WEEK ENDING NOVEMBER 5

PRODUCT Dialyzer Control:
a) Centrysystem 3 Catalog Nos.:
333103-001 - US 115v Centrysystem 3, BPM
333103-101 - US 115v Centrysystem 3 Single Needle, BPM
333103-121 - Euro 240v Centrysystem 3, Single Needle, BPM
333103-201 - US 115v Centrysystem 3+, BPM
333103-301 - US 115v Centrysystem 3+, Single Needle, BPM
333104-001 - US 115v Centrysystem 3, No Options
333104-101 - US 115v Centrysystem 3, Single Needle
333104-121 - Euro 240v Centrysystem 3, Single Needle
333104-201 - US 115v Centrysystem 3+, No Options;
b) Spare Transducer Assembly Catalog numbers:
501036-000 - Arterial/Venous Pressure Transducer Spare Assembly
501212-003 - Cartridge Holder Spare Assembly
501249-220 - Transducer Connector Spare Assembly.
CODE a) All devices manufactured after 11/01/1998, and all devices repaired with affected spares assemblies that were shipped after 11/01/1998. Includes machine serial numbers 3C39644 through 3C42411 (with exclusion of 460 devices within that range but released prior to 11/01/1998).
b) Lot numbers with prefix 11C, 12C, 01D, 02D, 03D, 04D, 05D, 06D.
MANUFACTURER Gambro Renal Care Products, Lakewood, Colorado.
DISTRIBUTION Nationwide and international.
QUANTITY 1,442 of the affected machines are in US distribution and 307 were shipped to international distributors. Also, 204 Transducer Spare Kits , 133 Cartridge Holder Spare Kits, and 3 Transducer Connector Spare Kits were distributed domestically.International distribution of these kits was 108, 8, and 0, respectively.
REASON The dialyzer alarm does not sound when the Maximum Arterial Pressure Alarm Limit is challenged.

PRODUCT Model  LI61U Soflex UV-Absorbing Silicone PC IOL.
CODE Lot Numbers 390T, 4BG1, 4BG7, 4CRA, 4DV1, 4BGB, 4CPB, 4CTJ, 4CUP, 4CUU, 4E2U, 4EN3, 4EPD, 4ERX, 4FUB
MANUFACTURER Bausch and Lomb Surgical, Clearwater, Florida.
DISTRIBUTION Nationwide.
QUANTITY 252 lenses were distributed; firm estimated that 124 units remained on market at time of recall initiation.
REASON Intraocular lenses may exhibit a cloudy appearance.

PRODUCT LifeStyle MV2 Multifocal, Hydrophilic, Sterile Contact Lenses in blister packs, Rx product.
CODE All lots.
MANUFACTURER St. Shine Optical Company, Ltd., Taiwan, Republic of China.
RECALLED BY The LifeStyle Company, Inc., Morganville, New Jersey
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 147,840 units were distributed.
REASON The contact lenses contain sorbic acid that is not declared on the labeling and may cause a burning sensation in the patient's eye.

PRODUCT Locking Blot Measuring Device, used to determine the required length of the locking bolt:
a) Part number 357.792; b) and Part number 357.113.311.
CODE Lot numbers: a) A4GG415; b) lot A4GF199.
MANUFACTURER Synthes USA, West Chester, Pennsylvania.
RECALLED BY Synthes USA, Paoli, Pennsylvania
DISTRIBUTION Arkansas, Florida, Minnesota, North Carolina, New Jersey, Pennsylvania, Germany.
QUANTITY 22 units were distributed.
REASON The ball that attaches to the measuring slider of the device may detach.

PRODUCT Synthes Anatomical Locking Plate System, used to treat fractures of long bones such as the femur: a) Part number 422.340.111; b) Part number 422.341.111; c) Part number 422.344.111; d) Part number 422.345.111; e) Part number 422.348.111 and f) Part number 422.349.111.
CODE Lot numbers: a) N2002, N2002.1, N2003, N2004, N2005; b) N2003, N2003.1, N2004, N2005; c) N2001, N2001.1, N2002, N2003, N2004, and N2005; d) N2001, N2001.1, N2002, N2003, N2004, N2005; e) N2001, N2001.1, N2002, N2003, N2004, N2005; f) N2001, N2001.1, N2002, N2003, N2004, N2005.
MANUFACTURER Mathys Medical Ltd., Bettlach, Switzerland.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Alabama, Colorado, Florida, Mississippi, North Carolina, New York.
QUANTITY 288 units were distributed.
REASON The fatigue strength of the plates did not meet the original specification.

PRODUCT Proximal Femoral Nail (PFN) System, used to ream a hole for the insertion of a femoral neck screw.
CODE Part #357.044, Lot Numbers 1006 through 1015.
MANUFACTURER Stratec Medical, Eimattstrasse, Switzerland.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION California, Connecticut, Illinois, Pennsylvania, Canada.
QUANTITY 14 units were distributed.
REASON The tip of the device may break when it comes in contact with a bent guidewire.

PRODUCT Navarre 6 French J-Curve Universal Drainage Catheter, Product reference number NUD6J, used only in non-vascular drainage procedures, and are intended to be used for abscess, cyst, and other general purpose drainage applications.
CODE Lot 990610, Use by 2002-04.
MANUFACTURER Navarre Biomedical, Ltd., Plymouth, Minnesota.
DISTRIBUTION Georgia, Indiana, Pennsylvania, Australia, Canada.
QUANTITY 105 catheters were distributed.
REASON The catheter size was incorrectly identified at the tops of the pouch labels of the catheters as 8 French (inside diameter), rather than as the actual size (6 French).

PRODUCT Pelvic Implant Set Graphic Case for Self-Tapping Screws, used to organize and store implants including tapping screws.
CODE Part #306.20, Lot #VC2671.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION California, Georgia, Iowa, South Carolina.
QUANTITY 4 units were distributed.
REASON Mislabeling - The rack in the graphic case that hold the self tapping screws is labeled with the part numbers for the standard screws instead of the self tapping screws.

PRODUCT Synthes Mandibular Modular Fixation System.
CODE Part number 449.014, Lot A3KJ682.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Alabama, California, Colorado, Florida, Hawaii, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Texas, Washington, Wisconsin.
QUANTITY 43 units were distributed.
REASON One of the outer labels of the device was purple instead of blue. A purple label corresponds with 2.4-mm plates. The color of the label is used to indicate the diameter of the screw that is used with the plate. The label still read what type and length the plate was in the package. The user would have realized that the color was incorrect.

PRODUCT Synthes TI-6AI-7NB Unreamed Femoral Nail, used for intramedullary stabilization for femoral shaft and subtrochanteric fractures, ipsilateral femoral neck and shaft fractures and impending pathologic fractures of the femur..
CODE Part number 464.34S, Lot A3CX522.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Arizona, California, Colorado, Florida, Massachusetts, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania.
QUANTITY 6 units were distributed.
REASON Mislabeling - The package was labeled as "9 x 340 mm Titanium Unreamed Femoral Nail" but contained an "11 x 340 mm Titanium Unreamed Femoral Nail".

PRODUCT Synthes Unreamed Humeral Nail (URHN)
CODE Part number 458.40S, Lot #A3JL013.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 95 units were distributed.
REASON The locking bolts were packaged as 40 mm in length but were actually 42mm in length.

PRODUCT Bone Staple(s): a) Part #282.80; b) Part #282.82.
CODE Lot Numbers: a) 2022, 2031, 2032, 2033, and 2034; b) 2026.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION California, Kansas, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Texas.
QUANTITY 250 units were distributed.
REASON Mislabeling - The package label states "intended for femoral fractures and osteotomies" which is not applicable for this device.

PRODUCT Saw Guide Assembly, Right and Left, HTO System, used as a guide for a bone saw: a) Part #P94025.013111; b) Part P94025.014011
CODE Lot numbers: a) A4GF675; b) A4GF681.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Missouri, Mississippi, Germany.
QUANTITY 6 units were distributed.
REASON The stud that is used to secure the saw guide to the guidewire may loosen from the base.

PRODUCT The Tracker Display Model #35360A is sold with the Detector Model #35300A and marketed together as the Keithley Model #90100 Tracker System, a radiation measurement system intended for use in quality assurance programs for high energy accelerators, and cobalt 60 machines.
CODE Serial Numbers: 83728-83747 and 84582-84601.
MANUFACTURER Inovision Radiation Measurements, Cleveland, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 40 units.
REASON A 1.6 Amp fuse may have been installed where a 1 Amp is specified.
 

WEEK ENDING NOVEMBER 12

PRODUCT RUBELLA IgG ELISA TEST KIT, diagnostic test kit used for detection of IgG antibody to rubella virus in human serum.
CODE Catalog/Product Number: RUE100-E, Lot #9DMGWW, EXP 4/30/00.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Meridian Diagnostics, Inc., Cincinnati, Ohio
DISTRIBUTION California, Florida, Massachusetts, Michigan, Minnesota, Missouri, New York, Oklahoma, Pennsylvania, Texas.
QUANTITY 178 units.
REASON Optical density (O.D.) values for the reference serum are outside of acceptable limits.

PRODUCT LIFEPAK 500 Automated External Defibrillator designed to be used by first responders to cardiac emergencies.
CODE Part Numbers: 3005400-000, 001, 002, 003, 004, 005, 009. 010, 011, 012, 013, 014, 018, 020, 021, 022, 029, 030, 031, 064, 065, 066, 067, 068, 070, 071, 074, 076, 078, 082, 083, 084 and 085.
Serial Numbers: All devices distributed prior to 8/21/98. The serial number range is for selected 8 digit serial numbers less than 10486696.
MANUFACTURER Medtronic Physio-Control Corporation, Redmond, Washington.
DISTRIBUTION Nationwide and international.
QUANTITY 10,746 units were distributed.
REASON Excessive electrical noise interfering with ECG analysis that, when present, may cause the shock advisory algorithm to render an incorrect decision.

PRODUCT Blood Pressure Cuff for the BP 410 and 412 Monitor: a) Part 17402-001: Blood pressure cuff, child Part 17403-001: Blood pressure cuff, adult Part 17403-003: Blood pressure cuff, large adult
b) Part 00304-001: 412 Blood pressure monitor (includes 71403-001); Part 00304-002: 412 Blood pressure monitor 50hz (includes 17403-001); Part 00304-B-001: 412 Blood pressure monitor 50hz (includes 17403-001).
CODE None (n/a).
MANUFACTURER Colin Medical Instruments Corporation, San Antonio, Texas.
RECALLED BY Quinton Instrument Company, Bothell, Washington
DISTRIBUTION Nationwide and international.
QUANTITY 630 units were distributed.
REASON The bladder and air hose of the blood pressure cuff contain undeclared rubber latex.

PRODUCT Portable Liquid Oxygen Units Models: AA-1000-EA, AA-1005-AA, AA-1010-AA, AB-1001-EA, AB-1002-EC, AB-1005-AA, AB-1005-AE, AB-1005-AG, AB-1005-EA, AB-1015-EA, AC-1005-AA, AD-1003-EA, AD-1005-AA, AD-1012-AA, AD-1017-EA, and AD-1014-EB.
CODE No Lot Numbers.
MANUFACTURER Penox Technologies, Inc., Pittston, Pennsylvania.
DISTRIBUTION Nationwide and international.
QUANTITY 1,144 units were distributed.
REASON Portable liquid oxygen unit was distributed with unrestricted flow regulator.

PRODUCT Schuhli Implant System, designed to lock a screw to a plate, independent of bony contact with the plate: Part numbers 219.401, 219.401S, 219.402, 219.402S, 219.404, 219.404S, 219.411, 219.411S, 219.412, 219.412S, 219.414, 219.414S, 419.401, 419.401S, 419.402, 419.402S, 419.404, 419.404S, 419.411, 419.411S, 419.412, 419.412S, 419.414, and 419.414S.
CODE All lots are involved.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Nationwide, Canada, Switzerland.
QUANTITY 3,827 units.
REASON In some instances the device may not lock securely into the plate.

PRODUCT Quickie Power Wheelchairs P200 Series, a powered wheelchair; battery operated medical device with wheels that is intended for medical purpose to provide mobility to persons restricted to a sitting position: a) Model P120; b) Model P200; c) Model P210; d) Model P300; e) Model P320.
CODE Model P120, Serial #s: P19-0290 to P19-6340
Model P200, Serial #s: P2-1006 to P2-13486
Model P210, Serial #s: P2-10010 to P2-13517
Model P300, Serial #s: P3-10500 to P3-12197
Model P320, Serial #s: P32-1000 to P32-4420.
MANUFACTURER Sunrise Medical Quickie Designs, Inc., Fresno, California.
DISTRIBUTION Nationwide and international.
QUANTITY 11,030 units.
REASON The failure of the front two bolts-caster plate-can result in the caster assembly separating from the chair frame.

PRODUCT Sterngold Black Era-RV (Reduced Vertical) Males Intended for the retention of partial dentures:Product Numbers:
a) 811105 Era RV Starter Kit; b) 811115 Era RV Attachment; c) 811125 Era RV Black Males;  d) 811166 Assorted Era RV Males;
e) 811168 Era RV Housing; f) 811203 Era Offset RV 4.5mm g) 811204 Era Offset RV 2.5mm.
CODE Lot Numbers: a) W1579; b) W1262, W1263, W1305, W1293, W1413, W1305,W1340, W1452, W1475, W1476,W1508, W1565, W1608, W1639, W1655, W1780, W1795, W1795, W1812, W1841, 990901-1, 990902-1; c) W1178, W1483; d) W1302, W1774 e) W1176, W1214, W1458; f) W1277, W1283, W1319, W1705 g) W1278, W1284, W1318, W1660, W1767.
MANUFACTURER Spectrum Plastics, Assonia, Connecticut.
RECALLED BY Sterngold, Attleboro, Massachusetts
DISTRIBUTION Nationwide and international.
QUANTITY 8,037 units.
REASON Incorrect height dimensions to the denture attachment.

PRODUCT LSL Sterile Tracheotomy Care and Clean Set, sterile, single patient use tray
CODE Product #LSL5110, Lot #9G3020.
MANUFACTURER LSL Industries, Inc., Chicago, Illinois (kit); Jiang Su Jin Hong Corporation, Jintan City, Jiangsu, China (gauze).
RECALLED BY LSL Industries, Inc., Chicago, Illinois
DISTRIBUTION Maine, Illinois, Missouri, New Jersey, Puerto Rico.
QUANTITY 1,160 trays.
REASON The kits may contain a contaminated gauze component. The gauze may contain an ETO resistant mold.

PRODUCT FreeHand Implantable Epimysial Electrodes for the NeuroControl FreeHand System, Part #1320-A and Model 200-19, all sizes/lengths. The system uses electrical muscle stimulation which is intended to improve a patient's ability to grasp, hold, and release objects.
CODE The affected serial numbers are: 243, 253, 259, 263, 289, 290, 368, 471, 493, 512, 800, 804, 820, 842, 850, 852, 873, 885, 900, 914, 893, 955, 968, 971, 977, 980, 983, 1077, 1127, 1151, 1153, 1172, 1217, 1221, 1241, 1250, 1255, 1261, 1307, 1564, 1582, 1604, 1606, 1630, 1635, 1651, 1955, 1965, 1966, 1976, 1981, 1999, 2001, 2006, 2044, 2045, 2046, 2055, 2325, 2062, 2232, 2063, 2065, 2067, 2008, 2069, 2160, 2198, 2229, 2234, 2235, 2236, 2237, 2249, 2253, 2276, 2291, 2293, 2294, 2295, 2299, 2315, 2323, 2326, 2327, 2331, 2424, and 2425.
MANUFACTURER NeuroControl Corporation, Valley View, Ohio (kits); Bio-Control Technology, Inc., Indiana, Pennsylvania (electrodes).
RECALLED BY NeuroControl Corporation, Valley View, Ohio
DISTRIBUTION New York, Pennsylvania, Indiana, Australia, United Kingdom, France.
QUANTITY 87 electrodes included in a total of 6 kits.
REASON Lack of assurance that the electrodes were sterilized.

PRODUCT a) Percutaneous Transluminal Angioplasty (PTA) Catheter, Catalog numbers: PTA-OS253, 303 and 403
b) Z-MED Dilation Catheter, Catalog Numbers: PDZ-S
c) Z-MED II Dilatation Catheter, Catalog Numbers: PDS-630, 643 and 655
d) PTA-OS Balloon Catheter, Catalog Numbers: VSB-030 and 040
e) Ghost II Dilation Catheter, Catalog Numbers: GII-109, 113, 121, 129, 130, 137, 138, 141. Recall #Z-135/139-0.
CODE
a) OS-0013THRU OS-0014, AND OS-0022 THRU OS-0024
b) Z-0774
c) ZZ-0240 THRU ZZ-0242
d) OS-0025/0026
e) GG0138 THRU GG0145.
MANUFACTURER NUMED, Inc., Hopkinton, New York.
DISTRIBUTION Massachusetts, United Kingdom, South Africa, Argentina.
QUANTITY 302 catheters were distributed.
REASON Non-sterility.

PRODUCT Surface Smoothness Sensor, Model 4206
CODE Model #4206.
MANUFACTURER Honeywell-Measurex Corporation, Cupertino, California.
DISTRIBUTION Nationwide.
QUANTITY 14 units.
REASON The laser product failed to comply with the Federal laser product performance standard, 21 CFR 10 1040.10(d) in that the product permitted human access to laser radiation in excess of the product class, and 1040.10(f)(2) in that the product failed to incorporate a safety interlock that was fail safe or redundant.

PRODUCT Abbott TestPack Plus H. pylori Reaction Discs, in vitro diagnostic, rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in serum, plasma and whole blood:
List 1D04-05 - 5 test kit (whole blood);
List 1D04-16 - 20 test kit (whole blood);
List 6C71-16 - 20 test kit (whole blood, plasma or serum).
CODE List number 1D04-05: Lot numbers 54412M300, 56628M200 List number 1D04-16: Lot numbers 54334M300, 56629M200 List number 6C71-16: Lot numbers 54417M300, 55211M300, 56631M200.
MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 5,003 kits were distributed.
REASON False positive results with some negative samples.

PRODUCT Abbott Gonozyme Diagnostic Kit, an EIA for detection of Neisseria gonorrhoeae antigens in urethral and endocervical swab specimens from humans; 100 test kit:
List 6502-24 - Kit with female swabs
List 6502-25 - Kit with male swabs
List 6502-62 - Reagent Kit with no swabs.
CODE Lot number 49762M300.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Texas, Germany, Italy, Japan, Singapore, Taiwan.
QUANTITY 136 kits were distributed.
REASON Stability failure.

PRODUCT Ameda Disposable Vacuum Assist Cup, a sterile, single use device for use with electric or hand-held vacuum pumps to facilitate vaginal delivery of term or near term infants exhibiting fetal distress.
CODE Sotck #17420, Lot #9E10.
MANUFACTURER Hollister, Inc., Cary, Illinois.
RECALLED BY Hollister, Inc., Libertyville, Illinois
DISTRIBUTION Nationwide.
QUANTITY 1,780 units were distributed.
REASON Some of the tubing adapters do not have the black "O-rings" in place.

PRODUCT Alpha IQ Mammographic X-Ray Units: a) Model IQ; b) Model RT. Recall #Z-152/153-0.
CODE Serial numbers 8140-8268, except 8251, 8189, 8254, 8257, 8219, and 8238.
MANUFACTURER Instrumentarium Corporation, Imaging Division, Tuusula, Finland.
RECALLED BY Instrumentarium Imaging, Inc., Milwaukee, Wisconsin
DISTRIBUTION Nationwide.
QUANTITY 62 units were distributed.
REASON There can be unintended motion of the C-arms of the X-ray units due to insufficient switch insulation.

PRODUCT Immunocard Toxin A, a diagnostic test kit
CODE Catalog # 711050, Lot Numbers: #711050.112 and #711050.113. Both lots expire on 5/29/00.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide.
QUANTITY 291 kits were distributed.
REASON Kits contain an improper sample transfer pipet (50ul instead of 25 ul).

PRODUCT Premier Giardia, a diagnostic test kit
CODE Catalog #614096, Lot Numbers: 614096.010 EXP 9/8/99 and 614096.011 EXP 11/10/99.
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide.
QUANTITY 601 kits were distributed.
REASON Weak positive test samples may be reported as false negative.

PRODUCT Abbott TestPack Chlamydia 20T-CE Kit, in-vitro diagnostic enzyme immunoassay for the detection of Chlamydia trachomatis antigen from endocervical swab specimens; 20 tests per kit.
CODE List 03436-18; Kit lot #56934M200; Swab lot #170.
MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 48 kits were distributed.
REASON Swab component expires prior to the kit expiration date.

PRODUCT ARCHITECT Estradiol Reagent Kit: List 6C22-20 and List 6C22-25, in-vitro diagnostic Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of estradiol in human serum and plasma.
CODE List 6C22-20 (400 tests): lots 47955M300, 54859M100, 54859M103, 54965M300, 55686M200;
List 6C22-25 (100 tests): lots 47955M301, 54859M101, 54965M301, 55686M201.
MANUFACTURER Abbott Laboratories, Inc., Abbott Park, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 825 400-test kits; 463 100-test kits were distributed.
REASON Under recovery of estradiol with undiluted patient specimens.

PRODUCT Abbott Test Pack Plus hCG Combo with on Board Controls (OBC) Reaction Disc, a self-performing immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in serum and urine for early detection of pregnancy.
CODE List 7B34, Lot Numbers 52412M200, 52414M200, 53867M100, 55058M200.
MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 32,036 kits were distributed.
REASON Lots may produce false positive results.

PRODUCT Abbott Vision Chem Controls, multianalyte controls used for verifying the performance of specific chemistry tests on the Abbott Vision System.
CODE
MANUFACTURER Abbott Laboratories, Inc. North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 2,589 kits were distributed.
REASON Chem Control II running below specification range when used with SGPT assay.
 

WEEK ENDING NOVEMBER 19

PRODUCT Spline HA-Coated Cylinder Dental Implants (Endosseous Implants), Part #1852.
CODE Lot Numbers: Lot No. 990530, 990652, 990820.
MANUFACTURER Sulzer Calcitek Inc., Carlsbad, California.
DISTRIBUTION Nationwide and internationl.
QUANTITY 1,010 implants were distributed.
REASON 13mm and 15mm implants were interchanged, each size in trays intended (labeled) for the other.

PRODUCT a) Percutaneous Transluminal Angioplasty (PTA) Catheter, Catalog Numbers: PTA-OS253, 303 and 403 b) Z-MED Dilation Catheter, Catalog #PDZ-S c) Z-MED II Dilatation Catheter, Catalog Numbers PDS-630, 643 and 655 d) PTA-OS Balloon Catheter, Catalog Numbers: VSB-030 and 040 e) Ghost II Dilation Catheter, Catalog Numbers GII-109, 113, 121, 129, 130, 137, 138, 141.
CODE Lot Numbers: a) OS-0013 THRU OS-0014, AND OS-0022 THRU OS-0024 b) Z-0774 c) ZZ-0240 THRU ZZ-0242 d) OS-0025/0026 e) GG0138 THRU GG0145
MANUFACTURER NuMed, Inc., Hopkinton, New York.
DISTRIBUTION Massachusetts, United Kingdom, South Africa.
QUANTITY 302 catheters were distributed.
REASON Non-sterility.

PRODUCT IMMULITE Anti-Thyroglobulin Antibody and IMMULITE Anti-Thyroid Peroxidase Antibody, for in-vitro diagnostic use:
a) IMMULITE Anti-Thyroglobulin Antibody - 50 Tests;
b) IMMULITE Anti-Thyroglobulin Antibody - 100 Tests;
c) IMMULITE Anti-Thyroglobulin Antibody - 500 Tests;
d) IMMULITE Anti-Thyroid Peroxidase Antibody - 50 Tests;
e) IMMULITE Anti-Thyroid Peroxidase Antibody - 100 Tests;
f) IMMULITE Anti-Thyroid Peroxidase Antibody - 500 Tests.
CODE a) Catalog No. LKTGZ, Lot Nos. 135 through 139, EXP 7/30/99; Lot No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot Nos. 144, 145, EXP 10/31/99;
b) Catalog No. LKTG1, Lot Nos. 135 through 139, EXP 7/30/99; Lot No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot Nos. 144, 145, EXP 10/31/99;
c) Catalog No. LKTG5, Lot Nos. 135 through 139, EXP 7/30/99; Lot No. 140, EXP 8/31/99; Lot Nos. 141, 142, EXP 9/30/99; and Lot Nos. 144, 145, EXP 10/31/99;
d) Catalog No. LKTOZ, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 11/30/99;
e) Catalog No. LKTO1, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 11/30/99;
f) Catalog No. LKTO5, Lot No. 143, EXP 4/30/99; Lot No. 144, EXP 6/30/99; Lot Nos. 145, 146, EXP 8/31/99; Lot No. 147, EXP 9/30/99; Lot No.148, 149, EXP 10/31/99; Lot No. 150, EXP 11/30/99.
MANUFACTURER Euro/DPC Ltd., Gwynedd, United Kingdom.
RECALLED BY Diagnostic Products Corporation, Los Angeles, California
DISTRIBUTION Nationwide and United Kingdom.
QUANTITY 1,269 kits were distributed.
REASON The sample diluent is non-homogeneous and may produce inaccurate test results.

PRODUCT PORT-A-CATH Implantable Access Systems in kits and trays. The kits each contain a "portal" and a catheter, and the trays each contain a portal, a catheter and an introducer set:
Titanium Venous System (kit), Product Numbers 21-4024 and 21-4024-22 (the Numbers ending in -22 are for exported product)
Titanium Venous System (tray), product Numbers 21-4025 and 21-4025-22
Low Profile Titanium Venous System (kit), product Numbers 21-4036 and 21-4036-22
Low Profile Titanium Venous System (tray), product Numbers 21-4037 and 21-4037-22 Port-A-Cath II Polysulfone/Titanium Venous System (kit), product Numbers 21-4052 and 21-4052-22 Port-A-Cath II Polysulfone/Titanium Venous System (tray), product Numbers 21-4053 and 21-4053-22 Port-A-Cath II Low Profile Polysulfone/Titanium Venous System (kit), product Numbers 21-4082 and 21-4082-22
Port-A-Cath II Low Profile Polysulfone/Titanium Venous System (tray), product Numbers 21-4083 and 21-4083-22
P.A.S PORT Titanium Venous System (kit), product Number 21-4500
P.A.S PORT Fluoro-Free Titanium Venous System (kit), product Number 21-4505
P.A.S PORT Fluoro-Free Titanium Venous System (tray), product Number 21-4506
P.A.S PORT T2 Titanium Venous System (kit), product Numbers 21-4572 and 21-4572-22
P.A.S PORT T2 Titanium Venous System (tray), product Numbers 21-4573 and 21-4573-22
Port-A-Cath II Fluoro-Free Polysulfone/Titanium Venous System (tray), product Number 21-4653
P.A.S PORT T2 Fluoro-Free Titanium Venous System (kit), product Numbers 21-4672 and 21-4672-22 P.A.S PORT T2 Fluoro-Free Titanium Venous System (tray), product Numbers 21-4673 and 21-4673-22 Port-A-Cath II Low Profile Fluoro-Free Polysulfone/Titanium Venous System (tray), product Numbers 21-4683 and 21-4683-22.
CODE Product Number Lot Numbers
21-4024 66596, 67174, 67672, 66597, 66930, 67175, 67445, 67673
21-4025 66598, 66931, 67176, 67446, 67674, , 7929, 66599, 67177, 67447, 67675, 67930
21-4036 66601, 67179, 67450, 66362, 66602, 66934, 67180, 67451, 67678
21-4037 66603, 66935, 66365, 66604, 66936, 67181, 67452
21-4052 66368, 66607, 66939, 67183, 67680, 66369, 66608, 67184, 67681, 67939
21-4053 66370, 66609, 66940, 67185, 67453, 67682, 66371, 66610, 66941, 67186, 67454, 67683
21-4082 66571 66948 67191 67459 67690 66381 66619 66949 67460 67691
21-4083 66382 66620 66950 67193 67462, 67692 66621 66951 67194 67463, 67693
21-4500 66623 66721 66752 66952 67195, 67464
21-4505 67196 67716
21-4506 67197 67477
21-4572 66728 67125 67465 67694 67952, 66729 67466 67695
21-4573 66731 67127 67468 67696 66732, 67469 67697
21-4653 66631 66958 67198 67470 67698
21-4672 66960 67129 67471 66961 67130, 67700 67814
21-4673 66733 66962 67131 67472 66734, 66963 67132 67473
21-4683 66632 66964 67474 67701 66633, 66965 67201 67702.
MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota.
DISTRIBUTION Nationwide and international.
QUANTITY 17,485 implantable access systems were distributed
REASON Fracture of device catheter can result in leaks.

PRODUCT Revision J Software in the Nellcor Puritan Bennett, 740 Ventilator System and 760 Ventilator System.
CODE Any ventilator with REV J Software.
MANUFACTURER Nellcor Puritan Bennett Ireland, Ltd., Galway, Ireland.
RECALLED BY Mallinckrodt, Inc., St. Louis, Missouri
DISTRIBUTION Nationwide and international.
QUANTITY 223 units.
REASON software can cause under or over-delivery of oxygen.

PRODUCT Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, a sterile non-conductive tubing used with a vacuum-powered suction apparatus
CODE Catalog #N510, Lot Y9J1813.
MANUFACTURER Allegiance Healthcare Corporation, Mexicali-Baja Cal, Mexico.
RECALLED BY Allegiance Healthcare Corporation, McGaw Park, Illinois
DISTRIBUTION Nationwide and international.
QUANTITY 8,340 units were distributed.
REASON The outer package seal may not hold, thus the sterility of the product may be compromised.

PRODUCT ALM Prismalix (PRX) Ceiling Mounted Surgical Lighting System, used to provide visible illumination of surgical patients and other patient examination procedures:
a) PRX 6401 Series;
b) PRX 8401 Series;
c) PRX 6601 Series;
d) PRX 8601 Series;
e) PRX 4401 Series;
f) PRX 6441 Series;
g) PRX 8441 Series;
h) PRX 4441 Series;
i) PRX 6001 Series;
j) PRX 8001;
k) PRX 4001 Series;
l) PRX 4401 Series;
m) PRX 4441 Series;
n) PRX 6601.
CODE
MODEL NUMBER MODEL DESCRIPTION
0032 PRX 6401 ACS/DF/CFF
50118 PRX 6401 ACS/DF/VZ
50116 PRX 6401/ACS/SF/CFF
50117 PRX 6401 ACS/SF/VZ
50077 PRX 6401 SA/DF/CFF
50037 PRX 6401 SA/DF/VZ
50107 PRX 6401 SA/SF/CFF
50036 PRX 6401 SA/SF/VZ
50048 PRX 8401 ACS/DF/CFF
50127 PRX 8401 ACS/DF/VZ
50125 PRX 8401 ACS/SF/CFF
50126 PRX 8401 ACS/SF/VZ
50122 PRX 6601 ACS/CFF
50123 PRX 6601 ACS/VZ
50129 PRX 8601 ACS/CFF
50130 PRX 8601 ACS/VX
50010 PRX 4401 SAI/DF/CFF
50013 PRX 4401 SAI/DF/VZ
50012 PRX 4401 SAI/SF/CFF
50105 PRX 4401 SAI/SF/VZ
50038 PRX ACS/DF/CFF
50121 PRX 6441 ACS/DF/VZ
50119 PRX 6441 ACS/SF/CFF
50120 PRX 6441 ACS/SF/VZ
50147 PRX 6441 SA/DF/CFF
50148 PRX 6441 SA/DF/VZ
50108 PRX 6441 SA/SF/CFF
50109 PRX 6441 SA/SF/VZ
50128 PRX 8441 ACS/DF/CFF
50053 PRX 8441 ACS/DF/VZ
50149 PRX 8441 ACS SF/CFF
50150 PRX 8441 ACS/SF/VZ
50018 PRX 4441 SAI/DF/CFF
50101 PRX 4441 SAI/DF/VZ
50100 PRX 4441 SAI/SF/CFF
50102 PRX 4441 SAI/SF/VZ
50115 PRX 6001 ACS/T
50095 PRX 6001 SA/T
50124 PRX 8001 ACS/T
50004 PRX 4001 SAI/DF/T
50005 PRX 4001 SAI/SF/T
50015 PRX 4401 SAD/DF/CFF
50114 PRX 4401 SAD/DF/VZ
50112 PRX 4401 SAD/SF/CFF
50113 PRX 4401 SAD/SF/VZ
50021 PRX 4441 SAD/DF/CFF
50103 PRX 4441 SAD/DF/VZ
50106 PRX 4441 SAD/SF/CFF
50104 PRX 4441 SAD/SF/VZ
50111 PRX 4001 SAD/DF/T
50110 PRX 4001 SAD/SF/T
50046 PRX 6601 SA/T.
There are 491 devices under recall representing 52 different models (noted directly above) and with each having a different serial number.
MANUFACTURER ALM SA, Parc De Limere, Ardon Orleans Cedex.
RECALLED BY ALM Surgical Equipment, Inc., Anaheim, California
DISTRIBUTION Nationwide, Guam, Canada.
QUANTITY 491 devices were distributed.
REASON The main arm of the device may fall from the shaft because of missing shaft-retaining clips.

PRODUCT Sri brand of Surgical Procedure Packs, an assembly of finished medical devices and other items used during the preparation and/or performance of surgical/medical procedures:
a) Pack No. 1003C; b) Pack No. 1003D; c) Pack No. 1724C; d) Pack No. 1808D; e) Pack No. 2082A; f) Pack No. 2104D; g) Pack No. 2106D; h) Pack No. 4148; i) Pack No. 7047A.
CODE Sterilized under Lot #7192574150, Work Order/Lot Numbers: a). 266908; b). 296909; c) 296934; d) 296936; e) 296956; f) 296960; g) 296961; h) 296973; i) 297054.
MANUFACTURER Sterile Recoveries, Inc., Long Beach, California.
DISTRIBUTION California.
QUANTITY 410 units were distributed.
REASON The devices were labeled and distributed as sterile devices without assurance that they were sterile. The total number of packs sterilized on the load exceeded the maximum validated QUANTITY allowed per load.

PRODUCT Tyshak brand Peripheral Balloon Dilation Catheter, Model 610532, Rated Burst Pressure: 3.5 ATM
CODE T-1774.
MANUFACTURER NuMed, Inc., Hopkinton, New York.
DISTRIBUTION Pennsylvania.
QUANTITY 7 catheters were distributed.
REASON The firm inadvertently attached a Tyshak II balloon to a Tyshak I catheter. The Tyshak I catheter is labeled with a Rated Burst Pressure of 3.5 ATM. The Tyhsak II balloon has a Rated Burst Pressure of 3.0 ATM. As a result, the balloon could burst prior to the labeled burst pressure.

PRODUCT OXY-PEEP Oxygen Diluter Kit, Model P-63000, dilutes oxygen being administered to a patient.
CODE Lot Numbers: 6309DX, 6309EW, 6309GP, 6309HP, 6309EV, 6309GJ, 6309HJ, 6309HY.
MANUFACTURER Pegasus Research Corporation, Santa Ana, California.
DISTRIBUTION Nationwide.
QUANTITY 516 units were distributed.
REASON The exhalation valve in the mask may stick.

PRODUCT Blood Collection Safety Systems as follows:
a) Safe Point M-D, Multi-Draw Needle Cover System, 21 gauge x 1 1/2" needle, packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. N-621)
b) Safe Point M-D, Multi-Draw Needle Cover System, 22 gauge x 1 1/2" needle, packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. N-622)
c) Safe Point VAC Needle Cover System with Blood Collection Needle Vacutainer Holder, 22 gauge x 1 1/2" needle (some labeled with 1" needle), packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. S-621 VAC)
d) Safe Point VAC Needle Cover System with Blood Collection Needle and Vacutainer Holder, 22 gauge x 1 1/2" needle, (some labeled with 1" needle) packaged 150 or 200 pieces per box, or individually packaged. (Reorder No. S-722VAC).
CODE All lots currently on the marketplace produced prior to 9/15/99.
MANUFACTURER North American Medical Products, Inc., Yorba Linda, California.
RECALLED BY North American Medical Products, Inc., Albany, New York
DISTRIBUTION Nationwide.
QUANTITY 28,900 catheters (bulk lots).
REASON Lack of assurance of sterility.

PRODUCT Proclear Compatibles Daily Wear Contact Lens.
CODE 416 lots of lenses each identified with a 10 digit reference number.
MANUFACTURER Biocompatibles Eyecare, Inc., Norfolk, Virginia.
DISTRIBUTION Nationwide and international.
QUANTITY 119,028 lenses were distributed in the United States.
REASON Leaking blister seal of contact lens packaging compromised sterility.
 

WEEK ENDING NOVEMBER 26

PRODUCT Stealth Surgical Clamps, indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery: a) Model No. A3220; Model No. A3219.
CODE a) Lot Nos. E9C012, E9C083, E9C084, 99E040, 99E419; b) Lot Nos. E9C014, E9C015, E9C087, 99F476, 99E418, 99E417.
MANUFACTURER Applied Medical Resources, Laguna Hills, California.
DISTRIBUTION Michigan, Mississippi, New York, Ohio, Texas.
QUANTITY a) 71 clamps; b) 418 clamps were distributed.
REASON The clamps have a potential for misalignment under high pressure which could cause the clamps to release prematurely or to tear the tissue held by the clamp.

PRODUCT Nellcor Puritan Bennett 740 Ventilator and 760 Ventilator System.
CODE All ventilators that operate at the consignee at a main voltage of 110v.
MANUFACTURER Nellcor Puritan Bennett Ireland, Galway, Ireland.
RECALLED BY Mallinckrodt, Inc., St. Louis, Missouri
DISTRIBUTION Nationwide and international.
QUANTITY 2,359 ventilators were distributed.
REASON Battery power can deplete when power supply switches voltage due to spikes.

PRODUCT Spinal Anesthesia Tray, a sterile, disposable, single use device for the administration of spinal anesthesia.
CODE Catalog #407225, Lot #8H300 EXP 8/99.
MANUFACTURER North American Sterilization and Packaging, Franklin, New Jersey.
RECALLED BY Becton Dickinson Anesthesia Systems, Franklin Lakes, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 218 trays remained on market at time of recall initiation.
REASON The vials of Tetracaine included on the tray has an expiration date of 4/99, while the trays are dated with an expiration of 8/99. There is a possibility that expired drug could be used resulting in ineffective anesthesia.