WEEK ENDING OCTOBER 1

PRODUCT V.A.D. Access Kit/Dressing Change Tray, a sterile single use tray containing the equipment needed, including heparin lock flush, to change the dressing on a vascular access device.
CODE Catalog #DC-680, Lot 906014, EXP 06/01.
MANUFACTURER MEDIKMARK, Inc., Buffalo Grove, Illinois.
DISTRIBUTION Illinois, New York, Texas, Arizona.
QUANTITY 360 trays.
REASON Tray may contain 1000 u/ml heparin instead of 100 u/ml heparin.

PRODUCT Gammamed 12i and 12it High Dose Rate Afterloader Sources, used for HDR afterloader radiation therapy, radionuclide brachytherapy source
CODE 6455-6464 (source).
MANUFACTURER MDS Nordion/Theratronics International, Ltd., Kanata, Ontario, Canada.
DISTRIBUTION Nationwide and Canada.
QUANTITY 36 units were distributed.
REASON Use of substandard Ir-192 sealed sources may lead to overexposure of the patient to radiation with the potential for a significant overdose.

PRODUCT Omni-Jug Disposable Suction Canister, 15000 cc, for collection, transport, and disposal of large amounts of irrigation fluid generated during surgical procedures:
a) Omni-Jug Disposable Suction Canister, Model #5036-00;
b) Omni-Jug Disposable Suction Canister, Model #5036-01.
CODE O-rings are not coded; Canister lids are stamped with run dates of 7/5/99 to 7/26/99.
MANUFACTURER Maryland Plastics, Inc., Federalsburg, Maryland.
RECALLED BY Waterstone Medical, Inc., Falls Church, Virginia
DISTRIBUTION Nationwide.
QUANTITY 8,000 units.
REASON The O-ring component of the suction canister may fail to properly seal, which may not allow proper vacuum seal.

PRODUCT Latex and Non-Latex Operating Room and Area Shoe Covers; Non Latex Gripper Shoe Covers and Boot Covers, packaged in cases of 50, 100, 150, 200 and 300 covers each, under the American Health & Safety Sure-Tread label:
a) NON23758 - Gripper Shoe Covers, Non-Conductive, Universal Size
NON24758 - Gripper Shoe Covers, Non-Conductive, Universal Size
NON24759 - Gripper Shoe Covers, Non-Conductive, X-Large
b) NON24752 - Gripper Sport Shoe Covers, Sport Shoe Size
NON24852 - Gripper Sport Shoe Covers, SMS Material, Sport Shoe Size
c) NON24758R - Gripper Reverse Shoe Covers, Universal Size, Reverse Seam, Blue
NON24759R - Gripper Reverse Shoe Covers, X-Large, Reverse Seam, Blue
d) NON24758L - Gripper II Spunbond Shoe Covers, White
e) NON27144 - Boot Cover Impervious Knee High No Latex
NON27144XL - Boot Cover Impervious Knee High No Latex
f) NON27752 - Shoe Cover w/Non Latex Grid Sport Size,
NON27758R - Shoe Cover W/Non Latex Grid Reverse Blue,
NON27759R - Shoe Cover W/Non Latex Grid X-Large Reverse,
NON27852 - Shoe Cover W/Non Latex Grid Sport Size SMS
g) NON27758 - Shoe Cover Gripper Non-Skid Blue No Latex,
NON27759 - Shoe Cover Gripper Blue X-Large No Latex,
h) AHS1151009 - American Heath & Safety Sure Tread Disposable Shoe Covers, Stretch Size 5-12.
CODE All lots ending with JC followed by a numeral of the part numbers/reorder numbers listed above.
MANUFACTURER Hangzhou Jinchen Knitting & Textiles Co., Ltd., Hangzhou, China.
RECALLED BY Medline Industries, Inc., Mundelein, Illinois
DISTRIBUTION Nationwide.
QUANTITY 39,266 cases.
REASON Some of the shoe covers have the gripper pattern made of a water- soluble substance, and may smear or may be more prone to slippage if exposed to water.

PRODUCT Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay, a quantitative immunoassay for the determination of cardiac troponin-I levels in serum and Plasma:
a) Catalog No. B5700-64 (Domestic), Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay - 120 Tests,;
b) Catalog No. B5700-64R (International), Stratus Cardiac Troponin-I Fluorometric Enzyme Immunoassay - 120 Tests
CODE Lot Numbers: a) KXTN-1146 through KXTN-1204, KXTN-1206 through KXTN-1210, KXTN 1212, KXTN-1214, KXTN-1215 and KXTN-1219, EXP Dates from Oct. 28, 1999 through Feb. 18, 2000; b) KXTN-1146 through KXTN-1204, KXTN-1206 through KXTN-1210, KXTN 1212, KXTN-1214, KXTN-1215 and KXTN-1219, EXP Dates from Oct. 28, 1999 through Feb. 18, 2000.
MANUFACTURER Dade Behring, Inc., Miami, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 12,604 kits were distributed.
REASON The device may produce false positive and false negative test results.
 

WEEK ENDING OCTOBER 8

PRODUCT Visualizer 2000 Diagnostic X-Ray System
CODE Model XV 903 C, Serial Numbers 848001 through 848062.
MANUFACTURER VF-Works, Inc., Palm Harbor, Florida.
DISTRIBUTION Nationwide.
QUANTITY 62 units.
REASON All units are in noncompliance with 21 CFR 1020.32(b)(2) because the collimator was not properly designed to provide necessary x-ray field limitation. In addition, 25 of the units manufactured on or before July 29, 1997, are also in noncompliance with 21 CFR 1020.32(h) because they were not equipped with a five-minute cumulative timer.

PRODUCT Aztech 70 X-Ray System, intended for use in dental radiography.
CODE Model Number: Aztech 70 Dental System.
MANUFACTURER Villa Sistemi Medicali S.p.A.
RECALLED BY The Aztech Group, Inc., Boulder, Colorado
DISTRIBUTION Nationwide.
QUANTITY 19 units were distributed.
REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications on equipment manufactured before September 1, 1999.

PRODUCT Codman Surgical Patties (size 1/2 x 1/2 inch), sterile, indicated use is protection of tissue, including brain and other tissues of the central nervous system, during surgery.
CODE Product Code: 80-1400, Lot #CR528.
MANUFACTURER Codman - A Johnson & Johnson Company, Norton, Massachusetts.
RECALLED BY Codman - A Johnson & Johnson Company, Raynham, Massachusetts
DISTRIBUTION Nationwide and international.
QUANTITY 67,200 patties were distributed.
REASON Surgical Patties incorrectly assembled without a radiopaque marker and string.

PRODUCT Model 35040 Keithley Therapy Dosimeter, intended use for calibration of dosimetry of therapeutic radiation treatment machine for high energy accelerators, cobalt 60, and brachytherapy equipment.
CODE Serial Numbers: 69450-69469; 80276-80295; 82666-82685; 81909-81928; 86087-86106
MANUFACTURER Inovision Radiation Measurements, Cleveland, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 89 units.
REASON A 1.6 Amp fuse may have been installed where a 1 Amp is specified.

PRODUCT The Tracker Display Model #35360A is sold with the Detector Model #35300A and marketed together as the Keithley Model #90100 Tracker System, a radiation measurement system intended for use in quality assurance programs for high energy accelerators, and cobalt 60 machines.
CODE Serial Numbers: 83728-83747; 84582-84601; 85682-85701; and 87309-87328.
MANUFACTURER Inovision Radiation Measurements, Cleveland, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 40 units.
REASON An incorrect fuse was installed on units causing power failures from blown fuse.

PRODUCT The Kid Kart 19-Inch Lap Belts, a component of mechanical chair with casters
CODE Part#: 9332100001, Model #s: EZ1, EZ2, EZB1, EZB2, EX1, EX2, EXB1, EXB2, SPICA, MT, MTB, AT, ATB, T-RACER.
MANUFACTURER Sunrise Mobility Products Division, Kid Kart Operations, Belgrade, Montana.
RECALLED BY Sunrise Medical, HHG, Mobility Products Division, Fresno, California
DISTRIBUTION Nationwide and international.
QUANTITY 68 units were distributed.
REASON The lap belts were assembled incorrectly.

PRODUCT Port-A-CATH Implantable Access System, designed to permit repeated access to the vascular system for the parenteral delivery of medications, nutritional solutions, and other fluids and for the sampling of venous blood.
CODE Catalog Number: 21-4023-22, Lot Number: 66161.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
DISTRIBUTION Europe.
QUANTITY 122 units were distributed.
REASON Product equipped with an incorrect size catheter introducer component. The recalled lot contain size 6 French introducers rather than the specified size 8.5 French introducers.
 

MEDICAL DEVICE SAFETY ALERT

PRODUCT Olympic Mini Bili-Lite, Model 70 and 71.
CODE Catalog Numbers: 51470 and 51471.
MANUFACTURER Burton Medical Products, Chatsworth, California.
DISTRIBUTION Nationwide and international.
QUANTITY 314 units were distributed.
REASON Interior casting in Bili-Lites may fracture causing light to fall.
 

WEEK ENDING OCTOBER 15

PRODUCT CryoValve Allograft Heart Valve
CODE Model PV05, Serial #3985652,
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON The firmís Quality Assurance has identified Donor 23718, received prior to 1/26/98, who does not meet the current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft Heart Valve: a) Model AVOO; b) Model PVOO
CODE Serial Numbers: a) 3924564; b) 3924556.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Maine and Utah.
QUANTITY 2 valves.
REASON Additional donor information on donor number 20995, not available at the time of release of the allografts, revealed that the donorís mother had tested positive for Hepatitis B Surface Antigen.

PRODUCT Precision Current Source Device, used in the dental field to stimulate bone growth and to act as an antibacteria agent.
CODE Serial Numbers: 101, 103 through 109.
MANUFACTURER T.H. Charters, Inc., Beaverton, Oregon.
DISTRIBUTION Texas.
QUANTITY 8 units were distributed.
REASON Product was distributed without a 510(k) or PMA.

PRODUCT Oxygen Concentrators: Models AS005-xx and AS006-xx NOTE: "xx" = any 2-digit number.
CODE Serial Numbers: 060000 thru 178885 for 120 v, 60 Hz units; Serial Numbers: 900000 thru 916792 for 220 v, 50/60 Hz units.
MANUFACTURER Airsep Corporation, Buffalo, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 135,470 units were distributed.
REASON The plastic capacitor may overheat, posing a fire hazard in the unit.

PRODUCT ARCHITECT LH Reagent Kit; a chemiluminescent microparticle immunoassay for quantitative determination of human leutenizing hormone in human serum and plasma for the prediction of ovulation, in the evaluation of infertility, and diagnosis of pituitary and gonadal disorders
CODE List 6C25-20 (400 test kits) and 6C25-25 (100 test kits); Lots 47384M200, 47384M202, 47384M210, 47384M212, 47384M201, 47384M203
MANUFACTURER Abbott Diagnostics, Division of Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 274 100-test kits and 503 400-test kits were distributed.
REASON Results generated with these lots may exhibit an over recovery.
 

WEEK ENDING OCTOBER 22

PRODUCT BLD PEEP-FLO resuscitator devices: a) Peep-Flo Positive Expiratory Pressure valve;
b) Pulmanex Manual Resuscitator with a PEEP-FLO Valve c) CPAP Chsuion-FLEX Mask packaged with BLD’s PEEP-FLO ValveValve
CODE a) PEEP-FLO Valve only
Product Number Lot Number
Number of Lots Range
BLD-8870 49 813085/909002
BLD-8872 28 813085/909002
BLD-8875 20 815075/850093
BLD-8876 11 820047/850093
b) BLD PULMANEX Manual Resuscitator with PEEP-FLO Valve
Product Number Lot Number
Number of Lots Range
BLD-9007-477 10 816065/909003
BLD-9007-5477 2 849045/903081
BLD-9017-477 5 815084/850092
BLD-9017-5477 30 815083/905048
BLD-9017-5477V 1 829082
BLD-9018-5477 13 814095/909000
BLD-9057-477 9 818040/849046
BLD-9058-477 10 834071/908104
BLD-9058-5477 18 823026/908100
BLD-9147-57 12 825047/906069
BLD-9154-5477 1 903035
BLD-9170-5477 4 827048/845055
BLD-9172-477 2 834055/849052
BLD-9172-5477 9 818022/909010
BLD-9178-4837 12 816049/903086
BLD-9257-477 4 816023/909004
BLD-9257-977 2 846024/904034
BLD-9274-477 2 823005/904063
BLD-9274-5477 3 901061/906003
BLD-9274-83 1 830087
BLD-9274-837 3 822040/902071
c) CPAP Chsuion-FLEX Mask with PEEP-FLO Valve
Product Number Lot Number
Number of Lots Range
BLD-8897 2 833054/903054
BLD-8898 3 815099/831016.
MANUFACTURER BLD Medical Products, Dallas, Texas.
DISTRIBUTION Nationwide and Canada.
QUANTITY A total of 62,018 PEEP-FLO valves were distributed: a) 10,808 units; b) 51,090; c) 120.
REASON The PEEP-FLO valve values are out of specification.

PRODUCT Sabraset 560112-L Administration Set with Spike and Cassette for use with the Sabratek 6060 Homerun Volumetric Infusion Pump only.
CODE Catalog #560112L; Lot #990356.
MANUFACTURER Pacific Device de Mexico, S.A. Privada EC Edifico E-1, Local B, Parque Industrial La Mesa, Tijuana, Mexico.
RECALLED BY Sabratek Corporation, Skokie, Illinois
DISTRIBUTION Iowa, Arizona, Indiana, Massachusetts, California, Oregon, South Carolina, Tennessee, Wisconsin, Virginia, Colorado, Florida, Illinois and England.
QUANTITY 2,790 sets were distributed.
REASON Tubing may separate from the filter.

PRODUCT Arrow Percutaneous Sheath Introducer Kit.
CODE Product #AK07903-AG; Lot Numbers: 9C592C, 9C6697, 9D7005,9E819F, 9F610E, and 9G807H.
Product #SI-07903-AG: Lot Numbers: MX9030230 and MX9030234. Product #JM-07903-AG: Lot Numbers: 9E8181 and 9G8849.
MANUFACTURER Arrow International, Inc., Reading, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 8,860 kits.
REASON Potential for separation of sheath from hemostasis valve body in use.

PRODUCT ATS 2000 Pneumatic Tourniquet, intended use is to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Catalog No. 60-2000-101-00.
CODE The serial numbers contain 8 digits/letters. The last 6 digits are either: '079920' or '089920'. These numbers are preceeded with one of the following sets of letters: AA, AG, AR, EJ, FE, FL, FR, AB, AJ, AS, EK, FF, FM, FS, AC, AL, AT, EN, FH, FN, FT, AE, AM, CK, EU, FJ, FP, FU, AF, AQ, EG, EW, FK, FQ, and FW.
MANUFACTURER Zimmer, Inc., Dover, Ohio.
RECALLED BY Zimmer Patient Care Inc., Dover Ohio
DISTRIBUTION Nebraska, Minnesota, Connecticut, California, Maine, Arizona, Illinois, Massachusetts, Wisconsin, Washington state, Texas, Pennsylvania.
QUANTITY 35 units were distributed.
REASON The buttons on the touch panel component may stick in position during use.

PRODUCT ABBOTT AXSYM TROPONIN-I Reagent Pack; a microparticle enzyme immunoassay (MEIA), to assist in the diagnosis of acute myocardial infarction.
CODE List #3C29-20, Lot numbers: 52735M300, 52735M301, 53053M200, 53053M201, 53053M202, 53446M100, 53446M101, 53448M100, 53448M101, 53577M100, 53577M101, 53879M200, 54860M100, 54860M101, 54885M100, 54885M101, 54886M100, 54886M101, 54887M100, 54887M101, 54889M100, 54889M101, 55153M200, 55153M201.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 47,010 kits were distributed.
REASON Calibration failures.
 

WEEK ENDING OCTOBER 29

PRODUCTS ACS: Centaur TROPONIN I IMMUNOASSAY (cTnI), For the quantitative determination of cardiac troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS: Centaur Chemiluminescence System, For In-Vitro Diagnostic use
CODE Lot 32 used in Kits with lot numbers:
Catalog No. 116993 100 Test Kit - Lot7409132
Catalog No. 116994 500 Test Kit - Lot 7409232 and 7464132.
MANUFACTURER Bayer Diagnostics, E. Walpole, Massachusetts.
DISTRIBUTION Nationwide and international.
QUANTITY 131 units were distributed.
REASON Controls and patient samples were recovering higher results than expected range.

PRODUCTS Drill Guide
CODE Part #388.02 lots A4GH708 and A4GB685.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 52 units were distributed.
REASON The cannulated center of the drill guide may not allow the drill bit to pass through.

PRODUCTS Blunt Side Opening Screw
CODE Part number CD948.001, Lot A4FK782.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION California, Florida, Georgia, Pennsylvania.
QUANTITY 15 units were distributed.
REASON The screws from the production lot were manufactured at greater length than specified.

PRODUCTS Reaming Rods with Offset, Straight and Smooth Tips and Medullary Tube: part numbers a) 351.71S; b) 351.76S; c) 355.041S; d) 355.01S.
CODE Lot Numbers: a) A3IO738, A3IP115, A3JQ213, A3JS141; b) A3IQ839, A3IQ842, A3JT680; c) A3JK922, A3II682, A3JQ545, A3JV989, A3JQ546; d). XVC2608 and XVC2609.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 3,915 units were distributed.
REASON In some sterile packages, the sterility may be compromised.

PRODUCTS a) Orion Tracheostomy Care Kit with 14-16 Fr Catheter; b) TRACHEOSTOMY CARE KIT; sterile, single patient use trays; reorder #3017.
CODE a) Item #AH3018, Lot S9258; b) Item #3017, Lot S9241.
MANUFACTURER Orion Life Systems, Inc., Wheeling, Illinois (trays); Jiang Su Jin Hong Corporation, Jintan City, Jiangsu, China (gauze).
RECALLED BY Orion Life Systems, Inc., Wheeling, Illinois
DISTRIBUTION New York, Tennessee, Wisconsin, Florida, Pennsylvania.
QUANTITY 3,040 kits were distributed.
REASON Gauze may be contaminated with ETO resistant mold.

PRODUCTS Nucletron Plato External Beam Planning Radiation Therapy Software V2.1.2 and MLC/Shape Software Module V2.3
CODE Plato RTS software version V2.1.2 used with software module MLC/Shape version V2.3.
MANUFACTURER Nucletron BV, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland
DISTRIBUTION Ohio and Mexico.
QUANTITY 31 copies of software were distributed.
REASON Coordinates for radiation beam used in therapy are mislabeled in software.

PRODUCTS Plato Brachytherapy Treatment Planning System.
CODE Plato BPS Software Version 13.2 and higher.
MANUFACTURER Nucletron BV, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland
DISTRIBUTION Nationwide.
QUANTITY 100 copies of software were distributed.
REASON Software implementation error.

PRODUCTS Oxygen Pressure Regulator, Models: 3125R1GREEN, 3125R2GREEN, 8725R2BLACK, 51B2215R2, 3125R2SILVER, 8700R1GREEN, 3125L1GREEN, 51B2215L1, 3125L1GREEN, 51B2225LD1 and 51B2225L1,L106-260, L270-220/240,L370-220-A, -B, -G, -GL and -R.
CODE Serial numbers apply TO ALL MODEL NUMBERS:
609478 THROUGH 629904
638835 THROUGH 656842
666805 THROUGH 667644.
MANUFACTURER Inovo, Inc., Naples, Florida.
DISTRIBUTION Illinois, California, Wisconsin, Utah, Arkansas, Minnesota, Indiana, Texas, Washington state, Tennessee, Pennsylvania, Missouri, Florida.
QUANTITY 4,856 regulators were distributed.
REASON Faulty DISS fittings causing inadequate flow.

PRODUCTS Bacterial/Viral Filters, used to filter air/gas on mechanical ventilators and anesthesia gas machines to provide an added means of cross-contamination protection:
a) Bacterial/Viral Filters, Catalogue No. 1605
b) Bacterial/Viral Filters, Catalogue No. 7178.
CODE a) Lot Numbers: 1-22910, 3-21910, 4-21910, and 3-29910 (for single patient use);
b) Lot Numbers: 2-03910 and 3-30910 (intended only for further manufacturing).
MANUFACTURER Hudson Respiratory Care, Inc., Temecula, California.
DISTRIBUTION Nationwide, Japan, Canada, Turkey.
QUANTITY 10,100 filters were distributed.
REASON The filters were manufactured by ultrasonic welders that were operating out of a state-of-control causing some over-welding conditions to occur, compromising the filterís efficiency.

PRODUCTS UV Absorbing Posterior Chamber Intraocular Lens:a) Model MC20BA; b) MC60CM.
CODE 60 lenses identified by a unique 9 digit serial number.
MANUFACTURER Alcon Surgical, Inc., Huntington, West Virginia.
RECALLED BY Alcon Japan, Ltd., Tokyo, Japan
DISTRIBUTION Japan.
QUANTITY 60 lenses.
REASON Mislabeling of registration number required for distribution of product in Japan. Label does not include information necessary for proper use of the product.

PRODUCTS VIA ABG & Chemistry Cal Kit, an accessory used to calibrate the VIA Blood Chemistry Monitoring System prior to patient attachment and during monitoring of patient.
CODE Catalog Number: ABG2, Lot Number: 9905182
MANUFACTURER VIA Medical Corporation, San Diego, California.
DISTRIBUTION California, Iowa, Illinois, Missouri, New Jersey, Pennsylvania, Texas.
QUANTITY 880 kits were distributed.
REASON An inappropriate calibration reference number was assigned to the lot of kits, which could affect the measurement of the pH parameter.

PRODUCTS Radiographic Film Cassettes with Intensifying Screens for Mammography:
a) MIN-R 2 Cassette with MIN-R Screen, Catalog Nos. 7087984 and 1821149 (18 X 24 cm);
b) MIN-R 2 Cassette with MIN-R Screen, Catalog Nos. 7091614 and 8410078 (24 X 30 cm);
c) MIN-R 2 Cassette with MIN-R 2000 Screen, Catalog Nos. 8104101 and 8928392 (18 X 24 cm);
d) MIN-R 2 Cassette with MIN-R 2000 Screen, Catalog No. 8999492 (24 X 30 cm);
e) MIN-R 2 Cassette with MIN-R 2190 Screen, Catalog Nos. 1260579 and 1650605 (18 X 24 cm);
f) MIN-R 2 Cassette with MIN-R 2190 Screen, Catalog Nos. 8910853 and 8851651 (24 X 30 cm).
CODE Case label: 139YY through 214YY.
MANUFACTURER Eastman Kodak Company, Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 7,105 cassettes/screen systems were distributed.
REASON The above-referenced cassettes potentially cause a small density variation of approximately 0.3 overall density between mammography films due to a change in supply of a small plastic strip that keeps the cassette foam in place.

PRODUCTS Reference Electrode Disposable Membrane Caps, intended for use with the IL 1600 Series Blood Gas Analyzer.
CODE Part Number: 70987-00, Lot Numbers:
81147 EXP 11/30/99
81250 EXP 12/13/99; 90101 EXP 1/31/00
I90102 EXP 1/20/00; I90103 EXP 1/31/00
I90104 EXP 1/13/00; I90205 EXP 2/28/00.
MANUFACTURER Instrumentation Laboratory Company, Milan, Italy.
RECALLED BY Instrumentation Laboratory Company, Lexington, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY 2,425 boxes were distributed.
REASON Mold contamination underneath membrane may cause stability issues.

PRODUCTS Siemens Accessory Set TCPO2+TCPCPO2 Probe, intended to continuously monitor noninvasive trending of transcutaneous carbon dioxide partial pressure in any patient population and to monitor oxygen in the neonatal population when the patient is not under gas anesthesia.
CODE Part #45 27 347 EH418, Kit Lot #R006.
MANUFACTURER Radiometer Medical A/S, Copenhagen, Denmark. Sticker labeled by: Siemens-Elema AB.
RECALLED BY Siemens Medical Systems, Inc., Danvers, Massachusetts
DISTRIBUTION International.
QUANTITY 17 kits were distributed.
REASON Mislabeled -tcpO2 membrane kits labeled as tcpO2/tcpCO2 membrane kits.

PRODUCTS Total B-hCG Controls, for in-vitro diagnostic use.
CODE List #9C21-10; Lot #53784Q100 EXP 12/23/99.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
DISTRIBUTION Nationwide and international.
QUANTITY 3,445 kits were distributed.
REASON Control values are greater than the package insert ranges with AxSYM or IMx systems.

PRODUCTS FreshLook DuraSoft Phemfilcon A 45%, water 55% Toric Contact Lenses for Astigmatism with Handling Tint; individually packaged sterile contact lenses for disposable or frequent replacement programs.
CODE Lot 081513 EXP 02/01 and 081514 EXP 02/01.
MANUFACTURER Wesley Jessen Corporation, Des Plaines, Illinois.
DISTRIBUTION Nationwide and Canada.
QUANTITY 873 lenses were distributed.
REASON Lenses were labeled with an axis of 90 degrees when they actually have an axis of 180 degrees.

PRODUCTS Jupiter PTA Balloon Catheters: a) Catalog #436502S; b) Catalog #436452S.
CODE Lot Numbers: a) A0699798; b) A0699797.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Alabama, Michigan, Illinois, Mississippi, Iowa, District of Columbia.
QUANTITY 27 units were distributed.
REASON The outer carton was mislabeled with incorrect dimensions on side panel.

PRODUCTS Nikon Children's Eyewear Frames in various colors, Model KD5303.
CODE Lot #N16134.
MANUFACTURER Nikon Optical Company, Ltd., Tokyo, Japan.
RECALLED BY Nikon, Inc., Melville, New York
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 198 units were distributed.
REASON The rubberized end of the earpiece may separate from the frame exposing the metal support rod that runs through the earpiece.