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 ventilator’s 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.