OCTOBER 2002

WEEK ENDING OCTOBER 5

 

PRODUCT Automated differential cell counters: a) Coulter LH 700 Series Hematology Analyzers; b) Coulter GEN S Hematology Analyzers.
CODE Lot numbers do not apply.
RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter, Inc., Brea, CA. Manufacturer: Coulter Corp., Hialeah, FL.
REASON Incorrectly gates Neutrophil population in patient samples.
VOLUME OF PRODUCT IN COMMERCE 1268.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT a) P645 Specialite Patient Light; b) P696IL Integris 1000 Patient Light; c) P2003B Integris B Patient Lite Rail; d) P780D Deep Impression Light for use with the Impression Series Headwall.
CODE All units distributed between May 24, 2002 and June 21, 2002.
RECALLING FIRM/MANUFACTURER Hill-Rom Co. Inc., Batesville, IN.
REASON Switch fails to function as intended due to incorrect amp size switch.
VOLUME OF PRODUCT IN COMMERCE  843.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite).

CODE All Serial numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Disetronic Medical Systems, Inc., St. Paul, MN.
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland.
REASON Some pumps started programming a bolus that was not initiated by the pump user, and the delivery of an unintended bolus was made unless interrupted by the device user.
VOLUME OF PRODUCT IN COMMERCE 3357 insulin infusion pumps in the U.S.
DISTRIBUTION Nationwide.

 

PRODUCT Aeroset Software Version 1.01ER000.
CODE Catalog number 2-94815-01, The AEROSET Software is not controlled by lot or control numbers.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX
REASON Sample results may be skewed by failure to properly 'blank' the sample.
VOLUME OF PRODUCT IN COMMERCE 1.
DISTRIBUTION FL.

 

PRODUCT a) Hill-Rom brand Advanta 1600 series hospital beds as follows: Model P1600B; full featured general hospital bed; b) Model P1603B; semi-de-featured general hospital bed; c) Model P1604B; de-featured general hospital bed.
CODE All units distributed prior to July 24, 2002.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Unintentional movement of the bed.
VOLUME OF PRODUCT IN COMMERCE 50,000.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Sterile 4" x 4", 16-ply gauze sponges packaged 10 sponges per formed plastic tray with tyvek lid, The following gauze products are being recalled: a) Medline Accu-Sorb X-Ray Detectable USP Type VII Gauze; b) Medline Gauze Sponge USP Type VII Gauze.
CODE a) Product number NON21430LF, lot numbers 02EA0473, 02FA0432; b) Product number NON21428, lot numbers 02EA0297, 02FA0317,
02FA0431.
RECALLING FIRM/MANUFACTURER Medline Industries, Inc., Mundelein, IL.
REASON Compromised packaging integrity - questionable sterility.
VOLUME OF PRODUCT IN COMMERCE 809 cases.
DISTRIBUTION Nationwide.

 

PRODUCT Defibrillator/ Pacer Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202.
CODE Serial Numbers 10392 thru 10540.
RECALLING FIRM/MANUFACTURER Recalling Firm: Medical Data Electronics, Inc., Arleta, CA.
Manufacturer: Medical Research Laboratories, Arleta, CA.
REASON Intermittent operation of the paddles.
VOLUME OF PRODUCT IN COMMERCE 54 sets of two paddles each.
DISTRIBUTION Nationwide and Pakistan and Mexico.

 

PRODUCT Parallax Medical brand EZFlow Cement Delivery System Catalog #s:
a) CDS-110; b) CDS-122; c) CDS-132; d) CDS-2210; e) CDS-2212.

CODE a) Lot # 021202 (Part # 40001); b) Lot #s 082701 (Part # 40004), 021302 (Part # 40004), 021302A (Part # 40004); c) Lot # 030102 (Part # 40032); d) Lot #s 083101 (Part # 40008), 082301 (Part # 40008), 082301A (Part # 40008), 103001, (Part # 40008), 103001A (Part # 40008), 103101 (Part # 40008), 103101A (Part # 40008); e) Lot #s 100401, (Part # 40009), 103001, (Part # 40009), 103001A (Part # 40009), 040202 (Part # 40009),
021402 (Part # 40009).
RECALLING FIRM/MANUFACTURER Parallax Medical, Inc., Scotts Valley, CA

REASON Firm has identified a number of units which may have breaches in the pouch seal.
VOLUME OF PRODUCT IN COMMERCE 3626 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT MDE Escort Prisim SE A portable patient monitor.
CODE Too numerous to detail.
RECALLING FIRM/MANUFACTURER Medical Data Electronics, Inc., Arleta, CA.
REASON Printed circuit board flaw might allow cuff to overinflate.
VOLUME OF PRODUCT IN COMMERCE 3,569.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) REF 220039, MicroJect 30 Pump, continuous low flow; b) REF 220041, MicroJect 200 Pump, intermittent or continuous flow.
CODE All MicroJect Ambulatory Infusion Pump, Model #30 and #200, manufactured from 5/1/2000 through 11/19/2001.Model #30 serial numbers in the range 37037 thru 64215. Model #200 serial numbers in the range 40069 thru 64008.
RECALLING FIRM/MANUFACTURER Sorenson Medical, Inc., West Jordan, UT.
REASON Reports of under-infusion and pump housing separation.
VOLUME OF PRODUCT IN COMMERCE  4,725.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) Balanced Knee System, PS Tibial Insert Size 6 16mm; b) Balanced Knee System, PS Tibial Insert Size 4 20mm. Each insert is a component of the Balanced Knee System, packaged individually.
CODE a) Catalog Number 163-1616, Lot Number W012563; b) Catalog Number 163-1420, Lot Number W012536.
RECALLING FIRM/MANUFACTURER Ortho Development Corp., Draper, UT.
REASON Outer box product label showed incorrect size.
VOLUME OF PRODUCT IN COMMERCE 39 units.
DISTRIBUTION Nationwide.

 

PRODUCT Somatom Smile Computed tomography system, Diagnostic Imaging -- Model #7053502.
CODE 4 units under the Siemens part # SMILE 7053502 Serial Numbers: 20041; 20035; 20031; 20032.
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Shanghai, Medical Equipment, Ltd., Shanghai, China 200090.
REASON Errors can occur when performing gantry tilt examinations.
VOLUME OF PRODUCT IN COMMERCE 3.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Vitek GNS-204, product #V4526, gram negative susceptibility cards individually wrapped in a mylar pouch, 20 cards per box, for use in the antimicrobial susceptibility testing of rapidly growing aerobic and/or facultatively anaerobic, gram-negative bacilli.
CODE S51B, Exp. 6/11/03.
RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Hazelwood, MO.
 REASON Mislabeled. This results in an incorrect susceptible/resistant result for the AST's included in the GNS 204 card.
VOLUME OF PRODUCT IN COMMERCE 2,572/20-card boxes.
DISTRIBUTION Nationwide.

 

PRODUCT Proteus XR/a Stationary X-ray System, Model Numbers: 2244165, 2259976, 2212259, 2259973 and 2268970.
CODE All serial numbers of units in distribution prior to the start of the field correction in January 2001 are affected.
RECALLING FIRM/MANUFACTURER General Electric Medical Systems, Waukesha, WI
REASON Screws that mount the collimator interface plate may loosen and fall out allowing the collimator to fall.
VOLUME OF PRODUCT IN COMMERCE 73 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Thoratec TLC-II Portable VAD Driver System Driver Model numbers: 20010-0000-081, 20010-0000-132.
CODE Controller Board Lot # 2001-36, 2002-17.
RECALLING FIRM/MANUFACTURER Thoratec Corp., Pleasant, CA
REASON Component defects that can cause TLC-II driver to abruptly stop functioning.
VOLUME OF PRODUCT IN COMMERCE 34 units.
DISTRIBUTION Nationwide and Australia, Canada and Singapore.

 

PRODUCT Ti Cann Troch Fixation Nail. The generic name is Trochanteric Fixation Nail.
CODE These devices expired in 5/2011. Part number 456.318S Lot number 4417099 Part number 456.322S Lot numbers 4417109, 4417111, and
4417112 Part number 456.416S Lot number 4417280.
RECALLING FIRM/MANUFACTURER Recalling Firm: Synthes (USA), Paoli, PA. Manufacturer: Synthes (USA), Monument, CO.
REASON Manufactured outside design specifications The medial side of the oblique hole may be oval instead of round.
VOLUME OF PRODUCT IN COMMERCE 66 units.
DISTRIBUTION Nationwide.

 

PRODUCT Misys Laboratory.
CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ.
REASON Software anomaly. Footnotes are incomplete and do not print on reports.
VOLUME OF PRODUCT IN COMMERCE 458.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Misys Laboratory.
CODE Versions 5.2, 5.23, 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ.
REASON Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved.
VOLUME OF PRODUCT IN COMMERCE 477.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Genuine ONE TOUCH *** Test Strips *** Lot No. *** Exp. Date ***  LIFESCAN INC a Johnson & Johnson company Milpitas, California; ***". UNI-CHECK Test Strips *** Catalog No.1702720 *** QTY: 24 Packages of 50 Strips/Package *** Lot No.: *** Expires:
CODE Johnson and Johnson One Touch, Lots 170814A, 170815A, 170892A and any other lots purchased from Medsource. Johnson and Johnson Uni-check, Lots 12115A7W and any other lots purchased from Medsource.
RECALLING FIRM/MANUFACTURER Farnes Enterprises dba MedSource Direct, Woods Cross, UT
REASON Blood glucose test strips were not approved for sale in the U.S. and Canada.
VOLUME OF PRODUCT IN COMMERCE 2,198 units.
DISTRIBUTION Nationwide.

 

PRODUCT Caleo Infant Warming System. The product is an incubator.
CODE Catalog Numbers: 4117025-006, 4117025-007, 4117025-008, 4117025-009, and 4117025-018.
RECALLING FIRM/MANUFACTURER Recalling Firm: Drager Medical, Telford, PA.
REASON Temperature measurement error.
VOLUME OF PRODUCT IN COMMERCE 66 units.
DISTRIBUTION CA, FL, GA, NC, NE, OH, PA and Canada.

 

PRODUCT Microject 30 Pump, Ref 220039. Packaged individually or in cases of 10.
CODE Lots 201139 and 202070.
RECALLING FIRM/MANUFACTURER Sorenson Medical, Inc., West Jordan, UT.
REASON Pumps were released after failing established AQL acceptance levels.
VOLUME OF PRODUCT IN COMMERCE 178 units.
DISTRIBUTION CA, CO, GA, IL, MO, NY, TX, and Canada, France, Singapore and Venezuela.

 

PRODUCT Solan Trephine Blade, 9 mm and also the 10mm sizes (different products), packed one unit per box. Corneal Trephine
CODE Catalog Number 00-09717, lot 25209500 and Catalog Number 00-09721, lot number 23214300.
RECALLING FIRM/MANUFACTURER Xomed, Inc., Jacksonville, FL.
REASON Outer box mislabeled as 9mm when product is 10mm.
VOLUME OF PRODUCT IN COMMERCE 8.
DISTRIBUTION MO, TX, IL KY and MI.

 

PRODUCT Freshlook Color Enhancers (phemfilcon A) Contact Lenses; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box.
CODE Lot 024909, exp. 2006-07, Blue, base curve: median, diameter: 14.5, sphere: -2.25.
RECALLING FIRM/MANUFACTURER Wesley Jessen Corp., Des Plaines, IL.
REASON Mislabeled for corrective power.
VOLUME OF PRODUCT IN COMMERCE 560 6-packs.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT MeriFluor CMV IgM IFA/IFT, packaged under the Gull label.
CODE
Lot Number: CM150.022, Exp. 20 DEC 02
Lot Number: CM150.023, Exp. 20 DEC 02
Lot Number: CM150.024, Exp. 20 DEC 02
Lot Number: CM150.025, Exp. 05 JAN 03.
RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH.
REASON The Negative Control does not meet labeled specifications.
VOLUME OF PRODUCT IN COMMERCE 189 kits.
DISTRIBUTION Nationwide and Canada, Belgium, Italy and Australia.

 

PRODUCT BD 5 ml preservative Urine Culture and Sensitivity (C&S) Tube).
CODE Catalog #364976 -- Lot 1026345.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ.
Manufacturer: Becton Dickinson Vacutainer Systems, Broken Bow, NE.
REASON Label placement on urine tube is incorrect which could cause filling below specs.
VOLUME OF PRODUCT IN COMMERCE 60,000.
DISTRIBUTION Nationwide.

 

PRODUCT BD Unopette Brand Capillary Pipettes for use with Unopette Blood Diluting Pipette System
CODE Lot Code: 1G107 Exp 9/20/2002.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ.
Manufacturer: Becton Dickinson Caribe Ltd., San Lorenzo, Puerto Rico.
REASON Mispackaging of 20uL pipettes in 10uL containers.
VOLUME OF PRODUCT IN COMMERCE 9,000 units.
DISTRIBUTION Nationwide and Japan.

 

PRODUCT Digene Corporation's Hybrid Capture(tm)2 High Risk Human Papillomavirus (HPV) In-vitro diagnostic test kit, containing one vial of High Risk HPV Calibrator.
CODE HPV Kit Lot 832, containing Calibrator, lot #35, Exp 8/15/2003.
RECALLING FIRM/MANUFACTURER Digene Corp., Gaithersburg, MD.
REASON Human Papilloma Virus IVD Test kit contains incorrect calibrator.
VOLUME OF PRODUCT IN COMMERCE 361 kits.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT VITAMIN B12 CALIBRATORS; For in vitro diagnostic use only. Catalog #154 0525.
CODE Lot Numbers:
231, Exp. 8/28/02
750, Exp. 10/27/02
751, Exp. 11/1/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY.
Manufacturer: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales
REASON Calibration Failures when restricted limits used.
VOLUME OF PRODUCT IN COMMERCE 603 units.
DISTRIBUTION Nationwide and Internationally

 

WEEK ENDING OCTOBER 12

 

PRODUCT Ethicon J-VAC Reservoir is a single-use, disposable device that provides suction and fluid collection for wound drains

CODE DOMESTIC U.S <pre>
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210706, 210707, 210709, 212334
216311 (300 mL) 213246
INTERNATIONAL ITALY
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210707, 210709,
216311 (300 mL) 213246
PORTUGAL
Product Codes Lot/Control Numbers
216111 (150 mL) 210711
216211 (450 mL) 210706
SAUDI ARABIA
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210707
SOUTH AFRICA
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777, 212778
216211 (450 mL) 210706, 210709
216311 (300 mL) 213246
TAIWAN
Product Codes Lot/Control Numbers
216111 (150 mL) 210711
UNITED ARAB EMIRATES
Product Codes Lot/Control Numbers
216111 (150 mL) 210711, 212777
216311 (300 mL) 213246
JAPAN
Product Codes Lot/Control Numbers
217711 (150 mL) 210697, 210698, 210699, 211645,
211646, 211647, 211648, 211649
217811 (450 mL) 208678, 208679, 208680
217911 (300 mL) 201500, 210168, 210169, 210170, 210171, 210176, 210177, 210178, 210179, 210180.</pre>
RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon, Inc., Somerville, NJ

Manufacturer: Pacific Device, Inc. (avail medical), San Diego, CA. Firm initiated recall is ongoing.
REASON Y Body of the Suction Port could separate from the reservoir.
VOLUME OF PRODUCT IN COMMERCE 15,380 units worldwide; 2580 units in US.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Misys Laboratory.
CODE Versions 5.2, 5.23 and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ.
REASON Software anomaly. Quality assurance flags were not appearing as they should on cumulative reports.
VOLUME OF PRODUCT IN COMMERCE 477.
DISTRIBUTION Nationwide and United Kingdom, Ireland, Canada, Saudi Arabia, Denmark and Bermuda.

 

PRODUCT Mono-plus Immunometric Assay In Vitro Diagnostic Kit. For Qualitative Detection (used in the diagnosis) of Infectious
Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood. Outer carton labeled in part, "PRODUCT NO. 84M4 30 TESTS For In Vitro Diagnostic Use MONO-plus***P-4204*** Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood***An aid in the diagnosis of Infectious Mononucleosis***For Professional Use Only***THIS PRODUCT CONTAINS DRY NATURAL RUBBER*** ***KIT CONTENTS: 30 EACH MONO-plus TEST DEVICES:Contain a membrane strip coated with bovine erythrocyte extracts and a pad impregnated with antibody-dye conjugate in a protein matrix containing 0.1% sodium azide. ***DEVELOPER SOLUTION (D):***MONO-plus POSITIVE CONTROL:***MONO-plus NEGATIVE CONTROL:***CAPILLARY TUBES***PACKAGE INSERT"Wampole Pouch labeled in part, "1 TEST DEVICE***MONO-plus***For In Vitro Diagnostic Use***Store at 2ú -30úC *** ***P-3201***FL-084M2-01***WB LOT 222B21 EXP MAR03***US. PATENT NO. 5,559,041" BioSign Pouch labeled in part, "BioSign Mono***One Step IM — IgM Test One Test Device*** For In Vitro Diagnostic Use.***Store at 4ú -30úC (40ú -86ú* F) sealed.***PBM***
Insert labeled in part, "P-5207-B***MONO-plus***Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood*** An aid in the diagnosis of Infectious Mononucleosis.***For In Vitro Diagnostic Use***CLIA COMPLEXITY: MODERATE***CDC ANALYTE IDENTIFIER CODE: 2809***CDC TEST SYSTEM IDENTIFIER CODE: 70084*** ***PRINTED IN USA 1997, 2000 CARTER-WALLACE, INC. IN-084M4-02 ISSUED: SEPTEMBER, 2000".
CODE Product Code: 84M4
Lot Numbers:<pre>
WB222B21 Pouch exp. MAR03 Carton Exp. FEB03 & MAR03
WB222B37 033103 033103
WB222B47 033103 033103.</pre>
RECALLING FIRM/MANUFACTURER Princeton Biomeditech Corp., Monmouth Junction, NJ.
REASON False positive results when whole blood used as test specimen.
VOLUME OF PRODUCT IN COMMERCE 45990 kits.
DISTRIBUTION Nationwide.

 

PRODUCT Product is an Ophthalmic Sponge under the brand name "Rhein PVAc Eye Spears" Product Code 09-70012. This product is for all anterior segment surgery of the eye and helps prevent line and other fibers from affecting the surgical site. The soft distal sponge tip conforms to the cornea and us used to absorb fluids during surgery.
CODE 1022B and 1190B.
RECALLING FIRM/MANUFACTURER Recalling Firm: Rhein Medical Tampa, FL. Manufacturer: M-Pact Corp., Eudora, KS.
REASON Field complaints of device causing keratitis of the stoma.
VOLUME OF PRODUCT IN COMMERCE Lot 1190B-10,000 units, Lot 10022B-9,000 units.
DISTRIBUTION MD, KY and Hong Kong and Belguim.

 

PRODUCT CNS-9303A Series Central Monitor Station.
CODE Serial Numbers: NK100006, NK100012, NK100018, NK100019, NK100051, NK100054, NK100055.
RECALLING FIRM/MANUFACTURER NKUS Lab (Nihon Koden), Irvine, CA.
REASON Capacitor failure causes screen to blank.
VOLUME OF PRODUCT IN COMMERCE 7.
DISTRIBUTION CA, NY and FL.

 

PRODUCT CryoValve Allograft, Human Heart Valve.
CODE Serial No. 6242596, Model Number PV05.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Failure to meet serodilution of plasma guidelines.
VOLUME OF PRODUCT IN COMMERCE One valve.
DISTRIBUTION CA.

 

PRODUCT CryoValve Allograft, Human Heart Valve.
CODE Serial Number 6171214, Model Number PV05.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Failure to meet serodilution of plasma guidelines.
VOLUME OF PRODUCT IN COMMERCE One valve.
DISTRIBUTION NY.

 

PRODUCT Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging.
Magnetom Harmony
Magnetom Symphony
Magnetom Harmony Upgrade Syngo MR
Magnetom Symphony Upgrade Syngo MR
CODE All codes under Model Numbers:
Harmony 4759309 K2200
Symphony 4760265 K2210
Harmony Upgrade Syngo MR 7106714 K2200
Symphony Upgrade Syngo MR 7106557 K2210
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Smoke generating from gradient cabinet.
VOLUME OF PRODUCT IN COMMERCE 304.
DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT Insight-Plus 9000 Phased Array Torso & Pelvis Coil, 1.5T field strength. The device is sold under the GE label.

CODE Part Number: 100189 (GE Medical Part #2289043-2); Serial Numbers: 302 through 500.
RECALLING FIRM/MANUFACTURER USA Instruments, Inc., Aurora, OH.
REASON The coil may overheat and cause skin burns during an MRI scan.
VOLUME OF PRODUCT IN COMMERCE 198 coils.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) Telemetry Digital Processors Models 90342, 90344, 90346, 90348; b) Integrated Multiparameter Module Model 90470; c) Telemetry Receiver Module Model 90478; d) Ultarview Command Module Model 90496.
CODE a) Models 90342, 90344, 90346, 90348 - software version 3.05.17EN
b) Model 90470 - software version 2.02.30EN
c) Model 90478 - software version 3.02.02EN
d) Model 90496 - software version 1.02.08EN.
RECALLING FIRM/MANUFACTURER Spacelabs Medical, Inc., Redmond, WA.
REASON ECG software fails to detect low heart rates in range of 12 to 15 bpm.
VOLUME OF PRODUCT IN COMMERCE 69,293 to domestic consignees and 38,769 to international consignees.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT AEROSET Magnesium Reagent, List Number 7D70-01.
CODE All nonexpired material with Lot Numbers: 68067HW00, 72032HW00, 75093HW00, 82014HW00, 84028HW00, 89051HW00.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., South Pasadena, CA.
Manufacturer: Thermo Trace Noble Park, Victoria, Australia.
REASON Elevated results.
VOLUME OF PRODUCT IN COMMERCE 1,751.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT DPC Immulite 2000 System. This product uses the Longwell LS-7C gray two prong power cord sold with Hewlett Packard DeskJet Printers 800 and 900 Series. The power cords were recalled by Hewlett Packard.
CODE Immulite systems using HP DeskJet Printers Serial Numbers F1340 through G1882, plus any system upgrade to an 800 or 900 HP printer series.
RECALLING FIRM/MANUFACTURER DPC Cirrus Inc., Flanders, NJ.
REASON Power cord may crack posing electrical hazard.
VOLUME OF PRODUCT IN COMMERCE 542.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Misys laboratory version 5.3 with custom Result Interface 11.
CODE Version 5.3 with custom Result Interface 11.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Inc., Tucson, AZ.
REASON Software anomaly causing mixing of patient data.
VOLUME OF PRODUCT IN COMMERCE 1.
DISTRIBUTION MN.

 

PRODUCT Custom Latex Tubing, sterile, packaged in sterile paper wrapper and labeled as "Custom Latex Tubing" and additionally labeled as "Latex Safe", for use in cardiovascular surgery, 5/16" x1/2 x12 ft, 25 tubes per case. Catalog #32-1526.
CODE Lot 273191, 273931, 274501.
RECALLING FIRM/MANUFACTURER Deroyal Surgical, Rose Hill, VA.
REASON Latex surgical tubing is labeled as latex-safe.
VOLUME OF PRODUCT IN COMMERCE 1 case, 25 tubes per case.
DISTRIBUTION NE.

 

PRODUCT Custom Angiography Procedure Kits which contain Heparin Sodium Injection that has been recalled. There are 43 different configurations of the kits involved.
CODE Angiography Drape Pack Cardiac Cath Lab Reorder # 398163, Lots: 99078949, 99089770, 99099771, 99128841, 99129632, 99151931,
99163515, 99168394, 99174255, 99178868, 99181345, 99182241, 99184093, 99190587, 9192213, 99194461, 99199681, 99204602, 99208694, 99214198, 99215867, 99220783
Angiography Drape Pack, Reorder # 398517, Lots: 99062209, 99078110, 99078719, 99089640, 99099065, 99099727, 99099860, 99109473, 99109817, 99129378, 99146106, 99148890, 99150973, 99160161, 99161041, 99166391, 99169689, 99173812, 99176358, 99176802, 99181415, 99182800, 99184720, 99188767, 99188995, 99191483, 99195501, 99204325
Angiography Drape Pack, Reorder # 398527, Lots: 99099333, 99119737, 99148880, 99174204, 99190243, 99218706
Angiography Drape Pack, Reorder # 398816, Lots: 99099172, 99129638, 99149775, 99168060, 99176768, 99182052, 99193329, 99214471
Angiography Drape Pack, Reorder # 398838, Lots: 99068803, 99099107, 99099823, 99109753, 99119823, 99128793, 99148691, 99153962, 99154711, 99163112, 99173650, 99173729, 99179858, 99180973, 99182668, 99184808, 99185307, 99186552, 99188908, 99188909, 99190443, 99190820, 99199679, 99208899, 99211427, 99214832, 99217574, 99221240, 99068149, 99089091
Angiography Drape Pack, Reorder #399086, Lots: 99068099, 99078018, 99078208, 99085435, 99089139, 99089567, 99099142, 99099392, 99099419, 99109357, 99109819, 99119260, 99119318, 99119511, 99129509, 99145571, 99146523, 99146960, 99148683, 99149965, 99153557, 99155314, 99160312, 99160938, 99163859, 99163862, 99164815, 99164981, 99167050, 99167629, 99170565, 99171515, 99171516, 99172108, 99173755, 99177247, 99178507, 99178780, 99181856, 99183069, 99183679, 99185313, 99188551, 99189966, 99191787, 99193363, 99196516, 99196948, 99199793, 99200133, 99200735, 99201231, 99202261, 99203627, 99209668, 99209859, 99211855, 99213753, 99217545, 99217898, 99220847, 99222318
Angiography Drape Pack, Reorder # 399360, Lots: 99078030, 99089152, 99099297, 99109386, 99109847, 99119811, 99145059, 99147408, 99149950, 99160863, 99164974, 99169679, 99175639, 99177832, 99183075, 99186877, 99192543, 99197468, 99205484, 99214169, 99217267, 99221017
Angiography Drape Pack, Reorder # 399452, Lots: 9907868 , 99089085, 99099119, 99099194, 99099608, 99109531, 99119162, 99129159, 99129491, 99148997, 99150935, 99154087, 99155321, 99164967, 99170367, 99171937, 99176231, 99181340, 99184530, 99188136, 99190449, 99192501, 99197525, 99206132, 99209987, 99213026, 99221043, 99222782, 99223248
Angiography Drape Pack, Reorder # 399580, Lots: 99089164, 99099425, 99109616, 99139095, 99148249, 99150575, 99154905, 99164214, 99168865, 99174207, 99179342, 99186979, 99193729, 99194452, 99195655, 99198225, 99202546, 99205069, 99208964, 99214049, 99218110, 99221259
Angio Procedure Pack Arteriogram, Reorder # 399835, Lots: 99062378, 99066992, 99078151, 99089581, 99099136, 99109275, 99119269, 99119831, 99119870, 99147538, 99149212, 99151080, 99155219, 99166276, 99170178, 99175386, 99176777, 99180433, 99182031, 99182528, 99186656, 99193851, 99196210, 99199433, 99205962, 99209085, 99212889, 99218676, 99221785
Angiography Drape Pack, Reorder # 399927, Lots: 99078189, 99085422, 99119489, 99149454, 99164971, 99173624, 99183232, 99185959, 99201364, 99207565, 99221563
Angiography Drape Pack, Reorder # 400086, Lots: 99078283, 99078409, 99079976, 99099553, 99099710, 99109742, 99119798, 99146817, 99148845, 99150871, 99154276, 99155233, 99162574, 99164726, 99167248, 99170804, 99173383, 99174223, 99175338, 99176457, 99185713, 99189231, 99195216, 99198044, 99205071, 99208602, 99213216, 99215603, 99216723, 99222194
Angiography Drape Pack Angio-Echo Tray, Reorder # 400164, Lots: 99078981, 99085447, 99161666, 99165918, 99169859, 99173032, 99176949, 99178516
EP Pack, Reorder # 400252, Lots: 99068805, 99078477, 99078935, 99099355, 99099945, 99119122, 99128728, 99129017, 99147545, 99151687
Angiography Drape Pack, Reorder # 400293, Lots: 99089044, 99206141
Special Procedure Pack, Reorder # 400452, Lots: 99062203, 99089060, 99089900, 99254899
Angiography Drape Pack, Reorder # 400601, Lots: 99085419, 99099936, 99109699, 99119651, 99145331, 99152142, 99166066, 99174189, 99177653, 99184132, 99186920, 99189402, 99194935, 99201420, 99204496, 99210165, 99216720, 99221232
Angiogram Drape Pack, Reorder # 400800, Lots: 99078046, 99078192, 99085671, 99089568, 99099141, 99099478, 99109138, 99109813, 99145721, 99145882, 99151522, 99153770, 99168047, 99170338, 99174210, 99174832, 99177156, 99182807, 99183281, 99184795, 99185518, 99190667, 99191359, 99199990, 99200241, 99202954, 99209458, 99216164, 99217515
Permanent Pacing Drape Pack, Reorder # 400801, Lots: 99078224, 99109645, 99119601, 99164336, 99167784
Cath Lab Angio Pack, Reorder # 400852, Lots: 99078478, 99089760, 99099224, 99109608, 99119469, 99129326, 99147004, 99150239, 99160407, 99166096, 99173622, 99176804, 99181334, 99183088, 99185370, 99190759, 99195941, 99198888, 99204242, 99207907, 99209052, 99220055
Angiography Drape Pack Arteriogram Tray, Reorder # 400907, Lots: 99099051, 99099360, 99099535, 99119242, 99129125, 99129514, 99145225, 99152026, 99164460, 99175021, 99178601, 99184240, 99185299, 99190119, 99194325, 99200019, 99204538, 99210435, 99216160
Angiography Drape Pack Imaging Sterile, Reorder # 401090, Lots: 99099302, 99109661, 99128518, 99149458, 99162341, 99171348, 99173958, 99182678, 99187285, 99195790, 99198722, 99207295, 99213377, 99221581
Angiography Drape Pack Infant Pack, Reorder # 401185, Lots: 99099429, 99109349, 99119514, 99139001, 99147503, 99148946, 99151387, 99164229, 99171351, 99176753, 99178566, 99180800, 99182755, 99188325, 99195585, 99199653, 99201739, 99209515, 99214107, 99219058
Angiography Drape Pack, Reorder # 401240, Lots: 99060681, 99089753, 99099686, 99109372, 99109453, 99119607, 99145536, 99148112, 99154892, 99166546, 99174190, 99181597, 99185300, 99190767, 99196992, 99200678, 99204204, 99205979, 99209520, 99211004, 99216152, 99221778, 99255398
Angiography Drape Pack, Reorder # 401307, Lots: 99089031, 99099417, 99109452, 99129494, 99147032, 99151244, 99161534, 99167216, 99171152, 99178350, 99178404, 99190869, 99195628, 99197839, 99207989, 99208073, 99215120, 99215125
Angiography Drape Pack, Reorder # 401380, Lots: 99078049, 99089675, 99099438, 99109554, 99119218, 99129129, 99129709, 99146396, 99149919, 99152755, 99161008, 99166021, 99168198, 99171889, 99175447, 99177621, 99181489, 99181932, 99186240, 99191932, 99193993, 99197793, 99203000, 99203170, 99209538, 99210989, 99215285,99218066, 99219843, 99223283
Catheter Placement Pack, Reorder # 401510, Lots: 99109229, 99109291
E. P. Tray, Reorder # 401518, Lots: 99099528
Angiography Drape Pack Special Procedure, Reorder # 401535, Lots: 99109674, 99151374, 99161395, 99166381, 99169683, 99172134
Angiography Drape Pack Cardiac Cath, Reorder # 401536, Lots: 99129722, 99166354, 99176725, 99182319, 99186806, 99189584
Cardiac Cath Pack, Reorder # 401561, Lots: 99148017, 99171932, 99173225, 99176007, 99182229, 99189134, 99195082, 99195624, 99206909, 99210988, 99213021, 99223832
Cardiac Cath Pack, Reorder # 401601, Lots: 99164614, 99168713, 99169374, 99171755, 99176348, 99176739, 99179798, 99180545, 99189159, 99192616, 99195107, 99197544, 99200751, 99201831, 99203005, 99208413, 99210858, 99212973, 99214314
Angiography Drape Pack, Reorder # 401685, Lots: 99183355, 99185882, 99197775, 99211142, 99220903
Pedi Heart Cath Tray, Reorder # 401688, Lots: 99187653, 99190140, 99192885, 99197670, 99208827, 99209641, 99214893
Acute Hemodialysis Tray, Reorder # 500323, Lots: 99079333, 99108050, 99147023, 99149272, 99152256, 99205131, 99218806, 99221457
Hemodialysis Pack, Reorder # 500326, Lots: 99064999, 99079389, 99088647, 99098058, 99108190, 99118774, 99148274, 99161069, 99163526, 99175004, 99178926, 99183741, 99185101, 99186382, 99192510, 99201536, 99209638, 99219146
Angiography Drape Pack, 500502, 99078691, 99147031, 99154219, 99163787, 99169653, 99170876, 99178544, 99178571, 99182908, 99189995, 99194556, 99194926, 99197429, 99201305, 99203958, 99212059, 99217023, 99218395
Advantec MLD, Reorder # 500507, Lots: 99151350
Pack, George Wash Diagnostic, Reorder # 0c-cp31303, Lots: 99200156, 99208565, 99209888, 99212999, 99213734, 99213734, 99219313, 99220732
Pack, Fairfield MC Cath Lab, Reorder # 0c-cp31445, Lots: 99200162, 99205373, 99210962, 99216945, 99220917, 99226918
Pack George Wash Interventional, Reorder # 0c-cp31465, Lots: 99203444, 99209868, 99210873, 99221727
Pack MC of Delaware, Reorder # 0c-cp32409, Lots: 99199893, 99199897, 99205537, 99208311, 99208548, 99211744, 99214516, 99215022, 99219063, 99219750, 99220302
Pack, Southwest Hosp Cath, Reorder # 0m-cp31863, Lots: 99195935.
RECALLING FIRM/MANUFACTURER Maximm Medical, Inc., Athens, TX.
REASON Kits contain recalled heparin sodium injection.
VOLUME OF PRODUCT IN COMMERCE 47,973 kits.
DISTRIBUTION Nationwide.

 

PRODUCT LifeScan brand OneTouch® SureStep® Test Strip and SureStep® Pro Test Strip used in OneTouch® SureStep® Blood Glucose Meter.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Lifescan, Inc., Milpitas, CA.
REASON Use of Test Strips may give inaccurate very low glucose results.
VOLUME OF PRODUCT IN COMMERCE Approx. 749,000,000 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Architect CA 19-9 Reagent Kit. a) list 6C04-20: 4 x 100 tests; b) list 6C04-25: 1 x 100 tests.
CODE a) lot 82267M300; b) lot 82267M301.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL.
REASON MCC1 control out of range low.
VOLUME OF PRODUCT IN COMMERCE 1262 - 400 test kits, 129 - 100 test kits.
DISTRIBUTION Canada, Germany, United Kingdom, Japan and Australia.

 

PRODUCT Portex Continous Epidural Tray- 18 Gauge Hustead Catalog No. 15536-22.
CODE Lot Number: K131991  USe By: 2003-12.
RECALLING FIRM/MANUFACTURER Recalling Firm: Portex, Inc., Keene, NH. Manufacturer: Sims Portex, Inc., Keene, NH.
REASON Trays may contain ampules of Bupivacaine HCl Inj. 0.50% instead of 0.25%.
VOLUME OF PRODUCT IN COMMERCE 1200 trays.
DISTRIBUTION FL, NC, ID and PA.

 

PRODUCT Freshlook Toric (Phemfilcon A) Soft Contact Lenses for Astigmatism with Handling Tint, the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 3 packs per box.
CODE Lot 30726, exp. 2006-08 and lot 30729, exp. 2006-03.
RECALLING FIRM/MANUFACTURER Wesley Jessen Corp., Des Plaines, IL.
REASON Mislabeled for corrective power, cylinder & axis.
VOLUME OF PRODUCT IN COMMERCE 33 3-packs.
DISTRIBUTION Germany, Great Britain and Italy.

 

PRODUCT Stryker M-1 roll-in system rugged ambulance cot, model 6100-003-000.
CODE Cots distributed from 11/1/00 through 7/19/01.
RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI.
REASON Legs supports may become loose and the cot may tip.
VOLUME OF PRODUCT IN COMMERCE 525 cots.
DISTRIBUTION Internationally.

 

PRODUCT AEROSET Magnesium Reagent, List Number 7D70-01.
CODE All nonexpired material with Lot Numbers: 68067HW00, 72032HW00, 75093HW00, 82014HW00, 84028HW00, 89051HW00.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA.
Manufacturer: Thermo Trace Noble Park, Victoria Australia.
REASON Elevated results.
VOLUME OF PRODUCT IN COMMERCE 1,751.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Cytomics RXP software.
CODE Version 1.0.
RECALLING FIRM/MANUFACTURER Beckman Coulter Inc., Brea, CA.
REASON When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if "% in Regions" is selected.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION IL, Germany and Canada.

 

PRODUCT Nasal Dorsum Style 7  a) Size 2; P/N: 400-724S L/N: 8221; b) Size 3; P/N: 400-734S L/N: 8228.
CODE a) Serial numbers WC4465 thru WC4474; b) Serial numbers WC4433 thru WC4442.
RECALLING FIRM/MANUFACTURER Spectrum Designs, Inc., Carpineteria, CA.
REASON Wrong sizes in packages.
VOLUME OF PRODUCT IN COMMERCE 10.
DISTRIBUTION CA.

 

PRODUCT Roche COBAS Integra ferritin, catalog # 753556.
CODE Lots 624570 (exp. 9/02), 626487 (exp. 12/02),  629938 (exp. 3/03), 634050 (exp. 6/03) and 636549 (exp. 9/03).
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN.
Manufacturer: Roche Diagnostics GmbH Mannheim, Germany.
REASON Some sera may under-recover ferritin by up to 35%.
VOLUME OF PRODUCT IN COMMERCE 10,897.
DISTRIBUTION Nationwide.

 

WEEK ENDING OCTOBER 19

 

PRODUCT Roche brand Elecsys 2010 clinical chemistry analyzers.
CODE Serial numbers 1058-11, 1164-70 and 0806-10. (All analyzers with software version 06-01.)
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN.
Manufacturer: Hitachi Ltd., Instrument Division, Ibaraki-ken, Japan.
REASON Possibile incorrect breast cancer marker results.
VOLUME OF PRODUCT IN COMMERCE 3.
DISTRIBUTION IL and WV.

 

PRODUCT Access 2 Immunoassay System--Beta Human Chorionic Gonadotropin Reagent.
CODE Lots 104702 and 104703.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Stability.
VOLUME OF PRODUCT IN COMMERCE 1508 kits.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT Medline Total Hip Pack Custom Sterile Kit.
CODE Catalog #DYNJ19079B, lot 02GD1484.
RECALLING FIRM/MANUFACTURER Medline Industries, Inc., Waukegan, IL.
REASON Questionable sterility.
VOLUME OF PRODUCT IN COMMERCE 8 kits.
DISTRIBUTION KY.

 

PRODUCT Toilet Seats, part number 50, used with several different models that do and do not lift patients to standing position

CODE All serial numbers of models listed.
RECALLING FIRM/MANUFACTURER Mobility Inc., San Diego, CA, by letter dated February 5, 2002.
REASON Patient assist toilet seat locks up and won't lift patient to standing again.
VOLUME OF PRODUCT IN COMMERCE 193 parts, toilet seats.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT

Somatom Model #
7005502 --Sensation 4
4806118 --Volume Zoom
7114023 --Volume Access
3810152 --Balance
3810160 --Emotion
3810160 --Emotion Duo
3810079 --Esprit
3810137 --Esprit +
CODE 300 Serial Numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON A false patient name will appear when MPPS function is used.
VOLUME OF PRODUCT IN COMMERCE 300.
DISTRIBUTION CT.

 

PRODUCT ICONOS R200 tilting X-Ray table.
CODE Siemens part #: 70 30 518. Serial Numbers: 01006, and 01008.
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Medical Solutions Erlangen, Germany.
REASON Due to metal washers, the tilt drive is reduced.
VOLUME OF PRODUCT IN COMMERCE 2.
DISTRIBUTION MA.

 

PRODUCT Cordis DUCOR Angiographic Catheter, TS 6F .038 100CM JR4 MOD, Diagnostic Catheter.
CODE Catalog Number MODC13312, lot number K1101455.
RECALLING FIRM/MANUFACTURER Cordis Corp., Miami Lakes, FL.
REASON Packages units seals may be opened compromising Sterility Barrier.
VOLUME OF PRODUCT IN COMMERCE 795.
DISTRIBUTION OH, MN, MI and AR.

 

PRODUCT The firm is Field correcting with a warning sticker their SRI Disposable Procedure Packs containing Kimberly Clark Corp. ORTHOARTS Lower Extremity Drapes, Non-Sterile, stock code 79278-10, ORTHOCARTS Lower Extremity Drapes, Stock Code 89278-10, ORTHOCARTS Hip Drape, Non-Sterile, Stock Code 79346-10 and ORTHOCARTS Hip Drape, Stock Code 89346-10, ORTHOARTS drapes Stock number 79267-10 and also ORTHOARTS drapes Stock Number 89267-10, various lot numbers. Kimberly Clark notified them initially on 12/19/01 and again on 1-31-02 (additional products and codes) of the recall (ATL monitored recall classified under Z-784/796-2) and the component was repacked into one of their Surgical Kits that had to be field corrected in the field with a warning sticker.The surgical kits under correction are labeled as: (1) "SADDLEBACK MEMORIAL ARTHROSCOPY PACK, REORDER # ORO433A LOT # 20077 EXP DATE 10/01/04; (2) GARDEN CITY HOSPITAL ORTHO KNEE PACK RECORDER # ORO665B, LOT # 20490, EXP. DATE 4/01/03; (3) GARDEN CITY HOSPITAL KNEE ARTHROSCOPY PACK, RECORDER # ORO667, LOT # 20491, EXP. DATE 04/01/06; (4) E OKLAHOMA OUTPATIENT STERILE EXTREMITY REORDER # ORO375 LOT # 10174, EXP. DATE 03/01/04 SRI/STERILE RECOVERIES.
CODE Product Code ORO433A Lot Numbers: 18427, 18588, 19294, 20077; Product Code OR0665B Lot Numbers: 19910, 20490, 21171; Product Code ORO0375 Lot Number: 10174; Product Code ORO667 Lot Number: 21547.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sterile Recoveries, Inc./Surgical Express Inc., Plant City, FL.
Surgical Express, Plant City, FL.
REASON Supplier is recalling because the product may compromise the sterile field.
VOLUME OF PRODUCT IN COMMERCE 268.
DISTRIBUTION CA, MI and OK.

 

PRODUCT Apligraf (Graftskin).
CODE Lot Number: GS0206.20.01.
RECALLING FIRM/MANUFACTURER Organogenesis Inc., Canton, MA.
REASON Product may be contaminated with mycoplasma.
VOLUME OF PRODUCT IN COMMERCE 117.
DISTRIBUTION Nationwide.

 

PRODUCT Bicor Hi-P and Neuorostar Hi-P Angiographic systems.
CODE

  Part No.      Serial Nos.

  62 58 383     01001-01173

  63 79 767     02001-02099

  62 58 425     01001-01030

  63 79 668     01101-01209
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Broken mounting bolts.
VOLUME OF PRODUCT IN COMMERCE 141 units.
DISTRIBUTION Nationwide.

 

PRODUCT AVA3X Advanced Venous Access Device (introducer valve)

Model numbers: IAVA3XI, M3L85FHS, M3L85FHSI, M3L85FHK, M3L85FHKI, M3L85FHK12, M3L85FHKIN, M3L85FKI

CODE 942C0182, 942D0480, 942C0183, 942D0481, 942C0184, 942D0497, 942CC185, 942DC479, 942CC186, 942E0662, 942CC187, 942E0663,

942CC188, 942E0666, 942CC189, 942EC664, 942CC190, 942EC665, 942C0191, 942EC741, 942D0474, 942G0157, 942D0475, 942GC162,

942D0477, 952CC326, 952DC602
RECALLING FIRM/MANUFACTURER Edwards Lifesciences Corporation of Puerto Rico, Anasco, Puerto Rico.
REASON Leakage betweem the anti-bleed back septum.
VOLUME OF PRODUCT IN COMMERCE 6,987 units.
DISTRIBUTION Nationwide and Bangkok, Canada, Tokyo and Belgium.

 

PRODUCT Encore Brand, linear array, phased array, curved array, and microconvex probes:
Model No. LK5.38EX, Encore L5, 5.5 MHz Linear probe
Model No. LK7.38EX, Encore L7, 7.0 MHz linear probe
Model NO. PK4.28EX, Encore V4, 3.5 MHz phased array probe
Model No. CK4.60EX, Encore C3, 3.5 MHz curved probe
Model No. CK6.10IX, Encore EC7, 6.5 MHz microconvex probe
Each probe is serialized. Individual probes are packaged in a cardboard carrying case with inner foam padding. Each shipper would contain 3 case units. There is no physical labeling on the product that identifies the product brand names as indicated above. Each probe unit is tagged with only the following information: a serial number and the model number or patrial brand name such as "C3" or "V4".
CODE Serial Number
1930 (36 pcs)
CK460EX-R:
00001
00002
00J100
00J101
00K102
00K103
00K104
00K105
00K106
00K107
00K108
01C131
00N110
00N112
00N111
01A113
01A114
01A115
01A116
01B117
01B118
01B119-1
01B120
01C121
01C122
01C123
01C124
01C125
01C126
01D136
01E137
01E138
01E139**
01E140**
01E141
01F151

1931 (31 PCS)
PK428EX-R
00001
00002
00J100
00K101**
00K102*
00K103**
00K104*
00M105**
00M106**
00N107**
00N108-1**
00N109**
00N110*
01A111
01A112
01A113
01A114
01A115*
01A116*
01A117
01B118**
01N119
01E124**
01E125*
01E126*
01E127*
01E128*
01E129*
01E130*
01E131
01E132

1995 (84 PCS)
CK460EX
01C127
01C128**
01C129**
01C130**
01C132**
01C133**
01C134**
01C135**
01F142**
01F143**
01F144**
01F145**
01F146**
01F147
01F148
01F149
01F150
01G152**
01G153
01G154**
01G155**
01G156**
01G157**
01G158**
01G159**
01G160**
01G161
01G162**
01G163**
01G164**
01G165**
01G166**
01G167
01H168
01H169**
01H170**
01H171
01H172**
01H173**
01J175**
01J176**
01J177**
01J178**
01J179**
01J180**
01J181**
01J183**
01J184**
01K185
01K186**
01K187**
01K188**
01K189**
01K190**
01K191**
01K192**
01K193**
01K194**
01K195**
01J182**
01M196**
01M197**
01M198**
01M199**
01N200
01N201**
01N202
01N203**
01N204
01N205**
01N206**
01N207**
01N208**
01N209**
01N210**
01N211
01N212
01N213
01N214**
01N215**
01N216**
01N217
01N218**
01N219**

1995 (4PCS)
PK428EX
01C120*
01C121*
01C122*
01C123*

1996 (10 PCS)
LK738EX
PP01-1
PP02**
PP03
PP04
PP05
PP06
PP07
PP08**
PP09
PP10

1999 (34 PCS)
EC7
01H001
01H002**
01K003
01K004
01K005
01K006
01M007**
01M008**
01M009
01M010
01M011**
01M012**
01M013**
01M014
01M015
01M106
01M107**
01N018
01N019**
01N020**
01N021**
01N022**
01N023**
01N024**
02A025**
02A026**
02A027**
02A028**
02A029**
02A030**
02A31**
02A32**
02A33**
02A34**

2076 (20 PCS)
LK738EX
PP1
PP12-3**
PP13**
01M001
01M002**
01M003**
01M004
01M005**
01M006**
01M007-1**
01M008-1**
01M009-2**
01M010-2**
01M011-1**
01N012**
01N013**
01N014
01N015
02A016
02A017**

2077 (17 PCS)
LK538EX
PP01
PP02
PP03-4**
PP04
PP05-4**
PP06
PP07
PP08-3**
PP09**
PP10-4**
PP11-4**
PP12-5**
PP13-4**
PP14-3**
PP15-3**
PP16**
PP17**
RECALLING FIRM/MANUFACTURER Recalling Firm: Thales Components Corporation, Totowa, NJ.
Manufacturer: Thales Microsonics, Sophia Antipolis Cedex, France.
REASON Excessive heat generated from probes.
VOLUME OF PRODUCT IN COMMERCE 236.
DISTRIBUTION MA.

 

PRODUCT CMI Velvet Touch Vacuum Extractor Cup Reusable Soft Silicone Cup for Vacuum Assisted Childbirth, Ref 202VT. Individually packaged. Non-Sterile. Latex free. Metal handle is stamped with the number 120301.
CODE Part Number: 202 VT, CMI Velvet Touch Cup, Lot 112179, Reusable Silicon Vacuum Cup, Lot 120748.
RECALLING FIRM/MANUFACTURER Utah Medical Products, Inc., Midvale, UT.
REASON Chrome plating reported flaking from the device handle.
VOLUME OF PRODUCT IN COMMERCE 67.
DISTRIBUTION Nationwide, Canada and Israel.

 

PRODUCT Baxter Swivel Wye Anesthesia Breathing Circuits: a) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 2 Liter Roughcoat Bag;
b) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 3 Liter Bag;
c) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag;
d) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Roughcoat Bag;
e) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag;
f) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 3 Liter Bag;
g) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port,and 3 Liter Bag;
h) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag;
i) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Roughcoat Bag;
j) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, and 3 Liter Roughcoat Bag;
k) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Gas Sampling Elbow with Luer Lock Port, and Two-Way Filters (Bacterial/Viral Retentive).
CODE a) catalog 2L3844, lots R01K12986, R01K13018; b) catalog 2L3919, lots R01K15070, R01K15211; c) catalog 2L3920, lots R01L09014, R01K12218, R01K13091, R01L19112, R02F12315, R02G17130, R02G30125, R02G30232, R02H06016; d) catalog 2L3926, lot R02G10150; e) catalog 2L3952, lots R02F05012, R02F06317, R02F16019,  R02G16017, R02G16082, R02G16165; f) catalog 2L3953, lots R02G08105, R02G30281, R02H12147; g) catalog 2L3963, lots R02F06259, R02F25143; h) catalog 2L3965, lot R02F06242; i) catalog 2L3967, lots R02G21017, R02H08061;
j) catalog 2L3968, lot R02H12139; k) catalog 2L4333, lot R02G29028.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL.
Manufacturer: Baxter Healthcare Corp., Cartago, Costa Rica.
REASON Cracks in anesthesia breathing circuits may cause inadequate ventilation.
VOLUME OF PRODUCT IN COMMERCE 54,509 units.
DISTRIBUTION Nationwide.

 

PRODUCT Contact Lenses.
CODE Lot number 0001707, expiration 2007/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA. Manufacturer: CIBA Vision Corp., DesPlaines, IL.
REASON Mislabeling on packages of multipak lenses.
VOLUME OF PRODUCT IN COMMERCE 50 six-pack cartons.
DISTRIBUTION Nationwide.

 

PRODUCT Remel Chocolate Agar, Product #01301, for use in the culturing of pathogenic Neisseria and Haemophilus, packaged 15 plates/pkg.
CODE Lot 231162, Exp. 9/26/02.
RECALLING FIRM/MANUFACTURER Remel Inc., Lenexa, KS.
REASON Doesn't exhibit growth of Haemophilus influenzae ATCC10211.
VOLUME OF PRODUCT IN COMMERCE 5,580 plates.
DISTRIBUTION KS, MO, MN, IA, FL, CA, IL, WI and RI.

 

PRODUCT Medtronic Bo-ject DHF 37 Disposable Hypodermic Needle Electrode, 37 mm x 0.41 mm, Product Catalog Number 9013S0441
CODE Lot 2773196.
RECALLING FIRM/MANUFACTURER Recalling Firm: Medtronic Gastroenterology and Urology Shoreview, MN.
Manufacturer: Medtronic A/S 2740 Skovlunde.
REASON Some of the recalled hypodermic needle electrodes have blocked or partially blocked needle cannulas, leading to no or insufficient flow.
VOLUME OF PRODUCT IN COMMERCE 264 Disposable Hypodermic Needle Electrodes.
DISTRIBUTION CA, MN, NC and Denmark, Finland, Greece and Switzerland.

 

PRODUCT Bausch & Lomb CX5710 Viscous Fluid Injector Accessory Pack.
CODE Lot Numbers 0104251244 and 0200211245.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bausch & Lomb Surgical, Inc., St. Louis, MO.
Manufacturer: Escalon Trek Medical, New Berlin, WI.
REASON The flange of the syringe included within the CX5710 Viscous Fluid Injection Accessory Pack is too large to properly fit into the syringe coupler.
VOLUME OF PRODUCT IN COMMERCE 351 boxes (6 accessory packs per box, 2,106 units in total).
DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING OCTOBER 26

 

FDA Warns Consumers Against Using Decorative Contact Lenses Obtained Without a Prescription or Professional Fitting

 

The Food and Drug Administration (FDA) is warning consumers about serious risks of permanent eye injury, potentially leading to blindness, presented by non-corrective, decorative contact lenses distributed without a prescription and without proper fitting by an eye care professional. FDA has learned that these products are being marketed and distributed directly to consumers through flea markets, convenience stores, and beach shops. Marketing of decorative lenses may increase during the upcoming Halloween season.

 

Decorative contact lenses present significant risks of blindness and other eye injury if they are distributed without a prescription or without proper fitting by a qualified eye care professional. FDA has received reports of corneal ulcer associated with wear of decorative contact lenses in excess of the recommended period. Corneal ulcer can progress rapidly, leading to internal ocular infection if left untreated. Uncontrolled infection can lead to corneal scarring and vision impairment. In extreme cases, this condition can result in blindness and eye loss.

Other risks associated with use of decorative contact lenses include conjunctivitis (an infection of the eye); corneal edema (swelling); allergic reaction; corneal abrasion from poor lens fit; and reduction in visual acuity, contrast sensitivity, and other visual functions, resulting in interference with driving and other activities.

 

FDA is issuing an import alert instructing FDA and Customs officials to detain automatically all decorative contact lenses presented at United States ports of entry. FDA will seize decorative contact lenses currently on the market in violation of federal law. FDA is also communicating with the public and with the eye care professional community concerning the dangers of using decorative contact lenses.

 

Consumers are urged to discontinue immediately use of decorative contact lenses obtained without proper fitting and a prescription and to notify FDA of any complaints or problems associated with these products. FDA requests that consumer reports be submitted to the FDA district office consumer complaint coordinator for your geographic area. Telephone and TTY contact information for FDA's consumer complaint coordinators is available via FDA's web site at http://www.fda.gov/opacom/backgrounders/complain.html. You may also report problems or complaints to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane (HF-2), Rockville, MD 20850.

 

PRODUCT Pulmonetic Systems Ventilators: Models: a) LTV-1000; b) LTV-950; c) LTV-900; d) LTV-800.
CODE a) Serial Numbers: A01030, A01038, A01046, A01056, A01057, A01063, A01085, A01088, A01114, A01148, A01156, A01157, A01161, A01181, A01210, A01213, A01217, A01230, A01258, A01270, A01302, A01307, A01311, A01313, A01323, A01331, A01337, A01343, A01393, A01414, A01417, A01429, A01431, A01434, A01436, A01453, A01456, A01458, A01459, A01492, A01496, A01498, A01499, A01536, A01561, A01564, A01574, A01582, A01588, A01633, A01637, A01652, A01668, A01671, A01677, A01682, A01737, A01747, A01778, A01785, A01794, A01815, A01816, A01846, A01847, A01848, A01872,A01876, A01880, A01893, A01906, A01912, A01926, A01929, A01937, A01938, A01974, A01980, A02016, A02037, A02053, A02068, A02078, A02127, A02128, A02137, A02141, A02144, A02149, A02159, A02181, A02197, A02219, A02253, A02269, A02290, A02359, A02374, A02416, A02422, A02453, A02485, A02490, A02550, A02553, A02647, A02669, A02676, A02767,
A02774, A02779, A02784, A02795, A02797, A02817, A02829, A02834, A02857, A02871, A02884, A02887, A02933, A02941, A02947, A02987, A02988, A03013, A03069, A03127, A03132, A03138, A03141, A03143, A03146, A03230, A03240, A03242, A03248, A03267, A03290, A03291, A03307, A03325, A03331, A03336, A03341, A03346, A03356, A03361, A03366, A03378, A03379, A03381, A03383, A03391, A03402, A03412, A03434, A03440, A03454, A03456, A03459, A03464, A03465, A03466, A03471, A03482, A03500, A03540, A03541, A03550, A03554, A03574, A03607, A03608, A03614, A03619, A03621, A03625, A03638, A03652, A03658, A03661, A03672, A03678, A03685, A03686, A03693, A03694, A03711, A03713, A03715, A03719, A03720, A03724, A03733, A03735, A03743, A03744, A03746, A03762, A03804, A03814, A03853, A04053, A04091, A04211, A04212, A04213, A04215, A04216, A04217, A04218, A04219, A04220, A04222, A04223 - A04228, A04230 - A04232, A04235, A04237, A04238, A04239, A04243, A04255, A04261, A04262, A04263, A04269, A04453, A04471 — A04499, A04501 — A04509, A04511 - A04650, A04652, A04654, A04655, A04657 - A04662, A04664, A04665, A04668, A04670, A04671, A04672, A04675 - A04684, A04686, A04688 - 04694, A04696 - A04718, A04720 - A04731, A04733 - A04736, A04738, A04739 - A04744, A04746, A04748, A04749, A04753, A04754, A04917 - and A04918 - A04941;
b) Serial Numbers: C01014, C01021, C01031, C01035, C01038, C01042, C01048, C01051, C01052, C01056, C01061, C01085, C01094, C01120, C01131, C01134, C01140, C01143, C01146, C01148, C01156, C01161, C01164, C01165, C01167, C01208, C01223, C01225, C01230, C01231, C01247, C01252, C01268, C01275, C01279, C01283, C01288, C01293, C01299, C01312, C01315, C01331, C01332, C01365, C01370, C01374, C01378, C01408, C01411, C01414, C01435, C01436, C01453, C01466, C01480, C01512, C01528, C01530, C01536, C01545, C01553, C01556, C01561, C01571, C01574, C01578,
C01599, C01603, C01614, C01616, C01619, C01622, C01632, C01636, C01637, C01652, C01663, C01672, C01677, C01681, C01704, C01710, C01717, C01721, C01731, C01732, C01770, C01771, C01774, C01788, C01793, C01842, C01854, C01862, C01873, C01886, C01887, C01893, C01920, C01929, C01930, C01945, C01949, C01967, C01969, C01970, C01974, C01992, C01993, C01997, C02012, C02027, C02030, C02075, C02079, C02093, C02097, C02100, C02106, C02113, C02134, C02141, C02154, C02158, C02160, C02175, C02180, C02181, C02185, C02194, C02207, C02210, C02242, C02261, C02277, C02278, C02298, C02303, C02316, C02341, C02344, C02346, C02402, C02403, C02430, C02439, C02446, C02458, C02465, C02522, C02523, C02525, C02526, C02530, C02542, C02550, C02551, C02572, C02576, C02602, C02610, C02690, C02694, C02708, C02721, C02729, C02747, C02754, C02757, C02763, C02777, C02778, C02787, C02788, C02794, C02796, C02797, C02805, C02811, C02817, C02821, C02830, C02839, C02844, C02849,
C02853, C02867, C02893, C02895, C02898, C02899, C02908, C02914, C02943, C02945, C02953, C02957, C02971, C02977, C03000, C03006, C03010, C03015, C03022, C03033, C03071, C03072, C03085, C03094, C03112, C03126, C03131, C03145, C03161, C03166, C03191, C03197, C03208, C03221, C03263, C03342, C03361, C03394, C03398, C03419, C03464, C03482, C03541, C03616, C03704, C03801 - C03805, C03857, C03871, C04080, C04093, C04179, C04259 - 04284, C04286 - C04301, C04303 - C04308, C04334 - C04383, C04410 - C04415, C04417 - C04451, C04453 — C04463, C04465, C04466, C04468 - C04487, C04489, C04490 - C04502, C04504 - C04514, C04516 - C04538, C04540 - C04584, C04586 - C04588, C04590 - C04593, C04595 - C04598, C04603 - C04605, C04607 - C04634, C04661 - C04663, C04666, C04668, C04670, C04673 - C04679, C04686, C04687, C04688, C04689, C04690 - C04711, C04713 - C04729, C04731 - C04786, C04788 - C04800, C05052 - C05076, C05102 - C05113, C05115, C05119 - C05122, and C05124 - C05126;
c) Serial Numbers: B01002, B01003, B01007, B01022, B01027, B01033, B01056, B01066, B01070, B01086, B01121, B01139, B01146, B01162, B01181, B01196, B01210, B01233, B01240, B01256, B01261, B01265, B01266, B01271, B01274, B01282, B01289, B01326, B01331, B01345, B01375, B01387, B01416, B01421, B01435, B01444, B01472, B01475, B01490, B01495, B01514, B01523, B01550, B01558, B01560, B01564, B01567, B01576, B01583, B01589, B01590, B01598, B01604, B01639, B01645, B01658, B01663, B01669, B01675, B01683, B01684, B01685, B01709, B01749, B01750, B01760, B01774, B01905, B01914, B01915, B01934, B01943, B01968, B02001, B02004, B02033, B02035, B02061, B02064, B02108, B02131, B02136, B02143, B02144, B02145, B02149, B02152, B02154, B02157, B02158, B02162, B02163, B02171, B02182, B02186, B02190, B02404, B02428 - B02435, B02437 - B02440, B02442 - B02470, B02472 - B02496, and B02498;
d) Serial Numbers: D01006, D01012, D01093 - D01102, and D01118 - D01127.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pulmonetic Systems, Inc., Minneapolis, MN.
Manufacturer: Pulmonetic Systems, Inc., Colton, CA.
REASON Printed circuit board malfunction may result in the ventilator becoming non-functional (no ventilation provided), with a possibility of no audible alarm sounding to alert the caregiver to the situation.
VOLUME OF PRODUCT IN COMMERCE 1425 Ventilators.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Medtronic Midas Rex Legend Attachments.
CODE Serial Numbers: T0205, T0206, T0267-T0273, T0284, T0285, T0288, T0355-T0360, T0362, T0382, T0383, T0385, T0386, T0388, T0445, T0446, T0467-T0469, T0471, T0472, T0525, T0527, T0529-T0531, T0558, T0559, T0561, T0564, T0566, T0593, T0595, T0624, T0625, T0629, T0632, T0633, T0636, T0637, T0649, T0652, T0731, T0732.
RECALLING FIRM/MANUFACTURER MIDAS REX, L.P. FORT WORTH, TX

REASON The o ring can fall out or migrate, causing difficulty of the attachment engaging the motor.
VOLUME OF PRODUCT IN COMMERCE 309.
DISTRIBUTION PA, FL, MI, VA, AZ, IL, OH and CT.

 

PRODUCT AxSYM Troponin-I Reagent Pack list: a) 3C29-20 (100 test pack);  b) 3C29-15 (50 test pack).
CODE a) lots 90172M300, 90172M301, 91268M300, 91268M301, 91269M300, 91269M301, 91270M300, 91270M301;
b) lots 91540M100, 91540M101, 91540M102, 87602M200.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL.
REASON Falsely high results.
VOLUME OF PRODUCT IN COMMERCE  a) 15,589 - 100 test kits;  b) 8,795 - 50 test kits.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT MicroFrance Instruments brand of Monopolar, non-Laparoscopic Electrosurgical (ESU) Instruments, Intended to remove tissue and control bleeding.
CODE All serial numbers are involved of the following Catalog/Model Numbers (same): CEP215, CP390-1 THROUGH CP390-11, CP604M, CP605M, MCEN-100-2-0, MCEN100-2-5, MCEN100-3-0, MCEN-100-3-5, MCEN100-4-0, MCEN101, MCEN102, MCEN105, MCEN11, MCO360-MCO363, MCO989, MCO990, MCO992, MCO994, MCL20, MCL205, MCL21, MCL210, MCL219, MCL219-1, MCL22, MCL23, MCL24, MCL241, MCL241-1, MCL41, MCL41-1, MCL59, MCL62, PS1CP390-7, PS1MCEN103, PS1MCEN11, PS1MCL20, PS1MC0771F, PS5, PS8, PS1CP390-3, PS1CP390-5, PS1MCEN101 AND SMCEN100-3-0.
RECALLING FIRM/MANUFACTURER Recalling Firm: Xomed, Inc., Jacksonville, FL.
Manufacturer: Medtronic Xomed France Sas Bourbon l'archambault.
REASON Dielectric withstand voltages tested below acceptable limits.
VOLUME OF PRODUCT IN COMMERCE 1912.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Baxter Syntra 120 & 160 Single Use Dialyzers; 24 dialyzers per case; a) catalog R5M6243: Syntra*120 - 1.2 square meters surface
area; b) catalog R5M6246: Syntra*160 - 1.6 square meters surface area.
CODE a) product code R5M6243, Model 120: lot numbers: H01C05093, H01C26032, H01D05034, H01D09036, H01D10091, H01D30040, H01E02129, H01G02067, H01G30068, H01H01075, H01H02032, H01H24077, H01H25025, H01I23481, H01I27029, H01I29017A, H01J13044, H01J15155, H01L12505, H01L14048, H02A29138, H02A30102, H02B02018, H02C13112, H02C13112A, H02C15083, H02C18152, H02C20133, H02C20133A, H02F11044, H02F13065, H02F14196, H02F14204, H02F17041, H02F18106, H02F18494;
b) product code R5M6246, Model 160: lot numbers: H01D02023, H01D03096, H01D16023, H01D17047, H01D18045, H01D23045, H01D24498, H01D25495, H01E03507, H01F18081, H01F24493, H01F26068, H01H16057, H01H19010, H01H26486, H01I30031A, H01J02153, H01J11097, H01K13034, H01K17035, H01K18025, H01K21508, H01L03116, H01L05178, H01L07026, H01L09014, H01L10103, H02B03016, H02B08049, H02B09047, H02B10490, H02C01083, H02C03493, H02C03493A, H02C07064, H02C10506, H02C11561, H02D02071, H02D07492, H02D22152,
H02D26112, H02F21118, H02F22025, H02F25028, H02F29020.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL.
Manufacturer: Baxter Healthcare Corporation, Mountain Home, AR.
REASON Saline and blood leaks from the header.
VOLUME OF PRODUCT IN COMMERCE 119,964.
DISTRIBUTION CA, IN and Internationally.

 

PRODUCT Novoste B-Rail 3.5F Delivery Catheters
CODE Catalog numbers: ABR-0340, ABR-6000 and CBR-6001.
RECALLING FIRM/MANUFACTURER Novoste Corp., Norcross, GA.
REASON Catheter tip damage and detachment.
VOLUME OF PRODUCT IN COMMERCE 7345 units.
DISTRIBUTIONNationwide and Internationally.

 

PRODUCT CADD-Prizm High Volume Administration Set, Reorder No. 21-7057-01, (for use with the CADD-Prizm Pump).
CODE Lot No. 018X22
RECALLING FIRM/MANUFACTURER Recalling Firm: Deltec, Inc., St. Paul, MN.
Manufacturer: Respiratory Support Products, Inc., San Diego, CA.
REASON Some shelf cartons of High Volume Administration Sets, Reorder 21-7057-01, were incorrectly labeled as High Volume Administration Sets with 0.2 micron filter and injection site, product 21-7055-01.
VOLUME OF PRODUCT IN COMMERCE 174 shelf cartons (each carton containing 15 individual pouches of product).
DISTRIBUTION Nationwide.

 

PRODUCT Livewire TC Bi-Directional Steerable Electrophysiology Catheter, Large Sweep, Reorder Number 402272
CODE Lot numbers 02AF28, 02AF51, 02AF56, and 02AG48.
RECALLING FIRM/MANUFACTURER St. Jude Medical, Daig Division, Inc., Minnetonka, MN

REASON The push-pull wire of the device can sometimes improperly protrude through the catheter side-wall.
VOLUME OF PRODUCT IN COMMERCE 54 units.
DISTRIBUTION Nationwide.

 

PRODUCT a) Duet II Glucose Control Monitoring System, In Charge tm;

b) Duet Glucose Control Monitoring System, Duet and ProPak tm. All Non-expired lots.
CODE All Codes and Products.
RECALLING FIRM/MANUFACTURER Lxn Corp., San Diego, CA.
REASON Stability.
VOLUME OF PRODUCT IN COMMERCE 1,894,480.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT The contact lens is covered with a sealed plastic envelope labeled in part: "ACUVUE 2 (etafilcon A) CONTACT LENS STERILE**BC**DIA**D**" ALSO THE EXPIRATION DATE AND LOT NUMBER IS ON THE LENS (MASTER AND TRAIL).The lens shelf box is labeled in Part: "***ACUVUE 2 BRAND CONTACT LENSES Johnson & Johnson VISTAKON, Jacksonville, Florida**Contents 6 lenses (58% H20) in buffered saline** LOT**PRODUCT CODE ***" CODE
The following lot numbers are under recall and they represent a standard "Master" lot number and a unique out of sequence "trail" code too numerous to list (over 3500 different out of sequence digits). ONLY THE ENTIRE CODE INCLUDING THE TRAIL CODE IS UNDER RECALL. THERE ARE LENSES NOT UNDER RECALL THAT HAVE THE SAME FIRST 6 MASTER CODE DIGITS BUT DIFFERENT TRAIL CODES. The firm can be called by the consignee/patient with the lot number to see if its under recall although all direct accounts will have their unique codes that are under recall listed on their recall letter. The Master codes are (the "XXX" in parentheses represents the unique trail code):
Lot B000GRS (XXX) (-3.00 D, 8.7 B.C.);
Lot B000WTK (XXX) (-2.50 D, 8.3 B.C.);
Lot B000WJK (XXX) (-5.00 D, 8.7 B.C.);
Lot B000JKV (XXX) (+4.50 D, 8.7 B.C.);
Lot B000JKW (XXX) (+4.50 D, 8.7 B.C.);
Lot B000JHJ (XXX) (-8.00 D, 8.3 B.C.);
Lot B000JHK (XXX) (-7.00 D, 8.3 B.C.).
RECALLING FIRM/MANUFACTURER Johnson & Johnson Vision Products, Inc., Jacksonville, FL

REASON Firm cannot adequately document if product lot went through sterilization.
VOLUME OF PRODUCT IN COMMERCE 3476.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT BD Interlink Lever Lock Cannula, reorder number 303370. Blunt plastic cannula, Used for Aspiration/Injection of fluids.
CODE All lots.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co., Franklin lakes, NJ.
Manufacturer: Becton Dickinson & Co., Columbus, NE.
REASON Leakage.
VOLUME OF PRODUCT IN COMMERCE 63,479,000 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Siemens Fluorospot compact, Digital image storage and processing.
CODE Siemens Part # 3078560, 3111668, 3111676, 5902767, 5902775 Serial Numbers: 01516, 01517, 01527, 01528, 01529, 01530, 24017, 24018, 24020, 24021, 24023, 24025, 24026, 24027, 24028, 34076, 34089, 34091, 34094, 34095, 34096, 34098, 34100, 34105, 34106, 34107, 34108, 34110, 34111, 34112, 34114, 34115, 34116, 34118, 34120, 34121, 34122, 34123, 34124, 34126, 34127, 34128, 34129, 34130, 34133, 34134, 34135, 34136, 01007, 01008, 01219, 01228, 01413, 01444, 01452, 01477, 01484, 01021, 01205, 01211, 01213, 01215, 01234, 01403, 01406, 01411, 01413, 01417, 01418, 01421, 01422, 01423, 01424, 01428, 01443, 01454, 01456, 01457.
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ.
Manufacturer: Siemens Medical Solutions Erlangen, Germany.
REASON Incorrect labeling of images in DICOM composed format.
VOLUME OF PRODUCT IN COMMERCE 78 units.
DISTRIBUTION Nationwide.

 

PRODUCT a) Stryker Adel Advanced Delivery System Maternity Bed, Model 4700;
b) Stryker Adel Advanced Delivery System Maternity Bed, Model 5012;
CODE All units distributed from September 2001 and July 2002.
RECALLING FIRM/MANUFACTURER Stryker Corp., Kalamazoo, MI.
REASON Foot section may fall off when the bed is moved.
VOLUME OF PRODUCT IN COMMERCE 421 beds.
DISTRIBUTION Nationwide and Australia, Canada, Chile, Hong Kong, Netherlands, Spain, Switzerland, Taiwan.

 

PRODUCT Aesculap Ti Bone Screws, 4x56 mm.
CODE Lot number 5634922.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aesculap, Inc., Center Valley, PA.
Manufacturer: Aesculap Ag & Co. Kg. Tuttlingen, Donau.
REASON Smaller than specified core diameter may lead to screw breakage during and post-implantation.
VOLUME OF PRODUCT IN COMMERCE 55 units.
DISTRIBUTION FL, NJ, and UT.

 

PRODUCT Bayer Glucometer Esprit 2 Blood Glucose Meter; product code 3960.
CODE Product code 3960; all units sold in South Africa.
RECALLING FIRM/MANUFACTURER Bayer Corp., Elkhart, IN

REASON Inappropriate measurement system for South African market.
VOLUME OF PRODUCT IN COMMERCE 300.
DISTRIBUTION South Africa.

 

PRODUCT Amana Model LD10 and LD10D Commercial Microwave Oven.
CODE Serial numbers beginning 0104. (The serial tag can be located by opening the oven door and looking on the left side of the control panel.)
RECALLING FIRM/MANUFACTURER Recalling Firm: Maytag Appliances, Amana Commercial Products Amana, IA.
Manufacturer: LG Electronics Inc. Gyeong, Nam, Korea.
REASON Microwave emission exceeded the power density limit.
VOLUME OF PRODUCT IN COMMERCE 1,192 ovens.
DISTRIBUTION Nationwide, Canada and Mexico.

 

PRODUCT Portex Spinal Tray 25G Whitacre Needle.
CODE Catalog Number: 49651-25; Lot Number: K131988; Exp. Date 01/2004.
RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH.
REASON Spinal tray incorrectly packaged with a Quincke spinal needle instead of a Whitacre spinal needle.
VOLUME OF PRODUCT IN COMMERCE 1160 trays.
DISTRIBUTION FL, MI, MO, NY, OR, PA, RI and WA.

 

PRODUCT Acuson brand Aspen® Diagnostic Ultrasound System Catalog Numbers: 82-47888, 82-61531, 82-47887, 82-53683.
CODE Serial number beginning with "3" followed by other digits (e.g., 3XXXX).
RECALLING FIRM/MANUFACTURER Acuson Corp., Mountain View, CA.
REASON Product labeling did not include ALARA (As Low As Reasonably Achievable) safety instructions.
VOLUME OF PRODUCT IN COMMERCE 600 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Somatom Sensation 16 systems. Software upgrade from Somaris/5 VA50A to VA50B.
CODE Model Number 7393114. Four serial numbers 50012, 50022, 50025, 50029.
RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ02.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany.
REASON Scans may be aborted if scans are started manually.
VOLUME OF PRODUCT IN COMMERCE 4.
DISTRIBUTION OH, NC and MA.

 

PRODUCT Disposable Sensory Needle Electrodes, Model Numbers:
a) 9013R0222 (0.70mm X 30mm); b) 9013R0252 (0.35mm X 30mm); c) 9013R0271 (0.35mm X 20mm).
CODE a) Lot 2663049; b) Lot 2617881; c) Lot 2601944.
RECALLING FIRM/MANUFACTURER Recalling Firm: Medtronic Gastroenterology & Urology Shoreview, MN.
Manufacturer: Medtronic A/S 2740 Skovlunde.
REASON Some needles were not the length specified on labeling.
VOLUME OF PRODUCT IN COMMERCE 1200 Disposable Sensory Needle Electrodes.
DISTRIBUTION CA, MA and Europe, Brazil and Hong Kong.