JANUARY 2004

WEEK ENDING JANUARY 3

PRODUCT Sonotrax Handheld Fetal Doppler Series and includes the Basic and Lite models. Product is a handheld fetal Doppler used to screen for fetal heart rate and averaged fetal heart rate.
CODE Product is uncoded.
RECALLING FIRM/MANUFACTURER Danatech Medical Systems Inc., Miami, FL.
REASON This prescription device, without an approved 510K, was distributed to unauthorized consumers, mostly pregnant women, on the internet.
VOLUME OF PRODUCT IN COMMERCE 89.
DISTRIBUTION Nationwide.

PRODUCT

a)Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion.

Reference: 8888-135192.
b) Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195.
CODE
a) Lot Number: 140885;
b) Lot Number: 140774.
RECALLING FIRM/MANUFACTURER Kendall Healthcare Products Co., Mansfield, MA.
REASON Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm.
VOLUME OF PRODUCT IN COMMERCE 55 catheters.
DISTRIBUTION IL, MA, OH, TN, TX, and VA.

WEEK ENDING JANUARY 10

PRODUCT Lorad M-IV and Lorad M-IV Platinum mammography systems. Mammographic X-Ray systems to conduct mammography.
Model Number: M-IV and M-IV Platinum.
CODE None.
RECALLING FIRM/MANUFACTURER Lorad, Danbury, Connecticut.
REASON System failed to meet the mAs accuracy specifications at low mAs values.
VOLUME OF PRODUCT IN COMMERCE 4,206.
DISTRIBUTION Nationwide.

WEEK ENDING JANUARY 17

PRODUCT HCMI operator control panels for chiropractic x-ray systems, Model #HF300, HF600, HF3SE, and HF3SEE.
CODE Serial numbers 108, 111, 140, 153, 160, 180, 214, 217, 238, 242, 246, 247, 251 thru 254, 256 thru 267, 269 thru 272, 275, 276, 279, 280, 283, 284, 287, 288, 289, 302 thru 318, 321, 322, 323, 330 thru 334, 352, and 1001 thru 1407.
RECALLING FIRM/MANUFACTURER Health Care Manufacturing, Inc., Springfield, MO.
REASON Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels.
VOLUME OF PRODUCT IN COMMERCE 476 units.
DISTRIBUTION Nationwide.

PRODUCT
a) SurgAssist System Circular Stapler DLU 29mm.
b) SurgAssist System Circular Stapler DLU 33mm.
CODE
a) Product Code CS29, Lot numbers LC-000125, LC000126, LC-000127, LC-000131, LC-000132, LC-000133, LC-000137, LC-000139, LC-000139-1, LC-000142, and LC-000143;
b) Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144.
RECALLING FIRM/MANUFACTURER Power Medical Interventions, New Hope, PA.
REASON Improper staple formation or anvil jam.
VOLUME OF PRODUCT IN COMMERCE 1,514 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Spacelabs flat panel monitor, Model 91415-A.
CODE Date code range: 0001xx through 0152xx. All defective power supplies fall within the date code of week 1, 2000 and week 52, 2001. The date code can be found on the underside of the power supply, embossed at the top of the text. It will be in the format of 0108A3, which means "01" is the year 2001, "08" is week 8 and "A3" is the line A3.
RECALLING FIRM/MANUFACTURER Datex-Ohmeda, Inc., Issaquah, WA.
REASON Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.
VOLUME OF PRODUCT IN COMMERCE 2,734 units Nationwide and 1,099 units Internationally.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Digital Diagnost VE.
b) Philips Digital Diagnost VT.
CODE
a) Site numbers: 82652, 82681, 82723, 82730, 83073, 85495, 85696, 85697, 85698, 86222, 86382, 86383, 86987, 86988, 100572, 100806, 101933, 102030, 102100, 102115, 102116, 102117, 102489, 102539, 102596, 102713, 102717, 102719, 102787, 102905, 103109, 103165, 103262, 103271, 103272,
103436, 103437, 103438, 103439, 103453, 103511, 103778, 103893, 103894, 103953, 103971, 103976, 104014, 104338, 104465, 104578, 104673, 104676, 104864, 104902, 104903, 104904, 104937, 104938, 105158, 105198, 105199, 105322, 105367, 105415, X1641, X1642, X1650, X1767, X1768.

The firm uses site numbers instead of serial numbers.
b) See list above. Site numbers could not be separated by model.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales & Service Region No. American, Bothell, WA.
REASON The support chain attachment on the detector carriage may fail and cause the counter weights or detector to fall.
VOLUME OF PRODUCT IN COMMERCE 70 devices.
DISTRIBUTION Nationwide.

PRODUCT Remel QC-Slide Gram Stain Control, Catalog #40142, packaged 45/box.
CODE Lot #001453, Exp. 2013-04-03.
RECALLING FIRM/MANUFACTURER Remel, Inc., Lenexa, KS.
REASON Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area.
VOLUME OF PRODUCT IN COMMERCE 25 boxes.
DISTRIBUTION Nationwide.

PRODUCT The AXSYM System, Clinical Chemistry Analyzer.
CODE Lot Number: 07A83-01, 07A083-03, 07A83-95, 07A83-98; All serial numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.
VOLUME OF PRODUCT IN COMMERCE 16,191.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
b) Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips.
CODE
a) 01143A, 01023A, 01173A, 01293A, 01293B, 01303A 01303B, 02263A, 02263B, 02273A, 02273B, 02273C, 03113A, 11182A, 12282A, 12302A, 03113A, 03213A, 03263A, 03283A, 03283B, 04153A, 05293B, 04153B, 05293C, 04213A, 05293A, 04303A, 06063A, 05293D, and 05303A;
b) Lots 01143A, 02263A, 03103A, 10222A, 12212A, 12312A, 03183A, 04293A, and 05273A.
RECALLING FIRM/MANUFACTURER Hypoguard USA, Inc., Edina, MN.
REASON When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
VOLUME OF PRODUCT IN COMMERCE 10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221; kits which include monitors and affected strips 10,670.
DISTRIBUTION Nationwide.

PRODUCT
a) Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4.
b) Package Insert for TDx/TDxFLx and TDxFLx Gentamicin Reagents, REF 9512, item numbers 34-1074/R3 and 69-5120/R2.
c) Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4.
d) Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4.
CODE
a) Reagent List 9515-60, lot 03492Q100 and Reagent List 9515-85, lot 04530Q100 that contain insert item number 69-5121/R4;
b) Reagent List 9512-60,lots 06313Q100, 01368Q101, 95380Q100, 93579Q100, 90107Q100; and Reagent List 9512-85, lots 06312Q100, 02010Q100, 96606Q100, 95106Q100, 90108Q100 that contain insert item numbers 34-1074/R3 or 69-5120/R2;
c) Reagent List 9500-60, lots 03136Q100, 92723Q102, 92723Q101, 92723Q100; and Reagent List 9500-85, lots 02285Q100, 92724Q100 that contain insert item number 69-5162/R4;
d) Reagent List 9523-60, lots 05105Q100, 03122Q100, 01649Q101, 01649Q100, 01179Q102, 01179Q101, 01179Q100;and Reagent List 9523-85, lots 05576Q100, 01742Q100, 96817Q100, 92749Q100 that contain insert item number 69-5726/R4.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON The package inserts contain incorrect values for the alternate unit (µmol/L) Control Ranges.
VOLUME OF PRODUCT IN COMMERCE 26,316 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Pediatric Air Aspirator Needle
CODE Part Number, 201015-000, Lot 278862.
RECALLING FIRM/MANUFACTURER Novosci Corp., The Woodlands, TX.
REASON The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.
VOLUME OF PRODUCT IN COMMERCE 200 units.
DISTRIBUTION TX. IL, and Germany.

PRODUCT Radiant Heater Door Vent for Ohmeda Medical's Giraffe (tm) OmniBed neonate bed.
CODE HDGDyyyyy HDGEyyyyy HDGFyyyyy HDGGyyyyy where "yyyyy" represents any number less than 60000.
RECALLING FIRM/MANUFACTURER Ohmeda Medical, A Division of Datex-Ohmeda, Inc., Laurel, MD.
REASON Heater vent door on neonatal incubator may malfunction.
VOLUME OF PRODUCT IN COMMERCE 1,404 beds.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient range adult to neonatal, memory function Approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hours, size: 42x68x20mm, weight 42g.
b) Pulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and
visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.
CODE
a) Model 3Si, Serial Nos: 22001453-22001469; 22001471-22001512; 22001514-22001599; 22001600-22001626; 22001628-22001632; 22001635-22001643; 22001645-22001651; 22001653-22001659; 22001661-22001676; 22001678-22001683; 22001685-22001686; 22001688-22001691; 22001712-22001714; 22001717-22001719; 22001721-22001723; 22001725; 22001727-22001732; 22001734-22001737; 22001740-22001745; 22001747-22001765; 22001767-22001770; 22001772; 22001776; 22001860; 22001862; 22001865; 22001868; 22001879; 22001881; 22001882; 22001885; 22001887;
22001893; 22001897; 22001899; 22001905.

b) Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
RECALLING FIRM/MANUFACTURER Minolta Corp., Ramsey, NJ.
REASON Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
VOLUME OF PRODUCT IN COMMERCE 300.
DISTRIBUTION UT.

PRODUCT Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units
are the same except for color.
CODE Serial Numbers: 9914-0820-0101 thru 9914-0820-0602 9914-0820-P2 9914-0820-P4 9914-0820-P5 9914-0820-P6.
RECALLING FIRM/MANUFACTURER Candela Laser Corp, Wayland, MA.
REASON Laser may pulse and not dispense cryogen resulting in patient injury.
VOLUME OF PRODUCT IN COMMERCE 506 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Guidant Brand VasoView(r) 5 Harvesting Cannula System, Model Number: VH-1000.
CODE Lot-- Exp Date: 3081371-- 7/2004, 3081471-- 7/2004, 3081571-- 7/2004, 3081871-- 7/2004, 3081972-- 7/2004, 3082071-- 7/2004, 3082171-- 7/2004, 3082271-- 7/2004, 3082272-- 7/2004, 3082571-- 7/2004, 3082671-- 7/2004, 3082772-- 7/2004, 3082871-- 7/2004, 3082972-- 7/2004, 3090271-- 8/2004, 3090371-- 8/2004, 3090471-- 8/2004, 3090571-- 8/2004, 3090871-- 8/2004, 3090971-- 8/2004, 3091072-- 8/2004, 3091171-- 8/2004, 3091271-- 8/2004, 3091571-- 8/2004, 3091671-- 8/2004, 3091771-- 8/2004, 3091871-- 8/2004, 3091971-- 8/2004, 3092271-- 8/2004, 3092372-- 8/2004, 3092471-- 8/2004, 3092571-- 8/2004, 3092671-- 8/2004, 3100271-- 9/2004.
RECALLING FIRM/MANUFACTURER Guidant Cardiac Surgery, Santa Clara, CA.
REASON VasoView(r) 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
VOLUME OF PRODUCT IN COMMERCE 2,597 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only.
CODE Lot no. 973H0589 Exp. date 2/2005.
RECALLING FIRM/MANUFACTURER Edwards Lifesciences Corp., of Puerto Rico, Anasco, PR.
REASON Lot is being recalled because some of the kits contain an incorrect guidewire.
VOLUME OF PRODUCT IN COMMERCE 315 UNITS.
DISTRIBUTION MD and DC.

WEEK ENDING JANUARY 24

PRODUCT
a) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
b) Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Vascular/Thin, Product #ATW35.
c) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD065.
d) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD063.
e) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.

f) FlexTray Procedure Delivery System Endopath Gynecology Tray, Product #FD064.
g) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KBW16.
h) FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #KNB21.
i) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL22.
j) General Laparoscopic Tray, Product #TGL33.
k) General Laparoscopic Tray, Product #TGL53.
l) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
m) FlexTray Procedure Delivery System Endopath Gynecololgy Tray, Product #FN065.
n) FlexTray Procedure Delivery System Endopath Gastric Tray, Product #KGB11.
o) FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL45.
CODE
a) Lot Numbers: T4VP02, T4VU1R, T4VV8G, T4VY38, T4W14P, T4W31X, T4W40L, T4W49R, T4W78J, T4W94K, T4W94L, T4WD1Z,
T4WE79, T4WG29, T4WH7T, T4WP20, T4WP6M, T4WR1U, T4WV5C, T4WV5D, T4WX38, T4WY96, T4WY9P, T4WZ5H, T4X06W, T4X19X,
T4X19Y, T4X21T, T4X54V, T4X84D, T4XC4X, T4XC4Y, T4XD42, T4XD46, T4XE9P, T4XF1L, T4XM0T, T4XM0U, T4XN1K, T4XV2R,
T4XV2T, T4XW1U, T4XW1V, T4XZ65, T4Y28Z, T4Y465, T4Y466, T4Y77P, T4Y801.
b) Lot Numbers: T4VM9R, T4VN0R, T4VNOX, T4VP71, T4VR0U, T4VR3F, T4VR8Z, T4VT68, T4VT75, T4VU1Z, T4VV8U, T4VW33,
T4VW34, T4VW7F, T4VW97, T4VX7P, T4VX7R, T4W03T, T4W11A, T4W11X, T4W188, T4W189, T4W31Y, T4W66N, T4W66T, T4W67V,
T4W70V, T4W86G, T4W86H, T4W86N, T4WA3R, T4WA6T, T4WA9Z, T4WD68, T4WD6L, T4WD6M, T4WG04, T4WG05, T4WG4K, T4WG6T, T4WG90, T4WH0K, T4WH5J, T4WH5X, T4WH7N, T4WH9G, T4WK6Z, T4WK70, T4WL2U, T4WM6V, T4WN19, T4WN2K, T4WT0F, T4WT0G, T4WU2P, T4WU4L, T4WU5G, T4WU9W, T4WV7E, T4WV8X, T4WX7E, T4WY7P, T4WY7R, T4WZ62, T4X11U, T4X15M, T4X16G, T4X27L, T4X28X, T4X35P, T4X367, T4X46T, T4X46U, T4X631, T4X634, T4X706, T4X707, T4X708, T4X78T, T4X83P, T4X904, T4X905, T4X929, T4XA2Z, T4XA30, T4XC31, T4XE0A, T4XE20, T4XE21, T4XE8Z, T4XE9M, T4XE9N, T4XG9Y, T4XG9Z, T4XH00, T4XH01, T4XK06, T4XK08, T4XK09, T4XM47, T4XM48, T4XM7L, T4XN4Z, T4XN53, T4XN5N, T4XR2N, T4XR2R, T4XT15, T4XU8W, T4XV2K, T4XV2N, T4XW40, T4XW79, T4XZ9L, T4Y01X, T4Y02U, T4Y16K, T4Y16L, T4Y16M, T4Y21N, T4Y21P, T4Y21R, T4Y26W, T4Y26X,
T4Y272, T4Y39G, T4Y39L, T4Y634, T4Y635, T4Y636, T4Y75M, T4Y75N, T4Y75P, T4Y75R, T4Y75T, T4YA05, T4YA06, T4YC2K,
T4YC2M, T4YC2P;
c) Lot Numbers: T4W63C, T4WA2D, T4WD82, T4WT5U, T4Y19Z;
d) Lot Numbers: T4W23Y, T4WA33, T4WN15, T4WN5A, T4XY22, T4XZ1E;
e) Lot Numbers: T4VZ68, T4W30K, T4W881, T4WL7Z, T4WR5X, T4WT38, T4WY34, T4X38G, T4X52L, T4YC9J;
f) Lot Numbers: T4W19H, T4WN1J;
g) Lot Numbers: T4XD0F, T4XK71;
h) Lot Numbers: T4VT9K, T4Y61F;
i) Lot Numbers: T4VU41, T4VY0X, T4W345, T4W346, T4WY38, T4X059, T4X33K, T4YC9Z, T4YE00;
j) Lot Numbers: T4WF6D, T4WT8Y, T4X52J, T4Y03E;
k) Lot Numbers: T4WP5P;
l) Lot Numbers: T4YD0G;
m) Lot Numbers: T4VX78, T4WK0G, T4WL8T, T4XH6P, T4Y96L;
n) Lot Numbers: T4VN3C, T4W02R, T4W76M, T4WA05, T4WK2N, T4X33J.
o) Lot Numbers: T4WX67, T4X22Y, T4X95D, T4XG4C, T4XK7M, T4XM7U, T4XY24, T4Y32W.
RECALLING FIRM/MANUFACTURER Ethicon Endo-Surgery, Cincinnati, OH.
REASON A defective articulation band may result in improper staple formation with possible hematosis.
VOLUME OF PRODUCT IN COMMERCE 67,530 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT ISPAN patient bracelet, given to patients post surgery to warn of further use of dinitrogen monoxide.
CODE All lots of the German translated patient bracelets.
RECALLING FIRM/MANUFACTURER Alcon Laboratories, Inc., Fort Worth, TX.
REASON The patient bracelet that is given to patients post surgery after administering either ISPAN Perfluoropropane or ISPAN Sulfur Hexafluordie referred to the term, "stickoxid", which is the general term for nitrogen oxide and may be interpreted as either nitrogen monoxide (NO) or dinitrogen monxoide. The firm is recalling the old (blue) bracelets and replacing them with new (gray) bracelets that now reference the specific term dinitrogen monoxide N20 (laughing gas).
VOLUME OF PRODUCT IN COMMERCE 3,142.
DISTRIBUTION Germany, Switzerland, and Austria.

PRODUCT IMx Tacrolimus II Assay, list 3C10-20.
CODE All lot numbers.
RECALLING FIRM Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
VOLUME OF PRODUCT IN COMMERCE Unspecified.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Fix pins associated with Stealth Station Treatment Guidance Platform.
CODE 3" fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5" fix pin - 9730477, Lot numbers 200302140564, and 200303030641.
RECALLING FIRM/MANUFACTURER Medtronic Surgical Navigation Tech, Inc., Louisville, CO.
REASON Surgical devices intended for single use were not labeled for single use.
VOLUME OF PRODUCT IN COMMERCE 127 devices.
DISTRIBUTION CA, FL, GA, KS, TX, Belgium, France, Germany, Hong Kong, and Japan.

PRODUCT Calculator/Data Processing Module for Clinical Use.
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
VOLUME OF PRODUCT IN COMMERCE 485.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) 3M Attest 1264 Biological Indicators, in boxes of 100 per box.
b) 3M Attest 1264P Biological Indicators, in boxes of 25 per box.
CODE
a) Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07 DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and 2005-08 DO;
b) Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL.
RECALLING FIRM/MANUFACTURER 3m Health Care, Saint Paul, MN.
REASON The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
VOLUME OF PRODUCT IN COMMERCE 11,436 boxes (25 to 100 biologic indicators per box).
DISTRIBUTION Nationwide and Internationally.

PRODUCT Misys Laboratory System.
CODE Version 5.3 build 63 thru 6.3.2 and Lab Access Results.
RECALLING FIRM/MANUFACTURER Misys Healthcare System, Tucson, AZ.
REASON Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
VOLUME OF PRODUCT IN COMMERCE 125.
DISTRIBUTION Nationwide, Canada, Saudi Arabia, United Kingdom.

PRODUCT AEROSET/ARCHITECT c8000 Urea Nitrogen Models: 7D75-01; 7D75-20; 7D75-30.
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div, South Pasadena, CA.
REASON False low results may occur with out error codes due to substrate depletion in samples with more than 220mg/dL BUN.
VOLUME OF PRODUCT IN COMMERCE Information not available. 192 domestic consignees.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Phototherapy Lamp, Model 9001W501JE.
CODE The potentially affected lamps have serial numbers within the following ranges: 2000 SN 00501XXxxxxx SN 501XXxxxxx SN 2000-501XXxxxxx 2001 SN 2001-501XXxxxxx SN 01-xx xx xxxxxx 2002 SN 02 xx xx xxxxxx 2003 SN 03 xx xx xxxxxx.
RECALLING FIRM/MANUFACTURER Fisher & Paykel Healthcare, Inc., Laguna Hills, CA.
REASON Component placement presents risk of electrocution to patients.
VOLUME OF PRODUCT IN COMMERCE 88
DISTRIBUTION Nationwide.

PRODUCT VAMP Direct Draw, Model VMP700 Needleless cannula for sampling blood.
CODE Lot 58151473.
RECALLING FIRM/MANUFACTURER Edwards Lifesciences AG, Haina, San Cristobal, DO.
REASON Seal integrity, sterility not assured.
VOLUME OF PRODUCT IN COMMERCE 21,150.
DISTRIBUTION Nationwide.

PRODUCT Prolene Polyproplyene Mesh, 3" x 6", Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII;
CODE Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07 Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.
RECALLING FIRM/MANUFACTURER Cardinal Health, McGaw Park, IL.
REASON Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
VOLUME OF PRODUCT IN COMMERCE 365 boxes.
DISTRIBUTION Nationwide.

PRODUCT
a) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only.
Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack);
b) NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only.
Sold under the Welch Allyn "Tycos" and Allegiance "Tactics" labels. The "4" represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); Allegiance Tactics #30502-113 (case of 40/2 tubes); Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); Welch Allyn Tycos/Allegiance #5082-241-16.
CODE
a) Code dates between June 20, 2003 and October 8, 2003. (Codes found on the outer carton only.);
b) Code dates between June 20, 2003 and October 8, 2003. (Codes found on outer carton only.).
RECALLING FIRM/MANUFACTURER Welch Allyn, Inc., Skaneateles Falls, NY.
REASON Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
VOLUME OF PRODUCT IN COMMERCE 26,190 units.
DISTRIBUTION Nationwide, Singapore, Ireland, Australia, and South Africa.

PRODUCT Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: "PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON" Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website:
CODE The firm found in their inventory codes listed in the Ethicon notice of lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07).
RECALLING FIRM/MANUFACTURER Q-Med Corporation, Ft Lauderdale, FL.
REASON This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
VOLUME OF PRODUCT IN COMMERCE 1,250 boxes of six.
DISTRIBUTION VA, and IL.

PRODUCT
a) Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced).
b) Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously serviced).
CODE
a) Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L. Serial Numbers (SR prefix): 8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728 Part Number:
7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705;
b) Number: 7204614, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 15601 16920 16981 18031 18066 18111 18143 18276 18354 15603 16924 16982 18032 18067 18112 18147 18278 18355 15604 16927 16983 18033 18068 18113 18149 18282 18358 15605 16932 16985 18035 18069 18114 18157 18283 18359 15607 16933 16987 18036 18070 18116 18158 18284 18362 15606 16935 16988 18039 18071 18118 18168 18288 18363 15609 16936 16989 18040 18072 18119 18169 18289 18370 15612 16950 16990 18041 18073 18120 18177 18291 18382 15617 16951 16991 18042 18074 18121 18187 18292 18391 15622 16957 16992 18043 18075 18122 18188 18295 18399 15623 16958 16993 18044 18076 18123 18189 18296 18445 15626 16961 16994 18045 18077 18125 18198 18300 18460 15630 16962 17005 18046 18078 18126 18199 18301 18461 16697 16964 17006 18047 18079 18127 18200 18303 18462 16713 16965 17025 18048 18080 18128 18201 18304 18464 16719 16966 17029 18049 18084 18129 18203 18306 18469 16720 16967 17030 18050 18088 18130 18204 18307 18470 16722 16968 17045 18051 18093 18131 18205 18308 18471 16726 16969 17050 18052 18097 18132 18206 18309 18476 16729 16970 17052 18053 18098 18133 18207 18310 18477 16797 16971 17068 18054 18100 18134 18209 18315 18478 16891 16972 17069 18055 18101 18135 18210 18325 18479 16897 16973 17092 18056 18102 18136 18212 18326 18480 16898 16974 17100 18057 18103 18137 18219 18336 16899 16975 18000 18059 18104 18138 18239 18342 16907 16976 18001 18060 18105 18139 18258 18346 16914 16977 18024 18062 18107 18140 18266 18351 16915 16978 18029 18063 18108 18141 18269 18352 16916 16980 18030 18064 18110 18142 18275 18353 Part Number: 7204614S, Camera Coupler, C-Mount, 35mm F.L. Serial Numbers (QW prefix): 18034 18096 18160 18259 18297 18383 18416 18434 18453 18038 18099 18161 18260 18313 18384 18417 18435 18454 18058 18106 18162 18261 18314 18385 18418 18436 18455 18061 18109 18163 18262 18316 18386 18419 18437 18456 18065 18115 18164 18263 18323 18393 18420 18438 18457 18081 18144 18165 18264 18324 18394 18421 18439 18458 18082 18145 18166 18267 18333 18395 18422 18440 18459 18083 18146 18167 18270 18334 18402 18423 18441 18463 18085 18148 18170 18272 18335 18403 18424 18442 18465 18086 18150 18171 18273 18344 18404 18425 18443 18466 18087 18151 18172 18274 18345 18405 18426 18444 18467 18089 18152 18231 18277 18356 18408 18427 18446 18472 18090 18153 18232 18279 18364 18411 18428 18447 18473 18091 18154 18246 18285 18366 18412 18429 18448 18474 18092 18155 18250 18287
18373 18413 18430 18450 18475 18094 18156 18256 18293 18374 18414 18431 18451 18095 18159 18257 18294 18376 18415 18433 18452.
RECALLING FIRM/MANUFACTURER Smith And Nephew, Inc., Endoscopy Division, Andover, MA.
REASON Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
VOLUME OF PRODUCT IN COMMERCE 447 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x 6", each mesh in a sealed pouch
package, 6 packages per papercard carton.
CODE All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
RECALLING FIRM/MANUFACTURER McKesson General Medical Corporation, Richmond, VA.
REASON Counterfeit product is an unapproved medical device with associated potential health hazard.
VOLUME OF PRODUCT IN COMMERCE 180 cartons (6 each/carton).
DISTRIBUTION Nationwide.

PRODUCT Solar 9500 Information Monitor.
CODE Software version 3A.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee, WI.
REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
VOLUME OF PRODUCT IN COMMERCE Maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Version. 3A software were manufactured plus 131 software update kits to update multiple).
DISTRIBUTION Nationwide.

PRODUCT PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3"x6", each mesh in a sealed pouch
package, 6 packages per papercard carton. ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***
CODE Lots RBE609 EXP 1/07, RJJ130 EXP7/07.
RECALLING FIRM/MANUFACTURER Owens & Minor Distribution, Inc., Glen Allen, VA.
REASON Counterfeit product is an unapproved medical device with associated potential health hazard.
VOLUME OF PRODUCT IN COMMERCE 423 cartons (6 meshes/carton).
DISTRIBUTION Nationwide.

PRODUCT
a) Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand and Quanta Technologies L.L.C. brand.
b) Irrigation aspiration system for Nexhat Dorsey type pumps with 33 cm probe and tubing, latex free, catalog # 55050. HYDRO-PRO brand.
c) Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflations tubing set 3- 5010 anti fog solution with sponge. Sterile.
single use. Quanta Technologies L.L.C. brand.
d) Auto Suture IRRIVAC MAX Suction irrigation system with 5 mm, 33 cm probe with double spike tubing. Sterile, single use. Catalog # 200-20. Tyco/Healthcare/United States Surgical brand.
CODE
a) Lot 50904994;
b) Lot 50904971;
c) Lot 994986;
d) Lots 50904937 and 50904995.
RECALLING FIRM/MANUFACTURER Vital Concepts, Inc., Grand Rapids, MI.
REASON The probe may separate from the cannula.
VOLUME OF PRODUCT IN COMMERCE 3,273
DISTRIBUTION AZ, IL, IN, MI, and PA.

PRODUCT
a) The ARCHITECT i2000, Clinical Chemistry Analyzer.
b) The ARCHITECT c8000, Clinical Chemistry Analyzer,
CODE
a) List number 3M74-01, all serial numbers;
b) List Number 1G06-01, all serial numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234).
VOLUME OF PRODUCT IN COMMERCE 371.
DISTRIBUTION TX, PA, SC, CA, IN, and Internationally.

PRODUCT CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
CODE Lot numbers: 207089, 209102, 02121321, 02171838, 02192048, 02212272, 02222332, 02242552, 02262741, 02272856, 02293066, 02313269, 02323381, 02333458, 02363752, 02383927, 02404141, 02414225, 02424507, 02434421, 02434520, 02444529, 02454627, 02454672, 02464725, 02474823, 02484921, 02505121, 03020326, 03040522, 03040669, 03060728, 03060803, 03060865, 03080924, 03101124, 03111222, 03131428, 03151624, 03171820, 03171998, 03192023, 03212226, 03212370, 03232422, 03242537, 03252628, 03262726, 03303276, and 03303313.
RECALLING FIRM/MANUFACTURER Bausch & Lomb, Inc., Rochester, NY.
REASON The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
VOLUME OF PRODUCT IN COMMERCE 2,500 six packs.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ.
CODE Lot numbers 548727, 548723, 544906, 542967, 542966.
RECALLING FIRM/MANUFACTURER Cardinal Health, McGaw Park, IL.
REASON The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile.
VOLUME OF PRODUCT IN COMMERCE 1,083 packs.
DISTRIBUTION GA, and AL.

PRODUCT Stryker brand Model 1550 Synergy Extended Stay Stretcher.
CODE All stretchers manufactured between 1/1/1993 and 11/07/2003.
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI.
REASON The user may be pinched by the siderail when raising or lowering the siderail.
VOLUME OF PRODUCT IN COMMERCE 3,903.
DISTRIBUTION Nationwide, Canada, Hong Kong, Israel, Mexico and Syria.

PRODUCT Bucky Diagnost FS Part number 9890-010-83651.
CODE Site numbers: 504495, 105355, 104447. The firm uses site numbers instead of serial numbers.
RECALLING FIRM/MANUFACTURER Philips Medical Systems Sales & Service Region No American, Bothell, WA.
REASON Support chain attachment on the Bucky carriage may fail and cause the counter weights or X-ray tube to fall.
VOLUME OF PRODUCT IN COMMERCE 3 devices.
DISTRIBUTION FL, NY, and CA.

PRODUCT IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20
(100 tests - reagents alone).
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing.
VOLUME OF PRODUCT IN COMMERCE 3,475 packs.
DISTRIBUTION Internationally.

PRODUCT Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack.
CODE Lot 611, Exp. 25 June 2004.
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY.
REASON Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
VOLUME OF PRODUCT IN COMMERCE 774 reagent packs.
DISTRIBUTION Nationwide and Canada.

PRODUCT MVP-10 Pediatric/ Neonatal Volume Ventilator.
CODE S/N: 3023031, 3025031, 0957951.
RECALLING FIRM/MANUFACTURER Bio-Med Devices, Inc., Guilford, CT.
REASON Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION ID, PA, and TX.

PRODUCT
a) Hill-Rom Newborn bassinet; model P247.
b) Hill-Rom Newborn bassinet; model P248.
CODE All units distributed between May 1989 and March 2001.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON The caster/wheel may come off of the bassinet, causing the bassinet to tip.
VOLUME OF PRODUCT IN COMMERCE 8,257.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Stryker brand Synergy extended stay stretcher; model 1050.
CODE All units.
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI.
REASON Users may be pinched in the side-rail assembly when raising or lowering the side-rail.
VOLUME OF PRODUCT IN COMMERCE 107.
DISTRIBUTION Nationwide and Colombia.

PRODUCT Performix X-ray Tube - Performix ADV, Performix Ultra, Solarix 630.

CODE Tube Catalog #'s D3132, D3172, D3182, and D3152 used on Gantry model #'s 2137130, 2137130-5, 2234921-3, 2260619, 2260619-3, 2281177, 2281177-2, 2281177-3, 2281177-4, 2305500, 2339985, 2341799, 2362605, and 5101272.
RECALLING FIRM/MANUFACTURER General Electric Med Systems, Waukesha, WI.
REASON Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.
VOLUME OF PRODUCT IN COMMERCE 400.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Eclipse Infusion Pump, 250 ml X 250 ml per hour) Part 5001247.
CODE Lot 262073.
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA.
REASON Slower than expected infusion of medications, such as antibiotics.
VOLUME OF PRODUCT IN COMMERCE 3,240.
DISTRIBUTION Nationwide.

PRODUCT Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120.
CODE Lot number 132185.
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA.
REASON Some pumps run at 2 ml/hr instead of 0.5 ml/hr.
VOLUME OF PRODUCT IN COMMERCE 950.
DISTRIBUTION France.

PRODUCT
a) Bard(r) Dimension(tm) Stone Basket, Rx only, Sterile.
b) Bard(r) Platinum Class(tm) II Flat Wire Stone Basket, Ureteral Stone Dislodger, Rx only, Sterile.
CODE
a) Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490;
b) Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.
RECALLING FIRM/MANUFACTURER C. R. Bard, Inc., Urological Division, Covington, GA.
REASON Product packaging may contain holes compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 12,684 units.
DISTRIBUTION Nationwide, Canada, Belgium and Japan.

PRODUCT VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase
Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle).
CODE Lot #777450001.
RECALLING FIRM/MANUFACTURER Biomerieux, Inc., Durham, NC.
REASON Kit may contain incorrect components.
VOLUME OF PRODUCT IN COMMERCE 329 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) AxSYM Tricyclic Antidepressants Reagent.
b) ADx Tricyclic Antidepressants Reagent.
c) TDx/TDxFLx Tricyclic Antidepressants Reagent.
CODE
a) Product list number: 3B34-20;
b) Product List number: 9681-55;
c) Product List number: 9681-60.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR.
REASON Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
VOLUME OF PRODUCT IN COMMERCE Information not provided. 532 domestic consignees.
DISTRIBUTION Nationwide.

PRODUCT
a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R.
b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.
c) Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
CODE All units with software version 5.61 or below.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
VOLUME OF PRODUCT IN COMMERCE 131.
DISTRIBUTION Nationwide.

PRODUCT
a) Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
b) Roche brand OMNI 2 Analyzer; catalog numbers GD0335 and GD0335R.
c) Roche brand OMNI 3 Analyzer; catalog numbers GD0355, GD0355R and GD035591.
d) Roche brand OMNI 4 Analyzer; catalog numbers GD0375 and GD0375R .
e) Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
f) Roche brand OMNI 6 Analyzer; catalog numbers GD0415, GD0415R and GD041591.
g) Roche brand OMNI 7 Analyzer; catalog numbers GD0435 and GD0435R.
h) Roche brand OMNI 8 Analyzer; catalog numbers GD0455 and GD0455R.
i) Roche brand OMNI 9 Analyzer; catalog numbers GD0475, GD0475R and GD047591.
CODE All units.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON The firm is withdrawing claims that pleural, pericardial, ascetic and cerebrospinal fluids are appropriate sample types for use on these instruments.
VOLUME OF PRODUCT IN COMMERCE 745.
DISTRIBUTION Nationwide.

PRODUCT Hill-Rom brand Century+ bed; model P1400.
CODE All beds distributed between August 3, 2003 and August 20, 2003.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON If fluid is spilled on the siderail or the bed control areas, the bed may change positions without user input.
VOLUME OF PRODUCT IN COMMERCE 222.
DISTRIBUTION Nationwide, Canada, Panama and Taiwan.

PRODUCT Hip Stem, Sterile Pkg. The implant consists of 2 metal components which fit together to form a femoral stem.
CODE Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931.
RECALLING FIRM/MANUFACTURER Plus Orthopedics, San Diego, CA.
REASON Design Change.
VOLUME OF PRODUCT IN COMMERCE 53.
DISTRIBUTION CA, AZ, NV, and CO.

PRODUCT
a) Baxter HomeChoice Automated PD Set with Lineo Connector, 4-prong, product codes R5C4479Q (English) and N5C4479Q (dual English/French label); 30 units per case.
b) Baxter Lineo Opticap Disconnect Cap, product codes R5C4599Q (English) and N5C4599Q (dual English/French label); 30 units per case. CODE
a) Product code R5C4479Q, lots H03J01492, H03J17027 and H03J24056 and product code N5C4479Q, lots H03I10114, H03I12078, H03J05030 and H03J15088.
b) Product code R5C4599Q, lots H03J02029 and H03J27067 and product code N5C4599Q, lots H03I18083, H03I23018 and H03J29022.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON Reports of loosening of the connections and disconnection of the device.
VOLUME OF PRODUCT IN COMMERCE 14,950 units.
DISTRIBUTION Canada and the United Kingdom.

PRODUCT
a) Invacare 2G Tarsys Seating System, Model 2GT.
b) Invacare 2G Tarsys Seating System, Model 2GR.
c) Invacare 2G Tarsys Seating System, Model 2GTR.
CODE
a) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
b) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
c) Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
RECALLING FIRM/MANUFACTURER Invacare Corporation, Elyria, OH.
REASON The weld joints on the seat back may fail and cause possible injury to the patient.
VOLUME OF PRODUCT IN COMMERCE 5,990 units.
DISTRIBUTION Nationwide, Canada, China, Oman, and West Indies.

PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors.
CODE Serial numbers PP80023 through PP80040 and PP037 through PP180.
RECALLING FIRM/MANUFACTURER Urologix, Inc., Minneapolis, MN.
REASON During treatment the Temperature Sensing System may change the rectal temperature reading by up to 2 degrees celcius and may briefly delay updates to the rectal temperature reading.
VOLUME OF PRODUCT IN COMMERCE 146.
DISTRIBUTION Nationwide, Australia, France, and Japan.

PRODUCT Platelia Aspergillus EIA.
CODE Lot number: 3F0001 Exp. 2004-05-15.
RECALLING FIRM/MANUFACTURER Bio Rad Laboratories, Inc., Redmond, WA.
REASON Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
VOLUME OF PRODUCT IN COMMERCE 147 kits.
DISTRIBUTION Nationwide.

PRODUCT
a) Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H.
b) Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a.
c) Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU.
d) Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8.
CODE
a) Lot 10830640 (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.);
b) Lot numbers: 10630840, 10230940, and 20230540. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04
or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.);
c) Lot numbers 10531140, 11230940, 20121440, and 21230140. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual units or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04 or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.);
d) Lot numbers: 20310140, 20910540, and 20910541. (All lot numbers having the last two digits ending in 40 or 41 and having the year of manufacture for individual unit or sterilization date for cases from 01 on a unit and 2001 on to case to 03 and 2003. Expiry year dates are 04
or 2004 to 06 or 2006. An example date is 01 03 09 on a unit which is read 2001 March 09 and for the case with the same date an example would be 2001 03 09.).
RECALLING FIRM/MANUFACTURER Toray Marketing & Sales (America), Inc., Houston, TX.
REASON Potential loose header (end cap) on hollow fiber dialyzers.
VOLUME OF PRODUCT IN COMMERCE 768 units.
DISTRIBUTION CA, NJ, FL, TX, OH, WI, NY, and WA.

PRODUCT ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0.
CODE Lots 94493M300 and 94493M301.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON The calibrator lots may yield Free T4 values that are depressed.
VOLUME OF PRODUCT IN COMMERCE 1,364 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Sure Temp Plus Model 690/692 Oral Temperature Probes.
CODE Welch Allyn(r) Part #s: 0690-XXX Serial Numbers/Lot Numbers 02692-000 Oral Probe 4 ft. 412003-442003, 472003, 522003-582003. 02692-100 Oral Probe 9 ft. 412003-442003, 472003, 522003-582003 02893-000 Oral Probe Well Kit 4 ft. 412003-442003, 472003, 522003-582003 02893-100 Oral Probe Well Kit 9 ft. 412003-442003, 472003, 522003-582003 Probes are contained in Welch Allyn(r) Thermometer Boxes with Part #s: 0690-XXX Serial Numbers/Lot Numbers 01690-000 03397655 - 03505486 01690-200 03397655 - 03505486 E-01690-200 03397655 - 03505486 01690-300 03397655 - 03505486 01690-400 03397655 - 03505486 01690-410 03397655 - 03505486 01690-500 03397655 - 03505486 E-01692-200 03397655 - 03505486 01692-200 03397655 - 03505486 01692-300 03397655 - 03505486 01692-400 03397655 - 03505486 01692-500 03397655 - 03505486 01692-700 03397655 - 03505486 Probes are contained in Welch Allyn(r) Vital Signs Monitor III boxes with Part Numbers: Serial Numbers/Lot Numbers 53NTO-E1 JA000244, JA000282, JA000283, JA000284, JA000285, JA000286, JA000287, JA000288, JA000289, JA000290, JA000291, JA000292, JA000293, JA000294, JA000295, JA000296, JA000297, JA000298, JA000299, JA000300, JA000301, JA000302, JA000303, JA000304, JA000305, JA000306, JA000307, JA000308, JA000309, JA000310, JA000311, JA000312, JA000313, JA000314, JA000315, JA000316, JA000317, JA000318, JA000319, JA000320, JA000331, JA000332, JA000333, JA000334, JA000335, JA000336, JA000337, JA000340, JA000341, JA000342, JA000343, JA000344, JA000345, JA000347, JA000348, JA000349, JA000352, JA000353, JA000354 53NTP-E1 JA000232, JA000243, JA000246, JA000255, JA000258, JA000259, JA000271, JA000278, JA000281, JA000326, JA000327, JA000328, JA000357.
RECALLING FIRM/MANUFACTURER Welch Allyn, Inc., San Diego, CA.
REASON Mechanical setting errors that result in calibration errors.
VOLUME OF PRODUCT IN COMMERCE 4,453.
DISTRIBUTION Nationwide.

PRODUCT Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.
CODE All lots are affected.
RECALLING FIRM/MANUFACTURER Abbott Laboratories Diagnostic Div, South Pasadena, CA.
REASON Complaints that instructions for use were not clear.
VOLUME OF PRODUCT IN COMMERCE 215.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. Model 7924. The product is shipped in cartons
containing 6 units.

CODE Lot number 200309 exp. 9/2005.
RECALLING FIRM/MANUFACTURER Boehringer Laboratories, Inc., Norristown, PA.
REASON Inadequate bond where the tube attaches to the inlet of the bulb.
VOLUME OF PRODUCT IN COMMERCE 273 units.
DISTRIBUTION Nationwide.

PRODUCT DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Drug Free Enterprises, Inc., Agoura Hills, CA.
REASON Lacks professional use labeling and firm name and address.
VOLUME OF PRODUCT IN COMMERCE 2,800.
DISTRIBUTION Nationwide.

PRODUCT
a) Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06520) Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card
and chart sticker. Kit sold individually or per case (5 trays/case)

b) Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510).Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle,
patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
c) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm
and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
d) Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: plastic port] Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling
instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
CODE
a) AP-06520 MF3074927 MF3075118 MF3085217 MF3085281 MF3095491 MF3095574 MF3095611;
b) AP-01510 MF3085292 MF3085315 MF3095551 MF3095651;
c) AP-06042 MF3075086 MF3075140 MF3085285;
d) AP-06022 MF3075080 MF3085227 MF3085410.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Mount Holly, NJ.
REASON The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
VOLUME OF PRODUCT IN COMMERCE 913.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software.
CODE Version 5.0A.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA.

REASON Accessory software fails to report certain reports following download of data from 712 pump.
VOLUME OF PRODUCT IN COMMERCE 1,020.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) POLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
b) POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum.
CODE
a) Lot numbers CP4274-0769M (EXP. 09/04) and CP4335-0812M (EXP. 11/04);
b) Lot numbers 1155J (EXP. 09/04) and 1388J (EXP. 10/04).
RECALLING FIRM/MANUFACTURER Polymedco, Inc., Cortlandt Manor, NY.
REASON Firm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.
VOLUME OF PRODUCT IN COMMERCE 749 lots.
DISTRIBUTION Nationwide.

PRODUCT Abbott Commander Flexible Pipetting Center (FPC) Operations Manual, list 6A97-27;
CODE All revision numbers, all versions.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON The Operations Manual has the wrong Farenheit temperature range listed (102-122) instead of (104-122) for the preparation of the Terg-A-Zyme solution used to clean pipettes of the Abbott Commander Flexible Pipetting Center.
VOLUME OF PRODUCT IN COMMERCE Est 380 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack.
CODE Lot #750, Exp. 14 January 2004.
RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY.
REASON Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
VOLUME OF PRODUCT IN COMMERCE 524 reagent packs.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Howell D.A.S.H. II Access System, Wire Guided Sphincterotome.
CODE Reorder Number: DASH-35-480, Lot Number: W1815864.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc, Winston Salem, NC.
REASON Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION AZ, CA, MN, NJ, NY, OH, and Egypt.

PRODUCT Pentalumen TD Thermodilution Catheter, Sterile.
CODE List No. 41233-01, Lot 04-187-SN.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Thermodilution catheters have a potential for ruptured lumens within the catheter.
VOLUME OF PRODUCT IN COMMERCE 495 units.
DISTRIBUTION Nationwide.

PRODUCT
a) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter.
EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes
ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.
b) EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter.
EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
c) DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as the ENDODIRECT
System, Product codes ED241, 242, 243, 244.
d) SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr.SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24.
e) Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
CODE
a) Lot Numbers 020349, 050327, 060337;
b) Lot Numbers 020347, 030343, 060338, 080348;
c) Lot Numbers 010367, 020342, 020378, 020379, 020380, 030353, 060358;
d) Lot numbers 030356, 050347, 060359;
e) Lot number 020374.
RECALLING FIRM/MANUFACTURER Heartport Inc, Somerville, NJ.
REASON Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
VOLUME OF PRODUCT IN COMMERCE 933.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) AxSYM CA 125 Reagent Pack, list 3B41-22 and IMx CA 125 Reagent Pack, list 7A89-22; 100 test kits.
b) Mx CA 125 Mode 1 Calibrator, list 7A89-40;
c) CA 125 Calibrators, list 9C22-01;
d) AxSYM CA 125 Master Calibrators, list 3B41-30.
e) CA 125 Controls, list 9C22-10;
CODE All lots.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the storage conditions, 69-6349/R2, refers to an outdated control package insert, 39-1642/R3, instead of the current control package insert 34-1047/R4.
VOLUME OF PRODUCT IN COMMERCE Not specified.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only.
CODE Lots: #5047293 and #5048892.
RECALLING FIRM/MANUFACTURER Cardinal Health, Groveport, OH.
REASON The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
VOLUME OF PRODUCT IN COMMERCE 110 units.
DISTRIBUTION OH, and PA.

PRODUCT Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable - Single Use Only, Quality System ISO 9001 Certified, Rx Only,
CODE Reorder number: OATS-11.5-5, Lot number: 1637695, 1651258, 1711817, 1713997, W1730838, W1752589, W1817595; Reorder number: OATS-11.5-7, Lot number: 1637696, 1651259, 1711818, 1711819, W1730839, W1738240; Reorder number: OATS-11.5-9, Lot number: 1637697, 1651260, 1702218, 1711820, 1711821, W1738241; Reorder number: OATS-11.5-12, Lot number: 1637694, 1651257, 1683866, W1730837, W1738238, W1752587; Reorder number: OATS-11.5-15 Lot number: 1692178, 1692179, 1711816, W1738239, W1752588.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc, Winston Salem, NC.
REASON Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm.
VOLUME OF PRODUCT IN COMMERCE 198 units.
DISTRIBUTION Japan.

WEEK ENDING JANUARY 31

PRODUCT Access AED and Access ALS Automated External Defibrillators Model No. 9100-0100.
CODE Serial Numbers: 77067 77341 77374 77401 77427 77468 77068 77344 77375 77402 77428 77469 77215 77351 77376 77403 77429 77470 77217 77352 77377 77404 77430 77471 77287 77353 77378 77405 77432 77472 77288 77354 77379 77406 77433 77473 77295 77355 77380 77407 77434 77474 77296 77356 77381 77408 77435 77475 77297 77357 77382 77409 77436 77476 77302 77358 77383 77410 77437 77477 77303 77359 77384 77411 77438 77479 77304 77360 77385 77412 77439 77480 77305 77361 77386 77413 77440 77481 77306 77362 77387 77414 77441 77483 77307 77363 77388 77415 77442 77484 77308 77364 77389 77416 77443 77485 77309 77365 77390 77417 77444 77651 77319 77366 77391 77418 77445 77335 77320 77367 77392 77420 77446 77321 77368 77394 77421 77447 77334 77369 77396 77422 77448 77336 77370 77397 77423 77462 77337 77371 77398 77424 77463 77338 77372 77399 77425 77464 77339 77373 77400 77426 77465.
RECALLING FIRM/MANUFACTURER Access CardioSystems, Concord, MA.
REASON Difibrillator may fail to operate due to a faulty component on the circuit board.
VOLUME OF PRODUCT IN COMMERCE 143 units.
REASON AL, CA, LA, FL, OR, NC, TN, and Grenada.