
composite, Recall # Z-0229-2009;
2) PREMISE, Part No. 32651, 10 PACK UNIDOSE PREMISE A2, dental
composite, Recall # Z-0230-2009;
3) PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental
composite, Recall # Z-0231-2009;
4) PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental
composite, Recall # Z-0232-2009;
5) PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental
composite, Recall # Z-0233-2009;
6) PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental
composite, Recall # Z-0234-2009;
7) PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental
composite, Recall # Z-0235-2009;
8) PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental
composite, Recall # Z-0236-2009;
9) PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental
composite, Recall # Z-0237-2009;
10) PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental
composite, Recall # Z-0238-2009;
11) PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental
composite, Recall # Z-0239-2009;
12) PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental
composite, Recall # Z-0240-2009;
13) PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental
composite, Recall # Z-0241-2009;
14) PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental
composite, Recall # Z-0242-2009;
15) PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental
composite, Recall # Z-0243-2009;
16) PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental
composite, Recall # Z-0244-2009;
17) PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental
composite, Recall # Z-0245-2009;
18) PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental
composite, Recall # Z-0246-2009;
19) PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental
composite, Recall # Z-0247-2009;
20) PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental
composite, Recall # Z-0248-2009;
21) PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental
composite, Recall # Z-0249-2009;
22) PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental
composite, Recall # Z-0250-2009;
23) PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental
composite, Recall # Z-0251-2009;
24) PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental
composite, Recall # Z-0252-2009;
25) PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental
composite, Recall # Z-0253-2009;
26) PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental
composite, Recall # Z-0254-2009;
27) PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental
composite, Recall # Z-0255-2009;
28) PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental
composite, Recall # Z-0256-2009;
29) PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0257-2009;
30) PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0258-2009;
31) PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0259-2009;
32) PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0260-2009;
33) PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0261-2009;
34) PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0262-2009;
35) PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0263-2009;
36) PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0264-2009;
37) PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0265-2009;
38) PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL
ONLY), dental composite, Recall # Z-0266-2009;
39) PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3
(INTERNATIONAL ONLY), dental composite, Recall # Z-0267-2009;
40) PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER
(INTERNATIONAL ONLY), dental composite, Recall # Z-0268-2009;
41) PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental
composite, Recall # Z-0269-2009;
42) PREMISE KIT, Part No. 33882, Unidose Premise Mini Kit, dental
composite, Recall # Z-0270-2009
MANUFACTURER: Kerr Corporation, Orange, CA, by letter beginning
September 8, 2008. Firm initiated recall is ongoing.
REASON: Material stiff: Material in several lots of Premise Unidose
appears to stiffen and become difficult to extrude over time.
PRODUCT: Uni-CP Compression Forceps (spreader);
Non-sterile, R only, Catalog number: 339001ND, Intended to open the
UNI-Compression Plate olive, which creates a compression, Recall #
Z-0307-2009
MANUFACTURER: Recalling Firm: Integra LifeSciences Corporation,
Plainsboro, NJ, by letters on September 30, 2008. Manufacturer: NewDeal
SA, Lyon, France. Firm initiated recall is ongoing.
REASON: Reports of the Uni-CP Compression Forceps breaking during the
Compression of the Uni-CP plate.
PRODUCT:
a) Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat
panel/digital imager). Model number 10252047. Universal fluoroscopic
x-ray diagnostic system, Recall # Z-0326-2009;
b) Axiom Luminos dRF without ST filter. Solid state x-ray imager (flat
panel/digital imager). Model number 10252048. Universal fluoroscopic
x-ray diagnostic system, Recall # Z-0326-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter dated August 2008. Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Issue may occur where an intended movement of the joystick may
unintentionally initiate an x-ray exposure.
CLASS III
PRODUCT: "LOCATOR Abudment for 5.7 Screw-Vent & Compatibles." Zest
Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm
diameter Tapered Screw-Vent Implant. The product is used with
supra-gingival, universal hinge, resilient overdenture attachment for
endosseous implants, Recall # Z-0298-2009
MANUFACTURER: Zest Anchors, Inc., Escondido, CA, by letter on April 23,
2008. Firm initiated recall is complete.
REASON: The recall was initiated after the firm discovered through a
customer complaint that the Locator Abutments for 5.7 Screw-vent &
Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm
diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11, TSV6B13,
TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator
Abutment bottoms out in the pilot hole of these implants causing up to a
half millimeter gap between the seating surface of the Locator Abutment
and the implant. This gap in the fit could allow bacteria to enter into
the implant body, contaminating the implant, or allow screw loosening
with the risk of abutment fracture.
PRODUCT:
a) Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF
43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434520. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0328-2009;
b) Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF
43-450, UPN M001434501, Sterilized with ethylene oxide gas . UPN for
inner pouch M001434500 Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0329-2009;
c) Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF
43-451, UPN M001434511, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434510. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0330-2009;
d) Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF
43-453 , M001434531, Sterilized with ethylene oxide gas. UPN for inner
pouch M001434530. Indicated for use endoscopically or percutaneously to
retrieve tissue sampling of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited
to, organs such as breast, liver, kidney or prostate, Recall #
Z-0331-2009;
e) Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF
43-454, UPN M001434541, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434540. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0332-2009;
f) Boston Scientific Easy Core" Biopsy System, 15 ga. x 10 cm, REF
43-456, UPN M001434561, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434560. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0333-2009;
g) Boston Scientific Easy Core" Biopsy System, 15 ga. x 15 cm, REF
43-457, UPN M001434571, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434570. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0334-2009;
h) Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF
43-458, UPN M001434581, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434580. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0335-2009;
i) Boston Scientific Easy Core" Biopsy System, 18 ga. x 15 cm, REF
43-459, UPN M001434591, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434590. Indicated for use endoscopically or
percutaneously to retrieve tissue sampling of soft organs, tumors or
masses for histological analysis. Soft tissue sampling includes, but is
not limited to, organs such as breast, liver, kidney or prostate, Recall
# Z-0336-2009;
j) Boston Scientific Easy Core" Biopsy System, 18 ga. x 21 cm, REF
43-460, UPN M001434601, Sterilized with ethylene oxide gas. UPN for
inner pouch M001434600. M001434601 43-460 Indicated for use
endoscopically or percutaneously to retrieve tissue sampling of soft
organs, tumors or masses for histological analysis. Soft tissue sampling
includes, but is not limited to, organs such as breast, liver, kidney or
prostate, Recall # Z-0337-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Maple
Grove, MN, by letter dated October 21, 2008. Manufacturer: Boston
Scientific Corporation, Spencer, IN. Firm initiated recall is ongoing.
REASON: Boston Scientific Corporation initiated a recall of its easy
Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula
latch on the device. This difficulty may result in an inability to use
the device.
PRODUCT: Fredrick’s Converse Retractor #5 F/O, Model
Number: 01-0485. A fiber optic retractor used in plastic surgery
procedures to retract tissue, Recall # Z-0415-2009
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letter
dated October 24, 2008. Firm initiated recall is ongoin
REASON: Fiber optic cable is missing from the Frederick’s Converse
Retractor.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
November 26, 2008
CLASS I
PRODUCT:
a) Battery Caps used with insulin pumps and glucose monitoring systems.
The pump is used to help maintain blood glucose targets. Part Number:
100-158-01, Recall # Z-0290-2009;
b) Battery Caps used with OneTouch Ping Glucose Monitoring System. The
pump is used to help maintain blood glucose targets. Part Numbers:
100-430-00, 100-431-00, 100-432-00, 100-434-00, and 100-435-00, Recall #
Z-0291-2009;
c) Battery Caps used with Animas 2020 Insulin Pump. The pump is used to
help maintain blood glucose targets. Part Numbers: 100-370-00,
100-370-02, 100-370-03, 100-370-51, 100-370-63, 100-370-65, 100-371-00,
100-371-02, 100-371-03, 100-371-51, 100-371-63, 100-371-65, 100-371-67,
100-372-00, 100-372-02, 100-372-03, 100-372-08, 100-372-51, 100-372-67,
100-374-00, 100-374-02, 100-374-51, 100-374-65, 100-375-00, 100-375-02,
100-375-08, 100-375-51, 100-375-60, 100-375-63, 100-375-65, 100-380-00,
100-380-02, 100-380-03, 100-380-05, 100-380-51, 100-380-57, 100-380-61,
100-380-63, 100-380-64, 100-380-65, 100-381-00, 100-381-03, 100-381-05,
100-381-51, 100-381-57, 100-381-61, 100-381-63, 100-381-65, 100-382-00,
100-382-02, 100-382-03, 100-382-51, 100-382-57, 100-382-63, 100-382-64,
100-382-65, 100-384-00, 100-384-51, 100-384-57, 100-384-65, 100-384-67,
100-385-00, 100-385-51, 100-385-65, 100-385-67, and 100-450-00, Recall #
Z-0292-2009;
d) Battery Caps used with Animas IR1200 Insulin Pump. The pump is used
to help maintain blood glucose targets. Part Numbers: 100-172-04,
100-200-00, 100-200-02, 100-200-03, 100-200-05, 100-200-08, 100-200-51,
100-200-53, 100-200-60, 100-200-61, 100-200-64, 100-200-65, 100-200-66,
100-201-00, 100-201-02, 100-201-03, 100-201-08, 100-201-51, 100-201-53,
100-201-63, 100-201-64, 100-201-65, 100-202-00, 100-202-02, 100-202-03,
100-202-04, 100-202-08, 100-202-51, 100-202-53, 100-202-60, 100-202-61,
100-202-64, 100-202-65, 100-202-66, and 100-400-00, Recall #
Z-0293-2009;
e) Battery Caps used with Animas IR1250 Insulin Pump. The pump is used
to help maintain blood glucose targets. Part Numbers: 100-250-00,
100-251-00, 100-252-00, and 100-399-00, Recall # Z-0294-2009
MANUFACTURER: Animas Corp., West Chester, PA, by letter and telephone on
August 5, 2008. Firm initiated recall is ongoing.
REASON: Unintentional rebooting--Pump products exhibit an intermittent
loss of power due intermittent loss of contact between battery cap and
battery canister resulting in the device resetting. The failure of the
battery cap may result in failure of the device to administer insulin
therapy which may result in hyperglycemia.
CLASS II
PRODUCT: Physio-Control Lifepak 20 defibrillator/monitor is intended for
the termination of certain fatal arrhythmias, Recall # Z-2388-2008
MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter on June 18,
2008. Firm initiated recall is ongoing.
REASON: Potential for the coin battery to drain prematurely causing the
monitor clock time and date to be incorrect and the service light
indicator to illuminate.
PRODUCT: One Touch Ultra Test Strips, part number
020-994-02, 25 count. Intended to be used for quantitative measurement
of glucose in fresh capillary whole blood. Intended for use 0outside the
body (in vitro diagnostic use) by people with diabetes at home and
healthcare professionals in a clinical setting as an aid to monitor the
effectiveness of diabetes control. Intended for use on the finger, arm,
or palm, Recall # Z-0004-2009
MANUFACTURER: Lifescan Inc., Milpitas, CA, by letters, dated September
19, 2008. Firm initiated recall is ongoing.
REASON: Products exceed inaccuracy threshold, with many complaints
resulting from inaccurate low results.
PRODUCT: Bone Marrow Aspiration Kit consists of 3 main
components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen
Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g
(3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
Part Number is 50-20-001, Recall # Z-0272-2009
MANUFACTURER: Recalling Firm: Theken Spine LLC, Akron, OH, by letters on
August 27, 2008 and by telephone on August 28, 2008. Manufacturer:
Promex Technologies, LLC, Franklin, IN. Firm initiated recall is
ongoing.
REASON: The kits were manufactured in 2005 with syringes that expire on
10/2009 and labeled with an overall expiration on 10/2010.
PRODUCT: Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm
Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile. A knee prosthesis
intended for single use implantation to replace the auricular portions
of the knee joint, Recall # Z-0289-2009
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 22,
2008. Firm initiated recall is ongoing.
REASON: The package is properly labeled, but the laser etch for size
incorrectly reads "16 X 63/63" instead of the correct size, "16 X
63/67".
PRODUCT:
a) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter,
neck length -3.5 mm, sterile; REF 00-6418-028-01 and 00-6428-028-01. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0299-2009;
b) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter,
neck length 0 mm, sterile; REF 00-6418-028-02 and 00-6428-028-02. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0300-2009;
c) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter,
neck length +3.5 mm, sterile; REF 00-6418-028-03 and 00-6428-028-03. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0301-2009;
c) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter,
neck length -3.5 mm, sterile; REF 00-6418-032-01 and 00-6428-032-01. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0302-2009;
d) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter,
neck length 0 mm, sterile; REF 00-6418-032-02 and 00-6428-032-02. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0303-2009;
e) Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter,
neck length +3.5 mm, sterile; REF 00-6418-032-03 and 00-6428-032-03. The
Alumina Ceramic Femoral Heads are modular components used in total hip
arthroplasty and indicated for patients suffering from severe hip pain
and disability due to rheumatoid arthritis, osteoarthritis, traumatic
arthritis, polyarthritis, collagen disorders, avascular necrosis of the
femoral head, and nonunion of previous fractures of the femur; patients
with congenital hip dysplasia, protrusio acetabuli, or slipped capital
femoral epiphysis; patients suffering from disability due to previous
fusion; patients with previously failed endoprostheses and/or total hip
components in the operative extremity; and patients with acute neck
fractures, Recall # Z-0304-2009;
MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter, dated June 11, 2008.
Firm initiated recall is ongoing.
REASON: When used with cobalt/chromium hip stems, the average test
values for ceramic head bursting falls below the guidance document
limits if the taper is made by casting instead of by forging.
PRODUCT: Giraffe OmniBed® is a combination of an infant
incubator and an infant warmer. The device can be operated as an
incubator or as a warmer and can transition from one mode to the other
on user's demand, Recall # Z-0305-2009
MANUFACTURER: Datex Ohmeda, Inc., dba, GE Healthcare, Laurel, MD, by
letter on June 20, 2008. Firm initiated recall is ongoing.
REASON: Manufacturer of neonatal incubators changed the device labeling
to account for new use and care instructions.
PRODUCT: CELL-DYN Sapphire Hematology Analyzer, List
numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology
analyzer designed for in vitro diagnostic use in counting and
characterizing blood cells, Recall # Z-0306-2009
MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by a Technical
service bulletin on August 22, 2008. Firm initiated recall is ongoing.
REASON: Exposed wire resulted in minor electrical shock and burn to the
service technician.
PRODUCT: Proven Cemented Semi-Constrained Total Knee. Part
number SC1591-38. The size is 38 and the thickness is 10 mm. The Proven
Knee System is a single use device intended for cemented reconstruction
of the femoral and/or tibial portion of severely disabled and/or painful
knee joints resulting from osteoarthritis, rheumatoid arthritis,
traumatic arthritis with or without varus, valgus or flexion
deformities, and revision surgery provided that there is radiographic
evidence of sufficient sound bone to seat the prosthesis, Recall #
Z-0308-2009
MANUFACTURER: Stelkast Co., Mcmurray, PA, by telephone on September 4,
2008. Firm initiated recall is complete.
REASON: Five (5) Three Peg Patella SC1591-29 were packaged in containers
labeled for SC1591-38 sharing the same lot number.
PRODUCT:
a) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump;
Model 801040. The Terumo(R) Advanced Perfusion System 1 is indicated for
use in extracorpeal circulation of blood for arterial perfusion,
regional perfusion, and cardiopulmonary bypass procedures only, when
used by a qualified perfusionist who is experienced in the operation of
Sarns(TM) or similar equipment, Recall # Z-0309-2009;
b) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump;
Model 801041. The Terumo ® Advanced Perfusion System 1 is indicated for
use in extracorpeal circulation of blood for arterial perfusion,
regional perfusion, and cardiopulmonary bypass procedures only, when
used by a qualified perfusionist who is experienced in the operation of
Sarns™ or similar equipment, Recall # Z-0310-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
telephone and letter dated July 18, 2008. Firm initiated recall is
ongoing.
REASON: The pumps may fail to power up or experience unplanned pump
stops.
PRODUCT:
a) Arjo Maxi 500 Patient Lift with 2 Point Spreader Bar and Scale; a
Non-AC-Powered Patient Lift; Model KM560101; The Maxi 500 is a mobile
passive lift intended to be for lifting and transferring of patients in
hospitals, nursing homes, or other health care facilities, Recall #
Z-0322-2009
b) Arjo Maxi 500 Patient Lift with 4 Point DPS (Dynamic Positioning
System) and Scale; a Non-AC-Powered Patient Lift; Models KM560181; The
Maxi 500 is a mobile passive lift intended to be for lifting and
transferring of patients in hospitals, nursing homes, or other health
care facilities, Recall # Z-0323-2009
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letter dated
October 20, 2008. Manufacturer: B.H.M. Medical, Inc., Magog, Canada.
Firm initiated recall is ongoing.
REASON: The pivot bolt that attaches the hanger bar to the scale of the
patient lift can break, resulting in the hanger bar falling.
PRODUCT: STERRAD 100S Sterilizer (Product Code 10101). The
sterilizer includes software and hardware components. The STERRAD
Sterilization System is a low-temperature, general purpose sterilizer
used to sterilize heat and moisture sensitive reusable medical devices,
Recall # Z-0340-2009
MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by letter
beginning November 24, 2008. Firm initiated recall is ongoing.
REASON: 1) Inability of the sterilizer to detect when an injection takes
place without hydrogen peroxide being transferred to the vaporizer bowl.
This situation can result in a cycle completion with the injection of
insufficient hydrogen peroxide sterilant and 2) Inability of the
sterilizer to detect an obstruction in the door travel path while the
door is closing. This situation can result in a hand becoming pinched
and bruised while the door is closing.
CLASS III
PRODUCT: Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw
(Non- sterile). The bone screw (Reference # 48694014) is a 04.0 x 14mm
used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the
anterior surface of the spine. The intended use of the system is as an
aid in cervical spinal fusion through unilateral fixation, Recall #
Z-0217-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letter on
August 18, 2008. Manufacturer: Stryker Spine, Cestas, Aquitane, France.
Firm initiated recall is complete.
REASON: The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw,
Lot NSZ, was determined to have been anodized with the incorrect color
for that screw.
PRODUCT: AxSYM Digoxin II Reagent Pack, Disk Version 1.
(3D53-01 or 3D53-02) The AxSYM Digoxin II assay is a Microparticle
Enzyme Immunoassay (MEIA) for the quantitative measurement of digoxin, a
cardiovascular drug, in serum or plasma. The measurements obtained are
used in the treatment of digoxin overdose and monitoring levels of
digoxin to ensure appropriate therapy, Recall # Z-0297-2009
MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by
letter, dated May 22, 2008. Firm initiated recall is ongoing.
REASON: AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not
contain the AxSYM Digoxin II Assay file. The instrument might require
installation of the AxSYM Digoxin II assay file.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
November 19, 2008
CLASS II
PRODUCT:
a) Physio-Control LIFEPAK® 12 defibrillator/monitor is indicated for the
termination of certain potentially fatal arrhythmias, such as
ventricular fibrillation and symptomatic ventricular tachycardia. PL12
Part number: DVLP12-02-000023, DVLP12-02-000055, DVLP12-02-000100,
DVLP12-02-000102, DVLP12-02-000170, DVLP12-02-000291, DVLP12-02-000450,
DVLP12-02-000456, DVLP12-02-000476, DVLP12-02-000547, DVLP12-02-000615,
DVLP12-02-000622, DVLP12-02-000629, DVLP12-02-000820, DVLP12-02-000827,
DVLP12-02-000872, DVLP12-02-000880, DVLP12-02-001007, DVLP12-02-001008,
DVLP12-02-001009, DVLP12-02-001042, DVLP12-02-001150, DVLP12-02-001152,
DVLP12-02-001357, DVLP12-02-001361, DVLP12-02-001370, DVLP12-02-001384,
DVLP12-02-001385, DVLP12-02-001396, DVLP12-02-001420, DVLP12-02-001433,
DVLP12-02-001452, DVLP12-02-001485, DVLP12-02-002006, DVLP12-02-002139,
DVLP12-02-002164, DVLP12-02-002174, DVLP12-02-002191, DVLP12-02-002230,
DVLP12-02-002266, DVLP12-02-002277, DVLP12-02-002279, DVLP12-02-002280,
DVLP12-02-002336, DVLP12-02-002509, DVLP12-02-002945, DVLP12-02-003473,
DVLP12-02-003487, DVLP12-02-003787, UVLP12-02-000022, UVLP12-02-000023,
UVLP12-02-000055, UVLP12-02-000066, UVLP12-02-000073, UVLP12-02-000099,
UVLP12-02-000107, UVLP12-02-000110, UVLP12-02-000170, UVLP12-02-000172,
UVLP12-02-000291, UVLP12-02-000295, UVLP12-02-000398, UVLP12-02-000455,
UVLP12-02-000476, UVLP12-02-000478, UVLP12-02-000544, UVLP12-02-000603,
UVLP12-02-000629, UVLP12-02-000740, UVLP12-02-000814, UVLP12-02-000866,
UVLP12-02-000872, UVLP12-02-000992, UVLP12-02-000997, UVLP12-02-001007,
UVLP12-02-001008, UVLP12-02-001009, UVLP12-02-001020, UVLP12-02-001038,
UVLP12-02-001040, UVLP12-02-001051, UVLP12-02-001067, UVLP12-02-001076,
UVLP12-02-001078, UVLP12-02-001091, UVLP12-02-001096, UVLP12-02-001097,
UVLP12-02-001110, UVLP12-02-001209, UVLP12-02-001219, UVLP12-02-001350,
UVLP12-02-001352, UVLP12-02-001353, UVLP12-02-001357, UVLP12-02-001358,
UVLP12-02-001361, UVLP12-02-001369, UVLP12-02-001384, UVLP12-02-001385,
UVLP12-02-001411, UVLP12-02-001420, UVLP12-02-001423, UVLP12-02-001432,
UVLP12-02-001446, UVLP12-02-001448, UVLP12-02-001450, UVLP12-02-001456,
UVLP12-02-001478, UVLP12-02-001520, UVLP12-02-001536, UVLP12-02-001543,
UVLP12-02-001550, UVLP12-02-001579, UVLP12-02-001601, UVLP12-02-001684,
UVLP12-02-001686, UVLP12-02-001724, UVLP12-02-001878, UVLP12-02-002078,
UVLP12-02-002136, UVLP12-02-002148, UVLP12-02-002153, UVLP12-02-002164,
UVLP12-02-002174, UVLP12-02-002176, UVLP12-02-002178, UVLP12-02-002188,
UVLP12-02-002191, UVLP12-02-002198, UVLP12-02-002214, UVLP12-02-002216,
UVLP12-02-002230, UVLP12-02-002234, UVLP12-02-002238, UVLP12-02-002240,
UVLP12-02-002266, UVLP12-02-002269, UVLP12-02-002277, UVLP12-02-002304,
UVLP12-02-002336, UVLP12-02-002373, UVLP12-02-002386, UVLP12-02-002426,
UVLP12-02-002430, UVLP12-02-002431, UVLP12-02-002476, UVLP12-02-002498,
UVLP12-02-002544, UVLP12-02-002764, UVLP12-02-002830, UVLP12-02-002888,
UVLP12-02-002908, UVLP12-02-002940, UVLP12-02-002982, UVLP12-02-002985,
UVLP12-02-003129, UVLP12-02-003147, UVLP12-02-003473, UVLP12-02-003484,
UVLP12-02-003486, UVLP12-02-003557, UVLP12-02-003565, UVLP12-02-003769,
UVLP12-02-003781, UVLP12-02-003959, UVLP12-02-003974, UVLP12-02-004287,
UVLP12-02-9001, UVLP12-02-9002, UVLP12-02-9003, UVLP12-02-9004,
UVLP12-02-9005, UVLP12-02-9006, UVLP12-02-9007, UVLP12-02-9008,
UVLP12-02-9009, UVLP12-02-9010, UVLP12-02-9011, UVLP12-02-9012,
VLP12-02-000021, VLP12-02-000022, VLP12-02-000023, VLP12-02-000024,
VLP12-02-000042, VLP12-02-000044, VLP12-02-000055, VLP12-02-000057,
VLP12-02-000058, VLP12-02-000059, VLP12-02-000064, VLP12-02-000066,
VLP12-02-000067, VLP12-02-000071, VLP12-02-000073, VLP12-02-000099,
VLP12-02-000100, VLP12-02-000102, VLP12-02-000103, VLP12-02-000107,
VLP12-02-000109, VLP12-02-000110, VLP12-02-000117, VLP12-02-000170,
VLP12-02-000171, VLP12-02-000174, VLP12-02-000182, VLP12-02-000183,
VLP12-02-000192, VLP12-02-000238, VLP12-02-000240, VLP12-02-000242,
VLP12-02-000287, VLP12-02-000288, VLP12-02-000289, VLP12-02-000291,
VLP12-02-000295, VLP12-02-000296, VLP12-02-000303, VLP12-02-000315,
VLP12-02-000338, VLP12-02-000339, VLP12-02-000350, VLP12-02-000442,
VLP12-02-000443, VLP12-02-000444, VLP12-02-000445, VLP12-02-000447,
VLP12-02-000449, VLP12-02-000450, VLP12-02-000451, VLP12-02-000455,
VLP12-02-000456, VLP12-02-000459, VLP12-02-000465, VLP12-02-000476,
VLP12-02-000489, VLP12-02-000496, VLP12-02-000508, VLP12-02-000525,
VLP12-02-000526, VLP12-02-000527, VLP12-02-000532, VLP12-02-000533,
VLP12-02-000560, VLP12-02-000597, VLP12-02-000604, VLP12-02-000615,
VLP12-02-000616, VLP12-02-000618, VLP12-02-000621, VLP12-02-000622,
VLP12-02-000623, VLP12-02-000624, VLP12-02-000625, VLP12-02-000628,
VLP12-02-000629, VLP12-02-000653, VLP12-02-000663, VLP12-02-000664,
VLP12-02-000689, VLP12-02-000701, VLP12-02-000707, VLP12-02-000718,
VLP12-02-000793, VLP12-02-000794, VLP12-02-000796, VLP12-02-000797,
VLP12-02-000799, VLP12-02-000800, VLP12-02-000801, VLP12-02-000808,
VLP12-02-000811, VLP12-02-000812, VLP12-02-000813, VLP12-02-000814,
VLP12-02-000820, VLP12-02-000827, VLP12-02-000841, VLP12-02-000844,
VLP12-02-000846, VLP12-02-000847, VLP12-02-000858, VLP12-02-000866,
VLP12-02-000867, VLP12-02-000869, VLP12-02-000872, VLP12-02-000873,
VLP12-02-000875, VLP12-02-000876, VLP12-02-000891, VLP12-02-000896,
VLP12-02-000921, VLP12-02-000964, VLP12-02-000979, VLP12-02-000981,
VLP12-02-000982, VLP12-02-000983, VLP12-02-000985, VLP12-02-000990,
VLP12-02-000994, VLP12-02-000997, VLP12-02-000998, VLP12-02-001000,
VLP12-02-001001, VLP12-02-001007, VLP12-02-001008, VLP12-02-001009,
VLP12-02-001010, VLP12-02-001012, VLP12-02-001013, VLP12-02-001015,
VLP12-02-001017, VLP12-02-001018, VLP12-02-001022, VLP12-02-001027,
VLP12-02-001029, VLP12-02-001035, VLP12-02-001036, VLP12-02-001038,
VLP12-02-001040, VLP12-02-001041, VLP12-02-001042, VLP12-02-001047,
VLP12-02-001049, VLP12-02-001051, VLP12-02-001066, VLP12-02-001069,
VLP12-02-001076, VLP12-02-001097, VLP12-02-001128, VLP12-02-001131,
VLP12-02-001144, VLP12-02-001151, VLP12-02-001152, VLP12-02-001159,
VLP12-02-001168, VLP12-02-001170, VLP12-02-001174, VLP12-02-001175,
VLP12-02-001188, VLP12-02-001193, VLP12-02-001195, VLP12-02-001198,
VLP12-02-001200, VLP12-02-001215, VLP12-02-001219, VLP12-02-001223,
VLP12-02-001257, VLP12-02-001259, VLP12-02-001266, VLP12-02-001296,
VLP12-02-001333, VLP12-02-001349, VLP12-02-001350, VLP12-02-001351,
VLP12-02-001352, VLP12-02-001353, VLP12-02-001354, VLP12-02-001356,
VLP12-02-001357, VLP12-02-001359, VLP12-02-001360, VLP12-02-001361,
VLP12-02-001364, VLP12-02-001366, VLP12-02-001367, VLP12-02-001369,
VLP12-02-001370, VLP12-02-001372, VLP12-02-001375, VLP12-02-001380,
VLP12-02-001384, VLP12-02-001385, VLP12-02-001387, VLP12-02-001390,
VLP12-02-001394, VLP12-02-001396, VLP12-02-001399, VLP12-02-001400,
VLP12-02-001401, VLP12-02-001413, VLP12-02-001421, VLP12-02-001423,
VLP12-02-001428, VLP12-02-001432, VLP12-02-001433, VLP12-02-001434,
VLP12-02-001435, VLP12-02-001437, VLP12-02-001438, VLP12-02-001439,
VLP12-02-001444, VLP12-02-001446, VLP12-02-001447, VLP12-02-001448,
VLP12-02-001449, VLP12-02-001450, VLP12-02-001452, VLP12-02-001457,
VLP12-02-001458, VLP12-02-001460, VLP12-02-001469, VLP12-02-001478,
VLP12-02-001490, VLP12-02-001499, VLP12-02-001500, VLP12-02-001502,
VLP12-02-001503, VLP12-02-001516, VLP12-02-001520, VLP12-02-001521,
VLP12-02-001527, VLP12-02-001534, VLP12-02-001543, VLP12-02-001545,
VLP12-02-001548, VLP12-02-001550, VLP12-02-001579, VLP12-02-001598,
VLP12-02-001599, VLP12-02-001601, VLP12-02-001622, VLP12-02-001636,
VLP12-02-001643, VLP12-02-001654, VLP12-02-001655, VLP12-02-001704,
VLP12-02-001705, VLP12-02-001712, VLP12-02-001714, VLP12-02-001718,
VLP12-02-001746, VLP12-02-001749, VLP12-02-001774, VLP12-02-001873,
VLP12-02-001895, VLP12-02-002000, VLP12-02-002001, VLP12-02-002002,
VLP12-02-002003, VLP12-02-002006, VLP12-02-002012, VLP12-02-002017,
VLP12-02-002024, VLP12-02-002027, VLP12-02-002043, VLP12-02-002046,
VLP12-02-002050, VLP12-02-002060, VLP12-02-002074, VLP12-02-002076,
VLP12-02-002084, VLP12-02-002125, VLP12-02-002130, VLP12-02-002131,
VLP12-02-002135, VLP12-02-002136, VLP12-02-002137, VLP12-02-002139,
VLP12-02-002148, VLP12-02-002153, VLP12-02-002161, VLP12-02-002163,
VLP12-02-002164, VLP12-02-002170, VLP12-02-002172, VLP12-02-002174,
VLP12-02-002175, VLP12-02-002176, VLP12-02-002177, VLP12-02-002178,
VLP12-02-002182, VLP12-02-002187, VLP12-02-002191, VLP12-02-002197,
VLP12-02-002198, VLP12-02-002199, VLP12-02-002200, VLP12-02-002201,
VLP12-02-002205, VLP12-02-002212, VLP12-02-002214, VLP12-02-002216,
VLP12-02-002219, VLP12-02-002222, VLP12-02-002224, VLP12-02-002229,
VLP12-02-002230, VLP12-02-002231, VLP12-02-002232, VLP12-02-002234,
VLP12-02-002238, VLP12-02-002239, VLP12-02-002242, VLP12-02-002246,
VLP12-02-002263, VLP12-02-002266, VLP12-02-002267, VLP12-02-002269,
VLP12-02-002271, VLP12-02-002277, VLP12-02-002279, VLP12-02-002280,
VLP12-02-002284, VLP12-02-002286, VLP12-02-002293, VLP12-02-002294,
VLP12-02-002298, VLP12-02-002313, VLP12-02-002323, VLP12-02-002325,
VLP12-02-002336, VLP12-02-002337, VLP12-02-002338, VLP12-02-002341,
VLP12-02-002342, VLP12-02-002344, VLP12-02-002350, VLP12-02-002352,
VLP12-02-002362, VLP12-02-002373, VLP12-02-002374, VLP12-02-002379,
VLP12-02-002386, VLP12-02-002388, VLP12-02-002394, VLP12-02-002395,
VLP12-02-002421, VLP12-02-002422, VLP12-02-002426, VLP12-02-002431,
VLP12-02-002437, VLP12-02-002441, VLP12-02-002453, VLP12-02-002455,
VLP12-02-002457, VLP12-02-002460, VLP12-02-002463, VLP12-02-002478,
VLP12-02-002483, VLP12-02-002489, VLP12-02-002498, VLP12-02-002514,
VLP12-02-002543, VLP12-02-002545, VLP12-02-002559, VLP12-02-002568,
VLP12-02-002571, VLP12-02-002575, VLP12-02-002587, VLP12-02-002609,
VLP12-02-002643, VLP12-02-002646, VLP12-02-002666, VLP12-02-002678,
VLP12-02-002691, VLP12-02-002698, VLP12-02-002747, VLP12-02-002787,
VLP12-02-002790, VLP12-02-002818, VLP12-02-002831, VLP12-02-002837,
VLP12-02-002866, VLP12-02-002875, VLP12-02-002890, VLP12-02-002895,
VLP12-02-002897, VLP12-02-002898, VLP12-02-002899, VLP12-02-002905,
VLP12-02-002910, VLP12-02-002915, VLP12-02-002930, VLP12-02-002934,
VLP12-02-002936, VLP12-02-002938, VLP12-02-002940, VLP12-02-002943,
VLP12-02-002945, VLP12-02-002982, VLP12-02-002985, VLP12-02-002986,
VLP12-02-002987, VLP12-02-002988, VLP12-02-002989, VLP12-02-002992,
VLP12-02-002994, VLP12-02-003123, VLP12-02-003141, VLP12-02-003147,
VLP12-02-003150, VLP12-02-003159, VLP12-02-003163, VLP12-02-003169,
VLP12-02-003175, VLP12-02-003187, VLP12-02-003193, VLP12-02-003209,
VLP12-02-003217, VLP12-02-003223, VLP12-02-003228, VLP12-02-003243,
VLP12-02-003253, VLP12-02-003257, VLP12-02-003260, VLP12-02-003264,
VLP12-02-003268, VLP12-02-003278, VLP12-02-003300, VLP12-02-003307,
VLP12-02-003309, VLP12-02-003313, VLP12-02-003315, VLP12-02-003321,
VLP12-02-003322, VLP12-02-003326, VLP12-02-003332, VLP12-02-003338,
VLP12-02-003358, VLP12-02-003369, VLP12-02-003382, VLP12-02-003385,
VLP12-02-003398, VLP12-02-003405, VLP12-02-003423, VLP12-02-003436,
VLP12-02-003445, VLP12-02-003450, VLP12-02-003452, VLP12-02-003455,
VLP12-02-003464, VLP12-02-003466, VLP12-02-003471, VLP12-02-003473,
VLP12-02-003476, VLP12-02-003479, VLP12-02-003484, VLP12-02-003486,
VLP12-02-003487, VLP12-02-003493, VLP12-02-003505, VLP12-02-003508,
VLP12-02-003511, VLP12-02-003513, VLP12-02-003516, VLP12-02-003518,
VLP12-02-003532, VLP12-02-003537, VLP12-02-003543, VLP12-02-003547,
VLP12-02-003549, VLP12-02-003551, VLP12-02-003557, VLP12-02-003558,
VLP12-02-003563, VLP12-02-003565, VLP12-02-003585, VLP12-02-003611,
VLP12-02-003625, VLP12-02-003665, VLP12-02-003669, VLP12-02-003675,
VLP12-02-003676, VLP12-02-003682, VLP12-02-003689, VLP12-02-003697,
VLP12-02-003711, VLP12-02-003724, VLP12-02-003729, VLP12-02-003731,
VLP12-02-003734, VLP12-02-003736, VLP12-02-003741, VLP12-02-003742,
VLP12-02-003748, VLP12-02-003751, VLP12-02-003760, VLP12-02-003764,
VLP12-02-003767, VLP12-02-003769, VLP12-02-003773, VLP12-02-003781,
VLP12-02-003782, VLP12-02-003787, VLP12-02-003789, VLP12-02-003795,
VLP12-02-003796, VLP12-02-003799, VLP12-02-003805, VLP12-02-003809,
VLP12-02-003831, VLP12-02-003835, VLP12-02-003836, VLP12-02-003842,
VLP12-02-003855, VLP12-02-003862, VLP12-02-003871, VLP12-02-003884,
VLP12-02-003892, VLP12-02-003898, VLP12-02-003934, VLP12-02-003950,
VLP12-02-003954, VLP12-02-003959, VLP12-02-003960, VLP12-02-003963,
VLP12-02-003964, VLP12-02-003969, VLP12-02-003971, VLP12-02-003972,
VLP12-02-003973, VLP12-02-003974, VLP12-02-003976, VLP12-02-003979,
VLP12-02-004009, VLP12-02-004029, VLP12-02-004038, VLP12-02-004039,
VLP12-02-004041, VLP12-02-004049, VLP12-02-004052, VLP12-02-004064,
VLP12-02-004070, VLP12-02-004081, VLP12-02-004084, VLP12-02-004087,
VLP12-02-004098, VLP12-02-004101, VLP12-02-004108, VLP12-02-004127,
VLP12-02-004130, VLP12-02-004132, VLP12-02-004142, VLP12-02-004169,
VLP12-02-004185, VLP12-02-004252, VLP12-02-004253, VLP12-02-004287,
VLP12-02-004289, VLP12-02-004304, VLP12-02-004329, VLP12-02-004428,
VLP12-02-004526, VLP12-02-004558, VLP12-02-004566, VLP12-02-004754,
VLP12-02-004771, VLP12-02-004820, VLP12-02-004845, VLP12-02-005007,
VLP12-02-005011, VLP12-02-005013, VLP12-02-005014, VLP12-02-005016,
VLP12-02-005019, VLP12-02-005023, VLP12-02-005025, VLP12-02-005026,
VLP12-02-005028, VLP12-02-005029, VLP12-02-005030, VLP12-02-005031,
VLP12-02-005033, VLP12-02-005035, VLP12-02-005036, VLP12-02-005045,
VLP12-02-005049, VLP12-02-005051, VLP12-02-005070, VLP12-02-005072,
VLP12-02-005077, VLP12-02-005078, VLP12-02-005079, VLP12-02-005081,
VLP12-02-005082, VLP12-02-005083, VLP12-02-005085, VLP12-02-005090,
VLP12-02-005093, VLP12-02-005100, VLP12-02-005101, VLP12-02-005104,
VLP12-02-005113, VLP12-02-005118, VLP12-02-005122, VLP12-02-005123,
VLP12-02-005125, VLP12-02-005132, VLP12-02-005135, VLP12-02-005136,
VLP12-02-005149, VLP12-02-005158, VLP12-02-005173, VLP12-02-005182,
VLP12-02-005189, VLP12-02-005190, VLP12-02-005191, VLP12-02-005195,
VLP12-02-005844, VLP12-02-005880, VLP12-02-005881, VLP12-02-005898,
VLP12-02-005953, VLP12-02-005956, VLP12-02-005957, VLP12-02-005958,
VLP12-02-005959, VLP12-02-005965, VLP12-02-005967, VLP12-02-005968,
VLP12-02-005969, VLP12-02-005970, VLP12-02-005971, VLP12-02-005972,
VLP12-02-005973, VLP12-02-005976, VLP12-02-005977, VLP12-02-005980,
VLP12-02-005981, VLP12-02-005984, VLP12-02-005985, VLP12-02-005986,
VLP12-02-005988, VLP12-02-005989, VLP12-02-005990, VLP12-02-005991,
VLP12-02-005992, VLP12-02-005993, VLP12-02-005994, VLP12-02-005996,
VLP12-02-005997, VLP12-02-006000, VLP12-02-006001, VLP12-02-006003,
VLP12-02-006009, VLP12-02-006011, VLP12-02-006012, VLP12-02-006013,
VLP12-02-006014, VLP12-02-006015, VLP12-02-006016, VLP12-02-006017,
VLP12-02-006018, VLP12-02-006019, VLP12-02-006020, VLP12-02-006021,
VLP12-02-006027, VLP12-02-006029, VLP12-02-006030, VLP12-02-006031,
VLP12-02-006033, VLP12-02-006034, VLP12-02-006035, VLP12-02-006036,
VLP12-02-006037, VLP12-02-006041, VLP12-02-006042, VLP12-02-006043,
VLP12-02-006044, VLP12-02-006046, VLP12-02-006051, VLP12-02-006052,
VLP12-02-006055, VLP12-02-006056, VLP12-02-006057, VLP12-02-006060,
VLP12-02-006061, VLP12-02-006063, VLP12-02-006064, VLP12-02-006065,
VLP12-02-006066, VLP12-02-006067, VLP12-02-006071, VLP12-02-006072,
VLP12-02-006075, VLP12-02-006076, VLP12-02-006077, VLP12-02-006079,
VLP12-02-006081, VLP12-02-006086, VLP12-02-006087, VLP12-02-006088,
VLP12-02-006089, VLP12-02-006091, VLP12-02-006093, VLP12-02-006095,
VLP12-02-006096, VLP12-02-006097, VLP12-02-006098, VLP12-02-006100,
VLP12-02-006101, VLP12-02-006102, VLP12-02-006103, VLP12-02-006105,
VLP12-02-006107, VLP12-02-006108, VLP12-02-006110, VLP12-02-006112,
VLP12-02-006113, VLP12-02-006114, VLP12-02-006115, VLP12-02-006116,
VLP12-02-006119, VLP12-02-006121, VLP12-02-006125, VLP12-02-006126,
VLP12-02-006137, VLP12-02-006138, VLP12-02-006139, VLP12-02-006140,
VLP12-02-006144, VLP12-02-006148, VLP12-02-006150, VLP12-02-006157,
VLP12-02-006159, VLP12-02-006160, VLP12-02-006167, VLP12-02-006168,
VLP12-02-006169, VLP12-02-006173, VLP12-02-006175, VLP12-02-006176,
VLP12-02-006179, VLP12-02-006180, VLP12-02-006181, VLP12-02-006187,
VLP12-02-006191, VLP12-02-006196, VLP12-02-006199, VLP12-02-006202,
VLP12-02-006203, VLP12-02-006206, VLP12-02-006207, VLP12-02-006210,
VLP12-02-006211, VLP12-02-006212, VLP12-02-006213, VLP12-02-006214,
VLP12-02-006215, VLP12-02-006223, VLP12-02-006226, VLP12-02-006227,
VLP12-02-006230, VLP12-02-006232, VLP12-02-006234, VLP12-02-006235,
VLP12-02-006238, VLP12-02-006251, VLP12-02-006252, VLP12-02-006253,
VLP12-02-006256, VLP12-02-006257, VLP12-02-006260, VLP12-02-006262,
VLP12-02-006263, VLP12-02-006266, VLP12-02-006267, VLP12-02-006268,
VLP12-02-006269, VLP12-02-006270, VLP12-02-006271, VLP12-02-006272,
VLP12-02-006275, VLP12-02-006278, VLP12-02-006280, VLP12-02-006286,
VLP12-02-006287, VLP12-02-006288, VLP12-02-006290, VLP12-02-006291,
VLP12-02-006301, VLP12-02-006304, VLP12-02-006305, VLP12-02-006306,
VLP12-02-006308, VLP12-02-006312, VLP12-02-006313, VLP12-02-006314,
VLP12-02-006315, VLP12-02-006321, VLP12-02-006322, VLP12-02-006329,
VLP12-02-006332, VLP12-02-006333, VLP12-02-006343, VLP12-02-006347,
VLP12-02-006349, VLP12-02-006351, VLP12-02-006354, VLP12-02-006358,
VLP12-02-006359, VLP12-02-006365, VLP12-02-006366, VLP12-02-006367,
VLP12-02-006372, VLP12-02-006373, VLP12-02-006374, VLP12-02-006375,
VLP12-02-006376, VLP12-02-006378, VLP12-02-006379, VLP12-02-006383,
VLP12-02-006388, VLP12-02-006391, VLP12-02-006393, VLP12-02-006394,
VLP12-02-006395, VLP12-02-006396, VLP12-02-006398, VLP12-02-006399,
VLP12-02-006402, VLP12-02-006403, VLP12-02-006405, VLP12-02-006406,
VLP12-02-006407, VLP12-02-006408, VLP12-02-006411, VLP12-02-006414,
VLP12-02-006416, VLP12-02-006419, VLP12-02-006423, VLP12-02-006429,
VLP12-02-006430, VLP12-02-006431, VLP12-02-006432, VLP12-02-006433,
VLP12-02-006434, VLP12-02-006435, VLP12-02-006436, VLP12-02-006437,
VLP12-02-006446, VLP12-02-006453, VLP12-02-006454, VLP12-02-006455,
VLP12-02-006457, VLP12-02-006462, VLP12-02-006466, VLP12-02-006473,
VLP12-02-006475, VLP12-02-006476, VLP12-02-006477, VLP12-02-006478,
VLP12-02-006479, VLP12-02-006480, VLP12-02-006482, VLP12-02-006483,
VLP12-02-006484, VLP12-02-006487, VLP12-02-006488, VLP12-02-006489,
VLP12-02-006490, VLP12-02-006492, VLP12-02-006495, VLP12-02-006500,
VLP12-02-006502, VLP12-02-006503, VLP12-02-006504, VLP12-02-006505,
VLP12-02-006508, VLP12-02-006515, VLP12-02-006518, VLP12-02-006525,
VLP12-02-006527, VLP12-02-006528, VLP12-02-006531, VLP12-02-006534,
VLP12-02-006538, VLP12-02-006542, VLP12-02-006543, VLP12-02-006544,
VLP12-02-006553, VLP12-02-006554, VLP12-02-006555, VLP12-02-006564,
VLP12-02-006565, VLP12-02-006576, VLP12-02-006577, VLP12-02-006578,
VLP12-02-006579, VLP12-02-006581, VLP12-02-006582, VLP12-02-006583,
VLP12-02-006588, VLP12-02-006589, VLP12-02-006592, VLP12-02-006593,
VLP12-02-006594, VLP12-02-006597, VLP12-02-006598, VLP12-02-006599,
VLP12-02-006600, VLP12-02-006602, VLP12-02-006609, VLP12-02-006615,
VLP12-02-006617, VLP12-02-006620, VLP12-02-006622, VLP12-02-006623,
VLP12-02-006624, VLP12-02-006625, VLP12-02-006635, VLP12-02-006637,
VLP12-02-006639, VLP12-02-006641, VLP12-02-006644, VLP12-02-006645,
VLP12-02-006647, VLP12-02-006650, VLP12-02-006663, VLP12-02-006666,
VLP12-02-006672, VLP12-02-006676, VLP12-02-006686, VLP12-02-006687,
VLP12-02-006721, VLP12-02-006722, VLP12-02-006723, VLP12-02-006738,
VLP12-02-006739, VLP12-02-006742, VLP12-02-006747, VLP12-02-006748,
VLP12-02-006757, VLP12-02-006767, VLP12-02-006770, VLP12-02-006771,
VLP12-02-006772, VLP12-02-006780, VLP12-02-006783, VLP12-02-006788,
VLP12-02-006789, VLP12-02-006793, VLP12-02-006795, VLP12-02-006797,
VLP12-02-006806, VLP12-02-006813, VLP12-02-006818, VLP12-02-006821,
VLP12-02-006822, VLP12-02-006823, VLP12-02-006829, VLP12-02-006832,
VLP12-02-006836, VLP12-02-006841, VLP12-02-006845, VLP12-02-006851,
VLP12-02-006863, VLP12-02-006865, VLP12-02-006867, VLP12-02-006870,
VLP12-02-006876, VLP12-02-006877, VLP12-02-006885, VLP12-02-006908,
VLP12-02-006909, VLP12-02-006911, VLP12-02-006922, VLP12-02-006926,
VLP12-02-006935, VLP12-02-006941, VLP12-02-006944, VLP12-02-006945,
VLP12-02-006948, VLP12-02-006954, VLP12-02-006962, VLP12-02-006964,
VLP12-02-006965, VLP12-02-006968, VLP12-02-006972, VLP12-02-006981,
VLP12-02-006982, VLP12-02-006984, VLP12-02-006990, VLP12-02-006996,
VLP12-02-007013, VLP12-02-007027, VLP12-02-007028, VLP12-02-007029,
VLP12-02-007044, VLP12-02-007047, VLP12-02-007053, VLP12-02-007057,
VLP12-02-007063, VLP12-02-007066, VLP12-02-007067, VLP12-02-007080,
VLP12-02-007082, VLP12-02-007085, VLP12-02-007098, VLP12-02-007109,
VLP12-02-007113, VLP12-02-007130, VLP12-02-007132, VLP12-02-007133,
VLP12-02-007143, VLP12-02-007148, VLP12-02-007149, VLP12-02-007155,
VLP12-02-007160, VLP12-02-007165, VLP12-02-007166, VLP12-02-007168,
VLP12-02-007169, VLP12-02-007170, VLP12-02-007171, VLP12-02-007173,
VLP12-02-007174, VLP12-02-007175, VLP12-02-007179, VLP12-02-007180,
VLP12-02-007183, VLP12-02-007184, VLP12-02-007185, VLP12-02-007189,
VLP12-02-007190, VLP12-02-007191, VLP12-02-007194, VLP12-02-007196,
VLP12-02-007197, VLP12-02-007198, vlp12-02-007199, VLP12-02-007200,
VLP12-02-007203, VLP12-02-007204, VLP12-02-007206, VLP12-02-007208,
VLP12-02-007209, VLP12-02-007210, VLP12-02-007211, VLP12-02-007212,
VLP12-02-007213, VLP12-02-007214, VLP12-02-007215, VLP12-02-007216,
VLP12-02-007217, vlp12-02-007218, VLP12-02-007219, VLP12-02-007220,
VLP12-02-007221, VLP12-02-007222, VLP12-02-007224, VLP12-02-007225,
VLP12-02-007226, VLP12-02-007228, VLP12-02-007231, VLP12-02-007234,
vlp12-02-007235, VLP12-02-007241, VLP12-02-007244, VLP12-02-007245,
VLP12-02-007246, VLP12-02-007247, VLP12-02-007248, VLP12-02-007249,
VLP12-02-007250, VLP12-02-007251, VLP12-02-007254, VLP12-02-007256,
VLP12-02-007257, VLP12-02-007259, VLP12-02-007261, VLP12-02-007262,
VLP12-02-007264, VLP12-02-007266, VLP12-02-007267, vlp12-02-007268,
VLP12-02-007269, VLP12-02-007270, VLP12-02-007271, VLP12-02-007275,
VLP12-02-007277, VLP12-02-007280, VLP12-02-007281, VLP12-02-007282,
VLP12-02-007283, vlp12-02-007284, VLP12-02-007286, VLP12-02-007288,
VLP12-02-007289, VLP12-02-007292, VLP12-02-007293, VLP12-02-007294,
VLP12-02-007295, VLP12-02-007299, VLP12-02-007300, VLP12-02-007303,
VLP12-02-007304, VLP12-02-007308, VLP12-02-007312, VLP12-02-007313,
VLP12-02-007315, VLP12-02-007316, VLP12-02-007317, VLP12-02-007321,
VLP12-02-007323, VLP12-02-007324, VLP12-02-007326, VLP12-02-007328,
VLP12-02-007330, VLP12-02-007331, VLP12-02-007336, VLP12-02-007338,
VLP12-02-007339, VLP12-02-007340, VLP12-02-007342, VLP12-02-007343,
VLP12-02-007344, VLP12-02-007345, VLP12-02-007346, VLP12-02-007351,
VLP12-02-007352, VLP12-02-007354, VLP12-02-007355, VLP12-02-007357,
VLP12-02-007359, VLP12-02-007364, VLP12-02-007365, VLP12-02-007366,
VLP12-02-007368, VLP12-02-007369, VLP12-02-007370, VLP12-02-007373,
VLP12-02-007374, VLP12-02-007375, VLP12-02-007379, VLP12-02-007384,
VLP12-02-007387, VLP12-02-007394, VLP12-02-007399, VLP12-02-007408 PL12,
Recall # Z-1904-2008;
b) Physio-Control LIFEPAK® 20 defibrillator/monitor is indicated for the
termination of certain potentially fatal arrhythmias, such as
ventricular fibrillation and symptomatic ventricular tachycardia. PL20
Part number: 3202487-000, 3202487-001, 3202487-002, 3202487-003,
3202487-005, 3202487-007, 3202487-008, 3202487-011, 3202487-015,
3202487-016, 3202487-017, 3202487-018, 3202487-022, 3202487-023,
3202487-025, 3202487-026, 3202487-029, 3202487-030, 3202487-031,
3202487-072, 3202487-073, 3202487-074, 3202487-075, 3202487-076,
3202487-077, 3202487-078, 3202487-079, 3202487-080, 3202487-081,
3202487-082, 3202487-083, 3202487-084, 3202487-086, 3202487-087,
3202487-088, 3202487-089, 3202487-090, 3202487-091, 3202487-092,
3202487-093, 3202487-094, 3202487-095, 3202487-098, 3202487-099,
3202487-100, 3202487-101, 3202487-102, 3202487-103, 3202488-000,
3202488-001, 3202488-002, 3202488-003, 3202488-007, 3202488-008,
3202488-009, 3202488-010, 3202488-011, 3202488-015, 3202488-036,
3202488-038, 3202488-039, 3202488-040, 3202488-041, 3202488-042,
3202488-044, 3202488-045, 3202488-046, 3202488-047, 3202488-048,
3202488-050, 3202488-051, 3202488-052, U3202487-000, U3202487-015,
U3202488-000 PL20, Recall # Z-1905-2008;
MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter on April 16,
2008. Firm initiated recall is ongoing.
REASON: The LIFEPAK 20 defibrillator / monitors with software versions
048, 052 and 054 have an increase in likelihood for an incorrect Shock
Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED
mode is On, leading to incorrectly render of shock or no shock decision.
When Auto Analyze is set to On in AED mode the device initiates the SAS
analysis immediately (no waiting period or warning prior to analysis)
when the therapy pads are connected to a patient and after the CPR
interval. Because there is no waiting period or warning prior to
analysis, the device may base an SAS decision on noise introduced by
application of the electrodes, CPR activity or other user activity.
PRODUCT: Sunquest Laboratory System. Software Version:
Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed
as an automated solution for managing laboratory processes including: 1)
Patient registration, 2) Order entry and order modification, 3) Specimen
collection, verification, suitability, and distribution, 4) Quality
assurance checking, 5) Workload recording, 6) Billing charge capture, 7)
Standards and controls recording, 8) Test order result inquiry and
reporting, 9) Organism susceptibility and epidemiology records, 10)
Microbiology culture direct examination and observation recording, 11)
Outreach clients, specimens, and results, 12) Client-specific reporting
capabilities, 13) Inbound client service request tracking, and 14)
Historical data. Recall # Z-0214-2009
MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by email
on August 1, 2008. Firm initiated recall is ongoing.
REASON: While performing in-house testing for the Sunquest Laboratory
System and under certain conditions, there have been instances in which
an error that occurred at the database level or originated in the
operating system (Cache) was not communicated or displayed in the
Graphic User Interface (GUI) application so the activity continued.
While this error was registered in the error log in the System Utilities
(Function UTL), suboption 2, System Error/Message Inquiry, it was not
displayed to the user. The user is still able to use the application on
the GUI, although the application will eventually crash. Rarely, this
will not occur and the user will not be able to receive errors that
could include quality assurance errors for blood-typing, diagnostic test
results, and related information.
PRODUCT: Gebauer's Fluro-Ethyl® Nonflammable Topical
Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product
consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl® is a
vapocoolant (skin refrigerant), topical anesthetic intended to control
the pain associated with minor surgical procedures, dermabrasion and
injection. It is also effective in providing temporary relief from the
pain associated with minor sports injuries, Recall # Z-0218-2009
MANUFACTURER: Gebauer Co., Cleveland, OH, by letter dated September 3,
2008. Firm initiated recall is ongoing.
REASON: Some units of Fluro-Ethyl containing the defective valve which
could malfunction and spray refrigerant out from the side of the valve
in addition to or instead of spraying in the normal inverted position
from the product's actuator. The product can also leak coolant from the
side of the valve onto the fingers of the user.
PRODUCT: NAMIC Custom Angiographic Kit, Right Heart Kit,
REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds
Assemblies, Product #’s 40338200 and 40336200 (foreign product for
further processing, e.g., packaging, labeling, sterilization, and
distribution under BSC). Angiographic Manifolds are intended for use in
fluid management and/or invasive pressure monitoring systems. Procedures
in which angiographic manifold may be used include hemodynamic pressure
monitoring and intra-arterial and intravenous administration of water
based solutions or radiographic contrast media. UPN/Material
#H749601902540, Recall # Z-0287-2009
MANUFACTURER: Navilyst Medical, Glens Falls, NY, by telephone and fax on
August 12, 2008. Firm initiated recall is ongoing.
REASON: A specific batch of the product may contain loose plastic
particulates in the fluid pathway.
CLASS III
PRODUCT: Architect LH MasterCheck (List 6C25-05). An in-vitro
diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1,
2 and 3. ARCHITECT LH MasterCheck is intended for use in the
verification of sensitivity, calibration linearity, and reportable range
of the LH assay on the Abbott ARCHITECT i System, Recall # Z-0216-2009
MANUFACTURER: Recalling Firm: Abbott Laboratories, Abbott Park, IL, by
letter dated September 5, 2008. Manufacturer: Bio-Rad Laboratories,
Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON: The values listed in the Architect LH MasterCheck, Lot 82520
data sheet are incorrect. When MasterChecks do not perform as intended,
the integrity of the system cannot be verified and patient results would
not be generated. Other commercially available materials are available
to customers in order to meet CLIA requirements.
PRODUCT: Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve,
sterile, use w/2.0 MM S.S. cable # 350800; REF. 350805. Intended for
general orthopedic repairs including long bone fractures, bone grafting,
reinforcement of bone and reattachment of the greater trochanter, Recall
# Z-0288-2009
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 24,
2008. Firm initiated recall is ongoing.
REASON: The outer package is properly labeled, but the inner package may
be labeled as a femoral component.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
November 12, 2008
CLASS I
PRODUCT: Vibe Technologies, VIBE machine, Vibrational Integrated
Biophotonic Energizer, Recall # Z-0201-2009
MANUFACTURER: VIBE Technologies, Greeley, CO, by letter on October 1,
2008. Firm initiated recall is ongoing.
REASON: Medical device marketed without marketing approval for claims
that include cures cancer, infections, and depression.
PRODUCT: ReliOn Insulin syringes, 1cc, 31 G, Recall #
Z-0284-2009
MANUFACTURER: Recalling Firm: Ttco Healthcare Group, LP, Mansfield, MA,
by letter on October 9, 2008. Manufacturer: Covidien, LP, Norfolk, NB.
Firm initiated recall is ongoing.
REASON: Mislabeled: Package labeled as an insulin syringe for use with
U-100 insulin contains an insulin syringe for use with U-40 insulin.
Risk of overdose of insulin.
CLASS II
PRODUCT: 18 gage XTW needles, sold as a component in SafeSheath
Hemostatic Tear-away Introducer System with Infusion Side Port kits or
sold Bulk Non Sterile (BNS), Recall # Z-0131-2009
MANUFACTURER: Thomas Medical Products, Inc., Malvern, PA, by letters on
September 11, 2008. Firm initiated recall is ongoing.
REASON: Difficulty inserting guidewire through introducer needle. Needle
hub is not tapered down to the needle cannula.
PRODUCT:
a) ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668, Recall #
Z-0133-2009;
b) ANGIOSTAR Plus X-Ray System, Model number 6379718, Recall #
Z-0134-2009;
c) MULTISTAR D X-Ray System, Model number 3772501, Recall # Z-0135-2009;
d) COROSKOP X-Ray System, Model numbers: 6258219 and 6379759, Recall #
Z-0136-2009;
e) BICOR X-Ray System, Model number 9023136, Recall # Z-0137-2009;
f) BICOR Hi-P X-Ray System, Model numbers 6379767 and 6258383, Recall #
Z-0138-2009;
g) MULTISTAR P X-Ray System, Model number 3773004, Recall # Z-0139-2009;
h) COROSKOP Top X-Ray System, Model number 6134808, Recall #
Z-0140-2009;
i) COROSKOP C X-Ray System, Model numbers 6005636 and 9108572, Recall #
Z-0141-2009;
j) MULTISTAR POLYDOROS X-Ray System, Model number 2845001, Recall #
Z-0142-2009;
k) BICOR HS X-Ray System, Model number 6005776, Recall # Z-0143-2009;
l) COROSKOP HS-ACS X-Ray System, Model number 6134659, Recall #
Z-0144-2009;
m) BICOR POLYDOROS X-Ray System, Model number 6134667, Recall #
Z-0145-2009;
n) BICOR TOP X-Ray System, Model number 6134816, Recall # Z-0146-2009;
o) NEUROSTAR X-Ray System, Model number 6134741, Recall # Z-0147-2009;
p) NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668, Recall
# Z-0148-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter on August 11, 2008. Manufacturer: Siemens AG,
Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON: Unintended movement of the system table and/or C arm.
PRODUCT:
a) LIFEPAK CR Plus Automated External Defibrillator (AED). Labeling on
the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with
ADAPTIV Biphasic Technology. The battery operated, small portable device
is primarily deployed in Public Access Defibrillator (PAD) environments
where the expected use for any one device is once every 20 months.
Product is capable of 30 full discharges. LIFEPAK CR Plus AEDs are
intended for use on victims/patients in cardiac arrest. It includes a
patented shock advisory system that notifies the user (i.e. minimally
trained responder) if it detects a cardiac rhythm that requires a shock.
The individual must be unresponsive (unconscious), not breathing
normally, and showing no signs of circulation (for example, no pulse, no
coughing, or no movement). With Infant/Child Reduced Energy
Defibrillation Electrodes, the LIFEPAK CR Plus AEDs may be used on
children who are up to 8 years old or who weigh up to 25kg (55 lb). The
device is designed specifically for infrequent use and for use by people
whose only training is in CPR and in using AED. Part Numbers:
3200731-000, 3200731-001, 3200731-002, 3200731-003, 3200731-004,
3200731-005, 3200731-006, 3200731-007, 3200731-009, 3200731-010,
3200731-020, 3200731-021, 3200731-022, 3200731-023, 3200731-024,
3200731-025, 3200731-026, 3200731-027, 3200731-046, 3200731-047,
3200731-062, 3200731-066, 3200731-067, 3200731-080, 3200731-082,
3200731-083, 3200731-086, 3200731-087, 3200731-103, 3200731-106,
3200731-107, 3200731-120, 3200731-126, 3200731-127, 3200731-142,
3200731-146, 3200731-147, 3200731-160, 3200731-162, 3200731-182,
3200731-186, 3200731-206, 3200731-207, 3200731-222, 3200731-244,
3200731-246, 3200731-247, 3200731-266, 3200731-267, 3200731-282,
3200731-283, 3200731-284, 3200731-321, 3200731-322, 3200731-323,
3200731-325, 3200731-346, 3200731-347, 3200731-362, 3200731-363,
3200731-364, 3200731-365, 3200731-366, 3200731-367, 3200731-385,
3200731-406, 3200731-407, 3200731-464, 3200731-503, 3200731-520,
3200731-521, 3200731-522, 3200731-523, 3200731-546, 3200731-547,
3200731-600, 3200731-620, 3200731-622, and 3200731-700, Recall #
Z-0149-2009;
b) LIFEPAK Express Automated External Defibrillator (AED). Labeling on
the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with
ADAPTIV Biphasic Technology. The battery operated, small portable device
is primarily deployed in Public Access Defibrillator (PAD) environments
where the expected use for any one device is once every 20 months.
Product is capable of 30 full discharges. Lifepak Express AEDs are
intended for use on victims/patients in cardiac arrest. It includes a
patented shock advisory system that notifies the user (i.e. minimally
trained responder) if it detects a cardiac rhythm that requires a shock.
The individual must be unresponsive (unconscious), not breathing
normally, and showing no signs of circulation (for example, no pulse, no
coughing, or no movement). With Infant/Child Reduced Energy
Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on
children who are up to 8 years old or who weigh up to 25kg (55 lb). The
device is designed specifically for infrequent use and for use by people
whose only training is in CPR and in using AEDs. Part Numbers:
3202177-000, 3202177-001, 3202177-002, 3202177-006, 3202177-024,
3202177-026, 3202177-046, 3202177-066, 3202177-080, 3202177-086, and
3202177-106, Recall # Z-0150-2009
MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter on July 24,
2008. Firm initiated recall is ongoing.
REASON: The device may not power on although it indicates it is ready
for use and would not be able to provide defibrillation therapy.
PRODUCT: HALO360+ Ablation Catheter, Model numbers
32041-22, 32041-28, 32041-31 and 32041-34, packed with HALO360 Sizing
Balloon model number 3441B (lot F1012719), Recall # Z-0192-2009
MANUFACTURER: Barrx Medical, Inc., Sunnyvale, CA, by letter on September
18, 2008. Firm initiated recall is ongoing.
REASON: Some units may contain the wrong filter, which does not have the
proper lock and may result in a leak.
PRODUCT:
a) AXIOM Artis. Angiographic X-ray System. The device is used to support
a patient during nuclear medicine procedures, i.e. Emission Computerized
Tomography (ECT), Recall # Z-0193-2009;
b) Artis zee. Angiographic X-ray System. The device is used to support a
patient during nuclear medicine procedures, i.e. Emission Computerized
Tomography (ECT), Recall # Z-0194-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions
USA, Inc., Malvern, PA, by letter dated July 4, 2008. Manufacturer:
Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall
is ongoing.
REASON: Patients could possibly fall off the table if not properly
secured when: 1) moving them onto the patient table, 2) moving them on
the patient table or 3) removing them from the patient table.
PRODUCT: a) DeRoyal Lap Appy TraceCart, REF53-1776, Rx
only, non-sterile. (custom surgical kit), Recall # Z-0197-2009; b)
DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical
kit), Recall # Z-0198-2009
MANUFACTURER: Recalling Firm: DeRoyal Industries Inc., Powell, TN, by
letters on October 2, 2008. Manufacturer: DeRoyal Lafollette, La
Follette, TN. Firm initiated recall is ongoing.
REASON: Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic
Linear Cutter White Reload/Cartridges.
PRODUCT: a) Terumo Advanced Perfusion System 1 Base,
100/120V; Model 801763. For use for up to 6 hours in the extracorporeal
circulation of blood for arterial perfusion, regional perfusion and
cardiopulmonary bypass procedures, Recall # Z-0203-2009;
b) Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This
product is not distributed in the United States. For use for up to 6
hours in the extracorporeal circulation of blood for arterial perfusion,
regional perfusion and cardiopulmonary bypass procedures, Recall #
Z-0204-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON: The units may exhibit blank or distorted displays, loss of local
control and/or may have local control knobs that are difficult to use.
PRODUCT: Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2
and 6.3. Sunquest Laboratory Information System is comprised of several
modules which are involved in aspects such as blood banking, collection
management, specimen tracking, and use with microbiology and molecular
diagnostics. Key capabilities include: 1) Autoverify results directly
from analyzers and reference laboratories 2) Track tubes and containers
from order to final disposition 3) Monitor key metrics such as
turnaround time and utilization using management reports 4) Produce
pathology results with Structured Reports 5) Suggest microbiology
workups online according to defined SOPs and rules 6) All data entered
into the system is accessible through audit trails and Ad Hoc Report
tools 7) Any change to patient results (inquiry, reports) is logged and
available for review, Recall # Z-0207-2009
MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ, by e-mail
on April 17, 2008 and May 7, 2008. Firm initiated recall is ongoing.
REASON: Sunquest has identified a problem with IGO interfaces when
performing an Online File Cleanup (OFC) that can lead to the test
results of one patient filing to another patient when the order codes
are the same. Performing an OFC prior to all results being assigned an
accession number may cause the patient results to remain in a temporary
file where they can be incorrectly associated to the wrong patient. When
this occurs, Sunquest generated reports and inquiry contains the
incorrect results.
PRODUCT:
a) Iris Sample Processing SafeCrit 75mm Tubes. Heparin-treated capillary
tube used for spun hematocrit packed cell volume (PCV) determination.
Catalog number: 59-002828-001 A, Recall # Z-0208-2009
b) Iris Sample Processing SafeCrit 40mm Tubes. Catalog number
59-000869-002 H, Catalog number 59-000857-002 G. Heparin-treated
capillary tube used for spun hematocrit packed cell volume (PCV)
determination, Recall # Z-0209-2009;
c) Separation Technology ClearCRIT Capillary Tubes 75mm/0.5mm ID.
Catalog number 270-107. Heparin-treated capillary tube used for spun
hematocrit packed cell volume (PCV) determination, Recall # Z-0210-2009;
d) Separation Technology ClearCRIT Capillary Tubes 75mm/1.1mm ID.
Catalog number 270-106. Heparin-treated capillary tube used for spun
hematocrit packed cell volume (PCV) determination, Recall # Z-0211-2009
MANUFACTURER: Drummond Scientific Co., Broomaill, Pa, by letters dated
August 1, 2008. Firm initiated recall is ongoing.
REASON: Presence of OSCS contaminant.
PRODUCT: BioStar OIA FLU AB, Catalog 90007. Packaged 30
devices per tray, Recall # Z-0212-2009
MANUFACTURER: Iverness Medical BioStar, Inc., Louisville, CO, by letter
on July 2, 2008. Firm initiated recall is ongoing.
REASON: Diagnostic kits for flu were distributed with incorrect
components.
PRODUCT:
a) Pointe Scientific Liquid Glucose HEX (R1) Reagent Set; Catalog #
HG420-R1. (Clinical chemistry), Recall # Z-0219-2009;
b) Pointe Scientific Liquid Glucose HEX (R2) Reagent Set; Catalog #
HG420-R2. (Clinical chemistry), Recall # Z-0220-2009;
c) Pointe Scientific Liquid Glucose HEX Reagent Set; Catalog # HG720-600
and HG920-756. (Clinical chemistry), Recall # Z-0221-2009;
d) Pointe Scientific Liquid Glucose (HEXO) Reagent Set; 1) Catalog #
HG920-1200, 2) HG920-2500 and 3) 12-HG920-144. (Clinical chemistry),
Recall # Z-0222-2009;
e) Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry), Recall #
Z-0223-2009;
f) Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry), Recall #
Z-0224-2009
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
September 10, 2008. Firm initiated recall is ongoing.
REASON: The inability of the product to maintain stated performance
specifications through the stated shelf life.
PRODUCT:
BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative
in vitro diagnostic test for the direct detection of nasal colonization
by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the
prevention and control of MRSA infections in healthcare settings. The
test performed on the Smart Cycler instrument with a nasal swab specimen
from patients at risk for colonization, utilizes polymerase chain
reaction (PCR) for the amplification of MRSA DNA and fluorgenic
target-specific hybridization probes for the detection of amplified DNA.
IDI-MRSA assay is not intended to diagnose MRSA infections nor to guide
or monitor treatment for MRSA infections. Concomitant cultures are
necessary only to recover organisms for epidemiological typing or for
further susceptibility testing, Recall # Z-0225-2009;
b) BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a
qualitative in vitro diagnostic test for the direct detection of nasal
colonization by methicillin-resistant Staphylococcus aureus (MRSA) to
aid in the prevention and control of MRSA infections in healthcare
settings. The test performed on the Smart Cycler instrument with a nasal
swab specimen from patients at risk for colonization, utilizes
polymerase chain reaction (PCR) for the amplification of MRSA DNA and
fluorgenic target-specific hybridization probes for the detection of
amplified DNA. IDI-MRSA assay is not intended to diagnose MRSA
infections nor to guide or monitor treatment for MRSA infections.
Concomitant cultures are necessary only to recover organisms for
epidemiological typing or for further susceptibility testing, Recall #
Z-0226-2009
MANUFACTURER: Recalling Firm: BD Diagnostics (GeneOhm Sciences, Inc),
San Diego, CA, by telephone on July 21, 2008 and by letter on July 22,
2008. Manufacturer: Infectio Diagnostic (IDI) Inc., Sainte-Foy, Canada.
Firm initiated recall is ongoing.
REASON: The product has the potential to identify a patient as falsely
positive for colonization with methicillin resistant Staphylococcus
aureus.
PRODUCT: Hipstar V40 Femoral Stem Howemedica. Used in
total and hemi hip arthroplasty for: noninflammatory degenerative joint
disease including osteoarthritis and avascular necrosis; Rheumatoid
arthritis; Correction of functional deformity; revision procedures where
other treatments or devices have failed; and treatment of nonunion,
femoral neck and trochanteric fractures of the proximal femur with head
involvement that are unmanageable using other techniques. Catalog # 1)
78501006; 2) 78501007; 3) 78501008; 4) 78501009; 5) 78501010; 6)
78501011; and 7) 78501012, Recall # Z-0227-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, by letters on August 20, 2008. Manufacturer: Benoist-Girard,
Herouville St Clair, France. Firm initiated recall is ongoing.
REASON: The warning label "do not use with heads more than +10, offset"
does not appear on 135 degree stem boxes. This warning is contained in
the instructions for use.
PRODUCT: Bag Tee Assembly Model P1407A. An accessory to
the dental flowmeter which has a connection function for complete
delivery of mixed gases to the breathing circuit portion of the gas
scavenging apparatus. The Bag Tee assembly features a non-breathing
valve and an Emergency Air Intake located on the bag tee which complies
with the American Dental Association guidelines, Recall # Z-0228-2009
MANUFACTURER: Porter Instrument Co. Inc., Hatfield, PA, by letter on
September 2, 2008. Firm initiated recall is ongoing.
REASON: Inverted check value on the bag tee assembly which can cause
leaking of mixed N2O/O2 gas.
PRODUCT: Precision Charger 1.0 (Model Number SC-5300) for
the Precision Spinal Cord Stimulator System labeled as BIONICS
SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply
(1) Adhesive Kit. The Precision Spinal Cord Stimulator System (Precision
System) is indicated as an aid in the management of chronic intractable
pain of the trunk and/or limbs, including unilateral or bilateral pain
associated with following: failed back surgery syndrome, intractable low
back pain and leg pain. The Precision System includes an implantable
16-output, multi-channel stimulator (IPG - Implantable Pulse Generator)
with a rechargeable battery power source. The IPG, commonly implanted in
the abdomen or buttock area (less frequently in the subclavicular area),
can be configured to accept one or two leads. The leads are implanted in
the epidural space, adjacent to the spinal column. The stimulation
delivered at the distal end of the lead is intended to mask the pain
signals. An externally used Charger is utilized to transcutaneously
recharge the IPG (Implantable Pulse Generator) battery. Currently,
Boston Scientific distributes Charger 2.0 (Model Number SC-5312). For
improved heat management, Charger 2.0 is equipped with thermistor
(temperature sensing component), designed to activate/deactivate
charging at a set temperature, Recall # Z-0271-2009
MANUFACTURER: Advanced Bionics, Corp., Valencia, CA, by letters on
September 22, 2008. Firm initiated recall is ongoing.
REASON: Patients have reported receiving second degree and third degree
burns in the area of charging while using Charger 1 .0. Some of these
events were the direct result of the patient disregarding the
instructions for use, such as sleeping with the Charger on or placing it
directly on the skin without the use of an Adhesive Patch or Charging
Belt.
PRODUCT: Gyrus ACMI, Inc. dissector PlasmaKnife (DPK)
Catalog No: 7035-3005 A single use only bipolar electrosurgical
instrument with the ability to cut and coagulate soft tissue in head and
neck surgery within an ambient air environment, Recall # Z-0273-2009
MANUFACTURER: Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by
letter on October 1, 2008. Manufacturer: Gyrus Medical, Cardiff, UK.
Firm initiated recall is ongoing.
REASON: Sterility may be compromised.
PRODUCT: PurePoint System Operator's Manual, Catalog
Number 8065751131, Rev. B for use with the Alcon PurePoint Laser,
Catalog Number 8065750597, Indicated for use in photocoagulation of both
anterior and posterior segments of the eye, Recall # Z-0274-2009
MANUFACTURER: Alcon Laboratories, Inc., Irvine, CA, by letter beginning
October 9, 2008. Firm initiated recall is ongoing.
REASON: Indications for use unapproved by the Food and Drug
Administration are included in the PurePoint Laser System Operator's
Manual, Catalog Number 8065751131, Revision B.
PRODUCT: ATEC Breast Biopsy and Excision System 12 gauge,
20 centimeter handpiece, sterile; Model number ATEC 1212-20. Intended
for partial or complete removal of tissue samples for diagnostic
testing, Recall # Z-0275-2009
MANUFACTURER: Hologic, Inc., Indianapolis, IN, by letter dated September
17, 2008. Firm initiated recall is ongoing.
REASON: The distal tip of the needle may become detached and remain in
the patient, requiring surgical removal.
PRODUCT: Barco Surgical Display, Model MDSC-2124; the
24-inch MDSC-2124 is a near-patient surgical display that uses
widescreen (16:10) LCD technology featuring full High Definition
resolution (1920 x 1200). Featuring broad input connectivity, the
MDSC-2124 offers a versatile display solution for HD endoscopy cameras,
room and boom cameras, ultrasound, PACS and patient information, Recall
# Z-0276-2009
MANUFACTURER: Barcoview, Kortrijk, Belgium, by letter on September 9,
2008. Firm initiated recall is ongoing.
REASON: The front protective cover may loosen and completely fall off.
PRODUCT: S/P® Orange 50g Glucose Tolerance Beverage, 10 oz
glass bottles, 12 bottles/case, labeled in part, For prescription use
only. Product is used in support of diagnostics testing for
hyperglycemia and hypoglycemia, Recall # Z-0278-2009
MANUFACTURER: Nerl Diagnostics LLC, Baltimore, MD, by letter dated April
23, 2008. Firm initiated recall is ongoing.
REASON: Beverage may contain glass particles.
PRODUCT: Outback LTD Re-Entry Catheter, Sterile, Single
Use. The Cordis LuMend OUTBACK LTD Re-Entry Catheter is indicated for
placement and positioning of guidewires within the peripheral
vasculature. The cannula is a nitinol needle that is used to re-enter
the true lumen of the vessel, Recall # Z-0279-2009
MANUFACTURER: Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter
on August 18, 2008. Manufacturer: Cordis de Mexico, S.A. de C.V.,
Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON: The Cordis LuMend Outback LTD Re-Entry Catheter - separation
rate of the cannula to the deployment slide of the handle assembly is
higher than anticipated. The cannula is unable to be retracted into the
device after deployment due to a separation of the inner key from the
cannula.
PRODUCT: 7F Bard SSV 13 cm Split Sheath with Valve and
sideport Catalog Number: 808700. The product is Intended for
introduction of various type of pacing leads and catheters, Recall #
Z-0280-2009
MANUFACTURER: Recalling Firm: C. R. Bard, Inc. /BardElectrophysiology
Div., Lowell, MA, by letter dated September 29, 2008. Manufacturer:
Thomas Medical Products, Inc., Malvern, PA. Firm initiated recall is
ongoing.
REASON: Failure to insert the guidewire through the introducer needle.
PRODUCT: ASP Automatic Endoscope Reprocessor, AER Plus
Product Code 20300 and AER with printer Product Code 20301 The AER is a
machine designed to automatically wash and high-level disinfect
flexible, submersible fiberoptic or video endoscopes, Recall #
Z-0281-2009
MANUFACTURER : Recalling Firm: Advanced Sterilization Products, Irvine,
CA, by letter beginning September 8, 2008. Manufacturer: Minntech Corp,
Plymouth, MN. Firm initiated recall is ongoing.
REASON: Residual high-level disinfectant solution remaining in
endoscopes that have been reprocessed in the ASP Automatic Endoscope
Reprocessor. If high-level disinfectant, or other fluids, remains in the
endoscope after reprocessing, contact with the mucous membranes may
occur and result in chemical burns, irritation (chemical colitis), or
other symptoms.
PRODUCT: HT X-Drive Screw, W. Lorenz Surgical. Screws for
use in the stabilization and fixation of mandibular fractures and
mandibular reconstructive surgical procedures, Recall # Z-0282, 2009
MANUFACTURER: Biomet Microfixation, Inc., Jacksonville, FL, by letter on
July 11, 2008. Firm initiated recall is ongoing.
REASON: The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot
493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.
PRODUCT: One Touch Ping Glucose Monitoring System Combines
the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R)
Ping (TM) Meter Remote through radio frequency (RF) communication.
Together, they provide an option to help make insulin delivery more
discreet and flexible. Also, allows the most recent blood glucose
results from the OneTouch(R) Ping(TM) Meter Remote to be automatically
entered into bolus insulin calculations to cover carbohydrates in food
or to correct for a high blood glucose level. Part numbers: 100-430-00,
100-431-00, 100-432-00, 100-434-00, and 100-435-00, Recall # Z-0283-2009
MANUFACTURER: Animas Corp., West Chester, PA, by telephone on August 6,
2008. Firm initiated recall is complete.
REASON: Display old, inaccurate values for bolus amount delivered and
amount of planned bolus totals.
PRODUCT:
a) Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level
sensor transducer for use with Sarns Advanced Perfusion System I,
Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular
Systems Corp., Ann Arbor, MI.; REF 195215. Level sensors are distributed
as a finished device, as part of a kit, with a perfusion system 8000
safety monitor or with an Advanced Perfusion System 1 base. Level
sensors are attached to the color coded connectors on the module and
then to a hard-shell reservoir. Level detection is used to monitor blood
levels in hard-shell reservoirs, Recall # Z-0295-2009;
b) Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor
transducer for use with Sarns Advanced Perfusion System I, Perfusion
System 800 and Perfusion System 900; REF 195274. Level sensors are
distributed as a finished device, as part of a kit, with a perfusion
system 8000 safety monitor or with an Advanced Perfusion System 1 base.
Level sensors are attached to the color coded connectors on the module
and then to a hard-shell reservoir. Level detection is used to monitor
blood levels in hard-shell reservoirs, Recall # Z-0296-2009
MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
letter dated May 23, 2008 and email on May 27, 2008. Firm initiated
recall is ongoing.
REASON: The level sensor may not properly couple to the reservoir,
resulting in a sensor "not attached" message, an alert or alarm
condition, or a failure to detect a low level condition.
CLASS III
PRODUCT: VACUETTE®, 2 ml Lithium Heparin Venous Blood Collection Tubes.
Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200
pcs in total, non ridged, Sterile). The Greiner Vacuette blood
collection tube with lithium heparin and gel separator is an evacuated
blood collection device containing lithium heparin, an anticoagulant
additive, and an inert polymeric barrier material. The product is
intended for use in holding and separating blood plasma from the
cellular components of blood, Recall # Z-0215-2009
MANUFACTURER: Greiner Bio-One North America, Inc., Monroe, NC, by letter
on July 29, 2008. Firm initiated recall is ongoing.
REASON: Labeling Error: Incorrect tube label reads "Z Serum Clot
Activator" instead of "LH Lithium Heparin" tube.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
November 5, 2008
CLASS II
*****CORRECTION*****
September 3, 2008 Enforcement Report: Smash Balloon Dilatation Catheter,
Recall # Z-1652-2008. This recall classification has been deleted,
because the devices were not manufactured or sold in the United States.
PRODUCT: Fabius Trio Gas machine, anesthesia or analgesia. Catalog
number 8606000. The product is used in operating rooms and ER, for
patient intubation, Recall # Z-2338-2008
MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by
letter dated July 7, 2008. Manufacturer: Draeger Aerospace Gmbh, Lubeck,
Germany. Firm initiated recall is ongoing.
REASON: The parent company became aware of instances where the lower
side rail of the frame of the machine broke inwards when being moved
across a threshold; resulting in the machine being unstable.
PRODUCT: Philips Healthcare Informatics iSite PACS
(Picture Archiving and Communications System), version 3.5.x. The system
is a software package used with general purpose computing hardware to
acquire, store, distribute, process and display images and associated
data throughout a clinical environment. The software performs digital
imaging, measurement, communication and storage, Recall # Z-2346-2008
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City, CA, by
letter on July 3, 2008. Firm initiated recall is ongoing.
REASON: Scout line and localizer crosshair on MPR images will display in
the incorrect position under certain circumstances.
PRODUCT:
a) Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS
INTEGRA, cobas c systems; 03038866322. An in-vitro diagnostic reagent
system intended for use on COBAS Integra systems for the quantitative
determination of LDL-Cholesterol concentrations in serum and plasma,
Recall # Z-0006-2009;
b) Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems;
03183696122. An in-vitro diagnostic reagent system intended for use on
COBAS Integra systems for the quantitative determination of iron in
serum and plasma, Recall # Z-0007-2009;
c) Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas
c systems; 03263991190. An in-vitro diagnostic reagent system intended
for use on COBAS Integra systems for the quantitative determination of
creatine in serum, urine and plasma, Recall # Z-0008-2009;
d) Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS
INTEGRA, cobas c systems; 20763454122. An in-vitro diagnostic reagent
system intended for use on COBAS Integra systems for the quantitative
determination of soluable transferrin receptor in serum and plasma,
Recall # Z-0009-2009;
e) Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS
INTEGRA, cobas c systems; 04399803190. An in-vitro diagnostic reagent
system intended for use on COMAS Integra systems for the quantitative
determination of HDL-cholesterol in serum and plasma, Recall #
Z-0010-2009;
f) Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA,
cobas c systems; 04469658190. An in-vitro diagnostic reagent system
intended for use on COBAS Integra systems for the quantitative
determination of albumin concentration in serum and plasma, Recall #
Z-0011-2009;
g) Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS Integra. An
in-vitro diagnostic reagent system intended for use on COBAS Integra
systems for the qualitative determination of NAPA in serum or plasma,
Recall # Z-0012-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
by letter dated June 11, 2008. Manufacturer: Roche Diagnostics Gmbh,
Mannheim, Germany. Firm initiated recall is ongoing.
REASON: Some of the labels are glossy, resulting in the bar code being
difficult to read by the bar code reader.
PRODUCT: Edwards Lifesciences***Fogarty Fortis***Arterial
Embolectomy Catheter is indicated for the removal of fresh, soft emboli
and thrombi from the vessels in the arterial system, Recall #
Z-0013-2009
MANUFACTURER: Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by
letter dated June 23, 2008. Manufacturer: Edwards Lifesciences
Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON: Potential for tubing fracture near the tip of the catheter.
PRODUCT: Mobetron Model 1000, mobile electron linear
accelerator, a device system which delivers radiation to an
intraoperative site. Recall # Z-0014-2009
MANUFACTURER: Intraop Medical Corp., Sunnyvale, CA, by letter on June
20, 2008. Firm initiated recall is ongoing.
REASON: Docking screw/nut failure, which may result in a treatment head
dropping, potentially impacting the patient.
PRODUCT:
a) Medline Latex Free C-Section CDS-LF, 1) Reorder # CDS820056A, 2)
reorder # CDS820118B, 3) reorder # CDS820118C, and C-Section
Supplemental CDS-LF; a single patient prescription procedure pack and
disposables, including a Gerber Nuk Pacifier; 4) reorder #CDS820024F, 5)
reorder #CDS820024G, Recall # Z-0015-2009;
b) Medline Latex Free Vaginal Delivery CDS-LF; a single patient
prescription procedure pack and disposables, including a Gerber Nuk
Pacifier; 1) Reorder # CDS830006A, 2) reorder # CDS830014I, 3) reorder
#CDS830014K, 4) reorder # CDS830161B, Recall # Z-0016-2008;
c) Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient
prescription procedure pack and disposables, including a Gerber Nuk
Pacifier; 1) Reorder # CDS830074D, 2) reorder # CDS830074F, Recall #
Z-0017-2008;
d) Medline Latex Free Labor & Delivery CDS-LF; a single patient
prescription procedure pack and disposables, including a Gerber Nuk
Pacifier; 1) Reorder # CDS830142, 2) reorder # CDS830142A, 3) reorder #
CDS830142A, 4) reorder # CDS830142D, Recall # Z-0018-2009;
e) Medline Latex Free Mom/Baby Admit Kit - LF; a single patient
prescription procedure pack and disposables, including a Gerber Nuk
Pacifier; 1) reorder # CDS981005, 2) reorder # CDS981005A, Recall #
Z-0019-2009
MANUFACTURER: Recalling Firm: Medline Industries Inc., Mundelein, IL, by
letters dated August 4, 2008. Manufacturer: Medline Industries, Inc.,
Waukegan, IL. Firm initiated recall is complete.
REASON: The latex free labor & delivery packs contain a latex Nuk
pacifier. The pacifier is packaged separately and offers no risk of
exposure of latex particles to other components of the pack.
PRODUCT: GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a
General Electric Company going to market as GE Healthcare, Datex-Ohmeda
Aisys Intended to provide general inhalation anesthesia and ventilatory
support to a wide range of patients. The device is intended for volume
or pressure control ventilation. The Aisys is not suitable for use in a
MRI environment, Recall # Z-0020-2009
MANUFACTURER: Datex – Ohmeda, Inc., Madison, WI, by letters dated August
12, 2008. Firm initiated recall is ongoing.
REASON: The electronic vaporization system in the GE Aisys Anesthesia
machine contains the following components: Backpressure Valve, Inflow
Check Valve and Cassette Interface Board, that can contribute to
independent failures.
PRODUCT: Vicryl Rapide (polyglactin 910) Braided Coated
Synthetic Absorbable Suture, Undyed, Non-USP. The product is used for
Soft Tissue approximation. a) Product code V2920G; b) Product code
PN1695H; c) Product code V2920H; d) Product code V4731H; e) Product code
VR214; f) Product code W9947; g) Product code VR214; h) Product code
V4851H, and i) Product code VR426, Recall # Z-0021-2009
MANUFACTURER: Recalling Firm: Ethicon, Inc., Somerville, NJ, by letters
on August 11 2008. Manufacturer: Ethicon GmbH, Norderstedt, Germany.
Firm initiated recall is ongoing.
REASON: Package defect compromised the integrity of the primary seal,
which could lead to premature suture degradation and/or impair the
sterile barrier of the product.
PRODUCT: BD Visitec High Viscosity Injector, 4 mm Ref:
585173. The product is intended for Vitroretinal Surgery. Recall #
Z-0022-2009
MANUFACTURER: Becton Dickinson and Co., Waltham, MA, by telephone on
September 15, 2008. Firm initiated recall is ongoing.
REASON: Product labeled as 4 mm High Viscosity Injector tip contains a 6
mm tip.
PRODUCT:
a) Applied Medical, Separator Abdominal Access System REF: C0604 15 x
100mm Non-threaded Separator System with Universal Seal, for
laparoscopic procedures, Recall # Z-0023-2009;
b) Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm
Threaded Separator System with Universal Seal, for laparoscopic
procedures, Recall # Z-0024-2009;
c) Applied Medical, Separator Abdominal Access System REF: C0606
15x150mm Non-threaded Separator System with Universal Seal, for
laparoscopic procedures, Recall # Z-0025-2009;
d) Applied Medical, Separator Abdominal Access System REF: C0607
15x150mm Threaded Separator System with Universal Seal, for laparoscopic
procedures, Recall # Z-0026-2009;
e) Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04,
5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded
Separator System w/Universal Seal, for laparoscopic procedures, Recall #
Z-0027-2009;
f) Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658,
11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm
Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1)
C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm
Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive
Grasper Reposable Cartridge, for laparoscopic procedures, Recall #
Z-0028-2009;
g) Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04,
5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator
System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1)
C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures,
Recall # Z-0029-2009
MANUFACTURER: Applied Medical Resources Corp., Rancho Santa Margarita,
CA, by letter on June 25, 2008. Firm initiated recall is ongoing.
REASON: Potential inability to insufflate through the stopcock. Under
certain circumstances, a flexible elastomeric component inside the 15mm
trocar can stretch into a configuration that blocks the flow of
insufflation gas (C02).
PRODUCT: a) Biomet brand Discovery Elbow, 3 mm x 75 mm
right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For
cemented use only, sterile; REF 114813. The product intended use is for
Orthopedic implant, Recall # Z-0032-2009;
b) Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with
bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only,
sterile; REF 114817. The product intended use is for Orthopedic implant,
Recall # Z-0033-2009
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated May 28, 2008.
Firm initiated recall is complete.
REASON: The component in the package is not the correct size.
PRODUCT:
1) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree; Model EX060201CD, Recall # Z-0035-2009;
2) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree; Model EX060203CD, Recall # Z-0036-2009;
3) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree. Model EX060301CD, Recall # Z-0037-2009;
4) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX060303CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Z-0038-2009;
5) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX060401CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0039-2009;
6) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX060403CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0040-2009;
7) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree, Model EX060601CD, Recall # Z-0041-2009;
8) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX060603CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0042-2009;
9) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree; Model EX060801CD, Recall # Z-0043-2009;
10) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree. Model EX060803CD, Recall # Z-0044-2009;
11) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System is intended for use in the palliation of malignant strictures (neoplasms)
in the biliary tree, Model EX070201CD, Recall # Z-0045-2009;
12) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System; Model EX070203CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0046-2009;
13) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070303CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0047-2009;
14) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070401CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0048-2009;
15) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070403CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0049-2009;
16) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070601CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0050-2009;
17) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070603CD, Recall # Z-0051-2009;
18) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070801CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0052-2009;
19) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070803CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0053-2009;
20) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080201CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0054-2009;
21) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080203CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0055-2009;
22) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080301CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0056-2009;
23) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080303CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0057-2009;
24) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080401CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0058-2009;
25) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080403CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0059-2009;
26) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080601CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0060-2009;
27) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080603CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0061-2009;
28) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080801CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0062-2009;
29) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX080803CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0063-2009;
30) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090201CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0064-2009;
31) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090203CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0065-2009;
32) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090301CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0066-2009;
33) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090303CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0067-2009;
34) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090401CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0068-2009;
35) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090403CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0069-2009;
36) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090601CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0070-2009;
37) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090603CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0071-2009;
38) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090801CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0072-2009;
39) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX090803CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0073-2009;
40) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100201CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0074-2009;
41) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100203CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0075-2009;
42) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100301CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0076-2009;
43) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100303CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0077-2009;
44) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100401CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0078-2009;
45) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100403CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0079-2009;
46) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100601CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0080-2009;
47) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100603CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0081-2009;
48) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100801CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0082-2009;
49) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100803CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0083-2009;
50) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX100903CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall #Z-0084-2009;
51) Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent
System, Model EX070301CD. The LifeStent FlexStar self-expanding biliary
stent system is intended for use in the palliation of malignant
strictures (neoplasms) in the biliary tree, Recall # Z-0085-2009
MANUFACTURER: Recalling Firm: Bard Peripheral Vascular Inc., Tempe, AZ,
by letters on August 29, 2008. Manufacturer: Edwards LifeSciences, LLC,
Irvine, CA. Firm initiated recall is ongoing.
REASON: Some LifeStent FlexStar Systems may exhibit a gap between the
tip of the delivery system and the primary sheath such that the
guidewire lumen is visible.
PRODUCT: Siemens Ultrasound, Acuson/Sonovista X300
ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and
3.0.02 ultrasound system with onscreen display, Recall # Z-0086-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by
letter on August 19, 2008. Firm initiated recall is ongoing.
REASON: Incorrect value calculations by the device may result in
inaccurate aortic stenosis estimates.
PRODUCT: Draeger Medical Apollo Anesthesia Machine,
catalog number 8606500, Recall # Z-0087-2009
MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by
letter on August 22, 2008. Manufacturer: Draeger Aerospace Gmbh, Lubeck,
Germany. Firm initiated recall is ongoing.
REASON: Sporadic errors in various device functions, including low
readings of the single gas flows for oxygen, nitrous oxide, or air
delivery, or mechanical ventilation failure. Alarms and error messages
function as designed.
PRODUCT: Envision E700 Low Airloss Therapy Surface. The
Envision E700 Low Airloss Therapy Surface helps prevent and treat stage
III and stage IV pressure ulcers in patients who weigh between 70 lb and
400 lb and are between 4'11" and 6' 4" in height, Recall # Z-0088-2009
MANUFACTURER: Hill-Rom Manufacturing, Inc., Charleston, SC, by
Modification Notice dated September 1, 2008. Firm initiated recall is
ongoing.
REASON: A defect in the software of the device may not allow the patient
bed exam alarm or the patient movement alarm to function correctly.
PRODUCT:
a) Coherence AG Therapist Part number 5863506, equipped with a Coherence
Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical
charged-particle radiation therapy system, Recall # Z-0089-2009;
b) Coherence Therapist System Part number 7339125 Medical
charged-particle radiation therapy system, Z-0090-2009;
c) Coherence Impression Therapist System equipped with a Coherence
Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number
7341410; Medical charged-particle radiation therapy system, Recall #
Z-0091-2009;
d) PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1,
and PRIMEVIEW 3iR2.0 or R2.1, part number 7341428 Medical
charged-particle radiation therapy system, Recall # Z-0092-2009;
e) AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0
or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345411 Medical
charged-particle radiation therapy system, Recall # Z-0093-2009;
f) Impression Therapist 3rd party V&R equipped with a Coherence
Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number
7345429 Medical charged-particle radiation therapy system, Recall #
Z-0094-2009;
g) Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0
or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7345437 Medical
charged-particle radiation therapy system, Recall # Z-0095-2009;
h) Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or
R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical
charged-particle radiation therapy system, Recall # Z-0096-2009;
i) PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or
R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 Medical
charged-particle radiation therapy system, Recall # Z-0097-2009;
j) Coherence Therapist System 2.1 equipped with a Coherence Therapist
R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 Medical
charged-particle radiation therapy system, Recall # Z-0098-2009;
k) PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or
R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147675 Medical
charged-particle radiation therapy system, Recall # Z-0099-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter on November 6, 2007. Firm initiated recall is ongoing.
REASON: Flat panel positioning calibration could be off by as much as 4
mm without the machine discovering detail.
PRODUCT: M3811B Philips Telemonitoring Clinical Review
Software part of Philips Telemonitoring System, M3810A, software
revision identified as Build 1.1.2.11d, B.02.07. Prescriptive medical
device used to automatically collect and transmit medical information
(weight, blood pressure, non-diagnostic ECG) over phone lines between
provider and patient, Recall # Z-0100-2009
MANUFACTURER: Philips Medical Systems, Andover, MA, by letters on
September 11, 2008. Firm initiated recall is ongoing.
REASON: Multiprint report may contain incorrect vital data for patients.
PRODUCT: AXIOM Luminos TF, model number 10093902 Intended
to be used for procedures that involve high skin doses, which can result
in deterministic effects, Recall # Z-0101-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter dated June 18, 2008. Manufacturer: Siemens
Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is
ongoing.
REASON: Liquids may enter the system and cause potential malfunction and
possible hazard to patients, user or other persons.
PRODUCT: Syngo Imaging with versions VB20B, VB20D, VB20F,
VB20G, VB25B, VB30A, VB30A-SP1, and VB30A-SP2. Model number: 10014063,
Recall # Z-0102-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by letter dated August 22, 2008. Manufacturer: Siemens
Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is
ongoing.
REASON: Image may not be visible after merge.
PRODUCT: a) Zyoptix XP Microkeratome maxon motor, Ref
#ZXP09183, Recall # Z-0103-2009; b) Zyoptix XP Microkeratome tray, Ref.
#ZXP1000, which contains a number of components, one of which is the
maxon motor, Recall # Z-0104-2009
MANUFACTURER: Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by
letter dated April 23, 2008 and by telephone on April 28, 2008.
Manufacturer: Maxon Motor Interlectric Ag, Sachseln, Switzerland. Firm
initiated recall is ongoing.
REASON: The plastic tip on the drive shaft may come off the shaft and
cause the blade to stop oscillating.
PRODUCT:
a) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190,
Sterilized with irradiation, Made in USA. Filter wire EZ" Embolic
Protection System is indicated for use as a guide wire and embolic
protection system to contain and remove embolic material
(thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid arteries. The
diameter of the vessel at the site of filter loop placement should be
between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft
procedures and between 3.5 mm and 5.5 mm for carotid procedures, Recall
# Z-0105-2009;
b) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 300cm, 3.5-5.5 mm, US, Material H749201003000, Catalog # 20100-300,
Sterilized with irradiation, Made in USA. Filter wire EZ" Embolic
Protection System is indicated for use as a guide wire and embolic
protection system to contain and remove embolic material
(thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid arteries. The
diameter of the vessel at the site of filter loop placement should be
between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft
procedures and between 3.5 mm and 5.5 mm for carotid procedures, Recall
# Z-0106-2009;
c) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, OUS CV, Material H749201003990, Catalog #
20100-399, Sterilized with irradiation, Made in USA. Filter wire EZ"
Embolic Protection System is indicated for use as a guide wire and
embolic protection system to contain and remove embolic material
(thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid
arteries. The diameter of the vessel at the site of filter
loop placement should be between 2.25 mm and 5.5 mm for coronary
saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for
carotid procedures, Recall # Z-0107-2009;
d Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 300cm, 3.5-5.5 mm, OUS CV, Material H749201004000, Catalog #
20100-400, Sterilized with irradiation. Filter wire EZ" Embolic
Protection System is indicated for use as a guide wire and embolic
protection system to contain and remove embolic material
(thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid arteries. The
diameter of the vessel at the site of filter loop placement should be
between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft
procedures and between 3.5 mm and 5.5 mm for carotid procedures, Recall
# Z-0108-2009;
e) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog #
20105-190, Sterilized with irradiation, Made in USA. Filter wire EZ"
Embolic Protection System is indicated for use as a guide wire and
embolic protection system to contain and remove embolic material
(thrombus/debris) while performing angioplasty and stenting procedures
in coronary saphenous vein bypass grafts and carotid arteries. The
diameter of the vessel at the site of filter loop placement should be
between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft
procedures and between 3.5 mm and 5.5 mm for carotid procedures, Recall
# Z-0109-2009;
f) Boston Scientific FilterWire EZ" Embolic Protection System, Model FW
EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H749201053000, Model #
20105-300, Sterilized with irradiation, Made in USA: 2011 Stierlin
Court, Mountain View, CA 94043-4655. Filter wire EZ" Embolic Protection
System is indicated for use as a guide wire and embolic protection
system to contain and remove embolic material (thrombus/debris) while
performing angioplasty and stenting procedures in coronary saphenous
vein bypass grafts and carotid arteries. The diameter of the vessel at
the site of filter loop placement should be between 2.25 mm and 5.5 mm
for coronary saphenous vein bypass graft procedures and between 3.5 mm
and 5.5 mm for carotid procedures, Recall # Z-0110-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated May 20, 2008. Manufacturer: Boston Scientific/EPI,
Mountain View, CA. Firm initiated recall is ongoing.
REASON: Boston Scientific is initiating a field correction for 48
lots/batches of the Filter Wire EZ" Embolic Protection System. Boston
Scientific has determined that the Directions for Use (DFU), which
accompanies each packaged device, may be missing. If the product does
not include a DFU and the user is unable to find a copy, the user will
have to seek another product box containing the DFU. This may cause a
delay in the procedure and hence risk of an injury to the patient.
PRODUCT: Acuson X300 ultrasound systems, ultrasound system
with onscreen display. Model numbers 10037409, 10038837, 10348531.
Potentially affected, but no volume currently: 10132987, 10133170,
10348532, 10348533, Recall # Z-0111-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by
letter on August 19, 2008. Firm initiated recall is ongoing.
REASON: Thermal Index cranial (TIC) is not displayed for the Neo-Head
exam type with the C8-5 transducer. This is a required display to
support the alara principle when imaging cranial structure.
PRODUCT: Centricity Perinatal (formerly Quantitative
Sentinel) System - Fluid Total Precision software; automatic patient
data management providing clinical information at the bedside in Labor &
Delivery, Mother-Baby and the Neonatal Intensive Care Unit, Recall #
Z-0112-2009
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by
letters dated April 20, 2007 and August 29, 2008. Firm initiated recall
is ongoing.
REASON: On the I&O chart, the IN, OUT and NET fluid totals values will
not honor the numeric precision configuration, always displaying a whole
number, losing decimal point accuracy.
PRODUCT: Zilver Expandable Metal Biliary Stent System,
ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction
System: 7 FR., Disposable-Single Use Only, Rx Only. The device is used
in palliation neoplasms in the biliary tree, Recall # Z-0113-2009
MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on/about
September 11, 2008. Firm initiated recall is ongoing.
REASON: A section of the introduction system may detach after the stent
has deployed.
PRODUCT: Safety Lancet for capillary blood sampling, 1.6
mm x 28G, Mini, Sarstedt. (Blood lancet). Product #85.1015.050, Recall #
Z-0114-2009
MANUFACTURER: Recalling Firm: Sarstedt Inc., Newton, NC, by letter on
August 27, 2008. Manufacturer: Sarstedt Ag & Co., Numbrecht, Germany.
Firm initiated recall is complete.
REASON: The product from this lot may not retract the lancet into the
safe position inside the lancet body after the trigger is actuated.
PRODUCT: Scorpio Series 7000 Tibial Impactor/Extractor,
Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325
Corporate Drive Mahwah, NJ 07430 The Impactor/Extractor is used for
insertion and removal of a tibial baseplate during total knee
arthroplasty, Recall # Z-0115-2009
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters
on July 2 and July 9, 2008. Firm initiated recall is ongoing.
REASON: Stryker Orthopaedics became aware that there is a potential
inability to release the Scorpio Series 7000 Tibial
Impactor/Extractor from a tibial baseplate during use.
PRODUCT: Artiste MV system, Part number 8139789, medical
linear accelerator equipped with COHERENCE therapist RTT4.1. Medical
Linear accelerator for radiation therapy. The device utilizes a console
system for selecting various treatment sequences and manages commands
for all motorized movement, Recall # Z-0116-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letters dated July 4, 2008 and July 11, 2008. Firm initiated recall is
ongoing.
REASON: Three issues: unexpected rotation of gantry, unexpected movement
of table between beams during patient setup, and single exposure images
will be overwritten by double exposure images.
PRODUCT: Exact Couch with Exact Couch Top, a component of
the C-Series Clinacs, Acuity and Ximatron treatment systems. Model
numbers H14, H18, H27, H72, H77. A powered radiation therapy patient
support assembly is an electrically powered adjustable couch intended to
support a patient during radiation therapy, Recall # Z-0117-2009
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by
letters on August 11, 2008. Firm initiated recall is ongoing.
REASON: During couch movement, a patient’s fingers may get pinched at
certain points which could result in broken, disengaged or pinched
fingers.
PRODUCT: iSite PACS (Picture Archiving and Communication
System), software versions 3.6.28.x and 4.1.x. The product is an image
management system (software package) used with general purpose computing
hardware to acquire, store, distribute, process and display images and
associated data throughout a clinical environment. Device is intended
for use by trained professionals, Recall # Z-0118-2009
MANUFACTURER: Philips Healthcare Informatics, Inc., Foster City, CA, by
letter dated August 29, 2008. Firm initiated recall is ongoing.
REASON: Two defects have been identified: 1) potential to display a
patient on the canvas page that is different from the patient whose
images are displayed on diagnostic monitors when using Conference
Presentation States and when opening two or more studies from a folder
or an exam worklist and 2) potential to miscalculate measurements when
Pixel Spacing and Imager Pixel Spacing DICOM tag values are both present
and different.
PRODUCT: Sonesta 6210 Fluoroscopy Procedure Table; a
motorized procedure table with adjustments (via a remote control) for
height, tilt, back and seat cushion position; Model 6210, Recall #
Z-0119-2009
MANUFACTURER: Stille AB, Solna, Sweden, by letter dated August 27, 2008.
Firm initiated recall is ongoing.
REASON: The table contains a battery backup, not mentioned in the User
Manual, which automatically will provide power to the electrical
actuators/motions in case of a power loss from the main power supply.
However, if a short circuit occurs, it can result in an uncontrolled
movement of the table which cannot be stopped by disconnecting the
device from the main power supply, as the battery automatically will
supply continuous power to the control box.
PRODUCT: Oscor Adelante Luer-Lock Peel Away Introducer
Set, for introduction of diagnostic or therapeutic devices into the
body, Recall # Z-0130-2009
MANUFACTURER: Oscor, Inc., Palm Harbor, FL, by letter on July 3, 2008.
Firm initiated recall is ongoing.
REASON: Difficulty breaking the sheath hub and subsequently to peel the
sheath off for Introducer Set, Adelante size 7F.
PRODUCT: Respiratory Gating System which includes:
Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model
#455011203131 and Model #455011203191, Recall # Z-0132-2009
MANUFACTURER: Philips Medical Systems (Cleveland), Inc.,
Cleveland, OH, by letters on September 8, 2008. Firm initiated recall is
ongoing.
REASON: Images not correlated: A leak between the Tube Interface and the
Outlet Tube of the transducer may result in a failure to produce
respiratory correlated images.
PRODUCT: Ray TFC Device with End Caps: Single Patient use;
Sterile; Stryker Spine Ray Cage 7-2021 20 (catalog #) mm diameter x 21
mm long. Ray Cages are indicated for use with autogenous bone graft in
patients with Degenerative Disc Disease (DDD) at one or two levels for
L2 to S1, Recall # Z-0151-2009
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters
on August 18, 2008. Manufacturer: Stryker Spine, Cestas, Aquitane,
France. Firm initiated recall is ongoing.
REASON: The label on one side on the Ray TFC Device (Ray Cage) is
incorrect. It reads 20 mm x 26 mm instead of 20 mm x 21 mm.
PRODUCT: Baxter Auto Syringe AS50 Infusion Pump, product
code 1M8550; Indicated for infusion via intravenous, intra-arterial,
epidural or subcutaneous routes of administration, Recall # Z-0152-2009
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,
by letters dated September 5, 2008. Manufacturer: Baxter Healthcare
Corp., Singapore. Firm initiated recall is ongoing.
REASON: Non-conforming Electrostatic Discharge (ESD) grounding squares
may cause the pump to be susceptible to shorting-out of circuitry,
resulting in a loss of audio, and/or interruption of therapy.
PRODUCT:
a) Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003
Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H
W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R;
IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved;
IT-BP1002 Thoracic Ball Handle Probe, Straight; DM-MR0530 Monoaxial
Screw Non-Winged, Size 5 x 30; DM-MR0535 Monoaxial Screw Non-Winged,
Size 5 x 35; DM-MR0540 Monoaxial Screw Non-Winged, Size 5 x 40;
DM-MR0545 Monoaxial Screw Non-Winged, Size 5 x 45; DM-MW0530 Monoaxial
Screw Winged, Size 5 x 30; DM-MW0535 Monoaxial Screw Winged, SizeS x 35;
DM-MW0540 Monoaxial Screw Winged, Size S x 40; DM-MW0545 Monoaxial Screw
Winged, Size 5 x 45; DM-MR0630 Monoaxial Screw Non-Winged, Size 6 x 30;
DM-MR0635 Monoaxial Screw Non-Winged, Size 6 x 35; DM-MR0640 Monoaxial
Screw Non-Winged, Size 6 x 40; DM-MR0645 Monoaxial Screw Non-Winged,
Size 6 x 45; DM-MR0650 Monoaxial Screw Non-Winged, Size 6 x 50;
DM-MW0630 Monoaxial Screw Winged, Size 6 x 30; DM-MW0635 Monoaxial Screw
Winged, Size 6 x 35; DM-MW0640 Monoaxial Screw Winged, Size 6 x 40;
DM-MW0645 Monoaxial Screw Winged, Size 6 x 45; DM-MR0735 Monoaxial Screw
Non-Winged, Size 7 x 35 DM-MR0740 Monoaxial Screw Non-Winged, Size 7 x
40; DM-MR0745 Monoaxial Screw Non-Winged, Size 7 x 45; RD-ST5541
Straight Rod, 4mm Hex Intended to help provide correction,
immobilization and stabilization of spinal segments as an adjunct to
fusion of the thoracic, lumbar and/or sacral space, Recall #
Z-0153-2009;
b) Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001
Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw
System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle);
IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher;
lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001
Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold
Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin
Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002
Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl
Bearing); IT-CT1002 Counter Torque (Short No Windows); IT-SD1006
Multiaxial Screwdriver (w/Windows); IT-TP1005 Tap, 4mm (Silver Tn-Fluted);
IT-TP1006 Tap, 5mm (Silver Tn-Fluted); IT-TP1007 Tap, 6mm (Silver Tn-Fluted);
IT-TP1008 Tap, 7mm (Silver Tn-Fluted); lT-HP1002 Head Positioner (All
Metal Handle); IT-RK1002 Rocker (Horse Shoe Style Tip); IT-SD1007
Screwdriver Shaft 8.5 (w/Ball Bearing); IT-CT1003 Counter Torque (Short
w/Windows); IT-TP1014 Tap, 4mm (Silver Circumferential); IT-TP1015 Tap,
5mm (Silver Circumferential); IT-TP1016 Tap, 6mm (Silver
Circumferential); IT-TP1017 Tap, 7mm (Silver Circumferential); IT-SD1007
Screwdriver Shaft 8.5 (No Ball Bearing); IT-XR1001 Extension Remover;
IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing); IT-FB1001 French Rod
Bender; IT-SP1001 Ball Tip Probe; IT-TR1001 Trial Rod; IT-RG 1002 Rod
Gripper, Ratcheting (Short Nose); IT-BP1003 Lumbar Probe, Straight
(Long); IT-BP1004 Lumbar Probe, Curved (Long); IT-SP1002 Sounder (Ball
Tip) Probe, Heavy Duty; RD-ST5540 Rod 5,5 x 400mm, Straight; IT-BA1001
Newport Awl; IT-PU 1001 Persuader; IT-RR1001 Retaining Ring; lT-NS1001
In-Situ Left; IT-N51002 In-Situ Right; IT-BP100S Lumbar Probe, Straight
(Short); IT-BP1006 Lumbar Probe, Curved (Short); IT-CP1001 Compressor;
IT-DT1001 Distractor; IT-BP1001 Thoracic Ball Handle Probe, Curved;
IT-BP1002 Thoracic Ball Handle Probe, Straight; IT-RH1002 Ratcheting
T-Handle; IT-NC1001 Locking Nut Caddy; IT-SG1001 Screw Gauge Block;
IT-RH1002 Ratcheting Handle, Straight; IT-T01002 Preset Torque Wrench
(With Connector); LG-LN1002 Locking Nut, Single Piece; LG-PR0530C
Polyaxial Screw, Non-Winged, 5 X 30; LG-PR0535C Polyaxial Screw,
Non-Winged, 5 X 35; LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40;
LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45; LG-PR0550C Polyaxial
Screw, Non-Winged, 5 X 50; LG-PR0630C Polyaxial Screw, Non-Winged, 6 X
30; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; LG-PR0640C Polyaxial
Screw, Non-Winged, 6 X 40; LG-PR0645C Polyaxial Screw, Non-Winged, 6 X
45; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; LG-PR0730C Polyaxial
Screw, Non-Winged, 7 X 30; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X
35; LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40; LG-PR074SC Polyaxial
Screw, Non-Winged, 7 X 45; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X
50; LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55; LG-PR083SC Polyaxial
Screw, Non-Winged, 8 X 35; LG-PR0840C Polyaxial Screw, Non-Winged, 8 X
40; LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45; LG-PR0850C Polyaxial
Screw, Non-Winged, 8 X 50; LG-PR0855C Polyaxial Screw, Non-Winged, 8)(
55; LG-PW0535C Polyaxial Screw, Winged, S X 35; LG-PW0540C Polyaxial
Screw, Winged, 5 X 40; LG-PW0545C Polyaxial Screw, Winged, 5 X 45;
LG-PW0635C Polyaxial Screw, Winged, 6 X 35; LG-PW0640C Polyaxial Screw,
Winged, 6 X 40; LG-PW0645C Polyaxial Screw, Winged, 6 X 45; LG-PW0735C
Polyaxial Screw, Winged, 7 X 35; LG-PW0740C Polyaxial Screw, Winged, 7 X
40; LG-PW0745C Polyaxial Screw, Winged, 7 X 45; RD-PB5504 ROD 5.5 X 40,
PRE-BENT; RD-PB5505 ROD 5.5 X 50, PRE-BENT; RD-PB5506 ROD 5.5 X 60,
PRE-BENT; RD-PB5507 ROD 5.5 X 70, PRE-BENT; RD-PB5508 ROD 5.5 X 80,
PRE-BENT; RD-PB5509 ROD 5.5 X 90, PRE-BENT; RD-PB5510 ROD 5.5 X 100,
PRE-BENT; RD-PB5511 ROD 5.5 X 110, PRE-BENT; RD-PB5512 ROD 5.5 X 120,
PRE-BENT; 7319-35 Tapered Pedicle Marker Set; 7783-05 Tapered Pedicle
Marker Set; PS103004-A Black Onion Shaped Handle, Non-Ratcheting;
73-8010-AS Custom Distractor (Boss); 23000-CS001C Custom Compressor
Intended for posterior, non-cervical fixation for the following
conditions: degenerative disc disease; spondylolisthesis; trauma; spinal
stenosis; curvatures; tumor pseudarthrosis; and/or failed previous
fusion, Recall # Z-0154-2009;
c) Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link,
Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 Cross
Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm,
Recall # Z-0155-2009
MANUFACTURER: Allez Spine, LLC, Irvine, CA, by letter beginning August
21, 2008. Firm initiated recall is ongoing.
REASON: This action is being taken voluntarily as a result of a Warning
Letter issued to AlIez Spine LLC by the Food & Drug Administration. The
Company decided it could better address the FDA's concerns regarding
Current Good Manufacturing Practice requirements of the Quality System
without any product in the market so it could focus all of its efforts
on responding to the FDA.
PRODUCT:
a) Weck Hemoclip Traditional Ligating Clips, Rx Only; The use of the
reusable Teleflex Medical metal ligating clips is transient, invasive
and intended for the application of hemostatic clips during general open
surgery. Ligation clips are non-absorbable to thermostatically restrict
flow of fluids within vessels. Clips are removed from the cartridge and
applied in such a manner as to engulf vessels. Teleflex Medical metal
ligating clips are intended for use in procedures involving vessels or
anatomic structures for which the surgeon determines ligating clips are
the best choice. Surgeons should select the size type, and material of
the clip based upon their experience, judgment and needs:
1) HEMOCLIP MEDIUM 250/BOX, Product Code: 523100;
2) HEMOCLIPS SMALL 300/BOX, Product Code: 523135;
3) HEMOCLIP MED-LGE 200/BOX, Product Code: 523160;
4) HEMOCLIP LARGE 150/BOX, Product Code: 523170;
5) HEMOCLIP TEN PAK MEDIUM 200/BOX, Product Code: 523300;
6) HEMOCLIP TEN PAK SMALL 240/BOX, Product Code: 523335;
7) HEMOCLIP TEN PAK MED-LG 160/BX, Product Code: 523360;
8) HEMOCLIP TEN PAK LG 120/BOX, Product Code: 523370;
9) HEMOCLIP S/S MEDIUM 250/BOX, Product Code: 523400;
10) HEMOCLIP S/S SMALL 300/BOX, Product Code; 523435;
11) HEMOCLIP S/S MED/LG 200/BOX, Product Code: 523460;
12) HEMOCLIP S/S LARGE 150/BOX, Product Code: 523470;
13) HEMOCLIP S/S MEDIUM 200/BOX, Product Code: 523600;
14) HEMOCLIP S/S SMALL 240/BOX, Product Code: 523635;
15) HEMOCLIP S/S MEDIUM-LARGE 160/BOX, Product Code: 523660;
16) HEMOCLIP S/S LARGE 120/BOX, Product Code: 523670;
17) HEMOCLIP TITANIUM MEDIUM 250/BOX, Product Code: 523700;
18) HEMOCLIP TITANIUM SMALL 300/BOX, Product Code: 523735;
19) HEMOCLIP TITANIUM MEDIUM-LARGE 200/BOX, Product Code: 523760;
20) HEMOCLIP TITANIUM LARGE 150/BOX, Product Code: 523770;
21) HEMOCLIP TITANIUM MEDIUM 200/BOX, Product Code: 523800;
22) HEMOCLIP TITANIUM SMALL 240/BOX, Product Code: 523835;
23) HEMOCLIP TITANIUM MEDIUM-LARGE 160/BOX, Product Code: 523860;
24) HEMOCLIP TITANIUM LARGE 120/BOX, Product Code: 523870;
Recall # Z-0156-2009;
b) Weck Hemoclip Plus® Ligating Clips, Rx Only, Sterile. The use of the
reusable Teleflex Medical metal ligating clips is transient, invasive
and intended for the application of hemostatic clips during general open
surgery. Ligation clips are non-absorbable to thermostatically restrict
flow of fluids within vessels. Clips are removed from the cartridge and
applied in such a manner as to engulf vessels. Teleflex Medical metal
ligating clips are intended for use in procedures involving vessels or
anatomic structures for which the surgeon determines ligating clips are
the best choice. Surgeons should select the size type, and material of
the clip based upon their experience, judgment and needs:
1) HEMO PLUS TITANIUM MEDIUM 25CLIP/10CART, Product Code: 533700;
2) HEMO PLUS TI 25/CART 250BOX NO TAPE, Product Code: 533702;
3) HEMO PLUS TITANIUM SMALL 25CLIP/12CART, Product Code: 533735;
4) HEMO PLUS TI 25/CART 300BOX NO TAPE, Product Code: 533737;
5) HEMO PLUS TITANIUM MEDIUM 10 CLIP/18CART, Product Code: 533800;
6) HEMO PLUS TI M10/18CART NO TAPE, Product Code: 533802;
7) HEMO PLUS TITANIUM SMALL 10 CLIP/18 CART, Product Code: 533835;
8) HEMO PLUS TI S10/18CART NO TAPE, Product Code: 533837;
9) HEMO PLUS TITANIUM MED-LGE 10CLIP/12CART, Product Code: 533860;
10) HEMO PLUS TI ML10/12CART NO TAPE, Product Code: 533862;
11) HEMO PLUS TITANIUM LARGE 10CLIP/12CART, Product Code: 533870;
12) HEMO PLUS TI L10/12CART NO TAPE, Product Code: 533872;
13) HEMO PLUS STRGPT TI SM25/CART, Product Code: 534735, 300/BX;
14) HEMO PLUS STRONGPOINT SM NOTAPE 300 25, Product Code: 534737;
15) HEMO PLUS STRGPT TI SM10/CART 180BX, Product Code: 534835;
16) HEMO PLUS STRONGPOINT SM NO TAPE 180 10, Product Code: 534837,
Recall # Z-0157-2009;
c)Weck , Horizon Titanium Clips, Rx Only, Sterile. The use of the
reusable Teleflex Medical metal ligating clips is transient, invasive
and intended for the application of hemostatic clips during general open
surgery. Ligation clips are non-absorbable to thermostatically restrict
flow of fluids within vessels. Clips are removed from the cartridge and
applied in such a manner as to engulf vessels. Teleflex Medical metal
ligating clips are intended for use in procedures involving vessels or
anatomic structures for which the surgeon determines ligating clips are
the best choice. Surgeons should select the size type, and material of
the clip based upon their experience, judgment and needs:
1) HORIZON SMALL TI 6 CLIP, Product Code, 001200;
2) HORIZON SMALL RED TI 6 CLIP WIDE SLOT, Product Code: 001201;
3) HORIZON MED TI CLIP, Product Code: 002200;
4) HORIZON MED/LRG TI 6 CLIP, Produce Code: 003200;
5) HORIZON LARGE TI 6 CLIP, Product Code: 004200;
6) HORIZON MICRO TI 6 CLIP/CART 30 CART/BX, Product Code; 005200;
Recall # Z-0158-2009;
d) WECK Hem-o-lokĀ® Non-absorbable Polymer Ligation Clips, Rx Only,
Sterile. The use of the reusable Teleflex Medical metal ligating clips
is transient, invasive and intended for the application of hemostatic
clips during general open surgery. Ligation clips are non-absorbable to
thermostatically restrict flow of fluids within vessels. Clips are
removed from the cartridge and applied in such a manner as to engulf
vessels. Teleflex Medical metal ligating clips are intended for use in
procedures involving vessels or anatomic structures for which the
surgeon determines ligating clips are the best choice. Surgeons should
select the size type, and material of the clip based upon their
experience, judgment and needs:
1) HOL SMALL CLIPS 1 PACK, Product Code: 544210;
2) HOL SMALL CLIPS 4 PACK, Product Code: 544214;
3) HOL SMX CLIPS, Product Code: 544220;
4) HOL ML CLIPS, Product Code: 544230;
5) HOL L CLIPS, Product Code: 544240;
6) HOL XL CLIPS (EXTRA LARGE), Product Code: 544250;
Recall # Z-0159-2009;
e) WECK HemoClip Auto, Rx Only, Sterile. The use of the reusable
Teleflex Medical metal ligating clips is transient, invasive and
intended for the application of hemostatic clips during general open
surgery. Ligation clips are non-absorbable to thermostatically restrict
flow of fluids within vessels. Clips are removed from the cartridge and
applied in such a manner as to engulf vessels. Teleflex Medical metal
ligating clips are intended for use in procedures involving vessels or
anatomic structures for which the surgeon determines ligating clips are
the best choice. Surgeons should select the size type, and material of
the clip based upon their experience, judgment and needs:
1) HemoClip Auto S/S Medium 200/Box, Product Code: 527100;
2) HemoClip Auto Titanium Medium 200/Box, Product Code: 527200;
3) HemoClip Auto Titanium Medium 100/Box, Product Code: 527203,
Recall # Z-0160-2009
MANUFACTURER: Recalling Firm: Teleflex Medical, Inc., Durham, NC, by
letters on/about August 22, 2008. Manufacturer: Teleflex Medical, Inc.,
Tecate, B.C., Mexico. Firm initiated recall is ongoing.
REASON: A hole in the sterile unit blister pack was detected that would
compromise sterility.
PRODUCT: Accessory Head Rest for Alphastar Operating
Tables. USA part number: 1130.67FO, Recall # Z-0161-2009
MANUFACTURER: Recalling Firm: Maquet Inc., Bridgewater, NJ, by letters
beginning September 26, 2008. Manufacturer: Maquet Aktiengesellschaft,
Rastatt, Germany. Firm initiated recall is ongoing.
REASON: During installation or cleaning there is a risk of crushing the
finger by handling the head rest in the area of the gas strut while
simultaneously actuating the release lever.
PRODUCT: GlobTek, Inc. Power Supply for Medical Use Part
No: TR9CE4000LCP-Y-MED Model: GTM21097-5012, Made in China. Indicated
for patients who would benefit from a suction device particularly as the
device may promote wound healing, including patients who would benefit
from vacuum assisted drainage and removal of infectious materials or
other fluid from wounds under the influence of continuous pressure,
Recall # Z-0162-2009
MANUFACTURER: Recalling Firm: Smith And Nephew, Inc. Wound Management
Division, Largo, FL, by letter dated August 7, 2008. Manufacturer: Atmos
Medizintechnik Gmbh & Co. KG, Lenzkirch, Germany. Firm initiated recall
is ongoing.
REASON: External battery chargers used with the Version 29 VISTA
Negative Pressure Wound Therapy pumps are failing to properly charge the
pump's battery.
PRODUCT: Axiom Aristos FX Multipurpose Radiography System,
stationary X-Ray Ssystem, Model number: 7414803, Recall # Z-0163-2009
MANUFACTURER: Recalling Firm: Siemens Medical Solution USA, Inc.,
Malvern, PA, by letter in August 2008. Manufacturer: Siemens Medical
Solutions, Inc., Erlangen, Germany. Firm initiated recall is complete.
REASON: Tube support arm or the detecting mounting hardware may become
loose at the joint with the telescope.
PRODUCT: Varian RV Software Varian Treatment for
Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46;
Designed to assist the operator of a radiation therapy device in
providing accurate treatment setups for each patient by monitoring set
up parameters and preventing the radiation therapy from commencing
irradiation while any parameter is out of conformance with the treatment
plan, Recall # Z-0164-2009
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by
letter on June 2, 2008. Firm initiated recall is ongoing.
REASON: A malfunction within the Varis software might result in a
misadministration (under dose). The software does not correctly
interpret the number, causing field parameters having decimal values to
be incorrect.
PRODUCT: Roche/Hitachi Modular E Module immunoassay
analyzer, GMMI Nos. 04998642001 and 03617505001, Recalling Firm:
Z-0165-2009
MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN,
by letter dated June 24, 2008. Manufacturer: Division, Hitachi Ltd.,
Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
REASON: A software bug may result in pipetting from an incorrect reagent
pack and/or assigning calibration curve parameters incorrectly.
PRODUCT:
a) Flexiguide Needle, Series-15, 25CM, with Female Luer Adaptor, Sharp
and Stylet with Male Luer Aaaptor (HDR); 10/PKG Quantity: 10/PKG
L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide
an enclosed pathway for localized radiation therapy using a Remote High
Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
Product No: NFV0001-004, Recall # Z-0166-2009;
b) Flexiguide Needle, Series-15, 20CM, with Female Luer Adaptor, Sharp
and Stylet with Male Luer Adaptor (HDR); 10/PKG Quantity: 10/PKG
L-NFV0003-003. Product No: NFV0003-003. The FlexiGuide is a flexible
needle designed to provide an enclosed pathway for localized radiation
therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low
Dose Rate (LDR) method, Recall # Z-0167-2009;
c) Custom Flexiguide Needle, Series 15, with Female Luer and Stylet with
Male Luer 28CM, Set of 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL-
NFV. The FlexiGuide is a flexible needle designed to provide an enclosed
pathway for localized radiation therapy using a Remote High Dose Rate
(HDR) Afterloader or manual Low Dose Rate (LDR) method. Product No:
SPECIAL-NFV, Recall # Z-0168-2009;
d) Flexiguide Needle, Series-15, 20 CM without Female Luer Adaptor,
Sharp and Stylet With 90-Degree Bend, 10/PKG Quantity: 10/PKG
L-NFW0001-009. Product No: FW0001-009. The FlexiGuide is a flexible
needle designed to provide an enclosed pathway for localized radiation
therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low
Dose Rate (LDR) method, Recall # Z-0169-2009;
e) Flexiguide Needle, Series-15, 25 CM without Female Luer Adaptor,
Sharp and Stylet with 90-Degree Bend, 10/PKG Quantity: 10/PKG
L-NFW0001-010. Product No: FW0001-010. The FlexiGuide is a flexible
needle designed to provide an enclosed pathway for localized radiation
therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low
Dose Rate (LDR) method, Recall # Z-0170-2009
MANUFACTURER: Alpha Omega Services Inc., Bellflower, CA, by letters
beginning November 15, 2007 and November 27,2007. Firm initiated recall
is complete.
REASON: There is a possibility that the Flexiguide Needle tip is
defective. There is the potential for the needles tip to leak, thereby
breaking the sterile boundary and possibly contaminating
other devices with body fluids.
PRODUCT: a) Liquid AST (SGOT) Reagent Set, in 150 ml
(Product no. A7561-150) and 450 ml (Product no A7561-450). For the
quantitative determination of aspartate amoinotransferase in human
serum, Recall # Z-0171-2009; b) AST R1 Reagent, 120 ml.; Catalog no.
8-A7561-R1-120. For the quantitative determination of aspartate
amoinotransferase in human serum, Recall # Z-0172-2009
MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated
August 22, 2008. Firm initiated recall is ongoing.
REASON: The R1 component may be contaminated with Serratia liquefaciens,
resulting decreased absorbance and failure of the reagent to produce
test results.
PRODUCT: Premier Value Lancing Device. UPC Code:
840986016707, The Package Includes: 1 Lancing Device, 1 Clear Cap and 5
Premier Value Ultra Thin Lancets. Lancing Device intended to be used by
diabetes patients that require a drop of capillary blood for testing,
Recalling # Z-0174-2009
MANUFACTURER: Facet Technologies, McDonough, GA, by letter on/about July
18, 2008. Firm initiated recall is ongoing.
REASON: The Alternate Site Cap was not included in the package as
indicated on the labeling.
PRODUCT:
a) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD,
Uterine Manipulator, REF 60-6085-000. Made in USA. The ConMed VCARE®
Retractor/Elevator is indicated for manipulation of the uterus and
injection of fluids or gases during laparoscopic procedures such as
Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic
laparoscopy and also maintains pneumoperitoneum by sealing the vagina
once colpotomy is performed, Recall # Z-0175-2009;
b) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL,
Uterine Manipulator, REF 60-6085-001. Made in USA. The ConMed VCARE®
Retractor/Elevator is indicated for manipulation of the uterus and
injection of fluids or gases during laparoscopic procedures such as
Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic
laparoscopy and also maintains pneumoperitoneum by sealing the vagina
once colpotomy is performed, Recall # Z-0176-2009;
c) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE,
Uterine Manipulator, REF 60-6085-002. Made in USA. The ConMed VCARE®
Retractor/Elevator is indicated for manipulation of the uterus and
injection of fluids or gases during laparoscopic procedures such as
Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic
laparoscopy and also maintains pneumoperitoneum by sealing the vagina
once colpotomy is performed, Recall # Z-0177-2009;
d) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD,
Uterine Manipulator, REF 60-6085-100. Made in USA. The ConMed VCARE®
Retractor/Elevator is indicated for manipulation of the uterus and
injection of fluids or gases during laparoscopic procedures such as
Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic
laparoscopy and also maintains pneumoperitoneum by sealing the vagina
once colpotomy is performed, Recall # Z-0178-2009;
e) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL,
Uterine Manipulator, REF 60-6085-101. Made in USA, Recall # Z-0179-2009;
f) VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE,
Uterine Manipulator, REF 60-6085-102. Made in USA. The ConMed VCARE®
Retractor/Elevator is indicated for manipulation of the uterus and
injection of fluids or gases during laparoscopic procedures such as
Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic
laparoscopy and also maintains pneumoperitoneum by sealing the vagina
once colpotomy is performed, Recall # Z-0180-2009
MANUFACTURER: ConMed, Corp., Utica, NY, by letters on September 8, 2008.
Firm initiated recall is ongoing.
REASON: The firm received several complaints sighting detachment of the
balloon at the distal end of the shaft. It was also noted that the
incidence of the forward cup slipping off the shaft and being retained
in the vaginal canal had increased.
PRODUCT: Biomet brand Modular Microplasty Cup Inserter,
3/8" thread, Model 31-400600. Non-powered, hand-held instrument intended
for use as an impactor during orthopedic surgery, Recall # Z-0181-2009
MANUFACTURER: Biomet Orthopedics, Inc., Warsaw, IN, by letter dated July
28, 2008. Firm initiated recall is ongoing.
REASON: The pin and clip may fracture during use.
PRODUCT: Circlip component of the Stryker Flat Panel and
Navigation Arm System. Stryker Flat Panel and Navigation Arm System are
intended for use as a ceiling-mounted device to support a medical grade
flat panel monitor or camera in the patient area. The Circlip within the
flat panel and navigation arms is part of the mechanical stop designed
to prevent the arm from rotating infinitely. It also prevents the cables
routed through the arm from becoming twisted during routine movement and
rotation of the arm. Part numbers: 0682-000-005 (A-O), 0682-000-200,
0682-000-270, 0682-000-280, 0682-000-281, 0682-000-850, and
0682-000-851, Recall # Z-0182-2009
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower
Mound, TX, by letter on September 5, 2008. Manufacturer: Ondal Indust
Gmbh, Hunfeld, Germany. Firm initiated recall is ongoing.
REASON: Circlip component used to suspend flat panel and navigation arm
system may become dislodged.
PRODUCT;
a) Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation , length:
40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic.
Method of Sterilization: Ethylene Oxide, Rx Only, Activa Therapy, Model
3387 Lead Kit, STIMLOC Burr Hole Kit; Implant manual: DBS Leads:
Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy
includes Activa Parkinson's Control Therapy and Activa Tremor Control
Therapy. Parkinson's Control Therapy: Bilateral stimulation of the
internal globus pallidus (GP) or the subthalamic nucleus (STN) using
Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive
therapy in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication.
Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic
Activa Tremor control system is indicated for the suppression of tremor
in the upper extremity. The system is intended for using patients who
are diagnosed with Essential Tremor or Parkinsonian tremor not
adequately controlled by medications and where the tremor constitutes a
significant functional disability., Recall # Z-0184-2009;
b) Medtronic DBS" 3389S-40 Lead Kit for Deep Brain Stimulation , length:
40 cm. Contents of the inner packages are Sterile and Non-Pyrogenic.
Method of Sterilization: Ethylene Ox ide, Rx Only, Activa Therapy, Model
3387 Lead Kit Manufactured at : Medtronic, Inc., Villalba, Puerto Rico,
STIMLOC Burr Hole Kit: Manufacturer: Medtronic Image-Guided Neurologics,
Melbourne, FL 32935-3145 Implant manual: DBS" Leads: Proximal 40 mm,
Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy includes Activa
Parkinson's Control Therapy and Activa Tremor Control Therapy.
Parkinson's Control Therapy: Bilateral stimulation of the internal
globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic
Activa Parkinson's Control Therapy is indicated for adjunctive therapy
in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication.
Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic
Activa Tremor control system is indicated for the suppression of tremor
in the upper extremity. The system is intended for using patients who
are diagnosed with Essential Tremor or Parkinsonian tremor not
adequately controlled by medications and where the tremor constitutes a
significant functional disability, Recall # Z-0185-2009;
c) Medtronic DBS" 3387 Lead Kit for Deep brain stimulation, DBS Leads:
Proximal 40 mm, Distal 12.0 mm, Medtronic, Inc. Medtronic Active Therapy
includes Activa Parkinson's Control Therapy and Activa Tremor Control
Therapy. Parkinson's Control Therapy: Bilateral stimulation of the
internal globus pallidus (GP) or the subthalamic nucleus (STN) using
Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive
therapy in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication.
Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic
Activa Tremor control system is indicated for the
suppression of tremor in the upper extremity. The system is intended for
using patients who are diagnosed with Essential Tremor or Parkinsonian
tremor not adequately controlled by medications and where the tremor
constitutes a significant functional disability, Recall # Z-0186-2009;
d) Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads:
Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. Medtronic Active Therapy
includes Activa Parkinson's Control Therapy and Activa Tremor Control
Therapy. Parkinson's Control Therapy: Bilateral stimulation of the
internal globus pallidus (GP) or the subthalamic nucleus (STN) using
Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive
therapy in reducing some of the symptoms of advanced, levodopa-responsive
Parkinson's disease that are not adequately controlled with medication.
Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic
Activa Tremor control system is indicated for the suppression of tremor
in the upper extremity. The system is intended for using patients who
are diagnosed with Essential Tremor or Parkinsonian tremor not
adequately controlled by medications and where the tremor constitutes a
significant functional disability, Recall # Z-0187-2009
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, by letter on August 20, 2008. Manufacturer: Medtronic Puerto Rico
Operations, Co., Villalba, PR. Firm initiated recall is ongoing.
REASON: Medtronic has received reports of DBS" leads being damaged at
the proximal connector end of the lead when the lead cap is used in the
implant procedure. The lead damage is the result of excessive torsion
and / or tensile lading of the proximal connector end of the lead. Data
also suggest that excessive torque while tightening or loosening the
setscrews may twist the setscrew connector block and damage the proximal
connector end of the lead. Depending on the extent of lead damage and
the need to use the affected lead contact(s) and/or conductor(S), lead
replacement may be required, exposing the patient to the risks of a
second lead implant procedure. To date, there have been no reports of
permanent patient impairment, life-threatening injury, or death as a
result of this issue.
PRODUCT:
a) Symbia T6 System; a dual-detector variable angle gamma camera with a
six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular
imaging, Hoffman Estates, IL 60192. The system is used to perform CT
scans and nuclear imaging studies with the same instrument, obtaining
attenuation corrected images and providing registration of anatomical
and physiological images within the patient's anatomy. The Symbia T6
System is used for advanced oncology, neurology and cardiology
applications. System part number 10275009; CT Subassembly 10165632,
Recall # Z-0189-2009;
b) Symbia T16 System; a dual-detector variable angle gamma camera with a
sixteen slice CT scanner; The system is used to perform CT scans and
nuclear imaging studies with the same instrument, obtaining attenuation
corrected images and providing registration of anatomical and
physiological images within the patient's anatomy. The Symbia T6 System
is used for advanced oncology, neurology and cardiology applications.
System part number 10275010; CT Subassembly 10165633, Recall #
Z-0190-2009
MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL,
by letters dated September 29, 2008. Firm initiated recall is ongoing.
REASON: The protective plastic cap over the CT gantry power switch on
the Line Connection Box may come loose, exposing the energized
electrical contacts within the switch, thereby causing an electric
hazard.
PRODUCT: Stryker Osteosynthesis Reduction Spoon; 1 single
unit to a package; non-sterile. Reduction spoons are sold separately or
as part of a kit. The Universal Rod with Reduction Spoon may be used as
a fracture reduction tool to facilitate Guide Wire insertion. Product
Code 1806-0125, Recall # Z-0191-2009
MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah,
NJ, letters on August 14, 2008. Manufacturer: Stryker Trauma GmbH,
Schonkirchen, Germany. Firm initiated recall is ongoing.
REASON: The potential for breakage of the Reduction Spoon designed prior
to 2003.
PRODUCT: Smallbore T-Port Extension Set with Female Luer
Lock Connector and Male Luer Lock T-Port with Ultrasite Injection Site 5
in. The product is shipped 100 units per carton. Item number 474515,
Recall # Z-0199-2009
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by
letter dated September 17, 2008. Manufacturer: B Braun Medical Inc.,
Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON: Product was assembled incorrectly and connected to the wrong
part.
PRODUCT: Monitor suspensions used with Advantx Legacy, RFX
Classical, SFX-90, Model # 46-240838G2, manufactured after March 8, 1985
for Advantx Legacy, RFX and SFX systems. General-purpose radiographic
system component used to suspend the system's image monitor, Recall #
Z-0200-2009
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated September 13,
2007. Firm initiated recall is complete.
REASON: GE Healthcare has recently become aware of a potential risk of
monitor dropping associated with the monitor suspension of the Advantx
system that may impact patient safety. It has been reported that
suspensions manufactured after March 8, 1995 did not have the required
thread locking agent applied to the setscrew, allowing the setscrew to
back out over time, which can lead to the monitor dropping.
PRODUCT: Oxylog 3000 Emergency and Transport Ventilator
Continuous Respirator with software version 1.10 pre-installed; Catalog
number 2M86300, Recall # Z-0202-2009
MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, Pa, by
letter dated September 2008. Manufacturer: Draeger Medical B.V., Best,
Netherlands. Firm initiated recall is ongoing.
REASON: May experience an interruption of ventilation for approximately
5 seconds.
CLASS III
PRODUCT:
a) Platinum Plus" LT, REF 46-601, UPN M001466010, LT/0.018/180,
Sterilized with ethylene oxide gas, Rx only. The Platinum Plus"
Guidewire facilitates placement of a catheter during diagnostic or
interventional intravascular procedures. The wire can be torqued to
facilitate navigation through tortuous arteries and/or avoid unwanted
side branches, Recall # Z-0030-2009;
b) Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260,
Sterilized with ethylene oxide gas, Rx only. The Platinum Plus"
Guidewire facilitates placement of a catheter during diagnostic or
interventional intravascular procedures. The wire can be torqued to
facilitate navigation through tortuous arteries and/or avoid unwanted
side branches, Recall # Z-0031-2009
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated August 25, 2008. Manufacturer: Boston Scientific Corp.,
Miami, FL. Firm initiated recall is ongoing.
REASON: Boston Scientific is initiating a voluntary recall of the
Platinum Plus" Guidewire (peripheral). BSC has received reports that
product may be labeled as a 260 CM long guidewire when the actual
packaged device is a 180 CM long guidewire and the product may be
labeled as a 180 CM long guidewire when the actual packaged device is a
260 CM long guidewire. There is no expected potential for injury to
either the patient or user resulting from this product issue. The most
serious adverse effect that is reasonably expected would be a slight
prolongation of the procedure due to product exchange. To date, Boston
Scientific has received two complaints in association to this product
issue. No adverse event have been reported to Boston Scientific.
PRODUCT: 3-0 Black Mono Nylon Suture, 12 units per box.
product number 925B. The product intended for use in general soft tissue
approximation and/or ligation including use in ophthalmic procedures,
Recall # Z-0034-2009
MANUFACTURER: Surgical Specialties Corp., Reading, PA, by letter dated
September 9, 2008. Firm initiated recall is ongoing.
REASON: Mislabeled product - labeled as 3-0 black mono nylon contains
4-0 black braided silk suture.
PRODUCT: IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay
for the quantitative determination of 25-hydroxyvitamin D and other
hydroxylated metabolites in serum or plasma. Ref: AC-57F1;
Enzymeimmunoassay for the quantitative determination of
25-hydroxyvitamin D and other hydroxylated metabolites in serum or
plasma, Recall # Z-0173-2009
MANUFACTURER: Recalling Firm: Immunodiagnostics Systems Inc., Fountain
Hills, AZ, by letter dated August 2, 2008 and August 8, 2008.
Manufacturer: Immunodiagnostics Systems Ltd., Boldon Colliery, UK. Firm
initiated recall is ongoing.
REASON: A small number of customers have experienced low absorbance
values when using kits from this batch.
PRODUCT: Bard Vacora Biopsy Vacuum Assisted Biopsy Probe;
Catalog numbers VB10118 and VB10140, Recall # Z-0183-2009
MANUFACTURER: Recalling Firm: Bard Peripheral Vascular Inc., Tempe, AZ,
by letter dated September 11, 2008 Manufacturer: Bard Shannon Limited,
Humacao, PR. Firm initiated recall is ongoing.
REASON: Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb
wheels from these lots may fracture when fired using the prime/pierce
option.
PRODUCT: 26" Vision Elect HDTV Surgical Viewing Monitor,
model number 0240030960, Manufactured by Stryker Endoscopy San Jose
Intended to be used as a visualization device for events occurring in
the sterile field for endoscopic surgical procedures, Recall #
Z-0196-2009
MANUFACTURER: Stryker Endoscopy, San Jose, CA, by letters dated
September 22, 2008. Firm initiated recall is ongoing.
REASON: Knob parts stick together, resulting in poor functionality of
the knob.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
October 29, 2008:
CLASS II
PRODUCT:
a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
(Versatile cardiac and Vascular imaging system). 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 of 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-1518-2008;
b) GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System
(Cardiovascular imaging system). 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 of 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-1519-2008;
c) GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System
(Vascular Angiography system). 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 of 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-1520-2008
MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by
visit beginning August 17, 2006. Manufacturer: GE Medical Systems, SCS,
Buc Cedex, France. Firm initiated recall is complete.
REASON: User was unable to hear the Innova 2100-IQ 5-minute fluoroscopy
warning signal from the Table Control TSSC interface. Inability of the
user to hear the audible signal indicating the completion of any preset
exposure time may lead to incorrect overall dose management, resulting
in unnecessary exposure and can be a contributing factor for skin
injury. The alarm can be heard in the control room.
PRODUCT: BI-700-00027 0-arm 1000 Imaging System Mobile
X-ray System Generating 2D and 3D images of human anatomy for surgical
applications, Recall # Z-2034-2008
MANUFACTURER: Medtronic Navigation, Inc., Littleton, MA, by site visit
on July 23, 2008. Firm initiated recall is complete.
REASON: Failure to comply with EER/AKR limits due to misinterpretation
of the measurement requirements specified in 21 CFR 1020.32 (d) (3)
(iii)
PRODUCT:
a) GE Precision MPi, model 5126893. GE Medical Systems - Americas,
Milwaukee, USA The product is used to generate radiographic and
fluoroscopic images of human anatomy, perform interventional procedures,
perform vascular and non-vascular procedures, and other specialized
applications, including angiographic studies, Recall # Z-2142-2008;
b) GE Precision MPi, model 2385125. The product is used to generate
radiographic and fluoroscopic images of human anatomy, perform
interventional procedures, perform vascular and non-vascular procedures,
and other specialized applications, including angiographic studies,
Recall # Z-2143-2008; c) GE Precision MPi, model 2398238. The product is
used to generate radiographic and fluoroscopic images of human anatomy,
perform interventional procedures, perform vascular and non-vascular
procedures, and other specialized applications, including angiographic
studies, Recall # Z-2144-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by visit
beginning June 2008. Manufacturer: NRT - Nordisk Rontgen Teknik A/S,
Hasselager, Denmark. Firm initiated recall is ongoing.
REASON: The Precision MPi collimator did not contain a label identifying
the device as being certified to comply with applicable requirements of
the x-ray performance standard.
PRODUCT:
a) Ultraview SL Command Module, Model 90496. The product is intended for
use with the Patient Care Monitoring System (PCMS) to acquire, monitor,
and process various clinical parameters from an adult or neonate/infant
populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include cardiac activity,
respiration, invasive and noninvasive pressure, temperature, oxygen
saturation (SpO2) and cardiac output. Acquired data may then be
communicated to an information network for display, recording, editing
and analysis, Recall # Z-2342-2008;
b) Ultraview SL Command Module, Model 91496 The product is intended for
use with the Patient Care Monitoring System (PCMS) to acquire, monitor,
and process various clinical parameters from an adult or neonate/infant
populations in any type of clinical environment other than home use.
Physiological parameters that may be monitored include cardiac activity,
respiration, invasive and noninvasive pressure, temperature, oxygen
saturation (SpO2) and cardiac output. Acquired data may then be
communicated to an information network for display, recording, editing
and analysis, Recall # Z-2343-2008
MANUFACTURER: Spacelabs Healthcare, Inc., Issaquah, WA, by letter on
July 22, 2008. Firm initiated recall is ongoing.
REASON: Potential for module to fail to obtain a NIBP reading on
hypertension patients.
PRODUCT:
a) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
44/38, code D; REF 01.00214.144. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2415-2008;
b) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
46/40, code F; REF 01.00214.146. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2416-2008;
c) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
48/42, code H; REF 01.00214.148. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2417-2008;
d) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
50/44, code J; REF 01.00214.150. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2418-2008;
e) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
52/46, code L; REF 01.00214.152. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2419-2008;
f) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
54/48, code N; REF 01.00214.154. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2420-2008;
g) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
56/50, code P; REF 01.00214.156. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2421-2008;
h) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
58/52, code R; REF 01.00214.158. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2422-2008;
i) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
60/54, code T; REF 01.00214.160. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2423-2008;
j) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
62/56, code V; REF 01.00214.162. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2424-2008;
k) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
64/58, code X; REF 01.00214.164. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2425-2008;
l) Zimmer Durom cup, Metasul Durom acetabular component, uncemented,
66/60, code Z; REF 01.00214.166. The product is component of the Metasul
LDH Head System intended for Noninflammatory degenerative joint disease.
(Hip replacement), Recall # Z-2426-2008
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN. by letter on
July 22, 2008 and by press release on July 23, 2008. Manufacturer:
Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
REASON: Instructions for use/surgical technique instructions are
inadequate.
PRODUCT: Ferno Model 35X PROFlexX Ambulance Stretcher,
Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance
stretcher is used to transport a patient during rescue or emergency
situations as well as a means to transport patients for general medical
purposes, Recall # Z-2465-2008
MANUFACTURER: Ferno-Washington, Inc., Wilmington, OH, by letters on
September 3, 2008. Firm initiated recall is ongoing.
REASON: The Ferno Model 35-X PROFlexx legs could experience metal
fatigue and possibly fracture after one to two years of use based on the
usage and method of operation.
PRODUCT: Foundation Knee System Tibial Fixed Impactor,
Revision A and B; Catalog #801-01-449. The Tibial Fixed Impactor, a part
of the Foundation Knee System, is a manual orthopedic surgical
instrument intended to lock onto the baseplate to impact the implant,
Recall # Z-2466-2008
MANUFACTURER: Encore Medical, Lp, Austin, TX, by letter starting on
August 4, 2007. Firm initiated recall is ongoing.
REASON: Complaints received regarding the fracture of the Nitronic 60
screw on the Tibial Fixed Impactor during surgery.
PRODUCT: Sonoline G50/G60 Ultrasound System, Software
versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile
software controlled diagnostic ultrasound system. Model numbers
07482800, 07482818, 07482826, 07478139, 07478147, and 07482479, Recall #
Z-2468-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc. Mountain View, CA, by
site visits beginning August 5, 2008. Firm initiated recall is ongoing.
REASON: As a result of bugs and calculation errors, the firm may display
incorrect or fail to display mechanical Index and thermal index values.
PRODUCT: Dideco, D901 Lilliput 1, Close Phisio, Sterile
EO, REF 05252). The product is intended for use in cardiopulmonary
bypass circuits as a device to replace the function of the lungs in
order to control the arterial/venous temperature and as a venous blood
reservoir, Recall # Z-2469-2008
MANUFACTURER: Recalling Firm: Sorin Group USA, Inc., Arvada, CO, by
letter on August 8, 2008. Manufacturer: Sorin Group, Mirandola, Italy.
Firm initiated recall is complete.
REASON: Under certain conditions, venous reservoir on oxygenator may
allow air into the system.
PRODUCT: Maxi Move Patient Lift with Lock & Load System (Combi
Hanger);
Models: 1) KMBB4CLU2FUS; 2) KMBB4MLU2FUS; 3) KMBB4MSU2FUS; 4)
KMBB4NLX2FUS; 5) KMBB4NSX2FUS, 6) KMBB4OLU2FUS; 7) KMBB4OSU2FUS; 8)
KMBB4PLX2FUS; 9) KMBB4PSX2FUS; 10) KMBB4QLU2FUS; 11) KMBB4RLX2FUS.
The lifter is intended to be used under the direct supervision of
trained personnel for the transfer of residents from one location to
another, Recall # Z-2470-2008
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by a Field Safety
Notice dated August 11, 2008. Manufacturer: Arjo Hospital Equipment,
Esloev, Sweden. Firm initiated recall is ongoing.
REASON: There is the potential for unintended dislocation of the Lock
and Load hanger assembly (Combi Hanger) from the t-bar attached to the
lifter jib of the Maxi Move patient lift.
PRODUCT:
a) Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation.
Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL
adjustable valve is an accessory designed for use with Medtronic
delivery systems to reduce blood loss during percutaneous catheter
procedures. It consists of an adjustable valve and flush port, Recall #
Z-2471-2008;
b) Medtronic Attain LDS 6216A, Left-heart delivery system. Sterilized.
The Medtronic Attain LDS Model 6216A Left-heart delivery system is
designed to facilitate lead implantation in the left heart, via the
coronary sinus. The Left-heart delivery system features one guide wire
to facilitate venous access, an adjustable valve to reduce blood loss
during the implant procedure, two pre-shaped guide catheters for passing
venogram balloon catheters and appropriate leads, a guide catheter
dilator to facilitate guide catheter passage, guide catheter slitters
for removing guide catheters, and a guide wire clip to help contain the
guide wire in the sterile field, Recall # Z-2472-2008;
c) Medtronic Attain ACCESS 6218A, Left-heart delivery system.
Sterilized. The Medtronic Attain Access Model 6218A Left-heart delivery
system is designed to facilitate lead implantation in the left heart,
via the coronary sinus. The Left-heart delivery system features one
guide wire to facilitate venous access, an adjustable valve to reduce
blood loss during the implant procedure, two guide catheters for passing
venogram balloon catheters and appropriate leads, a guide catheter
dilator to facilitate guide catheter passage, guide catheter slitters
for removing guide catheters, and a guide wire clip to help contain the
guide wire in the sterile field, Recall # Z-2473-2008
MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management,
Mounds View, MN, letter dated August 28, 2008. Manufacturer: Donatelle,
New Brighton, MN. Firm initiated recall is ongoing.
REASON: Medtronic has identified an issue with the packaging for
specific lots of the Medtronic Adjustable Valve and valves contained in
the Attain Left Heart Delivery System kits. A small number of valve
package seals could be compromised.
CLASS III
PRODUCT: Philips Telemonitoring System Software (M3811B) used with
Philips Telemonitoring System (M3810B) Revision: B.02.07 Prescriptive
medical device used to automatically collect and transmit medical
information (weight, blood pressure, non-diagnostic ECG) over phone
lines between provider and patient, Recall # Z-2369-2008
MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on July
22, 2008. Firm initiated recall is ongoing.
REASON: Software: If Weight Limits edited, values will return to default
values that were deleted
PRODUCT: FormPutty Bone Void Filler 10cc The product is
sealed in a foil pouch and then placed in a box following sterilization.
Part # 50-07-0100 Is a flowable resorbable porous bone void filler
composed of beta tricalcium phosphate and other calcium phosphates,
Recall # Z-2375-2008
MANUFACTURER: Recalling Firm: Theken Spine LLC, Akron, OH, by letter
dated July 11, 2008. Manufacturer: Therics, LLC, Akron, OH. Firm
initiated recall is ongoing.
REASON: The patient label inside the package has an expiration date of
2008-06 when the actual expiration date is 2010-06.
PRODUCT
a) Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343O,
Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for
cannula drainage of the superior and inferior vena cava during
extracorporeal circulation for a duration of less than and equal to 6
hours, Recall # Z-2401-2008;
b) Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA,
Sterile EO. Intended for cannula drainage of the superior and inferior
vena cava during extracorporeal circulation for a duration of less than
and equal to 6 hours, Recall # Z-2402-2008;
c) Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O,
33/43 Fr. x 39 cm, Sterile EO. Intended for cannula drainage of the
superior and inferior vena cava during extracorporeal circulation for a
duration of less than and equal to 6 hours, Recall # Z-2403-2008
MANUFACTURER: Edwards Lifesciences Research Medical, Inc., Midvale, UT,
by letter on July 14, and July 15, 2008. Firm initiated recall is
ongoing.
REASON: Reinforcement spring may detach from the cannula body resulting
in reduced venous blood return flow.
PRODUCT:
a) Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD
Kallestad (TM) HEp-2 Cell Line Substrate. Catalog #: 30471 - 12 well
kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit,
48 tests, Recall # Z-2428-2008;
b) Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells,
48 tests. Product labeled "BIO-RAD Kallestad (TM) Mouse Stomach/Kidney
Substrate, Recall # Z-2429-2008;
c) Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM)
Mouse Kidney Substrate; Catalog numbers: 30445 - 8 wells, 48 tests and
30447 - 8 well, 192 tests, Recall # Z-2430-2008
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letter on July 25,
2008. Firm initiated recall is ongoing.REASON: The Homogeneous Positive
control was released with a titer of 1:256 rather than the titer value
of 1:128 reported on the QC Report Label included with each test kit.
PRODUCT: OPHIT Optical Digital Visual Interface (DVI)
Extender, Part number 0100224051, a component of the Switchpoint
Infinity 1, Switchpoint Infinity 2, and Switchpoint Element. The OPHIT
Optical Digital Visual Interface (DVI) Extender is a converter and
transmitter for copper and fiber optic DVI signals, Recall # Z-2467-2008
MANUFACTURER: Stryker Communications, Corp., Flower Mound, TX, by
letters on April 1, 2008. Firm initiated recall is ongoing.
REASON: Product at times experiences intermittent signal loss due to
electromagnetic interference.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
October 22, 2008:
CLASS II
PRODUCT: Ultraview Digital Telemetry Transmitter, Model 91341-09 The
Spacelabs Medical Digital Telemetry system provides continuous
electrocardiographic (ECG) monitoring to detect ST segment changes,
abnormal cardiac rhythms, including a systole, ventricular fibrillation
and ventricular tachycardia, Recall # Z-2336-2008
MANUFACTURER: Spacelabs Healthcare, Inc., Issaquah, WA, by letter on
July 17, 2008. Firm initiated recall is ongoing.
REASON: During battery insertion there is potential for patient
waveforms to move to an open receiver module or to an occupied receiver
causing the intermittent inappropriate monitoring of both patients for
several minutes.
PRODUCT: HeartStarMRtX Defibrillator/Monitor Models:
M3535A/M3536A HeartStart MRx with a native 256Mbyte internal memory card
with date code "0308. The product is used for the termination of
ventricular tachycardia and ventricular fibrillation, Recall #
Z-2337-2008
MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on July
17, 2008. Firm initiated recall is ongoing.
REASON: Defective internal memory cards may exhibit one or more of the
following behaviors: "Device repeatedly restarts approximately every 20
seconds "Slow device start-up of approximately 15 seconds or more.
During this time, the MRx displays either a blank screen or the Philips
HeartStart MRx Start-up screen prior to displaying the selected mode of
operation (i.e. Monitor, AED, Pacing or Manual Defib mode). " Internal
Memory Failure INOP message when attempting to print an event from the
Data Management screen. "When printing from the Data Management screen,
a patients Event Summary prints with some clinical events missing.
PRODUCT: Sunrise Medical Quickie Groove Power Wheelchair
with Transit option The product is a powered wheelchair for human use,
Recall # Z-2339-2008
MANUFACTURER: Sunrise Medical, Inc., Fresno, CA, by telephone and
letters beginning on November 13, 2006. Firm initiated recall is
complete.
REASON: Rear bolts holding the frame in place may shear and the front
bolts may potentially come off the posts, resulting in partial or full
seat detachment in a sudden stop or crash.
PRODUCT
a) Exact Calcar Planer Rasp Style Blade, 38mm, REF 31-473795. Surgical
blades used to remove excess bone proximal to the broach face to all
instrument trial to seat properly, Recall # Z-2370-2008;
b) Exact Calcar Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc,
Warsaw, IN; REF 31-473796. Surgical blades used to remove excess bone
proximal to the broach face to all instrument trial to seat properly,
Recall # Z-2371-2008;
c) Exact Calcar Planer Rasp Style Blade, 46mm; REF 31-473797. Surgical
blades used to remove excess bone proximal to the broach face to all
instrument trial to seat properly, Recall # Z-2372-2008;
d) Exact Calcar Planer Rasp Style Blade, 50mm; REF 31-473798. Surgical
blades used to remove excess bone proximal to the broach face to all
instrument trial to seat properly, Recall # Z-2373-2008
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated July 18, 2008.
Firm initiated recall is ongoing.
REASON: The blades will oxidize after the first cleaning.
PRODUCT:
a) Access and Access 2 Immunoassay System, Recall # Z-2384-2008;
b) SYNCHRON LXi 725 System, Recall # Z-2385-2008;
c) Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System,
Recall # Z-2386-2008;
d) UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron
Access Clinical System, Recall # Z-2387-2008
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter
on April 16, 2008. Manufacturer: Beckman Coulter Inc., Fullerton, CA.
Firm initiated recall is ongoing.
REASON: The field action was initiated after the firm confirmed reports
of premature failure of the waste pump tubing in the Access and Access 2
Immunoassay Systems. Premature failure of the waste pump tubing may
negatively affect precision.
PRODUCT: NicoletOne photic adapter cable 085-463700,
Recall # Z-2389-2008
MANUFACTURER: Cardinal Health NeuroCare Division, Madison, WI, by letter
beginning June 5, 2008. Firm initiated recall is ongoing.
REASON: The photic adapter cable has a wiring error which delivers a
reduced voltage and results in a decreased intensity of the NicLED
photic. This reduced intensity may fail to elicit a response from a
photosensitive seizure disorder patient which may result in lack of
appropriate treatment for this disorder.
PRODUCT:
a) Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007,
Sterile, Latex free. The device is intended to be used as a urinary
incontinence device designed to drain urine from the bladder, Recall #
2390-2008;
b) Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018,
Sterile, Latex free. The device is intended to be used as a urinary
incontinence device designed to drain urine from the bladder, Recall #
Z-2391-2008;
c) Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036,
Sterile, Latex free. The device is intended to be used as a urinary
incontinence device designed to drain urine from the bladder, Recall #
Z-2392-2008; d) Apogee Intermittent Catheter with Coude tip, 12 Fr 16",
Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be
used as a urinary incontinence device designed to drain urine from the
bladder, Recall # Z-2393-2008;
e) Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref
No.1066, Sterile, Latex free. The device is intended to be used as a
urinary incontinence device designed to drain urine from the bladder,
Recall # Z-2394-2008
MANUFACTURER: Apogee Medical, Inc., Youngsville, NC, by letter on/about
July 17, 2008 with follow-up letters, telephone and emails. Firm
initiated recall is ongoing.
REASON: Due to a package seal defect the catheter tip may have been
inadvertently cut which could cause trauma to the urethra upon use. Also
the sterility of the product could be compromised.
PRODUCT: Power Drive. Battery-driven power tool system
intended for use during surgical procedures to provide power to operate
various accessories and attachments. Catalog number 530.100, Recall #
Z-2395-2008
MANUFACTURER: Synthes U S A, West Chester, PA, by letters beginning on
July 23, 2008. Manufacturer: Synthes Gmbh, Oberdorf, Switzerland. Firm
initiated recall is ongoing.
REASON: The product is mislabeled, as the validation for the previous
sterilization parameters cannot be replicated. The currently validated
sterilization parameter is a minimum of 24 minutes prevacuum.
PRODUCT:
a) Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With
Cuff 19cm From Tip), Catalog No./REF 10303101. Sterile, Recall #
Z-2396-2008;
b) Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With
Cuff 23cm From Tip), Catalog No./REF 10303102. Sterile, Recall #
Z-2397-2008;
c) Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With
Cuff 27cm From Tip), Catalog No./REF 10303103. Sterile, Recall #
Z-2398-2008
MANUFACTURER: Recalling Firm: Angiodynamics, Inc., Queensbury, NY, by
letters on/about July 10, 2008. Manufacturer: Via Biomedical, Maple
Grove, MN. Firm initiated recall is ongoing.
REASON: The cuff may be inadequately attached to the catheter, resulting
in possible catheter movement or leakage at the insertion site.
PRODUCT:
a) PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric
Immunoassay for the Quantitative Determination of Lp-PLA2 in human
plasma or serum. Product consists of a liquid, ready to use, two reagent
kit assembled in a kit box, Recall # Z-2399-2008;
b) PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the
quantitative determination of Lp-PLA2 in human plasma and serum, kit
containing coated microwell stripplate and reagents (12 strips, 1 set
calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23
mL, TMB, 11 mL, Stop solution, 11 mL, Recall # Z-2400-2008
MANUFACTURER: DiaDexus, Inc., South San Francisco, CA, by email and
letter dated July 18, 2008. Firm initiated recall is ongoing.
REASON: Product may give Lp-PLA2 values at up to 22% lower than accurate
values.
PRODUCT: GE Voluson® E8 Ultrasound System with software
versions 6.0.0, 6.0.1, 6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and
7.01. Intended for use by a qualified physician for ultrasound
evaluation of Fetal OB; abdominal (including GYN, pelvic and infertility
monitoring/follicle development); Pediatric; Small Organ (breast,
testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and
pediatric); Musculo-skeletal Conventional and Superficial; Peripheral
Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative
(abdominal , PV neurological), Recall # Z-2404-2008
MANUFACTURER: Recalling Firm: GE Healthcare, by letter dated April 1,
2008.
Manufacturer: GE Medical Systems, Kretziechnik GmbH & Co OHG, Zipf,
Austria. Firm initiated recall is ongoing.
REASON: Inaccurate dimension measurements in M-Mode when pan-Zoom is
activated in GE Voluson® E8 Ultrasound Systems. Of particular concern
are potential inaccuracies of fetal cardiac measurements that may impact
patient safety.
PRODUCT: Synchron Acetaminophen (ACTM) Reagent, Part
Number 472169. ACTM Reagent when used in conjunction with SYNCHRON LX
System(s), UniCel DxC 600/800 Systems and SYNCHRON Systems Drug
Calibrator 2 set, is intended for quantitative determination of
Acetaminophen concentration in human serum or plasma. Recall #
Z-2405-2008
MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by
letters beginning on July 21, 2008. Manufacturer: Beckman Coulter, Inc.,
Fullerton, CA. Firm initiated recall is ongoing.
REASON: Acetaminophen reagents (lots #M702524 & M703276) manufactured
with contaminated heparin has shown a negative bias in performance
between the assay made with contaminated and uncontaminated heparin.
PRODUCT: ACIST" BRACCO, AT P54 AngioTouch Kit, SKU #
014644, Sterile. Made in Mexico. Catalogue No: 800608-013 intended to be
used for the controlled infusion of radiopaque contrast media for
angiographic procedures, Recall # Z-2406-2008
MANUFACTURER: Recalling Firm: Acist Medical Systems, Eden Prairie, MN,
by letters dated July 9. 2008. Manufacturer: Nypro Healthcare Baja,
Tijuana, Mexico. Firm initiated recall is ongoing.
REASON: Some of the sterile package seals of AT P54 AngioTouch Kit were
breached. Breached package seals could compromise product sterility,
which could potentially lead to patient infection.
PRODUCT:
a) Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj
site, 2 Ultrasite inj sites, B/C valve 120 in. Item/Catalog number
375040. The product is shipped 20 units per carton. The product is used
with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion
System, Recall # Z-2407-2008; b) Adult Metriset w/Cassette 2 inj sites,
LL 120 in. Item/Catalog number 375043. The product is shipped 20 units
per carton. The product is used with the Horizon Pump, Horizon NXT Pump,
and Outlook Safety Infusion System, Recall # Z-2408-2008;
c) Safeline Metriset w/Cassette, inj sties, clamps LL 114 in.
Item/Catalog number 375122. The product is shipped 20 units per carton.
The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook
Safety Infusion System, Recall # Z-2409-2008;
d) Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog
number 375150. The product is shipped 20 units per carton. The product
is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety
Infusion System, Recall # Z-2410-2008;
e) Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site,
Ultrasite inj site, 88 in US1540. Item/Catalog number 375137. The
product is shipped 20 units per carton. The product is for use after
activation of shutoff valve (re-floating of disk), Recall #
Z-2411-2008;f) Add-On Burette Set with 150 ml burette and Ultrasite
Injection Site without automatic shutoff. Item/Catalog number 375111.
The product is shipped 20 units per carton. The product is for use after
activation of shutoff valve (re-floating of disk), Recall # Z-2412-2008;
g) Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site
with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set.
Item/Catalog number 375059. The product is shipped 20 units per carton.
The product is for use after activation of shutoff valve (re-floating of
disk), Recall # Z-2413-2008; h) Burette Set w/150 ml burette w/15 um
filter & inj site, inj site, with automatic shutoff 87 in. Item/Catalog
number 375113. The product is shipped 20 units per carton. The product
is for use after activation of shutoff valve (re-floating of disk),
Recall # Z-2414-2008
MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by
letter dated June 20, 2008. Manufacturer: B. Braun, Santo Domingosanto
Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON: Incorrect burette was packaged with the product.
PRODUCT: Kwiktrak Gate System; the rail system used with
the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists
of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550
- Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination
kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 -
Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560). The equipment
is intended for transferring lifts from one system track to another.
Recall # Z-2434-2008
MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated
August 1, 2008. Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm
initiated recall is ongoing.
REASON: There is a possibility that the Kwiktrak Gate System could
malfunction, resulting in the gate locks opening even though the
corresponding tracks are not properly aligned.
PRODUCT:
a) Innova 2000; The principle system components include a C-arm, image
acquisition, processing and archiving capabilities. Indicated for use in
generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Also indicated for generating
fluoroscopic images of human anatomy for cardiology, diagnostic, and
interventional procedures. Intended to replace fluoroscopic images
obtained through image intensifier technology, Recall # Z-2435-2008;
b) 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) Indicated for use in generating fluoroscopic images
of human anatomy for vascular angiography, diagnostic and interventional
procedures, and optionally, rotational imaging procedures. Also
indicated for generating fluoroscopic images of human anatomy for
cardiology, diagnostic, and interventional procedures. Intended to
replace fluoroscopic images obtained through image intensifier
technology, Recall # Z-2436-2008;
c) Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare,
Waukesha, WI 53188 (The system consists of an a monoplane Indicated for
use in generating fluoroscopic images of human anatomy for vascular
angiography, diagnostic and interventional procedures, and optionally,
rotational imaging procedures. Also indicated for generating
fluoroscopic images of human anatomy for cardiology, diagnostic, and
interventional procedures. Intended to replace fluoroscopic images
obtained through image intensifier technology, Recall # Z-2437-2008;
d) 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) Indicated for use in generating
fluoroscopic images of human anatomy for vascular angiography,
diagnostic and interventional procedures, and optionally, rotational
imaging procedures. Also indicated for generating fluoroscopic images of
human anatomy for cardiology, diagnostic, and interventional procedures.
Intended to replace fluoroscopic images obtained through image
intensifier technology, Recall # Z-2438-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter
dated July 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex,
France. Firm initiated recall is ongoing.
REASON: The charger and/or battery of the PDB may fail earlier than
expected with no advance warning and thus cause the system to shut down.
PRODUCT:
a) 500 mL InfoV.A.C. Canisters (with Gel); 1) Part #M8275063/5 (5
canister pack) and 2) Part #M8275063/10 (10 canister pack); products are
single use and labeled as STERILE, Recall # Z-2439-2008;
b) 500 mL InfoV.A.C. Canister (without Gel); 1) Part #M8275071/5 (5
canister pack) and 2) Part #M8275071/10 (10 canister pack); products are
single use and labeled as STERILE, Recall # Z-2440-2008
MANUFACTURER: Recalling Firm: KCI USA, Inc., San Antonio, TX, by letters
on July 29, 2008 Manufacturer: Avail State College, Bellefonte, PA. Firm
initiated recall is ongoing.
REASON: The port on the 500mL InfoV.A.C. Canister that connects to the
suction pump tubing was found to be partially or fully occluded with
plastic.
PRODUCT: MONARCH® II IOL Delivery System, Cartridge Model
B, part #8065977758, packaged in pouches, 10 pouches/carton, and labeled
in part ***for AcrySof® IOLs*** The product is used for implanting
intraocular lenses (IOLs) into the eye following cataract removal. Each
cartridge is imprinted with the model type on the wing of the Monarch II
cartridge which can be visually verified prior to use, Recall #
Z-2441-2008
MANUFACTURER: Recalling Firm: Alcon Laboratories, Inc., Fort Worth, TX,
by letter on July 7, 2008. Manufacturer: Alcon Manufacturing Ltd.,
Huntington, WV. Firm initiated recall is ongoing.
REASON: Delivery cartridge for implanting intraocular lenses is
mislabeled and may result in complicated insertion and damage to the
lens.
PRODUCT:
a) SERVO-i Ventilator System. The product is intended for treatment and
monitoring of patients in the range of neonates, infants and adults with
respiratory failure or respiratory insufficiency. Article number 64 87
800, Recall # Z-2442-2008;
b) SERVO-s Ventilator System. The product is intended for treatment and
monitoring of patients in the range of neonates, infants and adults with
respiratory failure or respiratory insufficiency. Article Number:
66-40-440, Recall # Z-2443-2008
MANUFACTURER: Recalling Firm: MAQUET Inc., Bridgewater, NJ, by letter on
July 7, 2008. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm
initiated recall is ongoing.
REASON: Maquet became aware of potentially defective crimpings at the
point connector attached to the cable in SERVO-i and SERVO-s
ventilators.
PRODUCT: Quicklock Tracker, Size 2; ref: 111.100. Device
is a surgical instrument, Recall # Z-2444-2008
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by telephone and
e-mail on/about April 27, 2006. Manufacturer: Orthosoft, Inc., Montreal,
Quebec, Canada. Firm initiated recall is complete.
REASON: The three-point array may break during use, resulting in
surgical delay and an increased risk of infection.
PRODUCT: NicoletOne 5.30.2 Software when used with CSeries
amplifiers in Fixed Room LTM Configurations with patient room kits. The
product is used for extended monitoring of EEG in a hospital setting.
The system provides connection between the patient room EEG acquisition
system and central control room, Recall # Z-2459-2008
MANUFACTURER: Cardinal Health NeuroCare Division, Madison, WI, by letter
dated June 23, 2008. Firm initiated recall is ongoing.
REASON: NicoletOne 5.30.2 Software when used with CSeries amplifiers in
Fixed Room LTM Configurations with patient room kits. The 3rd party room
relay connected to the A2 wall plate does not always activate if the
patient event button connected to the CSeries Amplifier is pressed twice
within one second.
PRODUCT: Cholestech GDX A1C Test Cartridge. The Cholestech
GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c
(HbA1c). Catalog #12-658, Recall # Z-2460-2008
MANUFACTURER: Recalling Firm: Cholestech Corp., Hayward, CA, by letter
dated August 3, 2006. Manufacturer: Provalis Diagnostics Limited,
Deeside, Flintshire CH5 2NU, UK. Firm initiated recall is complete.
REASON: Stability data indicated that the product would not meet
performance claims through the end of its shelf life.
PRODUCT: Quick Connect component p/n 201048. The component
is contained in: a) QPC1713 and b) QPC1724 Quick Connects. The QPC1724
is used to attach Pentax 70/70K/72/72K/80K/81K/90i/90K Series GI
Endoscopes with Water Jet to the C1160 Universal Flexible Processing
Tray in the SYSTEM 1 Sterile Processing System. The QPC1713 is used to
attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES without Water
Jet to the C1160 Universal Flexible Processing Tray in the SYSTEM 1
Sterile Processing System, Recall # Z-2462-2008
MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by letter dated
August 4, 2008. Manufacturer: Steris Corp., Hopkins Facility, Mentor,
OH. Firm initiated recall is ongoing.
REASON: During ongoing product development testing, it was discovered
that, when the two inflow barbs on adapter 201048 # 4 are in a position
to face one direction, the top Barlock may interfere with the top
surface of bottom barb of the adapter. The interference may cause the
plunger on the suction side to lift slightly which may affect flow of
sterilant into the suction lumen.
CLASS III
PRODUCT: Drystar AXYS, Hardcopy Printer A free standing device used to
print diagnostic conventional and mammography images on transparent film
for viewing on a standard view box. It may be used in any situation in
which a hard copy of an image generated by a medical imaging device is
required or desirable. ID number EYZ4E, Recall # Z-2136-2008
MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letters
on/about May 16, 2008. Manufacturer: Agfa-Gevart NV, Mortsel, Belgium.
Firm initiated recall is ongoing.
REASON: The "Film Calibration" setting on the printers was set to the
default "OFF" position instead of "ON".
PRODUCT: NobelReplace Tapered Groovy RP 4.3x10mm. These
products are root-form endosseous implants intended to be surgically
placed in the bone of the upper or lower jaw arches to support for
prosthetic devices. Ref 32216, Recall # Z-2240-2008
MANUFACTURER: Nobel Biocare USA, LLC, Yorba Linda, CA, by telephone and
letters beginning on November 2, 2007. Firm initiated recall is
complete.
REASON: The NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216
Lot#403504 has an incorrect cap label. The affected lot has a cap label
identifying the implant as "4.3x8". Since this cap label may be the only
means used for identifying the implant prior to surgery, it is possible
that a user would try to use the 10mm implant as an 8mm implant.
PRODUCT: Ocular Conformer, Sterile. The device is intended
to be used as a post eye surgery device to prevent closure or adhesion
during the healing process. Catalog number: 9574, Catalog number 9548,
Catalog number 9549, Catalog number 9779, and Catalog number 9780,
Recall # Z-2302-2008
MANUFACTURER: Recalling Firm: Porex Surgical, Inc., Newnan,GA, by phone
on March 28, 2008 and follow-up letter on/about March 31, 2008.
Manufacturer: R.O. Gulden & Co., Inc., Elkins Park, PA. Firm initiated
recall is complete.
REASON: The Ocular Conformers were distributed with an expired
expiration date.
PRODUCT: Histochemical PAS (Periodic Acid Schiff) Reaction
Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL,
Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL
and Periodic Acid Solution 225 mL'; Each kit provides reagents
sufficient for a maximum of 100 tests. Item number 64945/93, Recall #
Z-2303-2008
MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by e-mail and letter
on June 4, 2008. Firm initiated recall is ongoing.
REASON: Two complaints that kit was not performing properly with
positive controls.
PRODUCT: Corflo Anti-I.V. NG Tube for Pediatric and
Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe
Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP
and latex free; individually packaged, 10 tubes per carton; Product is
intended for use in those patients who require intermittent or
continuous tube feedings via the nasogastric or nasoenteric route.
Catalog/reorder number 20-1225AIV, Recall # Z-2306-2008
MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by
letter dated June 25, 2008. Manufacturer: VIASYS Medsystems, Wheeling,
IL. Firm initiated recall is ongoing.
REASON: The male Luer adapter may be the wrong component therefore the
feeding set would not be able to be connected to the tube nor would the
cap fit securely.
PRODUCT: Stryker Biotech OP- 1 Implant is indicated for
use as an alternative to autograft in recalcitrant long bone nonunions
where use of autograft is unfeasible and alternative treatments have
failed. Catalog Number: 100-25, Recall # Z-2311-2008
MANUFACTURER: Stryker Biotech, Hopkinton, MA, by letters dated June 24,
2008, June 30, 2008 and July 1, 2008. Firm initiated recall is ongoing.
REASON: Product package insert misprint-text offset.
PRODUCT:
a) Medtronic iCon Patient Programmer, model 3037. The Patient programmer
is a hand held, battery operated, microcontroller based device for use
by patients to control and monitor external and implantable devices. The
minimum amount of control involves the ability to turn therapy ON or
OFF; maximal control allows the patient to select from different
therapies and adjust the parameters with in the set therapy limits,
Recall # Z-2322-2008;
b) Medtronic Patient programmer, model 37742. The Patient programmer is
a hand held, battery operated, microcontroller based device for use by
patients to control and monitor external and implantable devices. The
minimum amount of control involves the ability to tun therapy ON or OFF;
maximal control allows the patient to select from different therapies
and adjust the parameters with in the set therapy limits, Recall #
Z-2323-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, by letters and visits beginning May 12, 2008. Manufacturer:
Benchmark Electronics Inc., Winona, MN. Firm initiated recall is
ongoing.
REASON: Medtronic is retrieving four (4) patient programmers that were
not properly loaded with application software. The application software
is needed for a patient programmer to synchronize and bond with a
neurostimulation device. Without this functionality a patient programmer
is not useable and can not communicate with a neurostimulation device.
PRODUCT: Integra Dermal Regeneration Template; 8 x 10 in.
(20 cm x 25 cm), Sterile; Catalog number 38101, Recall # Z-2328-2008
MANUFACTURER: Integra LifeSciences Corp., Plainsboro, NJ, by letter on
July 2, 2008. Firm initiated recall is ongoing.
REASON: Product labeled with an expiration date on May 2010, while the
actual expiration date should be April 2010.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
October 15, 2008:
CLASS II
PRODUCT: Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and
42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N
42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ
CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic
for use by health care professionals in the quantitative determination
of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the
quantitative measurement of creatinine in capillary, venous or arterial
blood. The Nova Biomedical products that contain the lithium batteries
include the following part numbers: Part # 41772 - Battery Assy, Part #
42215 - Battery Replacement pack, Part # 42224 - Kit Meter, Part # 43735
- Kit Meter EZ CHEM, Part # 43773 - Kit Meter, Part # 43811 - Battery
Replacement Pack EZ CHEM, Part # 44013 - Kit Meter, Part # 44014 - Kit
Meter and Part # 44251 - Kit Meter, Recall # Z-1472-2008
MANUFACTURER: Nova Biomedical Corporation, Waltham, MA, by telephone and
letters dated February 21, 2008 and March 17, 2008. Firm initiated
recall is ongoing.
REASON: Lithium batteries may fail if the glucose or creatinine meters
have been dropped.
PRODUCT:
a) Product Description : GE Healthcare Innova 3100 Digital Fluoroscopic
Imaging (Cardiovascular Imaging System), Recall # Z-1521-2008;
b) GE Healthcare Innova 4100 Digital Fluoroscopic Imaging, Recall #
Z-1522-2008
MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by
letter, dated June 2008. Manufacturer: GE Medical Systems, SCS, Buc
Cedex, France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of a potential condition that may
impact operator or patient safety. One customer has reported that
inability to terminate X-ray exposure after releasing the hand switch
control (located in the control room).
PRODUCT:
a) Deltec® 3000 Large Volume Infusion Pump, CE 0473, RX Only. Made in
UK. Reorder numbers 21-5301-01 & 21-5306-01. The product is used for
general drug delivery infusion therapies. The product is only intended
to be used by trained clinicians, Recall # Number : Z-1604-2008;
b) Deltec® Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only. Made
in the UK. Reorder number 21-5311-01. The product is used for general
drug delivery infusion therapies. The product is only intended to be
used by trained clinicians, Recall # Z-1605-2008
MANUFACTURER: Recalling Firm: Smiths Medical MD, Inc., Saint Paul MN, by
letter dated February 5, 2008. Manufacturer: Smiths Medical
International Ltd., Watford, UK. Firm initiated recall is ongoing.
REASON: The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models
3000 and 3100, may deliver an unintended bolus if the pump door is
opened and then immediately closed. This problem is due to a timing
delay when the pumping mechanism resets itself.
PRODUCT:
a) GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473,
2305495, 2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276,
2407576, 5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3,
2403790-3, and 2403791-3, GE Medical Systems - Americas: Milwaukee, USA.
The device is used to perform fluoroscopic examination of human anatomy,
Recall # Z-1610-2008;
b) Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424,
2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627,
2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5,
2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2,
46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE
Medical Systems – Americas: Milwaukee, USA. The device is used to
perform fluoroscopic examination of human anatomy, Recall # Z-1611-2008;
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated January 9,
2008. Firm initiated recall is ongoing.
REASON: GE Healthcare was notified that 2 recently installed Precision
500D systems were not in compliance with portions of the Performance
Standard for Diagnostic X-ray Equipment. X-ray production was possible
from the fluoroscopic X-ray tube when the Primary Protective Barrier was
not in position to intercept the X-ray beam. Users are recommended to
follow good clinical standards to ensure the Image Intensifier carriage
assembly is in the forward and locked position over the table top prior
to initiating a fluoroscopic X-ray procedure. A GE Healthcare Field
Engineer will schedule a field visit to inspect and replace the park
latch switch, as needed.
PRODUCT: Ultraview Digital Telemetry Transmitter, Model
90478 The Spacelabs Medical Digital Telemetry system provides continuous
electrocardiographic (ECG) monitoring to detect ST segment changes,
abnormal cardiac rhythms, including asystole, ventricular fibrillation
and ventricular tachycardia, Recall # Z-1652-2008
MANUFACTURER: Spacelabs Healthcare, Inc., Issaquah, WA, by letter dated
July 16, 2008. Firm initiated recall is ongoing.
REASON: Telemetry Modules are failing to alarm for low heart rate and
asystole.
PRODUCT:
a) Kendall Calf Garment - Reprocessed Sterile device used to cover calf
while conducting sterile procedures. Catalog No. 5329, Recall #
Z-1661-2008;
b) Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock
Connector Brown Trim, Latex Free - Reprocessed Sterile device --
Pneumatic tourniquet. Cataloge No 60-7075-006, Recall # Z-1662-2008;
c) Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed
Sterile device – Pulse Oximeter. Catalog No. MAX-N, Recall #
Z-1663-2008;
d) Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse
Oximeter. Catalog No. MAX-A, Recall # Z-1664-2008;
e) Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible
limb sleeve. Catalog No. P3808, Recall # Z-1665-2008;
f) Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile
device – Compressible limb sleeve. Catalog No DVT-10, Recall #
Z-1666-2008;
g) Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device --
Orthopedic Arthroscope. Catalog No 225301, Recall # Z-1667-2008;
h) Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device --
Orthopedic Arthroscope. Catalog No A1336-01, Recall # Z-1668-2008;
i) Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No AS1335-01, Recall # Z-1669-2008;
j) Mitek Angled Side Effect Electrode - Reprocessed Sterile device --
Orthopedic Arthroscope. Catalog No 225302, Recall # Z-1670-2008;
k) Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device --
Compressible limb sleeve. Catalog No DVT-30, Recall # Z-1671-2008;
l) VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible
limb sleeve. Catalog VP 520, Recall # Z-1672-2008;
m)Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile
device -- Pneumatic tourniquet. Catalog No 60-7075-003, Recall #
Z-1673-2008;
n) Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope
and accessories. Catalog No CTI-512N, Recall # Z-1674-2008;
o) Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered
Saw and Accessories. Catalog No 506090, Recall # Z-1675-2008;
p) Kendall Thigh Garment - Reprocessed Sterile device -- Compressible
limb sleeve. Catalog No 9530, Recall # Z-1676-2008;
q) Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device --
Powered Saw and Accessories. Catalog No 2296-3-105, Recall #
Z-1677-2008;
r) Color Cuff II, Double Port Single Bladder - Reprocessed Sterile
device -- Pneumatic tourniquet. Catalog No DT-7034-02-QC, Recall #
Z-1678-2008;
s) Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic
tourniquet. Catalogue No 60-7070-106, Recall # Z-1679-2008;
t) Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No AS1337-01, Recall # Z-1680-2008;
u) Mitek Angled Side Effect Electrode - Reprocessed Sterile device --
Orthopedic Arthroscope. Catalog No 225304, Recall # Z-1681-2008;
v) Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device --
Powered Sawand Accessories. Catalog No 2296-3-114, Recall # Z-1682-2008;
w) Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse
Oximeter. Catalog No I-20, Recall # Z-1683-2008
MANUFACTURER: Recalling Firm: Ascent Healthcare Solutions, Inc.,
Lakeland, FL, by letter on March 11, 2008. Manufacturer: Venice
International, Orlando, FL. Firm initiated recall is ongoing.
REASON: Sterility Compromised -- Ascent Healthcare Solutions cannot
validate the sterilization process for a variety products.
PRODUCT:
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827, Recall #
Z-1713-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by visit beginning March 29,
2007. Firm initiated recall is complete.
REASON: The actual average illuminance for the collimators are
approximately 140-lux. This does not meet the 160-lux requirement. GE
will be correcting the units by replacing all collimators.
PRODUCT: GE Datex-Ohmeda Engstrom Carestation. The
Carestation consists of three main components: a display, a ventilator
unit, and an optional module bay. The display allows the user to
interface with the system and control settings. The ventilator unit
controls electrical power, nebulization, and pneumatic gas flow to and
from the patient. The module bay allows the integration of various
patient monitoring modules with the ventilator. This issue affects all
of the Engström Carestations shipped between 12/4/2006 and 9/4/2007,
encompassed by serial numbers CBCK00464 through CBCL01134, Recall #
Z-1829-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter on
May 12, 2008. Manufacturer: Datex – Ohmeda, Inc., Madison, WI. Firm
initiated recall is ongoing.
REASON: There is a correction associated with Engstrom Carestation with
an integrated Aerogen Professional Nebulizer System. There is an issue
relating to the removal of the nebulizer cable from nebulizer connection
port, which, when done while the nebulizer is active, may result in the
discontinuance of mechanical ventilation.
PRODUCT: a) Gambro Cartridge Blood Set, 003410-510, is
intended for single use in a hemodialysis treatment using the Phoenix
and Centry system 3 Dialysis Delivery Systems, Z-1860-2008; b) Gambro
Cartridge Blood Set, 0141080XXXC, is intended for single use in a
hemodialysis treatment using the Phoenix and Centry system 3 Dialysis
Delivery
Systems, Recall # Z-1861-2008
MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO,
by letter on May 2, 2008 and May 27, 2008. Manufacturer: Gambro Renal
Products S.A. de C.V., Tijuana, B.C. Mexico. Firm initiated recall is
ongoing.
REASON: Dialysis tubing sets may have occlusions restricting blood flow.
PRODUCT: Hawkins III Breast Localization Needle. Product #
243075. The product is used in the marking of non-palpable lesions,
Recall # Z-1878-2008
MANUFACTURER: Medical Device Technologies, Inc., Gainesville, FL, by
letter on May 6, 2008. Firm initiated recall is ongoing.
REASON: The sterility of the product cannot be guaranteed.
PRODUCT: GE Healthcare Definium 8000 Digital Radiographic
System, model number 5135678. The intended use of this product is to
generate tomographic images of human anatomy, Recall # Z-1883-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by visit beginning January 1,
2008. Firm initiated recall is ongoing.
REASON: Not properly labeling the manual switch for disabling positive
beam limitation (PBL) located on the overhead tube support user
interface as required.
PRODUCT: a) GE OEC 9800 Fluoroscopic X-Ray System. The
intended use of this device is to perform mobile fluoroscopic
examination of human anatomy, Recall # Z-1884-2008; b) GE OEC 9900 Elite
Fluoroscopic X-Ray System. The intended use of this device is to perform
mobile fluoroscopic examination of human anatomy, Recall # Z-1885-2008
MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, UT, by letter
on August 12, 2008. Firm initiated recall is ongoing.
REASON: Beam limitation may be non-compliant on some X-ray units.
PRODUCT:
a) Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model
Number: 340-1001, Recall # Z-1896-2008;
b) Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001,
Recall # Z-1897-2008;
c) Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101,
Recall # Z-1898-2008;
d) Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model
Number: 360-1101, Recall # Z-1899-2008;
e) PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number:
360-1301;Recall # Z-1900-2008
MANUFACTURER: Curlin Medical Llc, Huntington Beach, CA, by letter on May
30, 2008. Firm initiated recall is ongoing.
REASON: Over-delivery/free-flow involving Curlin ambulatory peristaltic
multi-therapy infusion pumps where the pumping chamber door (platen) had
become deformed in a manner that permitted gravity flow.
PRODUCT:
1) Margron DTC Hip Replacement System; Margron hip - Femoral neck Y,
sterile; REF 1-746-000. Product is used for Orthopedic surgery, Recall #
Z-1931-2008;
2) Margron DTC Hip Replacement System; Margron hip - Femoral neck Z,
sterile;REF 1-747-000. Product is used for Orthopedic surgery, Recall #
Z-1932-2008;
3) Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ,
sterile;REF 1-750-000. Product is used for Orthopedic surgery, Recall #
Z-1933-2008;
4) Margron DTC Hip Replacement System; Margron hip - Femoral neck A,
sterile; REF 1-654-000. Product is used for Orthopedic surgery, Recall #
Z-1934-2008;
5) Margron DTC Hip Replacement System; Margron hip - Femoral neck B,
sterile; REF 1-656-000. Product is used for Orthopedic surgery, Recall #
Z-1935-2008;
6) Margron DTC Hip Replacement System; Margron hip - Femoral neck C,
sterile; REF 1-658-000. Product is used for Orthopedic surgery, Recall #
Z-1936-2008;
7) Margron DTC Hip Replacement System; Margron hip - Femoral neck CB+6,
sterile; REF 1-685-000. Product is used for Orthopedic surgery, Recall #
Z-1937-2008;
8) Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A,
sterile; REF 1-686-000. Product is used for Orthopedic surgery, Recall #
Z-1938-2008;
9) Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A,
sterile; REF 1-687-000. Product is used for Orthopedic surgery, Recall #
Z-1939-2008;
10) Margron DTC Hip Replacement System; Margron hip - Femoral neck C-B,
sterile; REF 1-688-000. Product is used for Orthopedic surgery, Recall #
Z-1940-2008;
11) Margron DTC Hip Replacement System; Margron hip - Femoral neck B+4,
sterile; REF 1-689-000. Product is used for Orthopedic surgery, Recall #
Z-1941-2008;
12) Margron DTC Hip Replacement System; Margron hip - Femoral neck C+6,
sterile; REF 1-690-000. Product is used for Orthopedic surgery, Recall #
Z-1942-2008;
13) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0,
sterile; REF 1-726-000. Product is used for Orthopedic surgery, Recall #
Z-1943-2008;
14) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0,
sterile; REF 1-727-000. Product is used for Orthopedic surgery, Recall #
Z-1944-2008;
15) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0,
sterile; REF 1-647-000. Product is used for Orthopedic surgery, Recall #
Z-1945-2008;
16) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+0,
sterile; REF 1-648-000. Product is used for Orthopedic surgery, Recall #
Z-1946-2008;
17) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+0,
sterile; REF 1-649-000. Product is used for Orthopedic surgery, Recall #
Z-1947-2008;
18) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+0,
sterile; REF 1-650-000. Product is used for Orthopedic surgery, Recall #
Z-1948-2008;
19) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0,
sterile; REF 1-651-000. Product is used for Orthopedic surgery, Recall #
Z-1949-2008;
20) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+0,
sterile; REF 1-652-000. Product is used for Orthopedic surgery, Recall #
Z-1950-2008;
21) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1,
sterile; REF 1-730-061. Product is used for Orthopedic surgery, Recall #
Z-1951-2008;
22) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+2,
sterile;REF 1-730-062. Product is used for Orthopedic surgery, Recall #
Z-1952-2008;
23) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1,
sterile; REF 1-730-071. Product is used for Orthopedic surgery, Recall #
Z-1953-2008;
24) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2,
sterile;REF 1-730-072. Product is used for Orthopedic surgery, Recall #
Z-1954-2008;
25) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+1,
sterile; REF 2-662-011. Product is used for Orthopedic surgery, Recall #
Z-1955-2008;
26) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2,
sterile, REF 2-662-012. Product is used for Orthopedic surgery, Recall #
Z-1956-2008;
27) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1,
sterile; REF 2-662-021. Product is used for Orthopedic surgery, Recall #
Z-1957-2008;
28) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2,
sterile, REF 2-662-022. Product is used for Orthopedic surgery, Recall #
Z-1958-2008;
29) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1,
sterile; REF 2-662-031. Product is used for Orthopedic surgery, Recall #
Z-1959-2008;
30) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+2,
sterile; REF 2-662-032. Product is used for Orthopedic surgery, Recall #
Z-1960-2008;
31) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+1,
sterile; REF 2-662-041. Product is used for Orthopedic surgery, Recall #
Z-1961-2008;
32) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2,
sterile; REF 2-662-042. Product is used for Orthopedic surgery, Recall #
Z-1962-2008;
33) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1,
sterile; REF 2-662-051. Product is used for Orthopedic surgery, Recall #
Z-1963-2008;
34) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2,
sterile; REF 2-662-052. Product is used for Orthopedic surgery, Recall #
Z-1964-2008;
35) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+1,
sterile; REF 2-662-061. Product is used for Orthopedic surgery, Recall #
Z-1965-2008;
36) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+2,
sterile; REF 2-662-062. Product is used for Orthopedic surgery, Recall #
Z-1966-2008;
37) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes Y+3, sterile; REF 1-730-963. Product is used for Orthopedic
surgery, Recall # Z-1967-2008;
38) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes Y+4, sterile; REF 1-730-964. Product is used for Orthopedic
surgery, Recall # Z-1968-2008;
39) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
sutureholes Y+5, sterile; REF 1-730-965. Product is used for Orthopedic
surgery, Recall # Z-1969-2008;
40) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
sutureholes Z+3, sterile; REF 1-730-973. Product is used for Orthopedic
surgery, Recall # Z-1970-2008;
41) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes Z+4, sterile; REF 1-730-974. Product is used for Orthopedic
surgery, Recall # Z-1971-2008;
42) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes Z+5, sterile; REF 1-730-975. Product is used for Orthopedic
surgery, Recall # Z-1972-2008;
43) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 1+3, sterile; REF 2-662-913. Product is used for Orthopedic
surgery, Recall # Z-1973-2008;
44) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 1+4, sterile; REF 2-662-914. Product is used for Orthopedic
surgery, Recall # Z-1974-2008;
45) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 1+5, sterile; REF 2-662-915. Product is used for Orthopedic
surgery, Recall # Z-1975-2008;
46) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 2+3, sterile; REF 2-662-923. Product is used for Orthopedic
surgery, Recall # Z-1976-2008;
47) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 2+4, sterile; REF 2-662-924. Product is used for Orthopedic
surgery, Recall # Z-1977-2008;
48) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 2+5, sterile, Portland Orthopaedics Inc., St. Clair, MI;
REF 2-662-925. Product is used for Orthopedic surgery, Recall #
Z-1978-2008;
49) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI;
REF 2-662-933. Product is used for Orthopedic surgery, Recall #
Z-1979-2008;
50) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 3+4, sterile, Portland Orthopaedics Inc., St. Clair, MI;
REF 2-662-934. Product is used for Orthopedic surgery, Recall #
Z-1980-2008
51) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 3+5, sterile; REF 2-662-935. Product is used for Orthopedic
surgery, Recall # Z-1981-2008;
52) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 4+3, sterile; REF 2-662-943. Product is used for Orthopedic
surgery, Recall # Z-1982-2008;
53) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 4+4, sterile; REF 2-662-944. Product is used for Orthopedic
surgery, Recall # Z-1983-2008;
54) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 4+5, sterile; REF 2-662-945. Product is used for Orthopedic
surgery, Recall # Z-1984-2008;
55) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 5+3, sterile; REF 2-662-953. Product is used for Orthopedic
surgery, Recall # Z-1985-2008;
56) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 5+4, sterile; REF 2-662-954. Product is used for Orthopedic
surgery, Recall # Z-1986-2008;
57) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 5+5, sterile; REF 2-662-955. Product is used for Orthopedic
surgery, Recall #Z-1987-2008;
58) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 5+6, sterile; REF 2-662-956. Product is used for Orthopedic
surgery, Recall # Z-1988-2008;
59) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes6+3, sterile; REF 2-662-963. Product is used for Orthopedic
surgery, Recall # Z-1989-2008;
60) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 6+4, sterile; REF 2-662-964. Product is used for Orthopedic
surgery, Recall # Z-1990-2008;
61) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 6+5, sterile; REF 2-662-965, Recall # Z-1991-2008;
62) Margron DTC Hip Replacement System; Margron hip - Femoral stem +
suture holes 6+6, sterile; REF 2-662-966, Recall # Z-1992-2008;
63) Margron DTC Hip Replacement System; Margron hip extension module
AA6, sterile; REF 2-662-201. Product is used for Orthopedic surgery,
Recall #Z-1993-2008;
64) Margron DTC Hip Replacement System; Margron hip extension module
AA7, sterile; REF 2-662-202. Product is used for Orthopedic surgery,
Recall # Z-1994-2008;
65) Margron DTC Hip Replacement System; Margron hip extension module
BB6, sterile, REF 2-662-203. Product is used for Orthopedic surgery,
Recall #Z-1995-2008;
66) Margron DTC Hip Replacement System; Margron hip extension module
BB7,sterile; REF 2-662-204. Product is used for Orthopedic surgery,
Recall # Z-1996-2008;
67) Margron DTC Hip Replacement System; Margron hip extension module
CC7, sterile; REF 2-662-205. Product is used for Orthopedic surgery,
Recall # Z-1997-2008;
68) Margron DTC Hip Replacement System; Margron hip extension module
YY6, sterile; REF 2-731-005. Product is used for Orthopedic surgery,
Recall # Z-1998-2008;
69) Margron DTC Hip Replacement System; Margron hip extension module
YY7, sterile; REF 2-731-006. Product is used for Orthopedic surgery,
Recall # Z-1999-2008;
70) Margron DTC Hip Replacement System; Margron hip extension module
ZZ6, sterile; REF 2-731-007. Product is used for Orthopedic surgery,
Recall # Z-2000-2008;
71) Margron DTC Hip Replacement System; Margron hip extension module
ZZ7, sterile; REF 2-731-008. Product is used for Orthopedic surgery,
Recall # Z-2001-2008
MANUFACTURER: Portland Orthopaedics Pty, Ltd., Saint George Hospital,
Kogarah, Australia, by letters dated June 20, 2008. Firm initiated
recall is ongoing.
REASON: Australian data indicates the product is associated with a
higher than average rate of hip replacement revision surgery.
PRODUCT: 6.5 Cancellous Bone Screw 25 mm; Made in USA;
Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to
augment the fixation of compatible acetabular cups, Recall # Z-2007-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
on December 20, 2005. Firm initiated recall is ongoing.
REASON: One lot of 6.5 Cancellous Bone Screws 25 mm was packaged and
labeled as 25 mm in length when it maybe 20 mm in length.
PRODUCT:
1) 5 Hole Locking 1st Tarsometatarsal Plate. REF 70-0007-S, Recall #
Z-2108-2008;
2) 4 Hole Locking 1st Tarsometatarsal Plate. REF 70-0008-S, Recall #
Z-2109-2008;
3) 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. REF 70-0009-S,
Recall # Z-2110-2008;
4) Left Locking Proximal Metatarsal Wedge Plate. REF 70-0010-S, Recall #
Z-2111-2008;
5) Right Locking Proximal Metatarsal Wedge Plate. REF 70-0011-S, Recall
# Z-2112-2008;
6) Left Locking Dorsal 1st MTP Fusion Plate. REF 70-0012-S, Recall #
Z-2113-2008;
7) Left Locking 1st MTP Revision Fusion Plate. REF 70-0018-S, Recall #
Z-2114-2008;
8) Right Locking 1st MTP Revision Fusion Plate. REF 70-0019-S, Recall #
Z-2115-2008;
9) Left Locking 2nd MTP/MPJ Combo Fusion Plate. REF 70-0036-S, Recall #
Z-2116-2008;
10) Right Locking 1st MTP/MPJ Combo Fusion Plate, REF 70-0037-S, Recall
# Z-2117-2008;
11) 6mm Bone Graft Drill. Product labeled in part, Size: 6mm Bone Graft
Drill... REF BG-8006-S, Recall # Z-2118-2008;
12) 10mm Bone Graft Drill. Product labeled in part, Size: 10mm Bone
Graft Drill... REF BG-8020-S, Recall # Z-2119-2008;
13) Locking Clavicle Plate, 10 Holes Large Left. Product labeled in
part, REF PL-CL10LL-S, Recall # Z-2120-2008;
14) Locking Clavicle Plate, 10 Holes Large Right. Product labeled in
part, REF PL-CL10LR-S, Recall # Z-2121-2008;
15) Locking Clavicle Plate, 6 Holes Small Left. REF PL-CL6SL-S, Recall #
Z-2122-2008;
16) Locking Clavicle Plate, 6 Holes Small Right. REF PL-CL6SR-S, Recall
# Z-2123-2008;
17) Locking Clavicle Plate, 8 Holes, J-Plate Left., REF PL-CL8JL-S,
Recall # Z-2124-2008;
18) Locking Clavicle Plate, 8 Holes, J-Plate Right. REF PL-CL8JR-S,
Recall # Z-2125-2008;
19) Locking Clavicle Plate, 8 Holes Large Left. REF PL-CL8LL-S, Recall #
Z-2126-2008;
20) Locking Clavicle Plate, 8 Holes Large Right. REF PL-CL8LR-S, Recall
# Z-2127-2008;
21) Locking Clavicle Plate, 8 Holes Medium Left. REF PL-CL8ML-S, Recall
# Z-2128-2008;
22) Locking Clavicle Plate, 8 Holes Medium Right. REF PL-CL8MR-S, Recall
# Z-2129-2008;
23) Locking Clavicle Plate, 8 Holes Small Right. REF PL-CL8SR-S, Recall
# Z-2130-2008;
24) Locking Clavicle Plate, 9 Holes, J-Plate Left. REF PL-CL9JL-S,
Recall # Z-2131-2008;
25) Locking Clavicle Plate, 9 Holes, J-Plate Right. REF PL-CL9JR-S,
Recall # Z-2132-2008
MANUFACTURER: Acumed LLC, Hillsboro, OR, by fax or e-mail on February
14, 2008, February 20, March 25, 2008 and July 16, 2008. Firm initiated
recall is ongoing.
REASON: Product sterility may be compromised.
PRODUCT: Isoloc Software, Version 6.6, 6.5, and 6.0. Part
# MT-NW-425-520. Software computer hard disc reads “ISOLOC 6.6 Copyright
NMPE Copyright 1997-2004 NMPE Build # 10302006 CIVCO Medical Solutions
is an EPID-based (electronic portal imaging device) version of
localization software for determining the treatment machine position of
radiotherapy targets, Recall # Z-2137-2008
MANUFACTURER: Recalling Firm: Civco Medical Instruments, Inc., Kalona,
IA, by letter on June 16, 2008. Manufacturer: Northwest Medical Physics
Equipment, Inc., Everett, WA. Firm initiated recall is ongoing.
REASON: A localization may be produced which has the incorrect moves,
and therefore, could place the patient in the incorrect location.
PRODUCT: GE Precision RXi Digital remote X-Ray Imaging R&F
System, model 5117828. The product is used for performing general R&F,
radiology, fluoroscopy, interventional and angiography
procedures/applications, Recall # Z-2145-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by visit
beginning May l, 2008. Manufacturer: General Medical Merate, Seriate,
Italy. Firm initiated recall is ongoing.
REASON: The Precision RXi collimator did not contain a label identifying
the device as being certified to comply with applicable requirements of
the x-ray performance standard.
PRODUCT:
a) GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS
Full Field Mammography system, models 2383168, 2383168-2, 2383168-3,
2383168-3-1, 2383168-4-1. The expected use of the Senographe DS
Stereotaxy is an optional accessory for the Senographe system for
mammography examinations, Recall # Z-2146-2008;
b) GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS
Full Field Mammography system, models 2383168, 2383168-2, 2383168-3,
2383168-3-1, 2383168-4-1. The expected use of the Senographe DS
Stereotaxy is an optional accessory for the Senographe system for
mammography examinations, Recall # Z-2147-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter,
dated March 3, 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex,
France. Firm initiated recall is ongoing.
REASON: GE Healthcare has recently become aware of x-ray emission beyond
the edge of the detector primary barrier. This issue occurs when an exam
is performed in a specific angulated view associated with use of the
Stereotactic Positioner of your Senographe DS Acquisition system and
could impact patient safety. If the Stereotactic Positioner is removed
when the examination arm is at 33 degrees and, the operator exits the
Stereo Medical application, then starts a new examination in standard
mode, this allows the user to perform an acquisition that leads to x-ray
emission beyond the edge of the detector. There have been no reports of
exposure to unintended x-ray emission.
PRODUCT:
a) Flexipet Denuding pipette 130 micron. The product is boxed with 5
vials of 10. The device is used for the intracytoplasmic single sperm
injection of oocytes, Recall # Z-
2176-2008;
b) Flexipet Manipulation pipette 300 micron. The device is used for the
intracytoplasmic single sperm injection of oocytes, Recall # Z-2177-2008
MANUFACTURER: Cook Vascular Inc., Vandergrift, PA, by letter on March 3,
2008. Firm initiated recall is complete.
REASON: Mislabeled - 300 micron flexipets labeled as 130 micron and vice
versa.
PRODUCT:
a) Hologic Discovery Bone Densitometers with Apex software versions 2.0,
2.1 and 2.2is indicated for the estimate of bone mineral density,
comparison of measured variables obtained from a given scan to a
database of reference values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2184-2008;
b) Hologic QDR4500 Bone Densitometers with Apex software versions 2.0,
2.1 and 2.2 is indicated for the estimate of bone mineral density,
comparison of measured variables obtained from a given scan to a
database of reference values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2185-2008;
c) Hologic Delphi Bone Densitometers with Apex software versions 2.0,
2.1 and 2.2 is indicated for the estimate of bone mineral density,
comparison of measured variables obtained from a given scan to a
database of reference values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2186-2008;
d) Hologic Explorer Bone Densitometers with Apex software versions 2.0,
2.1 and 2.2 is indicated for the estimate of bone mineral density,
comparison of measured variables obtained from a given scan to a
database of reference values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2187-2008;
e) Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1
and 2.2 is indicated for the estimate of bone mineral density,
comparison of measured variables obtained from a given scan to a
database of reference values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2188-1991
MANUFACTURER: Hologic, Inc., Bedford, MA, by letter dated June 27, 2008.
Firm initiated recall is ongoing.
REASON: Software densitometer readings for left hip and lumbar spine
under certain conditions may be inaccurate.
PRODUCT: Plastic Cannula Holdex® Tube Holder, Item number:
450216. It is intended for use in routine specimen withdrawal from
specimen collection bags or bottles through needleless cannula ports,
Recall # Z-2198-2008
MANUFACTURER: Recalling Firm: Greiner Bio-One North America, Inc.,
Monroe, NC, by letters on August 6, 2008. Manufacturer: Greiner Bio-One
Gmbh, Kremsmunster, Austria. Firm initiated recall is ongoing.
REASON: At removal of the tube from the holder the needle may dislodge
and become stuck in the tube stopper with the blunt end of the needle
facing out.
PRODUCT: MEDTOXscan Reader. Product number: 833062, Recall
# Z-2202-2008
MANUFACTURER: Medtox Diagnostics, Inc., Burlington, NC, by telephone
starting February 8, 2008. Firm initiated recall is ongoing.
REASON: Reader was marketed without a 510(k).
PRODUCT: Acuson CV70 Ultrasound systems Ultrasonic Pulsed
echo/doppler imaging system with Software revisions less than 4.0.0b,
material number 784539, 7848521, and 7848547. Is a general purpose,
mobile, software-controlled, diagnostic ultrasound system with an
on-screen display for thermal and mechanical indices related to
potential bioeffect mechanisms, Recall # Z-2212-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc, Mountain View, CA, by
visit beginning June 4, 2008. Firm initiated recall is ongoing.
REASON: System may either display incorrect mechanical and thermal index
values, or fail to display them altogether.
PRODUCT: Metal Hemiarthroplasty, MDL E536687, Part #
03-6000-1, 03-6000-02, 03-600-03, 03-6000-04. Hemi is designed to
supplement first metatarsal Phalangeal joint arthroplasty, Recall #
Z-2228-2008
MANUFACTURER: Recalling Firm: OrthoPro LLC, Salt Lake City, UT, verbally
notified on May 29, 2008. Manufacturer: Thortex (Malaysia) Sdn Bhd,
Penang, Malaysia. Firm initiated recall is complete.
REASON; Labeling presented conflicting information as to whether device
was sterile or not.
PRODUCT: Reflex Revision Screwdriver Inner Shaft is an
orthopedic manual surgical instrument that is a nonpowered, hand held
device intended for medical purposes to manipulate tissue or for use
with other devices in orthopedic surgery. Ref Number 48500900; Non
Sterile, Recall # Z-2238-2008
MANUFACTURER: Recalling Firm: Stryker Spine, Allendale, NJ, by letters
beginning June 5, 2008. Manufacturer: Stryker Spine, Cestas, Aquitane,
France. Firm initiated recall is ongoing.
REASON; The Inner Shaft does not extend far enough from the tip of the
Revision Screwdriver to fully engage the bone screw.
PRODUCT: ARCHITECT i1000SR System Assay CD ROM WW
(excluding US) Special edition Version 1.01 and Version 2.0; list
01P61-01 and 01P61-02. The device is intended to duplicate manual
analytical procedures by performing automatically various steps such as
pipetting, preparing filtrates, heating, and measuring color intensity,
Recall # Z-2239-2008
MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter on June
16, 2008. Firm initiated recall is ongoing.
REASON: When running the Automated Dilution Protocol with the assay
files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a
software error [9010 (Pipettor Robotics) preventing (Process Path) from
operating] is generated and the instrument stops running. No results are
generated.
PRODUCT: Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord
Stimulation (SCS). Contents of the inner package are STERILE. Method of
sterilization: Ethylene Oxide. Model 3998 lead is an implantable,
permanent lead. It is used to deliver electrical pulses to the dorsal
aspect of the spinal cord. The lead consists of two polyurethane lead
bodies joined to one silicone rubber paddle. The lead has two parallel
rows of four platinum iridium electrodes on the distal end, Recall #
Z-2241-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, by letters in May 2008. Manufacturer: Medtronic Puerto Rico Inc.,
Villalba, PR. Firm initiated recall is ongoing.
REASON: Package mislabeling issue. The package labeling incorrectly
states the lead length is 28 cm in length when it should state 20 cm.
PRODUCT: Zimmer NEXGEN Complete Knee Solution MIS Total
Knee Procedure Tibial Broach Impactor (a pounding instrument used during
knee surgery), nonsterile; REF 5951-90, Recall # Z-2301-2008
MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2008.
Firm initiated recall is ongoing.
REASON: The instrument may fracture during use, resulting in metal
fragments being left in the patient post-surgery, which could cause
implant failure.
PRODUCT: Abiomed: Abiocor Implantable Heart Replacement
Kit System; Catalog Number: 0034-8401-HD. The product is intended to be
implanted in the thoracic cavity and replaces operation and function of
the native heart, Recall # Z-2304-2008
MANUFACTURER: Abiomed, Inc., Danvers, MA, by letter and on site visit on
May 13, 2008. Firm initiated recall is complete.
REASON: Subassembly incorrectly aligned.
PRODUCT: Flexiflo Quantum Pump Set with Piercing Pin and
Flush Bag The product is used with Quantum pump to deliver ready-to-hang
(RTH) product in enterally-fed patients. List #50604, Recall #
Z-2305-2008
MANUFACTURER: Recalling Firm: Abbott Laboratories, Columbus, OH, by
letters on June 27, 2008. Manufacturer: Abbott Ireland, Sligo, Ireland.
Firm initiated recall is ongoing.
REASON: Product was incorrectly labeled as “Top-Fill Enteral Nutrition
Bag” instead of “Flexiflo Quantum Pump Set.
PRODUCT : ArthroCare ArthroWand Covator with Integrated
Cable Wand, Catalog number AC4340-01. The product is a medical device
for human use in electrosurgical cutting and coagulation accessories.
Product is indicated for resection, ablation and coagulation of soft
tissue and hemostasis of blood vessels in arthroscopic and orthopedic
procedures, Recall # Z-2309-2008
MANUFACTURER: ArthroCare Corp., Sunnyvale, CA, by letters on April 9,
2008, May 13, 2008 and June 24, 2008. Firm initiated recall is ongoing.
REASON: Product is not secure in packaging, and movement may damage the
product or render it non-sterile.
PRODUCT: AMO WaveScan WaveFront System Version 3.90/3.901,
Part Number 0070-1478. The device is used in conjunction with the VISX
STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for
wavefront-guided laser assisted in situ keratomileusis (LASIK) eye
surgery in certain patient populations. The WaveScan System is a
diagnostic instrument intended for the automated measurement, analysis
and recording of refractive errors of the eye. Recall # Z-2310-2008
MANUFACTURER: Recalling Firm: VISX Inc., a Subsidiary of AMO, Inc.,
Santa Clara, CA, by letter on June 9, 2008. Manufacturer: AMO
Manufacturing USA, LLC, Milpitas, CA. Firm initiated recall is ongoing.
REASON: Inaccurate measurements may be generated by the device, which
could result in improper treatment and deterioration of patient
eyesight.
PRODUCT: Advantage Workstation version 4.2P, 4.3 and 4.4
with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 &
5142878, Recall # Z-2312-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter
dated March 13, 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex,
France. Firm initiated recall is ongoing.
REASON: A possible mismatch between the label of the tracked vessel and
the underlying image associated with the cardio- vascular applications
of the Advantage workstation that may impact patient safety.
PRODUCT: The St. Jude Medical Livewire TC" Ablation
Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm,
Sterile EO The St. Jude Medical Livewire TC" Ablation Catheter is a
flexible electrode catheter constructed of a radiopaque polyurethane
insulation/shaft and incorporated platinum electrode. The distal tip
portion may be deflected by a remote control handle located a t the
proximal end of t the catheter, Recall # Z-2313-2008
MANUFACTURER: St. Jude Medical Cardiovascular Division, Minnetonka, MN,
by letter on June 5, 2008. Firm initiated recall is ongoing.
REASON: The product was mis-labelled as having an 8 mm tip instead of 4
mm tip. This could potentially result in elevated temperatures and
formation of coagulum at the tip electrode. If this coagulum were to
detach from the product, the worst case this could potentially result in
embolization.
PRODUCT: Spacelabs Medical Temperature Probe Adaptor
PN-700-0031-00. Device is packaged in clear plastic bags with an
attached insert card Insert card reads "TruLink series Dual Temperature
Cable REF 700-0032-00”, Recall # Z-2314-2008
MANUFACTURER: Spacelabs Healthcare, Inc., Issaquah, WA, by letter
beginning July 3, 2008. Firm initiated recall is ongoing.
REASON: Intermittent contact of temperature probe adaptors can cause a
loss of temperature monitoring which can cause a delay in care when an
alarm is missed.
PRODUCT:
a) Universal SlingBar 350 Product Number: 3156074 Used with the: Viking
XS, Viking S, Viking M, Viking L Patient Lifts, Recall # Z-2315-2008;
b) Universal SlingBar 450 Product Number: 3156075 Used with the: Viking
XS, Viking S, Viking M, Viking L Patient Lifts, Recall # Z-2316-2008;
c) Universal SlingBar 600 Product Number: 3156076 Used with the: Viking
XS, Viking S, Viking M, Viking L Patient Lifts, Recall # Z-2317-2008;
d) Universal SlingBar 350 with Quick-release Hook Product Number:
3156084 Used in combination with all lifts from Liko, i.e. mobile lifts
and overhead lifts, Recall # Z-2318-2008;
e) Universal SlingBar 450 with Quick-release Hook Product Number:
3156085 Used in combination with all lifts from Liko, i.e. mobile lifts
and overhead lifts, Recall # Z-2319-2008;
f) Universal SlingBar 600 with Quick-release Hook Product Number:
3156086 Used incombination with all lifts from Liko, i.e. mobile lifts
and overhead lifts, Recall # Z-2320-2008
MANUFACTURER: Liko AB, Lulea, Sweden, by letter dated June 30, 2008.
Firm initiated recall is ongoing.
REASON: A component securing the Universal SlingBar to the patient lift,
may experience a nut unthreading resulting in the sling bar detaching
from the lift causing the patient to fall.
PRODUCT: Medline RF Detect Sterile X-Ray Detectable USP
Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per
pack, 80 packs per case; Made in China; reorder: NON21432RF, Recall #
Z-2321-2008
MANUFACTURER: Recalling Firm: Medline Industries Inc., Mundelein, IL, by
letter dated June 13, 2008. Manufacturer: Allmed Medical Products Co
Ltd, Shanzen, China. Firm initiated recall is ongoing.
REASON: There is the potential for the RF ID tag to separate from the
retaining pouch.
PRODUCT: Ventlab-assembled Anesthesia breathing bags. The
recall involves (NC Facility): a) Part #720057B (3 Liter bags); b) Part
#720058B (2 Liter bags); and c) Part #720059B (1 Liter); (China
Facility): a) Part #720057B; b) Part #720058B; and c) Part #720059B,
latex free bags used with Medline anesthesia circuit kits. The bags are
sold in bulk, Recall # Z-2324-2008
MANUFACTURER: Recalling Firm: Ventlab Corp., Mocksville, NC, by letter
on/about December 5, 2007. Manufacturer: Amerasia Industries, Guangdong,
China. Firm initiated recall is ongoing.
REASON: During setup and potentially during procedures, the breathing
bag can become separated from the taped bushing that is part of the
breathing bag assembly.
PRODUCT:
a) Evita 2 dura Critical Care Ventilator. Continuous (Respirator).
Catalog number 8411800. Products recalled had the CO2 Carrier Printed
Circuit Board (PCB) part number 8306611 replaced between January 2005
and May 2008, Recall # Z-2325-2008;
b) Evita 4 Critical Care Ventilator. Continuous (Respirator); Catalog
number 8411900, Recall # Z-2326-2008;
c) Evita XL Critical Care Ventilator. Continuous (Respirator). Catalog
number 8414900, Recall # Z-2327-2008
MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by
letter dated July 2, 2008. Manufacturer: Draeger Aerospace Gmbh, Lubeck,
Germany. Firm initiated recall is ongoing.
REASON: Audible power failure alarm was not enunciated at the required
volume.
PRODUCT: Propper short gas-chex EO sterilization
indicators, 250 strips per box, Reorder No. 269001, Recall #
Z-2330-2008.
MANUFACTURER: Propper Manufacturing Co., Inc., Long Island City, NY, by
letters dated February 7, 2008. Firm initiated recall is ongoing.
REASON: A production specification discrepancy may cause the indicators
to show an inaccurate result.
PRODUCT:
a) Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent
Length: 5cm, Disposable-Single use only, Rx Only. Used to train
obstructed biliary ducts, Recall # Z-2331-2008;
b) Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length,
Disposable-Single use only, Rx Only. Used to train obstructed biliary
ducts, Recall # Z-2332-2008
MANUFACTURER: Cook Endoscopy, Winston-Salem, NC, on/about July 11, 2008.
Firm initiated recall is ongoing.
REASON: The product packaging label indicates the stent is 5cm, but the
actual stent inside the packaging measures 10cm.
PRODUCT: Permanent Pacing Lead (Catalog #: 03332, 03334,
03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633,
and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO
52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V,
MP52PV, MP40PV, C/IS-10; Pacing and sensing of the ventricle and/or
atrium of the heart in conjunction with a compatible, implantable pulse
generator/pacemaker, Recall # Z-2333-2008
MANUFACTURER: Oscor, Inc., Palm Harbor, FL, by letters on January 24,
3008. Firm initiated recall is ongoing.
REASON: The O-rings are over tolerance making it hard to connect the
leads to the pacemaker.
PRODUCT: ZOLL OneStep Multi-Function Electrode; Adult
Complete Part #: 8900-0214-01. The electrodes are indicated for the
following clinical applications: Defibrillation, Cardioversion,
Noninvasive pacing, and Electrocardiograph monitoring, Recall #
Z-2334-2008
MANUFACTURER: BioDetek, Inc., Pawtucket, RI, by letter dated June 16,
2008. Firm initiated recall is ongoing.
REASON: Multi-function electrode programmed as a Pediatric instead of
Adult.
PRODUCT: Radiation Reduction Gloves, sterile, Latex-free,
Catalog No. SSR1-7.5, SSR1-8.0, Recall # Z-2335-2008
MANUFACTURER: Recalling Firm: Integra Pain Management, Salt Lake City,
UT, by telephone and letter on July 3, 2008. Manufacturer: Protech
Leaded Eyewear, Palm Beach Gardens, FL. Firm initiated recall is
ongoing.
REASON: Radiation reduction gloves were labeled as "Latex-free", but
contain natural rubber latex.
PRODUCT:
a) PLV-100 Portable Lifecare Ventilator Life support ventilation. The
device is intended to mechanically control or assist patient breathing
by delivering a predetermined percentage of oxygen in the breathing gas.
Life support ventilation. Model/Catalog number PLV-100, Recall #
Z-2344-2008;
b) Power Board Kit for use with the PLV-100 Portable Lifecare repairs.
Model/Catalog number PLV-100. Circuit board part numbers 1034786 version
5 or 1036038 version 3, Recall # Z-2345-2008
MANUFACTURER: Respironics, Inc., Murrysville, PA, by letter dated July
8, 2008. Firm initiated recall is ongoing.
REASON: Certain PLV-100 ventilators may not trigger a signal to activate
third-party remote alarms or nurse call systems upon device failure.PRO
DUCT: Rejuvenate Broach Catalog No: 1601-1005, 1601-1006,
1601-1007, 1601-1008, 1601-1009, 1601-1010. Contours the proximal femur
to the geometry of the stem to provide a complimentary fit of the stem
to the bone. The broaches are designed with a series of teeth that are
intended to seat against highly densified cancellous bone for the
interference press-fit in the uncemented application, Recall #
Z-2349-2008
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter
on January 25, 2008. Firm initiated recall is complete.
REASON: Rejuvenate Broach system was designed in a manner that may
result in the potential for a medical calcar fracture.
PRODUCT: FloSeal Endoscopic Applicator , Product Code
1500181. The product is indicated in surgical procedures (other than in
neurosurgical, opthalmic, and urological) as an adjunct to hemostasis
when control of bleeding by ligature or conventional procedures is
ineffective or impractical. Product Code: 1500181, Recall # Z-2340-2008
MANUFACTURER: Recalling Firm: Baxter Bioscience, Westlake Village, CA,
by letter dated August 4, 2008. Manufacturer: Baxter Healthcare Corp.,
Medication Delivery Division, Irvine, CA. Firm initiated recall is
ongoing.
REASON: The recall is being conducted as a precautionary measure due to
potential discoloration of the FloSeal material noted in six (6)
non-medical complaints during delivery by the Endoscopic Applicator.
PRODUCT:
a) HACH SteriChek Sensitive Total Chloramines and Residual Chlorine
Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm
(mg/l), packaged in bottles containing 100 strips each, 5 bottles per
kit, Part #811909. The firm name on the label is Hach, Ames, IA. The
product is used in measuring for low levels of total chlorine (including
chloramines and free chlorine) in feed water used to prepare dialysate,
Recall # Z-2352-2008;
b) HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for
water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl.
per carton, 12 cartons per shipping case, Product #821972. The product
is used in measuring for low levels of total chlorine (including
chloramines and free chlorine) in feed water used to prepare dialysate,
Recall # Z-2353-2008;
c) RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips,
Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l),
packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays per
shipping case, Product code K100-0106 (HACH Part #812004). The product
is used in measuring for low levels of total chlorine (including
chloramines and free chlorine) in feed water used to prepare dialysate,
Recall # Z-2354-2008;
d) HACH SteriChek Sensitive Total Chloramines and Residual Chlorine
Reagent Strips, tests for feed water and rinse water down to 0.1 ppm
(mg/l), packaged in bags containing 1/100-strip bottle, one medicine
cup, and one insert. Each bag is sealed and labeled "812144 SteriChek
Sensitive, Bagged," 56 bags per cardboard tray, 5 trays per shipping
case. Product code 812144 The product is used in measuring for low
levels of total chlorine (including chloramines and free chlorine) in
feed water used to prepare dialysate, Recall # Z-2355-2008
MANUFACTURER: Hach Co., Ames, IA, by telephone on May 22, 2008, July
1-2, 2008 and by letters on July 21, 2008. Firm initiated recall is
ongoing.
REASON: Inconsistencies in total chlorine and free chlorine levels may
result in providing inaccurate false positive or false negative results.
PRODUCT:
a) 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 product is indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography
diagnostic and interventional procedures and optionally, rotational
imaging procedures. It is also intended for generating fluoroscopic
images of human anatomy for cardiology, diagnostic and interventional
procedures, Recall # Z-2356-2008;
b) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The
system consists of an a monoplane positioner, a vascular or cardiac
table, an X-ray system and a digital detector) The product is indicated
for use in generating fluoroscopic images of human anatomy for vascular
angiography diagnostic and interventional procedures and optionally,
rotational imaging procedures. It is also intended for
generating fluoroscopic images of human anatomy for cardiology,
diagnostic and interventional procedures, Recall # Z-2357-2008;
c) 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 product is indicated for use in generating fluoroscopic
images of human anatomy for vascular angiography diagnostic and
interventional procedures and optionally, rotational imaging procedures.
It is also intended for generating fluoroscopic images of human anatomy
for cardiology, diagnostic and interventional procedures, Recall #
Z-2358-2008;
d) Advantx-E The Advantx imaging system is intended to be used for
general purpose diagnostic angiographic fluoroscopy and radiographic
studies, Recall # Z-2359-2008;
e) Innova 2121-1Q/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
product is indicated for use in generating fluoroscopic images of human
anatomy for diagnostic and interventional cardiac angiography
procedures. These systems can be operated in a mobile or fixed site
environment, Recall # Z-2360-2008;
f) Innova 2000 The principle system components include a C-arm, image
acquisition, processing and archiving capabilities. The product is
indicated for use in generating fluoroscopic images of human anatomy for
diagnostic and interventional cardiac angiography procedures. These
systems can be operated in a mobile or fixed site environment, Recall #
Z-2361-2008.
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter
dated May 2008. Manufacturer: GE Medical Systems, SCS, Buc Cedex,
France. Firm initiated recall is ongoing.
REASON: GE Healthcare has become aware of 2 potential conditions that
could occur with the MAVIG GD Monitor Suspension that is used with
Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121
IQ/3131IQ cardiovascular systems. The two conditions include 1). Due to
insufficient securing of the connecting elements, the LCD vertical
monitor support may disengage from its arm and fall on the table or into
the table vicinity and 2). Only Service personnel working inside the
suspension may potentially experience this condition: Incorrect cable
routing on side, inside the LCD monitor suspension arm, may cause the
ECG monitor power cable to be damaged, potentially resulting in a short
circuit that could cause sparks. The potential risk of an electrical
shock affects only Service personnel working inside the Mavig suspension
without first tuning off both power supplies of the X-ray equipment and
of the ECG monitor.
PRODUCT:
a) 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO. The
product is used for injections of contrast medium during Coronary or
Peripheral Angiography and Angioplasty, Recall # Z-2366-2008;
b) 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R. The
product is used for injections of contrast medium during Coronary or
Peripheral Angiography and Angioplasty, Recall # Z-2367-2008;
c) 12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO. The
product is used for injections of contrast medium during Coronary or
Peripheral Angiography and Angioplasty, Recall # Z-2368-2008
MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letters
dated July 9, 2008. Firm initiated recall is ongoing.
REASON: Control Syringes may be non-sterile due to holes in the
packaging.
PRODUCT: BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases:
160 (4 x 40) Shelf Carton: 40 BD; Made in USA. Syringes for use in
aspiration and injection of medications. Reorder Number: 309653, Recall
# Z-2374-2008
MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes,
NJ, by letters on July 15, 2008. Manufacturer: Becton Dickinson & Co.,
Columbus, NB. Firm initiated recall is ongoing.
REASON: Becton Dickinson identified the presence of open seals during an
internal inspection process.
PRODUCT:
a) VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); Is an
AC powered, general purpose, mobile surgical table with
electro-hydraulically controlled movements which are part of a control
feedback system, Recall # Z-2376-2008;
b) VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with
5th wheel);Is an AC powered, general purpose, mobile surgical table with
electro-hydraulically controlled movements which are part of a control
feedback system, Recall # Z-2377-2008;
c) VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled
standard table); Is an AC powered, general purpose, mobile surgical
table with electro-hydraulically controlled movements which are part of
a control feedback system, Recall # Z-2378-2008;
d) VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled
standard table with 5th wheel); Is an AC powered, general purpose,
mobile surgical table with electro-hydraulically controlled movements
which are part of a control feedback system, Recall # Z-2379-2008
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower
Mound, TX, by letters on July 2, 2008. Manufacturer: Merivaara Corp.,
Lahti, Finland. Firm initiated recall is ongoing.
REASON: Hydraulic lines responsible for tilting the surgical table have
the potential to be severed when articulating table to its lowest
position, possibly resulting in the unexpected and rapid movement of the
table.
PRODUCT: Xpect Giardia/Cryptosporidium Kit, Ref 24050520,
20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the
direct qualitative detection of Giardia and Cryptosporidium antigens in
fecal specimens, Recall # Z-2432-2008
MANUFACTURER: Remel, Inc., Lenexa, KA, by letters dated June 19, 2008.
Firm initiated recall is ongoing.
REASON: Faint grey test lines for Cryptosporidium may be visible which
may be interpreted as false positive.
PRODUCT: BD Visitec Disposable Instrument (plastic handle)
Capsulorhexis Forceps, Sterile Ref: 581440, Used during cataract and
other ophthalmic surgery procedures to grasp lens capsule, Recall #
Z-2433-2008
MANUFACTURER: Recalling Firm: Becton Dickinson and Co., Waltham, MA,
telephone on July 7, 2008. Manufacturer: Becton Dickinson Ophthalmic
Systems, Warwickshire, UK. Firm initiated recall is ongoing.
REASON: Metal particulates present.
The following is condensed list of medical devices
involved in recalls listed by the FDA Enforcement Report as of
October
8, 2008
CLASS I
From October 1, 2008, Enforcement report:
Product: c) Medtronic Sutureless Pump Connector Revision Kit, model 8678, Recall #
Z-2382-2008; Should be Model 8578.
CLASS II
PRODUCT: NeoMedix Trabectome I/A Console, Model Number 550014, surgical
aspirator, Recall # Z-0071-2008
MANUFACTURER: Neomedix Corp., Tustin, CA, by letter on May 31, 2007.
Firm initiated recall is complete.
REASON: Failure of irrigation flow: The pinch valve in a few pumps may
not consistently open to allow irrigation flow. In over 450 surgeries,
the firm confirmed one instance of a valve that did not open. The
electrically activated pinch valve in the NeoMedix Trabectome I/A pump
activates irrigation flow to the eye during Trabectome surgery.
PRODUCT: GE Healthcare OEC 9900 mobile fluoroscopic x-ray system, Recall
# Z-0368-2008
MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, UT, by letter
on December 15, 2007. Firm initiated recall is ongoing.
REASON: Possible overexposure: Failure to apply the entrance exposure
rate (EER) tube current limit calibration to the automatic exposure rate
(AER) control system when the anatomical profile mode is changed from
the default selection to another selection. Manual technique modes are
not affected.
PRODUCT:
a) GE Healthcare Innova 3100 Digital Fluoroscopic Imaging
System with Bolus Chasing option, Recall # Z-1516-2008;
b) GE Healthcare Innova 4100 Digital Fluoroscopic Imaging System with Bolus Chasing
option, Recall # Z-1517-2008
MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter on
November 15, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex,
France. Firm initiated recall is ongoing.
REASON: Incorrect dose data: After 6 days and 4 hours without performing
a system reset or a system reboot (turning it off/on), the displayed
dose data on these systems (Innova 3100 / Innova 4100 with Bolus option)
may be underestimated by up to 50%. In order to avoid this issue, it is
necessary to perform a system reset or reboot every day. GE Healthcare
is working on a correction that will be installed on affected units.
PRODUCT:
a) ev3" 55442-2920, sterile EO, single Use, Visi-Pro
Balloon-Expandable Peripheral Stent System. Model Numbers:
PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080, PXB35-08-17-080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080, PXB35-09-17-135,
PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080, PXB35-10-27-135, and
PXB35-10-37-080, Recall # Z-1547-2008;
b) ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary
Stent System.
Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080, PXB35-08-27-135, PXB35-08-37-135, PXB35-08-57-080, and PXB35-09-17-135 4800, Recall # Z-1548-2008
MANUFACTURER: Ev3, Inc, Plymouth, MN, by letter dated July 1, 2008. Firm
initiated recall is ongoing.
REASON: Specific lots of the Visi-Pro" BE Stent system may not have
adequate securement of the stent to the delivery system and may have a
larger diameter/profile than intended.
PRODUCT: Eclipse Treatment Planning System, Client 8.1.18 and DCF
8.1.17, model number H48, Recall # Z-1612-2008
MANUFACTURER: Recalling Firm: Varian Medical Systems Oncology Systems,
Palo Alto, CA, by letter dated February 13, 2008. Manufacturer: Varian
Medical Systems, Finland 04, Helsinki, Finland. Firm initiated recall is
ongoing.
REASON: A software error causes the wedge accessory calculation to be
ignored in the radiotherapy treatment plan.
PRODUCT: Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS)
Model 802, Recall # Z-1692-2008
MANUFACTURER: Recalling Firm: Covidien Limited, Boulder, CO, by letter
dated March 21, 2008 and by visits on/about March 25, 2008.Manufacturer:
Nelicor Puritan Bennett Ireland, Ltd., Galway, Ireland. Firm initiated
recall is complete.
REASON: Wiring in battery back-up power supply may short and cause
thermal damage to ventilator.
PRODUCT: a) Toshiba America Medical Systems (TAMS) Aquilion 32 CT
system, computed tomography x-ray system, Recall # Z-1707-2008; b)
Toshiba America Medical Systems (TAMS) Aquilion 64 CT system, computed
tomography x-ray system, Recall # Z-1708-2008
MANUFACTURER: Toshiba American Medical Systems, Inc., Tustin, CA, by
letter in July 2007. Firm initiated recall is ongoing.
REASON: Excessive radiation: Intermittent shifting of CT numbers causes
the actual dose to the patient to be greater than expected, when Sure
Exposure option is used.
PRODUCT: Siemens Medical Solutions, syngo Dynamics 6.0 Workplace;
Picture archiving and communication system, Recall # Z-1751-2008
MANUFACTURER: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by a
safety advisory on February 8, 2008. Firm initiated recall is ongoing.
REASON: Incorrect data: A software bug may result in a transfer of
patient demographic data to a different patient’s file.
PRODUCT:
a) Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator,
part number
8515520 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy
system, Recall # Z-1753-2008;
b) Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator,
part
number 9411588 equipped with a Digital Electron Variable Applicator
(DEVA, Part
Number 8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy system, Recall # Z-1754-2008;
c) Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator,
part number
9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV. Medical charged-particle
radiation
therapy system, Recall # Z-1755-2008;
d) Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator,
part
number 9822693 equipped with a Digital Electron Variable Applicator
(DEVA, Part
Number 8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy system, Recall # Z-1756-2008;
e) Siemens Medical Solutions, Mevatron KD2 Digital Linear Accelerator,
part number
1940753 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV, Recall # Z-1757-2008;
f) Siemens Medical Solutions, Mevatron M2/ Primus Mid Digital Linear
Accelerator,
part number 1940035 equipped with a Digital Electron Variable Applicator
(DEVA,
Part Number 8485971) with available energy of 6 MeV, Recall #
Z-1758-2008;
g) Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator,
part number
4504200 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV, Recall # Z-1759-2008;
h) Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear
Accelerator,
part number 5857912 equipped with a Digital Electron Variable Applicator
(DEVA,
Part Number 8485971) with available energy of 6 MeV, Recall #
Z-1760-2008;
i) Siemens Medical Solutions, MEVATRON M2-6740 part number
9401407equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971)
with
available energy of 6 MeV, Recall # Z-1761-2008;
j) Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506
equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971)
with
available energy of 6 MeV, Recall # Z-1762-2008;
k) Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped
with a Digital Electron Variable Applicator (DEVA, Part Number 8485971)
with
available energy of 6 MeV, Recall # Z-1763-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter dated December 12, 2007. Firm initiated recall is ongoing.
REASON: Radiation leak: When used with field sizes of 5cm x 5cm or
smaller, product may leak radiation at a distance of 2 cm from the side
of the applicator body up to 13%, in excess of IEC standards.
PRODUCT: X-STOP Interspinous Process Decompression (lPD) System, (With
Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK
device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM
X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM
X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers include for X-STOP PEEK
Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk, 1-3210 US 10mm
X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk, 1-3216 US
16mm X STOPpk. Spinal implants, Recall # Z-1765-2008
MANUFACTURER: Kyphon, Inc., Sunnyvale, CA, by letter and teleconference
on January 30, 2008. Firm initiated recall is ongoing.
REASON: Physician instructions revised due to product breakage: During
the implantation of the X-STOP IPD Device, the product has the potential
to cause damage to and/or breakage of the X-STOP IPD Device's universal
wing assembly. This includes the potential for breakage of the wing
screw.
PRODUCT:
a) VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay
test completedby visual color comparison used for the detection of drugs of abuse. Sun
Biomedical
Part Number: 15-2016, Recall # Z-1873-2008;
b) VisuaLine Propoxyphene; Propoxyphene test system, intended for in
vitro
immunoassay test completed by visual color comparison used for the
detection of
drugs of abuse. Sun Biomedical Part Number: 15-2017, Recall #
Z-1874-2008;
c) VisuaLine Tricyclic Antidepressants: Six Dip
(COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip
(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in
vitro immunoassay test completed by visual color comparison used for the
detection
of drugs of abuse. Sun Biomedical 1) Part 15-2043; 2) Part 15-2046; 3)
Part 15-2065;
4) Part 15-2072; 5) Part 15-2080; 6) Part 15-2083; 7) Part 15-2085; 8)
Part 15-2095;
and 9) Part 15-2101, Recall # Z-1875-2008
MANUFACTURER: Sun Biomedical Laboratories, Inc., Blackwood, NJ, by
letters on May 29, 2008. Firm initiated recall is ongoing.
REASON: Product was sold while the devices were under FDA 510 (k)
review, which was subsequently denied.
PRODUCT: GE Centricity AW Suite software version 2.0 and 2.0.1 with Card
IQ Xpress Pro or Plus Module; for diagnostic image analysis, Recall #
Z-2183-2008
MANUFACTURER: GE Healthcare Integrated IT Solutions, Barrington, IL, by
letters dated June 11, 2008. Firm initiated recall is ongoing.
REASON: When using any vessel analysis protocol of the AW Suite Card IQ
application, the software can reload saved tracking objects (Save State)
incorrectly and display an incorrect vessel label over the restored
images. This failure only occurs when users create a custom label in the
vessel analysis protocol and include leading or trailing blank
characters (space bar) in the custom label.
PRODUCT: Surgical Table Column Casing Revision B, Product #0788-200-001
Revision B; component of Stryker's VERTIER Surgical Table. The tables
are AC-powered or air-powered devices intended for use during diagnostic
examination or surgical procedures to support the patient, Recall #
Z-2189-2008
MANUFACTURER: Recalling Firm: Stryker Communications Corp., Flower
Mound, TX, by letter dated April 1, 2008. Manufacturer: Merivaara Corp.,
Lahti, Finland. Firm initiated recall is ongoing.
REASON: Potential exists for energy chain, which is responsible for
protecting hydraulic and electrical cables during up and down motion on
VERTIER Surgical Table, to become lodged between column case sections
resulting in possible reduction or lose of function to hand and/or foot
controls or possible involuntary movement of the table.
PRODUCT: a) Vital Port Vascular Access System Polysulfone Petite with
detached 0.9mm catheter; Catalog number IP-S5118-N, Recall #
Z-2190-2008; b) Vital Port Vascular Access System Polysulfone Petite
with detached 1.0mm catheter; Catalog number IP-S6118, Recall #
Z-2191-2008
MANUFACTURER: Cook Vascular, Inc., Vandergrift, PA, by letter dated
April 30, 2008. Firm initiated recall is complete.
REASON: Mislabeled - wrong size catheter was packaged in the box.
PRODUCT: VectorVision (VV) Sky Navigation Platform (19" Computer Rack);
the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI,
BrainSUITE NET and BrainSUITE iCT systems; Intended to be an
intraoperative image guided localization system to enable minimally
invasive surgery. Indicated for any medical condition in which the use
of stereotactic surgery may be appropriate and where a reference to a
rigid anatomical structure can be identified to relative to a CT, CTA,
X-ray, MR, MRA and ultrasound based model of the anatomy, Recall #
Z-2209-2008
MANUFACTURER: Bainlab AG, Kirchheim B. Muenchen, Germany, by letters
dated November 12, 2007. Firm initiated recall is ongoing.
REASON: Diameter of cables used for installation are to small for the
applied current. If an internal short circuit is produced the medical
power supply will not shut down automatically and will continue to
deliver current, which could result in overheating cables.
PRODUCT:
a) OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base,
Porous Coated,
71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043.
Implant is
part of a system used to replace the tibial portion of the knee joint,
Recall # Z-2213-2008;
b) Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial
Base,
75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044.
Implant is
part of a system used to replace the tibial portion of the knee joint,
Recall # Z-2214-2008
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated November 7,
2007. Firm initiated recall is complete.
REASON: Mislabeled as to size: Product is labeled as reduced size, but
is actually standard size.
PRODUCT:
a) Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only,
Non-Sterile, 1 each,
Orthopaedic instrument used for the preparation of the implant site
prior to device
implantation, Recall # Z-2215-2008;
b) Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx only,
Non-Sterile,
1 each, Orthopaedic instrument used for the preparation of the implant
site prior to
device implantation, Recall # Z-2216-2008;
c) Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx only,
Non-Sterile,
1 each. Orthopaedic instrument used for the preparation of the implant
site prior to
device implantation, Recall # Z-2217-2008;
d) Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx only,
Non-Sterile,
1 each, Orthopaedic instrument used for the preparation of the implant
site prior to
device implantation, Recall # Z-2218-2008
MANUFACTURER: Recalling Firm: Wright Medical Technology Inc., Arlington,
TN, by letters on May 20, 2008 and June 4, 2008 and by telephone calls
on May 21 and 22, 2008.
Manufacturer: Patterson Machine, Union Grove, AL. Firm initiated recall
is ongoing.
REASON: Trials are 2.5 mm larger than marked.
PRODUCT:
a) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: B3856,
Size 6F x 24cm Urological stents are disposable single-use temporary
indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2219-2008;
b) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: B3857,
Size 6F x 26cm Urological stents are disposable single-use temporary
indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2220-2008;
c) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: B3855,
Size 6F x 22cm Urological stents are disposable single-use temporary
indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2221-2008;
d) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: B3827,
Size 6F multilength Urological stents are disposable single-use
temporary indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2222-2008;
e) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: BS123,
Size 6F multilength Urological stents are disposable sing-use temporary
indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2223-2008;
f) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model
Number: B3957,
Size 6F x 26cm Urological stents are disposable single-use temporary
indwelling
catheters that allow urine to drain through obstructed or strictured
ureters, Recall #
Z-2224-2008
MANUFACTURER: Applied Medical Resources, Corp., Rancho Santa Margarita,
CA, by letter on May 20, 2008. Firm initiated recall is ongoing.
REASON: Possible movement or dislodgement of the positioner marker band
during use.
PRODUCT: a) Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number
55019-19 Product is indicated for manual pipetting, Recall #
Z-2232-2008; b) Hamilton Soft Grip Pipettes, 1 ml adjustable volume,
model number 55019-40 is indicated for manual pipetting, Recall #
Z-2233-2008
MANUFACTURER: Hamilton Co., Reno, NV, by letter on May 7, 2008. Firm
initiated recall is ongoing.
REASON: Manufacturing issue with spring may restrict product to drawing
less than ½ of its stated measured capacity.
PRODUCT: NeuViz Dual series computed Tomography Scanner System, X-Ray
System The CT scanner is a whole body x-ray computed tomography scanner
which features a continuously rotating tube-detector system and
functions according to the fan beam principle, Recall # Z-2235-2008
MANUFACTURER: Philips and Neusoft Medical Systems, Co., Ltd., Liaoning,
China, by letter dated December 13, 2007. Firm initiated recall is
complete.
REASON: Labeling of patient position on scanned image does not match
actual patient orientation.
PRODUCT:
1) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
19cm, CS-15242, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2242-2008;
2) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
23cm, CS-15282, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2243-2008;
3) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
27cm, CS-15322, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2244-2008;
4) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
31cm, CS-15362, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2245-2008;
5) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
50cm, CS-15552, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2246-2008;
6) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
19cm, CSD-15242, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2247-2008;
7) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
23cm, CSD-15282, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2248-2008;
8) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
27cm, CSD-15322, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2249-2008;
9) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
31cm, CSD-15362, Intended for single use only, Sterile, Rx only, The product is
used for long
term hemodialysis vascular access, Recall # Z-2250-2008;
10) Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip:
50cm, CSD-15552, Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access, Recall # Z-2251-2008;
11) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
19cm, CS-15242-SP, Intended for single use only, Sterile, Rx only. The product is
used for
long term hemodialysis vascular access, Recall # Z-2252-2008;
12) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
23cm, CS-15282-SP, Intended for single use only, Sterile, Rx only. The product is
used for
long term hemodialysis vascular access, Recall # Z-2253-2008;
13) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
27cm, CS-15322-SP, Intended for single use only, Sterile, Rx only. The product is
used for
long term hemodialysis vascular access, Recall # Z-2254-2008;
14) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
31cm, CS-15362-SP, Intended for single use only, Sterile, Rx only. The product is
used for
long term hemodialysis vascular access, Recall # Z-2255-2008;
15) Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
50cm, CS-15552-SP, Intended for single use only, Sterile, Rx only. Road, The
product is
used for long term hemodialysis vascular access, Recall # Z-2256-2008;
16) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
19cm, CS-
15242-VSP, Intended for single use only, Sterile, Rx only. The product
is used for
long term hemodialysis vascular access, Recall # Z-2257-2008;
17) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
23cm, CS-15282-VSP, Intended for single use only, Sterile, Rx only. The product
is used for
long term hemodialysis vascular access, Recall # Z-2258-2008;
18) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
27cm, CS-15322-VSP, Intended for single use only, Sterile, Rx only. The product
is used for
long term hemodialysis vascular access, Recall # Z-2259-2008;
19) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
31cm, CS-
15362-VSP, Intended for single use only, Sterile, Rx only. The product
is used for
long term hemodialysis vascular access, Recall # Z-2260-2008;
20) Cannon® II Plus, Long-Term Access. Catheter Length, Cuff to Tip:
50cm, CS-15552-VSP, Intended for single use only, Sterile, Rx only. The product
is used for
long term hemodialysis vascular access, Recall # Z-2261-2008;
21) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access.
Catheter
Length, Cuff to Tip: 19cm, CSD-15242-SP, Intended for single use only,
Sterile,
Rx only. The product is used for long term hemodialysis vascular access,
Recall #
Z-2262-2008;
22) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access.
Catheter
Length, Cuff to Tip: 23cm, CSD-15282-SP, Intended for single use only,
Sterile,
Rx only. The product is used for long term hemodialysis vascular access,
Recall #
Z-2263-2008;
23) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access.
Catheter
Length, Cuff to Tip: 27cm, CSD-15322-SP, Intended for single use only,
Sterile,
Z-2264-2008;
24) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access.
Catheter
Length, Cuff to Tip: 31cm, CSD-15362-SP, Intended for single use only,
Sterile,
Rx only. The product is used for long term hemodialysis vascular access,
Recall #
Z-2265-2008;
25) Cannon® II Plus, Hemodialysis Catherization Set, Long-Term Access.
Catheter
Length, Cuff to Tip: 50cm, CSD-15552-SP, Intended for single use only,
Sterile,
Rx only. The product is used for long term hemodialysis vascular access,
Recall #
Z-2266-2008;
26) Cannon® II Plus, Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2267-2008;
27) Cannon® II Plus, Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-SPM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2268-2008;
28) Cannon® II Plus, Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 27cm, CS-15322-SPM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2269-2008;
29) Cannon® II Plus, Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-SPM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2270-2008;
30) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity",
Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2271-2008;
31) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity",
Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2272-2008;
32) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity",
Long-Term Access, Cuff to Tip: 27cm, CS-15322-IM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2273-2008;
33) ARROW Edge® Hemodialysis Catherization Set with Arrow Simplicity",
Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for single use
only,
Sterile, Rx only. The product is used for long term hemodialysis
vascular access,
Recall # Z-2274-2008;
34) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip:
31cm, ASK-15362-I, Intended for single use only, Sterile, Rx only. The
product is
used for long term hemodialysis vascular access, Recall # Z-2275-2008;
35) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip:
19cm, CS-15242-I, Intended for single use only, Sterile, Rx only. The
product is
used for long term hemodialysis vascular access, Recall # Z-2276-2008;
36) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip: 23cm, CS-15282-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
Recall # Z-2277-2008;
37) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip: 27cm, CS-15322-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
Recall # Z-2278-2008;
38) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access,
Catheter Length, Cuff to Tip: 31cm, CS-15362-I, Intended for single use
only, Sterile, Rx only. The product is used for long term hemodialysis
vascular access, Recall # Z-2279-2008;
39) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access,
Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use
only, Sterile, Rx only. The product is used for long term hemodialysis
vascular access, Recall # Z-2280-2008;
40) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip: 19cm, CSD-15242-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
Recall # Z-2281-2008;
41) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip: 23cm, CSD-15282-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
Recall # Z-2282-2008;
42) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access, Cuff
to Tip: 27cm, CSD-15322-I, Intended for single use only, Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
Recall # Z-2283-2008;
43) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access,
Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended for single use
only, Sterile, Rx only. The product is used for long term hemodialysis
vascular access, Recall # Z-2284-2008;
44) ARROW Edge® Hemodialysis Catherization Set, Long-Term Access,
Catheter Length, Cuff to Tip: 50cm, CSD-15552-I, Intended for single use
only, Sterile, Rx only. The product is used for long term hemodialysis
vascular access, Recall # Z-2285-2008
MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by
letter on/about June 10, 2008. Manufacturer: Arrow International Inc.,
Asheboro, NC. Firm Initiated recall is ongoing.
REASON: The tips may not have been adequately welded to the catheter
body.
PRODUCT: a) Piccolo Chemistry Analyzer software version
6.121. Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive
Metabolic Panel is a single-use self-contained reagent disk, intended
for use with the Piccolo and PiccoloXpress chemistry analyzers, for in
vitro qualitative determination., Recall # Z-2286-2008;
b) Piccolo Chemistry Analyzer software version 6.121 with Electrolyte
Panel, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte
Panel is a single-use, self-contained reagent disk intended for use with
the Piccolo and PiccoloXpress chemistry analyzers, for in vitro
qualitative determination, Recall # Z-2287-2008
MANUFACTURER: Abaxis, Inc., Union City, CA, by letter on April 21, 2008.
Firm initiated recall is ongoing.
REASON: The product will recover tCO2 at approximately 5-7 units high
relative to 03-10.
PRODUCT:
a) Stryker Navigation Pin for use with the Stryker Navigation System, 3
mm x 100 mm; Part 6007-003-100. Stryker Navigation Pin for use with the
Stryker navigation system is used for trauma and orthopedic
applications, e.g. hip and knee modules, Recall # Z-2288-2008;
b) Stryker Navigation Pin for use with the Stryker Navigation System, 3
mm x 150 mm; Part 6007-003-150. Stryker Navigation Pin for use with the
Stryker Navigation System is used for trauma and orthopedic
applications, e.g. hip and knee modules, Recall # Z-2289-2008;
c) Stryker Navigation Pin for use with the Stryker Navigation System, 4
mm x 100 mm; Part 6007-004-100. Stryker Navigation Pin for use with the
Stryker Navigation System is used for trauma and orthopedic
applications, e.g. hip and knee modules, Recall # Z-2290-2008;
d) Stryker Navigation Pin for use with the Stryker Navigation System, 4
mm x 150 mm; Part 6007-004-150. Stryker Navigation Pin for use with the
Stryker NavigationSystem is used for trauma and orthopedic applications,
e.g. hip and knee modules, Recall # Z-2291-2008;
e) Stryker Ortholock EX Pin for use with the Stryker Navigation System,
3 mm x 110 mm; Part 6007-103-110. Stryker Navigation Pin for use with
the Stryker Navigation System is used for trauma and orthopedic
applications, e.g. hip and knee modules, Recall # Z-2292-2008;
f) Stryker Ortholock EX Pin for use with the Stryker Navigation System,
4 mm x 150 Mm; Part 6007-104-150. Stryker Navigation Pin for use with
the Stryker Navigation System is used for trauma and orthopedic
applications, e.g. hip and knee modules, Recall # Z-2293-2008;
g) Stryker Ortholock; Part 6007-003-000. Stryker Ortholock is used to
firmly anchor a tracker intended for patient tracking during computer
aided orthopaedic and trauma applications, Recall # Z-2294-2008
MANUFACTURER: Recalling Firm: Stryker Instruments, Div. of Stryker
Corp., Portage, MI, by letter dated June 5, 2008. Manufacturer: Stryker
Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm
initiated recall is ongoing.
REASON: Instructions have been updated to include new warnings regarding
percutaneous pin placement during surgery in order to mitigate the risk
of femur fractures.
PRODUCT: Miller bone cement injector front loading
cartridge kit, compatible with Zimmer vacuum mixing system, QTY - 10,
sterile; Cat. No. 5069-52. The product is used for the injection of bone
cement, Recall # Z-2295-2008
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated
June 30, 2008 Manufacturer: Zimmer Orthopaedic Surgical Products, Dover,
OH. Firm initiated recall is ongoing.
REASON: The cartridge is brittle and at increased risk of breakage.
PRODUCT:
a) Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with
removable headboards; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The
product is an L shaped bar that is used with hospital beds set up for
traction. The bar allows mounting of a trapeze to help the patient pull
themselves up when in the hospital bed, Recall # Z-2296-2008;
b) Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care
beds; The product is a L shaped bar that is used with hospital beds set
up for traction. The bar allows mounting of a trapeze to help the
patient pull themselves up when in the hospital bed; Prod. Nos.
00-2700-965-02 and 00-0965-001-00, Recall # Z-2297-2008;
c) Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Prod.
Nos. 00-2700-965-00 and 00-0965-001-00. The product is a L shaped bar
that is used with hospital beds set up for traction. The bar allows
mounting of a trapeze to help the patient pull themselves up when in the
hospital bed, Recall # Z-2298-2008
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated
July 7, 2008 Manufacturer: Zimmer Orthopaedic Surgical Products, Dover,
OH. Firm initiated recall is ongoing.
REASON: If the bed is in the upright position and the bar is dropped
rapidly or in free-fall, it could strike the patient in the bed, and the
drop could present a laceration hazard by creating a sharp edge on the
metal bar.
PRODUCT: NeuViz Dual series computed Tomography Scanner
System, X-Ray System, Recall # Z-2307-2008
MANUFACTURER: Philips And Neusoft Medical Systems Co., Ltd., Shenyang,
Liaoning China, by letter dated June 10, 2008. Firm initiated recall is
ongoing.
REASON: Potential for R-host box and components inside to be detached of
its mounting during the gantry rotor rotation. There is a potential for
components to be damaged inside the system gantry and for the internal
components to be expelled from the system gantry and injure the patient,
operator, bystander or service people.
PRODUCT: Varian Medical Systems Eclipse device, model H48,
Version 6.5 is used to plan photon and electron radiation therapy
treatments, Recall # Z-2308-2008
MANUFACTURER: Varian Medical Systems Oncology Systems, Palo Alto, CA, by
letter on June 11, 2008. Firm initiated recall is ongoing.
REASON: Software anomaly in which swapping IDs of planning fields can
produce inconsistencies between dose matrix and field parameters.
PRODUCT: SoftPath GUI Release Software Versions 3.17 and
4.1. Used in pathology laboratory for receiving accessing specimen
reports, billing and management reports for surgical, GYN, NON-GYN and
Autopsy cases, Recall # Z-2329-2008
MANUFACTURER: SCC Soft Computer, Clearwater, FL, software corrections
were sent as of October 30, 2003 to clients. Firm initiated recall is
complete.
REASON: Loss of text misrepresented individual tissue diagnosis on the
final diagnosis print out from the HIS system software. The specimen
heading "J" was removed and the diagnosis appeared under the specimen
heading "I" as a result the specimen with the heading "I" had two
diagnosis.
PRODUCT: KyphX Osteo Introducer System with blunt tip
introducer stylet (as contained in the KyphoPak Tray, First Fracture,
15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine
LLC. Device is used to access vertebral body during balloon kyphoplasty,
a procedure designed to reduce and stabilize vertebral body compression
fractures (VCFS), Recall # Z-2347-2008
MANUFACTURER: Kyphon Inc., Sunnyvale, CA, by letter on June 23, 2008.
Firm initiated recall is ongoing.
REASON: Some products may contain the incorrect introducer stylet. If
the treating physician is unfamiliar with the use and design of the
diamond tip stylet, there is a possibility of serious injuring occurring
with the use of the diamond tip stylet during balloon kyphoplasty
procedure. Other risks include delay to surgery and inconvenience to
patient.
PRODUCT: Isotechnology, Isobalance System; Serial Numbers:
07-030. The product was being investigated as a device to determine
possible inner ear problems, Recall # Z-2348-2008
MANUFACTURER: Acacia Engineered Products LLC, Franklin, TN, by letter on
July 9, 2008 and by telephone. Firm initiated recall is ongoing.
REASON: The firm distributed an unapproved medical device.
PRODUCT: Steris Small Renaissance Eagle 3000 --
Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013
and 3023. Products are designed for efficient sterilization of
non-porous and porous, heat and moisture-stable materials used in
healthcare facilities, Recall # Z-2350-2008
MANUFACTURER: Recalling Firm: Steris Corp, Mentor, OH, by telephone
beginning on March 6, 2008. Manufacturer: Steris Mexico, Guadalupe,
Mexico. Firm initiated recall is ongoing.
REASON: Some Eagle 3000 units may have a door post pin missing which
could cause incomplete or no engagement of the radial arms into the lock
rails of the door. The sterilizer is designed with switches that prevent
cycle initiation if the door is not locked. However, in the event the
door switches are not properly adjusted they may falsely indicate that
the door is locked even though the radial arms may not be fully engaged
correctly. Risks associated with this problem include burns from
escaping steam or injury from the door failure.
PRODUCT: InterGro DBM Demineralized Bone Matrix in a lipid
carrier; REF DBM002. InterGro DBM product contain human tissue
(allograft bpm) and are intended for transplantation. Products are to be
used for filling bony voids or gaps in the extremities, and pelvis that
are not intrinsic to the bony stability of the structure, Recall #
Z-2351-2008
MANUFACTURER: Recalling Firm: Michigan Orthopaedic Products, Inc.,
Grandville, MI, by visit on or about May 5, 2008. Manufacturer: EBI, LP,
Parsippany NJ. Firm initiated recall is complete.
REASON: Exposure to temperature extremes -- Product was not stored under
controlled conditions and may have been temperature abused. Exposure to
temperature extremes could cause problems with device safety (e.g. risk
of infection) or problems with device effectiveness (e.g. lower healing
rates if the factors or collagen in the device were affected by the
temperature extremes).
PRODUCT:
a) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton
label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label]
H74917510. Sterilized with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire
has a shapeable and highly radiopaque distal platinum tip, Recall #
Z-2362-2008;
b) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton
label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label]
H74917520. Sterilized with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire
has a shapeable and highly radiopaque distal platinum tip, Recall #
Z-2363-2008;
c) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton
label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label]
H74917530. Sterilized with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire
has a shapeable and highly radiopaque distal platinum tip, Recall #
Z-2364-2008;
d) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton
label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label]
H74917540. Sterilized with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire
has a shapeable and highly radiopaque distal platinum tip, Recall #
Z-2365-2008
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
by letter dated June 19, 2008. Manufacturer: Boston Scientific Corp.,
Miami, FL. Firm initiated recall is ongoing.
REASON: The PTFE (polytetrafluoroethylene) coating on the Platinum Plus
Coronary Guidewires could be damaged in certain locations. This damage
of the coating creates the potential for small particles of the PTFE
coating to detach from the wire. If PTFE particles detach from the
guidewire and are released into the coronary vasculature, the particles
may occlude a blood vessel. The most serious adverse effect that is
reasonably expected would be a myocardial infarction. The particular
clinical effect(s) would depend on the site of occlusion. To date,
Boston Scientific has received no complaints in association to this
product issue. Further distribution or use of any remaining product
affected by this recall should cease immediately.
PRODUCT: Mainline Confirms Strep A, Group A Streptococcus;
A rapid one-step visual test for the detection of group A streptococcal
antigen directly from throat swabs; Catalog Nos. 3030-20 (20 test) and
3030-40 (40 test), Recall # Z-2427-2008
MANUFACTURER: Mainline Technology, Inc., Ann Arbor, MI, by telephone and
follow-up letter on or about November 6, 2006. Firm initiated recall is
complete.
REASON: Use of an incorrect dropper tip on the dispenser may result in
false positive A streptococcal results.
PRODUCT: Ace Heat Therapy, A BD Product Up to 10 hours of
Soothing Heat; Heat therapy for muscle and joint pain. Apply Directly to
Skin, Instant, Air-Activated Heat Patches; Catalog Numbers: 207569,
207570, 207535, 207541, 207542, 207543, 207544, 207545, 207549, 207550,
207557, 207565, 207582, 207583, and 207586, Recall # Z-2431-2008
MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin
Lakes, NJ, by letters on April 25, 2008. Manufacturer: Sanpou Chemical
Co., Tokyo, Japan. Firm initiated recall is ongoing.
REASON: Potential for skin irritation and burns associated with the use
of this product.
PRODUCT: Universal Optical Tracker Fixation, not sterile,
REF 111.031. Surgical instrument, Recall # Z-2445-2008
MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by e-mail on
August 6, 2007. Manufacturer: Orthosoft Inc., Montreal, Quebec, Canada.
Firm initiated recall is complete.
REASON: Inadequate weld on tracker, knob oversized and poor thread
design on attachment screw results in seizing. The instrument may break
during use, resulting in surgical delay and an increased risk of
infection.
PRODUCT:
a) Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each,
Sterile, Recall # Z-2446-2008;
b) Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each,
Sterile, Recall # Z-2447-2008
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by e-mail on July 30,
2008 and by telephone on July 30/31, 2008. Firm initiated recall is
ongoing.
REASON: Product contained a syringe whose package seal integrity can be
adversely affected when the product is exposed to low atmospheric
pressure. This may occur during shipping.
PRODUCT:
a) DYONICS 25 Fluid Management System bag for enclosure of wireless
remote control included with Disposable Inflow Tubeset. Catalog #
7211004. Bag is used for remote Control in a sterile field, Recall #
Z-2448-2008;
b) DYONICS 25 Fluid Management System bag for enclosure of wireless
remote control included with Disposable Inflow/Outflow Tubeset with
Single Suction. Catalog # 7211005. Bag is used for remote in a sterile
field, Recall # Z-2449-2008;
c) DYONICS 25 Fluid Management System Bag for enclosure of wireless
remote controlincluded with Disposable Inflow/Outflow Tubeset with
Forked Suction. Catalog #7211006. Bag is used for remote control in a
sterile field, Recall # Z-2450-2008;
d) DYONICS 25 Fluid Management System Bag for enclosure of wireless
remote control included with Disposable Patient Tubeset. Catalog #
7211008. Bag is used for remote control in a sterile field, Recall #
Z-2451-2008
MANUFACTURER: Recalling Firm: Smith & Nephew, Inc. Endoscopy Division,
Andover, MA, by letter and telephone on August 7, 2008. Manufacturer:
Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK. Firm
initiated recall is ongoing.
REASON: Integrity of the remote control bag may not be sufficient to
prevent tearing or opening of the bag during use.
PRODUCT:
a) SOMATOM Emotion 6. Computed tomography X-ray system; Model Numbers:
10165888, 10165977, and 10046789, Recall # Z-2452-2008;
b) SOMATOM Emotion 16. Computed tomography X-ray system; Model Numbers:
10165888, 10165977, and 10046789; Recall # Z-2453-2008
MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA, by Safety Update in July 2008. Manufacturer: Siemens
Shanghai Medical Equipment Ltd., Shanghai, China. Firm initiated recall
is ongoing.
REASON: Potential electrical shock hazard. The LCB power Switch (S1)
could break causing the protective plastic cap to come off exposing the
energized electrical contacts within the switch. The LCB S1 does have an
inline fuse which is designed to open in the event of a short circuit
condition between the internal switch contacts.
PRODUCT: a) Light Wand Orotracheal Lighted Stylet, Part
number: 3910. Sterile, packaged 20 per case, Recall # Z-2454-2008; b)
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile. Contains one
lighted stylet per pack, Recall # Z-2455-2008; c) Light Wand Intro Pack,
Part Number: 3960, Sterile. Contains 5 lighted stylets per pack, Recall
# Z-2456-2008
MANUFACTURER: Vital Signs Colorado, Inc., Englewood, CO, by letter on
August 11, 2008. Firm initiated recall is ongoing.
REASON: Light protector may detach from lighted stylet during
intubation.
PRODUCT: ConMed Linvatec Surgical Video Cart, Catalogue
Number: VP8500, Recall # Z-2458-2008
MANUFACTURER: Conmed Linvatec Endoscopy Division, Goleta, CA, by recall
information packet in May 2008. Firm initiated recall is complete.
REASON: The recall was initiated because ConMed Linvatec has determined
there is a possibility the wheel caster(s) may become loose which may
result in the wheel caster(s) falling out of the base of the VP8500
Video Cart. The potential for the wheel caster or casters to fall out of
the base of the cart may result in a potential tip hazard.
PRODUCT: AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18
cm, Sterile EO, REF 72404232, Manufacture Date 2008 Jun 20, Recall #
Z-2461-2008
MANUFACTURER: American Medical Systems, Minnetonka, MN, by telephone on
July 17, 2008 and by letter dated July 21, 2008. Firm initiated recall
is ongoing.
REASON: The carton labeling does not match the product packaged inside.
The package indicated that the device is an 18cm Preconnected MS pump
while it is actually an 18cm Ultrex Preconnected MS Pump.
PRODUCT: SoftPath ASCII Software Releases 1.2, 2.1, 2.2
and 2.3, Recall # Z-2463-2008
MANUFACTURER: SCC Soft Computer, Clearwater, FL, by letter beginning
February 23, 2006. Firm initiated recall is complete.
REASON: In the creation of revised report and supplemental reports
diagnosis, text was inserted from another case.
CLASS III
PRODUCT: Ev3 The Endovascular Company, IntraCoil Self-Expanding
Peripheral Stent, Sterile EO, Model REF VT-6-60-135, Use Before 2010-07,
Recall # Z-1816-2008
MANUFACTURER: Ev3, Inc., Plymouth, MN, by visit on April 15, 2008. Firm
initiated recall is ongoing.
REASON: An IntraCoil 6 mm x 40 mm stent was labeled as a 6 mm x 60 mm
stent.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
October 1, 2008
CLASS I
PRODUCT:
a) Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm
catheter with length markers and guide wire, 15 T-gauge introducer
needle, Sutureless pump connector with attached 7.6 cm catheter and
connector pin, Transparent Strain-relief sleeves (2), Anchors (4),
Recall # Z-2380-2008;
b) Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment
with length markers and guide wire, 66 cm pump segment, separate
connector pin, 15T gauge introducer needles (2) (11.4 cm and 9.3 cm),
Transparent strain-relief sleeves (2), Opaque Strain-relief sleeves (2),
V-wing Anchors (2), Recall # Z-2381-2008;
c) Medtronic Sutureless Pump Connector Revision Kit, model 8678.
Contents: Catheter interface with attached sutureless pump connector,
catheter, connector pin, and strain-relief sleeve, Strain-relief Sleeves
(2), Recall # Z-2382-2008;
d) Medtronic Intrathecal Catheter Pump Segment Revision Kit, model
8596SC. Contents: 66-cm pump segment with attached sutureless pump
connector, spinal segment strain-relief sleeves (2), Pump segment
strain-relief sleeves (2), Connector pin, Recall # Z-2383-2008
MANUFACTURER:: Medtronic Neuromodulation, Minneapolis, MN, by letter on
June 27, 2008. Firm initiated recall is ongoing.
REASON: Disconnection of the Medtronic sutureless connector (SC)
catheters from the catheter port on the pump, or occlusion between the
sutureless pump connector and the catheter port on the pump.
****CORRECTION****
In the September 24, 2008 Enforcement Report (08-38), Recall #
Z-1659-2008, under REASON – product LS-203 is incorrect it should be
LS-232.
CLASS II
PRODUCT: Xmatrx FISH (fluorescent in situ hybridization) Automated
Staining System, Catalog number AS4010B, Recall # Z-1471-2008
MANUFACTURER: Biogenex Laboratories, San Ramon, CA, by letter on January
24, 2008. Firm initiated recall is ongoing.
REASON: Bulk reagent dispensing mechanism may break resulting in reagent
spill and possible exposure to chemicals.
PRODUCT: a) GE Definium 8000, model 5135678, Digital Radiographic
Systems,
Recall # Z-1476-2008; b) GE Precision 500D, model 2403790-3,
Radiographic and Fluoroscopic Systems, Recall # Z-1477-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by site visit. Firm initiated
recall is ongoing.
REASON: Necessary certification labels are missing from the x-ray
control.
PRODUCT:
1) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain ,
3,2mm, 10Fr,
PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2555-020-05,
Recall #
Z-1480-2008;
2) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft
Drain , 4,8mm,
15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; REF
00-2555-030-05, Recall #
Z-1481-2008;
3) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain,
6,4mm, 19Fr,
PVC, 107cm, large, sterile, latex free, Rx only; REF 00-2555-040-05,
Recall #
Z-1482-2008;
4) Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit,
sterile, latex free,
Rx only; REF 00-2555-050-05, Recall # Z-1483-2008;
5) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain,
sterile, latex free,
Rx only; REF 00-2555-060-05, Recall # Z-1484-2008;
6) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC
w/trocar,
3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF
00-2500-000-10,
Recall # Z-1485-2008;
7) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC
w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only;
REF 00-
2500-700-10, Recall # Z-1486-2008;
8) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC
w/trocar,
4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF
00-2505-000-10,
Recall # Z-1487-2008;
9) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16"
PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx
only; REF 00-2505-700-10, Recall # Z-1488-2008;
10) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small,
sterile, latex free, Rx only; REF 00-2550-001-10, Recall # Z-1489-2008;
11) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm, medium,
sterile, latex free, Rx only; REF 00-2550-002-10, Recall # Z-1490-2008;
12) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/16" Drain, 4,8mm, 15Fr, PVC, 107cm, soft,
sterile, latex free, Rx only; REF 00-2550-003-10, Recall # Z-1491-2008;
13) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large,
sterile, latex free, Rx only; REF 00-2550-004-10, Recall # Z-1492-2008;
14) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC, 107cm,
medium, sterile, latex free, Rx only; REF 00-2550-702-10, Recall #
Z-1493-2008;
15) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC, 107cm,
soft, sterile, latex free, Rx only; REF 00-2550-703-10, Recall #
Z-1494-2008;
16) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free, Rx only; REF 00-2550-704-10, Recall #
Z-1495-2008;
17) Zimmer Hemovac Wound Drainage Device, Infection Control Kits,
Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; REF 00-2557-000-10,
Recall # Z-1496-2008;
18) Zimmer Hemovac Wound Drainage Device, 100 ml Hemovac Mini Evacuator,
sterile, latex free, Rx only; REF 00-2568-000-10, Recall # Z-1497-2008;
19) immer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC
w/trocar (4"), 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx
only; REF 00-2590-000-10, Recall # Z-1498-2008;
20) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC
w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only;
REF 00-2590-040-10, Recall # Z-1499-2008;
21) Zimmer Hemovac Wound Drainage Device, 400 ml EVAC 1/4" DR w/troc
spec., 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-2590-700-10, Recall # Z-1500-2008;
22) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC
w/trocar, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only;
REF 00-2595-000-10, Recall # Z-1501-2008;
23) Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP
EVAC w/O.P. Adapter Component Kit, to be used with OrthoPAT post op
suction set, sterile, latex free, Rx only; REF 00-2696-000-10, Recall #
Z-1502-2008;
24) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" PVC w/trocar,
3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF
00-5300-000-05 and 00-5300-000-10, Recall # Z-1503-2008;
25) Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit,
sterile, latex free, Rx only; REF 00-5300-004-10; Recall # Z-1504-2008;
26) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC w/trocar,
4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF
00-5305-000-05 and 00-5305-000-10, Recall # Z-1505-2008;
27) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil
w/trocar, 3,2mm, 10Fr, Si, 107cm, medium, sterile, latex free, Rx only;
REF 00-5340-000-05 and 00-5340-000-10, Recall # Z-1506-2008;
28) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" MP SIL
w/trocar, 4, 8mm, 15Fr, Si, 107cm, soft, sterile, latex free, Rx only;
REF 00-5341-000-05 and 00-5341-000-10, Recall # Z-1507-2008;
29) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP SIL
w/trocar, 6,4mm, 19Fr, Si, 107cm, large, sterile, latex free, Rx only;
REF 00-5345-000-10, Recall # Z-1508-2008;
30) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar,
6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-5390-040-10, Recall # Z-1509-2008
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letters dated
January 29, 2008, and March 17, 2008. Manufacturer: Zimmer Orthopedic
Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON: The sterility of the device may be compromised due to the
possible presence of slits or pinholes in the packaging.
PRODUCT:
a) Stryker Medical Secure II Med/Surg Bed, 115 V, Model 3002, Recall #
Z-1685-2008;
b) Stryker Medical Epic II Critical Care Bed, 115 V, Model 2030, Recall
# Z-1686-2008;
c) Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115
V, Model 2040, Recall # Z-1687-2008;
d) Stryker Medical Secure II Med/Surg Bed, 230 V, Model 3221 (not sold
in the U.S.),Recall # Z-1688-2008;
e) Stryker Medical Epic II Critical Care Bed, 230 V, Model 2031, (not
sold in the U.S.), Recall # Z-1689-2008
MANUFACTURER: Stryker Medical Division of Stryker Corp., Portage, MI, by
letter dated February 1, 2008. Firm initiated recall is ongoing.
REASON: The brakes may not have adequate holding power to lock the bed
in place.
PRODUCT: a) Universal Notch Preparation Guide, Size #3;
Non Sterile; Catalog Number 7650-3363, Recall # Z-1690-2008; b)
X-Celerate Universal Block Pegless Size #3, Non Sterile; Catalog Number
8000-3303, Recall # Z-1691-2008
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters
on March 18, 2008. Firm initiated recall is ongoing.
REASON: Discovery of the potential for Pin and Punch interference of the
Size 3 Scorpio Notch Preparation Guide that may result in damage to bone
if a user aggressively attempts to seat an obstructed punch.
PRODUCT: iLab Ultrasound Imaging System, Models 120INS and
240INS; UPN’s: H74900036130, H749FG000940, H749ILAB120INS0,
H749ILAB120INSR0, H749ILAB220INS0, H749240INS0, M004EPIL120INS0, Recall
# Z-1693-2008
MANUFACTURER: Boston Scientific Corp., Fremont, CA, by letters on April
4 and 10, 2008. Firm initiated recall is complete.
REASON: Improperly terminated wires on a component of the iLab
Acquisition processor power supply could cause the processor to lock-up
or stop, and prolong the patient’s procedure.
PRODUCT: GE OEC 9600 C-arm Fluoroscopy System, Recall #
Z-1709-2008
MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, UT, by letters
on July 2, 2008. Firm initiated recall is ongoing.
REASON: Secondary collimator filters may be missing on certain x-ray
units. It was discovered that the secondary collimator filter on some
OEC 9600 C-arms was omitted when a collimator assembly was replaced.
This would reduce the filtration and therefore the Half-Value-Layer
(HVL) of the X-ray beam, and may result in non-compliance with respect
to Maximum Entrance Exposure Rate (EER) unless the maximum EER
verification and/or calibration were performed after collimator
replacement.
PRODUCT:
a) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile. A
combination of legally marketed medical devices placed into one
container for the convenience of the user and used within the limits of
the products' intended uses, Recall # Z-1808-2008;
b) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile. A
combination of legally marketed medical devices placed into one
container for the convenience of the user and used within the limits of
the products' intended uses, Recall # Z-1809- 2008
MANUFACTURER: Recalling Firm: Merit Medical Systems, Inc., South Jordan,
UT, by visit on April 14, 2008. Manufacturer: Zimmer, Inc., Warsaw, IN.
Firm initiated recall is complete.
REASON: Sterility Compromised: Component of convenience kit was recalled
by its manufacturer for non-sterility.
PRODUCT: GE Healthcare Definium 8000 Digital Radiographic
System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis,
Recall # Z-1822-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated March 7,
2008. Firm initiated recall is ongoing.
REASON: Loss of image data: Software anomaly in the Processing Software
on the Definium 8000 system may impact patient safety when using the
VolumeRAD advanced application (option). The slice visualization of
VolumeRAD exams acquired on the wallstand receptor will be offset by
17mm. This prevents the visualization of anatomy WITHIN a distance of
17mm from the wallstand patient barrier (receptor cover). This lost
anatomy cannot be recovered or visualized by retrospective
reconstruction processing.
PRODUCT: GE Healthcare Definium 8000 Digital Radiographic
System, Recall # Z-1882-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated March 7,
2008. Firm initiated recall is ongoing.
REASON: Radiation dose reading greater than actual dose: Error in the
generator software on the GE Healthcare Revolution XR/d configured with
HP 8200 PC consoles and all Definium 8000 systems may impact patient
safety. Occasional generator software errors may cause light X-ray
Images with reported mAs readings higher than was actually exposed to
the patient using the overhead X-ray tube. The mAs readings reported
from the system could be up to ten times higher than what was actually
exposed to the patient. Occurrence is limited to the first exposure
after the focal spot is switched from small to large. The generator
incorrectly applies the small filament limit to the large focal spot,
which can cause the large focal spot to produce less current. Subsequent
large focal spot exposures will not exhibit this issue.
PRODUCT: IsoMed Refill Kit, Model 8553, is intended for
use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles,
extension tubing set with y-connector and clamp, Filter, 10-ml syringe,
60-ml lidded syringe, Fenestrated drape, Template; Product is packaged
in a sterile container, Recall # Z-1903-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, either by personal visits, or telephone, beginning February 4, 2008.
Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated
recall is complete.
REASON: Medtronic is retrieving all unused packages of ISOMED Refill Kit
Model 8553, Lot 60538731. This lot of product was released using
incorrect endotoxin specification limits. Endotoxin contamination can
potentially lead to fever, malaise, respiratory distress, septic shock,
and death.
PRODUCT: CyberKnife Robotic Radiosurgery System radiation
therapy device with Multiplan treatment Planning Software versions 1.5.2
and higher, Recall # Z-2056-2008
MANUFACTURER: Accuray, Inc., Sunnyvale, CA, by letter on April 16, 2008.
Firm initiated recall is ongoing.
REASON: Sample beam data (which should not be used to treat patients)
may differ from actual radiation output of an installed product, and
which may be used by users.
PRODUCT:
a) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530, Recall #
Z-2060-2008;
b) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535, Recall #
Z-2061-2008;
c) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545, Recall #
Z-2062-2008;
d) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630, Recall #
Z-2063-2008;
e) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635, Recall #
Z-2064-2008;
f) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640, Recall #
Z-2065-2008;
g) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650, Recall #
Z-2066-2008;
h) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw
Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR0750,
Recall # Z-2067-2008;
i) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740, Recall #
Z-2068-2008;
j) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745, Recall #
Z-2069-2008;
k) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535; Recall #
Z-2070-2008;
l) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540, Recall #
Z-2071-2008;
m) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545, Recall #
Z-2072-2008;
n) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size
(diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655, Recall #
Z-2073-2008;
o) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640, Recall #
Z-2074-2008;
p) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645, Recall #
Z-2075-2008;
q) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735, Recall #
Z-2076-2008;
r) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740, Recall #
Z-2077-2008;
s) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745, Recall #
Z-2078-2008
MANUFACTURER: Allez Spine, LLC, Irvine, CA, by telephone on November 8,
2007. Firm initiated recall is complete.
REASON: This recall was initiated after Internal Engineering Testing of
the conical seat design pedicle screws of sizes 5, 6 and 7 showed a
potential of partial displacement of screw shank when used in
combination with the single piece locking nuts. This partial
displacement of the screw shank could finally lead to total separation
and failure of the construct.
PRODUCT: Osteonics Scorpio Total Knee; Posteriorly
Stabilized Femoral Component; # 13 with posts, low friction lon
treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing
Components with Scorpio Patellar Components, Catalog No. 711-4513L,
Recall # Z-2079-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter
on March 18, 2005. Firm initiated recall is complete.
REASON: Component labeled and laser marked as a Left, was in fact a
Right component.
PRODUCT: Hoffman II compact Sterile Wrist Kit is used in
the stabilization of open and unstable fractures; Catalog Number:
4940-9-810, Recall # Z-2080-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
on August 17, 2005. Firm initiated recall is complete.
REASON: The pin of the Hoffmann II Compact External Fixation System may
jam into the Soft Tissue protector.
PRODUCT: VariSource® CT/MR Ring & Tandem Applicator Set,
catalog # AL13017000, containing 32mm titanium ring applicators, each
identified as part numbers AL07362000, AL07363000, and AL07364000,
Recall # Z-2081-2008
MANUFACTURER: Recalling Firm: Varian Medical Systems, Inc.,
Charlottesville, VA, by letter on March 12, 2008. Manufacturer: Varian
Medical Systems U.K. Ltd., Crawley, United Kingdom. Firm initiated
recall is ongoing.
REASON: Medical device may exhibit inaccurate positioning and lead to
unintended dose delivery during brachytherapy treatment.
PRODUCT:
a) TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2082-2008;
b) Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device
is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2083-2008;
c) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2084-2008;
d) TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2085-2008;
e) TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2086-2008;
f) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2087-2008;
g) TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2088-2008
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by letter on April 22,
2008 and e-mail on April 22, and April 23, 2008. Firm initiated recall
is complete.
REASON: One of the distal locking screw holes on a hindfoot fusion nail
was drilled with an
PRODUCT: NexStent Monorail Carotid Stent System, Material
number M 001553000, Catalog number 55-300, packaged in a PET tray,
Recall # Z-2089-2008
MANUFACTURER: Recalling Firm: Boston Scientific Cupertino, Corp.,
Cupertino, CA, by letters. Manufacturer: Boston Scientific Corp, Natick,
MA. Firm initiated recall is complete.
REASON: Tip may detach from stent delivery system.
PRODUCT: COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The
device is intended as an aid in monitoring patients for disease progress
or response to therapy, Recall # Z-2090-2008
MANUFACTURER: Siemens Medical Solutions Diagnostics, Los Angeles, CA, by
Customer Bulletin on May 21, 2008. Firm initiated recall is ongoing.
REASON: The Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low
bias, which is evident when comparing results with other methods,
including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for
example, approximately 20% lower when compared to results obtained with
the IMMULITE 2000 Third Generation PSA assay (L2KUP).
PRODUCT:
Radiation therapy system - Coherence AG Therapist Part number 5863506
and Therapist system Part number 7339125, equipped with a Coherence
Therapist RTT2.1 or Primeview 3i R2.1. This is a medical charged
particle radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO
standard medical imaging platform to provide comprehensive oncology
workflow solutions for radiation therapy, Recall # Z-2095-
2008;
b) Radiation therapy system - Coherence Impression Therapist System
equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part
number 7341410. Medical charged particle Radiation therapy system, part
of the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions
for radiation therapy, Recall # Z-2096-2008;
c) Radiation therapy system - PRIMEVIEW 3i System equipped with a
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy, Recall # Z-2097-2008;
d) Radiation therapy system - AG Therapist 3rd party V&R equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345411.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy, Recall # Z-2098-2008;
e) Radiation therapy system - Impression Therapist 3rd party V&R
equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part
number 7345429. Medical charged particle Radiation therapy system, part
of the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall
# Z-2099-2008;
f) Radiation therapy system - Syngo Based WS for 3rd party V&R equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number
7345437. Medical charged particle Radiation therapy system, part of the
firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall
# Z-2100-2008;
g) Radiation therapy system - Coherence Therapist 2.0 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy,
Recall # Z-2101-2008;
h) Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy,
Recall # Z-2102-2008;
i) Radiation therapy system - Coherence Therapist System 2.1 equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number
8147667. Medical charged particle Radiation therapy system, part of the
firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy. Applies
only to those parts used with the following devices identified in the
product descriptions, Recall # Z-2103-2008;
j) Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy.
Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or
Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318.
Applies only to those parts used with the following devices identified
in the product descriptions, Recall # Z-2104-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter on May 15, 2008. Firm initiated recall is ongoing.
REASON: Software - Under certain circumstances, the portal image may be
overwritten, which may lead to incorrect dosage.
PRODUCT:
a) GE 1.5T and 3.0T Signa® HDx MR System Model Numbers: 5127452,
2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging
device to produce axial sagittal, coronal and oblique images,
spectroscopic images, and/or spectra, dynamic images of the internal
structures and organs of the entire body, including, but not limited to,
head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints,
prostate, blood vessels, and musculoskeletal regions of the body, Recall
# Z-2210-2008;
b) GE Signa® Excite 1.5T MR System, GE Signa® Excite 3.0T MR System.
Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW. Indicated for
use as a diagnostic imaging device to produce axial sagittal, coronal
and oblique images, spectroscopic images, and/or spectra, dynamic images
of the internal structures and organs of the entire body, including, but
not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis,
joints, prostate, blood vessels, and musculoskeletal regions of the
body, Recall # Z-2211-2008
MANUFACTURER: GE Medical Systems LLC, Waukesha, WI, by letter dated
September 14, 2007. Firm initiated recall is ongoing.
REASON: A software issue that may result in misregistration of
functional and anatomical images associated with the 3.0T BrainwaveRT
fMRI Application on the 3.0T Signa HDx scanner.
PRODUCT: Naviscan PET Systems, Inc ("Naviscan") PEM Flex
Solo II PET Scanner. The PEM Flex Solo II images small body parts with
optimized PET technology, Recall # Z-2229-2008
MANUFACTURER: Naviscan PET Systems, San Diego, CA, by letter on June 19,
2008. Firm initiated recall is ongoing.
REASON: This field correction is being initiated as a result of the
firm's investigation into a report from a user indicating that the
motorized compression exceeded 25 pounds of compression force during the
pre-scan positioning of the patient. The investigation identified that a
secondary fault protection did not perform as expected.
PRODUCT: Siemens brand Ultrasound Transducer 17L5HD used
with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used
with System Models: 08245875, 08246951, 08255412, 08255413, 08267697,
08269627, 10038241, 10038242, 10040724, 10040725, 10041008; Product is
manufactured and distributed by The 17L5 transducer is intended for
breast and small body parts imaging, Recall # Z-2230-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by
letters on June 6, 2008. Firm initiated recall is ongoing.
REASON: The product assembly can cause a failure of the transducer which
results in a double and/or overlapped image which may ultimately result
in misleading or false information, inability to accurately diagnose,
incorrect positioning/locating/insertion of the biopsy needle and/or an
interruption during the biopsy procedure.
PRODUCT: ARCHITECT c8000 Processing Module, for in vitro
diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20,
Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01;
v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott
ARCHITECT cSystem is designed to perform automated, random access,
clinical chemistry analyzer which utilizes spectrophotometry
(monochromatic and bichromatic modes of measurement) for photometric
based determinations, Recall # Z-2231-2008
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on May
23, 2008. Firm initiated recall is ongoing.
REASON: Software defect can allow tests ordered for one sample to be
aspirated from a different sample, reporting erroneous results for the
affected sample.
CLASS III
PRODUCT:
a) Axis Gamma Camera, Scintillation (gamma) camera. Model Numbers:
210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis
System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4"
Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665
13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280
Axis System 3/8 Precision 4535 671 67421, or N211282 Axis System 3/4
Precision (Note: Due to a part number scheme change at the firm, either
number is representative of the identified system), Recall #
Z-1510-2008;
b) Irix Gamma Camera, Scintillation (gamma) camera. Model Numbers:
210857 and 210881. 4535 679 46991, or N210857 Irix System, 3/8" Crystal
4535 665 13551, or N210881 Irix System 3/4" Crystals 4535 679 46981, or
N211038 Irix System 3/8 Precision 4535 665 13571, or N211040 Irix System
3/4 Precision (Note: Due to a part number scheme change at the firm,
either number is representative of the identified system), Recall #
Z-1511-2008;
c) Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera,
Recall # Z-1512-2008
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH,
by letter on January 30, 2008. Firm initiated recall is ongoing.
REASON: Resistor Failure: The Rotate Motion Shunt Resistor may overheat
and results in the appearance of smoke, a burning smell, and an
electronic stop condition, which will disable the gamma camera rotate
motion and all other motions.
PRODUCT: Harleco Brand Ethanol Standard, 1.0 mg/ml 1.0 mg
Ethanol in 1 ml 10 ampules; Each ampule contains approximately 1.1 ml to
facilitate the removal of 1.0 ml, Item number 68991/95, Recall #
Z-1607-2008
MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by e-mail on March 27,
2008 and letters on April 3, 2008. Firm initiated recall is ongoing.
REASON: EMD Chemicals received 1 customer complaint regarding 2 ampules
measuring 2.0 mg/ml found in a lot of 20 ampules of 1.0 mg/ml Ethanol
Standard.
PRODUCT: Cholestech LDX High Sensitivity C-Reactive
Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity
C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the
quantitative determination of C-reactive protein in whole blood or
serum. Measurement of CRP is useful as an aid in the detection and
evaluation of infection, tissue injury, inflammatory disorders and
associated diseases. The test cassettes are for use with the LDX
analyzer; Catalog #12-807, Recall # Z-2457-2008
MANUFACTURER: Cholestech, Corp., Hayward, CA, by letter dated August 9,
2005. Firm initiated recall is complete.
REASON: Test results are high, outside of control material upper limit
specification . Results could be as high as 15%.The following is
condensed list of medical devices involved in recalls listed by the FDA
Enforcement Report as of October 1, 2008
CLASS I
PRODUCT:
a) Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm
catheter with length markers and guide wire, 15 T-gauge introducer
needle, Sutureless pump connector with attached 7.6 cm catheter and
connector pin, Transparent Strain-relief sleeves (2), Anchors (4),
Recall # Z-2380-2008;
b) Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment
with length markers and guide wire, 66 cm pump segment, separate
connector pin, 15T gauge introducer needles (2) (11.4 cm and 9.3 cm),
Transparent strain-relief sleeves (2), Opaque Strain-relief sleeves (2),
V-wing Anchors (2), Recall # Z-2381-2008;
c) Medtronic Sutureless Pump Connector Revision Kit, model 8678.
Contents: Catheter interface with attached sutureless pump connector,
catheter, connector pin, and strain-relief sleeve, Strain-relief Sleeves
(2), Recall # Z-2382-2008;
d) Medtronic Intrathecal Catheter Pump Segment Revision Kit, model
8596SC. Contents: 66-cm pump segment with attached sutureless pump
connector, spinal segment strain-relief sleeves (2), Pump segment
strain-relief sleeves (2), Connector pin, Recall # Z-2383-2008
MANUFACTURER:: Medtronic Neuromodulation, Minneapolis, MN, by letter on
June 27, 2008. Firm initiated recall is ongoing.
REASON: Disconnection of the Medtronic sutureless connector (SC)
catheters from the catheter port on the pump, or occlusion between the
sutureless pump connector and the catheter port on the pump.
****CORRECTION****
In the September 24, 2008 Enforcement Report (08-38), Recall #
Z-1659-2008, under REASON – product LS-203 is incorrect it should be
LS-232.
CLASS II
PRODUCT: Xmatrx FISH (fluorescent in situ hybridization) Automated
Staining System, Catalog number AS4010B, Recall # Z-1471-2008
MANUFACTURER: Biogenex Laboratories, San Ramon, CA, by letter on January
24, 2008. Firm initiated recall is ongoing.
REASON: Bulk reagent dispensing mechanism may break resulting in reagent
spill and possible exposure to chemicals.
PRODUCT: a) GE Definium 8000, model 5135678, Digital
Radiographic Systems,
Recall # Z-1476-2008; b) GE Precision 500D, model 2403790-3,
Radiographic and Fluoroscopic Systems, Recall # Z-1477-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by site visit. Firm initiated
recall is ongoing.
REASON: Necessary certification labels are missing from the x-ray
control.
PRODUCT:
1) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain ,
3,2mm, 10Fr,
PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2555-020-05,
Recall #
Z-1480-2008;
2) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft
Drain , 4,8mm,
15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; REF
00-2555-030-05, Recall # Z-1481-2008;
3) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain,
6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-2555-040-05, Recall # Z-1482-2008;
4) Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit,
sterile, latex free, Rx only; REF 00-2555-050-05, Recall # Z-1483-2008;
5) Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain,
sterile, latex free, Rx only; REF 00-2555-060-05, Recall # Z-1484-2008;
6) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC w/trocar,
3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF
00-2500-000-10, Recall # Z-1485-2008;
7) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC
w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only;
REF 00-2500-700-10, Recall # Z-1486-2008;
8) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar,
4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF
00-2505-000-10, Recall # Z-1487-2008;
9) Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16"
PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx
only; REF 00-2505-700-10, Recall # Z-1488-2008;
10) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small,
sterile, latex free, Rx only; REF 00-2550-001-10, Recall # Z-1489-2008;
11) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm, medium,
sterile, latex free, Rx only; REF 00-2550-002-10, Recall # Z-1490-2008;
12) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/16" Drain, 4,8mm, 15Fr, PVC, 107cm, soft,
sterile, latex free, Rx only; REF 00-2550-003-10, Recall # Z-1491-2008;
13) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large,
sterile, latex free, Rx only; REF 00-2550-004-10, Recall # Z-1492-2008;
14) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC, 107cm,
medium, sterile, latex free, Rx only; REF 00-2550-702-10, Recall #
Z-1493-2008;
15) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC, 107cm,
soft, sterile, latex free, Rx only; REF 00-2550-703-10, Recall #
Z-1494-2008;
16) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml
Infection Control Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free, Rx only; REF 00-2550-704-10, Recall #
Z-1495-2008;
17) Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac
I.C. Kit, sterile, latex free, Rx only; REF 00-2557-000-10, Recall #
Z-1496-2008;
18) Zimmer Hemovac Wound Drainage Device, 100 ml Hemovac Mini Evacuator,
sterile, latex free, Rx only; REF 00-2568-000-10, Recall # Z-1497-2008;
19) immer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar
(4"), 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-2590-000-10, Recall # Z-1498-2008;
20) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar,
6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-2590-040-10, Recall # Z-1499-2008;
21) Zimmer Hemovac Wound Drainage Device, 400 ml EVAC 1/4" DR w/troc
spec., 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-2590-700-10, Recall # Z-1500-2008;
22) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC w/trocar,
2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; REF
00-2595-000-10, Recall # Z-1501-2008;
23) Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP
EVAC w/O.P. Adapter Component Kit, to be used with OrthoPAT post op
suction set, sterile, latex free, Rx only; REF 00-2696-000-10, Recall #
Z-1502-2008;
24) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" PVC w/trocar,
3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF
00-5300-000-05 and 00-5300-000-10, Recall # Z-1503-2008;
25) Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit,
sterile, latex free, Rx only; REF 00-5300-004-10; Recall # Z-1504-2008;
26) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC w/trocar,
4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF
00-5305-000-05 and 00-5305-000-10, Recall # Z-1505-2008;
27) Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar,
3,2mm, 10Fr, Si, 107cm, medium, sterile, latex free, Rx only; REF
00-5340-000-05 and 00-5340-000-10, Recall # Z-1506-2008;
28) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" MP SIL w/trocar,
4, 8mm, 15Fr, Si, 107cm, soft, sterile, latex free, Rx only; REF
00-5341-000-05 and 00-5341-000-10, Recall # Z-1507-2008;
29) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP SIL w/trocar,
6,4mm, 19Fr, Si, 107cm, large, sterile, latex free, Rx only; REF
00-5345-000-10, Recall # Z-1508-2008;
30) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar,
6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; REF
00-5390-040-10, Recall # Z-1509-2008
MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letters dated
January 29, 2008, and March 17, 2008. Manufacturer: Zimmer Orthopedic
Surgical Products, Dover, OH. Firm initiated recall is ongoing.
REASON: The sterility of the device may be compromised due to the
possible presence of slits or pinholes in the packaging.
PRODUCT:
a) Stryker Medical Secure II Med/Surg Bed, 115 V, Model 3002, Recall #
Z-1685-2008;
b) Stryker Medical Epic II Critical Care Bed, 115 V, Model 2030, Recall
# Z-1686-2008;
c) Stryker Medical Epic II Critical Care Bed with Zoom Drive System, 115
V, Model 2040, Recall # Z-1687-2008;
d) Stryker Medical Secure II Med/Surg Bed, 230 V, Model 3221 (not sold
in the U.S.),Recall # Z-1688-2008;
e) Stryker Medical Epic II Critical Care Bed, 230 V, Model 2031, (not
sold in the U.S.), Recall # Z-1689-2008
MANUFACTURER: Stryker Medical Division of Stryker Corp., Portage, MI, by
letter dated February 1, 2008. Firm initiated recall is ongoing.
REASON: The brakes may not have adequate holding power to lock the bed
in place.
PRODUCT: a) Universal Notch Preparation Guide, Size #3;
Non Sterile; Catalog Number 7650-3363, Recall # Z-1690-2008; b) X-Celerate
Universal Block Pegless Size #3, Non Sterile; Catalog Number 8000-3303,
Recall # Z-1691-2008
MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters
on March 18, 2008. Firm initiated recall is ongoing.
REASON: Discovery of the potential for Pin and Punch interference of the
Size 3 Scorpio Notch Preparation Guide that may result in damage to bone
if a user aggressively attempts to seat an obstructed punch.
PRODUCT: iLab Ultrasound Imaging System, Models 120INS and
240INS; UPN’s: H74900036130, H749FG000940, H749ILAB120INS0,
H749ILAB120INSR0, H749ILAB220INS0, H749240INS0, M004EPIL120INS0, Recall
# Z-1693-2008
MANUFACTURER: Boston Scientific Corp., Fremont, CA, by letters on April
4 and 10, 2008. Firm initiated recall is complete.
REASON: Improperly terminated wires on a component of the iLab
Acquisition processor power supply could cause the processor to lock-up
or stop, and prolong the patient’s procedure.
PRODUCT: GE OEC 9600 C-arm Fluoroscopy System, Recall #
Z-1709-2008
MANUFACTURER: OEC Medical Systems, Inc., Salt Lake City, UT, by letters
on July 2, 2008. Firm initiated recall is ongoing.
REASON: Secondary collimator filters may be missing on certain x-ray
units. It was discovered that the secondary collimator filter on some
OEC 9600 C-arms was omitted when a collimator assembly was replaced.
This would reduce the filtration and therefore the Half-Value-Layer
(HVL) of the X-ray beam, and may result in non-compliance with respect
to Maximum Entrance Exposure Rate (EER) unless the maximum EER
verification and/or calibration were performed after collimator
replacement.
PRODUCT:
a) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile. A
combination of legally marketed medical devices placed into one
container for the convenience of the user and used within the limits of
the products' intended uses, Recall # Z-1808-2008;
b) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile. A
combination of legally marketed medical devices placed into one
container for the convenience of the user and used within the limits of
the products' intended uses, Recall # Z-1809- 2008
MANUFACTURER: Recalling Firm: Merit Medical Systems, Inc., South Jordan,
UT, by visit on April 14, 2008. Manufacturer: Zimmer, Inc., Warsaw, IN.
Firm initiated recall is complete.
REASON: Sterility Compromised: Component of convenience kit was recalled
by its manufacturer for non-sterility.
PRODUCT: GE Healthcare Definium 8000 Digital Radiographic
System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis,
Recall # Z-1822-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated March 7,
2008. Firm initiated recall is ongoing.
REASON: Loss of image data: Software anomaly in the Processing Software
on the Definium 8000 system may impact patient safety when using the
VolumeRAD advanced application (option). The slice visualization of
VolumeRAD exams acquired on the wallstand receptor will be offset by
17mm. This prevents the visualization of anatomy WITHIN a distance of
17mm from the wallstand patient barrier (receptor cover). This lost
anatomy cannot be recovered or visualized by retrospective
reconstruction processing.
PRODUCT: GE Healthcare Definium 8000 Digital Radiographic
System, Recall # Z-1882-2008
MANUFACTURER: GE Healthcare, Waukesha, WI, by letter dated March 7,
2008. Firm initiated recall is ongoing.
REASON: Radiation dose reading greater than actual dose: Error in the
generator software on the GE Healthcare Revolution XR/d configured with
HP 8200 PC consoles and all Definium 8000 systems may impact patient
safety. Occasional generator software errors may cause light X-ray
Images with reported mAs readings higher than was actually exposed to
the patient using the overhead X-ray tube. The mAs readings reported
from the system could be up to ten times higher than what was actually
exposed to the patient. Occurrence is limited to the first exposure
after the focal spot is switched from small to large. The generator
incorrectly applies the small filament limit to the large focal spot,
which can cause the large focal spot to produce less current. Subsequent
large focal spot exposures will not exhibit this issue.
PRODUCT: IsoMed Refill Kit, Model 8553, is intended for
use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles,
extension tubing set with y-connector and clamp, Filter, 10-ml syringe,
60-ml lidded syringe, Fenestrated drape, Template; Product is packaged
in a sterile container, Recall # Z-1903-2008
MANUFACTURER: Recalling Firm: Medtronic Neuromodulation, Minneapolis,
MN, either by personal visits, or telephone, beginning February 4, 2008.
Manufacturer: B. Braun Medical, Inc., Allentown, PA. Firm initiated
recall is complete.
REASON: Medtronic is retrieving all unused packages of ISOMED Refill Kit
Model 8553, Lot 60538731. This lot of product was released using
incorrect endotoxin specification limits. Endotoxin contamination can
potentially lead to fever, malaise, respiratory distress, septic shock,
and death.
PRODUCT: CyberKnife Robotic Radiosurgery System radiation
therapy device with Multiplan treatment Planning Software versions 1.5.2
and higher, Recall # Z-2056-2008
MANUFACTURER: Accuray, Inc., Sunnyvale, CA, by letter on April 16, 2008.
Firm initiated recall is ongoing.
REASON: Sample beam data (which should not be used to treat patients)
may differ from actual radiation output of an installed product, and
which may be used by users.
PRODUCT:
a) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530, Recall #
Z-2060-2008;
b) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535, Recall #
Z-2061-2008;
c) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545, Recall #
Z-2062-2008;
d) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630, Recall #
Z-2063-2008;
e) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635, Recall #
Z-2064-2008;
f) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640, Recall #
Z-2065-2008;
g) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650, Recall #
Z-2066-2008;
h) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw
Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR0750,
Recall # Z-2067-2008;
i) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740, Recall #
Z-2068-2008;
j) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745, Recall #
Z-2069-2008;
k) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535; Recall #
Z-2070-2008;
l) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540, Recall #
Z-2071-2008;
m) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545, Recall #
Z-2072-2008;
n) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size
(diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655, Recall #
Z-2073-2008;
o) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640, Recall #
Z-2074-2008;
p) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645, Recall #
Z-2075-2008;
q) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735, Recall #
Z-2076-2008;
r) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740, Recall #
Z-2077-2008;
s) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size
(diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745, Recall #
Z-2078-2008
MANUFACTURER: Allez Spine, LLC, Irvine, CA, by telephone on November 8,
2007. Firm initiated recall is complete.
REASON: This recall was initiated after Internal Engineering Testing of
the conical seat design pedicle screws of sizes 5, 6 and 7 showed a
potential of partial displacement of screw shank when used in
combination with the single piece locking nuts. This partial
displacement of the screw shank could finally lead to total separation
and failure of the construct.
PRODUCT: Osteonics Scorpio Total Knee; Posteriorly
Stabilized Femoral Component; # 13 with posts, low friction lon
treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing
Components with Scorpio Patellar Components, Catalog No. 711-4513L,
Recall # Z-2079-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter
on March 18, 2005. Firm initiated recall is complete.
REASON: Component labeled and laser marked as a Left, was in fact a
Right component.
PRODUCT: Hoffman II compact Sterile Wrist Kit is used in
the stabilization of open and unstable fractures; Catalog Number:
4940-9-810, Recall # Z-2080-2008
MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters
on August 17, 2005. Firm initiated recall is complete.
REASON: The pin of the Hoffmann II Compact External Fixation System may
jam into the Soft Tissue protector.
PRODUCT: VariSource® CT/MR Ring & Tandem Applicator Set,
catalog # AL13017000, containing 32mm titanium ring applicators, each
identified as part numbers AL07362000, AL07363000, and AL07364000,
Recall # Z-2081-2008
MANUFACTURER: Recalling Firm: Varian Medical Systems, Inc.,
Charlottesville, VA, by letter on March 12, 2008. Manufacturer: Varian
Medical Systems U.K. Ltd., Crawley, United Kingdom. Firm initiated
recall is ongoing.
REASON: Medical device may exhibit inaccurate positioning and lead to
unintended dose delivery during brachytherapy treatment.
PRODUCT:
a) TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2082-2008;
b) Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device
is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2083-2008;
c) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2084-2008;
d) TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2085-2008;
e) TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2086-2008;
f) TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2087-2008;
g) TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The
device is indicated for degeneration, deformity, or trauma of both the
tibiotalar and talocalcaneal articulations in the hindfoot, Recall #
Z-2088-2008
MANUFACTURER: Smith & Nephew, Inc., Memphis, TN, by letter on April 22,
2008 and e-mail on April 22, and April 23, 2008. Firm initiated recall
is complete.
REASON: One of the distal locking screw holes on a hindfoot fusion nail
was drilled with an
PRODUCT: NexStent Monorail Carotid Stent System, Material
number M 001553000, Catalog number 55-300, packaged in a PET tray,
Recall # Z-2089-2008
MANUFACTURER: Recalling Firm: Boston Scientific Cupertino, Corp.,
Cupertino, CA, by letters. Manufacturer: Boston Scientific Corp, Natick,
MA. Firm initiated recall is complete.
REASON: Tip may detach from stent delivery system.
PRODUCT: COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The
device is intended as an aid in monitoring patients for disease progress
or response to therapy, Recall # Z-2090-2008
MANUFACTURER: Siemens Medical Solutions Diagnostics, Los Angeles, CA, by
Customer Bulletin on May 21, 2008. Firm initiated recall is ongoing.
REASON: The Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low
bias, which is evident when comparing results with other methods,
including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for
example, approximately 20% lower when compared to results obtained with
the IMMULITE 2000 Third Generation PSA assay (L2KUP).
PRODUCT:
Radiation therapy system - Coherence AG Therapist Part number 5863506
and Therapist system Part number 7339125, equipped with a Coherence
Therapist RTT2.1 or Primeview 3i R2.1. This is a medical charged
particle radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO
standard medical imaging platform to provide comprehensive oncology
workflow solutions for radiation therapy, Recall # Z-2095-2008;
b) Radiation therapy system - Coherence Impression Therapist System
equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part
number 7341410. Medical charged particle Radiation therapy system, part
of the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall
# Z-2096-2008;
c) Radiation therapy system - PRIMEVIEW 3i System equipped with a
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7341428.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy, Recall # Z-2097-2008;
d) Radiation therapy system - AG Therapist 3rd party V&R equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345411.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy,
Recall # Z-2098-2008;
e) Radiation therapy system - Impression Therapist 3rd party V&R
equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part
number 7345429. Medical charged particle Radiation therapy system, part
of the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall
# Z-2099-2008;
f) Radiation therapy system - Syngo Based WS for 3rd party V&R equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number
7345437. Medical charged particle Radiation therapy system, part of the
firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy, Recall
# Z-2100-2008;
g) Radiation therapy system - Coherence Therapist 2.0 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy,
Recall # Z-2101-2008;
h) Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy, Recall # Z-2102-2008;
i) Radiation therapy system - Coherence Therapist System 2.1 equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number
8147667. Medical charged particle Radiation therapy system, part of the
firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy. Applies
only to those parts used with the following devices identified in the
product descriptions, Recall # Z-2103-2008;
j) Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with
Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675.
Medical charged particle Radiation therapy system, part of the firm's
beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy.
Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or
Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318.
Applies only to those parts used with the following devices identified
in the product descriptions, Recall # Z-2104-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by
letter on May 15, 2008. Firm initiated recall is ongoing.
REASON: Software - Under certain circumstances, the portal image may be
overwritten, which may lead to incorrect dosage.
PRODUCT:
a) GE 1.5T and 3.0T Signa® HDx MR System Model Numbers: 5127452,
2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging
device to produce axial sagittal, coronal and oblique images,
spectroscopic images, and/or spectra, dynamic images of the internal
structures and organs of the entire body, including, but not limited to,
head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints,
prostate, blood vessels, and musculoskeletal regions of the body, Recall
# Z-2210-2008;
b) GE Signa® Excite 1.5T MR System, GE Signa® Excite 3.0T MR System.
Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW. Indicated for
use as a diagnostic imaging device to produce axial sagittal, coronal
and oblique images, spectroscopic images, and/or spectra, dynamic images
of the internal structures and organs of the entire body, including, but
not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis,
joints, prostate, blood vessels, and musculoskeletal regions of the
body, Recall # Z-2211-2008
MANUFACTURER: GE Medical Systems LLC, Waukesha, WI, by letter dated
September 14, 2007. Firm initiated recall is ongoing.
REASON: A software issue that may result in misregistration of
functional and anatomical images associated with the 3.0T BrainwaveRT
fMRI Application on the 3.0T Signa HDx scanner.
PRODUCT: Naviscan PET Systems, Inc ("Naviscan") PEM Flex
Solo II PET Scanner. The PEM Flex Solo II images small body parts with
optimized PET technology, Recall # Z-2229-2008
MANUFACTURER: Naviscan PET Systems, San Diego, CA, by letter on June 19,
2008. Firm initiated recall is ongoing.
REASON: This field correction is being initiated as a result of the
firm's investigation into a report from a user indicating that the
motorized compression exceeded 25 pounds of compression force during the
pre-scan positioning of the patient. The investigation identified that a
secondary fault protection did not perform as expected.
PRODUCT: Siemens brand Ultrasound Transducer 17L5HD used
with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used
with System Models: 08245875, 08246951, 08255412, 08255413, 08267697,
08269627, 10038241, 10038242, 10040724, 10040725, 10041008; Product is
manufactured and distributed by The 17L5 transducer is intended for
breast and small body parts imaging, Recall # Z-2230-2008
MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by
letters on June 6, 2008. Firm initiated recall is ongoing.
REASON: The product assembly can cause a failure of the transducer which
results in a double and/or overlapped image which may ultimately result
in misleading or false information, inability to accurately diagnose,
incorrect positioning/locating/insertion of the biopsy needle and/or an
interruption during the biopsy procedure.
PRODUCT: ARCHITECT c8000 Processing Module, for in vitro
diagnostics; List Number 1G06-01 and 1G06-11, Affected software: v2.20,
Part #7-201738-01; v2.20DB, Part #7-201738-02; v2.60, Part #7-203715-01;
v3.10, Part #7-203715-02; 3.11, Part 7-203715-03; and 3.12. The Abbott
ARCHITECT cSystem is designed to perform automated, random access,
clinical chemistry analyzer which utilizes spectrophotometry
(monochromatic and bichromatic modes of measurement) for photometric
based determinations, Recall # Z-2231-2008
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on May
23, 2008. Firm initiated recall is ongoing.
REASON: Software defect can allow tests ordered for one sample to be
aspirated from a different sample, reporting erroneous results for the
affected sample.
CLASS III
PRODUCT:
a) Axis Gamma Camera, Scintillation (gamma) camera. Model Numbers:
210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis
System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4"
Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665
13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280
Axis System 3/8 Precision 4535 671 67421, or N211282 Axis System 3/4
Precision (Note: Due to a part number scheme change at the firm, either
number is representative of the identified system), Recall #
Z-1510-2008;
b) Irix Gamma Camera, Scintillation (gamma) camera. Model Numbers:
210857 and 210881. 4535 679 46991, or N210857 Irix System, 3/8" Crystal
4535 665 13551, or N210881 Irix System 3/4" Crystals 4535 679 46981, or
N211038 Irix System 3/8 Precision 4535 665 13571, or N211040 Irix System
3/4 Precision (Note: Due to a part number scheme change at the firm,
either number is representative of the identified system), Recall #
Z-1511-2008;
c) Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera,
Recall # Z-1512-2008
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH,
by letter on January 30, 2008. Firm initiated recall is ongoing.
REASON: Resistor Failure: The Rotate Motion Shunt Resistor may overheat
and results in the appearance of smoke, a burning smell, and an
electronic stop condition, which will disable the gamma camera rotate
motion and all other motions.
PRODUCT: Harleco Brand Ethanol Standard, 1.0 mg/ml 1.0 mg
Ethanol in 1 ml 10 ampules; Each ampule contains approximately 1.1 ml to
facilitate the removal of 1.0 ml, Item number 68991/95, Recall #
Z-1607-2008
MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by e-mail on March 27,
2008 and letters on April 3, 2008. Firm initiated recall is ongoing.
REASON: EMD Chemicals received 1 customer complaint regarding 2 ampules
measuring 2.0 mg/ml found in a lot of 20 ampules of 1.0 mg/ml Ethanol
Standard.
PRODUCT: Cholestech LDX High Sensitivity C-Reactive
Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity
C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the
quantitative determination of C-reactive protein in whole blood or
serum. Measurement of CRP is useful as an aid in the detection and
evaluation of infection, tissue injury, inflammatory disorders and
associated diseases. The test cassettes are for use with the LDX
analyzer; Catalog #12-807, Recall # Z-2457-2008
MANUFACTURER: Cholestech, Corp., Hayward, CA, by letter dated August 9,
2005. Firm initiated recall is complete.
REASON: Test results are high, outside of control material upper limit
specification . Results could be as high as 15%.
The following is condensed list of medical
devices involved in recalls listed by the FDA Enforcement Report as of
September 24, 2008
CLASS II
PRODUCT: Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging
device intended for radiographic, fluoroscopic, angiographic, and
interventional applications. Product number: 9896 002 04432. Site ID #:
506241, 500046, 521648, 522220, 520020, 533112, 533314, 533471, 533530,
535257, 535118, 535924, 540860, 541490, 539106, 547017, 547142, 549798,
547348, 550258, 553676, 553235, Recall # Z-1374-2008
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co.
Phillips, Bothell, WA, by letters on March 22, 2008. Manufacturer:
Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall
is ongoing.
REASON: Unexpected movement of the X-ray table may occur. These
movements may lead to patient injury, e.g., an uncontrolled tilt may
cause the patient to slip off.
PRODUCT: Altaire MRI System Emergency Rundown Switch Unit
(ERDU) is intended to provide the physician with physiological and
clinical information obtained non-invasive and without the use of
ionizing radiation, Recall # Z-1542-2008
MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc.,
Twinsburg, OH, by letter on February 11, 2008. Manufacturer: Hitachi
Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is
ongoing.
REASON: The firm’s Altaire MR Scanner’s Emergency Rundown Switch Unit
(ERDU), that is used to shut down the device in an emergency, was found
to be defective. An ERDU failure could delay or prevent patient access
leading to possible patient death or serious injury.
PRODUCT: VNUS Medical U-CLIP Removal Tool, UREM1860, is
intended for the removal of U-Clip anastomotic devices, Recall #
Z-1609-2008
MANUFACTURER: Recalling Firm: Medtronic Cardiac Surgery Technologies,
Minneapolis, MN, by letter on February 25, 2008. Manufacturer: Medtronic
Mexico EG, Sonora, Mexico. Firm initiated recall is ongoing.
REASON: Medtronic has identified one lot #0610315 of U-Clip Removal
Tools, Catalog UREM1860FW that was incorrectly assembled. The nose cone
attachment, on the body of the removal tool, may not contain sufficient
adhesive, which can allow the nose cone to separate from the body of the
device
PRODUCT:
a) ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device),
Recall # Z-1653-2008;
b) ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory
Device), Recall # Z-1654-2008
MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by
letter on February 28, 2008. Manufacturer: Radiometer Medical ApS,
Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON: Reported calibration errors are not displayed on the analyzers
parameter bar screen or on the patient results when the calibration
number is between 32768 - 65535 and 98303 - 131070. This may cause the
operator to perform measurements and obtain questionable results.
PRODUCT:
LIFEPAK 1000 defibrillator - portable battery powered semi-automated
model that can be operated in either of three modes: Automated external
defibrillator (AED), manual defibrillator and electrocardiographic (ECG)
mode. The defibrillator is intended for indoor or outdoor use in a wide
variety of hospital and pre-hospital settings including ground and air
ambulances, physician's offices, aircraft, stadiums and specialty
medical clinics. ECG monitoring is intended for use on conscious and
unconscious patients of all ages for the purpose of ECG rhythm
recognition and heart rate monitoring. Affected part numbers:
320371500021 through 320371500038, 320371500043, 320371500044,
320371500046, 320371500048, 320371500050, 320371500056, 320371500058,
320371500063, and 320371500067, Recall # Z-1656-2008
MANUFACTURER: Physio Control, Inc., Redmond, WA, by letter on February
27, 2008. Firm initiated recall is ongoing.
REASON: Potential for the display screen to dim and eventually go blank.
The risk to patient is a delay in defibrillation therapy if the
defibrillator was needed in a cardiac arrest situation. Death or
permanent impairment can occur if the user fails to deliver a
defibrillation shock or defibrillation is delayed.
PRODUCT: ArthroCare brand Topaz XL ArthroWand with
Integrated Cable Wand, Catalog Number: AC4045-01; Sterile Surgical
Device. Product is indicated for ablation and debridement of tendons in
orthopedic procedures, Recall # Z-1657-2008
MANUFACTURER: ArthroCare Corporation, Sunnyvale, CA, by letters dated
January 31, 2008. Firm initiated recall is ongoing.
REASON: Devices for which sterility may be compromised as evidenced by
punctures in the plastic tray during shipping. The risk to the patient
is a potential infection subsequent to the surgical procedure.
PRODUCT
Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument
used to prepare the natural shoulder glenoid surface for implanting a
Hybrid Glenoid component. This instrument is intended to function by
drilling a hole into the natural glenoid surface allowing the center
boss of glenoid implant to sit within the hole, and the non-articulating
surface of the glenoid implant to rest flush onto the natural glenoid
surface, Recall # Z-1658-2008
MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters dated March 13, 2008.
Firm initiated recall is ongoing.
REASON: The glenoid implant may not seat fully on the face of the
natural glenoid due to inadequate measurement tolerances (tolerance
stack-up) in the design of the cutter. Use of the instrument may lead to
incomplete seating of the glenoid implant, elevating the theoretical
risk of glenoid loosening, which may lead to early revision surgery. The
problem may contribute to early device failure and patient injury
because the stack-up tolerances could result in inadequate removal of
bone from the natural glenoid surface. Long range health consequences
may include: premature breakdown of cement mantle, excessive fatigue
loading, the potential for early device failure and patient injury.
PRODUCT:
a) LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring
component intended for use as a radiofrequency signal transmitter and
receiver of electrocardiograph physiological signals which are displayed
on the ECG monitors of various manufacturers' systems that have been
validated for compatibility, Recall # Z-1659-2008;
b) LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring
component intended for use as a radiofrequency signal transmitter and
receiver of electrocardiograph physiological signals which are displayed
on the ECG monitors of various manufacturers' systems that have been
validated for compatibility, Recall # Z-1660-2008
MANUFACTURER: GMP Companies/Lifesync Corp., Ft Lauderdale, FL, by letter
on December 14, 2007. Firm initiated recall is ongoing.
REASON: LifeSync Wireless ECG System - Intermittent failure when using
LS-202 and LS-203 LeadWear in conjunction with LS-41245 and LS-41285
Adaptors. The out of box failure manifests as a V-Lead failure, leading
to a possible delay in treatment based upon a delay in ECG monitoring.
PRODUCT:
Is-anti-Gliadin IgG Enzyme Immunoassay Test Kit packaged in cardboard
boxes with individual components secured within a foam insert. Catalog
Number # 720-800. Laboratory In-Vitro Diagnostic Assay intended for the
semi-quantitative detection of IgG antibodies to Gliadin in human serum
by indirect enzyme immunoassay as an aid in the diagnosis of celiac
disease, Recall # Z-1684-2008
MANUFACTURER: Recalling Firm: Diamedix Corporation, Miami, FL, by letter
on December 14, 2007. Manufacturer: D-Tek Sa, Mons, Belgium. Firm
initiated recall is ongoing.
REASON: Standards and controls in the Is-anti-Gliadin IgG Test Kits are
exhibiting low activity. A drop in the O.D.s the Positive Control could
potentially recover low out of range (which would invalidate the test),
or false positive test results could be obtained.
PRODUCT: Electrode Adaptor Cable Quick-Combo System, Model
9055. The 9055 Electrode Adaptor is intended for use by trained
personnel who use a Cardiac Science Automated External Defibrillator
(AED) for defibrillation with Medtronic QUICK-COMBO Electrodes, Recall #
Z-1714-2008
MANUFACTURER: Cardiac Science Corporation, Bothell, WA, by letter on
January 23, 2008. Firm initiated recall is complete.
REASON: Instructions For Use is not clear about how the AED voice and
text prompts will differ when the adapter is used.
PRODUCT: Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable
Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm)
Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine
BR Anchor System is indicated for use in soft tissue bone fixation.
Catalog Number 210711, Recall # Z-1810-2008
MANUFACTURER: Recalling Firm: DePuy Mitek, Inc., a Johnson & Johnson
Co., Raynham, MA, by letter dated April 29, 2008. Manufacturer: Ethicon
SARL, Neuchatel, Switzerland. Firm initiated recall is complete.
REASON: Lupine BR Anchor w/Orthocord was assembled with an incorrect
suture configuration. The suture loop was not assembled at the distal
end of the anchor. It was only threaded through the suture hole in the
anchor. Risk associated with incorrect suture configuration include
premature breakage.
PRODUCT: Intuitive Surgical DA Vinci Surgical System,
Mode; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number
420215-02. The IS2000 CPG is used during cardiac ablation procedures,
Recall # Z-1811-2008
MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by letter on
April 18, 2008. Firm initiated recall is complete.
REASON: The product has a software |
