WEEK ENDING JULY 2

PRODUCT Synthes Sterile Drill Bits, Part #356.982
CODE Lot numbers: A6G7403 and A6G6911.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide, Canada, Switzerland.
QUANTITY 283 units were distributed.
REASON Package insert was not placed in packaging when the product was sent out.

PRODUCT Synthes Mandibular Modular Fixation System, Part #449.236.
CODE Lot #1005.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California, Pennsylvania, North Carolina, New York, Tennessee, Texas.
QUANTITY 21 units were distributed.
REASON Package insert was not placed in packaging when the product was sent out.

PRODUCT Synthes Spine Anterior Thoracolumbar Rod Clamp.
CODE Part #498.160.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Pennsylvania, Texas, Utah, Virginia, Washington state.
QUANTITY 46 units were distributed.
REASON The connector is not compatible with VentroFix System. The distance at which the parallel connector maintains the rods is less than that which clamps provide.

PRODUCT SK (sterile kits) kits, consisting of replacement seals and valves for cannulas: Model SK1, SK2, SK3, SK4.
CODE Lots with Gibbons label: 981380 981691 981731 981781 983510 983511.
Lots with Smith & Nephew label: 981390 981671 981681 981700 982380 982780 982790 983450 983520.
MANUFACTURER Gibbons Surgical Corporation, Virginia Beach, Virginia.
DISTRIBUTION Alabama, California, Pennsylvania, Texas, Michigan, Massachusetts, Missouri, Austria, Germany.
QUANTITY 17,439 kits were distributed.
REASON Devices were dosed at a different level than that documented in validation study.

PRODUCT Liftmaster Patient Hoist, Models 160 and 190 (Catalog numbers AA8940/AA8945).
CODE All units in the United States.
MANUFACTURER Smith & Nephew Homecraft, Ltd., Farnham, Surrey, UK.
RECALLED BY Smith & Nephew, Inc., Germantown, Wisconsin
DISTRIBUTION Nationwide.
QUANTITY 24 lifts.
REASON A bolt attaching the load-spreader to the boom of the lift can fracture due to metal fatigue over time and allow the patient to fall to the floor.

PRODUCT Bard Cardiopulmonary Extracorporeal Cannulae, intended for use in cardiovascular surgery to cannulate vessels or perfuse arteries:
Z-1012-9 -- Models: 007300, 007301, 007302,007303. Overall Length: 17.5cm, 14-20F, 3/8 inch connector.
Z-1013-9 -- Models: 007350,007351. Overall Length: 17.5cm, 10&12F, 1/4 inch connector.
Z-1014-9 - Models: 007267, 007268, 007269, 007270, 007271. Overall Length: 41.5cm,16-24F, 3/8 inch connector.
Z-1015-9 - Models: 007274, 007275, 007276, 007277, 007278, 007279, 007280, 007281,007282. Overall Length: 41.5cm,10-26F, 1/4 inch Connector
Z-1016-9 - Model: 007773. Overall Length:27.5cm,12F, 1/4 inch connector.
Z-1017-9- Model: 007720, 007721, 007722, 007723. Overall Length: 27.5cm,10-16F, 1/4 inch connector.
Z-1018-9 - Model: GA***** Special Order product attributes, such as length, French size, etc. GA*****
Item #'s: 007274-007282, 007773, 007720-007723 Special order-GAXXXXXX * (X =ANY NUMBER 0-9)
CODE Lot numbers: All Lot Numbers 43CI--- through 43LI---, 43AJ--- through 43EJ--- and Lot Numbers 43BI2019, 43BI2023 and 43BI2025.
Lot Numbers 43BI--- through 43LI---, 43AJ---through 43EJ---. (- represents any number 0-9).
MANUFACTURER C.R. Bard Puerto Rico, Las Piedras, Puerto Rico.
RECALLED BY C.R. Bard, Inc., Haverhill, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY 46,539 units were distributed.
REASON Sterile barrier may be compromised.

PRODUCT Argyle DeLee Suction Catheter w/Mucous Trap, intended to aspirate liquids or semisolids from a patient's upper airway
CODE Product code: 8888-257360. Lot #9088054.
MANUFACTURER Kelsar, S.A., Tijuana, Mexico.
RECALLED BY Kendall Healthcare Products Company
DISTRIBUTION Nationwide and Canada.
QUANTITY 85 cases (50 units per case) were distributed.
REASON Product may be non-sterile.

PRODUCT Laser Systems and Communication Lasers:
a) Model No. DY Laser Systems;
b) Model No. DYH Laser Systems;
c) Model No. LCT Class IIIb Communication Laser.
CODE Model Number: DY and DYH Laser Systems and LCT Communication Laser Systems.
MANUFACTURER Power Technology, Inc., Mabelvale, Arkansas
DISTRIBUTION Nationwide.
QUANTITY 23 units were distributed.
REASON The model DY and DYH laser systems were introduced into commerce uncertified and did not comply with the performance standard (Section 538 of the Federal Food, Drug, and Cosmetic Act and 21 CFR 1010.2). The Class IIIb LCT communication lasers failed to have a remote interlock connector, an adequate beam attenuator, and the correct text on the warning logotype label (CFR 21 1040.10(f)(3), 21 CFR 1040.10(f)(6), (21 CFR 1040.10(g)(2)(iii).

PRODUCT Vitros ECi Immunodiagnostic System, a random access immunodiagnostic analyzer for use in clinical laboratories
CODE Catalog No. 8633893, All units with the MOD E2 upgrade including but not limited to Serial Nos. 30000256, 30000311, 30000333, 30000351, 30000358, 30000364, 30000369, 30000372, 30000376, 30000377, 30000386, 30000397, 30000402, 30000449, 30000451, 30000478, 30000578, 30000602, 30000622, 30000660, 30000671, 30000678, 30000697, 30000714, 30000736, 30000750, 30000752, 30000789, and 30000820.
MANUFACTURER Ortho-Clinical Diagnostics, Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 105 units are affected.
REASON The shear valves in the reagent monitoring system may seize and stop dispensing reagent.

PRODUCT MHS Manual Hexdriver, Part #10150, used to screw in or out the appropriate 10010-XX size bone screws that secure the Alphatec modular barrel plate extensions against the proximal femur
CODE Lot #M990188E.
MANUFACTURER Alphatec Manufacturing Inc., Palm Desert, California.
DISTRIBUTION Michigan, Georgia, Florida.
QUANTITY 27 units.
REASON The hexdriver shaft was not heat treated as indicated in the specifications.

PRODUCT IVAC MedSystem III Infusion System, a three-channel microprocessor based fluid delivery device for use to control and monitor infusion via intravenous, intra-arterial or subcutaneous routes:
a) Model 2860: three-channel, general purpose, infusion pump, 110V;
b) Model 2863: three-channel, general purpose, infusion pump, 110V;
c) Model 2866: three-channel, general purpose, infusion pump, 220V (international), and a power supply board kit for use as a replacement power supply board for the Medsystem III pump
CODE Pump Serial Numbers less than 3351884;Kit Serial Numbers: 2860646 and 2860531.
MANUFACTURER Alaris Medical Systems, Inc., San Diego, California.
DISTRIBUTION Nationwide, Canada, The Netherlands, Japan, American Somoa.
QUANTITY 2,851 pumps and 466 power supply board kits were distributed.
REASON Capacitors in the power supply board are failing causing the pumps to shut down/stop infusing without an alarm notifying the user.

PRODUCT 1.5 mm TI Cortex Screw Self Tapping 8 mm and 12 mm, Part numbers 400.808.96 and 400.812.96.
CODE Part number 400.808.96 Lot number A3KT631 and Part number 400.812.96 Lot number A3KU527.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania, by letter on April 8, 1998
DISTRIBUTION Nationwide.
QUANTITY 496 units were distributed.
REASON Product was mislabeled. The label placed on the device was blue instead of mauve. A blue label is for 2.0 mm diameter screws. The text on the label was correct.

PRODUCT Ortho Chlamydia Antigen ELISA Test, diagnostic test kits.
CODE Catalog #550080, Lot #550080.034, Expiration Dates: 8/23/99 (reagent), 8/3/99 (kits).
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY Meridian Diagnostics, Inc., Cincinnati, Ohio
DISTRIBUTION Nationwide.
QUANTITY 310 kits were distributed.
REASON OPD Substrate Tablets have deteriorated resulting in inaccurate test results.

PRODUCT ORTHO HSV Antigen ELISA Test, Modification, diagnostic test kits for the detection of herpes simplex virus.
CODE Catalog #550010, Lot #550010.042, EXP Date: 8/23/99 (reagent), 1/19/99 (kit).
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide and Italy.
QUANTITY 433 kits were distributed.
REASON The OPD Substrate Tablets have deteriorated resulting in inaccurate test results.

PRODUCT Synthes (USA) Midfacial System Part Numbers 446.516 and 447.515
CODE Part number 446.516 Lot A3LU954 and Part number 447.515 lot A3LZ375.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California, Florida, Michigan, Oregon, Texas.
QUANTITY 27 units were distributed.
REASON Product was mislabeled. The plates were anodized gold and should have been green/gray.

PRODUCT One Shots HDL Precipitating Reagent, for in-vitro diagnostic use in 0.5 ml tubes, packaged in a blue plastic pail containing 250 tubes
CODE Catalog No. 3335-250, Lot Nos. MI20, EXP 10/31/98, and NG07, EXP 8/31/99.
MANUFACTURER Data Medical Associates, Inc., Arlington, Texas.
DISTRIBUTION Nationwide and international.
QUANTITY 2,241 pails were distributed.
REASON The reagent tubes contain less reagent volume than indicated on the label.

PRODUCT Acufex Tibial Anchor Screw & Spiked Washer, indicated for use in fixation of soft tissue in orthopedic procedures.
CODE Catalog #7207-186.
MANUFACTURER Smith & Nephew, Inc., Mansfield, Massachusetts.
DISTRIBUTION Arkansas, Colorado, Massachusetts, Pennsylvania, Texas, Wisconsin, Africa, Belgium, Singapore, France, Denmark.
QUANTITY 182 units were distributed.
REASON The head of the screw may break during insertion.

PRODUCT IMx Estradiol Reagent Pack, List #2215-22, 100 tests,an in-vitro diagnostic microparticle enzyme immunoassay for the quantitative measurement of estradiol in human serumand plasma on the IMx Analyzer
CODE Lot Numbers: 49001M100, 51758M300, 51585M400.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 3,037 packs were distributed.
REASON Lots may show underrecovery of estradiol with undiluted patient specimens.
 

WEEK ENDING JULY 9

PRODUCT IMED Gemini PC-2, 220 Volt Volumetric Infusion Pump/Controller with a titration feature, used to provide automatic infusion of intravascular drugs, fluids, blood and blood components in a hospital environment.
CODE All serial numbers.
MANUFACTURER Alaris Medical Systems, Inc., San Diego, California.
DISTRIBUTION International.
QUANTITY 1,410 units were distributed.
REASON The device is subject to lockup, resulting in an interruption of fluid delivery caused by an incorrect installation of a Watchdog FET.

PRODUCT Ethox brand Weighted Feeding Tube, "Easy Glide", Catalog #9210, Nasogastric/nasointestinal feeding tube with stylet, sterile, disposable
CODE Lot #1712010.
MANUFACTURER Ethox Corporation, Buffalo, New York.
DISTRIBUTION Ohio, Illinois, New Jersey, Washington state, North Carolina, New York, Louisiana, Arizona, California, Puerto Rico, international.
QUANTITY 1,660 units were distributed; firm estimated that 622 units remained on market at time of recall initiation.
REASON The tungsten weighted tip may separate from the tube during use.

PRODUCT 40 cm H20 Pop-off Elbow, (sold separetely and component of Assist Circuit and Resuscitators):
a) Stand alone 40cm H20 Pop-off elbow, Product No. BLD-1024;
b) BLD Pulmonary Assist Circuit (PAC) containing the 40cm H20 Pop-off elbow, Product No. BLD-83124-2;
c) PULMANEX Pulmonary Manual Resuscitators, containing the 40cm H20 Pop-off elbow, Product Nos. BLD-9140, BLD-9142, BLD-9146, BLD-9147, BLD-9187, BLD-9192, BLD-9198, BLD-9244, BLD-9245, BLD-9246, BLD-9249, BLD-9257, BLD-9262, BLD-9291, BLD-9294, BLD-9348, BLD-9390, BLD-9392, BLD-9394, BLD-9395, BLD-9396, BLD-9397, BLD-9398, BLD-9410.
CODE a) Lot Nos. 908083, 909018, 914066; b) Lot Nos.847042, 849005, 907093, 911105, 913060, 915007, 916087, 917108, 919070; c) Lot Numbers between 846000 and 919000.
MANUFACTURER BLD Medical Products, Dallas, Texas.
DISTRIBUTUION Nationwide.
QUANTITY 53 elbows; 1,000 PACS and 7,973 resuscitators were distributed.
REASON The Pop-off elbow, used to limit valve to maximum pressure, may contain excess plastic material (flash) that could break off and migrate into the patient airway during treatment.

PRODUCT Amplicor Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Amplification Kit, Catalog No. 83319/07 59902 (Art. 07 59902), sold as an export only product
CODE Lot No. 19118, EXP 2/99.
MANUFACTURER Roche Molecular Systems, Inc., Somerville, New Jersey.
DISTRIBUTION Ohio, Michigan, New Jersey, international.
QUANTITY 2,116 units were distributed.
REASON The CT (+) Control and the CT Internal Control may give low absorbance readings which may give false negative results.

PRODUCT Synthes Elastic Intramedullary Nail (Ein) System, Part # 475.935S
CODE Lot S3AS978
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Arkansas, California, Massachusetts, Missouri, Pennsylvania.
QUANTITY 19 units.
REASON Product was packaged with insert GP0735 which is an insert for One Step Lag Screw. The product should have been packaged with insert GP0935.

PRODUCT Laminectomy Punch 40 Degree up-biting, Part #U44-255-30.
CODE Lot A7HA13.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Colorado and Missouri.
QUANTITY 2 units.
REASON Mislabeled - Label indicates punch has a 3 mm bite. The punch in the package (U44-255-20) has a 2 mm bite.

PRODUCT Boehringer Mannheim/Hitachi 917 Disk System, a clinical chemistry analyzer system
CODE All versions of the disk system software with an updated barcode reader. This includes the system with Serial No. 9715-05 and all Serial Numbers greater than 9805-10.
MANUFACTURER Hitachi Ltd., Instrument Division, Ibari-ken, Japan.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Arizona, California, Connecticut, Delaware, Illinois, Indiana, Iowa, Maryland, Massachusetts, Michigan, New Jersey, Ohio, Pennsylvania, Rhode Island, South Carolina, Washington, West Virginia, Wisconsin, Canada.
QUANTITY 32 analyzers were distributed in North America.
REASON The barcode reader can read the wrong sample barcode, mismatch the test results, and report them under the wrong sample.

PRODUCT CryoValve Allograft (Heart Valve), Model PV00.
CODE Serial #6337449, Donor #34109.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (Heart Valve), Model PV00.
CODE Serial #6185118, Donor #29400.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Louisiana.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (Heart Valve), Model PV00.
CODE Serial #6330061, Donor #33894.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (Heart Valve), Model PV00.
CODE Serial #6336493, Donor #34085.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Louisiana.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodiluiton of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (Heart Valve), Model PV00.
CODE Serial #6431348.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON During a recent review of donor 36936 records, discodant HbcAb results were discovered in the donorís serological testing profile. Current Federal regulations for human tissues mandate that any discordant serological testing results for viral markers be reported as "repeatedly reactive". This donorís serological test for HbcAb was incorrectly report as "nonreactive".

PRODUCT 4.5 mm Shaft Screw - 30 mm, Part #214.230.
CODE Lot #A3LV413
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION California and Oklahoma.
QUANTITY 2 units.
REASON Seven screws in the lot were mislabeled with a label from part number 209.870 lot #A3LR166 (7.3 mm Cannulated Screw - 70 mm).

PRODUCT Flexible Shaft Connector for use with Jacobs Chuck, Part # 351.16J
CODE Lot #3150851.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Arizona, California, Colorado, North Carolina.
QUANTITY 5 units.
REASON Flexible shaft connector for hand reaming (351.16) was packaged and labeled as a Flexible Shaft Connector for use with Jacobs Chuck (351.16J). The instructions to convert the part were not complete.

PRODUCT TI-6AL-7NB URTN, Part number 476.36S, a tibial nail.
CODE Lot #A3LO480.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Alabama, Hawaii, Kansas, Missouri, New Mexico, New York, Oklahoma, Virginia, Washington state.
QUANTITY 12 units.
REASON Mislabeled - The outside package indicates the product is a Ti Solid Tibial Nail 10 mm x 360 mm (476.36S). The contents of the inner package are a Ti Cannulated Tibial Nail 13 mm x 420 mm (458.342S) of Lot #A3LH315.

PRODUCT Synthes Anatomical Locking Plate System, Part #292.699.111.
CODE Lot 3153892.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Alabama, Colorado, Missouri, Mississippi, New York, Pennsylvania.
QUANTITY 210 units.
REASON The device is 275 mm long instead of 280 mm.
 

WEEK ENDING JULY 16

PRODUCT CVIS Insight Imaging Catheter for intraluminal coronary interventional procedures; 2.6French/30 MHz and 2.6French/40 MHz, Model C3020 and C3005, indicated for ultrasound examination of the coronary intravascular pathology only. Intravascular ultrasound is indicated in-patients who are candidates for transluminal coronary interventional procedures.
CODE UPN/Material #H749C30200, Catalog #C3020, Lots: All Lots UPN/Material #H749C30050, Catalog #C3005, Lots: All Lots.
MANUFACTURER Boston Scientific Corporation, San Jose, California.
DISTRIBUTION Nationwide and international.
QUANTITY 44,841 units were distributed.
REASON The product may separate from the proximal segment.

PRODUCT Midmark 73018 Attachment Accessories for the Midmark Magnum General Table, hydraulic, sold as kits and are designed for use in the support of patients during orthopedic surgery procedures.
CODE Serial Numbers: TFY1010 through TFY1025.
MANUFACTURER Midmark Corporation, Versailles, Ohio.
DISTRIBUTION New Jersey, Florida, Michigan, Louisiana, Minnesota, Texas, Missouri, District of Columbia.
QUANTITY 14 units.
REASON Defects of table accessories cause unintended motion during orthopedic surgery.

PRODUCT Henley Healthcare Fluidotherapy Unit, air-fluidized beds employing dry heat that is intended to treat local pain, range of motion and blood flow insufficiency in the body extremities:
a) Henley Healthcare Fluidotherapy, Model 110D;
b) Henley Healthcare Fluidotherapy, Model 110DE,
CODE a) Serial Numbers 2-00001 - 2-00369; b) Serial Numbers 2-00001 - 2-00006.
MANUFACTURER Henley Healthcare, Inc., Sugarland, Texas.
DISTRIBUTION Nationwide and international.
QUANTITY a) 369 units; b) 6 units were distributed.
REASON Excessively long metal bolts securing metal legs to the wooden base of the device protruded too far into the housing, contacting the electrical connection to the heater after collapsing a metal heater schroud, causing 13 amps of electrical current to be delivered to the metal legs.

PRODUCT Doctors Review System, OBLink software releases prior to 9.0.
CODE All units.
MANUFACTURER Digisonics, Inc., Houston, Texas.
DISTRIBUTION Nationwide.
QUANTITY 39 units were distributed.
REASON Y2K software error may produce an incorrect estimated delivery date (EDD).

PRODUCT QTEST(R) STREP, an IVD kit for P.O.C. testing to detect Group A streptococcus, using a sample throat swab, Catalog 494776 - 40 tests/kit; 494780 - 80 tests/kit.
CODE SERIAL NOS. 5648, 5663, 5664, 5673, 5665.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Marland.
DISTRIBUTION Nationwide.
QUANTITY 1,044 kits were distributed.
REASON The Vol-pak pouch sealer failed to provide an adequate seal, and the Quali-pak leak tester failed to detect the inadequate seal.

PRODUCT DIRECTIGEN 1-2-3 GROUP A STREP TEST, DEVICE LISTING 702228, an IVD kit used by hospitals for detection of Group A streptococcus using a sample of throat swabs or bacterial colonies.
CODE CATALOG # 852540, Serial Nos. 5638, 5662, 5670.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
DISTRIBUTION Washington state, Tennessee, Florida, Georgia, Connecticut, Utah, Kentucky, New Jersey, Pennsylvania, Indiana, Alaska, Illinois, Minnesota, Arkansas, California, Virginia, District of Columbia.
QUANTITY 1,230 kits were distributed.
REASON The VolPak pouch sealer failed to provide an adequate seal, and the QualiPak leak tester failed to detect the inadequate seal. An inadequate seal may lead to false negative results.

PRODUCT Quest Myocardial Protection System (MPS), a sterile, single-use, prescription device:
a) Model No. 5001101; b) Model No. 5001101 NE; c) Model No. 5001102.
CODE a) Lot No. 9306.05K; b) Lot No. 9373.08K; c) Lot Nos. 9267.08J, 290.03K, 9340.01L, 9357.03L, 9394-03L, 9403.04L, 404.07L, 9405.09L, 9415.03M, 9434.05M.
MANUFACTURER Quest Medical, Inc., (QMI), an Atrion company, Allen, Texas.
DISTRIBUTION Nationwide.
QUANTITY 3,430 units were distributed.
REASON The delivery sets may develop a leak in the main pump cassette during use.

PRODUCT Ampilcor HBV Monitor(tm) Kit, an IVD test that utilizes PCR nucleic acid amplification and DNA hybridization for the detection and quantitative measurement for Hepatitis B viral DNA in human serum or plasma:
a)Catalog No. 87521/0757160 (Domestic), Amplicor HBV Monitor(tm) Test "For Research Use Only";
b)Catalog No. 83271/0757152 (International), Amplicor HBV Monitor(tm) Test "For In Vitro Diagnostic Use".
CODE Lot numbers: a) Lot No. 9803, EXP 5/99; b) Lot No. 9804, EXP 5/99.
MANUFACTURER AB Sangtec Medical, Bromma, Sweden.
RECALLED BY Roche Molecular Systems, Inc., Somerville, New Jersey
DISTRIBUTION New Jersey, Pennsylvania, Maryland, North Carolina, Indiana, Michigan, Texas, California.
QUANTITY 91 kits were distributed.
REASON The IS values for the standards are low which results in HBV/IS OD ratios which are high and outside of the kit-specified acceptance criteria causing invalid runs.

PRODUCT Steris Process Biological Indicator; the kit includes 20 biological indicators (B.stearothermophilus), 20 vials filled with growth medium, and a Certificate of Performance and Instruction Card, to be used in conjunction with STERIS Chemical Monitoring Strips. The product is shipped frozen.
CODE Catalog Numbers: S3032, S3036, and S3036-2. The lot number is a 6-digit number. All lots which end with '613', '815', or '816' are subject to this recall. The expiration dates and ending lot numbers are as follows: '613'/exp 7/99; '815'/exp 8/99; and '816'/exp 3/99.
MANUFACTURER Steris Corporation, Mentor, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 8,553 kits were distributed.
REASON Product failed stability testing at three (3) months. The spore counts dropped below labeled specification.

PRODUCT Kodak Digital Science Medical Film EIR-11 Laser Imaging Film, intended for secondary imaging of radiographs, packed 150 sheets per box.
CODE Lot/Serial Nos. 4597-0128-003-11/-12/-13/-14/-15.
MANUFACTURER Eastman Kodak Company, Health Imaging Division, Rochester, New York.
DISTRIBUTION Arizona, Kansas, North Carolina, Nebraska, Ohio, Pennsylvania.
QUANTITY 32 cases (450 sheets per case) were distributed.
REASON The film was exposed to light during the rewind process, and has an elevated background fog. The normal level of fog has a Dmin of 0.18, while the identified product has a Dmin of 0.30.

PRODUCT ARCHITECT Estradiol Reagent Kit, list 6C22-20 - 4 x 100 tests and list 6C22-25 - 1 x 100 tests; an in-vitro diagnostic Chemiluminescent Microparitcle Immunoassay (CMIA) for the quantitative determination of estradiol in human serum and plasma.
CODE List 6C22-20, lot 49994M100 and List 6C22-25, lot 49994M101.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 245 400-test kits and 68 100-test kits were distributed.
REASON The Architect Estradiol Reagents may show under-recovery of estradiol with undiluted patient specimens.
 

WEEK ENDING JULY 23

PRODUCT Bubble Suction Tubing, Catalog #116740.
CODE Lot #41AJCM16 EXP 2004-01.
MANUFACTURER ConMed Corporation, El Paso, Texas.
DISTRIBUTION Florida and North Carolina.
QUANTITY 12 cases (50 units per case) were distributed.
REASON Non-Sterility.

PRODUCT Venturi Ventilators With CRT Monitor Part Number 1248.
CODE Serial numbers: 970129-970194 (not inclusive).
MANUFACTURER MICROVITECH, United Kingdom (manufacturer of CRT).
RECALLED BY Cardiopulmonary Corporation, Milford, Connecticut
DISTRIBUTION Russia, United Kingdom, Italy.
QUANTITY 43 units were distributed.
REASON CRT monitor does not meet the mean-time-between-failure (MTBF) specification. The failure may result in the CRT not displaying the monitored patient data.

PRODUCT Venturi Ventilator with Hard Drive Part Number 230012.
CODE Serial numbers: 970129-980258 (not inclusive).
MANUFACTURER Cardiopulmonary Corporation, Milford, Connecticut (ventilator); Segate, San Jose, California (hard drive).
RECALLED BY Cardiopulmonary Corporation, Milford, Connecticut
DISTRIBUTION Alabama, Connecticut, Florida, North Carolina, Italy, Russia, United Kingdom.
QUANTITY 59 units were distributed.
REASON User interface software will not load when unit is first powered on.

PRODUCT GE Millennium MPR/MPS Single Detector Nuclear Medicine System (Emission Computed Tomography System), Model 2151300.
CODE All units.
MANUFACTURER General Electric Medical System, Waukesha, Wisconsin.
DISTRIBUTION Nationwide and international.
QUANTITY 167 units were distributed.
REASON An unintended detector tilt motion can occur when the operator selects the table up/down motion.

PRODUCT Bone-Dri Femoral Surgical Wick, used to control and wick fluids from the femoral canal during surgery.
CODE Catalog Numbers: 6209-1-205 (package of 5 units) ,6209-1-201 (single unit) Sterility Lot Codes: 9902144, 9902145, 9902146, 9902147, 9902203, 9902204, 9902501, 9902542, 9902543, 9902544, 9902545, 9902744, 9902747, 9902748, 9902845, 9902846, 9902847, 9902848, 9902849, 9902852.
MANUFACTURER Howmedica Osteonics Corporation, San Jose, California.
DISTRIBUTION Nationwide.
QUANTITY 178 units were distributed.
REASON The sterility of the device has been compromised due to a lack of adequate sterilization.

PRODUCT King Systems brand Universal F2 Breathing Circuits with Co-Axial Filter.
CODE Various product numbers and lot numbers.
MANUFACTURER King Systems Corporation, Noblesville, Indiana.
DISTRIBUTION Nationwide and international.
QUANTITY 4,531 cases (101,580 breathing circuits) were distributed.
REASON Excessive flash in the filter housing may significantly increase resistance to flow in the expiratory side of the unit.

PRODUCT CryoValve Allograft (heart valve): a) Model AV00; b) PV00.
CODE Serial Numbers: a) 6280773; b) 6280765. Donor #32029
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Canada.
QUANTITY 2 units.
REASON Donors do not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (heart valve) Model PV00.
CODE Serial #3864863. Donor #19913.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

PRODUCT CryoValve Allograft (heart valve), Model AV00.
CODE Serial #3864855.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Idaho.
QUANTITY 1 unit.
REASON Donors do not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

PRODUCT Connecting screw and compression screw for titanium solid humeral nails, Part Numbers: 358.54 and 358.61.
CODE Part Number 358.54, Lot Numbers: A4FL336, A4GA308, A4GC384, A4GC813, A4HB049, A4HB716, A4HD872, and A4HD873;
Part Number 358.61, Lot numbers: A4GA932, A4GA933, A4GC425, A4GD662, A4GE889, and A4GK100.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 339 units were distributed.
REASON Product drawing contained an interference issue which created a potential for the connecting screw not to fit into or bind within the insertion handle.

PRODUCT DePuy Self-Centering Hip Cups: a) Size 22.225 mm, Product No. 1035-44-000; b) Size 28 mm, Product No. 1037-45-000.
CODE Lot numbers: a) S73LR1; b) S74DC1.
MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, Indiana.
DISTRIBUTION Missouri, New Jersey, Pennsylvania, Canada, England, Japan.
QUANTITY 2 lots of 10 units each were distributed.
REASON Labeling mix-up -- A 28 mm cup was found in a carton labeled as a 22.225 mm cup, and a 22.225 mm cup in a carton labeled as a 28 mm cup.

PRODUCT Bivona Fome-Cuf Pediatric Tracheostomy Tube with Stomaseal, Catalog No. 85P045.
CODE Lot No. 842260 EXP 03/2004.
MANUFACTURER Bivona Medical Tech., Division of UroQuest Med. Corporation, Gary, Indiana.
DISTRIBUTION Arizona, Florida, Michigan, New Hampshire, Texas, Virginia, Australia.
QUANTITY 21 units were distributed.
REASON The tube's outer shaft diameter printed on the neckflange of the tube differed from that on the label.
 

WEEK ENDING JULY 30

PRODUCT VIA Low Volume Mode (LVM) Monitor, an in-line beside medical device used on volume restricted patients.
CODE Catalog #V-LVMI. All units.
MANUFACTURER VIA Medical Corporation, San Diego, California.
DISTRIBUTION California, Iowa, Missouri, New Jersey, Texas.
QUANTITY 59 units were distributed.
REASON The device has a software problem that can cause the monitor, under unusual circumstances, to display and print a chemistry value from a previous sampling instead of the blood chemistry value from the current sampling.

PRODUCT ADVIA 120 Hematology System, a quantitative automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in-vitro diagnostic use in clinical laboratories: a) Catalog #453-0024-03; b) Catalog #453-0024-04.
CODE All serial numbers.
MANUFACTURER Bayer Diagnostics Mfg. Ltd., Dublin, Ireland.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,000 units.
REASON When running the ADVIA 120 system in the manual mode using the Host Query feature, and the timeout is set to 13 second, it is possible for the system to report incorrect patient results. The supplemental labeling instructions section of the product labeling instructs users to verify that the correct sample identification number appears on the status line before using either of the manual samplers. However, the user is not clearly told to review the supplemental operating instructions prior to the operation of the system.

PRODUCT ADVIA 120 Hematology System, a quantitative automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for in-vitro diagnostic use in clinical laboratories: a) Catalog 453-0024-03; b) Catalog #453-0024-04.
CODE All serial numbers.
MANUFACTURER Bayer Diagnostics Mfg. Ltd., Dublin, Ireland.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 1,000 units.
REASON The sample needle can be activated while the system is in stand-by mode during needle chamber cleaning procedure. Product labeling warns that the system must be either off or in the stand-by mode to perform routine maintenance, or personal injury from the may occur.

PRODUCT Techstar XL Percutaneous Vascular Surgical Device, intended for the percutaneous deployment and tying of sutures for surgical closure of arterial puncture sites resulting from diagnostic catheterization procedures:
a) Model TXL-431-06; b) TXLS-432-06 (Outside the US).
CODE All Techstar XL 6 French device produced on or after 2/1/99 and shipped on or prior to 7/2/99 that were manufactured on the Gray, Red, and Purple production lines.
MANUFACTURER Perclose, Inc., Redwood City, California.
DISTRIBUTION Nationwide and international.
QUANTITY 55,794 units were distributed.
REASON The needle tips may be misaligned during deployment.

PRODUCT Viscoelastic Systems, indicated for use as a surgical aid in anterior segment procedures including cataract extraction and intraocular lens implantation:
a) Viscoat Viscoelastic Solution, Catalog No. 8065-1839-05;
b) Duovisc Viscoelastic Systems, Catalog No. 8065-1831-05.
CODE Lot Numbers: a) 57010P, 57443P; b) 57446P.
MANUFACTURER Alcon Puerto Rico, Inc., Humacao, Puerto Rico.
DISTRIBUTION Nationwide.
QUANTITY 36,390 units were distributed.
REASON The product labeling refers to a Viscoat Cannula Locking Ring which is not present in all packages.

PRODUCT Sterile Micro-Kover for Wild, with or without Observer Tubes and Photographic System, Part #09-MK953, 40.5 W x 102" L (103cmx259cm).
CODE Lot #06092C0267.
MANUFACTURER Advance Medical Designs, Inc., Marietta, Georgia.
DISTRIBUTION New York , Tennessee, Australia, Portugal.
QUANTITY 420 units were distributed.
REASON The lot contained open package seals, thereby compromising the sterility of the device.

PRODUCT Sterile Micro-Kover for Wild, Part No. 09-MK957, 54"W x 150"L, with Monocular or Stereo Observer Tubes and Photographic System.
CODE Lot No. 08731C1985.
MANUFACTURER Advance Medical Designs, Inc., Marietta, Georgia.
DISTRIBUTION Montana, New Jersey Texas, Canada.
QUANTITY 375 units were distributed.
REASON The lot contained open package seals, thereby compromising the sterility of the device.

PRODUCT Sterile Custom Kover, Part No. 08-CC121, 40" x 60" without Rubber Band
CODE Lot Numbers: 07267C0572 and 0797C1076.
MANUFACTURER Advance Medical Designs, Inc., Marietta, Georgia.
DISTRIBUTION Alabama and North Dakota.
QUANTITY 925 units of lot 07267C0572 and 800 0797C1076 units of lot were distributed.
REASON The lots contained open package seals, thereby compromising the sterility of the device.

PRODUCT Modified Leveen Needle Electrode, for use in coagulation necrosis of soft tissue,
Model numbers: LE212, LE215, LE312, LE315, LE3512, LE3515, LE3525.
CODE All lots.
MANUFACTURER Radiotherapeutics Corporation, Mountain View, California.
DISTRIBUTION Nationwide and international.
QUANTITY 2,139 units were distributed.
REASON Sterility may be compromised as evidenced by a loss of package integrity.

PRODUCT Bayer Immuno I Automated Clinical Analyzer Reagents:
a)Carbamazepine Parameter, intended to measure carbamazepine, an anticonvulsant drug, in serum or plasma;
b)Valproic Acid Parameterm intended to measure valproic acid, an anticonvulsant durg in human serum or plasma.
CODE a) Catalog No.T01-3677-51, Lots: V23247, V25335 and V29367; b) Catalog No. T01-3698-01, Lots: V26346, V23428, V08450, V13604, V20984 and V31008.
MANUFACTURER Dade-Behring, San Jose, California.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUITON Nationwide and international.
QUANTITY a) 3,630; b) 3,561 were distributed.
REASON The above lots do not meet the on-system stability claim.

PRODUCT Bayer Technicon SETpoint Chemistry Calibrator, intended for in-vitro diagnostic use.
CODE Catalog No. T03-1291-62, Lot No. V25757 EXP Sep00;
MANUFACTURER Bayer Corporation, Business Group Diagnostics, Middletown, Virginia.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Michigan, Massachusetts, Missouri, New York, Pennsylvania, international.
QUANTITY Approximately 3,767 units were distributed.
REASON During review of the value assignment procedure it was learned that the operator manually entered intercept corrected SETpoint values into an Excel spreadsheet rather than letting the spreadsheet calculate the corrections from the true SETpoint. The values that were entered were incorrect and, therefore, the resulting value assignments were incorrect.

PRODUCT Bayer DCA 2000+ Microalbumin/Creatinine, intended for professional use in the measurement of microalbumin creatinine and albumin/creatinine ratio in urine.
CODE Catalog No. 6011, Lot No. 0988039 EXP March2001.
MANUFACTURER Bayer Corporation - Business Group Diagnostics, Mishawaka, Indiana.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION California, Colorado, Michigan, Texas, international.
QUANTITY 688 units were distributed.
REASON The above lot can produce erratic results (high and low) for both albumin, Creatinine and the ratio of albumin to Creatinine.

PRODUCT Vitros 250 Chemistry System, used to perform clinical tests on serum, urine, and cerebral spinal fluid specimens:
a) Catalog No. 8132086, Vitros 250 Chemistry System;
b) Catalog No. 1758143, Vitros 250AT Chemistry System.
CODE All serial numbers.
MANUFACTURER Ortho Clinical Diagnostics, Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 3,886 units were distributed.
REASON The devices may give negatively biased results for digoxin, phenytoin, and C-reactive protein.

PRODUCT Titanium Flexible Humeral Nail
a) Part Nos. 475.042 through 475.050;
b) Part Nos. 75.242 through 475.250.
CODE Part #475.042 lots: A4GM309, A4GO991, A4GQ670,A4HS309, A4HV924
Part #475.043 lots: A4GL128, A4GM308, A4GO992, A4GQ671, A4HB052, A4HM661, A4HS263, A4HV925
Part #475.044 lots: A4GL129, A4GM307, A4GO993, A4GQ672, A4HB053, A4HV921
Part #475.045 lots: A4GL130, A4GM306, A4GO994, A4GQ673, A4GQ846, A4HB054, A4HK005, A4HR690, A4HS751
Part #475.046 lots: A4GL131, A4GM305, A4GO995, A4GQ674, A4GQ847, A4HB055, A4HV920
Part #475.047 lots: A4GL132, A4GM304, A4GO996, A4GQ849, A4HB056, A4HR691, A4HV922
Part #475.048 lots: A4GL133, A4GM303, A4GO997, A4GQ848, A4HF356, A4HM662, A4HS244, A4HV927
Part #475.049 lots: A4GL133, A4GM302, A4GO998, A4GQ675, A4GQ676, A4HB057, A4HS245, A4HV928
Part #475.050 lots: A4GM301, A4GO999, A4GQ677, A4HB058, A4HS246, A4HV929
Part #475.242 lots: A4GM359, A4GN261, A4GP001, A4HB059
Part #475.243 lots: A4GM511, A4GN262, A4GP459, A4HB060, A4HS247
Part #475.244 lots: A4GN104, A4GN263, A4GP460, A4GQ850, A4HB061, A4HM663, A4HS248
Part #475.245 lots: A4GM510, A4GN264, A4GP461, A4GQ678, A4HB062
Part #475.246 lots: A4GM512, A4GN265, A4GP462, A4GQ679, A4HB063, A4HR692
Part #475.247 lots: A4GM508, A4GN266, A4GP463, A4GQ851, A4HB064
Part #475.248 lots: A4GN513, A4GN267, A4GP464, A4HB065, A4HC149, A4HS249
Part #475.249 lots: A4GM514, A4GN268, A4GP465, A4HB066, A4HM665, A4HS900
Part #475.250 lots: A4GM509, A4GN269, A4GP466, A4HB067, A4HC148, A4HS250.
MANUFACTURER Synthes (USA), West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Alabama, California, Maryland, Minnesota, North Carolina, Oregon, Washington state, Canada, Switzerland.
QUANTITY 538 units.
REASON The central wires may be undersized which could cause disengagement at the proximal end.