FEBRUARY 2004

WEEK ENDING FEBRUARY 7

PRODUCT Mammography X-Ray Systems.
CODE Model Number: Seneographe 2000D, DMR (all versions), 700T, 800T, 500 (all versions), and 600 (all versions).
RECALLING FIRM/MANUFACTURER General Electric Medical System, Waukesha, WI.
REASON The Mammography System's user information was missing the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
VOLUME OF PRODUCT IN COMMERCE 6,931 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp.
b) Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp.
CODE Catalog numbers 4115571, YG18568, YG19051, and YG19262.
RECALLING FIRM/MANUFACTURER Drager Medical, Inc., Telford, PA.
REASON The adjustment screw may break due to material fatigue.
VOLUME OF PRODUCT IN COMMERCE 51 units.
DISTRIBUTION Nationwide and Canada.

PRODUCT ICON 25 h CG test kit.

CODE Lot HCG030732.
RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA.
REASON Test can exhibit false negative results.
VOLUME OF PRODUCT IN COMMERCE 7,668.
DISTRIBUTION Nationwide.

PRODUCT Cidex Plus Test Strips.
CODE Product code 2924 - Lot 010185; Product code 2926 - Lot 010252.
RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA.
REASON Product may not accurately detect minimum effective concentration (MEC).
VOLUME OF PRODUCT IN COMMERCE 710 cases, 2 bottles per case.
DISTRIBUTION Nationwide, Japan, Puerto Rico, Latin America, and the Caribbean.

PRODUCT Baxter 6060 Multi-Therapy Infusion Pump, product code 2M9832.
CODE Serial numbers 108050HR, 108183HR, 108298HR, 109036HR, 109216HR, 109622HR, 110004HR, 110700HR, 111126HR, 111270HR, 111540HR, 112441HR, 201178HR, 308361HR/308440HR, 309001HJ/309030HJ, 309001HR/309345HR 309001HW/309015HW, 310001HG/310010HG , 310001HW/310010HW , 310007HR/310088HR, and HR1976/HR27480. Only those pumps within these serial numbers with installed motor assemblies from date codes 33/03, 34/03 and 35/03 are affected.
FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON Premature motor failure.
VOLUME OF PRODUCT IN COMMERCE 188 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Micromix BCR Compounder, product code 2M8297; a pharmacy automation device with a barcode reader used in preparation of parenteral solutions.
CODE Serial numbers T2001/T20014, T20016/T20018, T20021, T20023/T20028.
RECALLING FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL.
REASON The compounder may omit an ingredient during the compounding process.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION WI and UT.

PRODUCT MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens).
CODE SFC-25 (8 lots) 1180608, 1181078, 1181170,1181171, 1181396, 1181397, 1182237, 1184864 MTC-60 (25 lots) 1177222, 1177950, 1178121, 1178212, 1176868, 1177421, 1178738, 1178883, 1178885, 1179023, 1181789, 1181790, 1181797, 1181798, 1181980, 1182245, 1182342, 1182343, 1182344, 1182345, 1182675, 1182676, 1182677, 1182761.
RECALLING FIRM/MANUFACTURER Staar Surgical Co, Inc., Monrovia, CA.
REASON Increased numbers of lens tears during placement of lens into eye.
VOLUME OF PRODUCT IN COMMERCE 29,021.
DISTRIBUTION Nationwide, Canada and Australia.

PRODUCT CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). (OTC) Item Number: 191648.
CODE All lot codes.
RECALLING FIRM/MANUFACTURER CVS, Woonsocket, RI.
REASON Product label fails to provide adequate warning for use.
VOLUME OF PRODUCT IN COMMERCE 19,261 units.
DISTRIBUTION Nationwide.

PRODUCT
a) Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331.
b) Kendall Kerlix Large Roll, 4.5 in X 4.1 yd, Sterile Product Number: 6730.
c) Kendall Curity Disposable Laparotomy Sponges, 12 in x 12 in, Sterile Product Number: 6034.
CODE
a) Lot Number: 33492700;
b) Lot Numbers: 33462700 33462701 33462702 33462703 33472700 33472701;
c) Lot Number: 33452700.
RECALLING FIRM/MANUFACTURER Kendall Healthcare Products Co., Mansfield, MA.
REASON Sterility compromised due to lack of package seal integrity.
VOLUME OF PRODUCT IN COMMERCE 193 cases.
DISTRIBUTION Nationwide.

PRODUCT
a) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: 3i Implant DC500 LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE.
b) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DDK315 LOT Disposable Drill Kit with DT315 STERILE.
c) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT220 2.3mm (D)x 20.0 mm (L) STERILE.
d) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT 310 LOT 3.0 mm (D) X 10.0 mm (L) STERILE.
e) Products are various dental surgical drills packed in a sealed tray and labeled as sterile. The tray is labeled as follows: DT423 LOT 4.25 mm (D) X 13.0 mm (L) Disposable Twist Drill STERILE.
CODE
a) Lot # 219630;
b) Lot # 220995 and 221052;
c) Lot # 219636;
d) Lot # 221285;
e) Lot # 221393.
RECALLING FIRM/MANUFACTURER Implant Innovations, Inc.
REASON The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.
VOLUME OF PRODUCT IN COMMERCE 565.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Holdex(r) + Butterfly, Blood Collection Set, Single use only. Sterile.
CODE Item # 450271, Lot # 12-8461.
FIRM/MANUFACTURER Greiner VACUETTE North America, Monroe, NC.
REASON Product may have a defective connection.
VOLUME OF PRODUCT IN COMMERCE 5 cases (5000 pieces).
DISTRIBUTION IN, NY, and TX.

PRODUCT
a) ARCHITECT(r) Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Medium Control M 7.0 ng/mL;

b) ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL.
c) ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer.

d) ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30).
e) AxSYM Folate Specimen Diluent, list 3C81-50, 10 mL bottles containing TRIS buffer with protein stabilizer.
f) AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin.
g) AxSYM Folate Medium Control Pack, list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL.
h) Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL.
i) IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL.
j) IMx Folate Mode 1 Calibrator Pack, list 2220-40, the pack contains 3 - 2 mL bottles of IMx Folate Mode 1 Calibrator 3.0 ng/mL.
k) IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin.
l) IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells.
CODE
a) List 6C12-10, Lots 94718M200 and 04619M100;
b) List 6C12-11, Lot 06867M200;
c) List 6C12-50, Lots 07460M300, 11435M100;
d) List 6C12Y: lots 06537M100Y, 09888M100Y, 06537M101Y, 05081M100Y, 07465M300Y and 10587M200Y. These diluent lots were packaged in the following reagent kit lots: List 6C12-20 (4 x 100 tests), lots06537M100 and 09888M100; List 6C12-25 (100 tests), lots 06537M101and
05081M100; List 6C12-30 (4 x 500 tests), lots 07465M300 and 10587M200.
e) List 3C81-50, lots 91555M100, 05920M200;
f) List 3C81-65, lot 06783M100;
g) List 3C81-11, lot 01552M100;
h) List 9C13-10, lots 95523M200, 08899M100;
i) List 2220-11, lots 06320M200, 09655M100;
j) List 2220-40, lots 02181M200, 04441M300, 06371M200;
k) List 2220-50, lots 03234M300, 04030M300;
l) List 2220-88, lots 90376M300 and 90376M301.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON There is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
VOLUME OF PRODUCT IN COMMERCE 12,388 packs.
DISTRIBUTION Internationally.

PRODUCT Directigen (tm) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog # 256030.
CODE Lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04.
RECALLING FIRM/MANUFACTURER Becton Dickinson & Co., Sparks, MD.
REASON Diagnostic test kit may exhibit false positive results.
VOLUME OF PRODUCT IN COMMERCE 600 kits.
DISTRIBUTION Nationwide and Internationally.

FDA and Johnson and Johnson Warn Public About Counterfeit Contraceptive Patches Sold Through Foreign Internet Site

FDA and Johnson and Johnson Co. of Raritan, NJ are warning the public about an overseas internet site selling counterfeit contraceptive patches that contain no active ingredients. These counterfeit patches provide no protection against pregnancy.

This internet site's domain name, www.rxpharmacy.ws apparently is operated by American Style Products of New Delhi, India. The site also sells other products that purport to be versions of FDA-approved drugs. FDA is investigating these other products as well, and urges consumers to treat any drugs purchased from this firm as being suspect. None of these products should be considered safe or effective. Consumers who have any of these products should not use them, but instead contact their healthcare providers immediately.

The counterfeit contraceptive patches were promoted as Ortho Evra transdermal patches, which are FDA approved, and made by Johnson and Johnson's Ortho-McNeil Pharmaceutical, Inc. subsidiary.

Instead customers receive packages of patches without the active ingredient necessary to make the patches effective. Moreover, the counterfeits are sent in simple plastic zip-lock bags without identifying materials, lot numbers, expiration dating or any other labeling information needed to safely and effectively use this prescription product.

The FDA-approved Ortho Evra contraceptive patch is an adhesive patch that contains a combination of an estrogen and a progestin for contraception. The patch is applied to the skin of a woman's abdomen, upper outer arm, upper torso or buttock for seven days. A new patch is applied each week for three weeks (21 total days), followed by one patch-free week.

The FDA-approved patch product is 1¾ inches square, beige in color, made of a thin film, and comes packaged in a sealed, opaque, white pouch with the product label attached to one side of the pouch. The lot number and expiration date for the product are printed on the attached label and on the back side of the pouch without the attached label.

The counterfeit product is 1½ inches square, brown in color, made of woven material, and has 5 holes that appear as red dots on the middle of the top side of the patch. This product also has a ¾ inch orange square resembling gauze under the plastic liner on the back side of the patch.

The product does not come packaged in a sealed pouch and does not contain lot number or expiration date information.

Photos contrasting the legitimate contraceptive patch with the counterfeit are on display at the FDA's website: http://www.fda.gov/bbs/topics/news/photos/contraceptive/counterfeit.html

Women who have been sent contraceptive patches lacking proper labeling or not having the appearance of the approved Johnson and Johnson Ortho Evra product as described above should not use the product and should contact their healthcare providers immediately.

To date no reports of pregnancies linked to this product have been received by FDA and distribution of the counterfeit products appears limited to this internet site.

Consumers seeking to buy safe and effective drugs via the internet should only purchase from internet sites bearing the Verified Internet Pharmacy Practice Sites (VIPPS) seal showing that they are in accordance with the National Boards of Pharmacy standards.

WEEK ENDING FEBRUARY 14

PRODUCT 50 mL sterile plastic centrifuge tubes.
CODE Codes 3250, 3250P, 3252, 3252P and the lot numbers: 69766 through 87512 which were manufactured from 02/03/03 - 09/22/2003 Also: 3250-DES1, 3250P-DES1, 3252-DES1, 3252P-DES1, 3250P-MIS1, 3252P-MIS1, 3250P-USA1, 3252P-USA1.
RECALLING FIRM/MANUFACTURER Stockwell Scientific, Inc., Scottsdale, AZ.
REASON Tubes are brittle and break during centrifuging specimens.
VOLUME OF PRODUCT IN COMMERCE 3,762 cases (500 tube each).
REASON Nationwide and Canada.

PRODUCT Product is packaged in a box and is labeled: Syphilis TREP-CHEX No. 720-100-10, 960 test, For in Vitro Diagnostic Use.
CODE Lot Number 71303, expiration date June 2004.
RECALLING FIRM/MANUFACTURER Diamedix Corporation, Miami, FL.
REASON The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
VOLUME OF PRODUCT IN COMMERCE 8.
REASON AZ, CA and TX.

PRODUCT
a) TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-60;
b) TDx/TDxFLx REA Ethanol, list 9545-60;
c) TDx/TDxFLx Salicylate, list 9533-60;
d) TDx/TDxFLx Methadone, list 9676-60;
e) Adx Methadone, list 9676-55;
CODE
a) All lots with insert version 66-9771/R3. The corrected insert is version 34-2897/R4;
b) All lots with insert version 69-5787/R4. The corrected insert is version 34-2778/R5;
c) All lots with insert version 69-6373/R4, 69-6003/R3 or 66-6296/R2. The corrected insert is version 34-3033/R5;
d) All lots with insert version 69-5996/R3. The corrected insert is version 34-2361/R4;
e) All lots with insert version 69-5997/R4. The corrected insert is version 69-6506/R5.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table.
VOLUME OF PRODUCT IN COMMERCE 8,139 kits.
REASON Nationwide and Internationally.

PRODUCT
a) Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000.
b) Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000.
CODE
a) Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04; #195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440, Exp 4/29/04; #213466, Exp 5/24/04;
b) Lots #178052, Exp 2/7/04; #182567, Exp 1/7/04; #195339, Exp 2/18/04; #207487, Exp 4/29/04.
RECALLING FIRM/MANUFACTURER Perkin Elmer Life and Analytical Sciences, Inc., Norton, OH.
REASON The device is not stable throughout its labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 511 kits.
REASON Nationwide.

WEEK ENDING FEBRUARY 21

PRODUCT AG-920RA Multi-gas unit analyzer.
CODE Serial numbers 00001 to 00020, 00022, 00023, 00024, 00029.
RECALLING FIRM/MANUFACTURER Nihon Kohden America Inc., Foothill Ranch, CA.
REASON Manufacturing error results in screw affecting electromagnetic interferences.
VOLUME OF PRODUCT IN COMMERCE 24.
DISTRIBUTION CA, OK, and NV.

PRODUCT CryoValve, Pulmonary Valve & Conduit.
CODE Donor number: 71237, Serial number: 8214013, Model number: PV00.
RECALLING FIRM/MANUFACTURER Cryolife Inc., Kennesaw, GA.
REASON The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact
Case; 870055-Adult Complete in Display Case; 875500-b) Adult Update Kit.
LAERDAL Silicone Resuscitator (LSR), Pediatric Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 860050-Pediatric Basic w/o Mask in Carton; 860051-Pediatric Complete in Carton; 860052-Standard Child w/Child Mask 3-4 in Carton; 860053-Pediatric Complete in
Compact Case; 860055-Pediatric Complete in Display Case; 860056-Standard Term-Baby w/Infant Mask 0-1 in Carton; 865500-Pediatric Upgrade Kit.

c) LAERDAL Silicone Resuscitator (LSR), Preterm Size, containing an Intake/Reservoir Valve. Sold as Part Nos: 850050-Preterm Basic w/o Mask in Carton; 850051-Preterm Complete in Carton; 850053-Preterm Complete in Compact Case; 850055-Preterm Complete in Display Case; 855500-
Preterm Update Kit.

d) Intake/Reservoir Valve (Part No. 875400), used in all sizes of Laerdal Silicone Resuscitators.
CODE
a) All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
b) All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
c) All product shipped after 1/29/2003 is affected. The following lot numbers are the lot numbers for adult, pediatric and preterm size LSR: 0403, 0703, 0803, 0903, 1003, 1103, 1203, 1303, 1403, 1503, 1603, 1703, 1803, 1903, 2003, 2103, 2203, 2303, 2503, 2703, 2903, 3103, 3203, 3303, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303, 4403, 4503, 4603, 4703, 4803, 4903. NOTE: customers were NOT provided with lot numbers. They were
instructed to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
d) Lot numbers were not provided. All product shipped after 1/29/2003 is affected. Customers need to visually examine the Intake/Reservoir valve in order to determine if they have affected product.
RECALLING FIRM/MANUFACTURER Laerdal Medical Corporation, Wappingers Falls, NY.
REASON Potential for the Flap Valve component of the Intake/Reservoir Valve to become dislodged from its mount, rendering the resuscitator inoperative.
VOLUME OF PRODUCT IN COMMERCE 5,421 pieces.
DISTRIBUTION Nationwide, and Internationally.

PRODUCT Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029.
CODE Lot Number: 160760 Expiration Date: 2006-12.
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Danvers, MA.
REASON Catheter distal tip may separate.
VOLUME OF PRODUCT IN COMMERCE20 units.
DISTRIBUTION NC, and WA.

PRODUCT
a) Stryker brand Adel Maternity bed, model 4700, with night light.
b) Stryker brand Firstcare Ultra Maternity bed, model 5010, with night light.
c) Stryker brand Firstcare Ultra Maternity bed and Stryker brand Adel Maternity bed, 220 volt, model 5012, with night light.
CODE
a) All beds manufactured between August 1, 2000 and December 23, 2003;
b) and c) All beds manufactured between January 1, 1997 and December 23, 2003.
RECALLING FIRM/MANUFACTURER Stryker Medical, Kalamazoo, MI.
REASON A potential shock hazard exists if the night light is damaged.
VOLUME OF PRODUCT IN COMMERCE 2,396.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Synergraft CryoValve, Aortic Valve & Conduit SG. Donor #60525, Model #SGAV00.
b) CryoValve, Pulmonary Valve & Conduit. Donor #69666, Model #PV00.
c) CryoValve, Aortic Valve & Conduit. Donor #69666, Model #AV00.
CODE
a) Serial # 7759189;
b) Serial # 8008568;
c) Serial # 8008559.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Microorganisms were detected in associated tissue.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA, MI, and OK.

PRODUCT
a) Esaote brand Archimed 4220 ECG System; part 9704220000.
b) Esaote brand Formula for Archimed ECG System; part 9704220000.
c) Esaote brand ArchiWin Colour ECG System; part 9704325000.
d) Esaote brand Formul@ ECG System; part 9704220000.
CODE
a) Serial numbers: 110, 124, 125, 128, 131, 137, 189, 258, 325, 513, 514, 521, 522, 523, 525, 696, 877, 835, 836, 837, 1089, 1090, 1091, 1096, 1138, 1419, 1466 and 1467;
b) Serial numbers: 103, 106, 107, 108, 129, 135, 136, 197, 205, 242, 270, 348, 361, 373, 420, 441, 462, 464, 520 and 522;
c) Serial number 149;
d) Serial numbers 157 and 158.
RECALLING FIRM/MANUFACTURER Esaote Biomedica S.P.A., Indianapolis, IN.
REASON If certain keys on the keyboard are pressed during rest ECG procedure, the ECG data may be assigned to the wrong patient.
VOLUME OF PRODUCT IN COMMERCE 51.
DISTRIBUTION CA, FL, IN, KY, Brazil, Colombia and Japan.

PRODUCT Pump Tube, Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones.
CODE Part number 8170.121. There is no lot number or production code.
RECALLING FIRM/MANUFACTURER Richard Wolf Medical Instruments Corp., Vernon Hills, IL.
REASON If the drain tube is assembled incorrectly, the suction pump will not operate as intended.
VOLUME OF PRODUCT IN COMMERCE 2 tubing sets.
DISTRIBUTION TX, and NE.

PRODUCT
a) Magnetom Trio System. Nuclear Magnetic Resonance Imaging Diagnostic Device.
b) Magnetom Allegra System. Nuclear Magnetic Resonance Imaging Diagnostic Device.
CODE
a) Model #7387074 - Serial #'s: 20501 through 20508, 20510 through 20524, and 20550 through 20570. Model #7106441 - Serial # 20500.
b) Model #7106433 - Serial #'s 20101 through 20113. Model #7387736 - Serial #'s 20405, 20406, 20411, 20412, and 20419.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA.
REASON Tissue roll can become magnetic.
VOLUME OF PRODUCT IN COMMERCE 32 units.
DISTRIBUTION Nationwide.

PRODUCT CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version BIA.
CODE S/Ns: 100 thru 105, and 107 thru 116.
RECALLING FIRM/MANUFACTURER GVI Technology Partners, Twinsburg, OH.
REASON Due to limitations in the operating software, the acquired scan may not be processed properly.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION PA, OH, FL, and SC.

PRODUCT Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software.
CODE All software versions 5.0A and 5.0B.
RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA.
REASON A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software.
VOLUME OF PRODUCT IN COMMERCE Undisclosed.
DISTRIBUTION Nationwide.

PRODUCT Four Shooter Saeed Multi-Band Ligator. Reorder/Catalog number MBL-4XL.
CODE Lot W1842922.
RECALLING FIRM/MANUFACTURER Wilson-Cook Medical Inc., Winston Salem, NC.
REASON Product label lacks the symbols specifying the meaning of the manufacturing and expiration date.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

WEEK ENDING FEBRUARY 28

PRODUCT Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00.
CODE CPU Serial Numbers: LT00001-LT000015, LT000017-LT000019, TA00274, TA00415, TA00415-HA, TA00468, TA00554, TA00582, TA 00587, TA00587-HA, TA00639, TA00738, TA00745, TA00854, TA00856, TA00861, TA00880, TA00889, TA00891, TA01200, TA01217, TA01218, TA01253, TA01278, TA01279, TA01286, TA01304, TA01306, TA01327, TA01359, TA01359-HA, TA01387, TA01387-HA, TA01388-TA01398, TA01391HA, TA01400-TA01411, TA01413-TA01423, TA01426-TA01435, TA01433-HA, TA01438--TA01446, TA01448-TA01455, TA01453-HA, TA01457-TA01461, TA01463, TA01463-HA, TA01464, TA01466-TA01469, TA01471-TA01480, TA01473-HA, TA01478-HA, TA01481-HA, TA01482-TA01486, TA01484-HA, TA01485-HA, TA01488, TA01488-HA, TA01490-TA01493, TA01493-HA, TA01499-TA01515, TA01508-HA, TA01509-HA, TA01510-HA, TA01515-HA, TA01517-TA01526, TA01522-HA, TA01523-HA, TA01525-TA01528, TA01530-TA01546, TA01534-HA, TA01535-HA, TA01536-HA, TA01537-HA, TA01544-HA, TA01548-TA01550, TA01552--TA01561, TA01561-HA, TA01563-TA01570, TA01567-HA, TA01568-HA, TA01574.
RECALLING FIRM/MANUFACTURER Welch Allyn Protocol, Inc., Beaverton, OR.
REASON Potential failure to audibly alarm due to speaker hardware component failure.
VOLUME OF PRODUCT IN COMMERCE 233 devices.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF.
CODE No Codes.
RECALLING FIRM/MANUFACTURER Staar Surgical Co., Inc., Monrovia, CA.
REASON Risk of hyperopic refractive changes.
VOLUME OF PRODUCT IN COMMERCE 160,642.
DISTRIBUTION Nationwide and Internationally.