WEEK ENDING DECEMBER 3

PRODUCT IMED Gemini PC-4 Volumetric Infusion Pump and Controller with Version 1.85 Software:
a) PC-4 Infusion Pump, Model 1340, 110 volts;
b) PC-4 Infusion Pump, Model 1341, 220 volts.
CODE All pumps that carry software version 1.85.
MANUFACTURER Alaris Medical Systems, Inc., San Diego, California.
DISTRIBUTION Nationwide and International.
QUANTITY 4,753 (model 1340, 110 volts) and 132 (model 1341, 220 volts) pumps were distributed.
REASON Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages.

PRODUCT Maxxim Medical Custom Tray Kits containing DeRoyal Light Handle Covers: a) Custom Tray Models, containing DeRoyal Non-sterile, Model No. 26-011-NS SAF-T-GRIP Light Handle Covers; Custom Tray Models, containing DeRoyal Sterile,
Model No. 26-012 Light Handle Covers
CODE GROUP 1. 5,100 LIGHT HANDLE COVERS, OF VARIOUS DEROYAL LOT NUMBERS
DESIGNATED WITH THE DEROYAL PART NUMBER AND NAME," 26-011NS COVER, LIGHT HANDLE/ SAF-T-GRIP". 3,364 OF THESE HANDLE COVERS WERE INCORPORATED INTO 1,796 PRODUCTS BY MAXXIM UNDER THE MODEL NUMBERS AND LOT NUMBERS SHOWN BELOW. THE PRODUCTS IN THIS GROUP WERE SENT TO SEVEN CONSIGNEES IN SEVERAL STATES. EACH PRODUCT MAY CONTAIN FROM 1 TO 4 LIGHT HANDLE COVERS.
MODEL BAC375B LOT 69060645
MODEL BAC376C LOT 69060243
MODEL CVC378E LOT 69050844 & 69051000
MODEL GSC377D LOT 69060813
MODEL LZC380D LOT 69061316
MODEL OPC369 LOT 69060802
MODEL OPC383F LOT 69060387
MODEL GSM396B LOT 69060791
MODEL OBK314D LOT 69060202
MODEL OBK547D LOT 69061045
MODEL GSS515B LOT 69070159
MODEL LZS813C LOT 69061306
MODEL CVN758 LOT 69060918
MODEL GSM542C LOT 69061343
MODEL GSM543B LOT 69061081
MODEL OPM548D LOT 69060335
MODEL OPM549C LOTS 69060134 & 69060235
GROUP 2. CONSISTS OF 1080 LIGHT HANDLE COVERS RECEIVED FROM DEROYAL UNDER VARIOUS DEROYAL LOT NUMBERS AND BEAR THE DEROYAL NAME AND CATALOG NUMBER, "COVER LIGHT HANDLE STR 2'S, #26-012". 656 OF THESE LIGHT HANDLE COVERS WERE PACKED INTO 636 PRODUCTS. THESE WERE SENT TO ONLY ONE NSIGNEE/HOSPITAL. EACH KIT CONTAINS 1 OR 2 LIGHT HANDLE COVERS.
MODEL CVT022 LOT 69060406 BASIN CV PACK
MODEL GST013 LOT 69060773 MAJOR PACK
MODEL GST018 LOT 69060189 MINOR PACK
MODEL LZT012 LOT 69060115 LAP CHOLE PACK
MODEL NRT016 LOT 69060116 NEURO BACK PACK
MODEL NRT021 LOT 69061115 CHRANI PACK
MODEL OPT014 LOTS 69060423 & 69070106 ORTHO EXTREMITY PACK
MODEL OPT015 LOT 69050584 SHOULDER PACK
MODEL OPT015A LOT 69060514 SHOULDER PACK
MODEL OPT019 LOTS 69060281 & 69070034 FRACTURE TABLE PACK
MODEL OPT024 LOT 69060424 TOTAL HIP PACK
MANUFACTURER DeRoyal Surgical, Inc., Powell, Tennessee (component supplier).
RECALLED BY Maxxim Medical, Temecula, California
DISTRIBUTION Arizona, California, Idaho, Montana, New Mexico, Texas.
QUANTITY 4066
REASON The light handle covers have the potential to fall off the light handle or split during use.

PRODUCT Promotional Material for TAB250 Mouse Anti-HER2[c-erbB-2] Antibody
CODE Immunochemica Newsletter Vol. 11, No. 1
Immunochemica Newsletter Vol. 11, No. 2
V-Liner Mailer
HER2 Flyer
Labels and Specification Sheet: Catalog No. 28-0003, Lot No. 9034624
MANUFACTURER Zymed Laboratories, Inc., South San Francisco, California.
DISTRIBUTION Nationwide.
QUANTITY 33,659 promotional material and 38 label & specification sheets were distributed.
REASON Devices were labeled for an intended use not included in the existing 510(k) or PMA.

PRODUCT 3M Sarns Brand Myocardial Protection Sets in clear plastic trays, indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery:
1. Conducer Cardioplegia Set with MP-4, 4:1 ratio, no recirculation. Catalog #: 165720 Product Order #: 98-0702-0012-0. Lots: W504044, W503670, W502672, W502889, W502825, W502931, W503155, W503265, W503014, W503573, W503408, W504193.
2. Integrated Cardioplegia Delivery System Blood Mix Cardioplegia Disposable Tubset. Catalog #: 14915 Product Order #: 98-0702-0108-6 Lots: W503643, W503311, W502914, W503419, W503095.
3. MP-4 Clear Cardioplegia Set Recirculation from the Cannula Connection. Catalog #: 15486 Product Order #: 98-0702-0123-5 Lots: W503231, W503503, W502742, W503099, W502917.
4. MP-4 Clear Cardioplegia Set Recirculation for the Monitor Module. Catalog #: 15501 Product Order #: 98-0702-0125-0 Lots: W503642, W503866, W503151, W502740, W503360, W503405, W502951, W504284.
5. MP-4 Blood Cardioplegia Set 4:1 Ratio, Recirculation from the Cannula Connection. Catalog #: 15928 Product Order #: 98-0702-0139-1 Lot: W503042.
6. MP-4 Blood Cardioplegia Set 4:1 Ratio, No Recirculation. Catalog #: 16010 Product Order #: 98-0702-0142-5 Lots: W503784, W503394, W503682, W503111, W503260, W503479, W503623, W502829, W502993, W504097, W504161.
7. MP-4 Clear Cardioplegia Set Filtered Recirculation from the Monitor Module. Catalog #: 16010 Product Order #: 98-0702-0143-3 Lots: W503020, W503229, W502870, W503454.
8. MP-4 Clear Cardioplegia Set Filtered Recirculation from the Cannula Connection. Catalog #: 16015 Product Order #: 98-0702-0012-0 Lot: W503248.
9. Custom MP-4 Hackensack Medical Center. Catalog #: N/A Product Order #: 98-0702-0153-2 Lots: W503681, W503113, W503471, W503361, W502833, W504045.
10. MP-4 Blood Cardioplegia Set 2:1 Ratio, No Recirculation. Catalog #: 16200 Product Order #: 98-0702-0224-1 Lots: W503621, W502721, W502990.
11. Conducer Cardioplegia Set 4:1 Ratio, No Recirculation. Catalog #: 9457 Product Order #: 98-0702-0344-7 Lots: W503634, W503364, W503439, W503439, W502984, W504080.
12. Conducer Cardioplegia Set with MP-4, 2:1 Ratio, No Recirculation. Catalog #: 9499 Product Order #: 98-0702-0554-1 Lots: W503956, W503358, W502915, W503590, W504150.
13. Custom MP-4 Conducer Rochester General. Catalog #: N/A Product Order #: 98-0702-0594-7 Lots: W504030, W50337, W503722, W503864, W503489, W502846, W503050, W504269.
14. Conducer Cardioplegia Set 1:1 Ratio, No Recirculation. Catalog #: 4414 Product Order #: 98-0702-0630-9 Lots: W502926, W502675, W503451, W502847.
15. Conducer Cardioplegia Set with MP-4 8:1 Ratio, No Recirculation. Catalog #: 4459 Product Order #: 98-0702-0656-4 Lots: W503717, W503200, W503594, W503362, W502731, W504152.
16. Custom MP-4 St Luke’s Hospital. Catalog #: N/A Product Order #: 98-0702-0686-1 Lots: W503770, W503309, W502874, W504076.
17. Custom Conducer Houston Life Support. Catalog #: N/A Product Order #: 98-0702-0720-8 Lots: W503392, W502832.
18. Custom MP-4 Conducer Hill. Catalogn #: N/A Product Order #: 98-0702-0723-2 Lots: W503352, W503135, W503710.
19. Custom MP-4 Conducer Presbyterian New York. Catalog #: N/A Product Order #: 98-0702-0756-2 Lots: W503583, W503407, W502928, W503258.
20. Custom 4:1 Hackensack Medical Center. Catalog #: N/A Product Order #: 98-0702-0760-4 Lots: W504074, W503660, W502863, W503022, W503421.
21. Custom Conducer 8:1 Sacred Heart Hospital. Catalog #: N/A Product Order #: 98-0702-0845-3 Lots: W503661, W503143, W503452, W502848.
22. Custom MP-4 Conducer CPMC Ozomiser Infusion System. Catalog #: N/A Product Order #: 98-0702-0955-0 Lot: W502788.
23. Conducer Cardioplegia St with Bridge 4:1, No Recirculation. Catalog #: 6376 Product Order #: 98-0702-0966-7 Lots: W503150, W502708, W503403, W503601, W503232, W502950, W504159.
24. Conducer Cardioplegia Set with PM-4 and Bridge 4:1 Ratio, No Recirculation. Catalog #: 6375 Product Order #: 98-0702-0967-5 Lots: W504040, W503882, W503830, W503480, W503591, W503202, W503266, W503404, W503052, W503635, W502730, W504242, W504288, W504148.
25. Custom MP-4 Conducer B Trap, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-0969-1 Lots: W503910, W502804.
26. Customized:Bld, Conducer B Trap, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1005-3 Lots: W503356.
27. Conducer Cardioplegia Set Low-Prime 4:1 Ratio. Catalog #: 5852 Product Order #: 98-0702-1022-8 Lots: W503338, W502676, W502918.
28. Custom MP-4 Conducer 8:1 with Bridge Perfusion Products. Catalog #: N/A Product Order #: 98-0702-1118-4 Lots: W503217, W503547.
29. Custom MP-4 Houston Life Support SETA. Catalog #: N/A Product Order #: 98-0702-1154-9 Lots: W503295, W502859.
30. Custom Conducer 4:1 Bridge University of Iowa. Catalog #: N/A Product Order #: 98-0702-1181-2. Lot W503676.
31. Customized:MUF,BLD, 4:1 Conducer, B Trap, Bridge 4/cs. Catalog #: N/A Product Order #: 98-0702-1209-1 Lots: W503871, W503619, W502706, W503336.
32. Custom Conducer with MP-4 University of Virginia Medical Center. Catalog #: N/A Product Order #: 98-0702-1210-9 Lot: W502691.
33. Customized: Clear Conducer Reverse Flow D.C. 4/cs. Catalog #: N/A Product Order #: 98-0702-1243-0 Lot: W502858.
34. Customized: Blood 4:1 MP-4 Coil, Pump Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1250-5 Lots W503680, W503194, W503484, W502912.
35. Custom MP-4 with Recirculation UPMC. Catalog #: N/A Product Order #: 98-0702-1205-7 Lots: W504031, W503416, W503096, W503555, W502771, W504120.
36. Customized: Blood 4:1 MP-4 Coil 4/cs. Catalog #: N/A Product Order #: 98-0702-1307-3 Lots: W503712, W502741, W502986, W503423, W504111.
37. Custom MP-4 4:1 Ratio with Recirculation Bellin Hospital. Catalog #: N/A Product Order #: 98-0702-1420-4 Lots: W504032, W503114, W503600, W503355.
38. Custom MP-4 Clear with Recirculation St Vincent Hospital. Catalog #: N/A Product Order #: 98-0702-1441-0 Lots: W503228, W502831, W503455.
39. Customized: Blood 4:1 Conducer Bubble Trap No Recirculation 4/cs. Catalog #: N/A Product Order #: 98-0702-1458-4 Lot: W503193.
40. Customized: Blood 4:1 Conducer MP-4 120' Table Line 4/cs. Catalog #: N/A Product Order #: 98-0702-1469-1 Lots: W503552, W503256.
41. Customized: Blood 2:1 MP-4 Conducer Bridge. Catalog #: N/A Product Order #: 98-0702-1504-5 Lots: W503440, W502772.
42. Customized: Blood Conducer Bubble Trap 4/cs. Catalog #: N/A Product Order #: 98-0702-1510-2 Lots: W503192, W502769, W503649, W504147.
43. Customized: Blood 4:1 Coil Bridge 4/cs. Catalog #: N/A Product Order #: 98-0702-1553-2 Lots: W502999, W502727.
44. Customized: Blood 4:1 MP-4 B Trap Conducer MUF. Catalog #: N/A Product Order #: 98-0702-1572-2 Lot: W503550.
45. Customized: Clear MP-4 Coil Double Spike, Recirculation. Catalog #: N/A Product Order #: 98-0702-1589-6 Lots: W503620, W503911, W503267, W503453, W502739, W503021, W504100.
46. Customized: Blood 4:1 MP-4 Prelief Conducer Low Prime. Catalog #: N/A Product Order #: 98-0702-1594-6 Lots: W503666, W502927, W504233.
47. Customized: Blood 8:1 B Trap Conducer. Catalog #: N/A Product Order #: 98-0702-1672-0 Lots: W502948, W503437, W503677, W503067, W504114.
48. Customized: Blood 4:1 B Trap Conducer MUF. Catalog #: N/A Product Order #: 98-0702-1679-5 Lots: W503726, W502983, W503585, W502770.
49. Customized: Blood Conducer RFDC Isolater Single Spike. Catalog #: N/A Product Order #: 98-0702-1786-8 Lot: W503796.
50. Customized: Blood 4:1 Conducer Bubble Trap Filter. Catalog #: Product Order #: 98-0702-1786-8 Lot: W503796.
51. Customized: Blood 4:1 Conducer Bubble Trap Filter. Catalog #: N/A Product Order #: 98-0702-1789-2 Lots: W503917, W502705, W503593, W503006, W503789, W503043.
52. Customized ICDS Blood Set Bridged Table Line. Catalog #: N/A Product Order #: 98-0702-1798-3 Lots: W503255, W503496.
53. Customized: Conducer B Trap Single Spike MUF. Catalog #: N/A Product Order #: 98-0702-1804-9 Lot: W502716.
54. Customized: Blood 4:1 Bridge MP-4 Coil Prelief 4/cs. Catalog #: N/A Product Order #: 98-0702-1819-7 Lots: W502723, W503000, W503195.

55. Customized: Blood 4:1 Conducer MP-4 Prelief 4/cs. Catalog #: N/A Product Order #: 98-0702-1850-2 Lots: W503438, W503297, W503718.

WEEK ENDING DECEMBER 17

PRODUCT CMS ACCUPROBE 530,a cryosurgical system used for controlled ablation and destruction of malignant/benign tissue in the body. Device supercools liquid nitrogen applied to tissue for destruction.
CODE Serial Numbers: 530-1001 to 530-1019.
MANUFACTURER Cryomedical Sciences, Inc., Rockville, Maryland.
DISTRIBUTION Nationwide.
QUANTITY 19 systems were distributed.
REASON Device wiring found to be corroded, burned, or fatigued.

PRODUCT Toxo IgM Enzyme-Linked Immunosorbent Assay (ELISA)
a) Product No. 1029-315Z, Toxo IgM ELISA - 96 Tests;
b) Product No. B1029-315Z, Toxo IgM ELISA.
CODE Lot Numbers: a) 1S&T010880 EXP 06-30-00; b) 8TOXO02918 EXP 02-24-00.
MANUFACTURER Zeus Scientific, Inc., Branchburg, New Jersey.
DISTRIBUTION Washington state.
QUANTITY a) 30 kits; b) 25 kits were distributed; firm estimates none remains on the market.
REASON Device may produce high rates of false positive test results.

PRODUCT Procedure Based Delivery Systems Module, used in surgery, composed of subassembly kits, including the set up subassembly kit, which contains a skin/scrub prep tray that had latex gloves packaged in the tray; Packaged by Allegiance Healthcare Corporation
CODE Skin/Scrub Prep Tray contained in Set Up subassembly kit PZ90LFCSC contained in the following modules manufactured between 9/9/99 and 11/8/99:
Module PG90MALFC, PBDS Pathways General Surgery Latex Free Kit;
Module PL90CSLFB, PBDS Pathways C-Section Latex Free Kit;
Module PN90CYLFB, PBDS Pathways Neurosurgery Latex Free Kit;
Module PO90MJLFB, PBDS Pathways Orthopedic Latex Free Kit.
MANUFACTURER Allegiance Healthcare Corporation, Montgomery, New York.
RECALLED BY Allegiance Healthcare Corporation, McGaw Park, Illinois
DISTRIBUTION Nationwide.
QUANTITY 138 modules.
REASON Kits labeled as latex free contain latex gloves.

PRODUCT PACEART CardioVoice Telephones include:
a) CardioVoice Speaker Phone, Model No. CVP-1A;
b) CardioVoice Trimline Phone, Model No. CVP-1;
c) CardioVoice Portable Transmitters (or CardioVoice Phone Portable Option), a compact real-time transmitter that can send a patient's real-time electrocardiogram (ECG) to a receiving center at a physician's office or a specialized monitoring service from any location, Model No. CT-1.
CODE a) Sale Code: CVP-1A; b) Sale Code: CVP-1; c) Sale Code: CT-1. All units shipped to consignees between 5/1/98 to 7/15/99.
MANUFACTURER PACEART Associates, L.P., Fairfield, New Jersey.
DISTRIBUTION a) California, Florida, Georgia, Missouri, New York, Ohio, Washington state, China; b) Alabama, Delaware, Kansas, Kentucky, Missouri, Michigan, New Jersey, New York, Ohio, Texas, China, and England; c) California, District of Columbia, Florida, Kentucky, Louisiana, Massachusetts, Maryland, Missouri, New Jersey, New York, Oregon, Pennsylvania, Virginia, Washington state, Australia.
QUANTITY Undetermined.
REASON The devices fail to comply with the performance standard for electrode lead wires and patient cables, 21 CFR 898.

PRODUCT Medtronic GEM Implantable Cardioverter Defibrillators:
a) Medtronic GEM Model No. 7227Cx Implantable Cardioverter Defibrillator;
b) Medtronic GEM Model No. 7229Cx Implantable Cardioverter Defibrillator
CODE All serial numbers ending with the letter "H".
MANUFACTURER Medtronic Med Rel, Inc., Humacoa, PR.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota
DISTRIBUTION Nationwide and international.
QUANTITY a) 9654; b) 44 units were distributed.
REASON Improper P+ wire routing and less than required silicone adhesive insulation on the P+ wire in the connector module.

PRODUCT Cryolife Allograft Heart Valve: a) Model AVOO; b) Model PVOO
CODE Serial Numbers: a) 6272991; b) 6273009.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Ohio and California.
QUANTITY 2 units.
REASON The liver from the donor of the allografts had been diagnosed with cancer.

PRODUCT K-1 Infant Transport Incubators:
a) Transport Incubator 100 - Globetrotter (GT67);
b) Transport Incubator 100 - Trailblazer (TB67);
c) Transport Incubator 100 - Roadrunner (RR67);
d) Transport Incubator 500 - Globetrotter (GT500).
CODE Various serial numbers.
MANUFACTURER Hill-Rom Air-Shields, Hatboro, Pennsylvania.
DISTRIBUTION Nationwide and international.
QUANTITY 568 units were distributed.
REASON The devices have a faulty design of the hand ventilator which does not indicate the true pressure in the incubator.

PRODUCT CAPTIA Rubella-M, Product No. 800-920, used for the detection of IgM antibodies to rubella in human serum as an aid to the diagnosis of recent or current rubella infection
CODE Lot Numbers: 34K2029 EXP 18-MAR-00; 34K0358 EXP 18-MAR-00; and 34K2019 EXP 15-APR-00.
MANUFACTURER Trinity Biotech plc, Bray, Co. Wicklow, Ireland
DISTRIBUTION Nationwide and international.
QUANTITY 296 kits.
REASON The High Titre Positive (HTP) Control is reading below the stated Optical Density value of >0.9 for the HTP in the kit labeling.

PRODUCT Sarns 3M Centrifugal Pump, Catalog No. 164275.
CODE Lot No. W504470 and W504471.
MANUFACTURER of Plastic Pouches Kenpak, City of Commerce, California.
RECALLED BY Terumo Cardiovascular Systems Corporation, Ann Arbor
DISTRIBUTION Arizona, California, Florida, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, Pennsylvania, Pureto Rico, Rhode Island, Texas, Utah, District of Columbia, Wisconsin.
QUANTITY 960 units were distributed.
REASON Some of the pouches had weak areas near the seams and, post-sterilization, sampling found some pouches had opened up.

PRODUCT Abbott ACCLAIM Infusion Pump and Abbott ACCLAIM Encore Infusion Pump Model: 12032-04 and 12237-04.
CODE None.
MANUFACTURER Abbott Laboratories, Inc., Morgan Hill, California.
DISTRIBUTION Nationwide.
QUANTITY 2,005 units.
REASON Failure of the temperature compensation sensor circuit can lead to inaccurate delivery.

PRODUCT Allograft Heart Valves
CODE
Model Number AV00 - Serial Number 6267068
Model Number PV00 - Serial Number 6267033
Model Number AV05 - Serial Number 3978516
Model Number PV05 - Serial Number 3978524
Model Number PV00 - Serial Number 6276466
Model Number AV00 - Serial Number 6206476
Model Number AV00 - Serial Number 6003915.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION California, Massachusetts, Michigan, Nebraska, New Hampshire, Tennessee, Texas.
QUANTITY 7 units.
REASON Donors do not meet current guidelines regarding serodilution of plasma.

PRODUCT CryoLife Allograft Heart Valve, Model No. AVOO.
CODE Serial #6635253.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Nevada.
QUANTITY 1 unit.
REASON Additional donor information not available at the time of initial donor and tissue review by quality assurance indicates the donor had viral mycocarditis at the time of death.

PRODUCT Datascope Safety Guidewire, Size .020"x145cm, used in conjunction with the firm's 8 French Intra Aortic Balloon (IAB) Catheters.
CODE Catalog #0684-00-0254-04.
MANUFACTURER Datascope Corporation, Cardiac Assist Division, Fairfield, New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY 46 10-packs were distributed.
REASON Size .030" guidewire was found in the .020" guidewire package.

PRODUCT Disposable Argon Plasma Coagulation (APC) Probe for Flexible Endoscopy, single use sterile probes: a) Part Number 20132-071;
b) Part Number 20132-072.
CODE a) Lot Number A070535; b) Lot Number A070535.
MANUFACTURER ERBE, Tubingen, Germany.
RECALLED BY ERBE USA, Inc., Marietta, Georgia
DISTRIBUTION Nationwide.
QUANTITY 2,031 probes were distributed.
REASON Some of APC Probes may have an incorrect label on the pouch. The pouch has two labels, one international label (four languages) and one US label (English only). The international label may have an incorrect part number and probe diameter. The US label is correct.

MEDICAL DEVICE SAFETY ALERTS:

PRODUCT PCA I and PCA II Syringe Infusion Pumps, capable of both continuous and intermittent infusion of parenteral fluids with a Patient Controlled Analgesia mode intended primarily for the infusion of analgesics into the patient upon the patient's request by use of the patient button.
CODE All Baxter PCA Sets without anti-siphon technology used with both the Baxter PCA I Syringe Infusion Pump, Product Code 2L3103 and Baxter PCA II Syringe Infusion Pump, Product Code 2L3104.
The affected sets without anti-siphon technology are of the following product codes:
2C9205 - Baxter Tamper Resistant PCA Extension Set, Volume 0.8 mL, Length 60", also marketed under 6466500
2C9206 - Baxter Tamper Resistant PCA Extension Set, Volume 1.2 mL, Length 96"
2L3507 - Baxter Tamper Resistant PCA Combination Set, Volume 2.5 mL, Length 101".
MANUFACTURER Baxter Healthcare Corporation, Aibonito, Puerto Rico. The Aibonito, PR plant manufactures the sets. The PCA I pumps were made by Baxter at their North Reading, MA plant, and the PCA II pumps are made by Baxter at their Singapore plant.
ALERTED BY Baxter Healthcare Corporation, Round Lake, Illinois
DISTRIBUTION Nationwide.
QUANTITY 22,800 pumps.
REASON Uncontrolled flow of medication if user improperly loads syringe into PCA pump.
 

WEEK ENDING DECEMBER 24

PRODUCT IMED Gemini PC-4 Volumetric Infusion Pump and Controller with Version 1.85 Software:
a) PC-4 Infusion Pump, Model 1340, 110 volts;
b) PC-4 Infusion Pump, Model 1341, 220 volts.
CODE Identification Plates with Model 1304D and 1341B.
MANUFACTURER Alaris Medical Systems, San Diego, California.
DISTRIBUTION Nationwide and international.
QUANTITY a) 4576; b) 13 units were distributed.
REASON Due to a software modification, the devices will stop infusing and alarm if the processors receive conflicting or confusing messages.

PRODUCT i-STAT Cartridges, manufactured for use with the i-STAT portable analyzer, an in-vitro quantification of arterial, venous or capillary whole blood:
a) G3+ Cartridge, Catalog No. 220100
b) EG6+ Cartridge, Catalog No. 220200
c) EG7+ Cartridge, Catalog No. 220300
CODE
a) Lots EXP Date Lots EXP Date
K99091 11/29/99 K99096 12/4/99
K99097 12/5/99 K99105 12/13/99
K99106 12/14/99 K99108 12/16/99
K99109 12/17/99 K99109A 12/17/99
K99113 12/21/99 K99114 12/22/99
K99118A 12/26/99 K99120 12/28/99
K99122 12/30/99 K99129 1/6/00
K99134 1/11/00 K99136 1/13/00
K99147A 1/24/00 K99148 1/25/00
K99150 1/27/00 K99150A 1/27/00
M99088 11/26/99 M99094A 12/2/99
M99095 12/3/99 M99095A 12/3/99
M99096 12/4/99 M99098 12/6/99
M99102 12/10/99 M99103A 12/11/99
M99104 12/12/99 M99105 12/13/99
M99110 12/18/99 M99111 12/19/99
M99112A 12/20/99 M99114 12/22/99
M99116 12/24/99 M99159 2/5/00
P99092 11/30/99 P99093A 12/1/99
P99100A 12/8/99 P99102 12/10/99
P99102A 12/10/99 P99103 12/11/99
P99108 12/16/99 P99108A 12/16/99
P99110 12/18/99 P99115 12/23/99
P99118 12/26/99 P99122 12/30/99
P99124 1/1/00 P99129 1/6/00
P99136 1/13/00 P99152 1/29/00
P99159 2/5/00
b)Lots EXP DATE Lots EXP DATE
M99092 11/30/99 M99097 12/5/99
M99103 12/11/99 M99106 12/14/99
M99118B 12/26/99 M99124 1/1/00
M99132 1/9/00 M99132A 1/9/00
M99136 1/13/00 M99151 1/28/00
c) Lots EXP DATE Lots EXP DTE
M99085 11/23/99 M99086 11/24/99
M99087 11/25/99 M99089 11/27/99
M99091 11/29/99 M99094 12/2/99
M99100 12/8/99 M99101 12/9/99
M99101A 12/9/99 M99102 12/10/99
M99102A 12/10/99 M99108 12/16/99
M99109 12/17/99 M99112B 12/20/99
M99113 12/21/99 M99121 12/29/99
M99122 12/30/99 M99129A 1/6/00
M99130 1/7/00 M99131 1/8/00
M99133 1/10/00 M99134A 1/11/00
M99135 1/12/00 M99137 1/14/00
M99140 1/17/00 M99146 1/23/00
M99147 1/24/00 M99148 1/25/00
P99130 1/7/00 P99132 1/9/00
P99137 1/14/00 P99144 1/21/00.
MANUFACTURER i-STAT Canada Limited, Kanata, Ontario, Canada.
RECALLED BY i-STAT Corporation, East Windsor, New Jersey
DISTRIBUTION Nationwide and international.
QUANTITY
Lot # Name Distributed
K99091 G3+ 17850
K99096 G3+ 23025
K99097 G3+ 17200
K99105 G3+ 15375
K99106 G3+ 16275
K99108 G3+ 17250
K99109 G3+ 9075
K99109A G3+ 6850
K99113 G3+ 12025
K99114 G3+ 625
K99118A G3+ 1250
K99120 G3+ 50
K99122 G3+ 17875
K99129 G3+ 1650
K99134 G3+ 300
K99136 G3+ 25
K99147A G3+ 100
K99148 G3+ 1125
K99150 G3+ 1000
K99150A G3+ 9100
M99085 EG7+ 14900
M99086 EG7+ 21850
M99087 EG7+ 16700
M99088 G3+ 27000
M99089 EG7+ 18025
M99091 EG7+ 17450
M99092 EG6+ 16325
M99094 EG7+ 8850
M99094A G3+ 17600
M99095 G3+ 14150
M99095A G3+ 3750
M99096 G3+ 25400
M99097 EG6+ 12825
M99098 G3+ 18700
M99100 EG7+ 8675
M99101 EG7+ 11650
M99101A EG7+ 6850
M99102 EG7+ 3900
M99102A EG7+ 13450
M99103 EG6+ 4850
M99103A G3+ 9275
M99104 G3+ 18125
M99105 G3+ 17725
M99106 EG6+ 17825
M99108 EG7+ 8925
M99109 EG7+ 11225
M99110 G3+ 17600
M99111 G3+ 15275
M99112A G3+ 2600
M99112B EG7+ 4375
M99113 EG7+ 2650
M99114 G3+ 6025
M99116 G3+ 25
M99118B EG6+ 17150
M99121 EG7+ 18275
M99122 EG7+ 5100
M99124 EG6+ 500
M99129A EG7+ 5150
M99130 EG7+ 2700
M99131 EG7+ 6850
M99132 EG6+ 8875
M99132A EG6+ 3025
M99133 EG7+ 175
M99134A EG7+ 250
M99135 EG7+ 50
M99136 EG6+ 4600
M99137 EG7+ 650
M99140 EG7+ 7775
M99146 EG7+ 150
M99147 EG7+ 1100
M99148 EG7+ 450
M99151 EG6+ 950
M99159 G3+ 3925
P99092 G3+ 3125
P99093A G3+ 2150
P99100A G3+ 3025
P99102 G3+ 1900
P99102A G3+ 1100
P99103 G3+ 3925
P99108 G3+ 3025
P99108A G3+ 3250
P99110 G3+ 4275
P99115 G3+ 50
P99116A G3+ 100
P99118 G3+ 350
P99122 G3+ 100
P99124 G3+ 4525
P99129 G3+ 75
P99130 EG7+ 10175
P99132 EG7+ 3700
P99136 G3+ 50
P99137 EG7+ 2250
P99144 EG7+ 1300
P99152 G3+ 0525
P99159 G3+ 5175.
REASON Devices have the potential to provide incorrect reading and fail to function as intended.

PRODUCT Allograft Heart Valves: a) Model PVOO; b) AVOO.
CODE Serial Numbers: a) 6206484; b) 6276458.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION North Carolina and West Virginia.
QUANTITY 2 units.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Colclough (Love-Kerri) Laminectomy Rongeur, a manual instrument used to remove small pieces of bone.
CODE Catalog #00-3352-002-00, Lot #62891100.
MANUFACTURER Zimmer, Inc., a Bristol-Myers Squibb Company, Warsaw, Indiana.
DISTRIBUTION Nationwide, Australia, Korea, Singapore.
QUANTITY 21 units were distributed.
REASON The 3mm Ronguer was incorrectly identified (etched) and labeled as a 5mm Rongeur.

PRODUCT VENTAK MINI III AICD Automatic Implantable Cardioverter Defibrillators, Models 1772, 1773, 1776, 1782, 1783, 1786, 1788, and 1789
CODE
Model Serial numbers
1772 100074 and below
1773 200114 and below
1776 300033 and below
1782 505047 and below, 600806 - 600877
1783 603047 and below
1786 701747 and below
1788 700598 and below
1789 800631 and below
MANUFACTURER Guidant Corporation, Cardiac Rhythm Management, St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 10,165 units.
REASON Subpectoral implantation of this device exerts unique forces on its exterior that can be transferred to its interior components and has the potential to affect the device performance.

PRODUCT Stryker Endoscopy Pressure Sensing Cannula, intended to be used by surgeons on orthopedic joints, including the knee, shoulder, ankle, elbow, wrist for carpal tunnel procedure, and for temporomandibular joints. It is used to sense pressure and also provides fluid to joints.
CODE
All Serial/lot numbers are affected. Part numbers are as follows:
350-300-101, 350-300, 350-310-101
350-320-101, 350-400, 350-400-131
350-410-101, 350-500, 350-500-101
350-500-131, 350-510, 350-600-101
350-600-131, 350-610, 350-700-101
350-700-131, 350-710.
MANUFACTURER Stryker Endoscopy, Santa Clara, California.
DISTRIBUTION Nationwide and international.
QUANTITY 406 units.
REASON Product has the potential to separate from the tip end during surgery.

PRODUCT Miller Bone Cement Injector Flexible Nozzle, 12 inch length, 0.25 O.D., intended for use to fill the intramedullary canal with bone cement and is labeled as sterile.
CODE Catalog #5069-54, Lot #32135900.
MANUFACTURER Zimmer Patient Care, Dover, Ohio.
RECALLED BY Zimmer, Inc., Warsaw, Indiana
DISTRIBUTION California, Illinois, New Jersey, North Carolina, Pennsylvania.
QUANTITY 10 boxes (10 units per box) were distributed.
REASON The packages contained 16 inch nozzles instead of 12 inch, as labeled.
 

WEEK ENDING DECEMBER 31

PRODUCT ELASTIC HEAD STRAP, sold as a standard accessory in the Laerdal Pocket Mask with Oxygen inlet and headstrap, used to facilitate exhaled air ventilation in emergencies, whereby the rescuer exhales air through the mask and into the lungs of the patient.
CODE Model 830011-33, Lot #13799.
MANUFACTURER Laerdal Medical AS, Stavanger, Norway.
RECALLED BY Laerdal Medical Corporation, Wappingers Falls, New York
DISTRIBUTION Nationwide and 1 international facility.
QUANTITY 3,775 units.
REASON The headstrap of the device contains latex which is not declared on the label.

PRODUCT Ancure Endograft System, an endovascular catheter designed to deliver the Endograft and is completely removed from the patient once Endograft is implanted.
a) The Ancure Tube System, indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms;
b) The Ancure Bifurcated System, indicated for the endovascular treatment of infrarenal abdominal aortic or aortic-iliac aneurysms
CODE All devices with serial numbers less than 9C12980*, with the following exceptions:
9C12261 T 9C12596 T 9C12605 T 9C12825 T 9C12928 T 9C12955 T 9C12273 T 9C12597 T 9C12608 T 9C12827 T
9C12929 T 9C12956 T 9C12275 T 9C12598 T 9C12609 T 9C12831 T 9C12930 T 9C12957 T 9C12276 T 9C12599 T
9C12610 T 9C12832 T 9C12931 T 9C12958 T 9C12490 T 9C12600 T 9C12611 T 9C12894 T 9C12932 T 9C12567 T
9C12601 T 9C12762 T 9C12895 T 9C12953 T 9C12595 T 9C12604 T 9C12823 T 9C12898 T 9C12954 T
* The last character is an Alpha character and is not part of the serial number sequence.
MANUFACTURER Guidant Corporation, Cardiac & Vascular Surgery Group, Menlo Park, California.
QUANTITY 287 units.
REASON The monofilament tie, used in the manufacturing process, is not removed from the endograft prior to completion of the manufacturing process the attachment system cannot deploy, leaving the implant in a partial deployed state.

PRODUCT Abbott Alcyon Analyzers with Alcyon System Software Version 1.6.
CODE List #4E73-04.
MANUFACTURER Abbott Laboratories, Inc., Irving, Texas.
DISTRIBUTION Nationwide and Japan.
QUANTITY 55 units were distributed.
REASON The device may give incorrect tests results or reference ranges when printing the "Complete Report (header)", "Incomplete Report (DRAFT)", and the "Control Results printout."

PRODUCT Nellcor Puritan Bennett ventilator, all model #7200 series types, prescription microprocessor mechanical ventilator which combines microprocessor technology with a Pneumatic system to achieve gas delivery and patient monitoring:
a) 7200a series
4-026700-00 7200a domestic English
4-026701-00 7200a international English
4-026702-00 7200a international English
4-026703-00 7200a international French
4-026704-00 7200a international French
4-026705-00 7200a international German
4-026706-00 7200a international Spanish
4-026707-00 7200a international Spanish
4-026708-00 7200a international Japanese
4-026709-00 7200a international Japanese
4-026710-00 7200a international Saudi Arabia
4-026712-00 7200a international Italian
b) 7200sp/spi
4-026720-00 7200sp domestic English
4-026721-00 7200sp 220v/50hz English
4-026722-00 7200sp 240v/50hz English
4-026724-00 7200sp 220v/50hz French
4-026725-00 720spi 220v/50hz German
4-026726-00 720spi 115v/60hz Spanish
4-026727-00 720spi 220v/50hz Spanish
4-026728-00 720spi 100v/50hz Japanese
4-026729-00 720spi 100v/60hz Japanese
4-026730-00 720spi 220v/50hz Saudi Arabia
4-026731-00 720spi 115v/60hz French
4-026732-00 720spi 220v/50hz Italian
c) 7200ae series
4-pb7200-DL 7200ae demo loaner
4-pb7200-DS 7200ae demo sale
4-026734-DP 7200ae w/display
4-026734-00 7200ae w/o display
4-026735-DP 7200 spe w/display
4-026735-00 7200spe w/o display
4-026741-00 7200e
CODE All ventilators with the aforementioned model numbers regardless of the individual unit's serial number.
MANUFACTURER Nellcor Puritan Bennett, Inc., a division of Mallinckrodt, Inc., Carlsbad, California.
DISTRIBUTION Nationwide and international.
QUANTITY 46,468 units were distributed.
REASON The ventilators may deliver an unexpected high inspiratory pressure and flow when the following set of parameters are selected at one time: Mode - SIMV, Rate 15, Tidal volume 0.3L, Peak flow 10 liters/min., Flow pattern = sine wave, Peep =5, and Fi02 = 0.6.

PRODUCT Various types of human tissue and bone allografts, contained in either plastic bags or bottles with screw on caps with a computer generated label: a) Dura Mater; b) Dura Strips
CODE a) Dura Mater, Tissue Deposit Number AD-24050085-96 (from donor #APS-2405-95) and Tissue Deposit Number AD-24050086-90 (from donor #APS-2405-95).
b) Dura Strips, Tissue Deposit Numbers AD24050090-96 and AD2405088-96 (both from donor #APS-2405-95).
MANUFACTURER LifeLink Tissue Bank, Tampa, Florida.
DISTRIBUTION Florida and Alabama.
QUANTITY 4 allografts from one donor are involved.
REASON The firm did not adequately evaluate the combination of blood and colloids used in viral market testing and based the hemodilution determination on the donor's serum total protein.

PRODUCT Bio-Laser Systems, used for biostimulation: a) Model 1000; b) Model 2000.
CODE Bio-Laser Models 1000, 2000.
MANUFACTURER Bio-Laser Response Corporaton, Dr. Alvin Stjernholm, Lakewood, Colorado.
DISTRIBUTION Nationwide.
QUANTITY a) 9 units; b) 1 unit.
REASON The devices were distributed for human use without a 510(k) or PMA; andfailed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliances.

PRODUCT Patient Cables used in Models: HP M1770A, M1771A, M1772A PageWriter Electrocardiographs and Model 2488A StressWriter testing system
CODE All serial numbers.
MANUFACTURER China Hewlett-Packard Company, Ltd., Qingdao (cables).
RECALLED BY Agilent Technologies (formerly Hewlett-Packard Co.), Andover, Massachusetts
DISTRIBUTION Nationwide and international.
QUANTITY 28,700 units were distributed.
REASON Damaged cables may lead to distorted ECG waveforms.

PRODUCT PSA Reagent Pack, for the in vitro quantitative measurement of PSA (Prostate Specific Antigen) in serum and plasma. This test is used to monitor response to treatment in patients with prostate cancer and to aid in the identification of recurrence of prostate cancer prior to manifestation of clinical symptoms. The PSA Reagent pack is intended for use with the Vitros ECi Immunodiagnostic System
CODE Catalog Number 188 6704, Lots 30 and 40.
MANUFACTURER Fujirebio Diagnostics, Inc., Malvern, Pennsylvania.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Virginia and international.
QUANTITY Lot 30: 371 units; Lot 40: 26 units.
REASON Microbial contamination of reagent.

PRODUCT ARCHITECT Free T3 Reagent Kit; a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine(Free T3) in human serum and plasma: a)List6C48- 25 - 1 x 100 tests;b) List 6C48-30 - 4 x 500 tests
CODE List 6C48-30 (2000 test kit), lot 47106M200, 46944M200, 50665M200, 56285M300; List 6C48-25 (100 test kit), lot 47107M200, 49672M100, 46947M200.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Nationwide, Canada, and international.
QUANTITY 1,830 kits were distributed.
REASON Single analyte high control goes out of specification low, falling below the concentration range listed in the package insert.

PRODUCT Greer Dia-Kit, a diagnostic aid for hypersensitivity pneumonitis. A gel diffusion kit for demonstrating precipitating antibodies.
CODE Lot K17B-8C-1 and K178B-8C-2.
MANUFACTURER Greer Laboratories, Inc., Lenoir, North Carolina.
DISTRIBUTION California, Florida, Idaho, Illinois, Massachusetts, North Carolina, Utah, Virginia.
QUANTITY 42 vials.
REASON When freeze dried product was reconstituted, the bulk manufacturing date was not added to the manufacturing record. This product was given an incorrect expiration date.

PRODUCT Laserflo BPM2 Blood Perfusion Monitor, intended to monitor blood flow and perfusion
CODE Serial Numbers: 3401, 3405, 3406, 3407, 3412, 3413, 3414, 3415, 3416, and 3417.
MANUFACTURER Vasamedics, L.L.C., Little Canada, Minnesota.
DISTRIBUTION California, Colorado, Indiana, Missouri, Tennessee, Canada, Japan, Turkey.
QUANTITY 10 units.
REASON The devices contain a chip at main circuit board position U47 that does not meet performance specifications due to a chip substitution error made by a vendor.

PRODUCT Erythropoietin Quantikine IVD Human EPO Immunoassay (ELISA kit), Catalog number DEP00, used for the in vitro diagnostic determination of erythropoietin concentration in human serum as an aid in the diagnosis of anemia and polycythemia
CODE Catalog #DEPOO. Lot Numbers:
9943159 EXP 03Aug00
9944387 EXP 03Aug00
9947180 EXP 03Aug00
9947181 EXP 05Nov00.
MANUFACTURER R&D Systems, Inc., Minneapolis, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 546 units were distributed.
REASON Deterioration of kit components leads to incorrect Erythropoietin assays.