MARCH 2002

WEEK ENDING MARCH 9

 

PRODUCT FlexiLab Laboratory Information System, Version 5.2, 5.23, and 5.3,

CODE Versions 5.2, 5.23, and 5.3.

RECALLING FIRM/MANUFACTURER Sunquest Information Systems Inc., Tucson, AZ

REASON Software glitch can cause results to be filed under an incorrect accession number under certain conditions.

VOLUME OF PRODUCT IN COMMERCE 573.

DISTRIBUTION Nationwide and United Kingdom, Ireland, Canada, Denmark, and Bermuda.

 

PRODUCT Thumper Cardiopulmonary Resuscitator.  Model 1007 catalog # 14000 and 15000.

CODE Units manufactured prior to October 2000.

RECALLING FIRM/MANUFACTURER Michigan Instruments Inc., Grand Rapids, MI

REASON Compressions may vary from 5:1 compression-ventilation ratio.

VOLUME OF PRODUCT IN COMMERCE 619.

DISTRIBUTION Nationwide and Canada, Japan, Korea, Spain, Taiwan and Turkey.

 

PRODUCT Valleylab CUSA EXcel Manifold Tubing 36kHz, Sterile, Made in Mexico, Packaged 6 per case.

CODE Catalog No. C3601, Lot No. U12632.

RECALLING FIRM/MANUFACTURER Recalling Firm: Valleylab Inc., Boulder, CO

Manufacturer:  Nellcor, Div. of Tyco Healthcare Group LP, Tijuana, MX. 

REASON Sterilization can not be assured for entire lot.

VOLUME OF PRODUCT IN COMMERCE 312 cases (6 per case).

DISTRIBUTION Nationwide and Australia, Canada, France, Japan and South Africa.

 

PRODUCT Surgimate (tm) brand, Sterile Instrument Pouches, aka "surgical drapes", packed in surgical grade white paper pouches, 100 pouches per case.  Pouches are labeled with item #31-283, sterility exp. date "2006-11". 

CODE Lots 249729, 250788, 251361, 252476, 253250, 253798, and 253842, sterility exp. date "2006-11".

RECALLING FIRM/MANUFACTURER Deroyal Surgical, Rose Hill, VA

REASON Surgical drapes labeled as sterile may contain non-sterile product. 

VOLUME OF PRODUCT IN COMMERCE 1300 drapes.

DISTRIBUTION TN and SC.

 

PRODUCT Dermabond Topical Skin Adhesive, Model No. BD12.

CODE Lot Number 061057, 061058, 061059.

RECALLING FIRM/MANUFACTURER Closure Medical Corp., Raleigh, NC

REASON Inadequate seal in the blister packaging.

VOLUME OF PRODUCT IN COMMERCE 130,116 units.

DISTRIBUTION Nationwide.

 

PRODUCT 35cm J-Hook Electrode

CODE Catalog ES3510B, Lots FI,FJ,FK,GA,GB,GC,GE,GI.

RECALLING FIRM/MANUFACTURER Encision Inc., Boulder, CO

REASON J-hook, fixed-tip electrode may break off during electrosurgical use.

VOLUME OF PRODUCT IN COMMERCE 219 units.

DISTRIBUTION GA, PA, WA, IA and MS.

 

PRODUCT Infant Apnea Monitors as follows: a) AMI 9700 Apnea Monitor; b) AMI 9700A Apnea Monitor; c) AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor,

CODE a) AMI 9700 Apnea Monitor; b) AMI 9700A Apnea Monitor; c) AMI Plus 9700B Infant Central Apnea/Heart Rate Monitor.

RECALLING FIRM/MANUFACTURER Cas Medical Systems Inc., Branford, CT

REASON Infant Apnea Monitor may shut down and the audible alarm may fail to sound.

VOLUME OF PRODUCT IN COMMERCE 5282.

DISTRIBUTION Nationwide and Canada, Brazil, Argentina and Nellcor PB the Netherlands.

 

PRODUCT Dual Stage Venous Return Cannula with Bullet Tip intended for use as a single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open-heart surgery.  The product is labled in part: "Dual Stage Venous Return Cannulae

Chase Medical, Inc., Richardson, TX", packaged individually, sterile and 10 to a case.

CODE All codes are recalled.

RECALLING FIRM/MANUFACTURER Chase Medical Inc., Athens, TX

REASON Venous Return Cannula Tip may separate in use.

VOLUME OF PRODUCT IN COMMERCE 3,715.

DISTRIBUTION Internationally.

 

PRODUCT Rx Multi Link Penta Coronary Stent Systems, U.S. and Rx Multi Link Penta Coronary Stent Systems, CE. Common Name for this device is Rapid Exchange Coronary Stent System. Classification Name is Coronary Stent.

CODE Batch Numbers: 1112232,1112231,1111933,1112331,1111932,1112031,1111931,1112131,1111931,1112032

RECALLING FIRM/MANUFACTURER Guidant Corp., Temecula, CA

REASON Potential compromise of sterility.

VOLUME OF PRODUCT IN COMMERCE 1,000.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Supreme Blood Glucose Test Strips, Product Number 880050, 50-count bottles and Select GT Blood Glucose Test Strips, Product Number 660100, 100-count (a carton containing two 50-count bottles). 

CODE Select GT test strips: Lot 12290A; Supreme test strips: Lots 12150B, 12220B, 12280B, 12290B, and 01031B.

RECALLING FIRM/MANUFACTURER Hypoguard (USA) Inc., formerly Chronimed  Inc., Edina, MN

REASON The product gives abnormally low readings when samples have high glucose levels.   

VOLUME OF PRODUCT IN COMMERCE 11,625 bottles of 50 strips.

DISTRIBUTION Nationwide.

 

PRODUCT Colleague Infusion Pumps: a) Colleague Single Channel Volumetric Infusion Pumps, b) Colleague 3 Triple Channel Volumetric Infusion Pumps, Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL.  Made in Singapore.

CODE Codes: all serial numbers prior to 1201XXXXYY (XXXX = sequential number and YY represents a product code) of the following pumps: a) Colleague Infusion Pump - Single Channel   product code 2M8151 - U.S. Distribution

   2M8151R - Refurbished, U.S. Distribution

   2M8151K - CE Marked, English language

   FKM8151 - English language

   CNM8151 - Swedish language

   DNM8151 - French language

   GNM8151 - Danish language

   HNM8151 - German language

   PNM8151 - Spanish language

   WNM8151 - Dutch language;

b) Colleague 3 Infusion Pump - Triple Channel

   product code 2M8153 - U.S. distribution

   2M8153R - Refurbished, U.S. distribution

   2M8153K - CE Marked, English language

   CNM8153 - Swedish language

   DNM8153 - French language

   GNM8153 - Danish language

   HNM8153 - German language

   PNM8153 - Spanish language

   WNM8153 - Dutch language.

RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL

Manufacturer: Baxter Healthcare Corp., Singapore, SN.

REASON Malfunction of on/off circuit.

VOLUME OF PRODUCT IN COMMERCE 126,800 units.

DISTRIBUTION Internationally.

 

PRODUCT CD HORIZON Spinal System Laminar Hook. REF/Catalog # 84101H. Non-sterile. The product is distributed in individual packages.

CODE Lots 16352, 17659, 22752, 33841, 40131 and 40132.

RECALLING FIRM/MANUFACTURER Medtronic Sofamor Danek Manufacturing, Warsaw, IN

REASON Reduced tensile strength.

VOLUME OF PRODUCT IN COMMERCE 269.

DISTRIBUTION DE, FL, MI, MS, NY, PA, TX and Argentina, Australia, Austria, Belgium, France, Italy, Morocco, Norway, South Africa and Spain.

 

PRODUCT Sterile upper extremity drape surgical kits containing an "S" hook component, The "S" hook is used to attach the rope to the stockinette to hold the arm in position for the surgery.

CODE Catalog #IN 9300 CLF, lots 0P133, 1B007, 1B064, 1C057, 1D136, 1E016, 1F061, 1F085, 1F091, 1F194, 1G077; Catalog #IN 9300 E, lot 1E152; Catalog #SD-199, lots 1A129, 1D120, 1E116.

RECALLING FIRM/MANUFACTURER Medikmark Inc., Waukegan, IL

REASON S-hook may fail during use in surgery.

VOLUME OF PRODUCT IN COMMERCE 19,356 kits.

DISTRIBUTION MI and FL.

 

PRODUCT Monopolar Foot Control Electrosurgical Pencils, as follows: a) Foot Switch Pencil with Standard Electrode, single use, sterile.  Catalog # PEN05; b) Foot Switch Pencil with Coated Electrode, single use, non-sterile. Catalog # CK205.

CODE a) Catalog # PEN05.  Lot # 0346; b) Catalog # CK205.  Lot # 0354. 

RECALLING FIRM/MANUFACTURER New Deantronics Taiwan LTD., Hsin Tien City

REASON Terminal may pull out of pencil body while the blade is being changed.

VOLUME OF PRODUCT IN COMMERCE 1,300 units.

DISTRIBUTION Nationwide.

 

PRODUCT Magnetom Harmony, Symphony, Sonata, and Allegra Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging.

Magnetom Harmony, Magnetom Symphony, Magnetom Sonata and Magnetom Allegra Nuclear Resonance Magnetic Imaging Systems, Diagnostic Imaging.  Brand Label:  "SIEMENS MAGNETOM Harmony MAGNETOM Symphony*** Whole Body Magnetic Resonance System*** Siemens Aktiengesellschaft*** Medical Engineering Group*** Henkestrasse 127, D-91052 Erlangen*** Order No. A91001-M2235-G800-2-7600" 

"SIEMENS MAGNETOM*** Harmony Perfect your performance*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** aOrder No. A91100-M2220-E866-1-7600"

"SIEMENS MAGNETOM Symphony Master excellence in MR*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-9105 Erlangen*** Order No. A91100-M2220-E927-1-7600"

"SIEMENS MAGNETOM Sonata*** The Dedicated Cardiovascular MR System*** Siemens Aktiengesellschaft, Medical Engineering Group, Henkestrasse 127, D-91052 Erlangen*** Order No. A91004-M2220-E850-1-4A00"

"SIEMENS Preliminary Data Sheet*** MAGNETOM Allegra*** 3 Tesla Dedicated MR System*** version 4.5*** August 29, 2001".

CODE                                                     Model Numbers:                  Serial No.:

Magnetom Harmony           47 59 309                K2200                     10001-10429

Magnetom Symphony        47 60 265                K2200                     13001-13580

Magnetom Sonata               57 54 655                K2240                     21001-21036

Magnetom Allegra               71 05 658                K2183                     20001-20012.

RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems Inc., Iselin, NJ

Manufacturer: Siemens Medical Solutions, Erlangen, Germany.

REASON Image reconstruction errors.

VOLUME OF PRODUCT IN COMMERCE 1057.

DISTRIBUTION Nationwide.

 

WEEK ENDING MARCH 16

 

PRODUCT Premier Adenoclone Type 40/41, an EIA diagnostic test kit.

CODE Lot Number: 696006.015. Expiration Date: 04 Feb 02.

RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH

REASON The kits may product false positive test results due to cross-reactivity.

VOLUME OF PRODUCT IN COMMERCE 695 kits.

DISTRIBUTION Nationwide and Canada, Italy, Japan, Great Britain and  Belgium.

 

PRODUCT Vacuette 3.5 ml Coagulation Tube (blue top tubes), Item # 454327.

CODE Lot No. A040109 and A040110.

RECALLING FIRM/MANUFACTURER Recalling Firm: Greiner bio-one North America, Inc., Monroe, NC

Manufacturer:  Greiner bio-one, Austria. 

REASON Partially filed tubes which can cause erroneous results.

VOLUME OF PRODUCT IN COMMERCE 347 boxes.

DISTRIBUTION Nationwide.

 

PRODUCT Torisoft Daily Wear Soft Contact Lens.

CODE 1290275, 1297633, 1291090, 1295628, 1295636, 1296202, 1298017, 1298014.

RECALLING FIRM/MANUFACTURER Ciba Vision Corp., Duluth, GA

REASON Experimental design tool was used to manufacture product.

VOLUME OF PRODUCT IN COMMERCE 18 lenses.

DISTRIBUTION AZ, LA, MI, MN, NJ, NY, OH, UT and VA.

 

PRODUCT Symmetry Bypass System Aortic Connector, Model Number ACN-5055.

CODE Lot Number: 65930.

RECALLING FIRM/MANUFACTURER St. Jude Medical ATG, Inc., St. Jude Medical, Inc., Maple Grove, MN

REASON The wrong sized vein transfer sheath was included in the product packages.

VOLUME OF PRODUCT IN COMMERCE 45 devices.

DISTRIBUTION Nationwide.

 

PRODUCT Parallax brand EZflow Cement Delivery System.

CODE All Lot numbers including: 111300; 021401; 030901; 050101; 050701; 060201; 080301; 100201; 100201.   

RECALLING FIRM/MANUFACTURER Parallax Medical, Inc., Scotts Valley, CA

REASON The cannula may break when subjected to high torsional load.

VOLUME OF PRODUCT IN COMMERCE 1084 units.

DISTRIBUTION Nationwide.

 

PRODUCT Coulter GEN S (tm) Hematology Analyzers.

CODE Part Numbers: 6605381, 6605360, 6605470.

RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter Inc., Brea, CA

Manufacturer: Beckman Coulter Inc., Miami, FL.

REASON Erroneous low results as an artifact of dilution of blood sample at aspiration.

VOLUME OF PRODUCT IN COMMERCE 2000.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Simplastin HTF.

CODE Lot 161600.

RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC

REASON Increased frequency of inconsistent & possibly incorrect clot times.

VOLUME OF PRODUCT IN COMMERCE 612 kits.

DISTRIBUTION CO, GA, IL, NY, NC and Canada, China and the United Kingdom.

 

PRODUCT Portex Inner Cannula for the Blue Line Tracheal Tube.

CODE Portex Inner Cannula for the Blue Line Tracheal Tube:

a) Inner Cannula  Size 7.0mm  Catalog Number: 566070  Lot Number: 108760

b) Inner Cannula Size: 8mm   Catalog Numbers: 109055, 110735, 111493, 111578

c) Inner Cannula Size: 9.0mm   Catalog Number: 566090   Lot Numbers: 110736, 111579.

RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH

REASON Sterility of the device may be compromised due to loss of package seal integrity.

VOLUME OF PRODUCT IN COMMERCE 3536.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT Nellcor Puritan Bennett LP Power Motor Board Kits, Model L-1687 for LP Series (LP6 and LP10) Ventilators.

CODE Lots YW25640 and YW26024.

RECALLING FIRM/MANUFACTURER Nellcor Puritan Bennett, Inc., Minneapolis, MN

REASON Power Motor Board failure could lead to ventilator failure.

VOLUME OF PRODUCT IN COMMERCE 10 kits.

DISTRIBUTION NJ, SC, TN, Singapore and Japan.

 

PRODUCT a) LeMaitre Vascular VascuTape Glow'n Tell Tape, Sterile Product ; b) LeMaitre Vascular VascuTape Stent Guide. 

CODE a) Product Nos.: 1100-20 (20 strips), 1100-50 (50 Strips) and 1100-00 (100 strips).  Lot No. SGL 1042;

b) Product Nos.: 1102-20 (20 strips), 1102-50 (50 strips) and 1102-00 (100 strips). Lot Number: LSG 1028.

RECALLING FIRM/MANUFACTURER LEmaitre Vascular, Inc., Burlington, MA

REASON Sterility of the device may be compromised due to a loss of seal  integrity.

VOLUME OF PRODUCT IN COMMERCE a) Glow'n  Tape= 4,610 boxes; b) Stent Guide=2,840 boxes. 

DISTRIBUTION Nationwide.

 

PRODUCT PSA Reagent Pack. For in vitro diagnostic use only, 100 test units per pack. Distributed by: Ortho-Clinical Diagnostics, Amersham, UK.

CODE Lot 190, Exp.  2/22/02.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY

Manufactured by: Centocor Diagnostics of PA, Inc. 

REASON Product labeled for use outside U.S. shipped to domestic customers.

VOLUME OF PRODUCT IN COMMERCE 473 reagent packs.

DISTRIBUTION Nationwide and Internationally.

 

FDA ISSUES NATIONWIDE/INTERNATIONAL ALERT ON POTENTIALLY DANGEROUS OB/GYN SURGICAL DEVICES

 

FDA is alerting consumers and health care professionals about medical devices labeled as sterile manufactured by A&A of Alpharetta, Ga. and distributed nationally and internationally. The firm also does business as A&A Medical/Rocket USA DBA LifeQuest. Some of the products manufactured by this company have been labeled and shipped internationally as sterile but in fact may not have undergone any sterilization process. This has the potential of causing death or serious injury such as infection, infertility, and miscarriage. This problem potentially affects product labeled and shipped as sterile since 1999.

 

This firm manufactures many types of obstetrics and gynecological surgical devices. These devices are used only in the clinical setting during surgical and gynecological procedures. These products include, but are not limited to curettes (flexible and rigid), uterine dilators, e.g. Laminaria, endometrial sampling sets, fetal blood samplers, fetal bladder drains, laparoscopy accessories, bone marrow needles, harvesting pumps used in in-vitro fertilization, and aspiration sets.

 

FDA is urging the company to recall these products and will take the appropriate measures to assure these products are removed as soon as possible. Distributors and health care providers who have received these products should cease their distribution and use immediately.

Those seeking additional information may want to contact the company at 1-800-424-1234 or contact the FDA Center for Devices and Radiological Health in Rockville, Md. at 1-800-638-2041.

 

WEEK ENDING MARCH 23

 

Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes
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On November 30, 2001, Olympus America, Inc., of Melville, New York initiated a voluntary recall of their bronchoscopes after a medical facility reported bacteria growing in video bronchoscopes, which possibly caused two illnesses. A bronchoscope is a flexible tube with a small light and camera used to evaluate the airway and lungs to diagnose or rule out respiratory problems such as pneumonia and lung cancer. Olympus issued a recall notification letter to hospitals and medical facilities about the suspect bronchoscopes on November 30, 2001, requesting they be returned to Olympus for modification.

 

Olympus determined the original biopsy channel port was made of plastic, and fitted with a cap that was not intended to be removable. However, the medical facility, which reported two illnesses among patients treated with the bronchoscopes, discovered the caps on the two bronchoscopes used became loose, and could be removed by twisting. Olympus is replacing the bronchoscopes' biopsy channel port with a port made from stainless steel, which will not bend or distort during use or reprocessing. In addition, Olympus will use more adhesive to hold the cap in place and prevent the cap from loosening.

 

On February 27, 2002, Olympus issued a second recall notification letter to facilities that did not respond to their first letter.

The following are the Olympus Bronchoscope Models that have been recalled: BF-40, BF-P40, BF-IT40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-IT240, BF-6C240, BF-160, BF-P160, BF-IT160, BF-3C160, BF-XT160.

 

The bronchoscopes were distributed nationwide and to Canada, Mexico, Dominican Republic, Argentina, Brazil, Panama, Chile, Peru, Ecuador, Columbia, Venezuela, Paraguay, Uruguay, Costa Rica, and El Salvador between June 5, 1997 and December 10, 2001.

FDA continues to work with Olympus to get this problem resolved.

 

If you recently had a lung or airway examination with a bronchoscope, and are experiencing respiratory problems, FDA recommends that you contact your physician. In addition, you should report your problem to FDA's MedWatch Reporting Program by telephone, 1-800-332-1088 or on line at http://www.fda.gov/medwatch/. For additional information on this recall you can access the firm's web site at: http://www.olympusamerica.com/innards/h_endoscopy.asp?s=11&p=15


The recall contact is:

Laura Storms-Tyler,
Director, Regulatory Affairs and Quality Assurance
Olympus America Inc.,
Two Corporate Center Drive,
Melville, NY 11747-3157
(631) 844-5688

 

To contact the Consumer Staff in FDA's Center for Devices and Radiological Health call 1-888-463-6332. When prompted, press 1, press 2, press 2, press 3, and press 1. To speak to a Consumer Affairs Specialist (from 8:00 AM to 4:30 PM EST), press 5. To request information after business hours, press 4 and leave a message.

 

WEEK ENDING MARCH 30

 

PRODUCT Brand name: Olympus Bronchoscope 15 Model Numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160.

Common name: Video Bronchoscope     Classification name: Bronchoscope (flexible or rigid).

CODE All serial numbers for the following 15 Model Numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-

1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160.

RECALLING FIRM/MANUFACTURER Recalling Firm: Olympus America Inc., Melville, NY

Manufacturer: Olympus Optical Co., Ltd., Shinjuku-ku, Tokyo, Japan. 

REASON Loosened bronchoscope biopsy channel port & microbial contamination of the port.

VOLUME OF PRODUCT IN COMMERCE 5157 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Various OB/GYN surgical devices labeled as sterile or processed by ETO.

CODE All lots labeled as sterile.

RECALLING FIRM/MANUFACTURER A & A Medical/Rocket USA, Alpharetta, GA

REASON GMP deficiencies.

VOLUME OF PRODUCT IN COMMERCE Unknown at this time.

DISTRIBUTION Nationwide and Worldwide.

 

PRODUCT Intro-Flex Percutaneous Introducer Kits with AMC Thromboshield  an Antimicrobial Heparin Coating.  Size 8.5 F (Model 1652BF85H) and 6F (Model 1500F6).

CODE Model 1500F6       Lot No.  951H0629    Exp. date 8/2003;  Model 1652BF85H    Lot No.  951H0609    Exp. Date 2/2003.

RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Edwards Anasco, Puerto Rico

Manufacturer:  Edwards Lifesciences, LLC Anasco, Puerto Rico.

REASON Product may have inadequate tray seal strength to ensure the sterility of the product for its stated life shelf.

VOLUME OF PRODUCT IN COMMERCE 100 units.

DISTRIBUTION MI, NJ, MD, ME and London and St Asaph.

 

PRODUCT Becton Dickinson's Directigen(tm) Flu A+B in-vitro diagnostic test kit, packaged in papercard boxes, each box containing instructions, reagents and controls to perform 20 tests.

CODE

1058950 exp 6/21/2001

1061952 exp 10/15/2001

1081953 exp 11/12/2001

1056950 exp 11/12/2001

1066951 exp 11/12/2001

1073950 exp 10/26/2001

1073951 exp 11/12/2001

1086955 exp 11/12/2001

1121951 exp 11/12/2001

1173950 exp 11/13/2001

1193951 exp 12/17/2001

1263950 exp 2/18/2002

1263951 exp 2/18/2001

1263952 exp 2/18/2002

1276954 exp 2/18/2002

1276955 exp 2/18/2002

1276956 exp 3/13/2002

1276957 exp 3/13/2002

1276958 exp 3/13/2002

1288950 exp 3/13/2002

1281951 exp 3/13/2002

1295951 exp 3/13/2002

1295952 exp 3/13/2002

1302952 exp 3/13/2002

1309951 exp 3/13/2002

1309952 exp 3/16/2002

1309953 exp 4/19/2002

1309954 exp 4/19/2002

1309955 exp 4/19/2002

1318950 exp 6/01/2002

1318951 exp 6/01/2002

1318952 exp 6/01/2002

1318953 exp 6/01/2002.

RECALLING FIRM/MANUFACTURER Becton Dickinson Diagnostic Systems, Sparks, MD

REASON Directigen (tm) test kit for Influenza may give false positive result.

VOLUME OF PRODUCT IN COMMERCE 7853 kits.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) ANGIO-SEAL Vascular Closure Device 6F STS Platform, product re-order number 610110;

b) ANGIO-SEAL 6F Vascular Closure Device, product re-order number 610092. 

CODE a) lots 01EJ50 and 01EC81; b) lot number 01EJ95.

RECALLING FIRM/MANUFACTURERST. Jude Medical, Inc., Daig Div., Minnetonka, MN

REASON There are missing drip and blood inlet holes from the arteriotomy locator of some of the devices.

VOLUME OF PRODUCT IN COMMERCE 7,800 units.

DISTRIBUTION Nationwide.

 

PRODUCT BCI Handheld Pulse Oximeter, Catalog number 3303.

CODE Serial Numbers: 390414715, 470346940, 702659223 - 702659228, 702659231 - 702659237, 702659239 - 702659242, 702659244, 702659246 - 702659256, 702659258 - 702659264, 702659266 - 702659282, 702659289 - 702659291, 702659293 - 702659296, 702659299, 702783001, 702783002, 702783004 - 702783017, 702783020, 702783021, 702783023 - 702783026,  702783030, 702783033,  702784025,  702784026,  702784028, 702784030, 702784031, 702784033 – 702784036.

RECALLING FIRM/MANUFACTURER Bci, Inc., Waukesha, WI

REASON Inappropriate restart of the device can occur in about 10% of the devices if the audio alarm is set to the highest volume.  Restart is a 2 minute period without alarms.

VOLUME OF PRODUCT IN COMMERCE 99 units.

DISTRIBUTION Nationwide and Brazil, Qatar and Saudi Arabia. 

 

PRODUCT AEROSET System Software v1.00ER005.2 and v1.0ER005Catalog Numbers: 2-8996-02 and 2-89996-01.

CODE All Codes are affected by this field correction.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX

REASON System may incorrectly associate sample ID & test requests under certain conditions of non-bar coded or unreadable

bar coded samples.

VOLUME OF PRODUCT IN COMMERCE 535.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Battery pack for the Criticare Multiple Parameter Telemetry MPT 2.4, Catalog Number 944-C. 

CODE All serial numbers.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Criticare Systems Inc., Waukesha, WI

Manufacturer: Badger Electronics, Franksville, WI.

REASON Some of the battery packs overheat during use.  The heat may melt the battery casing and device case. 

VOLUME OF PRODUCT IN COMMERCE 219 battery packs.

DISTRIBUTION FL.

 

PRODUCT Survivalink FirstSave STAR Biphasic Automatic External Defibrillators, Model Numbers 9200, 9210, 9200D, & 9210D.

CODE Serial Numbers Affected:   800067,  800076 - 800080, 800098 - 800105,  800107,  800109,  800111 - 800116, 800118,  800120 - 800121, 800125 - 800126,  800128, 800133,  800142,  800144,  800154 - 800155,  800159 -800160, 800162,  800210,  800427,  800448,  800456,  800462, 800481 - 800482,  800484 - 800487,  800489,  800491, 800495, 800497,  800499 - 800501,  800503 - 800504,  800527, 800540, 800542,  800560 - 800561,  800614,  800624 - 800625, 800638, 800748 - 800749,  800760,  800764,  800766 - 800768, 800793, 800806,  800810,  800826,  800850,  801197, 801292, 801394, 801564,  801571,  801580,  801591,  801593,  801602 -801603, 801605,  801613 - 801615,  801618 - 801620,  801628, 801665, 801679,  801951,  801994,  802443,  802536,  802547, 802550, 802632,  804091,  804324,  806441,  806457,  807047, 807505 - 807506,  807508,  807547,  807931, 808598, 808611, 809500,  809589,  809731,  809822,  810085,  811189, 812820, 812822,  812824,  812826,  812828,  812830,  812832 -812841, 813164,  813292,  813333,  813395,  813731,  813809, 813824, 813860,  813862,  814591,  814594,  814597,  814598, 814611, 814621 - 814630,  814633 - 814634, 814636,  814638 -814647, 814649,  814651 - 814652,  814654 - 814706,  814708 -814710, 814771,  814891 - 815187,  815189 - 815190,  815197, 815734, 815779,  815783,  815881 - 815910,  816211 - 816292, 816294 - 816360,  816380,  816408,  816411,  816417, 816420 - 816424,  816427 - 816428,  816430,  816433 - 816434,816436,  816439,  816441 - 816442,  816444 - 816480,  816502, 816551,  816569,  816580,  816622,  816624,  816626,  816628, 816630,  816661 - 816780,  816819,  816828,  816866,  816894, 816904,  816915,  816931 - 817275,  817277 - 817452, 817454 - 817503,  817515,  817517 - 817526,  817528 - 817686, 817688 - 817745,  817747 - 817755,  817758 - 817760,  817763, 817764,  817766 - 817770,  817772,  817780,  817785,  817788, 817790,  817791,  817793,  817794,  817798,  817799, 817801 - 817817,  817819 - 817832,  817835 - 817842, 817845 - 817847,  817849 - 818098,  818100 - 818155, 818159 - 818217,  818219 - 818222,  818224 - 818228, 818230 - 818251,  818253 - 818256,  818258,  818260 - 818282, 818284 - 818288,  818290 - 818306,  818308 - 818332, 818334 - 818664,  818666 - 818699,  818701,  818702, 818704 - 818730,  818761 - 818885,  818887 - 818934, 818936 - 818957,  818959 - 818964,  818966 - 819018, 819020 - 819030,  819032,  819033,  819035 - 819044, 819046 - 819064,  819066 - 819067,  819069,  819070,  819077,  819079 - 819081,  819083 – 819090,  819121 - 819150,  819301 - 819359,  819361 - 819393,  819395 - 819411,  819413 - 819421,  819423 - 819464,  819466 - 819493,  819495 – 819529,  819531 - 819559,  819561 - 819575,  819577 - 819592,  819594 - 819598,  819601,  819603 - 819605,  819661 - 819723,  819725 - 819735,  819752,  819961 - 819990,  820651 - 820676,  820678 - 820710.

RECALLING FIRM/MANUFACTURER Survivalink Corp., Minneapolis, MN

REASON Product could fail to deliver defribrillation shocks.

VOLUME OF PRODUCT IN COMMERCE 3,440 units.

DISTRIBUTION Nationwide and International.

 

PRODUCT TotalCare treatment beds, as follows: a) Hill-Rom brand TotalCare beds; b) Hill-Rom brand TotalCare SpO2RT beds

CODE All Model P1900 TotalCare units distributed prior to December 5, 2000.

RECALLING FIRM/MANUFACTURER HILL-ROM, Inc., Batesville, IN

REASON Unintentional movement of bed or failure of controls to operate.

VOLUME OF PRODUCT IN COMMERCE 22,849.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Abbott Carbon Dioxide Calibrator, In-Vitro Diagnostic.

CODE Lot numbers 71296M300 and 75689M200.

RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA

Manufacturer: Microgenics, Fremont, CA. 

REASON Results run low.

VOLUME OF PRODUCT IN COMMERCE 1079.

DISTRIBUTION Nationwide and to Mexico, Columbia, Brazil, Canada, England, Singapore, Hong Kong, Trinidad, Barbados, Turkey and St. Lucia.

 

PRODUCT a) Bayer Immuno 1(R) System, Bayer(R) TESTpoint(TM) TROPONIN      I CONTROLS;

b) Bayer Immuno 1(TM) System Bayer SETpoint(TM) TROPONIN I    CALIBRATORS.

CODE a) Part Number T-03-4006-1, Lot V56149, exp. 6/22/02; b) Part Number T-03-3888-01, Lot V56982, exp. 6/30/02.

RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY. 

Manufacturer: Fisher Scientific, Middletown, VA.

REASON Degradation of products under current storage conditions.

VOLUME OF PRODUCT IN COMMERCE a) 151 units; b) 330.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT OrthoPAT Autotransfusion Set, Sterile Distributed by: Zimmer, Dover, OH.

CODE Ref: 00255511506. Lot Numbers: J01191 and K01184.

RECALLING FIRM/MANUFACTURER Haemonetics Corp., Braintree, MA

REASON Product's sterility maybe compromised as the sterilization dose was not adequate.

VOLUME OF PRODUCT IN COMMERCE 834 units.

DISTRIBUTION NC.

 

PRODUCT Brand Name: Bayer ADVIA(R) Centaur(TM) Rubella IgG Assay Common Name: A chemiluminescence test for determination of IgG  antibodies to the Rubella virus (an in vitro diagnostic).

CODE Catalog Number: 117710

Lot Numbers: 1090311 (expiration date 12/14/01) 1227712 (expiration date 07/19/02) 1356813 (expiration date 09/14/02).

RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corporation, Business Group Diagnostics Tarrytown, NY

Manufacturer:   Bayer Corporation, Business Group Diagnostics East Walpole, MA.  

REASON Use of assay for quantification of IgG antibodies may yield incorrect results.

VOLUME OF PRODUCT IN COMMERCE 725 units.

DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT Hill-Rom TotalCare SpO2RT pulmonary therapy bed system.

CODE All units manufactured as, or upgraded to, a SpO2RT unit prior to February 4, 2002.

RECALLING FIRM/MANUFACTURER HILL-ROM, Inc., Batesville, IN

REASON Siderails may stay up without latching into place.

VOLUME OF PRODUCT IN COMMERCE 2,627 beds.

DISTRIBUTION Nationwide, Canada and Japan.

 

PRODUCT Graham-Field brand Ultrasound Scanning Gel, packed in 1 gallon (128 oz.) plastic jugs, four (4) units per carton, packaged under the GRAHAM-FIELD private label. 

CODE Lot Numbers: 145557 and 134038.

RECALLING FIRM/MANUFACTURER Chester Labs, Inc., Cincinnati, OH

REASON Products distributed prior to complete manufacturing process validation.  The lots failed microbial specifications.

VOLUME OF PRODUCT IN COMMERCE 26 cases.

DISTRIBUTION Nationwide.

 

PRODUCT Anspach brand 2.15 X 22.0 mm Spiral Router. 

CODE Catalog Number A-CRN-S, lot number 51179197.

RECALLING FIRM/MANUFACTURER The Anspach Effort, Inc., Palm Beach Gardens, FL

REASON High speed cutters will not fit into the motor drill system.

VOLUME OF PRODUCT IN COMMERCE 100.

DISTRIBUTION CA, MT, HI, TX and FL and Korea, the United Kingdom, South Africa, the Netherlands and Syria.

 

PRODUCT LIGACLIP Extra Ligating Clip Cartridge, implantable, sterile, single patient use.  Each cartridge contains 6 titanium ligating

clips, individually packaged in a copolyester blister and heat-sealed with a Tyvek lid/pouch.  Each sales unit/carton contains 36

cartridges.  Size: Medium. 

CODE Lot Number: P4P81H Catalog/Item Number: LT200.

RECALLING FIRM/MANUFACTURER Recalling Firm: Ethicon Endo-Surgery, Inc., Cincinnati, OH

Manufacturer:  Ethicon LLP San Lorenzo, Puerto Rico. 

REASON Sterility of the device may be compromised as evidenced by a loss of package integrity.

VOLUME OF PRODUCT IN COMMERCE 81 sales units/cartons.

DISTRIBUTION TX, NC, CT, CA, IL, MO, and KY and Netherlands, Uruguay, Korea, South Africa, Argentina, Australia, Spain, and Saudi Arabia.

 

PRODUCT SangStat brand Celsior™ Cold Storage Solution. 

CODE Batch numbers: CE031; CE032; CE033; CE032-1; CE032-2; Lot Number: CE032-2 was distributed in USA only.

RECALLING FIRM/MANUFACTURER Sangstat Medical Corporation Fremont, CA

REASON Product is contaminated with unknown black residue.

VOLUME OF PRODUCT IN COMMERCE 3,020 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Arrow Spring Wire Guide 0.025" x 23 5/8".  The catalog number is AW-14725. 

CODE Lot # CF1091343.

RECALLING FIRM/MANUFACTURER Recalling Firm: Arrow Intl., Inc., Reading, PA

Manufacturer:  Arrow Internacional de Mexico, S.A. DE C.V. COL. Panamericana, Chihuahua. 

REASON Mislabeled 0.025 when it is actually 0.035 diameter.

VOLUME OF PRODUCT IN COMMERCE 35 units.

DISTRIBUTION Nationwide.

 

PRODUCT Leonardo Workstation, Image processing system, Diagnostic imaging.

CODE Siemens Part #5225128

Serial Numbers:  1010; 1020; 1032; 1033; 1036; 1039; 1042; 1049; 1050; 1052; 1059; 1202; 1204; 1220; 1221; 1228; 1229; 1231; 1232; 1234; 1239;  1240; 1242;  1259;  1262; 1271;  1272;  1275;  1280;  1282; 1284;  1285;  1287;  1291;  1295; 1296;  1297;  1298;  1301;  1304;

1305; 2003; 2048; 2050; 2051; 2053; 2057.

RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ

Manufacturer: Siemens AG Medical Solutions, Forchheim, Germany.

REASON Partial X-Ray images being transmitted to other receiving workstations.

VOLUME OF PRODUCT IN COMMERCE 47 units.

DISTRIBUTION Nationwide.

 

PRODUCT Renasol Liquid Bicarbonate Concentrate BC-1-L Part B in one gallon (3.78 liter) bottles.  Centrasol Liquid Bicarbonate Concentrate MB-330-L Part B in one gallon (3.78 liter) bottles.

CODE Lots 51G109, 40H107, 146H121, 147H121, 148H121, 149H121, 39H107, 51H108, 230H130, 231H130, 121H117, 109H116, 119H117, 111H116, and 108J117.

RECALLING FIRM/MANUFACTURER Minntech Corp., Minneapolis, MN

REASON Aureobasidium pullulans, a yeast that can form chains as a fungus, is in the recalled products.

VOLUME OF PRODUCT IN COMMERCE 13365 cases (4 one-gallon bottles per case).

DISTRIBUTION Nationwide.

 

PRODUCT a) ACOM.PC Angiographic X-ray System; b) Digital Image Communications System.

CODE Siemens part number: a) ACOM.PC V3.0-4371105; b) Quantcor V4.0-4786898, 5915553, 5915579.

Equipment Concerned:

Product:                   Part No.                  Serial No.

LVA V 4.0 single station  47 86 898     >=01439              

LVA V 4.0 1x Floating            59 15 553                              all

LVA V 4.0 3x Floating            59 15 561                              all

LVA V 4.0 6x Floating            59 15 579                              all

LVA V 4.0 10x Floating          59 15 587                              all.

RECALLING FIRM/MANUFACTURER Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ

Manufacturer:  Siemens AG Medical Engineering, Forcheim, Germany.

REASON Software problem in recording heights and weights.

VOLUME OF PRODUCT IN COMMERCE 34.

DISTRIBUTION Nationwide.

 

PRODUCT Renatron II, Renatron PA, and Renatron 100 Dialyzer Reprocessing System machines, and the Renaclear Dialyzer Cleaning system.

CODE The serial numbers for the affected devices are identified below, following the device names. 

Renatron II Dialyzer Reprocessing System

14003

14488

14495

14525

14530

14595

14688

14706

14715

14723

Renatron PA Dialyzer Reprocessing System

PA1873

PA1879

PA1882

Renatron 100 Dialyzer Reprocessing System

14334

14693

14695

14696

14699

14700

14717

14720

14721

14724

14739

Renaclear Dialyzer Cleaning System

RC01125

RC01167.

RECALLING FIRM/MANUFACTURER Minntech Corporation, Minneapolis, MN

REASON The recalled devices have internal stainless steel valve components that may corrode.

VOLUME OF PRODUCT IN COMMERCE 26 units.

DISTRIBUTION Nationwide and Malaysia.

 

PRODUCT Abbott AxSYM System Solution 4 Line Diluent; 10 L cubitainers (bag in box); item no. 8A46-01; for in vitro diagnostic use; 0.1 M Phosphate Buffer with sodium azide preservative and antimicrobial agent; Abbott Laboratories, Abbott Park, IL.

CODE Lot numbers 79809M101, 80072M200, 80074M200, 80075M200, 80296M100, 80300M100, 81013M300, 81014M300, 81022M300, 81023M300, 81024M300, 81025M300, 81026M300, 81027M300, 81028M300, 81029M300, 81030M300, 81038M300, 81040M300, 81041M300, 81241M100, 81242M100, 81243M100, 81244M100, 81621M100, 81827M300, 81830M300, 81831M300, 81832M300, 81839M300, 81840M300, 81841M300, 81843M300, 81844M300, 81845M300, 81846M300, 81851M300, 81852M300, 81854M300, 81855M300, 81856M300, 81857M300, 81858M300, 81860M300, 81861M300, 81862M300, 81865M300, 81868M300, 81869M300, 81870M300, 81871M300, 81872M300, 81873M300, and

81874M300.  The lots expire between 11/10/03 and 12/19/03.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL

REASON Line Diluent causes opiate assay controls out of range high.

VOLUME OF PRODUCT IN COMMERCE 36,850 units.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Architect Prolactin Calibrators, list number 6C27-01; 2 - 4 mL bottles of calibrators per box; Abbott Laboratories, Diagnostics

Division, Abbott Park, IL.

CODE Lot numbers 75941M300 and 75941M301, both with expiraiton date 03/24/02.

RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL

REASON Calibration failures.

VOLUME OF PRODUCT IN COMMERCE 532 kits.

DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Clinitek 100 Software Kit.

CODE Version 7.00.

RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer Corp., Elkhart, IN

Manufacturer: Bayer Corporation, Mishawaka, IN.

REASON False negative results when high concentrations of ketone exist.

VOLUME OF PRODUCT IN COMMERCE 5.

DISTRIBUTION CT, MD, MA, NY and TX.

 

PRODUCT Immulite Thyroid Autoantibody Control Module.

CODE Expire May 31, 2003.

RECALLING FIRM/MANUFACTURER Diagnostic Products Corp., Los Angeles, CA

REASON Negative bias in control values.

VOLUME OF PRODUCT IN COMMERCE 464.

DISTRIBUTION Nationwide.

 

PRODUCT Brand Name: IL Test(TM) Cal 1 Solution Calibrator for use with IL  Synthesis, 500 mL, for in vitro diagnostic use (only).

 (IL: Instrumentation Laboratory)

CODE Part Number: 9833200 Lot Number: N0811766, expiration date 8/2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory Co., Lexington, MA

Manufacturer:  Instrumentation Laboratory Co., Orangeburg, NY.

REASON Elevated electrolyte values with lot N0811766.

VOLUME OF PRODUCT IN COMMERCE 3,674 bottles.

DISTRIBUTION Nationwide and Canada, Mexico and Italy. 

 

PRODUCT DENT-X Image-X 70(R) Plus Intra-Oral X-Ray Imaging System, Intraoral Diagnostic X-Ray Unit With X-Mind(R) Timer Control,

Catalog/Model Number 9992700100. 510(k)# K000551. The Installation, Operation & Service Manual (Part Number 897-000001) is the affected component for this "Field Correction".

CODE All Serial Numbers manufactured & distributed between May 26, 2000 and April 20, 2001.

RECALLING FIRM/MANUFACTURER Recalling Firm: AFP Imaging Corp., Elmsford, NY

Manufacturer:  ARDET s.r.l. 20090, Buccinasco, MI.

REASON Incorrect wiring instructions - connection for the line and neutral terminals were reversed.

VOLUME OF PRODUCT IN COMMERCE 674 units.

DISTRIBUTION Nationwide and Puerto Rico.