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