NOVEMBER 2003

WEEK ENDING NOVEMBER 1

PRODUCT Sedecal Portable X-Ray System. Model Number SP-HF-4.0.
CODE Not supplied.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal USA, Inc, Arlington Heights, IL.
Manufacturer: Sedecal SA, Madrid, Spain.
REASON A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in your SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VT.

PRODUCT Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Catalog No. 606-2511 FX UPN H7396062511FX3.
CODE Lot T0601010, expiration date 2004-05.
RECALLING FIRM/MANUFACTURER Cordis Neurovascular, Inc., Miami Lakes, FL.
REASON These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray.
VOLUME OF PRODUCT IN COMMERCE 54.
DISTRIBUTION US and Japan.

PRODUCT Sharpoint 2.75 mm x 3.75 mm Clear Trap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
CODE M190500 exp 11/2007 and M203840 exp 12/2007.
RECALLING FIRM/MANUFACTURER Surgical Specialties Corp., Reading, PA.
REASON The text on product handle is incorrect.
VOLUME OF PRODUCT IN COMMERCE 666 units.
DISTRIBUTION CA. NC, IL, Belgium, Canada, and Australia.

PRODUCT Dow Corning Silastic brand Medical Adhesive Silicone, Type A, non-sterile, 57 gram tube; material numbers 3242901 (100 tubes) and 3242897 (6 tubes).
CODE Lots 0001531727, 001583486 and 0001671243; lot 0001604743.
RECALLING FIRM/MANUFACTURER Dow Corning Corp, Hemlock, MI.
REASON The product maybe contaminated with iron, chromium and nickel from stainless steel equipment failure during manufacture.
VOLUME OF PRODUCT IN COMMERCE 4,176 tubes.
DISTRIBUTION Nationwide.

PRODUCT
a) Coulter AcT 5diff Open Vial Hematology Analyzers, Part Numbers: 6605580, 6605581, 6605604.
b) Coulter AcT 5diff Cap Pierce Hematology Analyzers, Part Numbers: 6605641, 6605705.
CODE
a) All instruments are affected;
b) None apply.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Samples with high fat content will not count platelets accurately.
VOLUME OF PRODUCT IN COMMERCE 1,221.
DISTRIBUTION Nationwide and Canada.

PRODUCT SONOLINE Antares Diagnostic Ultrasound System. Catalog No. 5936518, 7035415, 5936682, 5936682, 5936708, 5936716, 5936724. CODE Serial numbers: 10106, 10107, 10108, 10253, 10323, 10347, 10352, 10392, 10393, 10394, 10407, 10429, 10430, 10431, 10462, 10465, 10470, 10475, 10492, 10504, 10511, 10535, 10540, 10541, 10542, 10543, 10576, 10585, 10611, 10614, 10626, 10651, 10662, 10712, 10724, 10727, 10745, 10819, 10829, 10837, 10843, 10848, 10849, 10850, 10851, 10852, 10861, 10869, 10873, 10875, 10921, 11008, 11022, 11025, 11049, 11050, 11051, 11053, 11054, 11071, 11102, 11104, 10012, 10027, 10195, 10471, 10483, 10484, 10491, 10583, 10664, 10703, 11033, 11034, 10781, 10432, 10257, 10262, 10274, 10281, 10338, 10383, 10493, 10686, 10836, 10847, 11009, 11030, 11057, 10400, 10401, 10453, 10466, 10737, 10752, 10777, 10778, 10784, 11027, 11028, 11029, 10286, 10602, 10753, 10923, 10018, 10058, 10071, 10116, 10434 , 10668, 10970, 10351, 10697, 10991, 10997, 10277, 10681, 11073, 10130, 10267, 10782, 11002, 11019, 11032, 11072, 10648.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Issaquah, WA.
REASON Product labeling failed to include complete information about ALARA (As Low As Reasonably Achievable) safety instructions.
VOLUME OF PRODUCT IN COMMERCE 136 units.
DISTRIBUTION Nationwide.

PRODUCT Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System. Part # 252-0300.
CODE Lot # W007919.
RECALLING FIRM/MANUFACTURER Ortho Development Corporation, Draper, UT.
REASON The guide pin which rotationally constrains the tibial punch within the punch guide, has fallen out on several parts of the Balanced Knee System.
VOLUME OF PRODUCT IN COMMERCE 27.
DISTRIBUTION Nationwide and Japan.

PRODUCT LifeSite Hemodialysis Cannula Exchange Kit Part Number: LHCEK0000.
CODE Lot Number: 30956.
RECALLING FIRM/MANUFACTURER Vasca, Inc., Tewksbury, MA.
REASON Outer kit mislabeled with an extended expiration date.
VOLUME OF PRODUCT IN COMMERCE 81 units.
DISTRIBUTION Nationwide.

PRODUCT Brodmerkel Colon Decompression Set, CDSB-10, Catheter Diameter: 10 Fr. Catheter Length: 350 cm. Sideports: 10, Standard wire Guide: .035"/480 cm. Disposable - Single use only, Rx Only. Catalog # CDSB-10.
CODE Lot # 1589467.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston-Salem, NC.
REASON Product may be packaged with an incorrect instructions for use (IFU) booklet.
VOLUME OF PRODUCT IN COMMERCE 9 pieces.
DISTRIBUTION CA, NC, PA, and WI.

PRODUCT a) Channel Neuroendoscope, Standard Resolution, 21.6 cm.Catalog No. 2232-001.

b) Channel Neuroendoscope, Standard Resolution, 13 cm. Catalog No. 2232-003.
CODE
a) A20284;
b) A22148.
RECALLING FIRM/MANUFACTURER Medtronic Neurosurgery, Goleta, CA.
REASON Size mix-up. 13cm product may be labeled as 21.6 mm and visaversa.
VOLUME OF PRODUCT IN COMMERCE 20.
DISTRIBUTION TN, CO, GA, and Japan.

WEEK ENDING NOVEMBER 8

PRODUCT Pulse Generator Pacemaker, Integrity, Identity, and Verity.
CODE Integrity ADx DR Model 5360 & 5366 Identity Adx DR model 5286, 5380, 5386 & 5480 Verity ADx DR 5256, 5356 & 5456.
RECALLING FIRM/MANUFACTURER St. Jude Medical, Sylmar, CA.
REASON Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.
VOLUME OF PRODUCT IN COMMERCE 775 implanted plus 211 sold.
DISTRIBUTION Nationwide.

PRODUCT e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures; all e.cam models: 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7332625, 7332633, 7760809, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823979.
CODE Serial numbers 1 through 9091.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Hoffman Estates, IL.
REASON The detector's radial brake may not be applied properly, allowing unintended motion which could result in injury to the patient or operator.
VOLUME OF PRODUCT IN COMMERCE 2,386 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Western Medica OPC Portable Oxygen Conserving Regulator, Model OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label.

b) Western Medica OPC Portable Oxygen Conserving Regulator, Model LIN-7005, 1/2 - 5 LPM, packaged under the Lincare label.
c) Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label.
CODE
a) Unit S/Ns beginning with "HE0010xxxxx"and "HE001100001" thru "DHE001102881";
b) Unit S/Ns beginning with "DHE0010xxxxx" and "DHE001100001" thru "DHE001102881";
c) Unit S/Ns beginning with "DHE0010xxxxx" and "DHE001100001" thru "DHE001102881".
RECALLING FIRM/MANUFACTURER Western a Scott Fetzer Co., Westlake, OH.
REASON The demand valve is defective and does not function as intended in the "Conservative Mode".
VOLUME OF PRODUCT IN COMMERCE 2,972.
DISTRIBUTION Nationwide, China and Japan.

PRODUCT
a) FLEXICAIR(r) II, Low Airloss Therapy unit. This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.
b) FLEXICAIR MC3(r) Low Airloss Therapy unit.
CODE
a) Model #13000, IBxxxxxx (where xxxxxxx is a 6-digit number sequence);
b) MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).
RECALLING FIRM/MANUFACTURER Hill-Rom Manufacturing, Inc., Charleston, SC.
REASON Reports of patient entrapment between mattress and side-rails.
VOLUME OF PRODUCT IN COMMERCE 2,339 units.
DISTRIBUTION Nationwide, Canada, Austria, Germany and the U.K.

PRODUCT
a) Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394.
b) Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer) Part # 37271
CODE
a) Lot Number Exp. Date 304716 2/29/04 304074 2/29/04 303798 1/31/04 303515 1/31/04 303479 1/31/04 303222 1/31/04 302808 12/31/03 302652 12/31/03 302267 12/31/03 301844 11/30/03 301443 11/30/03 301219 11/30/03 212490
b) Lot Number Exp. Date 304828 7/31/04 304543 7/31/04 304296 7/31/04 303793 6/30/04 303519 6/30/04 303401 6/30/04 302670 5/31/04 302242 5/31/04 301126 4/30/04 212130 3/31/04 211349 2/29/04.
RECALLING FIRM/MANUFACTURER Nova Biomedical Corporation, Waltham, MA.
REASON Degradation of the magnesium sensor could result in low ionized magnesium patient samples.
VOLUME OF PRODUCT IN COMMERCE 939 sensors.
DISTRIBUTION Nationwide and Internationally.

PRODUCT IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL.
CODE List 3C10-10, lots 94165M100 and 94164M100.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Invalid test results are being generated due to calibration errors when using calibrator lots 94165M100 and 94164M100.
VOLUME OF PRODUCT IN COMMERCE 2,677 kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units).
CODE Lot Numbers 0933A and 1003I.
RECALLING FIRM/MANUFACTURER Acist Medical Systems, Eden Prairie, MN.
REASON Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
VOLUME OF PRODUCT IN COMMERCE 7,120 kits.
DISTRIBUTION Nationwide.

PRODUCT CryoValve, Pulmonary Heart Valve, Donor #68830, Model #PV10.
CODE Serial #8038836.
RECALLING FIRM/MANUFACTURER Cryolife Inc., Kennesaw, GA.
REASON Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Bayer Rapidpoint 405 Blood Gas Analyzer.
CODE Software Versions below 3.1.
RECALLING FIRM/MANUFACTURER Bayer Corp., Medfield, MA.
REASON Potential for bias shift in p02 values due to air bubble in sample path.
VOLUME OF PRODUCT IN COMMERCE 494 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Synchron CX4, CX5 and CX9 Pro Systems.
CODE None provided.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, Ca.
REASON Motor driver boards may contain wrong type of microchip which does not have obstruction detection feature.
VOLUME OF PRODUCT IN COMMERCE 351.
DISTRIBUTION Nationwide and Canada.

PRODUCT Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only.
CODE Lots 1602780, 160281, 1602782, 1602784, 1602785, 1602786, 1602788, 1602789, 1602790, 1602791, 1602792, 1602793, 1602794, 1602795, 1602796, 1602797, 1602798, 1602799, 1602800, 1602801, 1602802, 1607143, 1607144, 1610890, 1611901, 1613669, 1613670, 1614712, 1615429, 1615745, 1617031, 1617649, 1618498, 1620684, 1620928., 1621381, 1621496, 1621691, 1621692, 1622879, 16254321, 1626364, 1626669, 1627928, 1628134, 1629489, 1630384, 1630385, 1633042, 1633043, 1620783, 1623781, 1624348, 1625245, 1627107, 1629245, 1630813, 1634319, 1633787, 1634878, and 1635692.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston-Salem, NC.
REASON The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
VOLUME OF PRODUCT IN COMMERCE 2,062 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Remel Thayer Martin Agar (Improved), packaged in 10-packs (Cat. #01884), 15-packs (Cat. #01885), and 100 per case (Cat. #01886). CODE 10 pack - Lot #384341, Exp. 11/03/2003; 15 pack - Lot #384342, Exp. 11/3/2003; 100/cs - Lot #384343
RECALLING FIRM/MANUFACTURER Remel, Lenexa, KS.
REASON Some of the product lots exhibit no growth of quality control strains of Neisseria gonorrhoeae.
VOLUME OF PRODUCT IN COMMERCE 404/10-pks; 67/15-pks; 18/100-pk. Cs.
DISTRIBUTION Nationwide.

PRODUCT

a) Wire Driver Coupler, Model 7100-045, a component of MicroAire Drill/Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part.
b) Pin Driver Coupler, component of MicroAire Drill\Reamer Model 7500. Driver couplers are reuseable medical devices, non-sterile, packed one per box and labeled in part.
CODE
a) Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 1020, 1021, 1022, 1024, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032, 1033, 1034, 1035, 1036, 1037, 1038, 1039, 1042, 1043, 1044, 1045, 1047, 1049, 1050, 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061, 1062, 1064, 1065, 1066, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1079, 1082, 1083, 1084, 1087, 1088, 1089, 1090, 1094, 1095, 1096, 1097, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1112, 1113, 1114, 1115, 1117, 1118, 1119, 1120, 1121, 1122, 1124, 1126, 1127, 1128, 1129, 1130, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1162, 1163, 1164, 1165, 1166, 1167, 1168, 1169, 1170, 1171, 1172, 1173, 1175, 1176, 1177, 1178, 1179.
b) Serial numbers: 1007, 1008, 1009, 1010, 1011, 1012, 1013, 1014, 1016, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1030, 1031, 1032, 1034, 1035, 1036, 1038, 1039, 1040, 1041, 1042, 1043, 1046, 1047, 1048, 1049, 1051, 1052, 1053, 1054, 1057, 1058, 1059, 1060, 1061, 1062, 1065, 1066, 1067, 1068, 1069, 1070, 1071, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1084, 1085, 1086, 1087, 1088, 1089, 1090, 1091, 1093, 1095, 1096, 1097, 1098, 1099, 1100, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 1109, 1110, 1111, 1113, 1114, 1115, 1116, 1119, 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140, 1141, 1142, 1143, 1144, 1145, 1146, 1149, 1150, 1151, 1152, 1153, 1155, 1156, 1157, 1158.
RECALLING FIRM/MANUFACTURER MicroAire Surgical Instruments, Charlottesville, VA.
REASON Wiring pin locking mechanism defective, potential to come apart in surgical site.
VOLUME OF PRODUCT IN COMMERCE 264.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.
CODE Lots 616096.095, 096, and 097. Expiration Date: 23 Jul 03.
RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH.
REASON The kits were packaged with incorrect dispensing pipettes.
VOLUME OF PRODUCT IN COMMERCE 1,077 kits.
DISTRIBUTION Nationwide and Internationally.

WEEK ENDING NOVEMBER 15

PRODUCT Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271. Model 8963.535.
CODE Lot number M000580.
RECALLING FIRM/MANUFACTURER Richard Wolf Medical Instruments Corp., Vernon Hills, IL.

REASON The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
VOLUME OF PRODUCT IN COMMERCE 10 probes.
DISTRIBUTION NE, OR, MN, and IL.

PRODUCT
a) Concentric brand Concentric Retriever(tm) X5 Percutaneous Catheter Model REF 90035.
b) Concentric brand Concentric Retriever(tm) X6 Percutaneous Catheter Model REF 90037.
CODE a) and b) Lot numbers: 31494 or lower.
RECALLING FIRM/MANUFACTURER Concentric Medical Inc, Mountain View, CA.
REASON The device has the potential for tip breakage during use.
VOLUME OF PRODUCT IN COMMERCE 97 Units.
DISTRIBUTION MA, GA, NY, OH, MO, and CA.

PRODUCT Digital Fluorographic System model DFP-2000A.
CODE All serial numbers, all codes.
RECALLING FIRM/MANUFACTURER Toshiba American Medical Systems, Inc., Tustin, CA.
REASON Images display with wrong patient demographics.
VOLUME OF PRODUCT IN COMMERCE 471.
DISTRIBUTION Nationwide.

PRODUCT
a) Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm. Catalog number AK-25703.
b) Arrow central venous catheterization kit, 14 ga x 20 cm. Catalog number AK-04700.
c) Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm. Catalog number CC-03600.
CODE
a) Lot number RF3066892;
b) Lot number RF3067086;
c) Lot number RF3066991.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, PA.
REASON Wrong product in box.
VOLUME OF PRODUCT IN COMMERCE 4,754 units.
DISTRIBUTION Nationwide.

WEEK ENDING NOVEMBER 22

PRODUCT Sedecal SP-HF 4.0 Portable X-Ray System.
CODE Serial # PK10058.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL.
Manufacturer: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, Algete (Madrid) Spain.
REASON A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VT.

PRODUCT Propper brand cal-mark(, Micro-Hematocrit Calibrated Capillary Tubes, Calibrated-Heparinized, reorder no. 043021, 6 Vials, 100 Tubes per Vial, Length 75 mm., 0.55 mm. I.D., 1040-1.75mm. O.D. Calibrated 60mm from end for use in direct reading centrifuges.
CODE Lot # C0402.
RECALLING FIRM/MANUFACTURER Propper Manufacturing Co., Inc., Long Island City, NY.
REASON Deviation in capillary tubes could cause a 10% increase in read out values which could make a slight anemic patient appear to have a normal reading.
VOLUME OF PRODUCT IN COMMERCE 178 boxes.
DISTRIBUTION Nationwide.

PRODUCT Clinitron At Home( Air Fluidized Therapy Unit. Model 206 (CS).
CODE Serial numbers 101671 and 103443 510K K942184.
RECALLING FIRM/MANUFACTURER Hill-Rom Manufacturing, Inc, Charleston, SC.
REASON Power cord overheating.
VOLUME OF PRODUCT IN COMMERCE 1,703 units.
DISTRIBUTION Nationwide.

PRODUCT AEROSET System Software, Catalog 2-95068-01 version 1.02ER000 and Catalog 2-95175-01 AEROSET System Software, version 1.02ER000 Upgrade Kit.
CODE Version 1.02ER000 and Version 1.02ER000 Upgrade Kit.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX.
REASON Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
VOLUME OF PRODUCT IN COMMERCE 133.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Solar 8000M Patient Monitor.
CODE All devices with Solar 8000M software versions 3A, 3B or 3C.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee, WI.
REASON Various user settings may change without an audible warning or visual indication. Examples of settings that may change are pacemaker detection which may turn from on to off, selected ECG leads for display, and selected gain settings for a selected waveform.
VOLUME OF PRODUCT IN COMMERCE 2,809 monitors and 238 software update kits.
DISTRIBUTION Nationwide and Internationally.

PRODUCT ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14. Product is packed in plastic Tyvek packaging and is labeled as sterile.
CODE Lot 432978 Serial Numbers 0460912 to 0460954; Lot 433954 Serial Numbers 0471589 to 0482514; Lot 434846

Serial Numbers 0482490 to 0482514.
RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL.
REASON Instrument is excessively flexible making it unusable by the surgeon.
VOLUME OF PRODUCT IN COMMERCE 21.
DISTRIBUTION LA, ME, NV, and GA.

PRODUCT Siemens Biograph, biograph LSO and CTI Models: Reveal RT.
CODE All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
RECALLING FIRM/MANUFACTURER Cti Pet Systems Inc., Knoxville, TN.
REASON CPS has found that in some instances, when the CTE-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion.
VOLUME OF PRODUCT IN COMMERCE 73.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Mdline Blue O.R. Towel, Sterile; Reorder # MDT2168204, 4 towels per pack, 20 packs per case.
CODE Lot 03IA0532.
RECALLING FIRM/MANUFACTURER Medline Industries, Inc., Mundelein, IL
REASON The product labeled as sterile, had not gone through the sterilization process at the time of shipment.
VOLUME OF PRODUCT IN COMMERCE 44 cases.
DISTRIBUTION OH, IA, IL, WI, and IN.

PRODUCT ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035" Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Catalog numbers: ZILBS-10-4, ZILBS-6-4, ZILBS-8-4, ZILBS-10-6, ZILBS-6-6, ZILBS-8-6, ZILBS-10-8, ZILBS-6-8, ZILBS-8-8.
CODE Lot numbers: 1616783, 1616787, 1622794, 1622798, 1622802, 166958, 1622966, 162970, 162993, 1623007, 1623016, 1626424, 1631805, 1616784, 1616788, 1622795, 1622799, 1622803, 1622959, 1622803, 1622959, 1622963, 1622967, 1622982, 1622994, 1623008, 1623017, 1631388, 1633707, 1616785, 1616789, 1622796, 1622800, 1622804, 1622960, 1622964, 1622968, 1622985, 1623001, 1623009, 1623018, 1631803, 1634239, 1616786, 1616790, 1622797, 1622801, 1622956, 1622961, 1622965, 1622969, 1622986, 1623002, 1623015, 1626423, 1631804, 1635626.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc, Winston Salem, NC.
REASON Complaints were reported of difficulty in stent deployment.
VOLUME OF PRODUCT IN COMMERCE 155 units.
DISTRIBUTION Nationwide, Ireland and Jordan.

PRODUCT FastPack Total Testosterone Immunoassay. Device to determine quantitative total testosterone in human serum. Catalog #: 25000009.
CODE Lots: 0307042, 0308019, and 0308020.
RECALLING FIRM/MANUFACTURER Qualigen, Inc., Carlsbad, CA.
REASON Kits may produce results that are falsely elevated.
VOLUME OF PRODUCT IN COMMERCE 81.
DISTRIBUTION Nationwide and Switzerland.

PRODUCT ComforTEC Plus Impedance Probe, a part of the Insight S980000 Gastrointestinal motility system. Product Model ZAN S61C01E. CODE Lot Number Z0306005.
RECALLING FIRM/MANUFACTURER Sandhill Scientific, Inc., Highlands Ranch, CO.
REASON Pouch containing pediatric probes was labeled as containing adult probes.
VOLUME OF PRODUCT IN COMMERCE 17 probes.
DISTRIBUTION CO, MT, and TX.

WEEK ENDING NOVEMBER 29

PRODUCT OEC UroView 2800 Digital Imaging System.
CODE Manufacturing date prior to September 9, 2002.
RECALLING FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT.
REASON
"Condition 1": Involving systems, manufactured prior to June 25, 2002, that include the optional 15 pulse per second fluoroscopic mode. In these systems, it is possible for the maximum entrance exposure rate (EER) to exceed the regulatory limit of 20 R/minute in high-level control (HLC) mode.
"Condition 2": Involving systems equipped with radiographic spot film mode manufactured prior to September 9, 2002. This condition is met when the FILM button is not held down continuously until the adjacent LED remains lit and control panel display indicates FILM MODE READY, causing the system to not readjust the x-ray field size to the proper fluoroscopic setting for fluoroscopic procedures. When this occurs, the x-ray field size for any subsequent fluoroscopic exposures may be larger than the patient anatomy being viewed.
VOLUME OF PRODUCT IN COMMERCE 153 units.
DISTRIBUTION Nationwide.

PRODUCT LySonix 2000 Ultrasonic Surgical Systems, Model No. LY-2000.
CODE Serial numbers between 0100 and 1219 (inclusive).
RECALLING FIRM/MANUFACTURER Misonix, Inc., Farmingdale, NY.
REASON Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
VOLUME OF PRODUCT IN COMMERCE 1,119 units (approx.).
DISTRIBUTION Nationwide and Internationally.

PRODUCT PeriVac( brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with Pigtail Drainage Catheter; Model/Catalog Numbers: 4304 and 4305.
CODE Batch numbers: All units of this models; UPN numbers: M00443041, M00443051, M00443040, M00443050.
RECALLING FIRM/MANUFACTURER Boston Scientific, San Jose, CA.
REASON The product has the potential to break during withdrawal process.
VOLUME OF PRODUCT IN COMMERCE 11,835 units.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT
a) Belos DR Implantable Cardioverter Defibrillator.
b) Belos DR-T Implantable Cardioverter Defibrillator.
c) Belos VR Implantable Cardioverter Defibrillator.
d) Belos VR-T Implantable Cardioverter Defibrillator.
CODE
a) Serial Number 79610175;
b) Serial Numbers: 79640026, 79640028, 79640030, 79640031, 79640032, 79640033, 79640035, 79640037, 79640039, 79640044, 79640048, 79640049, 79640053, 79640058, 79640060, 79640062, 79640064, 79640065, 79640070, 79640078, 79640079, 79640080, 79640081, 79640082, 79640085, 79640086, 79640087, 79640088, 79640089, 79640091, 79640093, 79640094, 79640095, 79640097, 79640104, 79640116, 79640117, 79640121, 79640239, 79640247, 79640252, 79640323, 79640324.
c) Serial Numbers: 78112903, 78112904, 78112905, 78112906, 78112907, 78112908, 78112909, 78113004, 78113012, 78113013, 78113014, 78113015, 78113016, 78113017, 78113018, 78113019, 78113020, 78113022, 78113054, 78113055, 78113057, 78113058, 78113059, 78113060, 78113061, 78113062, 78113063, 78113064, 78113066, 78113067, 78113071, 78113082, 78113084, 78113085, 78113086, 78113090, 78113091, 78113092, 78113093, 78113094, 78113095, 78113096, 78113113, 78113114, 78113115, 78113116, 78113117, 78113118, 78113119, 78113120, 78113121, 78113122, 78113123, 78113124.
d) Serial Numbers: 78140141, 78140145, 78140146, 78140147, 78140148, 78140150, 78140151, 78140152.
RECALLING FIRM/MANUFACTURER Biotronik, Inc., Lake Oswego, OR.
REASON Potential extended charge time anomalies.
VOLUME OF PRODUCT IN COMMERCE 106 devices.
DISTRIBUTION Nationwide.

PRODUCT
a) Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
b) Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
CODE
a) Serial Numbers: 7811xxxx;
b) Serial Numbers: 7814xxxx.
RECALLING FIRM/MANUFACTURER Biotronik, Inc., Lake Oswego, OR.
REASON Potential for early depletion of Implantable Cardioverter Defibrillator battery.
VOLUME OF PRODUCT IN COMMERCE 1,066 devices.
DISTRIBUTION Nationwide.

PRODUCT LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703. Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.
CODE Units shipped prior to 3/03.
RECALLING FIRM/MANUFACTURER Electro Medical Systems (EMS SA), Nyon, CH.
REASON Failure of foot pedal to activate device.
VOLUME OF PRODUCT IN COMMERCE 96 units.
DISTRIBUTION Nationwide.

PRODUCT RITA brand ThermoPad, Electrosurgical RF Generator and accessories Part Number: 700-102649
CODE Lot number: Y072103-3.
RECALLING FIRM/MANUFACTURER Rita Medical Systems, Mountain View, CA.
REASON The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
VOLUME OF PRODUCT IN COMMERCE 137 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
b) Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.
CODE a) and b) Serial numbers 0001 through 0599.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp., Ann Arbor, MI.
REASON The roller pump tube clamp mechanism may fail to release, making it difficult to remove or insert the tubing, and thereby delaying perfusion.
VOLUME OF PRODUCT IN COMMERCE 548.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 2 1/2 inches in length. Catalog # 281-01-01.
b) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 2 3/4 inches in length. Catalog # 281-01-02.
c) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 inches in length. Catalog # 281-01-03.
d) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/4 inches in length. Catalog # 281-01-04.
e) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-01-05.
f) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 3 3/4 inches in length. Catalog # 281-01-06.
g) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 inches in length. Catalog # 281-01-07.
h) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-01-08.
i) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-01-10.
j) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 inches in length. Catalog # 281-01-11.
k) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 5 3/4 inches in length. Catalog # 281-01-14.
l) Zimmer brand Knowles pin with 5/32 in. threaded diameter, 1/8 in. shaft diameter and 6 inches in length. Catalog # 281-01-15.
m) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 inches in length. Catalog # 281-02-03.
n) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 1/4 inches in length. Catalog # 281-02-04.
o) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 1/2 inches in length. Catalog # 281-02-05.
p) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 3 3/4 inches in length. Catalog # 281-02-06.
q) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 inches in length. Catalog # 281-02-07.
r) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 1/4 inches in length. Catalog # 281-02-08.
s) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 1/2 inches in length. Catalog # 281-02-09.
t) Zimmer brand Knowles pin with 3/16 in. threaded diameter, 5/32 in. shaft diameter and 4 3/4 inches in length. Catalog # 281-02-10.
CODE
a) Lot Numbers: 00327200, 55416800 and 60019267;
b) Lots 54382000, 55444200, 60008252 and 60011140;
c) Lots 54382100, 54396500, 54987200, 55416900, 60010924, 60023409 and 60028438;
d) Lots 53826200, 54382200, 55444300 and 60019268;
e) Lots 00330600, 54162100, 54382300, 55039300, 55147500, 55236100, 55417000, 60013747 and 60019270;
f) Lots 54382400, 54396600, 55039400, 55102400, 55236200, 60013749 and 60024242;
g) Lots 54146500, 54458400, 55039500, 55236300, 60019272 and 60028439;
h) Lots 30003800, 54881700, 55039600, 55236400, 60013751 and 60019275;
i) Lots 55444400 and 60028441;
j) Lot 60033279;
k) Lot 54008400;
l) Lot 54008500;
m) Lots 54396700, 55102500, 60008253, 60011141, and 60013753;
n) Lots 54978600, 60011142 and 60013758;
o) Lots 00041400, 00087800, 54008600, 54162200, 54493900, 55039700, 60004569, 60013760 and 60019282;
p) Lots 60008254, 60013762 and 60019284;
q) Lots 53826300, 54162300, 54382500, 55102600, 55247300, 60011144, 60013765, 60019287, 60025555 and 60035945;
r) Lot 60028449;
s) Lot 60028450;
t) Lots 60028451 and 60031021.
RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN.
REASON The pin may fail because the metal used to make the pin does not meet the firm's hardness specification.
VOLUME OF PRODUCT IN COMMERCE 4,608.
DISTRIBUTION Nationwide and Internationally.