MAY 2000

WEEK ENDING MAY 5

PRODUCT Pro Med Kits assembles first aid kits on key chains each containing a CLINIPAD Alcohol Prep, Antiseptic.
CODE No kit codes, all kits contain Clinipad Alcohol Prep, Antiseptic, coded "920311".
MANUFACTURER Promed Kits, Davis, California.
COMPONENT MANUFACTURER Clilnipad Corporation, Charlotte, North Carolina.
DISTRIBUTION California.
QUANTITY 2,500 kits.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT PEG kits, T-J Tube kits, Epidural Trays, Spinal Procedure, Universal Block trays, Paracentesis Trays containing recalled Clinipad products: Models 0150-14, 0150-20, 0150-24, 0160-14, 0160-20, 0160-24, 0260-16, 0260-18, 0260-22, 182125, 182131, 182184, 182224, 182229, 182230, 18236, 18259, 18283, 18289, 18668, 18178, 18184, 18202, 60432, 60433.
CODE 0150-14, 0150-20, 0150-24, 0160-14, 0160-20, 0160-24, 0260-16, 0260-18, 0260-22, 182125, 182131, 182184, 182224, 182229, 182230, 18236, 18259, 18283, 18289, 18668, 18178, 18184, 18202, 60432, 60433
MANUFACTURER Ballard Medical Products, Draper, Utah.
COMPONET MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 41,231 kits/trays.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Procedure kits containing recalled Clinipad products: a) LEEP Redikit - Product Number: 6060 b) Hysteroscopy Kit -Product Number: 6160 c) Cervical Block Kit- Product Number: 6161.
CODE All lots.
MANUFACTURER CooperSurgical, Inc., Shelton, Connecticut.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 32,145 kits.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT T.E.D. Sequential Compression Sleeves:
a) Model No. 5329 SCD Blue Sleeves, Knee Length;
b) Model No. 5330 SCD Blue Sleeves, Thigh Length Medium;
c) Model No. 5345 SCD Blue Sleeves, Thigh Length Small;
d) Model No. 5480 SCD Blue Sleeves, Thigh Length Large.
CODE All lot numbers beginning with B01, B02, B03, B04, B05, B07, B09, and B10.
MANUFACTURER The Kendall Co. LP, Seneca, South Carolina.
RECALLED BY The Kendall Co. LP, Mansfield, Massachusetts
DISTRIBUTION Nationwide and international.
QUANTITY 6,292 cases were distributed.
REASON The compression sleeves may have occluded airway tubes.

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:
a) Model No. DWF-3651S;
b) Model No. DWF-3240S;
c) Model No. DWF-3446S;
d) Model No. DWF-3651S;
e) Model No. UDW3651;
f) Model No. UDW3240;
g) Model No. UDW3446.
MANUFACTURER Chase Medical, Inc., Athens, Texas.
RECALLED BY Chase Medical, Inc., Richardson, Texas
DISTRIBUTION Pennsylvania, Texas, Nebraska, Wisconsin, Virginia, Louisiana, Massachusetts, Washington state, Virginia, New Jersey, Connecticut, and international.
QUANTITY 1,787 units were distributed.
REASON The cannula may separate between the tip and body during use.

PRODUCT 24French Aortic Arch Cannula, indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass:
a) Model No. ANC-S824S   b) Model No. ANC-P824S;
c) Model No. ANC-L824S;   d) Model No. ANC-S824S-NF;
e) Model No. ANC-P824S-NF   f) Model No. ANC-L824-NF;
g) Model No. AWC-S824S   h) Model No. UACs824S;
i) Model No. UACP824S   j) Model No. UACL824S;
k) Model No. FACL824   l) Model No. UWCS824.
CODE All lots manufactured from 4/1/98 to 11/30/99.
MANUFACTURER Chase Medical, Inc., Athens, Texas.
RECALLED BY Chase Medical, Inc., Richardson, Texas
DISTRIBUTION Texas, California, Florida, Minnesota, Alabama, Massachusetts, Mississippi, Georgia, Virginia, New Jersey, Connecticut, and international.
QUANTITY 3,860 units were distributed.
REASON The cannula may leak under certain flow and device manipulation conditions.

PRODUCT Bayer SETpoint Unconjugated Estriol Reagent (uE3) for Bayer Immuno 1 System, an assay to measure unconjugated estriol in human serum.
CODE Kit Lot #T37369 EXP 3/31/01.
MANUFACTURER Bayer Corporation, Business Group Diagnostics, Middletown Manufacturing Plant, Middletown, Virginia.
RECALLED BY Bayer Corporatiaon, Elkhart, Indiana
DISTRIBUTION Nationwide and international.
QUANTITY 330 units were distributed.
REASON The device is associated with a failure to calibrate the assay on the system RSS limits, erratic quality control results, and a calibration interval of less than seven days.

PRODUCT ARCHITECT i System with Software Version 1.0 Processing Module, List No. 08C89-00-1, designed to perform automated immunoassay tests bassed on the use of Chemiluminescent Microparticle Immunoassay CMIA) detection technology.
CODE All units.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Irving, Texas.
DISTRIBUTION California, Florida, Illinois, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, international.
QUANTITY 22 units were distributed.
REASON Software errors can potentially result in printed Patient Report to incorrectly associate tests results with patients Ids under certain conditions.

PRODUCT Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000.
CODE All units/software versions.
MANUFACTURER/SOFTWARE SITE/SOFTWARE SITE: Hitachi Instruments Division, Ibari-ken, 312 Japan.
RECALLED BY Roche Diagnostics Corporation, Indianapolis
DISTRIBUTION Nationwide.
QUANTITY 500 units were distributed.
REASON There is a potential for mismatch of sample identification information and results on all versions of software.

PRODUCT Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes.
CODE Catalog number 914000. All units with software version 3.0.
MANUFACTURER/SOFTWARE SITE: Roche Diagnostic Corporation, Indianapolis, Indiana.
DISTRIBUTION Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico and Texas.
QUANTITY 56 units were distributed
REASON There is a potential for mismatch of sample identification information and results on this version of software.

PRODUCT LCS Total Knee System - PS Tibial Insert:
a) Small Size, Catalog Nos. 1781-20-100, 1781-20-125, 1781-20-150, 1781-20-175, 1781-20-200;
b) Small + Size, Catalog Nos. 1781-21-100, 1781-21-125, 1781-21-150, 1781-21-175, 1781-21-200;
c) Standard Size, Catalog Nos. 1781-22-100, 1781-22-125, 1781-22-150, 1781-22-175, 1781-22-200;
d) Standard + Size, Catalog Nos. 1781-23-100, 1781-23-125, 1781-23-150, 1781-23-175, 1781-23-200;
e) Large Size, Catalog Nos. 1781-24-100, 1781-24-125, 1781-24-150, 1781- 24-175, 1781-24-200;
f) Large + Size, Catalog Nos. 1781-25-100, 1781-25-125, 1781-25-150, 1781-25-175, 1781-25-200.
CODE All lot numbers.
MANUFACTURER Depuy Orthopaedics, Inc., Warsaw, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 236 units are subject to recall.
REASON The devices can cause the escape of fluid from blood vessels into the tissues or a cavity and cause knee pain.

PRODUCT Sarns MP-6 Integrated Cardioiplegia Sets, used for delivery of temperature controlled cardioplegia solutions to the heart during cardiopulmonary bypass surgery:
a) MP-6 Integrated Cardioplegia Set, Catalog No. 4972, Lot No. 98-0702-1659-7 (1:1 Ratio, No Recirculation);
b) MP-6 Integrated Cardioplegia Set, Catalog No. 4973, Lot No. 98-0702-1660-5 2:1 Ratio, No Recirculation);
c) MP-6 Integrated Cardioplegia Set, Catalog No. 4974, Lot No. 98-0702-1661-3 (4:1 Ratio, No Recirculation);
d) MP-6 Integrated Cardioplegia Set, Catalog No. 4975, Lot No. 98-0702-1662-1 4:1 Ratio, With Bridge, No Recirculation);
e) MP-6 Integrated Cardioplegia Set, Catalog No. 4976, Lot No. 98-0702-1663-9 (8:1 Ratio, No Recirculation);
f) MP-6 Integrated Cardioplegia Set, Catalog No. 4977, Lot No. 98-0702-1664-7 (4:1 Ratio, No Recirculation).
CODE See above. These units were manufactured during the time period of 10/27/99 through 3/13/00 and each device has an expiration of 3 years.
MANUFACTURER Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan.
DISTRIBUTION Nationwide and Germany.
QUANTITY 708 units were distributed.
REASON Holes in the mylar side of the passdown line pouch are inadequate which results in compromising the sterility of the device.

PRODUCT a) Ankle Contracture Boot and Boot Sole Accessory, Model Numbers: 4300, 4301, 4302, 4305, 4306, and R4307; b) Boot Sole Accessory #4300/05WK. Devices intended to stabilize the ankle after trauma or injury.
CODE None.
MANUFACTURER DeRoyal Industries, Powell, Tennessee.
DISTRIBUTION Nationwide.
QUANTITY 22,538 units were distributed.
REASON The device fails to bear a caution label that it is not intended for weight bearing purposes, and as a result, the bolt on the bottom of the boot holding the boot sole in place, cracks and breaks, causing the sole to dislodge.

PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions
a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy.
CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C.
MANUFACTURER Cyberonics, Inc., Inc., Houston, Texas.
DISTRIBUTION a) Canada; b) Belgium and Europe.
QUANTITY a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10 units of lot 27137C and 50 units of lot 27735C were distributed.
REASON The label insert sheets were printed with the incorrect lot number.

PRODUCT IMMUNOCARD H. Pylori, for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood.
CODE Catalog #710030, Lot #710030.089, EXP 1/22/01; and Lot #710030.090, EXP 1/30/01.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide, Canada, Japan, Italy, Germany.
QUANTITY 546 kits were distributed.
REASON Variations of the positive control and test ports may lead to invalid results.

PRODUCT Boehringer Mannheim Systems Creatinine Plus, for the quantitative determination of creatinine in serum, plasma, and urine:
a) Catalog No. 1775685; b) Catalog No. 1775642; c) Catalog No. 1775677.
CODE Lot Numbers: a) 60054701, Exp. Date 03/2000, 60173701, Exp. 04/2000; b) 60375601, Exp. Date 04/2000; c) 60217901, Exp. Date 06/2000.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,500 kits were distributed.
REASON These lots exhibit positive interference from lactate. The lactate interference is undetectable in samples containing normal levels of lactate.

PRODUCT Carolon Trinity Pneumatic Pump, Model 480000.
CODE Serial Numbers 1011 through 1510.
MANUFACTURER MJS Healthcare, Ltd., Barton, Bedfordshire, England.
RECALLED BY Carolon Company, Rural Hall, North Carolina
DISTRIBUTION Nationwide
QUANTITY 499 pumps were distributed.
REASON A plug portal area with a hairline crack and recession of receptor prong into casing could result in a potential fire hazard within the cord.

WEEK ENDING MAY 12

PRODUCT Cypress Medical Products Sterile Procedure Kits and Tray containing antiseptic products recalled by Clinipad Corporation.
CODE a) Kits containing Clinidine Ointment, Sterile, 1.0 gram I.V. Start Kits:
Reorder #82-03, Economy, 50 kits/case, lot 80410, and all lots starting with "9" or "0"
Reorder #82-05, Deluxe, 50 kits/case, all lots starting with "9" or "0"
Reorder #82-06, Latex-free, 50 kits/case, all lots starting with "9" or "0"
Reorder #82-07, Premium, 50 kits/case, lots 71103, 71104, 80409, all lots starting with "9" or "0".
Daily Catheter Care Trays, 20 trays/case, reorder #86-101, lot 71205, 71208, 90403, 90225.
b) Kits containing Clinidine Ointment - 4339SC, Clinguard Protective Dressing Prep Pad - 8133S-B, Cliniswab Isopropyl Alcohol Antiseptic Swabsticks - 1245SB, and Clinipad Alcohol Prep - 0110:
Omnicare Central Line Dressing Kit, reorder #84-117, lots 71215 and 80404;
c) Kits containing Clinipad Alcohol Prep - 0110: Sharp Debridement Package, 20 kits/case, order number SDP, reorder #84-160, lots 70812 and 70813;
d) Kits containing Clinipad Iodophor PVP Iodine USP Prep Pads - 9153: Skin Staple Remover kits:
Reorder #82-15, Premium, 50 kits/case, lot 71016
Reorder #1295-815, Starline, 50 kits/case, lot 70903
Reorder #241, PSS Select, 50 kits/case, lot 80214
Suture Removal Kit, reorder #81-213, lot 80305.
MANUFACTURER Cypress Medical Products, Ltd., McHenry, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 96,736 kits/trays were distributed.
REASON The antiseptic products may be contaminated with bacteria.

PRODUCT Various Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation:
ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with T-Fasteners, Complete Kit, 14 French (List #00227); ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with T-Fasteners, Complete Kit, 18 French (List #00238); ROSS Flexiflo Introducer Gastrostomy Kit with Brown/Mueller T-Fastener Set, Complete Kit, 18 French (List #50190); Ross Inverta-PEG Pull Technique Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #52002); Ross Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #52354); ROSS Flexiflow Versa-PEG Gastrostomy Kit, Complete Kit, 22 French (list #50520); ROSS Flexiflo Inverta-PEG Over-the-Guidewire Gastrostomy Kit with Roll-Tip Bumper, Complete Kit with Snare, 20 French (List #51492) [Obsolete].
CODE All lot numbers beginning with 25 through 62.
MANUFACTURER Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide, Chile, Hungary, Korea, Mexico, Netherlands, Singapore, Turkey.
QUANTITY 77,492 (including the Class II portion).
REASON Kits contain Clinipad antiseptic products which may be contaminated with bacteria.

PRODUCT Sterile Procedure Kits containing antiseptic products recalled by Clinipad Corporation:
ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 16 French (List #50724); ROSS Flexiflo Over-the-Guidewire Gastrostomy Kit with Reinforced Webbed Bumper, Complete Kit, 20 French (List #50738).
CODE All lot numbers beginning with 25 through 62.
MANUFACTURER Ross Products Division, Abbott Laboratories, Inc., Columbus, Ohio.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide, Chile, Hungary, Korea, Mexico, Netherlands, Singapore, Turkey.
QUANTITY 77,492 (including the Class I portion).
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Heart Valve Allograft Models AVOO, PVOO, AVO5.
CODE Serial Numbers: 3887502, 3887391, 6100597, 6276377.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION Tennessee, Oklahoma, Michigan.
QUANTITY 4 valves.
REASON Donor did not meet current guidelines regarding serodilution of plasma.

PRODUCT Hemodialysis/Apheresis Trays containing recalled Clinipad products.
CODE All items listed below are Vas-Cath products.
5500102 Soft-Cell Catheterless Tray
5500103 Soft-Cell Tray 12.5F x 19cm
5500114 Flexxicon II Catheterless Tray
5500125 Soft-Cell Tray 12.5F x 27cm
550012 Soft-Cell Tray 12.5F x 15cm
5500130 Soft-Cell Tray 12.5F x 17cm
5500132 Soft-Cell Tray 12.5F x 27cm
5525150 Flexxicon II Tray 12F x 15cm
5525200 Flexxicon II Tray 12F x 20cm
5525240 Flexxicon II Tray 12F x 24cm
5526120 Flexxicon II 12.5 cm Tray
5526150 Flexxicon II Tray 12F x 15cm
5526200 Flexxicon II Tray 12F x 20cm
5526620 Flexxicon II Tray 12F x 12.5cm
5526650 Flexxicon II Tray 12F x 15cm
5526700 Flexxicon II Tray 12F x 20cm
5535120 Soft-Cell Tray 12.5 x 12cm
5535190 Soft-Cell Tray 12.5F x 19cm
5535230 Soft-Cell Tray 12.5F x 23cm
5535620 Soft-Cell Tray 12.5F x 12cm
5535690 Soft-Cell Tray 12.5F x 19cm
5535730 Soft-Cell Tray 12.5F x 23cm
5536120 Soft-Cell Tray 12.5F x 12cm
5536190 Soft-Cell Tray 12.5F x 19cm
5536230 Soft Cell Pre-Curved Dual Lumen Chronic Catheter
5545150 Vaccess Tray 8F x 15cm
5545200 Vaccess Tray 8F x 20cm
5545700 Vaccess Tray 8F x 20cm
5591000 Niagara Catheterless Tray
5595150 Niagara Tray 13.5F x 15cm
5595200 Niagara Tray 13.5F x 20cm
5595240 Niagara Tray 13.5F x 24cm
5596120 Niagara Tray 13.5F x 12.5cm
5596150 Niagara Tray 13.5F x 15cm
5596200 Niagara Tray 13.5F x 20cm
6531000 Opti-Flow Catheterless Tray
5635192 Opti-Flow Tray 14.5F x 19cm
5635692 Opti-Flow Tray 14.5F x 19cm
5635732 Opti-Flow Tray 14.5F x 23cm
5635232 Opti-Flow Tray 14.5F x 23cm
5636192 Opti-Flow Tray 14.5F x 19cm
5636232 Opti-Flow Tray 14.5F x 23cm.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
COMPONENT MANUFACTURER Clinipad, Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 108,347 kits/trays were distributed.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT LSL Sterile Mid-Stream Urine Specimen Kit, 120 ml, containing recalled Clinipad product
CODE Kit Reorder #LSL1030, All lots beginning with 7, 8, 9, and 0A3006, 0B3007.
MANUFACTURER LSL Industries, Inc., Chicago, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Tennessee, Kansas, Vermont, Texas, Michigan, Pennsylvania, New York, Oklahoma, Massachusetts, Indiana, Florida, New Jersey, Oregon, Arizona, Alaska.
QUANTITY 64,400 kits were distributed.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Deltec Procedural Tray (containing recalled Clinipad products) for use with CliniCath Peripherally Inserted Catheters, Product Numbers 21-2501-01 and 21-2515-01; Deltec CliniCath Peripherally Inserted Catheters, with Tray, Product Numbers 21-2508-01, 21-2509-01, 21-2510-01, 21-2511-01, 21-2512-01, and 21-2513-01
CODE All lots distributed since 1/1/97.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 3,512 trays were distributed.
REASON Trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT Zipprep Electrode Starter Kits containing Clinipad Alcohol Antiseptic Swabsticks, intended for use with EEG monitoring Systems.
CODE Aspect Product #185-0043; Aspect Lot Numbers: 418442, 413659, 423659, 417506.
MANUFACTURER Aspect Medical Systems, Inc., Natick, Massachusetts.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Washington state, Florida, West Virginia, California, Ohio, Massachusetts, Pennsylvania, Louisiana, Kentucky, and international.
QUANTITY 81 kits (all past expiration dating).
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT General Procedure Kit.
CODE Catalog DYNJTS0300, Lot 9904007
DYNJTS4302, Lot 9904002
DYNJTS0400, Lot 9903041
DYNJTS4306, Lot 9903037
DYNJTS7025, Lot 9903035
DYNJTS4301, Lot 9904001
DYNJTS4303, Lot 9903036.
MANUFACTURER Physician Industries Manufacturing, West Valley City, Utah.
DISTRIBUTION Georgia, Illinois, Nevada, Pennsylvania, Texas.
QUANTITY 2,880 kits were distributed.
REASON Distributed kits had positive bioburden test results after EtO sterilization.

PRODUCT Allograft Heart Valve, Model AVOO and PVOO.
CODE Serial Numbers: 3887693, 3887707, 3895343, 3895351, 6004946, 6004954, 6262155, 6268331, 6297846.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION New York, Colorado, Tennessee, Florida, Michigan, Maryland, Ohio, California.
QUANTITY 9 valves.
REASON Donor did not meet current guideline regarding serodilution of plasma.

PRODUCT Hermitage Eye Pads, Sterile 2 1/8" X 2 5/8", Product of China. Sterilized in the U.S.A, for use as a bandage over the eye for protection or absorption of secretions: a) Item No. EP-1600; b) Item No. EP-2000.
CODE Lot #5588.
MANUFACTURER Shaoxing Life Surgical Dressing Company, Ltd., Zhejiang Prov. Shaoxing County, China.
RECALLED BY Hermitage Hospital Products, Inc., Niantic, Connecticut
DISTRIBUTION Arkansas, California, Oklahoma, Puerto Rico.
QUANTITY a) 33 cases (600 per case); b) 33 cases (2000 per case).
REASON Product was not sterilized and incorrectly transferred to released inventory without being gamma sterilized.

PRODUCT Allograft Heart Valve, Models PV00, AV00, AV40, MV10 PV05.
CODE Serial Numbers: 3889149, 3911446, 3911454, 6965792, 6965768, 6313744.
MANUFACTURER Cryolife, Inc., Kennesaw, Georgia.
DISTRIBUTION New York, Pennsylvania, Louisiana, California, North Carolina, Canada.
QUANTITY 6 valves.
REASON Donors did not meet current guidelines regarding serodilution of plasma.

PRODUCT Disposable Coronary Control Syringe, 20mL, Catalog #K01-04072.
CODE Lot #A140030.
MANUFACTURER Merit Medical Systems, Inc., South Jordan, Utah.
DISTRIBUTION South Carolina.
QUANTITY 25 syringes.
REASON Syringes were shipped to customer prior to terminal sterilization processing.

PRODUCT Flo-Rester Sizer Pack (of blood vessel sizers), used to determine the internal diameters of arteries and veins: Catalog Numbers: a) FRSZPK05; b) FRSZ400; c) FRSZ300; d) FRSZ250; e) FRSZ200; f) FRSZ150.
CODE Lot Numbers: a) 526069, 525165, 523878, 522704, 521864, 518549, and 515997; b) 526067, 525588, 524943, 520805, and 516003; c) lot number 516002; d) 516001; e) 516000; f) 515999.
MANUFACTURER Bio-Vascular, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide, Brazil, Canada, Denmark, Germany, United Kingdom.
QUANTITY 107 sizers were distributed.
REASON The bulb of the device may loosen and become detached from the shaft.

PRODUCT VACUTAINER Urine Collection Kit for Midstream Specimens containing recalled Clinipad products.
CODE Catalog Number 364952 Vacutainer Urine Collection kit with sterile cup, 5ml preservative tube, and Clinipad Rantex Wipe, Lot 9E165, 9F229, 9H142, 9J205, 9J206; Catalog Number 364972 Vacutainer Urine Collection kit with sterile cup, 12 ml conical urinalysis tube, 5 ml preservative tube, and Clinical Rantex Wipe, Lot 9E170, 9E171, 9F233, 9G085, 9H147, 9J201.
MANUFACTURER Becton Dickinson & Company, Broken Bow, Nebraska.
RECALLED BY Becton Dickinson & Company, Franklin Lakes, New Jersey
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 1,428,050 kits were distributed.
REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility.

PRODUCT FLOW-20, used as a gastrointestinal feeding tube: a) Flow-20-Push; b) Flow-20-Pull; c) Flow-20-Pull-S.
CODE Lot Numbers: a) 1276176 and 1280434; b) 1276560; c) 1277439 and 1278396.
MANUFACTURER Wilson-Cook Medical, Inc., Winston-Salem, North Carolina.
DISTRIBUTION Alabama, Arizona, California, Connecticut, Florida, Louisiana, Massachusetts, Missouri, New Hampshire, New York, North Dakota, Ohio, Pennsylvania, Texas, Vermont, Wisconsin, Australia, Hungary, Jordan, Singapore.
QUANTITY 246 units were distributed.
REASON Kits may contain a larger external bumper, which may not properly secure the feeding tube.

PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP).
CODE Each unit is identified with a unique serial number. Those units sold (194 units) in the USA with the software version 2A2.7B are listed as follows: 03010, 03011, 03014, 03015, 03020, 03022, 03023, 03026, 03027, 03034, 03036, 03047, 03048, 03054, 03055, 03058, 03059, 03060, 03062, 03063, 03064, 03066, 03067, 03068, 03069, 03070, 03073, 03084, 03088, 03091, 03094, 03095, 03096, 03097, 03099, 03102, 03103, 03115, 03116, 03120, 03121, 03125, 03130, 03139, 03141, 03144, 03146, 03148, 03155, 03157, 03158, 03160, 03164, 03168, 03169, 03179, 03185, 03186, 03188, 03189, 03202, 03203, 03205, 03209, 03212, 03213, 03215, 03218, 03222, 03227, 03228, 03229, 03230, 03231, 03234, 03235, 03236, 03237, 03238, 03239, 03240, 03242, 03245, 03256, 03257, 03258, 03261, 03262, 04004, 04015, 04016, 04017, 04019, 04020, 04026, 04027, 04028, 04031, 04033, 04036, 04037, 04038, 04041, 04042, 04044, 04045, 04046, 04047, 04049, 04052, 04053, 04058, 04059, 04063, 04064, 04068, 04070, 04076, 04080, 04082, 04083, 04084, 04087, 04094, 04095, 04096, 04099, 04102, 04105, 04107, 04108, 04114, 04115, 04117, 04119, 04121, 04126, 04127, 04128, 04136, 04137, 04142, 04147, 04153, 04154, 04156, 04157, 04160, 04162, 04163, 04164, 04166, 04167, 04169, 04170, 04171, 04172, 04173, 04176, 04180, 04189, 04190, 04192, 04201, 04204, 04208, 04209, 04210, 04211, 04213, 04214, 04215, 04218, 04220, 04229, 04238, 04244, 04248, 04258, 04259, 04265, 04266, 04268, 04273, 04274, 04277, 04278, 04279, 04280, 04285, 04289, 04290, 04292, 04296
Those units sold overseas (193 units) are with the affected software version are listed below: 03006, 03013, 03018, 03019, 03024, 03025, 03031, 03033, 03039, 03042, 03045, 03046, 03049, 03051, 03057, 03061, 03071, 03072, 03078, 03080, 03081, 03082, 03083, 03086, 03093, 03108, 03109, 03111, 03112, 03113, 03114, 03118, 03119, 03122, 03124, 03126, 03127, 03129, 03131, 03132, 03133, 03135, 03143, 03145, 03147, 03151, 03153, 03154, 03165, 03166, 03170, 03171, 03173, 03182, 03183, 03184, 03187, 03190, 03191, 03208, 03217, 03224, 03226, 03244, 03246, 03260, 04002, 04003, 04005, 04007, 04008, 04012, 04013, 04018, 04021, 04023, 04024, 04025, 04029, 04030, 04032, 04039, 04040, 04043, 04048, 04050, 04055, 04056, 04060, 04061, 04062, 04065, 04066, 04069, 04071, 04072, 04073, 04074, 04075, 04077, 04078, 04079, 04086, 04088, 04090, 04092, 04093, 04097, 04100, 04104, 04109, 04110, 04111, 04113, 04118, 04124, 04125, 04129, 04130, 04131, 04132, 04133, 04134, 04139, 04143, 04144, 04146, 04148, 04149, 04150, 04152, 04158, 04175, 04177, 04178, 04179, 04181, 04183, 04184, 04185, 04186, 04191, 04193, 04194, 04195, 04197, 04198, 04199, 04200, 04205, 04206, 04216, 04217, 04221, 04223, 04224, 04225, 04228, 04233, 04234, 04235, 04236, 04246, 04247, 04249, 04250, 04251, 04252, 04253, 04254, 04255, 04256, 04257, 04260, 04261, 04262, 04263, 04264, 04269, 04271, 04272, 04275, 04276, 04282, 04283, 04288, 04291, 04294, 04295, 04301, 04302, 04303, 04304.
MANUFACTURER Siemens AG, Erlangen, Germany.
RECALLED BY Siemens Medical Systems, Inc., Iselin, New Jersey
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 387 units.
REASON Patients who are registered on the MRI systems with birth dates of January 1, 2000 or later will be misinterpreted by the software to have been born in 1900.

PRODUCT Product insert for Acetaminophen (Enzymatic Rate) Reagent, used for the quantitative determination of Acetaminophen in serum, Catalog #502-13.
CODE Catalog No. 502-13.
MANUFACTURER Diagnostic Chemicals Ltd., Charlottestown, PE, Canada.
DISTRIBUTION Nationwide and Canada
QUANTITY 310 units were distributed.
REASON The "Product Insert" does not contain information on interference from N-acetylcysteine (NAC), the drug of choice for treating acetaminophen overdose.

PRODUCT GAP IgG Helicobacter Pylori Enzyme Immunoassay Kit, for the qualitative detection of IgG specific antibodies to helicobacter pylori in human serum.
CODE Catalog #404 2050, Lot #0426753-1/2 EXP 11/00.
MANUFACTURER Biomerica, Inc., Newport Beach, California.
DISTRIBUTION California.
QUANTITY 252 kits were distributed.
REASON The stability parameters were starting to draft and would be out-of-specification before the expiration date.

PRODUCT Endoscopic Blunt Dissecting Instrument, used to probe or move organs during surgery.
CODE KJJU02, KJJU03, BKJU01, BKJU02.
MANUFACTURER Manufacturas Frontera Norte SA de CV, CD Juarez, Mexico.
RECALLED BY Eagle Endoscopic, Inc., Bartonville, Texas
DISTRIBUTION Illinois and Tennessee.
QUANTITY 473 cases (20 units per case) were distributed.
REASON Tip separated from body while in use.

PRODUCT Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers: 006-04100-00, 006-04100-01, 006-04100-00S, 006-04100-01S, and 006-04100-02.
CODE All units shipped prior to March 30, 2000.
MANUFACTURER Nicolet, Madison, Wisconsin.
RECALLED BY Merge Technologies, Inc., West Allis, Wisconsin
DISTRIBUTION California, Connecticut, Kansas, Minnesota, Missouri, Nebraska, Ohio, Oregon, Virginia, Wisconsin, Brazil, Netherlands, Sweden.
QUANTITY 103 units were distributed.
REASON There is a potential for horizontal banding to appear on video screen images and images printed on laser film.

PRODUCT Kodak Oncology Film, identified as ECFLM film, 35 x 43 cm, Catalog No. 8715757.
CODE Emulsion Numbers: 0116-022-12, 0116-022-14, 0116-022-16.
MANUFACTURER Eastman Kodak Company, Windsor, Colorado.
RECALLED BY Eastman Kodak Company, Rochester, New York
DISTRIBUTION California, Missouri, North Carolina, Pennsylvania, Texas, Wisconsin.
QUANTITY 26 boxes (100 sheets per box) were distributed.
REASON Graphic Arts film was slit, chopped, and packaged as Oncology X-ray Film.

PRODUCT Ampicillin/Sulbactam 10/10 mcg Antimicrobial Susceptibility Test Disk, packaged 50 disks per box, intended for use in the standardized disk susceptibility test and is the recommended method of performing antimicrobial disk diffusion testing
CODE Product #33-135, Lot #216785 EXP 4/02.
MANUFACTURER Oxoid Ltd., Basingstoke Hants RG248PW, United Kingdom.
RECALLED BY Remel Inc., Lenexa, Kansas
DISTRIBUTION Nationwide.
QUANTITY 100 packages were distributed.
REASON The zones of inhibition obtained were below the acceptable zone diameter of the NCCLS Standard for Antimicrobial Disk Susceptibility Tests.

PRODUCT Abbott Ambulatory Infusion Manager Plus Single-Channel Infusion Pump, five types of programming options available for TPN, pain management, intermittent, variable time and contiuous delivery of medications and nutritional fluids.
CODE List #13967, Serial Numbers 12300001/12320000.
MANUFACTURER Abbott Laboratories, Inc., San Diego, California.
ALERTED BY Abbott Laboratories, Inc., Abbott Park, Illinois, by letter date, by letter on March 2, 2000.
DISTRIBUTION Nationwide.
QUANTITY 15,947 units were distributed.
REASON There is a possibility that medication therapy may be missed on March 1, 2000, due to the leap year, if the pumps were not appropriately reprogrammed on March 1, 2000.

WEEK ENDING MAY 19

PRODUCT Medline SPT Surgical and Procedure Kits and Trays containing recalled Clinipad products.
CODE The affected kits/trays contain the following Clinipad components alone or in combination:
Medline/SPT Part #                 Clinipad Reorder #                 Description
05766                                                     1245S-B                         Alcohol Swabstick 3/PK
06235                                                     1247S-B                         Acetone Alcohol Swabstick
05413                                                     1248S-B                         Acetone Alcohol Swabstick
07762                                                     3943S-B                         Clinidine Povidone Iodine
CLI1243                                                     1243                           Iodine Tincture Swabstick
CLI372211                                             372211                           E-Z Prep PVP Wing Sponge
CLI4444CD                                           4444CD                         Clinidine PVP Sol. 4 oz.
CLI4474CD                                           4474CD                         Cliniscrub PVP Scrub 4 oz.
00546                                                     1291B                             Iodorphor PVP Swabstick 3pk
01200                                                     9153B                             Iodophor PVP Prep Pad
02176                                                     1230B                             Swabstick BZK 3:1 PK
05160                                                     0250B                             Alcohol Prep Pad
05165                                                     1241B                             PVP Swabstick 1/PK
05481                                                     1233B                             Skin Protectant Swabstick
95488                                                     1251B                             Alcohol Swabstick
05768                                                     4339B                             Ointment Iodophor PVP 1 GR
05789                                                     1242B                             PVP Scrub Swabstick 1/PK
05836                                                     0310B                             Acetone Alcohol Pad
06070                                                     3925B                             Isopropyl Alcohol 1 oz.
06233                                                     1231B                             Compound Benzoin Tincture Swabstick
08990                                                     1244B                             PVP Scrub Swabstick 3/PK
10096                                                     8133                                Skin Protectant Prep Pad
(NOTE: If necessary a complete list of kits and part numbers can be obtained from the Chicago District Recall Coordinator).
MANUFACTURER Medline Industries, Inc., SPT Division, Waukegan, Illinois.
RECALLED BY Medline Industries, Inc., Mundelein, Illinois
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 175,500 kits in commerce by FDA estimate.
REASON Kits contain Clinipad antiseptic products that may be contaminated with bacteria.

PRODUCT Sterile Surgical and Procedure Kits/Trays distributed under labels identifying: Medikmark Inc., 900 Asbury Drive, Buffalo Grove, IL 60089; Medikmark, Inc., 3600 Bur Wood Drive, Waukegan, IL 60085; Distributed by Maxxim Medical, Case Management Division, Clearwater, FL 34622; Manufactured for R&J Medical Supply, Milwaukee, WI 53223; Distributed by Triad Medical, Laguna Hills, CA 92653
CODE One or more of the following Clinipad products were packaged in each of the Medikmark manufactured kits/trays, but the lot numbers of the Clinipad products are unknown:
a) 0250B, Clinipad Alcohol Prep
b) 0310S-B, Clinipad Acetone Alcohol Prep Pad
c) 1251S-B, Cliniswab Isopropyl Alcohol Swabstick
d) 1248S-B, Cliniswab Acetone Alcohol Swabtick, 3 swabs
e) 0110BS, CliniPad Alcohol Prep
f) 1245S-B, Cliniswab Isopropyl Alcohol Swabstick, 3 swabs
g) 1230BS
h) 1231S-B, Cliniswab Compound Benzoin Tincture Swabstick
i) 1233S-B, Cliniguard Protective Dressing Swabstick
j) 3943S-B, Clinidine Povidone Iodine 1% USP Solution, 1oz.
k) 9153S-B, Clinipad Iodophor PVP Povidone Iodine USP Prep Pad
l) 1244S-B, Cliniswab Iodophor PVP Scrub Povidone Iodine USP, 3 Swabsticks
m) 1241S-B, Cliniswab Iodophor PVP Povidone Iodine USP, 1 Swabstick
n) 1291S-B, Cliniswab Iodophor PVP Povidone Iodine USP, 3 Swabsticks
o) 2395B3, Clinipad Antiseptic Towelette
p) 3925B, Clinipad Isopropyl Alcohol 70%, 1 oz.
q) 4444-D, Clinidine Solution, Povidone Iodine, 4 oz.
r) 4446, Clinidine Solution, Povidone Iodine, 2 oz.
s) 4474-SC, Cliniscrub Surgical Scrub, Povidone Iodine, 4 oz.
t) 4476, Cliniscrub Surgical Scrub, Povidone Iodine, 2 oz.
u) 4484
v) HK4444, Clinidine Solution, Povidone Iodine, 4 oz.
x) 4338SB
All lots of kits/trays manufactured in the last three years are being recalled. (NOTE: If necessary, a complete list of lot numbers can be obtained from the Chicago District Office Recall Coordinator.)
MANUFACTURER Medikmark, Inc., Waukegan, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 1,350,000 kits in commerce FDA estimate.
REASON The kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria.

PRODUCT Various Sterile Procedure Kits and Trays containing antiseptic products that may be contaminated with bacteria
CODE All lots of Clinipad Procedure Kits containing recalled Sterile and Non-Sterile Drug Products- Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, Alcohol, and Sterile Cliniguard Protective Dressing. (NOTE: If necessary, a complete list of all kits/trays (approximately 1,208) can be obtained from the New England District Office Recall Coordinator.)
MANUFACTURER Clinipad Corporation, Norwich, Connecticut.
RECALLED BY Clinipad Corporation, Rocky Hill, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 2,000,000 units.
REASON Class I - Antiseptic products may be contaminated with bacteria. Class II - Kits/trays contain products for which the sterility could be assured. Recall has been classified as Class I and II: Kits/trays manufactured and listed with specific lot numbers -- Class I. Kits/Trays not specifically listed with lot numbers, but which contain products for which the sterility could not be assured -- Class II

PRODUCT Various sterile procedure kits containing antiseptic products recalled by Clinipad Corporation under the Kendall brand (Curity, Kenguard and Sage); and private label: Allegiance, Source and Respiratory Support Products, Inc. (RSP).
CODE All lots containing the recalled Clinipad antiseptic Item #3944S-B, Lot #91988 and other Clinipad products. (NOTE: If necessary, a complete detailed list and product codes can be obtained from the New England District Office Recall Coordinator.)
MANUFACTURER KenMex, Tijuana, Mexico, Kendall Healthcare, Chatswork, California.
RECALLED BY The Kendall Company, LP, Mansfield, Massachusetts
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 100,000 cases were distributed.
REASON Class I - Kits contain antiseptic products that may be contaminated with bacteria.
Class II - Kits contain Clinipad antiseptic products labeled as sterile for which Clinipad is unable to assure the sterility. Recall has been classified as Class I and II: Kits manufactured with the recalled antiseptic product (assigned Kendall Lot Numbers 9348004 and 9355014) - Class I Kits not containing those specific lots, but which contain Clinipad products for which the sterility could not be assured - Class II

WEEK ENDING MAY 26

PRODUCT Sterile Custom Surgical & Procedure Kits/Trays packaged by Allegiance Healthcare Corp., McGaw Park, IL, under three divisions, Custom Sterile Division, Medsurg/Isolyser Division and Custom Products/PBDS Division. These kits, containing antiseptic products recalled by Clinipad Corporation, are packed according to the special order requirements of the customer.
CODE (Note: If necessary a complete list of model information, codes/lot numbers can be obtained from the Chicago District Recall Coordinator).
MANUFACTURER Allegiance Healthcare Corporation, Custom Sterile Divis, McGaw Park, Illinois.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 341,746 kits/trays were distributed.
REASON Class I - Kits/trays contain Clinipad antiseptic products that may be contaminated with bacteria.
Class II - Kits/trays contain Clinipad products for which the sterility could not be assured.
Recall has been classified as Class I and Class II Devices packaged and distributed by Allegiance Healthcare Medsurg and PBDS Division - Class I. Kits/Trays packaged and distributed by the firm's Custom Sterile Division, which was able to identify the Clinipad products and lots used, for which the sterility could not be assured - Class II.

PRODUCT Ash Split Cath II Hemodialysis Catheter containing triCitrasol:
a) Model No. ASPC24-2T; b) Model No. ASPC28-2T; c) Model No. ASPC32-2T; d) Model No. ASPC36-2T; e) Model No. ASPC55-2T; f) Model No. TRAY552-2T; g) Model No. TRAY553-2T; h) Model No. TRAY593-2T; i) Model No. TRAY594-2T.
CODE All lots numbers.
MANUFACTURER Medical Components, Inc., Harleysville, Pennsylvania.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY 7,175 units were distributed.
REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA.

PRODUCT Medcomp Bio-Flex Catheter (CS100) containing triCitrasol, Model No. BFR-6T.
CODE All lot numbers.
MANUFACTURER Medical Components, Inc., Harleysville, Pennsylvania.
DISTRIBUTION Undetermined.
QUANTITY 5 units were distributed.
REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA.

PRODUCT TriCitrasol (46.7% trisodium citrate), Citra and Medcomp part/catalog #PN6030.
CODE All lot numbers.
MANUFACTURER Cytosol Laboratories, Inc., Braintree, Massachusetts.
RECALLED BY Medical Components, Inc., Harleysville, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 16,950 vials were distributed.
REASON TriCitrasol may be inadvertently administered into patients at full strength (46.7 percent) rather than being diluted as intended. In addition, the devices were distributed without appropriate clearances from FDA.

PRODUCT TriCitrasol Anticogulant Sodium Citrate Concentrate 46.7% Trisodium Citrate, 30 mL glass vial, used to keep bloodlines open
CODE PN6030 (50/pack) and PN6032 (12/pack). All Lots.
MANUFACTURER Cytosol Laboratories, Inc., Braintree, Massachusetts.
DISTRIBUTION Nationwide and Canada.
QUANTITY 420,968 30mL-vials were distributed.
REASON TriCitrasol may be inadvertently administrated into patients at full strength (46.7%) rather than being diluted as intended. In addition, the device was distributed without appropriate clearances from FDA.

PRODUCT Boehringer Mannheim Cretinine Jaffe Reagent, for the quantitative determination of creatinine in serum, plasma, and urine.
CODE Catalog #1875647. Lot numbers: 69938801 EXP 07/31/01, 69692201 EXP 01/01, and 69518201 EXP 01/01.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana
DISTRIBUTION California, Colorado, Florida, Hawaii, Illinois, Indiana, Michigan, Mississippi, New Jersey, New York, North Carolina, Wisconsin.
QUANTITY 127 kits were distributed.
REASON Product does not meet the specifications for bilirubin interference.

PRODUCT Model Elite/Corium Laser Systems, for use in dermatology, dentistry, ophthalmology, ENT, etc.
CODE None.
MANUFACTURER FISMA, Inc., Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 147 units were distributed.
REASON If a single component on the light feedback circuit were to fail, the laser would emit full power at any power setting.

PRODUCT B-D 1 ml Safety-Lok Insulin Syringe, 29G 1/2 Ultrafine Needle, Reorder No. 329464.
CODE Lot numbers 0005853 and 0106646.
MANUFACTURER Becton Dickinson, BD Medical Systems, Franklin Lakes, New Jersey.
DISTRIBUTION Mississippi, Louisiana, Tennessee, Texas, Pennsylvania, Indiana, Minnesota, Ohio, Michigan.
QUANTITY 10,500 units were distributed.
REASON Product was marked in ml scale instead of insulin units.

PRODUCT Infant and Pediatric Ventilators, intended for neonatal, infant, and pediatric ventilation:
a) Model IV-100B/Model IV-200 infant and Pediatric Ventilator;
b) Model IV-100B/Model IV-200 SAVI System (Ventilator with Synchronized Assisted Ventilation of infants Module).
CODE Model IV-100B Series w/serial numbers 13460-14490; Model IV-200 Series w/serial numbers 22209-23030 are subject to this recall.) Affected factory overhauls wherein the firm would have attached a battery bracket include any IV-100B or IV-200 Ventilator that received an overhaul between June 10, 1998 and November 19, 1999.
MANUFACTURER Seachrist Industries, Inc., Anaheim, California.
DISTRIBUTION Nationwide and international.
QUANTITY 1,831 units were distributed.
REASON The metallic battery brackets can become dislodged from the inside back cover of the ventilator and contact the main circuit board assembly of the ventilatorís operating system.

PRODUCT Roche Reflotron Plus Analyzer, Catalog #747461, a bench top photometric chemistry analyzer for clinical use, which utilizes reagent strips for testing of multiple analytes.
CODE All serial numbers from 4027788 through 4031233 plus all units serviced since November 1997 and had the lower heating plate replaced.
MANUFACTURER Roche Diagnostics GmbH, Mannheim, Germany.
RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indianapolis
DISTRIBUTION Nationwide.
QUANTITY Approximately 5,000 units were distributed.
REASON There is a potential for erroneous results due to a loose screw in the lower heating plate, which affects the lower heating unit of the analyzer.