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Recall Archives 21

FDA Recalls

July 1, 2007 -  December 30, 2007

 

 

 

 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 26, 2007:

CLASS II
MANUFACTURER: OrthoHelix Surgical Designs Inc, Akron, OH, by letter on Sept. 4, 2007. Firm initiated recall is ongoing
PRODUCT:
a) DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate;
b) Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24;
c) Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw cadies, Recall # Z-0136-2008
REASON: Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.

MANUFACTURER: Freedom Designs Inc, Simi Valley, CA, by letter on May 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Recall # Z-0137-2008
REASON: Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter and e-mail on September 4, 2007. Manufacturer: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, Size 6 X 12, MATL: Steel/Titanium, Rx only,
Recall # Z-0138-2008;
b) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972246, Size 6 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0139-2008;
c) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972266, Size 6 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0140-2008;
d) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, Size 7 X 14, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0141-2008;
e) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972267, Size 7 X 16, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0142-2008;
f) Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972287, Size 7 X 18, MATL: Stainless Steel/Titanium,
Rx only, Recall # Z-0143-2008
REASON: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

MANUFACTURER: Gen-Probe Inc, San Diego, CA, by telephone on May 2nd and 3rd, 2007 and by letter on May 3, 2007. Firm initiated recall is complete.
PRODUCT: Accuprobe Group B Streptococcus Culture Identification Test, Catalog number: 2820B, Batch number: 531379, Recall # Z-0145-2008
REASON: Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone and letter on August 8, 2007. Firm initiated recall is complete.
PRODUCT: a) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert, Catalog #: 508-00-036, Sterile, Recall # Z-0184-2008;
b) Encore® Reverse® Shoulder Prosthesis (RSP) System, Standard Size 40 RSP
Humeral Socket Insert, Catalog #: 508-00-040, Sterile, Recall # Z-0185-2008;
REASON: Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.

MANUFACTURER: Recalling Firm: Ellex USA, Eden Prairie, MN, by telephone on June 13, 2007 and by letters on September 27, 2007. Manufacturer: Ellex Medical Pty Ltd, Adelaide, SA Australia. Firm initiated recall is ongoing.
PRODUCT:
a) Ellex Solitarie Opthalmic Laser System, Model No: LP 4532 - DGS P/N 303896; Solitaire-SGS P/N 3038960, Recall # Z-0286-2008;
b) Ellex Integre Duo, Model No: LP1RG -S P/N 3040000. The Integre Duo is a dual-wavelength surgical photocagulator laser intended for use in a clinic, outpatient
clinic, or a retinal specialist's office, Recall # Z-0287-2008
REASON: Electric Shock from Power Supply: The power supply has a defect which can cause an electrical shock to user.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated September 11, 2007. Manufacturer: Danish Diagnostic Dev. A/S, Hrsholm, Denmark. Firm initiated recall is ongoing.
PRODUCT: C.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed), Model No: 9VIR1200, Recall # Z-0304-2008
REASON: Unintended Motion: A hardware fault in the c.cam system can cause the system to experience unintended motion, thereby causing a collision hazard.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 19, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Global Protection Corp., Boston, MA, by e-mail on September 11, 2007. Manufacturer: Guilin Latex Factory, Guilin, Guangxi, China. Firm initiated recall is complete.
PRODUCT: Lubricated Latex Condom. Labeled in part: “Coming Together in DC”, Recall # Z-0054-2008
REASON: Condoms fail the water leak test and package integrity.

MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA, Inc, Memphis, TN, by letters on August 24, 2007. Manufacturer: Warsaw Orthopedic, Inc., dba Medtronic SOFAMOR DANEK, Warsaw, IN. Firm initiated recall is complete.
PRODUCT: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Recall # Z-0074-2008
REASON: Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cement Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size. Labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: VNUS Medical Technologies, Inc, CA, by letters on March 6, 2007. Firm initiated recall is complete.
PRODUCT: VNUS ClosureFAST catheters, Model number: CL7-7-100, Recall # Z-0132-2008
REASON: Sterility (package integrity) Compromised. Product sterility may be compromised due to a pinhole under the pouch foldover.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letters on September 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008;
b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall # Z-0147-2008
REASON: Incorrect Sample/Test Identification: Due to a software timing defect with certain versions of ARCHITECT cSystem Software, test results may be incorrectly associated to a Sample Identification during specific sample-processing conditions of the Robotic Sample Handler.
MANUFACTURER: Mizuho Orthopedic Systems, Inc., Union City, CA, by letter and telephone on February 28, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Recall # Z-0241-2008;
b) OSI ProFx Operating Room Table 6850 , Pelvic Reconstruction Orthopedic
Surgery Table-- Stand alone single-pedestal AC power or battery operated table, Recall # Z-0242-2008
REASON: Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha, WI, by letter letters dated September 10, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Advantage Workstations, Advantage Workstation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2, Recall # Z-0265-2008
REASON: Aortic Length over-estimated: Incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should not be used.

MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Recall # Z-0316-2008;
b) Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Recall # Z-0317-2008
REASON: Clip Detachment. The retainer c-clip can detach from the instrument during use and may fall into the surgical wound.

MANUFACTURER: Axya Medical, Beverly, MA, by letter dated September 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Axya Bone Anchor , 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Recall # Z-0331-2008;
b) Axya Bone Anchor, 5.0 mm Titanium with Nylon Suture Catalog Number: CAT1227, Recall # Z-0332-2008;
c) Axya Bone Anchor, 6.5 mm Titanium with Nylon Suture, Catalog Number: CAT1238, Recall # Z-0333-2008;
d) Axya Bone Anchor 3.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1268, Recall # Z-0334-2008;
e) Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1269, Recall # Z-0335-2008;
f) Axya Anchor, 5.0 mm Titanium in Super Kit, Catalog Number: CAT1270, Recall # Z-0336-2008;
g) Axya Bone Anchor 3.0 mm Titanium in Super Kit Catalog Number: CAT1274, Recall # Z-0337-2008;
h) Axya Bone Anchor, 3.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1230, Recall # Z-0338-2008;
i) Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Recall Z-0339-2008;
j) Axya Bone Anchor 6.5 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1264, Recall # Z-0340-2008;
k) Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Recall # Z-0341-2008;
l) Axya Bone Anchor 3.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1266, Recall # Z-0342-2008;
m) Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Recall # Z-0343-2008;
n) Axya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Recall Z-0344-2008;
o) Axya Bone Anchor 3.0 mm Bioabsorbable in Super Kit Catalog Number: CAT1273, Recall # Z-0345-2008;
p) Arthocare 5mm ParaFix Anchor (5mm x 14.5mm) -2 strands of #2 braided suture, Part Number: 22-5001, Recall # Z-0346-2008;
q) Arthocare 3mm ParaFix Anchor (3mm x 9mm) -single strand of #2 braided suture,Part Number: 22-5002, Recall # Z-0347-2008;
r) Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Recall # Z-0348-2008;
s) Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Recall # Z-0349-2008;
t) Arthrocare 6.5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5012, Recall # Z-0350-2008;
u) Arthrocare 3.0mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Recall Z-0351-2008;
v) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055, Recall # Z-0352-2008;
w) Arthrocare 5.5mm ParaSorb, pre-loaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number: 22-5055N, Recall # Z-0353-2008;
x) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, Recall # Z-0354-2008;
y) Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Recall # Z-0355-2008
REASON: Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging.

MANUFACTURER: Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated November 2, 2007. Manufacturer: Stryker Medical Quebec, LP, L'Isletville, Canada. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker inTouch Critical Care bed; Model 2130, Recall # Z-0356-2008;
b) Stryker inTouch Zoom Critical Care bed, Model 2140, Recall # Z-0357-2008
REASON: Multiple defects: 1) beds exhibit reverse motions when the Fowler, gatch or foot section is activated; 2) a battery charging defect which may result in a depletion of battery power; 3) the touch screen on the footboard freezing, resulting in controls to powered, pressure-relief mattresses being difficult to access; 4) beds equipped with zoom drive systems may have an overdrive problem which could result in the bed not being readily movable.

MANUFACTURER: Haemonetics Corp., Braintree, MA, by letter on October 15, 2007. Firm initiated recall is ongoing.
PRODUCT: Haemonetics cardioPAT System. Product list number 02050, (Cardiovascular Perioperative Autotransfusion), Recall # Z-0358-2008
REASON: Labeling (additional) use instructions to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient’s chest.

MANUFACTURER: Acist Medical Systems, Eden Prairie, MN, by letter on October 3 and 4, 2007, Firm initiated recall is ongoing.
PRODUCT: ACIST Multi-Use Syringe Kit, Model A2000; SKU #: 014612; labeled as STERILE; Catalogue No: 800061-003. (The multiple use A20000 syringe kit is comprised of a terminally sterilized syringe barrel and a contrast spike assembly), Recall # Z-0359-2008
REASON: Syringe Fracture: The syringe may be fractured, causing contrast to be sprayed from syringe fracture.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on November 13, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Recall # Z-0361-2008
REASON: Labeling Error: The VKS PE Ultra-congruent insert package may actually contain a Standard PE insert.

MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on Nov. 27, 2007 Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
PRODUCT: VKS Tibial Trial, Right/Left, Prep Guide, Recall # Z-0362-2008
REASON: The VKS "Tibial Trial" was found to have an incorrect fixation pin hole diameter.

MANUFACTURER: Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by phone, e-mail and fax on April 30, 2007. Manufacturer: Blackstone Medical Inc., Springfield, MA. Firm initiated recall is complete.
PRODUCT: Ascent POCTS (Posterior Occipital Cervical Thoracic System). Recall # Z-0363-2008
REASON: Manufacturing Defect: The saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. The extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. As a consequence, there is a potential for set-screw cross-threading during implantation. Cross-threading could in turn lead to a compromise of the integrity of the multi-axial locking mechanism.

MANUFACTURER: Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008
REASON: Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.

MANUFACTURER: Recalling Firm: Abbott Point of Care Inc., East Windsor, NJ.
Manufacturer: Abbott Point Of Care, Mississauga, Canada, Firm initiated recall is ongoing
PRODUCT:
a) Abbott Point of Care, i-STAT 6+ Cartridge (Na K CL BUN/Urea GLU Hct), Recall # Z-0370-2008
b) Abbott Point of Care, i-STAT E3+ Cartridge, (NA K Hct), Recall # Z-0371-2008
c) Abbott Point of Care, i-STAT EC4+ Cartridge; (NA K Glu Hct), Recall # Z-0372-2008
d) Abbott Point of Care, i-STAT CREA Cartridge (Creatine/Crea), Recall # Z-0373-2008
e) Abbott Point of Care, i-STAT EC8+ Cartridge; (NA K CL Glu pH PCO 2 UN/Urea Hct), Recall # Z-0374-2008
f) Abbott Point of Care, i-STAT G Cartridge; (Glucose/Glu), Recall # Z-0375-2008
REASON: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed

MANUFACTURER: Recalling Firm: Aesculap Implant Systems, Center Valley, PA, by letter dated Oct. 10, 2007. Manufacturer: Aesculap AG & Co. KG., Tuttlingen, Germany, Firm initiated recall is complete.
PRODUCT:
a) Excia Cemented Hip Stems, Size 9mm, Recall # Z-0436-2008;
b) Excia Cemented Hip Stems, Size 10mm, Recall # Z-0437-2008;
c) Excia Cemented Hip Stems, Size 11mm, Recall # Z-0438-2008;
d) Excia Cemented Hip Stems, Size 12mm, Recall # Z-0439-2008;
e) Excia Cemented Hip Stems, Size 13mm, Recall # Z-0440-2008;
f) Excia Cemented Hip Stems, Size 14mm, Recall # Z-0441-2008;
g) Excia Cemented Hip Stems, Size 15mm, Recall # Z-0442-2008;
h) Excia Cemented Hip Stems, Size 16mm, Recall # Z-0443-2008;
i) Excia Cemented Hip Stems, Size 17mm, Recall # Z-0444-2008;
j) Excia Cemented Hip Stems, Size 18mm, Recall # Z-0445-2008
REASON: Sterility (package integrity) Compromised: Device package damaged during shipment.

MANUFACTURER: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letter on September 19, 2006. Firm initiated recall is complete.
PRODUCT:
a) Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Recall # Z-0448-2008;
b) Triathlon MIS Femoral Adjustment Block; Catalog Number: 6541-5-601, Recall # Z-0449-2008;
c) Triathlon MIS Modular Capture; Catalog Number: 6541-5-723, Recall # Z-0450-2008
REASON: Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated November 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008
REASON: Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group

MANUFACTURER: Recalling Firm: ConMed Electrosurgery, Centennial, CO, by letter on November 2, 2007. Manufacture: ConMed Corporation, Utica, NY. Firm initiated recall is ongoing.
PRODUCT: Conmed Accessory Electrode, Universal Electrodes, Part/REF Numbers: 138100 through 138-105, 138107, 138110, 138112 and 138113, and Ultra Clean Accessory Electrode, Part/REF Numbers: 139100, 139107, 139108, 139321, 139112, 139104 EXT. 139105EXT, 139110EXT, and 139112EXT, Sterile, Rx Only, Recall # Z-0452-2008
REASON: Sterility (package integrity) Compromised: packages of the electrosurgical blades and needles have an inadequate packaging seal.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter and telephone on November 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in), Sterile, Catalog #/REF #: 585155, Recall Z-0453-2008;
b) BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27 G x 7/8 in), Catalog #/REF #: 585793, Recall # Z-0454-2008
REASON: No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated August 30, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **,LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732, Recall # Z-0459-2008
REASON: False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 28, 2007. Manufacturer: Benoist, Herouville, St Clair, France. Firm initiated recall is ongoing.
PRODUCT:
a) Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm; Sterile; IMPLANT SIZE 1, Recall # Z-0463-2008;
b) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002, IMPLANT SIZE 2, Sterile, Recall # Z-0464-2008;
c) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-003, IMPLANT SIZE 3, Sterile; Recall # Z-0465-2008;
d) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-004, IMPLANT SIZE 4, Sterile; Recall # Z-0466-2008;
e) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Recall # Z-0467-2008;
f) Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Recall # Z-0468-2008;
g) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Recall # Z-0469-2008;
h) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8, Recall # Z-0470-2008;
i) V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Recall # Z-0471-2008;
j) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Recall # Z-0472-2008;
k) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Recall # Z-0473-2008;
l) Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Recall # Z-0474-2008
REASON: Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters dated October 17, 2007. Manufacturer: Benoist, Herouville St Clair, France. Firm initiated recall is ongoing.
PRODUCT: Hipstar TMZF Cementless Hip Stem Protocol, Product number: LSP60, Recall # Z-0475-2008
REASON: Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of + 12 should have been omitted.

CLASS III
MANUFACTURER: Arkray USA, Inc., Minneapolis, MN, by letter on October 18, 2007 and October 26, 2007. Firm initiated recall is ongoing.
PRODUCT: Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Coding chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide), Recall # Z-0458-2008
REASON: Mis-labeled/coded strips: Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter will function properly and give accurate results if the "687" code chip and "867" test strips are used together. However to minimize possibility for confusion or inconvenience by the end user, ARKRAY has decided to recall the product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 12, 2007:

CLASS II
MANUFACTURER: Biomet, Inc. Warsaw, IN, by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Recall # Z-0123-2008
REASON: Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

MANUFACTURER: Recalling Firm: Arjo, Inc. Roselle IL, by letter on October 15, 2007. Manufacturer: Arjo Hospital Equipment, Esloev, Sweden. Firm initiated recall is ongoing.
PRODUCT: Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift, Recall # Z-0261-2008
REASON: Male patient genitals may be pinched between the seat and the frame of the patient lift chair when the Care Raiser seat is returned to its lowest position.

MANUFACTURER: Recalling Firm: Straumann USA LLC, Andover, MA, by letters on September 28, 2007 Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Straumann Palatal Implant, 04.1 L 4.2 mm, Article Number: 042.335S,
Recall # Z-0277-2008; b) Straumann Palatal Implant, 4.8 L 4.2 mm, Article Number: 042.336S, Recall # Z-0278-2008
REASON: Sticking Transfer Piece. The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Recall # Z-0321-2008;
b) Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Recall # Z-0322-2008
REASON: Failure to Operate: The pump may fail to operate, and be difficult to hand crank, due to an internal electrical short condition.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter dated September 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number: 801046, Recall # Z-0323-2008
REASON: Failure to operate: The unit display may go blank and reset when the start button is pressed, due to an internal electrical short, resulting in a centrifugal pump that fails to start as expected.

MANUFACTURER: Boston Scientific Corp, Spencer, IN, by letter on July 19, 2007. Firm initiated recall is complete.
PRODUCT: Boston Scientific Accustick II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF, Recall # Z-0328-2008
REASON: Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Bothell, WA, by letter dated September 21, 2007. Manufacturer: Philips Medical Systems Netherlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Allura Xper FD20 X-Ray System, Release 2.2, Recall # Z-0329-2008;
b) Allura Xper FD20/10, Release 1.2, Recall # Z-0330-2008
REASON: Inaccurate anatomical measurements when using the optional SmartMask feature.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter dated December 6, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High Energy Medical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0380-2008;
b) Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners,
Recall # Z-0381-2008;
c) Siemens, Oncor Impression, Part No.: 58 57 920, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Recall # Z-0382-2008;
d) Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0383-2008;
e) Siemens, Mevatron M2 Primus, Part No.: 19 40 035, Mid-Energy Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners,
Recall Z-0384-2008
REASON: Products collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.

MANUFACTURER: Depuy Orthopedics, Inc., Warsaw, IN, by letters dated September 27, 2007. Firm initiated recall is ongoing.
PRODUCT:
1) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430, Recall # Z-0385-2008;
2) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431,
Recall # Z-0386-2008;
3) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432;
Recall # Z-0387-2008;
4) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433,
Recall # Z-0388-2008;
5) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440,
Recall # Z-0389-2008;
6) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441,
Recall # Z-0390-2008;
7) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442,
Recall # Z-0391-2008;
8) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451, Recall # Z-0392-
2008;
9) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452,
Recall # Z-0393-2008;
10) Depuy P.F.C. ® E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453,
Recall # Z-0394-2008;
11) Depuy P.F.C. ® E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471,
Recall # Z-0395-2008;
12) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521,
Recall # Z-0396-2008;
13) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522,
Recall # Z-0397-2008;
14) Depuy P.F.C. ® E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product
Code/REF 96-0523, Recall # Z-0398-2008;
15) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527,
Recall # Z-0399-2008;
16) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544, Recall # Z-0400-
2008;
17) Depuy P.F.C. ® E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551, Recall # Z-0401-
2008;
18) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630,
Recall # Z-0402-2008;
19) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640,
Recall # Z-0403-2008;
20) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641,
Recall # Z-0404-2008;
21) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650,
Recall # Z-0405-2008;
22) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651,
Recall # Z-0406-2008;
23) Depuy P.F.C. ® E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF
96-0663, Recall # Z-0407-2008;
24) Depuy P.F.C. ® E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041,
Recall # Z-0408-2008;
25) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122,
Recall # Z-0409-2008;
26) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131,
Recall # Z-0410-2008;
27) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132,
Recall # Z-0411-2008;
28) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133,
Recall # Z-0412-2008;
29) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134,
Recall # Z-0413-2008;
30) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert(RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141,
Recall # Z-0414-2008;
31) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2142,
Recall # Z-0415-2008;
32) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2161,
Recall # Z-0416-2008;
33) Depuy P.F.C. ® E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 6, UHMWPE, sterile; Product Code/REF 96-2164,
Recall # Z-0417-2008;
34) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643,
Recall # Z-0418-2008;
35) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650,
Recall # Z-0419-2008;
36) Depuy P.F.C. ® E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652,
Recall # Z-0420-2008;
37) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712,
Recall # Z-0421-2008;
38) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713,
Recall # Z-0422-2008;
39) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF
96-2730, Recall # Z-0423-2008;
40) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2731, Recall # Z-0424-2008;
41) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 15 mm, 3, UHMWPE, sterile; Product Code/REF
96-2732, Recall # Z-0425-2008;
42) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS),71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF
96-2733, Recall # Z-0426-2008;
43) Depuy P.F.C. ® E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF
96-2736, Recall # Z-0427-2008;
44) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310, Recall # Z-0428-2008;
45) Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410, Recall # Z-0429-2008;
46) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206, Recall # Z-0430-2008;
47) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208, Recall # Z-0431-2008;
48) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406, Recall # Z-0432-2008;
49) Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506, Recall # Z-0433-2008;

REASON: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
CLASS III
MANUFACTURER: Boston Scientific Corp., Miami, FL, by letter on June 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific Target, Transend EX Soft Tip Guide Wire .014 in /205cm, UPN: M001468060, Catalog Number: 46-806, Recall # Z-0122-2008
REASON: Mislabeling. Product is labeled with the wrong expiration date: 2009-12. The correct expiration date is 2008-12.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letter on October 12, 2007.Manufacturer: TFX Engineering Ltd., Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Business Park, Annacotty, C. Limerick, Ireland ****Inner Pouch Label: Boston Scientific, Imager II Angiographic Catheter,UPN M001315080, 5 Fr, 100 cm, Catalog No. 31-508, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Recall # Z-0279-2008
REASON: Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 5, 2007:

CLASS II
MANUFACTURER: Cyberonics, Inc., Houston, TX, by correction notice in June of 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Cyberonics Neuro Cyberonics Prothesis System NCP Bipolar Lead, Model #300; Sterile, Single use only, Z-0171-2008;
b) Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only, Recall # Z-0172-2008;
c) Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only, Recall # Z-0173-2008
REASON: Dissolution/Fractures to the leads of the VNS Therapy System.

MANUFACTURER: Recalling Firm: Oridion Capnography Inc., Needham Heights, MA, by letters dated, August 21, 2007. Manufacturer: Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
PRODUCT:
a) Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical, Recall # Z-0177-2008;
b) Capnostream20 Monitor with Masimor Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical, Recall # Z-0178-2008
REASON: Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

MANUFACTURER: Edwards Lifesciences, Llc, Irvine, CA, by letter dated March 15, 2007. Firm initiated recall is complete.
PRODUCT: Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM stent, 80 CM Delivery System, Recall # Z-0179-2008
REASON: Failure to deploy.

MANUFACTURER: Recalling Firm: Teleflex Medical, Durham, NC, letter on/about November 1/2007. Manufacturer: Rai Wenzier Gmbh, Balgheim, Germany, Federal Republic of. Firm initiated recall is ongoing.
PRODUCT:
a) Pilling® Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Recall # Z-0266-2008;
b) Pilling® Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Recall # Z-0267-2008;
c) Pilling® Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws,Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Recall # Z-0268-2008
REASON: The specified insulation is not present on the shaft of the devices, leaving a risk of arcing and/or damage to surrounding tissue.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Knoxville, TN, by letter dated June 15, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Siemens ECAT ACCEL, Catalog No. 3545584, PET/CT Scanner, Recall # Z-0269-2008;
b) Siemens ECAT ART, Catalog No.. 3545584, PET/CT Scanner, Recall # Z-0270-2008;
c) Siemens ECAT EXACT 47, Catalog No. 1788772, PET/CT Scanner, Recall # Z-0271-2008;
d) Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Recall # Z-0272-2008;
e) Siemens ECAT EXACT HR+, Catalog No. 3548083, PET/CT Scanner, Recall # Z-0273-2008
REASON: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.

MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated September 26, 2007. Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is ongoing.
PRODUCT: a) Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.154, Recall # Z-0275-2008;
b) Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L;
Catalog No.: 01.00211.146, Recall # Z-0276-2008
REASON: Mislabeled as to size; 54mm package contains 46 mm device and vice versa.

MANUFACTURER: Wright Medical Technology, Inc., Arlington, TN, by letters on October 4, 2007. Firm initiated recall is ongoing.
PRODUCT: Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Recall # Z-0290-2008
REASON: Breakage. Breaking of the connecting foot that is on the distal surface of the instrument.

MANUFACTURER: Pioneer Surgical Technology, Marquette, MI, by letter dated October 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Recall # Z-0291-2008
REASON: The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.

MANUFACTURER: Recalling Firm: Toshiba America Medical Systems, Inc., Tustine, CA, by letters beginning on October 2, 2007. Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Otawara-Shi, Tochigi, Japan. Firm initiated recall is ongoing.
PRODUCT: Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equipped with Digital Radiography System with Software version 3.4er000, Recall # Z-0293-2008
REASON: System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

MANUFACTURER: Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007. Manufacturer : Medtronic Navigation, Inc., Littleton, MA
PRODUCT: Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008
REASON: Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

MANUFACTURER: Xoran Technologies, Inc., Ann Arbor, MI, by visit between July 25, 2006 and August 10, 2007. Firm initiated recall is complete.
PRODUCT: Xoran MiniCAT for ENT. This device is a cone beam CT scan for sinue, temporal bones and maxillofacial imaging, Recall # Z-0296-2008
REASON: The hard drive may crash, resulting in loss of data from patient CT scans. 

 The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 28, 2007

CLASS I
MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letter on October 19, 2007 and by press statement on November 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001, Recall # Z-0212-2008
REASON: Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).

CLASS II
MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by WEB site posting on March 13, 2007 and by letter beginning on March 16, 2007.
Manufacturer: Boston Scientific Corporation CRM Ireland, Clomel, County Tipperary
Ireland. Firm initiated recall is ongoing.
PRODUCT:
a) Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872, Recall # Z-0047-2008;
b) Guidant VITALITY AVT, Models A135 and A155. Implantable Cardioverter Defibrillator, ICD. Atrial and Ventricular Therapies, Recall # Z-0048-2008;
c) Guidant ASSURE, Model B301, Implantable Cardioverter Defibrillators (ICD). (This model is not available in the USA), Recall # Z-0049-2008;
d) Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter
Defibrillators (ICD). Recall # Z-0050-2008;
e) Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Recall # Z-0051-2008;
f) Guidant CONTAK RENEWAL 3 (Models H170, H173, H175), Guidant CONTAK RENEWAL 3 HE (Models H177, H179). Guidant CONTAK RENEWAL 4 (Models H190,H195) *, Guidant CONTAK RENEWAL 4 HE (Models H197, H199)* Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. (* models are not available in the USA), Recall # Z-0052-2008;
g) Guidant CONTAK RENEWAL 3 AVT (Models M150, M155) Guidant CONTAK RENEWAL 3 AVT HE (Models M157, M159), Guidant CONTAK RENEWAL 4 AVT (Models M170, M175)*, Guidant CONTAK RENEWAL 4 AVT HE (Models M177 and M179)*. Cardiac Resynchronization Therapy Defibrillator (CRT-D). (* models are not available in the USA), Recall # Z-0053-2008;
REASON: Erroneous Display/Atypical Charge Time Behavior: 1)-End of Life (EOL) or Elective Replacement Indicator (ERI) is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2) Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time .

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on October 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat Lift Actuator or a Seat Post to attach the seat to the vehicle; Model Number(s) 300F, 600C, 600T, and 600F, Recall # Z-0174-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on May 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Recall # Z-0175-2008
REASON: Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding the Seat Lift Actuator in place will loosen break off or fall out; 2) Models assembled with Seat Lift Actuator or Seat Post Mounting Bolts, the seat may wobble or the seat will break off from the vehicle; 3) Models using Seat-On Lifting brackets with a hoist to raise an EMC vehicle equipped with a Seat Lift, seat may not fully retract because of incorrect Seat-On Lift bracket Installation.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on November 9, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips, Voxel Q workstations, utilizing AcQSim or AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 and any Mx8000, Mx8001DT, or Brilliance 6, 10, 16, 16P, and Big Bore CT systems connected to the VoxelQ, Recall # Z-0180-2008
REASON: Incorrect simulation and/or beam placement: An anomaly has been identified with the Philips VoxelQ workstation utilizing AcQPlan software version 4.2, 4.2.1, 4.9, 4.9.1, 4.9.2, 4.9.3, 5.0, 5.0.1, 5.0.2 or 5.0.3 when computing absolute patient marking coordinates with data containing reconstruction offsets from the Mx800, the Mx8001DT, and the Brilliance 6, 10, 16, 16P, and Big Bore CT systems. When data from these systems contain reconstruction offsets, the absolute marking coordinates computed within Virtual Fluoroscopy package can be incorrect. Absolute patient marking coordinates computed on data without any reconstruction offsets are correct.

MANUFACTURER: Applied Biotech, Inc., San Diego, CA, by letter on September 28, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Clearview, hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0244-2008;
b) Clearview hCG Combo Waived for urine & Moderate for serum, ABI List No/Product No. 6026KCV; Contents 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Recall # Z-0245-2008
REASON: Sensitivity: Kits contain test devices which may not meet the label claims for sensitivity; therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter dated September 18, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/Ref 141232, Recall # Z-0255-2008
REASON: Mislabeled as to size. The package actually contained a 71 mm tray.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on November 10, 2007. Manufacturer: Inpeco Spa, Segrate, Italy. Firm initiated recall is ongoing.
PRODUCT: Abbott Accelerator APS System Input/Output Module (IOM); List Number: 7L01-01, Recall # Z-0257-2008
REASON: Sample problems. Five issues identified related to software utilized by the ACCELERATOR APS System Input/Output Module, to include: Under three specific conditions, the post-aspiration radio-frequency identification (RF ID) read of the tube carrier is not performed and the APS work cell may not appropriately generate Sample Presentation/Sample Queue errors with APS software version 1.1.1 or earlier, which may result in Sample ID mis-association, sample contamination and/or a sample being reprocessed to remain on the Priority Output Lane without any associated tests downloaded for reprocessing. The other two conditions are related to Sample Identification (SID) usage and lower case alpha characters and APS work cell configuration.

MANUFACTURER: Recalling Firm: Baxter Bioscience, Westlake Village, CA, by letter dated October 24, 2007. Manufacturer: Baxter Healthcare Corporation Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Recall # Z-0263-2008
REASON: Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.

MANUFACTURER: Recalling Firm: B. Braun Interventional Systems, Plymouth, MN, by letter on October 10, 2007. Manufacturer: B. Braun Celsa Medical, Chasseneuil, France. Firm initiated recall is ongoing.
PRODUCT: Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP.. (The VenaTech LP vena cava filter is pre-loaded in a syringe (cartridge) and provided as a system with introducer accessories and instructions to accommodate delivery and implantation either via the femoral or jugular approach.), Recall # Z-0264-2008
REASON: Sterility (package integrity) compromised. Package sealing problem leaving packaging partially open on one of the four sealed Tyvek pouch edges.

MANUFACTURER: Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA, by letter on August 10, 2007. Manufacturer: Thermo Fisher Microgenics, Fremont, CA. Firm initiated recall is ongoing.
PRODUCT: Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator, List Number (LN) 1E66-03 & List Number (LN) 1E66-04, Recall # Z-0288-2008
REASON: Incorrect Calibrator values. Changes in a raw material used in the Bilirubin Calibrator value assignment process contributed to variability in the preparation of the standard.

MANUFACTURER: Metrika, Inc., Sunnyvale, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: A1CNOW+ with sampler 10-Test Kits (Product No: 3022), (This test provides quantitative measurement of the percent of glycated hemoglobin (%A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is used by professional healthcare providers to monitor long-term glycemic control in people with diabetes. The product is sold as a kit with a disposable monitor and reagents for ten A1C tests and is suitable for use at the point-of-care, Recall # Z-0289-2008
REASON: Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

CLASS III
MANUFACTURER: Bio-Rad Laboratories, Inc., Hercules, CA, by telephone and fax on September 25, 2007. Firm initiated recall is ongoing.
PRODUCT: BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD, Recall # Z-0256-2008
REASON: Mislabeling. Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive).

MANUFACTURER: Recalling Firm: Boston Scientific Target, Fremont, CA, by letter dated July11, 2007. Manufacturer: Boston Scientific Corp-Plymouth Tech. Center, Plymouth, MN. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number: 10042, Made in USA, Recall # Z-0259-2008;
b) Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: Recall # Z-0260-2008
REASON: Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter).

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 21, 2007

CLASS II
MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated August 20 and August 23, 2007.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Philips Medical System - BV Pulsera Mobil C-arms with Remote Control Option, Recall # Z-0059-2008;
b) Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control Option, Recall # Z-0060-2008
REASON: System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.

MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by letter on July 13, 2007 and July 23, 2007. Manufacturer: Depuy CMW, Blackpool, Lancashire, UK. Firm initiated recall is ongoing.
PRODUCT: SmartSeal Wedge Femoral Pressurizer; Product Code/Catalog No: 3206002. This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures, Recall # Z-0176-2008
REASON: Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems, Recall # Z-0181-2008
REASON: Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.MANUFACTURER: Pacific Bioscience Lab, Inc., Bellevue, WA, by press release and its Website on August 30, 2007, Firm initiated recall is ongoing.

PRODUCT: Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Recall # Z-0182-2008
REASON: Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Product Description : GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, Recall # Z-0183-2008
REASON: Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

MANUFACTURER: Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 27, 2007. Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
PRODUCT: Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Recall # Z-0214-2008
REASON: Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

MANUFACTURER: Recalling Firm: SKF USA Inc., Norristown, PA, by letter on or about July 24, 2007. Manufacturer: Magnetic Elektromotoren, Liestal, Switzerland. Firm initiated recall is ongoing.
PRODUCT:
a) Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, Recall # Z-0215-2008;
b) Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, Recall # Z-0216-2008;
c) Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000,Recall # Z-0217-2008
REASON: Sudden failure of the actuator during lifting operation.

MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage MI, by letter dated September 24, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Stryker Zoom (Atlas) powered patient transport stretcher, Model 660, Recall # Z-0219-2008;
b) Stryker Transport wheeled stretcher, Model 720, Recall # Z-0220-2008;
c) Stryker Transport wheeled stretcher, Model 721, Recall # Z-0221-2008;
d) Stryker OEM wheeled stretcher, Model 722, Recall # Z-0222-2008;
e) Stryker Transport wheeled stretcher, Model 735 (ST104), Recall # Z-0223-2008;
f) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1001,Recall # Z-0224-2008;
g) Stryker Trauma wheeled stretcher, Model 1002, Recall # Z-0225-2008;
h) Stryker M-Series wheeled stretcher, Model 1005 (SM104), Recall # Z-0226-2008;
i) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009, Recall # Z-0227-2008;
j) Stryker M-Series wheeled stretcher, Model 1015 (SM204), Recall # Z-0228-2008;
k) Stryker Trauma wheeled stretcher, Model 1020, Recall # Z-0229-2008;
l) Stryker M-series powered patient transport stretcher, Model 1025 (SM304), Recall # Z-0230-2008;
m) Stryker Eye Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069, Recall # Z-0231-2008;
n) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1210, Recall # Z-0232-2008;
o) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1211, Recall # Z-0233-2008;
p) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231, Recall # Z-0234-2008;
q) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501, Recall # Z-0235-2008;
r) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Recall # Z-0236-2008;
s) Stryker Renaissance Series PACU wheeled stretcher, Model 1710, Recall # Z-0237-2008;
t) Stryker Renaissance Series PACU wheeled stretcher, Model 1711, Recall # Z-0238-2008;
u) Stryker Renaissance Series PACU wheeled stretcher, Model 1731,Recall # Z-0239-2008
REASON: The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Recall # Z-0240-2008
REASON: False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the side rail being able to be lowered without pulling on the release handle.

CLASS III
MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on August 29, 2007. Manufacturer: Matsushita Electric Industrial Co., Ltd. - Med. Sys. Division, Yokohama City, Kanagawa, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B,V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008;
b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008
REASON: Multiple problems including: (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 14, 2007:

CLASS I
MANUFACTURER: Welch Allyn Protocol, Inc, Beaverton, OR, by letter dated October 26, 2007, and by press release on October 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 10, Automated External Defibrillator, a portable 12V internal battery powered defibrillator; Model AED10; Part Numbers: 970302E,970308E,970309E, 970310E and 970311E; Recall # Z-0129-2008
REASON: Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.

CLASS II
MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on July 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Diagnostic International, Ltd.-- AxSYM Digoxin III Reagent Pack, List (6L07-20), For In Vitro Diagnostic use. This reagent system is composed of one bottle of Digoxin-Alkaline Phosphates Conjugate, one bottle of Anti-Digoxin (Rabbit) Coated microparticles, one bottle of MEIA buffer, and one bottle of Digoxin Probe wash solution., Recall # Z-0064-2008
REASON: Incorrect Results -- Error codes 1062, 1063, 1113, and 1118 observed when running patient samples on the AxSYM Digoxin III assay, rather than a concentration, is reported for the patient sample.

MANUFACTURER: Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by visit on August 2007. Manufacturer: Suinsa, Madrid, Spain. Firm initiated recall is ongoing.
PRODUCT: Sunisa Flexi-DT S0014115 Digital Table Flexi-DT, 115-240 V // Internal Battery 24V, 4-2A Internal Battery 8A, 50-60Hz. Model Numbers 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, Recall # Z-0075-2008
REASON: Suinsa Flex-DT Table - Reports of several problems including: 1) Hot Brake (Longitudinal Overheating) potential risk of burns 2) Brake Locks and Sudden Releases 3) Emergency Stop Circuit Button; open instead of closed 4) Longitudinal Brakes Release does not engage properly 5) Tilting Movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) Lodging Pins on floor Uncovered; may cause potential risk of falling to patient and/or operator.

MANUFACTURER: Encore Medical, Lp, Austin, TX, by telephone, e-mail and letters beginning on August 2, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Foundation® Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; Recall # Z-0082-2008;
b) Foundation® Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; Recall # Z-0083-2008;
c) Foundation® Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; Recall Z-0084-2008;
d) Foundation® Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; Recall # Z-0085-2008;
e) Foundation® Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; Recall # Z-0086-2008;
f) Foundation® Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; Recall # Z-0087-2008;
g) Foundation® Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; Recall # Z-0088-2008;
h) Foundation® Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; Recall # Z-0089-2008;
i) Foundation® Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048;Sterile; assembly required by physician prior to implant; Recall # Z-0090-2008;
j) Foundation® Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; Recall # Z-0091-2008;
k) Foundation® Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050;Sterile; assembly required by physician prior to implant; Recall # Z-0092-2008;
l) Foundation® Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; Recall # Z-0093-2008;
m) Foundation® Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; sterile; assembly required by physician prior to implant; Recall # Z-0094-2008;
n) Foundation® Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; Recall # Z-0095-2008;
o) Foundation® Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; Recall # Z-0096-2008;
p) Foundation® Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; Recall # Z-0097-2008;
q) Foundation® Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; Recall # Z-0098-2008;
r) Foundation® Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; Recall # Z-0099-2008
REASON: Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date.

MANUFACTURER: Recalling Firm: Smiths Medical ASD, Inc., Keene, NH, by letter on September 18, 2007. Manufacturer: Smiths Medical, Kent, UK. Firm initiated recall is ongoing.
PRODUCT: Portex perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090, Recall # Z-0100-2008
REASON: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.

MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letters on July 15, 2007. Manufacturer: GE Medical Systems, Kretztechnik GmbH & Co. OHG, Zipf, Austria. Firm initiated recall is ongoing.
PRODUCT: GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; Recall # Z-0113-2008
REASON: When a spectrum of a Pulsed Wave Doppler shows an angle correction unequal to 0 is reloaded from the archive or the image is sent to a DICOM station, this angle correction is mistakenly disregarded resulting in an underestimation of the flow velocities.

MANUFACTURER: Recalling Firm: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek, Warsaw, IN, by letter dated September 4, 2007. Manufacturer: Zinnanti Surgical Design LLC, Hershey, PA. Firm initiated recall is ongoing.
PRODUCT: Medtronic Sofamor Danek METRx ™ System Bayonet Electrosurgical Pencil, sterile; REF (P/N) 9560575; Recall # Z-0114-2008
REASON: Packaging weakness may compromise sterility and instructions for use are inadequate.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on October 1, 2007. Firm initiated recall is ongoing.
PRODUCT: The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application. All Brilliance CT Big Bore Scanners with Tumor Localization software versions v2.2.1, v2.2.2, & v2.2.5. This software version is included on Brilliance CT Big Bore Scanners, Model Number 728243; Recall # Z-0121-2008
REASON: The maximum intensity projection (MIP) images produced from respiratory gated images by the Tumor Localization (Tumor LOC) software application on Brilliance Big Bore CT scanners will be labeled incorrectly for certain patient orientations and view conventions when saved for later viewing.

MANUFACTURER: Recalling Firm: Karl Storz Endoscopy America, Inc., Culver City, CA, by letter on September 10, 2007. Manufacturer: Mpe, Inc., Milwaukee, WI. Firm initiated recall is ongoing.
PRODUCT: Storz Equipment, Fluid Management Stand, for Fluid Management Systems, Product number: 26601EQ-KT, Recall # Z-0144-2008
REASON: Outflow Difference. The accuracy of the equipment displayed value could be influenced by external factors of the cart/stand and may result in a fluctuating or inaccurate reading.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 26, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Mevatron KD2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 1940753; Recall # Z-0155-2008;
b) Mevatron KD-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 8515520 and 9822685; Recall # Z-0156-2008;
c) Mevatron KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401522; Recall # Z-0157-2008;
d) Mevatron KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 9411588 and 9822693; Recall # Z-0158-2008;
e) Mevatron-2 6300, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401316; Recall # Z-0159-2008;
f) Mevatron M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401407; Recall # Z-0160-2008;
g) Mevatron M-2 6740, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401506; Recall # Z-0161-2008;
h) Mevatron MD-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401654; Recall # Z-0162-2008;
i) Mevatron MDX-2, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 9401746; Recall # Z-0163-2008;
j) Oncor Avant Garde, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5863472; Recall # Z-0164-2008;
k) Oncor Expression,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Numbers: 7360204 and 7360717; Recall # Z-0165-2008;
l) Oncor Impression Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),Model Number: 5857912; Recall # Z-0166-2008;
m) Oncor Impression, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 5857920; Recall # Z-0167-2008;
n) Mevatron M2/Primus Mid, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number 1940035,; Recall # Z-0168-2008;
o) Primus Plus, Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator), Model Number: 4504200; Recall # Z-0169-2008
REASON: Mistreatment of radiation therapy due to inadvertent parameter changes or miss-calibration in Service Mode. The miss-calibration can affect the beam profile and Virtual Wedge angle. This leads to patient mistreatment and alteration of future treatment plans. A second reason is an unplanned Dosimetry calibration data set can be erroneously copied during "Service Mode.

MANUFACTURER: Recalling Firm: GE Healthcare, Waukesha WI, by field service visits in December 2006. Manufacturer: GE Hangwei Medical Systems Co., LTD, Beijing PR, China. Firm initiated recall is complete.
PRODUCT: Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8; Recall # Z-0170-2008
REASON: Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 25, 2007. Firm initiated recall is ongoing.
PRODUCT: Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems, Recall # Z-0213-2008
REASON: Unexpected loss of Treatment Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., dba Alaris Products, San Diego, CA, by letters on August 30, 2007. Manufacturer: Cardinal Health 303, Inc., Creedmoor, NC. Firm initiated recall is ongoing.
PRODUCT: Texium Closed Male Luer (CML), Model Number: 10012241, Recall # Z-0218-2008
REASON: Leaks. There is a risk of leakage at the female end of the Texium closed male luer (CML) when attached to a spin luer. (NOTE: users who connect the female portion of the Texium closed male luer to fixed (one-piece) male luers on tubing or on syringes are not affected by this issue).

MANUFACTURER: OPTI Medical Systems, Inc., Roswell, GA, by e-mail and fax on/about July 18, 2007. Firm initiated recall is ongoing.
PRODUCT: OPTI® LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, Recall # Z-0119-2008
REASON: Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device.

CLASS III

MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letter on August 27, 2007. Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
PRODUCT: Medtronic Paceart System, 2006 Edition, The Paceart System can act as a Practice Management software application and is intended for use by facilities that provide services such as event monitoring, trans-telephonic pacemaker evaluation, and in-office evaluation of implanted cardiac devices; Recall # Recall Number : Z-0081-2008
REASON: An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting no episodes have occurred, instead of indicating that no data is available.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 7, 2007:

CLASS II
MANUFACTURER: Recalling Firm: Bio-Logic Systems Corp., Mundelein, IL, by letters dated July 26, 2007. Manufacturer: TLK Industries Inc., Palatine, IL. Firm initiated recall is ongoing.
PRODUCT: Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video, Recall Z-0001-2008
REASON: Bio-logic System Corp Camera Pole may weaken and detach at the base of the telescoping camera pole during transport causing pole to break at the welded base and fall.

MANUFACTURER: Medtronic, Inc., Danvers, MA, by letter dated August 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic Export XT Aspiration Catheter, 6F Model Numbers: G146200USB (US Distribution) G1452006B (Outside US), Recall # Z-0063-2008
REASON: Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on or about July 24, 2007 and letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT:
a) Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)-- Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Recall # Z-0076-2008;
b) Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116, Recall # Z-0077-2008
REASON: Incorrect Product -- Mislabeled as to size. An 18 mm x 65 mm tibula implant is enclosed in a package labeled as 12 mm x 80 mm.

MANUFACTURER: Gambro BCT, Inc., Lakewood, CO, by telephone beginning September 17, 2007 and letters on September 22, 2007. Firm initiated recall is ongoing.
PRODUCT: Spectra Optia apheresis system, a blood component separator. Part No. 61000, Recall # Z-0078-2008
REASON: Under specific conditions, apheresis machine could return up to 60 mL. of air to the patient.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on May 9, 2007 and November 1, 2007. Firm initiated recall is complete.
PRODUCT: ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite coated; Titanium Plasma Spray; Product No. 5351-4507 to 5351-4515; 5351-4608. 5351-4610 and 5351-4612, Recall # Z-0080-2008
REASON: The plasma spray may delaminate from the proximal portion of the humeral stem.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 25, 2007. Manufacturer: Philips Medical Systems Technolo, Haifa, Israel. Firm initiated recall is ongoing.
PRODUCT: a) Brilliance CT Systems, 40 slice configuration. Computed tomography scanner, Model No. 728231, Recall # Z-0110-2008;b) Brilliance CT Systems 64 slice configuration. Computed tomography scanner. Model No. 728235, Recall # Z-0111-2008
REASON: Two potential artifacts may appear in some images from head scans on the Brilliance 40/64 systems. These artifacts may lead to misdiagnosis.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter on August 28, 2007. Manufacturer: Boston Scientific Corporation, Global Park, Heredia,Costa Rica. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 UPN Number: M00513321 REF: 1332-20, Recall # Z-0116-2008;
b) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20, Recall # Z-0117-2008;
c) Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40, Recall # Z-0118-2008;
REASON: Device lacked manufacturing finishing process resulting in scope damage.

CLASS III
PRODUCT: Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit, Catalog # 26174, Recall # Z-0065-2008
MANUFACTURER: Bio-Rad Laboratories, Redmond, WA, by letters on September 5, 2007 and September 19, 2007. Firm initiated recall is complete.
REASON: Incorrect Instructions. The packages insert states to add 100L of conjugate; it should state to add 100uL.

MANUFACTURER: Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated September 20, 2007. Manufacturer: Aomori Olympus Co Ltd, Aomori, Japan. Firm initiated recall is ongoing.
PRODUCT:
a) Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Recall # Z-0105-2008;
b) Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Recall # Z-0106-2008;
c) Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Recall # Z-0107-2008;
d) Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Recall # Z-0108-2008
REASON: Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath.

MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Marlborough, MA, by letter dated September 10, 2007. Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303, Recall # Z-0109-2008
REASON: Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.

MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by letter dated July 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; Item # 660/75 1 liter and Item 660/85 /4 liter poly bottles, Recall # Z-0133-2008
REASON: Batch Out of Specifications. The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 31, 2007

CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

CLASS II
MANUFACTURER: Recalling Firm: Smith and Nephew, Inc., Memphis, TN, by telephone on July 12, 20007 and letter dated July 24, 2007. Manufacturer: Finsbury Orthopaedics, Leatherhead, UK. Firm initiated recall is ongoing.
PRODUCT:
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 44 mm cup Ref.: 74120144. Hip implant component, Recall # Z-0017-2008
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 46 mm cup Ref.: 74120146. Hip implant component, Recall # Z-0018-2008
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 48 mm cup Ref.: 74120148. Hip implant component, Recall # Z-0019-2008;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120150. Hip implant component, Recall # Z-0020-2008;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 52 mm cup Ref.: 74120152. Hip implant component, Recall # Z-0021-2008;
f) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 54 mm cup Ref.: 74120154. Hip implant component, Recall # Z-0022-2008;
g) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 56 mm cup Ref.: 74120156. Hip implant component, Recall # Z-0023-2008;
h) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120158. Hip implant component, Recall # Z-0024-2008;
i) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 60 mm cup Ref.: 74120160. Hip implant component, Recall # Z-0025-2008;
j) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120162. Hip implant component, Recall # Z-0026-2008;
k) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 64 mm cup Ref.: 74120164. Hip implant component, Recall # Z-0027-2008;
l) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 66 mm cup Ref.: 74120166. Hip implant component, Recall # Z-0028-2008;
m) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0029-2008;
n) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 50 mm cup Ref.: 74120250. Hip implant component, Recall # Z-0030-2008;
o) Smith + Nephew, Birmingham Hip Resurfacing, Dysplasia Cup, 54 mm cup Ref.: 74120254. Hip implant component, Recall # Z-0031-2008;
p) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 58 mm cup Ref.: 74120258. Hip implant component, Recall # Z-0032-2008;
q) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup, 62 mm cup Ref.: 74120262. Hip implant component, Recall # Z-0033-2008
REASON: The carton label may not reflect the correct size of the Acetabular cup.

MANUFACTURER: Remington Medical, Inc., Alpharetta, GA, by letter dated July 23, 2007. Firm initiated recall is ongoing.
PRODUCT: Urinary Drainage Bags: 500ml Disposable Urinary Leg Bag (Order number: 500-D) and 1000ml Disposible Urinary Leg Bag (Order number 1000-D) -- Sterile Fluid Path, For Single Use Only, Recall # Z-0058-2008
REASON: Sterility, inadequate -- Pathway may not be sterile as labeled.

MANUFACTURER: Philips, Medical Systems, Andover, MA, by letter dated September 4, 2007. Firm initiated recall is ongoing.
PRODUCT: HeartStart XL Defibrillator/Monitor, Model: M4735A, Recall # Z-0062-2008
REASON: Inadequate shipping package causing damage to control boards resulting in unit failure. Failure to deliver therapy (defibrillation, pacing or cardioversion) may occur as a result of undetected damage to the PCB assembly.

MANUFACTURER: Becton Dickinson and Company, Waltham, MA, by letter dated August 9, 2007. Firm initiated recall is complete.
PRODUCT: BD Microkeratome K3000 and K4000; Catalog Number: 378660, Recall # Z-0066-2008
REASON: Microkeratome blade may stop oscillating and transverse the eye causing injury to the cornea.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on August 30, 2007. Firm initiated recall is ongoing.
PRODUCT: a) Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Sterile, Made in USA, Recall # Z-0072-2008; b) HA Solid Back Acetabular Shell; Arc Deposited HA Coated Included Dome hole
Plug; Hip prosthesis component. Sterile; made in USA, Recall # Z-0073-2008
REASON: Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

MANUFACTURER: Steris Corporation Hopkins Facility, Mentor, OH, by telephone on September 12, 2007, and by letters on September 28, 2007. Firm initiated recall is ongoing.
PRODUCT: Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope., Recall # Z-0101-2008
REASON: Loose or missing adaptor. The center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor’s housing. The absence of adaptor #6’s center insert may affect the sterilization process of the attached endoscope.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by telephone on August 9, 2007 and by letter dated August 31, 2007. Firm initiated recall is complete.
PRODUCT: Biomet Orthopedics Apical Hole Plug, 3/8 – 24 threaded, TI-6AL-4V alloy, sterile; REF123741, Recall # Z-0102-2008
REASON: Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended.

MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by telephone, interoffice memo and letter on September 11, 2007. Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO, Recall # Z-0103-2008;
b) Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico, Recall # Z-0104-2008
REASON: Missing holes: Catheters are missing the catheter's side holes.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
MANUFACTURER: Recalling Firm: Medtronic, Inc., Rhythm Management, Minneapolis, MN, by press release, FDA Statement and letter dated October 15, 2007.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba Pr, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Medtronic Sprint Fidelis 6930 Steroid eluting, tripolar, ventricular lead with tined tip and right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0067-2008;
b) Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0068-2008;
c) Medtronic Sprint Fidelis 6948 Steroid eluting, quadripolar, ventricular lead with tined tip and right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0069-2008;
d) Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies, Recall # Z-0070-2008
REASON: Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and the President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians. Information is also available for patients and physicians at www.medtronic.com/fidelis. This decision is based on a variety of factors that, when viewed together, indicate that suspending distribution is the appropriate action. Lead fractures may present clinically as audible alerts, inappropriate shocks and/or loss of output.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 24, 2007

CLASS II
MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on February 22, 2007, Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
PRODUCT: FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use. Recall # Z-0002-2008
REASON: Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter, on or about September 28, 2007. Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems. Catalog Number 366356, Recall # Z-0044-2008;
b) Microtainer Safety Flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm blade width; Becton Dickinson Vacutainer System.Catalog number 365759, Recall # Z-0045-2008;
c) Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems, Catalog number 366357, Recall # Z-0046-2008
REASON: Potential for the blade and holder assembly to become loose and then separate from the main body of the lancet during the process of disposal.

CLASS III
MANUFACTURER: Esa Biosciences, Inc., Chelmsford, MA, by telephone and letter on September 20, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762, Recall # Z-0042-2008;
b) ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142, Recall # Z-0043-2008
REASON: Level 1 and Level 2 Control values were incorrectly assigned.

MANUFACTURER: Zoll Lifecor Corporation, Pittsburgh, PA, by letters on September 14, 2007. Firm initiated recall is ongoing.
PRODUCT: Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). Product number 10A0894-A01. Recall # Z-0061-2008
REASON: Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 17, 2007

CLASS II
MANUFACTURER: Encore Medical, Lp, Austin, TX, by letter on August 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) EPIK® KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0009-2008;
b) EPIK® KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0010-2008
REASON: Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

MANUFACTURER: Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on August 17, 2007. Firm initiated recall is ongoing.
PRODUCT: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates. PML's catalog #P1174, Recall # Z-0011-2008
REASON: Marketed a regulated product without a 510(k).

MANUFACTURER: Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on April 23, 2007. Firm initiated recall is ongoing.
PRODUCT: Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML for screening for Vancomycin Resistant Enterococc, Catalog #P1174, Recall # Z-0014-2008
REASON: Plates manufactured without vancomycin. Possibility for false resistant results.

MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by letter beginning on July 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008
REASON: A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by telephone call or service representative visit beginning July 18, 2007. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers, Recall # Z-0038-2008:
REASON: Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on July 30, 2007. Manufacturer: Diagnostica Stago - Taverny Site, Taverny, France. Firm initiated recall is ongoing.
PRODUCT: STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic, Recall # Z-0039-2008
REASON: Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by letters beginning on July 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic InterStim INS (Model 3023) with N’Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N’Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control, Recall # Z-0040-2007-8
REASON: Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N’Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

MANUFACTURER: Advanced Bionics Corp., Sylmar, CA, by visit on August 3, 2007. Firm initiated recall is complete.
PRODUCT: Precision Implantable Pulse Generator (IPG), Model Number SC-110, Recall # Z-0055-2008
REASON: Mislabeled. Product labeled with the incorrect shelf-life information.

MANUFACTURER: Mallinckrodt Inc., Cincinnati, OH, by letter on September 20, 2007. Firm initiated recall is ongoing.
PRODUCT: Angiomat Illumena Injector with Auxiliary Console, , Recall # Z-0056-2008
REASON: Synchronization problems. Units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit’s main console and the unit’s auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection delivered to the patient.

MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by letter on March 27, 2007. Firm initiated recall is complete.
PRODUCT: ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, anesthetic/ narcotic medication pump. Recall # Z-0057-2008
REASON: Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.

CLASS III
MANUFACTURER: Naviscan PET Systems, San Diego, CA, by telephone and letters on August 1 and 2, 2007 and August 16, 2007. Firm initiated recall is ongoing.
PRODUCT: PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008
REASON: Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet remains open while subsequent measurements are being made on another applet (12 slice view). This software defect results in unreliable andlor inconsistent readings in the size, distance between lesions and mass measurement, which could result in the physician selecting inaccurate margins for surgery. 2. In addition, under these same circumstances the Region of Interest (ROI) numbering might not be sequential or multiple regions within the same image might have the same number. Duplicative numbering could result in confusion in definition of the region of interest. 3. When images, user defined as "Other," are acquired, the thumbnail image is mislabeled as "LCC" (Left Craniocaudal) while the caption contains the correct user-defined labeling. This thumbnail mislabeling could result in reader confusion in the body part being displayed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 10, 2007

CLASS II
MANUFACTURER: Meretek Diagnostics, Inc., Lafayette, CO, by letter on May 2, 2007. Firm initiated recall is complete.
PRODUCT: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic, Recall # Z-0003-2008
REASON: Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.

MANUFACTURER: Recalling Firm: Lemaitre Vascular, Inc., Burlington, MA, by “Advisory Notice" on July 18, 2007 and September 24, 2007. Manufacturer: Cardiovascular Innovations, Athens, TX. Firm initiated recall is ongoing.
PRODUCT: CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC), Recall # Z-0008-2008
REASON: Sterility of device may be compromised due to breach in sterile barrier.

MANUFACTURER: Abbott Spine, Austin , TX, by telephone on July 18, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-50, Recall # Z-0004-2008;
b) PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60, Recall # Z-0005-2008
REASON: Tip of PathFinder surgical instrument broke during procedure.

MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by letter dated July 19, 2007. Manufacturer: Molecular Products, Ltd., Dunmow, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems, Recall # Z-0006-2008
REASON: Elevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.

CLASS III
MANUFACTURER: Recalling Firm: Tosoh Bioscience Inc., Grove City, OH, by letter dated July 2, 2006. Manufacturer: Tosoh Corporation, Minato-Ku, Japan. Firm initiated recall is ongoing.
PRODUCT: 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. Catalog # 020661, Recall # Z-0007-2008
REASON: Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was measured. Tosoh AIA confirmed that deterioration of the product occurred over time and resulted in a deviation from the assigned value.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on August 10, 2007. Manufacturer: Becton Dickinson Medical Systems, Hancock, NY. Firm initiated recall is ongoing.
PRODUCT:
a) Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Reorder number 371111, Recall # Z-0012-2008;
b) Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place Product in a puncture resistant container and dispose properly. Reorder number 371211, Recall # Z-0013-2008
REASON: Complaints received of rust on the blades of BD Bard-Parker Surgical blades.

MANUFACTURER: Recalling Firm: Thermo Fisher Scientific, Pittsburgh, PA, by a Technical Bulletin dated July 24, 2007. Manufacturer: Thermo Fisher Scientific, Victoria, Australia. Firm initiated recall is ongoing.
PRODUCT: Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic, Recall # Z-0015-2008
REASON: Method is susceptible to positive interference from endogenous ALT in patient samples.

MANUFACTURER: Louisville Apl Diagnostics, Inc., Seabrook, TX, by FedEx on July 18, 2006. Firm initiated recall is complete.
PRODUCT: APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic, Recall # Z-0034-2008
REASON: Product mislabeled. Outer container labeled with incorrect lot number.

MANUFACTURER: Recalling Firm: Heraeus Kulzer Inc., Dental Products Division, South Bend, IN, by telephone or letter beginning on or about July 9, 2007.
Manufacturer: Heraeus Kulzer Gmbh & Co. KG (Medical Division), Wehrheim 1, Federal Republic of Germany. Firm initiated recall is ongoing.
PRODUCT:
a) Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent; Reorder No. 66001710, Recall # Z-0035-2008;
b) Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent; Reorder No. 6018222, Recall # Z-0036-2008
REASON: The material may solidify in the bottle, and thus be rendered unusable.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of October 3, 2007

CLASS I
MANUFACTURER: Baxa Corporation, Englewood, CO, by telephone and letter on June 27, 2007. Firm initiated recall is ongoing.
PRODUCT: Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007
REASON: A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution.

CLASS II
MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letters on November 3, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems, Recall # Z-0013-2007;
b) Brilliance (a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.Recall # Z-0014-2007
REASON: A potential anomaly was identified on the CT subsystem, which could result in the radiation dose being different than the calculated dose reported to the operator.

MANUFACTURER: Cardinal Health 301 LLC DBA Cardinal Health Pyxis Products, San Diego, CA, by telephone and letter beginning on August 13, 2007. Firm initiated recall is ongoing.
PRODUCT: Pyxis Anesthesia System 3500, Model 3500, Recall # Z-0555-2007
REASON: System lock up; mini-drawers -under certain circumstances during use, are not accessible, delaying the user from accessing critical medications.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on March 1, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) OEC 9900 Elite image-intensified fluoroscopic x-ray system, Recall # Z-0676-2007;
b) OEC 9800 image-intensified fluoroscopic x-ray system, Recall # Z-0677-2007;
c) OEC 8800 image-intensified fluoroscopic x-ray system, Recall # Z-0678-2007;
d) OEC 9900 Elite MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, Recall # Z-0679-2007;
e) OEC FluoroTrak 9800 PLUS, image-intensified fluoroscopic x-ray system, Recall # Z-0680-2007;
f) OEC 9800 MD Motorized C-Arm System, image-intensified fluoroscopic x-ray system, Recall # Z-0681-2007;
g) OEC 9800 Plus (Flourotrak) Image-intensified fluoroscopic x-ray system, Recall # Z-0682-2007;
h) OEC 9900 Elite (NAV) Image-intensified fluoroscopic x-ray system, Recall # Z-0683-2007
REASON: During routine service, primary and/or secondary collimators may not have been properly reinstalled.

MANUFACTURER: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters starting April 3, 2007 through April 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Practix 33 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0762-2007;
b) Practix 160 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0763-2007
c) Practix 300 Mobile X-ray systems. The systems are used in general purpose diagnostic imaging, and are specifically used as mobile X-ray systems for bedside radiological examinations, Recall # Z-0764-2007
REASON: X-ray systems lack product report certification demonstrating compliance, and were illegally introduced into the United States commerce.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated July 9, 2007 and August 20, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Philips Bucky Diagnost X-Ray System, Recall # Z-0907-2007;
b) Philips Digital Diagnost X-Ray system, Recall # Z-0908-2007;
c) Philips Easy Diagnost X-Ray System, Recall # Z-0909-2007;
d) Philips Easy Diagnost Eleva, Recall # Z-0910-2007;
e) Philips Omni Diagnost Eleva, Recall # Z-0911-2007;
f) Philips Multi Diagnost Eleva, Recall # Z-0912-2007
REASON: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic procedures.

MANUFACTURER: General Electric Medical Systems, LLC, Waukesha, WI, by visit beginning on May 31, 2006. Firm initiated recall is complete.
PRODUCT: GE Healthcare Proteus XR/a General Purpose Radiographic System, Models 2259973-4 and 2380179 containing Proteus Operator Console model# 2259976, Recall # Z-1087-2007
REASON: Labeling; failure to properly label per 21 CFR 1010.2 and 1010.3 -The Operator Console of the Proteus XR/a General Purpose Radiographic Systems were not properly labeled.

MANUFACTURER: Recalling Firm: General Electric Medical Systems, LLC, Waukesha, WI, by visit beginning on June 6, 2006. Manufacturer: General Electric Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is complete.
PRODUCT: GE Innova 2100-IQ Digital Fluoroscopic Imaging System, Versatile cardiac and vascular imaging system. Recall # Z-1088-2007
REASON: The systems do not contain a certification label on the C2 Cabinet (Beam-limiting control).

MANUFACTURER: K Tex, Galvez, LA, by letter dated November 3, 2006. Firm initiated recall is ongoing.
PRODUCT:
a) Laser Distance and Level Transmitters, Model No. LT4C, Recall # Z-1120-2007;
b) Laser Level Transmitters, Model No. LM4C, Recall # Z-1121-2007;
c) LaserTrak, Model No. LT80, Recall # Z-1122-2007;
d) Laser Meter, Model No. LTM80, Recall # Z-1123-2007;
e) Laser Distance and Level Transmitters, Model No. LT200, Recall # Z-1124-2007;
f) Laser Distance and Level Transmitters, Model No. LM200, Recall # Z-1125-2007;
g) Laser Distance and Level Transmitters, Model No. LM02, Recall # Z-1126-2007
REASON: Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)

MANUFACTURER: Philips Nuclear Medicine, Inc., Fitchburg, WI, by letter on August 21, 2007. Firm initiated recall is ongoing.
PRODUCT: The Pinnacle3 Radiation Therapy Planning (RTP) system and its associated software; composed of several modules including the core Pinnacle3 functionality, Syntegra (TM), P3IMRT, P3MD and AcQSim3 (TM). The Pinnacle3 RTP system is composed of a Sun UNIX workstation (or UNIX-complaint computer) running the Solaris operating system and software, and a UNIX terminal emulation package on a personal computer, which allows the user to enter patient data into the system, use that data to construct a plan for radiation therapy, and evaluate the plan- Philips Medical Systems-Model #9200-0652A-ENG, 9200-0700A-ENG, 9200-0700B-ENG, 9200-0700C-ENG (with software versions 7.6C, 8.0d and 8.0h), Recall # Z-1212-2007
REASON: Incorrect Absolute Marking Coordinates when used with PQ-Series scanners due to a software malfunction.

MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on August 2, 2007. Firm initiated recall is ongoing.
PRODUCT: Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics. Product numbers: 5537-G-109, 5537-G-111, 5537-G-113, 5537-G-116, 5537-G-119, 5537-G-122, 5537-G-125, 5537-G-128, 5537-G-131, 5537-G-209, 5537-G-211, 5537-G-213, 5537-G-216, 5537-G-219, 5537-G-222, 5537-G-225, 5537-G-228, 5537-G-231, 5537-G-309, 5537-G-311, 5537-G-313, 5537-G-316, 5537-G-319, 5537-G-322, 5537-G-325, 5537-G-328, 5537-G-331, 5537-G-409, 5537-G-411, 5537-G-413, 5537-G-416, 5537-G-419, 5537-G-422, 5537-G-425, 5537-G-428, 5537-G-431, 5537-G-509, 5537-G-511, 5537-G-513, 5537-G-516, 5537-G-519, 5537-G-522, 5537-G-525, 5537-G-528, 5537-G-531, 5537-G-609, 5537-G-611, 5537-G-613, 5537-G-616, 5537-G-619, 5537-G-622, 5537-G-625, 5537-G-628, 5537-G-631, 5537-G-709, 5537-G-711, 5537-G-713, 5537-G-716, 5537-G-719, 5537-G-722, 5537-G-725, 5537-G-728, 5537-G-731, 5537-G-809, 5537-G-811, 5537-G-813, 5537-G-816, 5537-G-819, 5537-G-822, 5537-G-825, 5537-G-828, 5537-G-831, Recall # Z-1231-2007
REASON: Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post.

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on July 31, 2007 and by press release on September 14, 2007. Manufacturer: AM2PAT, Angier, NC. Firm initiated recall is ongoing.
PRODUCT:
a) Normal Saline 3ml in 12ml Syringe. The product is shipped 120 units per carton, Recall # Z-1235-2007;
b) Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton, Recall # Z-1236-2007
REASON: Particulate matter in product.

MANUFACTURER: Cerner Corp., Kansas City, MO, by telephone on August 23, 2007 and by letters dated August 29, 2007 and September 4, 2007. Firm initiated recall is complete.
PRODUCT: Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities Recall # Z-1243-2007
REASON: Defects in the Auto Launch functionality make it possible for a mismatch of patient data.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Endoscopic Instrument Control System (da Vinci Surgical System) Model IS1200, A4.3 SW level, Recall # Z-1244-2007
REASON: Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the previous User Manual.

MANUFACTURER: Intuitive Surgical, Inc., Sunnyvale, CA, by visit beginning on September 12, 2007. Firm initiated recall is ongoing.
PRODUCT: daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system. Model number IS2000, part number 351040-04, Recall # Z-1245-2007
REASON: Product may malfunction and fail to start up on AC power.

MANUFACTURER: Stryker Howmedica Osteonics Corp. Mahwah, NJ, by letters on March 13, 2006. Firm initiated recall is complete.
PRODUCT: Trident PSL Acetabular Shell; Arc Deposited; Hydroxylapatite Coated; Cluster Screw Holes; Hip prosthesis component. Recall # Z-1261-2007
REASON: Dimensional anomaly.

MANUFACTURER: Merit Medical Systems, Inc, South Jordan, UT, by letter on August 22, 2007. Firm initiated recall is ongoing.
PRODUCT: Merit Medical Surgical Convenience Kits, Custom and SPPT,. Part numbers: K05-01767A, K05-01769, K05-01769A, K09-03843M, K09-03951M, K09-05894F, K09-08610, K10-00033Q, K10-00382M, K10-00685K, K10-00984F, K10-01531F, K10-01826D, K10-01826F, K10-02902B, K10-03080D, K10-03378C, K10-03397B, K10-03590A, K10-03590B, K10-03659D, K10-03659F, K10-03659G, K10-03689, K10-03907B, K12-01342D, K12-01444B, K12-01468, K12-01484A, K12-01487, K12-01490A, K12-01593, K12-01638, K12-01661, K12-01667, K12-01667A, K12-01964, K12-01968, K12-02098, SPPT-100/C, SPPT-5F-10C, SPPT-5F-10L/A, SPPT-5F-7/C, SPPT-5F-7L/A, Recall # Z-1262-2007
REASON: Expiration Dating; Some Convenience Kits contain medications and/or skin preparations that may expire before the expiration date on the outer package label.

MANUFACTURER: Recalling Firm: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on July 30, 2007. Manufacturer: Hitachi Medical Corporation, Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT: Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) body. A portion of the cable is referred to as the balun assembly or balun trap. The shoulder coil assembly is packaged in a cardboard box with foam inserts. Recall # Recall Number : Z-1263-2007
REASON: Overheating; A portion (balun assembly) of the cable that connects the shoulder coil to the actual MRI unit may malfunction and result in overheating of the balun assembly. The overheating of the balun assembly could result in injury to the patient or operator if either came into contact with the assembly.

MANUFACTURER: Spectrum Designs, Inc., Carpinteria, CA, by letters on July 24, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Spectrum Designs Medical-Nasal Dorsal Columella Implant, Catalog Number: S400-314S, Recall # Z-1264-2007;
b) Spectrum Designs Medical Anatomical Chin Implant; Catalog Number 250-134S; Recall # Z-1265-2007
REASON: Mispackaging/Mislabeling: a portion of packaged Nasal LOT 31053 contained chin implants instead of the nasal implant.

MANUFACTURER: Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letter on July 16, 2007 and July 23,2007. Manufacturer: BARD SHANNON LIMITED, Humacao, PR. Firm initiated recall is ongoing.
PRODUCT:
a) Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished), Recall # Z-1266-2007;
b) Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished),
Recall # Z-1267-2007;
c) Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished), Recall # Z- Z-1268-2007;
d) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058, Recall Number : Z-1269-2007
e) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035, Recall # Z-1270-2007;
f) Davol Salute Laparoscopic 38cm Sterile Implant Cartridge 60 Q-ring;5/Box, Item Number: 0113059, Recall # Z-1271-2007;
g) Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043m, Recall # Z-1272-2007;
h) Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box, Item Number: 0113061, Recall # Z-1273-2007
REASON: Malformed constructs (straight shots) may form causing injury to user/patient. Abdominal mesh attachment system component, for use in hernia repair.

CLASS III
MANUFACTURER: Abbott Laboratories Inc., South Pasadena, CA, by letter on April 04, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott Aeroset/Architect Clinical Chemistry, AST Activated (ASTA), List Number: 8D37-30, Recall # Z-1079-2007
REASON: Mislabeling: The empty cartridges supplied with Clinical Chemistry ASTA, lot number 46059HW00, have an incorrect top label. The top label on the cartridge incorrectly indicates ALTA instead of ASTA

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 26, 2007

CLASS I
MANUFACTURER: Recalling Firm: Welch Allyn Protocol, Inc., Beaverton, OR, by press release on August 23, 2007 and letters on August 29, 2007. Manufacturer: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL. Firm initiated recall is ongoing.
PRODUCT: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E), Recall # Z-1223-2007
REASON: Failure to deliver shock: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated August 15, 2007. Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: Baxter Colleague CX Single Channel Volumetric Infusion Pumps; product code 2M8161, Recall # Z-1224-2007
REASON: Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

CLASS II
MANUFACTURER: Stryker Medical Div. of Stryker Corporation, Portage, MI, by letter dated May 7, 2007. Firm initiated recall is ongoing.
PRODUCT: Stryker Medical – Wheeled Electric Stretcher, Model 1550, Recall # Z-1009-2007
REASON: The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.

MANUFACTURER: Recalling Firm: Newport Medical Instruments Inc., Costa Mesa, CA, by Important Medical Correction letters on September 14, 2007.
Manufacturer: Flight Medical Ltd., Lod, Israel. Firm initiated recall is ongoing.
PRODUCT: Newport HT50 Ventilator (all Models), Recall # Z-1192-2007
REASON: Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.

MANUFACTURER: Humagen Fertility Diagnostics, Inc., Charlottesville, VA, by telephone and e-mail on May 7, 2007. Firm initiated recall is complete.
PRODUCT: IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL, Recall # Z-1220-2007
REASON: Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

MANUFACTURER: Biomet 3i, Palm Beach Gardens, FL, by e-mail and fax letter on August 3, 2007. Firm initiated recall is ongoing.
PRODUCT: LTX XP Miniplant, Dental Implant, Sterile, Model No. LTX3211 and Model No. LTX3213, Recall # Z-1221-2007
REASON:The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter dated July 6, 2007. Manufacturer: Bio-Rad Diagnostics Group, Irvine, CA. Firm initiated recall is ongoing.
PRODUCT: ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; list 6C27-05, Recall # Z-1222-2007
REASON: The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.

MANUFACTURER: Nicolet Biomedical Div of Viasys Healthcare, Madison, WI, by letters on July 17, 2007. Firm initiated recall is ongoing.
PRODUCT: BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne, Recall # Z-1225-2007
REASON: The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on June 21, 2007. Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
PRODUCT: ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin, Catalog number 326743, Recall # Z-1226-2007
REASON: Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters dated August 1, 2007. Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
PRODUCT: Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag serves as the product sterile barrier, Recall # Z-1227-2007
REASON: Medtronic Custom Tubing Packs might have open header bag seals.

MANUFACTURER: Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by letter, on August 24, 2007. Manufacturer: Medimexico, S. de R.L. de C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT: NxStage Cartridge Express, CAR-170, for hemodialysis, Recall # Z-1228-2007
REASON: Potential for dialysate leaks from the cartridge during treatment.

MANUFACTURER: Bard Access Systems, Inc., Salt Lake City, UT, by letter on August 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Product Code 5583705, Recall # Z-1229-2007
REASON: Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

MANUFACTURER: Stryker Spine, Allendale, NJ, by letters on July 10, 2007. Firm initiated recall is ongoing.
PRODUCT: Stryker Radius Locking Caps, Catalog Number: 486610000, Recall # Z-1239-2007
REASON: Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod.

CLASS III

MANUFACTURER: Recalling Firm: Mentor Texas, Inc., Irving, TX, by letter on July 27, 2007. Manufacturer: Misonix, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
PRODUCT: 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530, Recall # Z-1230-2007
REASON: Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone and letter on August 21, 2007. Firm initiated recall is ongoing.
PRODUCT: 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E, Recall # Z-1237-2007
REASON: 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.

MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by letter on July 18, 2007. Firm initiated recall is ongoing.
PRODUCT: BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers: 340400, 3404001, and 3404002, Recall # Z-1240-2007
REASON: Phantom pacer spikes caused by a damaged resistor.

MANUFACTURER: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on October 17, 2006. Firm initiated recall is complete.
PRODUCT: Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325, Recall # Z-1241-2007
REASON: Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 19, 2007

CLASS II
MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA, by letters on June 1, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Clinical Chemistry Lipase, in vitro diagnostic test reagent. List Numbers: 7D80-20 and 7D80-30, Recall # Z-1232-2007;
b) MULTIGENT Acetaminophen, in vitro diagnostic test reagent. List Number 2K99-20, Recall # Z-1233-2007
REASON: Lipase results are falsely elevated when a MULTIGENT Acetaminophen test is pipetted immediately before a Lipase test from the same sample cup or tube on the ARCHITECT c8000.

MANUFACTURER: Recalling Firm: Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on September 4, 2007. Manufacturer: Teal Electronics Corp., San Diego, CA. Firm initiated recall is ongoing.
PRODUCT: The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** Recall # Z-1234-2007
REASON: The TEAL Power Conditioning units may fail and result in the unit emitting fire and/or smoke. Note: the TEAL Power Conditioning Unit has the potential to fail when the scanner that is attached to the TEAL is powered and in use as well as when not in use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 12, 2007

CLASS II

MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on March 20, 2007. Manufacturer: BD Medical Systems Infusion Therapy, Nogales, Sonora, Mexico. Firm initiated recall is complete.
PRODUCT: BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder. Color green. 21 Gauge. Translucent, integrated protective shield that provides one-handed activation immediately after use, 0.75 in needle length, 12 in tubing, Luer adapter and holder, wings, sterile, Catalog # 368652, Recall # Z-0777-2007
REASON: The BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder has a problem where the non-patient needle (in the holder) may become separated from the hub and remain the stopper of an evacuated blood collection tube.

MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letter on April 23, 2007. Firm initiated recall is ongoing.
PRODUCT: OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems:
a)OneTouch Ultra,
b) OneTouch InDuo,
c) OneTouch Ultra2,
d) OneTouch UltraMini,
e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01(50 pack mail order)), Recall # Z-1042-2007
REASON: Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated July 2007. Firm initiated recall is ongoing.
PRODUCT: Intellivue Central Station Software for the: Intellivue Information Center, Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169, Recall # Z-1182-2007
REASON: Incorrect Patient Assignment: The information center will in most cases be associated with the “incorrect” patient.

MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters on September 1, 2007. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
PRODUCT: Kion Anesthesia Workstation, Article number: 6454800, Recall # Z-1203-2007
REASON: Overcharging of batteries and the release of acid fumes.

MANUFACTURER: Recalling Firm: Molnlycke Health Care, Inc., Norcross, GA, by letter on July 23, 2007 Manufacturer: Regent Hospital Products, Sdn Bhd, Kulim, Kedah Darulaman, Malaysia. Firm initiated recall is ongoing.
PRODUCT: Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8), Recall # Z-1219-2007
REASON: Sterility compromised (package integrity): The primary packaging for a portion of the lot may contain gloves that were not sealed properly.

CLASS III
MANUFACTURER: BioHorizons Implant Systems, Inc., Birmingham, AL, by letters and visit on March 12, 2007. Firm initiated recall is complete.
PRODUCT:
a) BioHorizons 0.035 Hex Driver, REF 300-377, non-sterile, Rx only, REF 300-377, Recall # Z-0692-2007;
b) BioHorizons 0.050 Hex Driver, Regular, REF 300-350, non-sterile, Rx only, Recall # Z-0693-2007;
c) BioHorizons 0.050 Hex Driver, Long, REF 300-351, non-sterile, Rx only, Recall # Z-0694-2007;
d) BioHorizons 0.050 Hex Driver, Regular, REF 134-350, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K, Recall # Z-1164-2007
REASON: Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.

MANUFACTURER: Avazzia, Inc., Dallas, TX, by letter on June 29, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Avazzia Tennant Biomodulator®; Model: BEST AV-1; P/N #TB04303-103, Recall # Z-1207-2007;
b) Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103, Recall # Z-1208-2007;
c) Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103, Recall # Z-1208-2007;
d) Avazzia Med-Sport Massager; Model: BEST AV-1; P/N #MS04182-103, Recall # Z-1210-2007
REASON: Plastic Cases may crack due to manufacturing by the supplier not meeting specifications.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of September 5, 2007

CLASS II
MANUFACTURER: Varian Medical Systems Inc, Palo Alto, CA, by letter on April 18, 2007. Firm initiated recall is ongoing.
PRODUCT: Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator, Recall # Z-1195-2007
REASON: Patient positioning errors may occur because of mechanical variations during product installation.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letter on August 16, 2007, and visit to follow. Firm initiated recall is ongoing.
PRODUCT:
a) Abbott CELL-DYN 3000 Hematology Analyzer, Model number
CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03,
CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03,
Recall # Z-1198-2007;
b) Abbott CELL-DYN 3500 Hematology Analyzer, Model number
CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03,
Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03,
91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P,
91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96,
91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000,
91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000,
Recall # Z-1199-2007;
c) Abbott CELL-DYN 3700 Hematology Analyzer, Model number CELL-DYN 3700 CS, List Numbers 02H30-01and 91340-02, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3700 SL, List Numbers 02H31-01 and 02H31-03, all serial numbers distributed on or before May 3, 2007: 02H30-01 EA CD3700 CS(EA) 1.000 20222AN 01/16/2004 0708421226 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21423AK 04/16/2003 0705836717 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 01/17/2001 0700657123 ZINS 1024, 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 11/14/2001 0701853939 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 04/02/2002 0702540521 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20158AK 01/20/2000 30001171534T2 NC 1024, 02H30-01 EA CD3700 CS 1.000 19966AN 03/17/2000 30003160556T2 NC 1024, 02H31-01 EA CD3700 SL 1.000 20210AK 02/15/2000 30002100642T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 11/20/2000 0700475941 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20333AK 05/30/2000 0700023564 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 05/29/2002 0702793182 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 10/09/2001 0701535236 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21151K 04/26/2002 0702654355 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20215AK 02/23/2000 30002110316T2 NC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21526AK 08/22/2003 0707048787 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21195AK 05/29/2002 0702793121 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21193AK 05/29/2002 0702759492 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19953AN 01/21/2000 39912022083U3 SALE 1025 02H30-01 EA CD3700 CS 1.000 19966AN 03/08/2000 30002101167U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20210AK 01/27/2000 39912213420U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20215AK 01/27/2000 39912212921U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20333AK 05/18/2000 30004103499U2 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/29/2000 0700519549 ZINS 1024, 02H30-01 EA CD3700 CS 1.000 19953AN 01/27/2000 30001270601T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 10/31/2000 0700430444 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 10/25/2001 0701722636 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20106AN 02/14/2002 0702285397 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/30/2000 0700531142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/30/2000 0700531141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 12/01/2000 0700419159 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 12/01/2000 0700419161 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 12/01/2000 0700419160 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 03/08/2001 0700818411 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 03/01/2002 0702067225 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21151AK 04/22/2002 0702638488 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 04/26/2002 0702536142 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21508AK 08/18/2003 0706963179 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22038AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22039AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22035AK 03/08/2005 0721102104 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22041AK 03/10/2005 0721127061 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 01/17/2001 0700657124 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 11/29/2001 0701921151 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 22055AK 03/22/2005 0721231650 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21836AK 08/26/2004 0710348806 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20368AK 06/15/2000 0700067140 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20369AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20370AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20371AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20372AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20373AK 06/21/2000 0700067141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20340AK 05/26/2000 0700022704 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20344AK 05/30/2000 0700022198 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20347AK 05/26/2000 0700022704 ZOR 1025, 02H30-01 EA CD3700 CS(EA) 1.000 20010AN 10/11/2000 0700390326 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20036AN 02/27/2001 0700702499 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20037AN 02/28/2001 0700665110 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20039AN 03/08/2001 0700764419 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20059AN 05/23/2001 0701034352 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20069AN 07/13/2001 0701274789 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20073AN 07/25/2001 0701296466 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20075AN 07/25/2001 0701296466 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20117AK96 03/12/2004 0708902744 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20154AK96 08/28/2006 0724669259 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20200AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20201AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20233AN 02/17/2004 0708707057 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20465AK96 09/29/2006 0724957687 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20645AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20646AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20700AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20703AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20704AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20705AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20707AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20708AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20710AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20711AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20712AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20716AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20742AK 04/24/2001 0700847325 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20869AK 08/06/2001 0701363650 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20870AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20871AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20877AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20881AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20882AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20883AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20884AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20885AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20886AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20887AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20888AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20889AK 08/17/2001 0701419778 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20891AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20892AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20893AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20894AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20896AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20897AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20898AK 08/23/2001 0701439537 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20902AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20903AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20904AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20905AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20907AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20908AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20909AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20910AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20911AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20912AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20913AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20914AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20915AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20917AK 08/31/2001 0701419777 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20940AK96 03/08/2004 0708891681 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20967AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20970AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20987AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20989AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20991AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20992AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20993AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20994AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20996AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20997AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20998AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20999AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21000AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21001AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21002AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21003AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21004AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21005AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21045AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21046AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21048AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21049AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21050AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21058AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21059AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21060AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21061AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21062AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21063AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21064AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21065AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21067AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21068AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21069AK 02/15/2002 0702299928 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21070AK 02/19/2002 0702311964 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21076AK 02/26/2002 0702357048 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21082AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21083AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21084AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21089AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21090AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21091AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21092AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21093AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21094AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21095AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21096AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21097AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21098AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21099AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21100AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21101AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21102AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21103AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21104AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21105AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21107AK 03/19/2002 0702409792 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21127AK96 02/27/2004 0708817941 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21163AK 04/25/2002 0702452514 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21180AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21181AK 05/10/2002 0702726862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21182AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21183AK 05/10/2002 0702726862 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21244AK96 08/28/2006 0724669259 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21245AK96 08/17/2006 0724616503 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21473AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21474AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21475AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21476AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21478AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21479AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21480AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21481AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21482AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21483AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21485AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21590AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21592AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21624AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21625AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21627AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21628AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21629AK 01/26/2004 0708230220 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21630AK 01/27/2004 0708520940 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21639AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21640AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21643AK 02/10/2004 0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21644AK 02/12/2004 0708585284 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21645AK 02/10/2004 0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21647AK 02/17/2004 0708688571 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21650AK 02/23/2004 0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21651AK 02/24/2004 0708707083 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21652AK 02/23/2004 0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21654AK 03/04/2004 0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21655AK 03/04/2004 0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21656AK 03/04/2004 0708707086 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21657AK 03/04/2004 0708707086 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21658AK 03/04/2004 0708707089 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21659AK 03/04/2004 0708707089 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21660AK 03/05/2004 0708788543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21662AK 03/05/2004 0708707090 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21663AK 03/05/2004 0708707090 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21711AK 05/05/2004 0708707092 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21712AK 05/05/2004 0708707092 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21713AK 05/06/2004 0708707095 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21714AK 05/06/2004 0708707095 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21715AK 05/06/2004 0708707098 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21716AK 05/06/2004 0708707098 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21839AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21841AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21843AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22022AK 02/10/2005 0720995106 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22111AK 04/13/2005 0721376532 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22113AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22114AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22118AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22119AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22138AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22154AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22169AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22171AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22184AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22186AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22187AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22200AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22201AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22215AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22217AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22218AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22220AK 09/09/2005 0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22221AK 09/09/2005 0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22233AK 09/08/2005 0722353178 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22260AK 10/12/2005 0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22261AK 10/12/2005 0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22287AK 11/10/2005 0722807036 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22303AK 02/02/2006 0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22318AK 12/20/2005 0723075608 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22341AK 01/18/2006 0723279431 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22357AK 03/03/2006 0723573497 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22385AK 02/02/2006 0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22404AK 03/24/2006 0723666112 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22486AK 06/08/2006 0724084813 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22518AK 06/27/2006 0724306909 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22579AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22581AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22582AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22584AK 08/14/2006 0724381933 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22586AK 08/16/2006 0724600552 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22606AK 08/31/2006 0724658143 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22610AK 09/11/2006 0724831647 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22618AK 09/11/2006 0724794142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22645AK 10/09/2006 0725013284 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20407AK 07/18/2000 0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20409AK 07/18/2000 0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20414AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20415AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20417AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20418AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20419AK 07/25/2000 0700179062 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20435AK 08/07/2000 0700214053 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20438AK 08/09/2000 0700214054 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20474AK 09/11/2000 0700242470 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20478AK 09/21/2000 0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20480AK 09/21/2000 0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20484AK 09/21/2000 0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20487AK 09/21/2000 0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20516AK 10/11/2000 0700308524 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20518AK 10/13/2000 0700242473 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20527AK 10/19/2000 0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20528AK 10/19/2000 0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20531AK 10/24/2000 0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20533AK 10/24/2000 0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20555AK 11/14/2000 0700242476 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20556AK 11/15/2000 0700488515 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20607AK 01/22/2001 0700242477 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20609AK 01/23/2001 0700668678 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20619AK 02/06/2001 0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20620AK 02/06/2001 0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20621AK 02/06/2001 0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20623AK 02/06/2001 0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20642AK 02/27/2001 0700399168 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20653AK 02/28/2001 0700311275 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20684AK 03/20/2001 0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20687AK 03/20/2001 0700764417 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20688AK 03/20/2001 0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20691AK 03/22/2001 0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20692AK 03/22/2001 0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20698AK 03/27/2001 0700311278 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20702AK 03/27/2001 0700311278 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20366AK 06/15/2000 0700067139 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19954AN 01/19/2000 30001052430U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20201AK 01/19/2000 30001052492U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20202AK 01/19/2000 30001052475U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20222AK 02/07/2000 30001272996U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20227AK 02/10/2000 30001272997U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20228AK 02/10/2000 30001272998U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20230AK 02/15/2000 30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20232AK 02/15/2000 30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20237AK 02/18/2000 30001273000U3 SALE 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000 30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000 30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000 30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000 30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000 30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000 30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000 30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000 30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000 30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000 30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007 0725947869 ZOR 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000 30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000 30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000 30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000 30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000 30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000 30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000 30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000 30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000 30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000 30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007 0725947869 ZOR 1025, Recall # Z-1200-2007
REASON: The product failed electrostatic discharge testing, which could result in product failure.

MANUFACTURER: Sendx Medical Inc., Carlsbad, CA, by e-mail on June 6, 2007. Firm initiated recall is ongoing.
PRODUCT: ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863, Recall # Z-1201-2007
REASON: The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation error.

MANUFACTURER: Abbott Diagnostic International, Ltd, Barceloneta, PR, by letter dated March 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Abbott AxSYM System Digoxin III Reagent Pack, Recall # Z-1202-2007
REASON: Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

MANUFACTURER: DeRoyal Lafollette, LaFollette, TN, by letters on July 3, 2007 and July 18, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Assorted sterile surgical kits/ trays:
DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico;
DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only,
assembled in Mexico;
DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico;
DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico;
DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only;
DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only;
DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only;
DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only;
DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only;
DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only;
DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only;
DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only;
DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only;
DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal;
DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only;
DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only;
DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only;
DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only;
DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only;
DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only;
DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only;
DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only;
DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only;
DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only;
DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only;
DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only;
DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only;
DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only;
DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only;
DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only;
DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only;
DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only;
DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only;
DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only;
DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only;
DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only;
DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only;
DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only;
DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only;
DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only;
DeRoyal C-Section Pack, REF 50-13134.09, Rx only;
DeRoyal Ortho Basic Tray, REF 89-2650.14, sterile, Rx only;
DeRoyal Head/Neck Pack, REF 89-5736.01, exp. 2012-04, sterile, Rx only;
DeRoyal Major Pack, REF 50-12783.06, sterile, Rx only;
DeRoyal AAA Tray, REF 89-3453.05 A, sterile, Rx only,
DeRoyal AAA Tray, REF 89-3453.05 B, sterile, Rx only;
DeRoyal Foot Pack, REF 89-5713.01, sterile, Rx only;
DeRoyal Cardiac Cath Tray, REF 50-13027.16, sterile, Rx only;
DeRoyal PEDS Accessory Tray, REF 50-13017.16, sterile, Rx only;
DeRoyal Head and Neck Tray, REF 50-7738.18, sterile, Rx only;
DeRoyal Spine Tray II Pgybk, REF 89-3792.04 A, sterile, Rx only;
DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, sterile, Rx only;
DeRoyal C-Section Tray, REF 94-0007.08, Rx only;
DeRoyal Open Heart Tray, REF 89-4196.10 A, sterile, Rx only;
DeRoyal Open Heart Tray, REF 89-4196.10 B, sterile, Rx only;
DeRoyal Open Heart Tray, REF 89-4196.10 S, sterile, Rx only;
DeRoyal Shoulder Tray, REF 89-4184.05, sterile, Rx only;
DeRoyal Cysto Tray, REF 89-3251.07, sterile, Rx only;
DeRoyal C-Section Tray, REF 89-3619.04, sterile, Rx only;
DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only;
DeRoyal Hand/Foot Tray, REF 89-4181.06, sterile, Rx only;
DeRoyal Major Pack, REF 89-4251.03, sterile, Rx only;
DeRoyal Knee Arthroscopy Pack, REF 89-4307.05, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 89-4342.02, sterile, Rx only;
DeRoyal Shoulder Arthroscopy, REF 89-4453.02, sterile, Rx only;
DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, sterile, Rx only,
DeRoyal General Pack, REF 89-5231.03, sterile, Rx only;
DeRoyal Knee Arthroscopy Pack, REF 89-5295.01, sterile, Rx only;
DeRoyal Thoracotomy Tray, REF 50-8130.09, sterile, Rx only;
DeRoyal JIT C-Section Pack, REF 89-2572.06, sterile, Rx only;
DeRoyal C-Section w/Pouch Drape, REF 89-3435.02, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 50-11064.09, sterile, Rx only;
DeRoyal Open Heart Tray II, REF 89-3181.05, sterile, Rx only;
DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, sterile, Rx only;
DeRoyal Open Heart Tray, REF 50-4504.14, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 50-12788.08, sterile, Rx only;
DeRoyal Carotid Tray, REF 50-7650.22, sterile, Rx only;
DeRoyal General/Plastic Tray Standard, REF 89-5031.01, sterile, Rx only;
DeRoyal Cataract Tray, REF 50-12183.07, sterile, Rx only;
DeRoyal Cath Lab Tray, REF 50-12050.11, sterile, Rx only;
DeRoyal Ear Tray, REF 50-3028.18, sterile, Rx only;
DeRoyal All Service Basic, REF 89-2651.09, sterile, Rx only;
DeRoyal CV Drape Pack, REF 89-5137.01, sterile, Rx only;
DeRoyal Extremity Tray, REF 89-5164.02, sterile, Rx only;
DeRoyal Shoulder Arthroscopy, REF 89-5258.05, sterile, Rx only;
DeRoyal C Section Tray Pgybk, REF 94-0101.08, sterile, Rx only;
DeRoyal Cysto Tray, REF 89-3251.07, sterile, Rx only;
DeRoyal Liposuction Tray, REF 89-3763.02, sterile, Rx only;
DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, sterile, Rx only;
DeRoyal Shoulder Pack, REF 89-5725.01, , Rx only;
DeRoyal Open Heart Tray I, REF 89-3182.05, sterile, Rx only;
DeRoyal Arteriogram Tray, REF 50-12994.14, sterile, Rx only;
DeRoyal Total Hip, REF 50-13535.08, sterile, Rx only;
DeRoyal Basic Pack, REF 89-2746.03, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-3645.03, sterile, Rx only;
DeRoyal C-Section Pack, REF 89-2310.02, sterile, Rx only;
DeRoyal Total Knee Tray, REF 89-3987.04, sterile, Rx only;
DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, sterile, Rx only;
DeRoyal Basic Endo Tray, REF 89-3456.04, sterile, Rx only;
DeRoyal Minor Tray, REF 89-3823.13, sterile, Rx only;
DeRoyal Shoulder Pack, REF 89-5154.01, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 89-5291.01, sterile, Rx only;
DeRoyal Hand Pack, REF 89-5810.01, sterile, Rx only9;
DeRoyal LAP Chole Tray, REF 50-11036.07, sterile, Rx only;
DeRoyal CABG Pack, REF 50-13509.10, sterile, Rx only;
DeRoyal Total Hip Basin Set, REF 89-1319.05, sterile, Rx only;
DeRoyal Total Knee Basin Set, REF 89-1321.07, sterile, Rx only;
DeRoyal Total Hip, REF 89-2608.06, sterile, Rx only;
DeRoyal Angiography Tray, REF 89-3558.07, sterile, Rx only;
DeRoyal Abdohyst, Lapaexpl, REF 89-2497.12, sterile, Rx only;
DeRoyal General Surgery Tray, REF 89-4094.02, sterile, Rx only;
DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, sterile, Rx only;
DeRoyal TAH Tray, REF 89-2672.09, sterile, Rx only;
DeRoyal LAP Hernia Tray, REF 89-3468.04, sterile, Rx only;
DeRoyal C-Section Tray 3/Case, REF 50-2688.19, sterile, Rx only;
DeRoyal Peripheral Vascular Tray, REF 89-3874.05, sterile, Rx only;
DeRoyal Major Abdominal Tray, REF 89-4155.04, sterile, Rx only;
DeRoyal Open Heart Pack, REF 89-5339.02 A, sterile, Rx only;
DeRoyal Open Heart Pack, REF 89-5339.02 B, sterile, Rx only;
DeRoyal LAP Chole Tray, REF 50-12892, sterile, Rx only;
DeRoyal Auxilary Towel Pack, REF 50-12925.11, sterile, Rx only;
DeRoyal Fayette Arthroscopy Tray, REF 50-12975.06, sterile, Rx only;
DeRoyal Craniotomy Tray, REF 89-3563.11, sterile, Rx only;
DeRoyal O.R. Basin Tray 4/CS, REF 50-3482.22, sterile, Rx only;
DeRoyal Basic Set, REF 89-3514.05, sterile, Rx only;
DeRoyal C-Section Tray, REF 89-4849.02, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-3188.07, sterile, Rx only;
DeRoyal Major Vascular Tray, REF 89-3561.07, sterile, Rx only;
DeRoyal Basic Pack, REF 89-4101.06, sterile, Rx only;
DeRoyal Basic Extremity Pack, REF 89-4309.05, sterile, Rx only;
DeRoyal Minor Joint Tray, REF 89-4615.05, sterile, Rx only;
DeRoyal Shoulder Arthroscopy Pack, REF 89-4974.03, sterile, Rx only;
DeRoyal Basic Set, REF 94-0146.05, sterile, Rx only;
DeRoyal C-Section Pack, REF 50-12111.02, sterile, Rx only;
DeRoyal Upper Extremity Value Set, REF 89-4426.04, sterile, Rx only;
DeRoyal Laparotomy Pack, REF 50-12471.07, sterile, Rx only;
DeRoyal Podiatry Tray, REF 50-835.06, sterile, Rx only;
DeRoyal Basic Cath Tray, REF 89-4173.05, sterile, Rx only;
DeRoyal Cardiac Cath Tray, REF 50-13119.19, sterile, Rx only;
DeRoyal Limb Pack, REF 50-3836.23, sterile, Rx only;
DeRoyal Extremity Tray, REF 89-5113.05, sterile, Rx only;
DeRoyal Basic Pack, REF 89-5798.01, sterile, Rx only;
DeRoyal Pacemaker Tray, REF 89-3727.06, sterile, Rx only;
DeRoyal Kellog Back Pack, REF 89-5817.01, sterile, Rx only;
DeRoyal Basic Pack, REF 89-5155.02, sterile, Rx only
DeRoyal Abdominalplasty Tray, REF 89-5677.01, sterile, Rx only;
DeRoyal Extremity Pack, REF 89-5812.01, sterile, Rx only;
DeRoyal General Orthopedic Tray, REF 89-2851.06, sterile, Rx only;
DeRoyal Total Hip Pack, REF 89-3876.03, sterile, Rx only;
DeRoyal LAMI Pack, REF 89-4114.03, sterile, Rx only;
DeRoyal Podiatry Tray, REF 50-13341.04, sterile, Rx only;
DeRoyal Total Knee Tray, REF 89-3288.04, sterile, Rx only;
DeRoyal Basic LAP Tray, REF 89-3297.06, sterile, Rx only;
DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, sterile, Rx only;
DeRoyal NW ASC Shoulder Arthro, REF 89-4569.07, sterile, Rx only;
DeRoyal TVT Pack, REF 89-5782.01, sterile, Rx only;
DeRoyal Double Basin Set, REF 89-0191.05, sterile, Rx only;
DeRoyal Vascular AV Fistula Pack, REF 50-8118.08, sterile, Rx only;
DeRoyal Arthroscopy Pack, REF 50-12988.10, sterile, Rx only;
DeRoyal Gyn Laparoscopy, REF 89-2646.10, sterile, Rx only;
DeRoyal Heart Tray, REF 89-3916.05 A, sterile, Rx only;
DeRoyal Heart Tray, REF 89-3916.05 B, sterile, Rx only;
DeRoyal Arthroscopy Tray, REF 89-5714.01, sterile, Rx only;
DeRoyal Lumbar Disk, REF 89-3390.06, sterile, Rx only;
DeRoyal Cath Lab Accessory Tray, REF 89-4023.07, sterile, Rx only;
DeRoyal Extremity Pack, REF 89-2565.08, sterile, Rx only;
DeRoyal Custom hand Tray, REF 89-4593.03, sterile, Rx only;
DeRoyal Basic Major Tray, REF 94-0283.11, sterile, Rx only;
DeRoyal Cardiac Cath Lab Tray, REF 89-5109.01, sterile, Rx only;
DeRoyal Open Heart Drape Pack, REF 89-5202.01, sterile, Rx only;
DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 A, sterile, Rx only;
DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 B, sterile, Rx only;
DeRoyal Clevens Facelift Pack, REF 89-5728.01, sterile, Rx only;
DeRoyal C-Section Tray, REF 50-12505.08, sterile, Rx only;
Recall # Z-1204-2007
b) Assorted non- sterile Tracecarts (with sterile component(s));
1) DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only;
2) DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only;
3) DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only;
4) DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only;
5) DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile, Rx only;
6) DeRoyal Heart Tracecart, REF 53-1897.02, Rx only;
7) DeRoyal LAP Chole Tracecart, REF 53-1862.03, non-sterile, Rx only;
8) DeRoyal LAP Chole Tracepak, REF 90-2774.10, non-sterile, Rx only;
9) DeRoyal Total Knee Tracecart, REF 53-1838.02, non-sterile, Rx only;
10) DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only;
11) DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx only;
12) DeRoyal C-Section Tracecart, REF 53-1837.03, non-sterile, Rx only;
13) DeRoyal C-Section Tracecart, REF 53-1781.04, non-sterile, Rx only;
14) DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only;
15) DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only,
16) DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only;
17) DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile, Rx only,
Recall # Z-1205-2007
REASON: Packaging failure. Lack of sterility assurance.

MANUFACTURER: Spectrum Designs, Inc., Carpinteria, CA, by telephone on June 15, 2007, and by letters on June 18, 2007. Firm initiated recall is complete.
PRODUCT: Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S, Recall # Z-1206-2007
REASON: The product is being recalled because it was discovered that at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.

MANUFACTURER:
Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA, by letters on July 16, 2007. Firm initiated recall is ongoing.
PRODUCT: Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, Recall # Z-1211-2007
REASON: The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.

MANUFACTURER: Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by letter on June 18, 2007. Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, B.C., Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female
Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24, Sterile, Recall # Z-1213-2007;
b) Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile, Recall # Z-1214;
c) Smiths CADD Medication Cassette Reservoir, With clamp and female Luer, Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO, Recall # Z-1215
REASON: Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have

MANUFACTURER: Summit Industries, Inc., Chicago, IL, by letters dated August 3, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator, Recall # Z-1216-2007;
b) LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator, Recall # Z-1217-2007;
c) PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator, Recall # Z-1218-2007
REASON: The D800 Swivel Collimator may come loose from the tube stand and fall onto the x-ray table.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of August 29, 2007

CLASS II
MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter dated July 3, 2007. Firm initiated recall is ongoing.
PRODUCT: EasyLink Informatics System, software version 3.0, Part Number 1000034941, Recall # Z-1174-2007
REASON: Sample ID and Patient results could be associated with the wrong patient.

MANUFACTURER: Recalling Firm: Carmel Pharma, Inc., Columbus, OH, by letters on June 15, 2007. Manufacturer: Carmel Pharma Ab, Gotenburg, Sweden. Firm initiated recall is ongoing.
PRODUCT: a) PhaSeal, Protector 14, Item No. P14, US Order No. 21320, Recall # Z-1178-2007; b) PhaSeal Injector Luer Lock, Model Item N31, US Order No. 10310, Recall # Z-1179-2007; c) PhaSeal, Protector 21, Item No. P21, US Order No. 22020, Recall # Z-1180-2007; d) PhaSeal, Protector 50, Item No. P50, US Order No. 22050, Recall # Z-1181-207
REASON: Risk of Leakage. When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.

MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters beginning May 31, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01, Recall # Z-1185-2007;
b) AxSYM Quinidine Controls - are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5mL -Control Low, Control Medium, Control High) containing
quinidine prepared in human serum to yield the different concentration ranges-Product List Number 7A73-10, Recall # Z-1186-2007;
c) XSYSTEMS Quinidine Calibrators consists of six bottles of Cal A-F (2.5 mL each). Product List Number-9506-01, Recall # Z-1187-2007;
d) XSYSTEMS Quinidine Controls are composed of 3 bottles of controls (AxSYM 8mL & XSYSTEM 2.5ml) containing quinidine prepared in human serum to yield different concentration ranges.-Product List Number 9506-10, Recall # Z-1188-2007
REASON: Controls Out of Range/Specification.

MANUFACTURER: bioMerieux, Inc., Durham, NC, by letter on February. Firm initiated recall is ongoing.
PRODUCT: BacT/ALERT® FN Culture Bottles, Product Number 259793, Recall # Z-1189-2007
REASON: Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

MANUFACTURER: Recalling Firm: Steris Corp., Mentor, OH, by telephone on March 22, 2007. Manufacturer: Steris Mexico, Guadalupe, Mexico. Firm initiated recall is ongoing.
PRODUCT: Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm), Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H, Recall # Z-1193-2007
REASON: The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.

MANUFACTURER: Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated June 25, 2007. Manufacturer: Zimmer Gmbh, Winterthur, Switzerland. Firm initiated recall is complete.
PRODUCT: Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370, Recall # Z-1194-2007
REASON: The package actually contains a knee patellar implant.

MANUFACTURER: Sendx Medical Inc., Carlsbad, CA, by letters on March 27, 2007. Firm initiated recall is ongoing.
PRODUCT: ABL80 FLEX Analyzer, Model #393-839, Recall # Z-1196-2007
REASON: There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer when excessive pressure builds within the waste line.

CLASS III
MANUFACTURER: Volcano Corporation, Rancho Cordova, CA, by letter beginning April 2, 2007. Firm initiated recall is ongoing.
PRODUCT: Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM). Device listing A863634, part number 804200-100. monitor part number that is being replaced: 90X0315A, Recall # Z-1190-2007
REASON: During emissions testing, it was discovered that the product exceeds emissions limits for electromagnetic compatibility.

MANUFACTURER: Boston Scientific, Corp., San Jose, CA, by letters on June 26, 2007. Firm initiated recall is ongoing.
PRODUCT: Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Catalog Model number/Product UPN number M0049663S0, Recall # Z1191-2007
REASON: Product is mislabeled as hexapolar (6 electrodes), but is actually quadripolar (4 electrodes).

MANUFACTURER: Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by telephone and letter on July 11, 2007. Manufacturer: Alcon Manufacturing LTD, Sinking Spring, PA. Firm initiated recall is complete.
PRODUCT: Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each, Recall # Z-1197-2007
REASON: Mislabeled. Boxes actually contained Tri-Fact needles.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of as of August 22, 2007

CLASS II
MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letters dated February 16, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) GE Medical Systems Mac-Lab System, cardiac catheterization data system. Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007;
b) GE Medical Systems CardioLab System, electrophysiological data system, Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007;
c) GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System, Software Version 6.5 2021423-015 Revision D and CardioLab System, Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems, Recall # Z-1134-2007
REASON: GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.

MANUFACTURER: Sunrise Medical Inc., Fresno, CA, by telephone and letter on May 1, 2007. Firm initiated recall is ongoing.
PRODUCT: Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays), Recall # Z-1163-2007
REASON: The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.

MANUFACTURER: Recalling Firm: Lifescan Inc., Milpitas, CA, by letter on March 30, 2007. Manufacturer: Owen Mumfordltd, Oxford, UK. Firm initiated recall is ongoing.
PRODUCT: One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200, Recall # Z-1165-2007
REASON: Lancet tip may not fully retract and cause needle stick and exposure to used lancets.

MANUFACTURER: Recalling Firm: ICU Medical, Inc., San Clemente, CA, by letter dated September 26, 2006 and January 10, 2007.Manufacturer: ICU Medical, Vernon, CT. Firm initiated recall is complete.
PRODUCT: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291, Recall # Z-1166-2007
REASON: The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by e-mail on May 17, 2007 and by letter on May 18, 2007. Firm initiated recall is ongoing.
PRODUCT: VITROS® 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS® Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375, Recall # Z-1167-2007
REASON: Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS® Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabinoids (THC) or Amphetamines (AMPH) could occur when using VITROS® Chemistry Products THC or AMPH Reagents.

MANUFACTURER: Cook Urological, Inc., Spencer, IN, by letter dated June 29, 2007. Firm initiated recall is ongoing.
PRODUCT: Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724, Recall # Z-1168-2007
REASON: The radiographic band may detach from the stent and remain in the patient after removal of the stent.

MANUFACTURER: Recalling Firm: Hamilton Co., Reno, NV, by letter and e-mail on March 29, 2007. Manufacturer: Hamilton Bonaduz AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.
PRODUCT: Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use, Recall # Z-1169-2007
REASON: Some product containers may be leaking.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on May 7 and May 16, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software controlled medical device for diagnostic use., and CELL DYN Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Recall # Z-1170-2007
b) Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and 03H57-03, software controlled medical device for diagnostic use and CELL DYN Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700, Recall # Z-1171-2007
REASON: Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay parameter limit has been exceeded)

MANUFACTURER: Recalling Firm: The Sisus Corporation, Santa Cruz, CA, by letter on June 8, 2007. Manufacturer: Trolli King (Holding) Ltd., Pin Hu, Shenzhen, Guangdong, China (Mainland). Firm initiated recall is ongoing.
PRODUCT: Non-AC-powered Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" is identified as Model SBB10.0, and "Shower Helper" may be identified a Model SBH10.0 or as "Sisus All In One", Recall # Z-1172-2007
REASON: Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.

MANUFACTURER: Sendx Medical, Inc., Carlsbad, CA, by e-mail on June 29, 2007. Firm initiated recall is ongoing.
PRODUCT: ABL77 Cal Pack, Model number 944-069, calibration solutions for use with the ABL77 Blood Gas/Electrolyte analyzer, Recall # Z-1173-2007
REASON: Error in the Ca 12 calibration value for pC02 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pC02 results at the high end of the measuring range.

MANUFACTURER: Louisville Apl Diagnostics, Inc., Seabrook, TX, by fax on May – June 2005. Firm initiated recall is complete.
PRODUCT:
a) APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM, Recall # Z-1175-2007;
b) APhL® HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G, Recall # Z-1176-2007;
c) APhL® HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M, Recall # Z-1177-2007
REASON: Mislabeing. Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.

MANUFACTURER: Arizant Healthcare, Inc., Eden Prairie, MN, by letter dated June 25, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24200. For use with a Ranger warming unit, Recall # Z-1183-2007;
b) Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection port and extension set, Part Number 24250. For use with a Ranger warming unit, Recall # Z-1184-2007
REASON: Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 15, 2007

CLASS II
MANUFACTURER: Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by visit and letter dated May 23, 2007. Manufacturer: Cybersonics, Inc., Erie, PA. Firm initiated recall is ongoing.
PRODUCT: Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray, Recall # Z-1073-2007
REASON: Sterilization Instructions not adequate for sterilizing.

MANUFACTURER: Instrumentation Laboratory, Co., Lexington, MA, by letter, on June 19, 2007. Firm initiated recall is ongoing.
PRODUCT: Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000, Recall # Z-1127-2007
REASON: ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter dated June 11, 2007. Firm initiated recall is ongoing.
PRODUCT: Philips Medical HeartStartXL Defibrillator/Monitor Model: M4735A, Recall # Z-1128-2007.
REASON: The ECG signal may become unusable to assess patient condition and need for therapy.

MANUFACTURER: Curlin Medical Llc, Huntington Beach, CA, by letter on February 9, 2007 and March 15, 2007. Firm initiated recall is complete.
PRODUCT: Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets, Recall # Z-1129-2007
REASON: The Administration Sets may leak at the reservoir bag.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN, by letter dated June 19, 2007. Firm initiated recall is ongoing.
PRODUCT: Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, (These sets are used with the new AngioJet Ultra Console), Recall # Z-1131-2007.
REASON: Mislabeling. Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should be indicated for use only for peripheral arteries.

MANUFACTURER: Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH, by letter dated June 25, 2007 and July 26, 2007. Manufacturer: Abbott Laboratories, Inc., Columbus, OH. Firm initiated recall is ongoing.
PRODUCT: Embrace Enteral Pump, Recall # Z-1141-2007
REASON: Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding

MANUFACTURER: Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH, by letter dated June 25, 2007 and July 26, 2007. Manufacturer: Frantz Medical Development Ltd, Mentor, OH. Firm initiated recall is ongoing.
PRODUCT: The Companion ClearStar Pump System, for enteral feeding, Recall # Z-1142-2007.
REASON: The transducer adapter bracket on the pump could crack or break and potentially result in an under delivery of the enteral product.

MANUFACTURER: Recalling Firm: Kimberly-Clark Corp., Roswell, GA, by letter on/about June 4, 2007 and fax on June 5, 2007. Manufacturer: Unomedical, Kedahkedah, Malaysia. Firm initiated recall is ongoing.
PRODUCT: a) Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm, 4.0mm, and 4.5mm, Rx Only, Sterile, Product code 35111-07, 35112-07, 35113-07 and 35114-07, Recall # Z-1143-2007;b) Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Product code 35161-07, 35162-07, 35163-07 and 35164-07, Recall # Z-1144-2007
REASON: The tubes may kink during use which may impede or prevent ventilation.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on January 6, 2006. Firm initiated recall is complete.
PRODUCT: Isoloc software Version 6.5, Part Number NT-NW-425-520. Software for image guided radiation therapy, Recall # Z-1145-2007
REASON: Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 7, 2006. Firm initiated recall is ongoing.
PRODUCT: ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007
REASON: This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on May 31, 2005. Firm initiated recall is ongoing.
PRODUCT: ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007
REASON: When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.

MANUFACTURER: Applied Composite Technology, Gunnison, UT, by telephone on June 20 and 21, 2007. Firm initiated recall is ongoing
PRODUCT: VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right), Recall # Z-1149-2007.
REASON: Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letter on June 13, 2007. Firm initiated recall is ongoing.
PRODUCT: Biomet Straight Magnum Inserter Handle, a preparatory instrument used for Acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Recall # Z-1151-2007.
REASON: The instrument was manufactured incorrectly and use could result in the instrument binding to the Acetabular component and cause implant to not release following impaction.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 28, 2005. Firm initiated recall is ongoing.
PRODUCT: ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software, Recall # Z-1152-2007
REASON: When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 11, 2005. Firm initiated recall is ongoing.
PRODUCT: ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy, Part Number NT-NW-425-520, Recall # Z-1153-2007
REASON: When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on December 30, 2004. Firm initiated recall is ongoing.
PRODUCT: ISOLOC Software Version 6.0, Part Number NT-NW-425-520, Recall # Z-1154-2007
REASON: When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.

MANUFACTURER: Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on November 30, 2004. Firm initiated recall is ongoing.
PRODUCT: ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software, Recall Z-1155-2007
REASON: When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.

MANUFACTURER: Recalling Firm: Datascope Corp., Fairfield, NJ, by letter the week of May 7, 2007. Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
PRODUCT: a) Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system) The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R, Part number KTV 15,
Recall # Z-1156-2007; b) The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors. Datascope Cardiac Assist Sterile, Part Number KTV 17, Recall # Z-1157-2007;c) Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device, Part number PBD01, Recall # Z-1158-2007
REASON: Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick MA, by letter on May 1, 2007. Manufacturer Firm: Boston Scientific, Cupertino, CA. Firm initiated recall is ongoing.
PRODUCT: Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Recall # Z-1161-2007
REASON: Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.

MANUFACTURER: Cook Urological, Inc. Spencer, IN, by letter dated June 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413, Recall # Z-1162-2007
REASON: Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.

CLASS III
MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by telephone, memo and letter dated June 4, 2007. Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
PRODUCT:
a) Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic Catheters, Recall# Z-1159-2007;
b) Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters. Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391221, (Single Pack Carton/Pouch Label), Angiographic Catheters, Recall # Z-1160-2007
REASON: Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letter on May 8, 2007. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
PRODUCT: STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C, 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex, Catalog number: 0516, Recall # Z-1072-2007
REASON: Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 18, 2007. Firm initiated recall is ongoing.
PRODUCT: Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV, Recall # Z-1130-2007
REASON: Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity

MANUFACTURER: Recalling Firm: Encore Medical, Lp, Austin, TX, by letter on August 25, 2006. Manufacturer: Terray Corp., Arnptiot Ontario, Canada. Firm initiated recall is complete.
PRODUCT:
a) Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1135-2007;
b) Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1136-2007;
c) Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1137-2007;
d) Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1138-2007;
e) Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1139-2007;
f) Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1140-2007
REASON: Complaints received that device used to prepare femur to receive femoral implant would split during surgery.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 8, 2007
CLASS II
MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by telephone and letters on June 5, 2007. Manufacturer: Sistemos Medicos Alaris, Tijuana, B.C., Mexico. Firm initiated recall is ongoing.
PRODUCT: Alaris Medical Systems IV Administration Set, Low Sorbing Extension Set, Model C20014, Rx Only, Alaris Medical Systems, Recall # Z-1078-2007
REASON: The sterility of the product may be compromised as the packaging used for the sterility barrier was not designed for the sterility process used by the firm.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter dated June 11, 2007. Firm initiated recall is ongoing
PRODUCT: Biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers), Recall # Z-1148-2007
REASON: Reduced Shock. The device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

MANUFACTURER: Zinnanti Surgical Design LLC, Hershey, PA, by telephone and letter dated July 24, 2007. Firm initiated recall is ongoing.
PRODUCT: Bayonet Electrosurgical Pencil. P/N 9560575-900. The product is shipped in cases containing 100 blades/pencils, Recall # Z-1150-2007
REASON: Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised

MANUFACTURER: Recalling Firm: Cardinal Health 303 Inc., DBA Alaris Products, San Diego, CA, by letter beginning on June 18, 2007 Manufacturer: Sistemos Medicos Alaris, Parque Ind. El Florido, Tijuana, B.C. Mexico. Firm initiated recall is ongoing.
PRODUCT: All IV Administration Infusion Sets intended for use with the Gemini Infusion Pump and Alaris Pump module (a.k.a. Medley Pump module) including: Alaris SmartSite Low Sorbing Set, Alaris Vented Syringe Adapter Set, Alaris Burette Set, Cardinal Health SmartSite Infusion Set, Alaris Infusion Set, Alaris SmartSite Burette Set, Cardinal Health SmartSite Burette Set, Alaris SmartSite Administration Set, Alaris Infusion Burette Set, Alaris SmartSite Blood Set, Cardinal Health SmartSite Combination Infusion Set, Cardinal Health Blood Set, Alaris Medley/Gemini Infusion Set, Alaris Medley/Gemini Blood Set, Alaris Latex-Free Infusion Set, Alaris Light Sensitive Solution Set, Alaris Medley/Gemini Enteral Set, Imed Gemini 20 Vented/Nonvented Primary Administration Set, Imed Vented/Nonvented Gemini Prime-Saver Set, Imed Vented/Nonvented Gemini Short Set, Alaris Half Set, Cardinal Health Half Set, Alaris Latex-Free Burette Set, Alaris Opaque Set, Alaris Medley/Gemini Combination Infusion Set, Recall # Z-1020-2007
REASON: It has been determined that with low probability, over-infusion may occur as a result of an open safety clamp fitment (a.k.a. Flo-Stop fitment) on the pumping segment, whether opened intentionally in the course of expected clinical practice, or as a result of inadvertent action. The over-infusion occurrence is dependent on the user not closing the roller clamp first, as required by clinical practice and the IV administration set Directions for Use, and then intentionally or inadvertently opening the secondary back-up mechanism (safety clamp fitment).

MANUFACTURER: Recalling Firm: Bausch & Lomb Inc, Rochester NY, by telephone between June 8-12, 2007. Manufacturer: Bausch And Lomb Inc, Saint Louis, MO. Firm initiated recall is ongoing.
PRODUCT:
a) Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall, Recall # Z-1021-2007;
b) Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reusable. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall, Recall # Z-1022-2007
REASON: Reports have been received of stromal incursions after use of the product.

MANUFACTURER: Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters on May 21, 2007. Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
PRODUCT:
a) Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests, Recall # Z-1106-2007;
b) Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0, Catalog number 03576710190, Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB, Recall # Z-1107-2007
REASON: For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.

CLASS III
MANUFACTURER: Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Oklahoma City, OK, by letters on October 12-13, 2004, November 10, 2004, and by letters, telephone and visit on December 1, 2004 and January 26, 2005. Manufacturer: Royal Distributors, Inc., Temecula,CA. Firm initiated recall is complete.
PRODUCT: Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791, Recall # Z-1105-2007
REASON: Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 1, 2007

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 1 2007
CLASS I
MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on June 8, 2007. Firm initiated recall is ongoing
PRODUCT: Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system; Catalog number 20010-0000-032, Recall # Z-1108-2007
REASON: Component Failure; Device Failure without warning. Due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.

MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on March 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number 14086-2550-000, Recall # Z-1109-2007
REASON: Incorrect collet nut assembly (inadvertent use of the incorrect (Black) collet nut) during surgical implantation (wrong size collet nut) to secure the inflow cannula to the PVAD has resulted in patient deaths.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 21, 2007, Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT:
a) Baxter Flo-Gard 6201, SIngle Channel, Volumetric Infusion Pump; Product Code # 2M8063, Recall # Z-1111-2007;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Product code # 2M8064, Recall # Z-1112-2007;
c) Baxter Colleague Single Channel Volumetric Infusion Pumps; Made in Singapore; Product codes 2M8151 and 2M8161 (Colleague CX), Recall # Z-1113-2007;
d) Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore; Product codes 2M8153 and 2M8163 (Colleague CX Triple), Recall # Z-1114-2007
REASON: Falsified Repair/Test and Inspection records: Pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.

CLASS II

MANUFACTURER: Manufacturer: Gebauer Company, Cleveland, OH, by letter on April 17, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Gebauer's Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02), Recall # Z-1057-2007;
b) Gebauer's Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sports injuries. Rx only- 3.5 fl. oz. (103.5ml) can. Product Number 0386-0004-04, Recall # Z-1058-2007;
c) Gebauer's Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103.5ml) can. (Product Number: 0386-0010-05), Recall # Z-1059-2007;
d) Gebauer's Instant Ice Medium Stream for temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can. (Product Number-0386-0010-01), Recall # Z-1060-2007;
e) Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can. (Product Number-0386-0008-03), Recall # Z-1061-2007;
f) Gebauer's Pain Ease Sample Spray -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can. (Product Number-0386-0008-01), Recall # Z-1062-2007
REASON: Mold contamination

MANUFACTURER: Encore Medical, Lp, Austin, TX, by letters on April 14, 2007. Firm initiated recall is complete
PRODUCT:
a) ALFA’ II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter: 18.0mm; Catalog # 651-06-180; component of the ENCORE Hip System; Single Use, Sterile; Recall # Z-1063-2007;
b) ALFA’ II Modular Femoral Revision Stem Porous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; Recall # Z-1064-2007;
c) ALFA’ II Modular Femoral Revision Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; Recall # Z-1065-2007;
d) ALFA’ II Modular Femoral Revision Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; Recall # Z-1066-2007
REASON: Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.

MANUFACTURER: Recalling: Synovis Surgical Innovation, Saint Paul, MN, by letter on June 19, 2007. Manufacturer: TMX Engineering & Manufacturing Inc., Santa Ana, CA. Firm initiated recall is ongoing
PRODUCT:
a) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 10 mm, 250 mm long, Recall # Z-1080-2007;
b) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System, Catalog ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long, Recall # Z-1081-2007;
c) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long, Recall # Z-1082-2007;
d) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DG. Sterile, One Time Use, Contents 4 sets 1-guide rod, 23 mm, 250 mm long, dilating, Recall # Z-1083-2007;
e) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-23DGPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 23 mm, 250 mm long, dilating, Recall # Z-1084-2007;
f) Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, Recall # Z-1085-2007
REASON: There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.

MANUFACTURER: Smiths Medical PM, Inc., Waukesha, WI, by a Safety Action Bulletin on June 5, 2007. Firm initiated recall is ongoing.
PRODUCT: BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200), Recall # Z-1089-2007
REASON: Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters dated June 4, 2007. Manufacturer: RanD S.r.l., Medolla, MO Italy. Firm initiated recall is ongoing.
PRODUCT: Medtronic Performer CPB-Universal R2100375. Catalog Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures, Recall # Z-1090-2007
REASON: Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter starting May 14, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Architect Ausab Reagent list number 1L82-25 has the following components:
    1) Architect Ausab microparticles and
    2) Architect Ausab Conjugate. in vitro diagnostic, Recall # Z-1096-2007;
b) Architect Ausab Calibrators IVD - list number 1L82-01 has six (6) bottles with the following components:
    1) Calibrator A and
    2) Calibrators B thru F. in vitro diagnostic, Recall # Z-1097-2007;
c) Architect Ausab Controls list number 1L82-10 have two bottles with the following components:
    1) Negative Control and 2) Positive Control. in vitro diagnostic, Recall # Z-1098-2007
REASON: During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.

MANUFACTURER: Power Medical Interventions, Inc., Langhome, PA, by telephone on May 14, 2007.
PRODUCT: Power Linear Cutter Reusable Digital Loading Units with Reloads. Common name - Implantable staple. Model number PLC60, Recall # Z-1099-2007
REASON: Malfunction. Improper staple formation.

MANUFACTURER: Sunnex, Inc., Natick, MA, by letter on March 9, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile), Recall # Z-1100-2007;
b) Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount), TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile), Recall # Z-1101-2007
REASON: Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

MANUFACTURER: Louisville APL Diagnostics, Inc., Seabrook, TX, by telephone on August 10, 2004. Firm initiated recall is complete.
PRODUCT:
a) american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE® aPL IgM ELISA Kit, Product #649M; Recall # Z-1103-2007;
b) american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc.
IMUCLONE® aPL IgG ELISA Kit, Product #649G, Recall # Z-1104-2007
REASON: Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by visit on April 18, 2007 and by letter on April 24, 2007. Manufacturer: Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico. Firm initiated recall is complete.
PRODUCT: Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Recall # Z-1110-2007
REASON: Pyrogen Levels detected above specification: The product contains a pyrogen level above Medtronic's internal specifications while the product is labeled as nonpyrogenic.

MANUFACTURER: Kensey Nash Corp., Exton, PA, by voice mail on May 21, 2007. Firm initiated recall is complete.
PRODUCT: ThromCat Thrombectomy Catheter System. Catalog number 63000-01, Recall # Z-1115-2007
REASON: Defective Component (power supply).

MANUFACTURER: Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letter on June 5, 2007. Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is ongoing
PRODUCT: Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton, Recall # Z-1116-2007
REASON: Cracks at the Catheter Tip.

MANUFACTURER: Recalling Firm: Liko North America Inc., Franklin, MA, by letter on June 13, 2007. Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.
PRODUCT:
a) Liko Universal Sling Bar 450 Quick Release Hook (QRH) Product Number: 3156085, Used with Liko patient lifts, Recall # Z-1117-2007;
b) Liko Universal Sling Bar 450 R2R Product Number: 3156095, Used with Liko patient lifts, Recall # Z-1118-2007
REASON: Sling bar may have a center bolt break at the adapter while in use.

MANUFACTURER: Biomedicare, Inc., Cypress, CA, by telephone and letters on June 30, 2007. Firm initiated recall is ongoing.
PRODUCT: Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W, Endosseous Dental Implant, Recall # Z-1119-2007
REASON: Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.

CLASS III
MANUFACTURER: Thommen Medical, AG, Waldenburg, Switzerland, by telephone and letter on May 14, 2007. Firm initiated recall is ongoing.
PRODUCT: SPI EASY Abutment. Endosseous dental implant abutment, #4_03_700 Batch 8007 REF: 1.03.700, Recall # Z-1086-2007
REASON: The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by Safety Alert Notice on November 13, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT:
a) ABL 700 Series blood gas analyzers equipped with Software Version 3.833, Recall # Z-1094-2007;
b) ABL 800 FLEX series blood gas analyzers containing software version 5.24, Recall # Z-1095-2007;
REASON: Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein removal program instead of the cleaning program, this may damage the reference membrane and result in incorrect pH and electrolyte values being reported.

MANUFACTURER: Veridex, LLC, Warren, NJ, by letter on May 24, June 1, 2007 and June 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, Ref 7900001, Ref 7900000, Recall # Z-1102-2007.
REASON: An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.
 

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 25, 2007

CLASS I
MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by telephone on June 20-21, 2007 and by letters dated June 22, 2007. Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
PRODUCT: Baxter Colleague Triple Channel Volumetric Infusion Pumps; Made in Singapore, product codes 2M8153, 2M8163, 2M9163, Recall # Z-1091-2007
REASON: A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.

MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by press release on May 25 and 26, 2007. Manufacturer: Advanced Medical Optics Manufacturing Spain, S.L., Alcobendas (Madrid), Spain. Firm initiated recall is ongoing
PRODUCT
a) COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X; Fourteen US Product Numbers distributed under the COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION brand include: 90104 (MoisturePLUS, 12 oz.), 90105 (MoisturePLUS, 2 X 12 oz), 90106 (Complete MoisturePLUS Lens Comfort Pack), 90168 (Complete MoisturePLUS 2 oz Starter Kit + Lens Case), 90169TR (Complete MoisturePLUS, 2 X 16 oz, TRAY), 90170 (Complete MoisturePLUS, 4 oz + Lens Case), 93184 (Active Pack, Complete MoisturePLUS 2 oz & B-N-C 5m1 + Lens Case), 93185 (Complete MoisturePLUS, 12 oz, BEAUTIFUL EYES PROMO), 93186 (Complete MoisturePLUS, 2 X 12 oz, BEAUTIFUL EYE PROMO), 93187 (Complete MoisturePLUS, 2 X 16 oz, BEAUTIFUL EYES PROMO), 93220 (Rejuvenate Kit -contains Complete MoisturePLUS 90174), 93221 (Complete MoisturePLUS, 12 oz + Blink Sample), 93280 (Complete Starter Kit -2 oz Complete MoisturePLUS + Lens Case), 93341 (Complete MoisturePLUS, 4 oz); The same formula (9451X) was sold in (1)Canada (Product Numbers:90113EC, 90175QW, 90176EC, 90177EC, 90187EC & 90197EC),
(2)Europe (Product Numbers: 90086DF, 90086FC, 90086SA, 90089AX, 90089FP, 90089GB, 90089NR, 90090EQ, 90090GM, 90090RR, 90090RY, 90091EG, 90091GB, 90091GM, 90091KZ, 90091NR, 90091RH, 9009SA, 90096AX, 90096EJ, 90096EQ, 90096EW, 90096FL, 90096FP, 90096GB, 90096GM, 90096LM, 90096RW, 90096RY, 90096SA, 90109FM, 90110EW, 90110FC, 90110FL, 90110KK, 90110KKD, 90115AX,
90115EW, 90115FP, 90115GB, 90115GM, 90115KH, 90117FP, 90117RH, 90118RR, 90119GM, 90119RH, 90124XQ, 90157KK, 90157KKD, 93099EQ, 93099RW, 93136LM, 93137LM, 93365GB & 93365NR),
(3)China (Product Numbers: 90281CH, 90282CH, 90283CH, 93095CH, 93191CH, 93262CH, 93283CH, 93404CH, 93407CH, 93416CH & 93464CH) & (4)Various Asia Pacific countries (to include Hong Kong, Australia, New Zealand, Korea, Vietnam, Singapore, India, Indonesia, Sri Lanka, Taiwan, Malaysia, Pakistan and the Philippines) under Product Numbers: 90104, 90190ED, 90192ED, 90193ED, 90194ED, 90195ED, 90228ED, 90281AS, 90281KO, 90282AS, 90282KO, 90283AS, 90283KO, 90283UT, 93126AS, 93126KO, 93126UT, 93233UT, 93262AS, 93375AS, 93376AS, 93377AS, 93378AS, 93378AS, 93379AS & 93447AS, Recall # Z-1092-2007;
b) COMPLETE Amino Moist Multi-Purpose Solution (JAPAN only brand), Formula 9451X, Product Numbers: 93323JA, 93324JA, 93325JA, 93326JA, 93327JA, 93328JA, 93329JA, 93330JA, 93331JA, 93332JA, 93333JA, 93334JA, 93335JA, 93336JA & 93337JA,
Recall # Z-1093-2007
REASON: In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.

CLASS II
MANUFACTURER: Recalling Firm: Teleflex Creek Dr, Durham, NC, by letter, telephone, e-mail or fax on June 7, 2007. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing
PRODUCT
a) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek®, TOPS ASSY P/P SLING, Catalog #84414323, Recall # Z-1011-2007;
b) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture:
Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2,
Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2,
Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2,
Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,
Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213,
Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Recall # Z-1012-2007;
c) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture—
Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,
Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP,
Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP,
Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P,
Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,
Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P,
Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P,
Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,
Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P,
Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P,
Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P,
Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P,
Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP,
Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Recall # Z-1013-2007;
d) Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures –
Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N,
Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN,
Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N,
Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N, Recall # Z-1014-2007;
e) Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-
SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2;
SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6,
SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,
SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7,
SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2,
SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6,
SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,
SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B,
SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235,
SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399, Recall # Z-1015-2007;
f) Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Recall # Z-1016-2007;
g) Various Types and Sizes of Polyethylene Synthetic Nonabsorable Sutures-Polyester, TEV GN BR 0 TC-43/HR 262N, Catalog #833-114, Recall # Z-1017-2007;
h) Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123, Recall # Z-1018-2007;
i) Various Sizes of Sterile Plyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0 C-2/CST43 2N36, Catalog #833-135, Recall # Z-1019-2007;
REASON: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

CLASS III
MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letter on March 20, 2007. Firm initiated recall is ongoing.
PRODUCT: TDx/TDxFLx Methotrexate II Reagent-List Number 07A12-60 - a reagent system for In Vitro diagnostic use. This reagent system is composed of one bottle of Wash Solution, one bottle of Methotrexate Antibody, one bottle of Methotrexate Fluorescein Tracer and one bottle of Pretreatment Solution, Recall # Z-1056-2007
REASON: Incorrect configuration: kits contain reagent bottles in the order S-W-T-P instead of the correct order, W-S-T-P.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 18, 2007

CLASS II
MANUFACTURER: Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone beginning on May 22, 2007 and by follow-up letters sent between May 23, 2007 and June 14, 2007. Manufacturer: Avalon Laboratories Inc., Rancho Dominguez, CA. Firm initiated recall is ongoing.
PRODUCT
a) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567, Recall # Z-0874-2007;
b) Terumo TenderFlow Pediatric Arterial Cannulae, 2.0mm (6Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813568, Recall # Z-0875-2007;
c) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569, Recall # Z-0876-2007;
d) Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813570, Recall # Z-0877-2007;
e) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3 mm (10Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813571, Recall # Z-0878-2007;
f) Terumo TenderFlow Pediatric Arterial Cannulae, 3.3mm (10 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813572, Recall # Z-0879-2007;
g) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0 mm (12 FR) OD, with 1/4 inch ventedconnector, 9 inch (22.9 cm) long; Catalog no. 813573, Recall # Z-0880-2007;
h) Terumo TenderFlow Pediatric Arterial Cannulae, 4.0mm (12 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813574, Recall # Z-0881-2007;
i) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7 mm (14Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813575, Recall # Z-0882-2007;
j) Terumo TenderFlow Pediatric Arterial Cannulae, 4.7mm (14 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813576, Recall # Z-0883-2007;
k) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3 mm (16 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813577, Recall # Z-0884-2007;
l) Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578, Recall # Z-0885-2007
REASON: The bond may fail and a leak or separations of the device occur at the distal end (where this device connects to the arterial line).

MANUFACTURER: Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH, by telephone and letter dated April 27, 2007. Manufacturer: Abbott Ireland, Sligo, Ireland. Firm initiated recall is ongoing.
PRODUCT
Patrol enteral pump set with piercing pin, list #520540, Recall # Z-0888-2007
REASON: The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on July 6, 2007. Firm initiated recall is ongoing
PRODUCT
a) GEHC OEC 9900 ESP-15 Elite C-Arm fluoroscopic X-ray system, Recall # Z-0989-2007;
b) GEHC OEC 9800 ESP-15 C-Arm fluoroscopic X-ray system, Recall # Z-0990-2007
REASON: The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.

MANUFACTURER: Ev3, Inc., Plymouth, MN, by letter on May 18, 2007. Firm initiated recall is ongoing.
PRODUCT: Amplatz Goose Neck Snare Kit, 6 Fr, REF: GN3000, Sterile EO ev3. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter, Recall # Z-0992-2007
REASON: Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.

MANUFACTURER: The Anspach Effort, Inc., Palm Beach Gardens, FL, by letter on May 18th, 2007. Firm initiated recall is ongoing
PRODUCT: Anspach Single Use, Sterile Bone Cutting Burrs, Recall # Z-1008-2007
REASON: The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by letter dated April 23, 2007. Firm initiated recall is ongoing
PRODUCT
a) AxSYM Troponin-I ADV Reagent Pack; list 02J44-20; 100 test pack; in-vitro diagnostic; Recall # Z-1023-2007;
b) AxSYM Toxo IgG Reagent Pack; list 03B22-22; 100 test pack; an in vitro diagnostic; Recall # Z-1024-2007;
c) AxSYM Rubella IgG Reagent Pack; list 03B23-20; 100 test pack; an in vitro diagnostic; Recall # Z-1025-2007;
d) AxSYM CA 125 Reagent Pack; list 03B41-22; 100 test pack; an in vitro diagnostic; Recall # Z-1026-2007;
e) AxSYM CA 15-3 Reagent Pack; list 03B42-22; 100 test pack; an in vitro diagnostic; Recall # Z-1027-2007;
f) AxSYM AUSAB Reagent Pack; list 03C74-20; 100 test pack; in-vitro diagnostic; Recall # Z-1028-2007;
g) AxSYM Folate Reagent Pack; list 03C81-20; 100 test pack; in-vitro diagnostic; Recall # Z-1029-2007;
h) AxSYM Myoglobin Reagent Pack; list 03E43-20; 100 test pack; in-vitro diagnostic; Recall # Z-1030-2007;
i) AxSYM Toxo IgM Reagent Pack; list 04B25-22; 100 test pack; in-vitro diagnostic; Recall # Z-1031-2007;
j) AxSYM Rubella IgM Reagent Pack; list 04B46-20; 100 test pack; in-vitro diagnostic; Recall # Z-1032-2007;
k) AxSYM CMV IgG Reagent Pack; list 04B47-20; 100 test pack; in-vitro diagnostic; Recall # Z-1033-2007;
l) AxSYM Anti-HCV Reagent Pack; list 05C36-20; 100 test pack; in-vitro diagnostic; Recall Z-1034-2007;
m) AxSYM CMV IgM Reagent Pack; list 05C78-20; 100 test pack; in-vitro diagnostic; Recall Z-1035-2007;
n) AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20-20; 100 test pack; in-vitro diagnostic; Recall Z-1036-2007;
o) AxSYM CORE 2.0 Reagent Pack; list 08B88-20; 100 test pack; in-vitro diagnostic; Recall # Z-1037-2007;
p) AxSYM CORE-M 2.0 Reagent Pack; list 08B89-20; 100 test pack; in-vitro diagnostic; Recall # Z-1038-2007;
q) AxSYM HAVAB 2.0 Reagent Pack; list 08D21-20; 100 test pack; in-vitro diagnostic; Recall # Z-1039-2007;
r) AxSYM HBsAg Reagent Pack; list 09B01-20; 100 test pack; in-vitro diagnostic;Recall # Z-1040-2007
REASON: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxSYM instrument.

MANUFACTURER: Lifescan, Inc., Milpitas, CA, by letters and web postings on April 23, 2007. Firm initiated recall is ongoing
PRODUCT: OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems:
a) OneTouch Ultra,
b) OneTouch InDuo,
c) OneTouch Ultra2,
d) OneTouch UltraMini,
e) OneTouch UltraSmart. 25 strips per vial. Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order), Recall # Z-1042-2007
REASON: Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.

MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by “Safety Notice" dated January 24, 2007. Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
PRODUCT
a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular), Recall # Z-1043-2007;
b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System), Recall Number: Z-1044-2007
REASON: Caution on the non-detection of small invasive objects/devices, which project out from the skin surfaces (e.g. biopsy or other needles) while using the Innova Sense software option designed for patient contouring. Usage of Innova Sense patient contouring for such devices could potentially lead to patient injury.

MANUFACTURER: Wallach Surgical Devices, Inc., Orange, CT, by fax or email on June 6, 2007 with follow-up telephone calls. Firm initiated recall is ongoing
PRODUCT
a) Wallach Cryotip T-00337 Anorectal Tip used with the Cryosurgical LL100 or LL50X Cryosurgical Systems Reference: 900218, Recall # Z-1045-2007;
b) Wallach Cryotip T-00337 Anorectal Tip, teflon Coated used with the Cryosurgical LL100 or LL50X Reference: 900220, Recall # Z-1046-2007
REASON: The tip may separate from the probe.

MANUFACTURER: Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by letter dated April 5, 2007. Manufacturer: Boston Scientific Corporation CRM Ireland, Clomel, Tipperary, Ireland
PRODUCT
a) Contak Renewal 3 (model H170, H175) Contak Renewal 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D), Recall # Z-1047-2007;
b) These models are not available in the US. Contak Renewal 4 (model H190, H195). Contak Renewal 4 HE (model H197, H199) Cardiac Resynchronization Therapy
Defibrillator (CRT-D), Recall # Z-1048-2007;
c) Contak Renewal; 3 RF (model H210, H215), Contak Renewal; 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D), Recall # Z-1049-2007;
d) These models are not available in the US. Guidant CONTAK RENEWAL 4 RF/HE (model H230, H235) Guidant CONTAK RENEWAL 4 RF HE (model H239)
cardiac resynchronization therapy defibrillator (CRT-D), Recall # Z-1050-2007;
e) These models are not available in the US. CONTACT RENEWAL 4 AVT HE
(model number M170, M175, M177, M179). Cardiac Resynchronization Therapy Defibrillator, Z-1051-2007;
f) Vitality AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies, Recall # Z-1052-2007;
g) Vitality 2 (model T165, T175), Vitality DS (model T125, T135), Vitality EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies
include both low- and high-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing),
and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing), Recall # 1053-2007
h) Vitality DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. This ICD is designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-eneergy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. The device offers dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), Recall # Z-1054-2007;
i) VITALITY 2 EL DR/VR (model T167, T177). Contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias. Recall # Z-1055-2007;
REASON: Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.

MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters on April 10, 2007. Firm initiated recall is ongoing.
PRODUCT
a) AxSYM Total B-hCG Reagent List 7A59-21 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B-hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-21. 100 Tests. For In Vitro Diagnostic Use, Recall # Z-1067-2007;
b) AxSYM Total B-hCG Reagent List 7A59-22 is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti- B- hCG Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. REF 7A59-22. 100 Tests. For In Vitro Diagnostic Use, Recall # Z-1068-2007;
c) IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent, Recall # Z-1069-2007;
d) Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent
containing animal serum, Recall # Z-1070-2007
REASON: An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yielding false positive results for pregnancy and or Dilution Inaccuracy.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letter on May 2, 2007. Firm initiated recall is ongoing
PRODUCT: Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D, Recall # Z-1074-2007
REASON: The wedge tray may slip out of the Clinac interface mount during gantry rotation.

MANUFACTURER: Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letters dated June 1, 2007. Manufacturer: Cardinal Health-Medical Products and Services, Riverside, CA. Firm initiated recall is ongoing.
PRODUCT: AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Catalog Number 006900, Firmware Version 2.02, Recall # Z-1075-2007
REASON: Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance.

MANUFACTURER: Recalling Firm: Ossur, Reykjavik, Iceland, by letter on April 2, 2007. Manufacturer: Ossur Engineering, Inc., Albion, MI. Firm initiated recall is ongoing
PRODUCT: Ossur Total Knee Model Number 2100, external knee prosthesis, Recall # Z-1076-2007
REASON: Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.

MANUFACTURER: Dental Equipment LLC, Newberg, OR, by telephone on May 1, 2007. Firm initiated recall is complete.
PRODUCT: DCI Equipment Track Mount Light Assembly, 110v, Dental Lights, Recall # Z-1077-2007.
REASON: Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.

CLASS III
MANUFACTURER: Recalling Firm: Wako Chemicals USA, Inc., Richmond, VA, by fax on March 30, 2007 and April 26, 2007. Manufacturer: Wako Pure Chemical Industries Ltd., Osaka, Japan. Firm initiated recall is ongoing.
PRODUCT: NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use***, Recall # Z-1071-2007
REASON: Diagnostic reagent for clinical laboratory testing was incorrectly labeled.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 11, 2007

CLASS I
MANUFACTURER: Bayer Healthcare LLC, Mishawaka, IN, by telephone on June 6, 2007 and by e-mail on June 12, 2007. Firm initiated recall is ongoing.
PRODUCT: Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A, Recall # Z-1001-2007.
REASON: Incorrect Unit of Measure displayed: The meters report results in the wrong unit of measurement for Canadian users.

CLASS II
MANUFACTURER: Carestream Health, Inc., Rochester, NY, by field service representative visit beginning on March 6, 2007. Firm initiated recall is complete.
PRODUCT: Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386, Recall # Z-0717-2007.
REASON: The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).

MANUFACTURER: Carestream Health, Inc., Rochester, NY, by field service representative visit beginning on March 6, 2007. Firm initiated recall is complete.
PRODUCT: Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary X-Ray System. Device Listing # E222512, Recall # Z-0738-2007.
REASON: The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on June 12, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) GE OEC 9900 Elite Fluoroscopic X-ray System, Recall # Z-0848-2007;
b) GE OEC 9800 Fluoroscopic X-ray System, Recall # Z-0849-2007;
c) GE OEC 8800 Fluoroscopic X-ray System, Recall # Z-0850-2007;
d) GE OEC 6800 Fluoroscopic X-ray System, Recall # Z-0851-2007;
e) GE OEC 2800 mobile Fluoroscopic X-ray System, Recall # Z-0852-2007
REASON: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letter on March 13, 2007. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
PRODUCT: STA Liatest VWF:Ag, Product Catalog Number : 0518. This is a Immuno-Turbidimetric Assay of von Willebrand Factor, Recall # Z-0853-2007.
REASON: A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by Safety Alert letters on March 30, 2007. Firm initiated recall is ongoing.
PRODUCT
a) LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics, Recall # Z-0886-2007;
b) Batteries used with the LIFEPAK 20 defibrillator/monitor. Battery Product Part Number: 3200497-000, Recall # Z-0887-2007
REASON: Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 24, 2007. Firm initiated recall is ongoing.
PRODUCT: OEC Miniview 6800 mobile fluoroscopic x-ray system, Recall # Z-0928-2007.
REASON: X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures.

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter on June 6, 2007. Firm initiated recall is ongoing.
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-0929-2007;
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-0930-2007.
REASON: System 1 power supply may electrically short to the main console, disrupting normal system operation by causing unexpected re-setting or shutdown of pumps and modules, false alarms and/or overheating and failure of the central control monitor.

MANUFACTURER: Abbott Diagnostic International, LTD., Barceloneta, PR, by letters on April 11, 2007. Firm initiated recall is ongoing.
PRODUCT: IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer, Recall # Z-0958-2007.
REASON: A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).

MANUFACTURER: Invacare Corp., Elyria, OH, by letter dated March 19, 2007. Firm initiated recall is ongoing.
PRODUCT: Invacare Storm TDX Power Wheelchair, Models: # TDX3-PS, TDX3-SE-PS, TDX4-PS, Recall # Z-0966-2007.
REASON: Software error may permit the chair to recline too far.

MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated June 22, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
PRODUCT: SafeClinitubes, REF 942-892, D957P-70-100x1, contained in kits containing 250 SafeClinitubes, insert, mixing wires and end caps. Capillary samplers for drawing small amounts of blood for blood gas analysis, Recall # Z-0975-2007.
REASON: The clinitubes are not able to be filled due to contamination with silicone during production.

MANUFACTURER: Philips Medical Systems, Bothell, WA, by letters dated April 23, 2007. Firm initiated recall is ongoing.
PRODUCT: HDllXE Diagnostic Ultrasound System, Recall # Z-0987-2007.
REASON: Potential for erroneous measurements which may lead to incorrect diagnosis based upon the presence of an inaccurate, undetectable error in clinical measurement or calculation. If the user exits an imaging mode while Active Annotation is in use, the system can enter an undefined state where the image scale calibration may not match the scale of the on-screen measurements and graphics and possibly leading to erroneous measurements that may be off by plus or minus 10-50 percent.

MANUFACTURER: Recalling Firm: Smiths Medical PM, Inc., Waukesha, WI, by telephone between May 10 and May 24, 2007. The end users were also mailed on May 21, 2007. Manufacturer: SIMS Pneu Pac, Ltd., Luton, Beds, United Kingdom. Firm initiated recall is ongoing.
PRODUCT: Pneupac VR1 Standard and VR1 Responder are hand held portable, time cycled, gas powered, flow generator ventilator resuscitators that are intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and for intra- and inter- hospital transport, Recall # Z-0991-2007.
REASON: Smiths Medical is conducting a recall of 93 Pneupac VR1 Emergency & Transport Ventilators following the identification of a problem which may exist with the demand valve that could cause the ventilator to stop cycling & to deliver continuous flow output to the patient.

MANUFACTURER: Oasis Medical, Inc., Glendora, CA, by letter on June 8, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Premier Edge MVR 19g Microsurgical Knife, Item PE-3519, Recall # Z-0995-2007;
b) Premier Edge MVR 20g Microsurgical Knife, Item PE-3520, Recall # Z-0996-2007;
c) Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A, Recall # Z-0997-2007;
d) Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020, Recall # Z-0998-2007
REASON: This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

MANUFACTURER: Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Minneapolis, MN, by letters on February 12, 2007. Manufacturer: Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland. Firm initiated recall is ongoing.
PRODUCT
a) Vitatron C-Series dual chamber Rate Responsive Pacemakers (C60DR) includes the following models: C60A1 and C60A3 for US distribution and C50A1, ..A2, A3, C60A2 for international distribution (the single chamber is not involved). C-series software is VSF11/VSF12 Version 1.0. Recall # Z-0999-2007;
b) Vitatron T-Series Dual Chamber pacemaker T60 DR (model T60A1) for US distribution (the single chamber is not involved) and the T70A1 for internationally distribution. T-Series software VSF07/VSF08 Version 1.2, Recall Z-1000-2007
REASON: Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated June 22, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402, Recall # Z-1002-2007;
b) Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407;Recall # Z-1003-2007;
c) Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395, Recall # Z-1004-2007;
d) Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States), Recall # Z-1005-2007
REASON: Roller Pump: Due to a circuit board malfunction the roller pumps may stop during use without displaying an error message, may stop during use with an overspeed error posted on the local display, or may fail to start/restart resulting in the pump(s) being non-functional.

MANUFACTURER: Recalling Firm: Resmed Corporation, Poway, CA, by letter and press release on April 23, 2007. Manufacturer: ResMed Ltd., Bella Vista, NSW, Australia. Firm initiated recall is ongoing.
PRODUCT: ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007, Recall # Z-1006-2007.
REASON: S8 devices manufactured between July 2004 and May 15, 2006 are susceptible to fatigue in the connection of the AC appliance inlet connector and the power supply (power cord) leading to possible failure (short circuit, electrical failure, sparks, smoke).

MANUFACTURER: Medtronic MiniMed, Northridge, CA, by letters on April 24, 2007. Firm initiated recall is ongoing.
PRODUCT: Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall # Z-1007-2007
REASON: Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemia.

MANUFACTURER: Brainlab AG, Kirchheim B. Muenchen, Germany, by letter dated June 4, 2007 and by e-mail on June 5, 2007. Firm initiated recall is ongoing.
PRODUCT: BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; catalog/version number 40700-3A, Recall # Z-1010-2007
REASON: Target Alignment Error. A mechanical component/software incompatibility caused by a specific combination of the BrainLAB Target Positioner version 40700-3A for Leksell headrings and BrainLAB planning software resulted in a 1.25 mm shift in target area alignment during radiosurgery treatment.

MANUFACTURER: Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on May 15, 2007. Manufacturer: Inpeco Spa, Segrate, Italy. Firm initiated recall is ongoing.
PRODUCT: ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01, Clinical Laboratory Workstation, Recall # Z-1041-2007.
REASON: Product's hinged lid can fall, if not fully opened as designed, representing a potential injury hazard to the operator.

CLASS III
MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated June 6, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040, Recall # Z-0923-2007;
b) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041, Recall # Z-0924-2007
REASON: A belt slip message may be displayed on the roller pump due to low belt tension or the presence of grease.

MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated June 6, 2007. Firm initiated recall is ongoing.
PRODUCT:
a) Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041, Recall # Z-0931-2007;
b) Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040,Recall # Z-0932-2007
REASON: The tube clamp mechanism on the roller pump may not open when the rotation knob is turned, making it difficult to remove and/or insert tubing.

MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on March 30, 2007. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall isongoing.
PRODUCT: STA Neoplastine CI Plus (10), (cat. 0667). 12 x 10 ml. in vitro diagnostic for the determination of prothrombin time (PT), Recall # Z-0979-2007.
REASON: Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

MANUFACTURER: Medispectra, Inc., Lexington, MA, by telephone on May 15, 2007 and follow-up letter. Firm initiated recall is complete.
PRODUCT: MediSpectra Luma Cervical Imaging System, Model number: 3-02600, Recall # Z-0988-2007
REASON: Power supply may fail and render the unit inoperable.

MANUFACTURER: Biomet, Inc., Warsaw, IN, by letters dated June 11, 2007 and June 13, 2007. Firm initiated recall is ongoing.
PRODUCT
a) Graft Preparation System, sterile, single use, disposable; REF 800-0300,Recall # Z-0993-2007;
b) Vortech Graft Preparation System, sterile, single use, disposable; REF 800-0300V. (Not sold in the United States), Recall # Z-0994-2007.
REASON: The syringe assembly has an obstruction in the tube that prevents the plunger from being depressed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 4, 2007
CLASS II
MANUFACTURER: Oasis Medical Inc., Glendora, CA, by letter on April 9, 2007. Firm initiated recall is ongoing
PRODUCT
a) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A – Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Disposable Bimanuals Irrigation/Aspiration Set, 19g, Open End; Item #1719-S
Disposable Bimanuals Irrigation/Aspiration Set, 19g, Dual Port, Smooth. For use in cataract surgical procedures, Recall # Z-0740-2007;
b) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A – Disposable Bimanual Aspiration Handpiece 20g; Item #1720-I Disposable Bimanuals Irrigation/Aspiration Set 20g, Open End; Item #1720-S Disposable Bimanuals Irrigation/Aspiration Set, 20g, Dual Port, Smooth. For use in cataract surgical procedures, Recall # Z-0741-2007;
c) Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A – Disposable Bimanual Aspiration Handpiece 21g; Item #1721-I Disposable Bimanuals Irrigation/Aspiration Set, 21g, Open End; Item #1721-S Disposable Bimanuals Irrigation/Aspiration Set, 21g, Dual Port, Smooth. For use in cataract surgical procedures, Recall # Z-0742-2007
REASON: Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

MANUFACTURER: Recalling Firm: Medtronic Cardiac Surgery Technologies, Minneapolis, MN, by letter on February 8, 2007. Manufacturer: Medtronic Mexico EG, Empame, Sonora, Mexico. Firm initiated recall is ongoing.
PRODUCT: Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices, Recall # Z-0968-2007.
REASON: Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.

MANUFACTURER: Recalling Firm: Fisher & Paykel Healthcare Inc, Irvine, CA, by letter on December 4, 2006. Manufacturer: Fisher & Paykel Healthcare Ltd, Auckland, New Zealand. Firm initiated recall is ongoing.
PRODUCT
a) Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks, Recall # Z-0969-2007;
b) Fisher & Paykel Aclaim Nasal Mask, Part Numbers: HC401A & 900HC401. CPAP masks, Recall # Z-0970-2007;
c) Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks, Recall # Z-0971-2007;
d) Fisher & Paykel Infinity Direct Nasal Mask, Part Numbers: HC481A & HC481SL. CPAP masks, Recall # Z-0972-2007;
e) Fisher & Paykel Oracle Oral Mask, Part Numbers: 900HC451, 900HC451T, HC451A, HC452A & HC452F. CPAP masks, Recall # Z-0973-2007;
f) Fisher & Paykel Spares CPAP Mask and Connectors, Part Numbers: 400HC202 (Elbow non-diffuser holes),400HC203 (Elbow + vent NR valve), 400HC209 (Oracle 452 flexitube kit vent NR), 400HC502 (HC407 mask no headgear), 400HC503 (HC431 mask no headgear), 400HC505 (Infinity HC481 mask base), 400HCHC510 (HC406 mask no headgear) , 900HC402 (Aclaim mask no headgear), 900HC405 (HC405 sleep lab mask kit), 900HC406 (HC405 mask no headgear), 900HC412 (Aclaim flexitube kit), 900HC441 (Elbow diffuser and swivel) & 900HC463 (HC451 flexitube kit). CPAP masks, Recall # Z-0974-2997.
REASON: Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feature tab connectors and are not affected by this recall.

MANUFACTURER: Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated May 24, 2007. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
PRODUCT: Diamond Mammographic X-Ray System, type MGX-2000, model 5111771, Recall # Z-0976-2007.
REASON: GE Healthcare has become aware of the absence of thread-locking compound associated with the C-arm fasteners of your Diamond mammographic x-ray system that may impact patient safety.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated May 15, 2007. Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
PRODUCT: Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; Catalog no. 11875116122. in vitro diagnostic, Recall # Z-0977-2007
REASON: The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

MANUFACTURER: Recalling Firm: Varian Medical Systems Inc., Palo Alto, CA, by letter dated March 9, 2007. Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA. Firm initiated recall is ongoing
PRODUCT: LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1., Recall # Z-0978-2007.
REASON: A software anomaly in a medical device used for patient treatment could result in accidental or unintended radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.

MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letters dated April 2, 2007 and April 3, 2007. Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
PRODUCT: Proximate PPH, Procedure for Prolapse and Hemorrhoids Set, REF PPH03. Each set contains: 1 hemorrhoidal circular stapler, 1 suture threader, 1 circular anal dilator, and 1 purse string suture anoscope, Recall # Z-0980-2007.
REASON: The adhesive used to bond the casing of the device may have migrated to the staple driver. While the device still fires, it may result in audible and tactile feedback at the midpoint of the firing cycle which may be interpreted by some surgeons as a completed firing cycle, which may cause the surgeon to prematurely stop firing the device and result in incomplete staple formation or cut line.

MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated April 25, 2007 Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
PRODUCT:
a) Gyroscan MRI, Recall # Z-0981-2007;
b) Intera MRI, Recall # Z-0982-2007;
c) Achieva MRI, Recall # Z-0983-2007;
d) Panorama 1.0T MRI, Recall # Z-0984-2007,
REASON: Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

MANUFACTURER: Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on February 2, 2007. Manufacturer: Toshiba Medical Systems Corp., Tokyo, Japan. Firm initiated recall is ongoing.
PRODUCT
a) Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software, Recall # Z-0985-2007;
b) Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software, Recall # Z-0986-2007
REASON: When using the LV measurement function and making numerous measurements the value displayed on the image screen may on occasion not update correctly. The values that are stored in MDA (measurement display area) are correct and no issue has been reported with these values.

 
 

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