FEBRUARY


WEEK ENDING FEBRUARY 4

PRODUCT CryoValve Allograft, Model AVOO and PVOO.
CODE Serial Numbers 6321836 and 6321844.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Connecticut and Canada.
QUANTITY 2 valves.
REASON Donor unsuitability.

PRODUCT AMS Urolume Endoprostheses, stents for recurrent bulbar urethral stricture and prostatic obstruction secondary to benign prostatic hyperplasia:
a)AMS Urolume Endoprostheses, Models 72402010 (2.0 cm) and 72402011 (2.5 cm); AMS Urolume Endourethral Prosthesis Plus Stricture, Models 72401841 (2.0 cm) and 72401843 (3.0 cm); c) AMS Urolume Endourethral Prosthesis Plus Prostate, Models 72401800 (1.5 cm), 72401801 (2.0 cm) and 72401802 (2.5 cm).
CODE All lots.
MANUFACTURER Schneider (Europe) A.G., Bulach, Switzerland.
RECALLED BY American Medical Systems, Inc., Minnetonka, Minnesota
DISTRIBUTION Nationwide and international.
QUANTITY 5,698 units.
REASON The delivery tool of the devices, which is supposed to place the stent in the urethra, could fail to deploy and place the stent in position.

PRODUCT Hewlett-Packard Model M1026A Anesthetic Gas Module with Watertrap Option, used in operating rooms to measure concentration of anesthetic agent and 02 in the breathing circuit to supplement indications given on the anesthesia machine and other monitors.
CODE All serial numbers.
MANUFACTURER Hewlett-Packard GMbH, Boeblingen, Baden-WTTBG, Germany.
RECALLED BY Agilent Technologies (subsidiary of Hewlett-Packard Company), Andover, Massachusetts
DISTRIBUTION Nationwide, Canada, Mexico, Costa Rica, Brazil, Venezuela.
QUANTITY 1,542 units were distributed.
REASON Values of CO2 and anesthetic agents may be lower than actual due to dilution.

PRODUCT Versys Cemented Hip Stem: a) Versys Cemented Plus Hip Stem, Size 15, Catalog No. 00-7852-015-00; b) Versys Cemented Hip Stem, Size 15, Catalog No. 00-7853-015-01.
CODE a) Lot Nos. 63124100, 63380400, 63380500 and 63491200; b) Lot Nos. 62773300, 63491900, 63493600, 63891400, 63893100, 64223900, 62773200 and 63892900.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 244 units were distributed.
REASON An anomaly in the vendor forging die created an intermittent flaw in the mid-section region that could reduce the ultimate fatigue strength.

PRODUCT Duraflow II Heparin Treated Thin-Flex Single Venous Return Cannula Wire Reinforced Open Lighthouse Tip, Model No. DII-TF-036-L.
CODE Lot #93965-9. Use before date of 02/2001.
MANUFACTURER Baxter Research Medical, Inc., also known as Research Medical, Inc., Midvale, Utah.
RECALLED BY Baxter Healthcare Corporation, Cardiovascular Group, Irvine, California
DISTRIBUTION Kansas, Japan, Belgium.
QUANTITY 316 units were distributed.
REASON The size 30 French was found in the 36 French package.
 

WEEK ENDING FEBRUARY 11

PRODUCT Olympic Mini Bili-Lite (halogen phototherapy light), Models 77 and 78.
CODE Catalog Numbers: 51477 and 51478.
MANUFACTURER Olympic Medical, Seattle, Washington.
DISTRIBUTION Nationwide, Canada, Argentina, Croatia, Hong Kong, India, Panama.
QUANTITY 797 lights.
REASON Potential for light to fall due to a broken spring.

PRODUCT System 98 Intra-Aortic Balloon Pumps containing software Revision B, used to inflate and deflate intra-aortic balloons:
a) Model No. 0998-00-0466-51
b) Model No. 0998-00-0466-53
c) Model No. 0998-00-0466-55
d) Model No. 0998-00-0466-57
e) Model No. 0998-00-0466-58
f) Model No. 0998-00-0466-61
g) Model No. 0998-00-0466-64
h) Model No. 0998-00-0466-65
i) Model No. 0998-00-0466-67
j) Model No. 0998-00-0466-83
k) Model No. 0998-00-0466-94.
CODE Pumps containing software revision B.
MANUFACTURER Datascope Corporation, Patient Monitoring Division, Paramus, New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY 550 units were distributed.
REASON Some units may fail to power-up and displays "Electrical Code Failure #5" on the pump screen.

PRODUCT Contrast hCG Urine/Serum Test, a rapid immunoassay for the qualitative detection of Human Chorionic Gonadotropin in urine or serum for the early detection of pregnancy.
CODE
Catalog No.                             Lot No.
BHF 1003 (30 test kit)         B14016
BHF 1003                              B13984
BHF 1203(individual test)  B13989. Lots Expire 10-2001
BHF 1203                              B13961. Lot Expires 11-2001.
MANUFACTURER Genzyme Diagnostics, San Carlos, California.
RECALLED BY Genzyme Corporation Diagnostics Division, Cambridge, Massachusetts
DISTRIBUTION Nationwide, Colombia, Venezuela.
QUANTITY Lot B14016=785 kits; Lot B13984=245 kits; Lot B13989=9,500 tests; Lot B13961=11,250 pouches.
REASON Increase incidence of false positive results using serum specimens.
 

WEEK ENDING FEBRUARY 25

PRODUCT ADCON-L, ANTI-ADHESION CONTROL IN A BARRIER GEL, packaged in a 5-gram aluminum tube, placed in a tyvek pouch, used by surgeons only during single-level, posterior, lumbar laminectomy, or laminotomy procedures, where roots are exposed to inhibit post-surgical peridural fibrosis.
CODE Catalog #G0001, Lot Numbers: A8069N1, A8106N1, A8138N1, A8145N1, A8153N1, A8180N1, A8187N1, A8201N1, A8208N1, A8216N1, A8236N1, and A8243N1.
MANUFACTURER Gliatech, Inc., Cleveland, Ohio.
DISTRIBUTION Nationwide.
QUANTITY 13,800 units.
REASON The sterility of the device cannot be assured due to a packaging defect.

PRODUCT ABIOMED(R) BVS 5000 and BVS 5000i BI-Ventricular Support System, a mechanical circulatory system for use in patients suffering reversible ventricular function.
CODE Serial Numbers: 1359-1396 and 1552-1738.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
DISTRIBUTION Nationwide and international.
QUANTITY 223 units.
REASON Consoles will not switch into weaning mode when activated.

PRODUCT Tap, 7mm Bioscrew, Catalog #C8657.
CODE A60528, A60529, SA60819, SA60820, SA73981, SA86826, SB74552, SB74553, SB74554, SB74555, SB74556, SB74802, SB74803, SB99534, SC76127, SC76128, SD64343, SE84417, SE84418, SF66001, SH68532, SH68533, SJ69944, SJ69946, SJ69947, SJ73064, SK61267, SK61268, SK61269, SM62496,SM62497, SM62498, SM62504, EM62505,SM75666, SRB60070, SRB81696, SRB81697, SRB81698, SRB81699, SRB81700, SRF71142, SRF83000, SRK71511, SRL60388, SRM60390, SRM71588.
MANUFACTURER Linvatec Corporation, Largo, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 537 units.
REASON Screw may break at weld.

PRODUCT Joslyn Steam Sterilizer/Steam Modernization Kit, Model 1626 and 2038..
CODE Various serial numbers.
MANUFACTURER Joslyn Sterilizer Corporation, Farmington, New York.
RECALLED BY Steris Corporation, Mentor, Ohio
DISTRIBUTION Alabama, Colorado, Connecticut, Idaho, Illinois, Massachusetts, Michigan, New York, Ohio, Pennsylvania, Utah, Washington state.
QUANTITY 60 units,
REASON Retention bolts may fail due to fatigue.

PRODUCT Silon(tm) Transparent Wound Dressing.
CODE Lot Numbers: K1023, T2926-S264, T2930-S264, and T2931-S264.
MANUFACTURER Bio Med Sciences, Inc., Bethelhem, Pennsylvania.
DISTRIBUTION Alaska, Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Massachusetts, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington state, France.
QUANTITY 378 units.
REASON Product's sterility may be compromised due to some of the pouches being inappropriately sealed.

PRODUCT Chiron Diagnostics Automated Chemiluminescence System, Model ADVIA:CENTAUR for the quantitative determination of various in vitro diagnostic assays using direct chemiluminescent technology.
CODE Catalog Numbers: 114564, 572561, 572562, 572563, 572564, and 572566. All ADVIA:Centaur Immunoassay Analyzers with software versions 2.01 and 2.11.
MANUFACTURER Bayer Corporation, Oberlin, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 660 units.
REASON Software may incorrectly link previous assay results to a different patient ID.

PRODUCT Allograft Heart valve.
CODE Serial Numbers 387011, 3870081, 3873323, 3873331, 3893472, 3893499, 3874907, 3874893, 6028314, 6028322, 6189717.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Florida, Michigan, Ohio, Pennsylvania, South Carolina, Tennessee.
QUANTITY 11 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Medical Tilt and Recline Chairs, allows patients to sit comfortably, includes tilt and recline features and has various accessories available including trays and headrests: Model Numbers: HTR3000, HTR3500, HTR5000, and HTR5500.
CODE All Serial Numbers beginning with 96H through 99E, inclusive.
MANUFACTURER Invacare Corporation - Canada, Mississauga, Ontario, Canada.
RECALLED BY Invacare Corporation, Elyria, Ohio
DISTRIBUTION Nationwide and international.
QUANTITY 6,246 units.
REASON Injury to patient's fingers may result when returning chair to upright position.

PRODUCT Pilot Model 9200 Vital Signs Monitor, used to measure blood pressure and heart rate non-invasively.
CODE Serial Numbers 000031 through 000077.
MANUFACTURER Calin Corporation, Hayashi, Komaki City, Japan.
RECALLED BY Colin Medical Instruments Corporation, San Antonio
DISTRIBUTION Nationwide, Italy, Colombia, Japan.
QUANTITY 46 units were distributed in the United States.
REASON Leakage from a capacitor in the power supply would cause the power supply to fall.

PRODUCT Chiron Vision, Soflex Model C31UB, Intraocular Lens (IOL).
CODE Lot Numbers: 1015871 which is the 25.5 power diopter model; expires in July 2004; 1015835 which is the 15.0 power diopter model; expires in July 2004. The IOL'S also carry a serial number: 9920010620 9920010625 9920010630 9920010635 9920010621 9920010626 9920010631 9920010636 9920010622 9920010627 9920010632 9920010637 9920010623 9920010628 9920010633 9920010567 9920010624 9920010629 9920010634 9920010595 9920010596.
MANUFACTURER Bausch & Lomb Surgical, Inc., Irvine, California.
DISTRIBUTION Arizona, Florida, Indiana, Kentucky, Michigan, Minnesota, North Carolina, Ohio, Pennsylvania.
QUANTITY 21 lenses were distributed.
REASON The labels for lot 1015871 (25.5 diopter lenses) were switched with labels for lot 1015835 (15.0 diopter lenses), which resulted in refractive errors requiring explanation.

PRODUCT Fourex Natural Skin Condoms.
CODE 443, 443P, 444, 444R, 446, 451, 451R, 452,452C, 452R, 462, 463.
MANUFACTURER London International Group, PLC, Norcross, Georgia.
DISTRIBUTION Nationwide.
QUANTITY 1,016,146 units.
REASON Products may exhibit objectionable odor, dried out or become brittle and unusable.

PRODUCT Castle Steam Sterilizers: (a) Chambers with Door cross-sections of 16"x16" and 20"x20" - Sentry models #s 200/212/220/230, 3020, 3012, 3022, 3023, 3025, 3120, 3122, 3123, 3125, 3130, 3133, 3322, 3323, 3325, 3333, 3522, 3523, 3525, 3533; (b) Chambers with door cross-sections of 24"x36" and 26" x 36" -Model #s 3220, 3222, 3223, 3230, 3233, 3422, 3423, 3433, 3622, 3633, 3641 (c) Chambers with door cross-sections of 26"x62" - Model #s 4030, 4033, 4133, 4233.
CODE All codes.
MANUFACTURER Getinge/Castle, Inc., Rochester, New York.
DISTRIBUTION Nationwide.
QUANTITY 13,300 in operation, 4,750 with steam generator attachments.
REASON Under certain conditions, hot water may enter the chamber, resulting in serious risk of burn injury when the chamber door is opened.

PRODUCT STIC-KIT, needle/sharps containment system, packaged as 6 units/card and shrink-wrapped, used primarily by Para-Medical Services, including EMTs, as part of their First Response Kit.
CODE Catalog #EM82691. All Lots manufactured and distributed since October 26, 1998 beginning with '10 28 98'.
MANUFACTURER Kohlbrat & Bunz Corporation, Mooresville, North Carolina.
RECALLED BY E.M. Innovations, Inc., Kent, Ohio
DISTRIBUTION Ohio, Missouri, Florida, New Hampshire, Arizona, Wisconsin, California, South Carolina, Oregon, New York, Alaska.
QUANTITY 244 units.
REASON Needles/sharps may penetrate through container wall and stick healthcare worker.

PRODUCT Allograft Heart Valves Model PVOO and Model AVOO.
CODE
Model Number PV00 - Serial Number 3874818
Model Number AV00 - Serial Number 3874826
Model Number AV00 - Serial Number 6094996
Model Number PV00 - Serial Number 6095003.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Michigan, Pennsylvania, California.
QUANTITY 4 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT a) Bard Biopty-Cut Biopsy Needle; b) Bard Biopty-Cut Needle with Spacer.
CODE Lot Numbers: a) 22JJ1105, 22JJ1135;b) 22IJ0925.
MANUFACTURER Bard Reynosa, S.S. de C.V., Reynosa, Mexico.
RECALLED BY Bard Peropheral Technologies, C.R. Bard, Inc., Covington, Georgia
DISTRIBUTION Arkansas, California, Florida, Illinois, Indiana, Kentucky, Mississippi, Missouri, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, West Virginia, Wisconsin, Australia, Belgium.
QUANTITY Firm estimated that 1,052 units remained on market at time of recall initiation.
REASON Product is labeled as a Bard Biopty-Cut Needle, 18 gauge x 16cm long but contains a Bard Biopty-Cut Needle, 18 gauge x 20 cm long.

PRODUCT Corning Calcium pH analyzer 634, intended for the measurement of pH and ionized calcium in whole blood.
CODE Model 634 Reagent Pack, Part #478548. Lot Numbers: 9F001 EXP 4/30/01, 9G010 EXP 5/31/01.
MANUFACTURER Bayer Diagnostics, Sudbury, Suffolk, England.
DISTRIBUTION Nationwide.
QUANTITY 127 packs of lot #9F001. 204 packs of lot #9G10 at 4 bottles per pack.
REASON Pseudomonas aeruginosa contamination causing increase in quality control values of pH.

PRODUCT Premier Giardia Diagnostic Test Kits, an enzyme immunoassay (EIA) for the detection of Giardia lamblia antigens in human stool.
CODE Lot #614096.012 EXP 5/2/2000.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide, Germany and Italy. 478 kits were distributed.
REASON Kits do not meet manufacturerís specifications due to design failure.

PRODUCT Abbott Vision Cholesterol TestPack, List #1415-10, 10 tests per package, Enzymatic Esterase - Oxidase, Cholesterol test pack used in the Abbott Vision System for the quantitative determination of cholesterol in anticoagulated whole blood, plasma or serum and are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
CODE Lot Numbers: 54166M200, 54476M300, 54477M300, 55603M100, 55604M100, 55857M300, 55858M300, 56015M300, 57226M100, 57227M100, 57228M100, 57761M100, 58048M100, 58049M100, 58641M200, 58642M200, 58741M400, 58742M400, 59365M300.
MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY Abbott Laboratories Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide, Australia, Taiwan, Singapore, Japan, Italy and Germany.
QUANTITY 46,034 ten-packs were distributed.
REASON ENDPOINT NOT REACHED error messages.

PRODUCT LOFRICÆ CATH-Kit, a urinary catheter intended for intermittent urinary catherization.
CODE Product #92084; Lot #3418 EXP 12/02.
MANUFACTURER Astra Tech AB, Molndale, Sweden.
RECALLED BY Astra Tech, Inc., Lexington, Massachusetts
DISTRIBUTION California, Washington state.
QUANTITY 560 units were distributed.
REASON Catheter has no holes for drainage.

PRODUCT IMx Reaction Cells, list 8397-05; an accesssory device for use with the IMx Select Analyzer for MEIA assays; 100 cells per carton.
CODE Lot #54034M400.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 5,490 boxes were distributed.
REASON Manufacturing defect may result in inadequate flow of the reagents through the reaction cell.

PRODUCT Triage Cardiac Test Panel, Part #97000, an in-vitro diagnostic test kit intended to be used in a medical setting.
CODE Lot #W-17837B.
MANUFACTURER Biosite Diagnostics, Inc., San Diego, California.
DISTRIBUTION Arkansas, Arizona, California, Florida, Georgia, Idaho, Illinois, Kentucky, Maine, Nebraska, New Jersey, Nevada, New York, South Carolina, Tennessee, Texas, Wisconsin.
QUANTITY 112 kits were distributed.
REASON The reagents were inadvertently switched between the test troughs, resulting in irreproducible and inconsistent test results.