JANUARY 2000

WEEK ENDING JANUARY 7

PRODUCT Julian Anesthesia Machine.
CODE Catalog #8601110.
MANUFACTURER Drager Medizintechnik GMBH, Luebeck, Germany.
RECALLED BY North American Drager, Telford, Pennsylvania
DISTRIBUTION Pennsylvania and California.
QUANTITY 8 units were distributed.
REASON The oxygen can contaminate the air supply line and/or air can contaminate the oxygen supply line under certain conditions.

PRODUCT Nu-TRAKE Emergency Cricotyrotomy Device, Catalog #B10100.
CODE Lot #754870.
MANUFACTURER Bivona Medical Technologies, Division of UroQuest Medical Corporation, Gary, Indiana.
DISTRIBUTION Nationwide, Canada, Germany, The Netherlands.
QUANTITY 499 units were distributed.
REASON The cannula body may be missing in unopened packages.

PRODUCT Heart Access Plus, a portable, battery-operated, cardiac memory electrocardiogram (ECG) event recorder and a voice diary.
CODE All units shipped between 5/11/98 to 7/15/99 (PLEASE CHECK)
MANUFACTURER Paceart Asscoiates, L.P , Fairfield, New Jersey.
DISTRIBUTION Delaware, Florida, Maryland, New York, Australia, China.
QUANTITY 35 units were distributed.
REASON The device fails to comply within performance standard for electrode lead wires and patient cables, 21 CFR 898.

PRODUCT Sterile Drape Bag and Coupler for Endoscopic Camera System.
CODE Lot Numbers: 08484C1585, 0885C2088, 09215C0297, 09296C0895.
MANUFACTURER Advanced Medical Designs, Marietta, Georgia.
DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY 5,540 units were distributed.
REASON The assembled components were inadequately glued resulting in the plastic lens cap separating from the sterile drape bag.

PRODUCT IMMUNOCARD TOXIN A, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxin A in human stool.
CODE Kit Catalog Number: 711050. Kit Lot Numbers: 711050.116, 711050.117, 711050.118, and 711050.119. Exp Date: 9/23/2000 ( for all 4 lots).
MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio.
DISTRIBUTION Nationwide, Canada, Japan, Germany, Italy.
QUANTITY 597 kits were distributed.
REASON The substrate reagent exhibits a blue color which may affect final test results.
 

WEEK ENDING JANUARY 14

PRODUCT Trans-Lift Resident Sling Scale, used as an accessory to the Trans-Lift Resident Sling which is used to transport immobile patients.
CODE Catalog #P823A.
MANUFACTURER Sensor Developments, Inc., Lake Orion, Michigan (contract manufacturer).
RECALLED BY Hill-Rom, Inc., North Charleston, South Carolina
DISTRIBUTION Nationwide.
QUANTITY 40 scales were distributed.
REASON The device failed due to metal fatigue.

PRODUCT Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
CODE Serial numbers with suffix numbers -20A2, -20A3, -20A4, -20A5.
MANUFACTURER Mini-Med, Inc., Sylmar, California.
DISTRIBUTION Nationwide.
QUANTITY 2,909 units were distributed.
REASON The pumpís software has an error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in the day and different from the expected current rate based on the pumpís present program.

PRODUCT Stryker Heavy Duty Blades, Sterile, used by surgeons for cutting bone:
a) Sagittal Blades with Part Nos. 2108-100, 102, 103, 105, 108, 110, 111, 115, 118, 120, 125, 131, 137, 140, 144, 145, 148, 150, 151, 152, 155, 156, 158, 160, 175, 176, 177, 182, 183, 185, 189, 192, 193, 195, 197, 218;
b) Aggressive Tooth Blades with Part Nos. 2108-302, 305, 309, 310, 318, 328, 351, 352, 356, 376, 377, 382, 383, 385, 389, 393, 2108-888-185.
CODE All Lots beginning with 9901, 9902, 9903, 9904, 9905, 9906 and labeled as Product of Ireland.
MANUFACTURER Stryker Ireland, Ltd., Carrigtwohill, County Cork, Ireland.
RECALLED BY Stryker Instruments, Kalamazoo, Michigan
DISTRIBUTION Nationwide and international.
QUANTITY 144,127 blades were distributed.
REASON The sterility cannot be assured through the labeled expiration date due to the potential for a package integrity failure.

PRODUCT Valleylab E2516H-GNSB Electrosurgical Pencils, intended for use in the operating room for surgical procedures requiring cutting and coagulation.
CODE Lot #41967.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
DISTRIBUTION Virginia and Illinois.
QUANTITY 10,800 pencils were distributed.
REASON The insulation on the blade electrode may have stress cracks, allowing for the possibility of burns to the patient or surgical personnel.

PRODUCT Guide Shaft, used as an insertion aide between wrench and screw.
CODE Part #338.21, Lot #1050.
MANUFACTURER Stratec Medical, Eimattstrasse, Switzerland.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION Nationwide and Canada.
QUANTITY 89 units.
REASON Guide shaft may be outside specified dimensions.

PRODUCT Custom Procedure Trays containing Heparin Sodium Injection a) RDG393 EP STUDY TRAY; b) HCG185A CARDIAC CATH TRAY; c) HCF876B SWAN GANZ TRAY.
CODE Lot Numbers: a) 67070538, 67100784, 67101233; b) 67060048, 67090667; c) 67050887, 67070017, 67070261, 67070811, 67081290, 67090222.
MANUFACTURER Maxxim Medical, Temecula, California.
DISTRIBUTION California.
QUANTITY 584 trays were distributed.
REASON The Heparin Sodium Injection ampule may contain particulate matter.

PRODUCT Clinitek hCG Test Strips, for the qualitative determination of human chorionic gonadotropin in urine and are intended for use in the early detection of pregnancy:
a) Product No. 2043, CLINITEK hCG Test Strips - 25 Foiled Strips;
b) Product No. 2044, CLINITEK hCG Test Strips - 25 Strips.
CODE Lot Numbers: a) 0320N00701, EXP Date 01/07/2000; b) 0308N00701, EXP Date 01/08/2000.
MANUFACTURER Quidel Corporation, San Diego, California.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Nationwide and international.
QUANTITY 1,604 packages were distributed.
REASON The devices may give false positive results.

PRODUCT AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners.
CODE All units using the AcQPlan Therapy Planning software version 4.04 are affected.
MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio.
DISTRIBUTION Georgia, California, Pennsylvania, Florida, Kentucky, Alabama, Washington State, Hawaii, North Dakota, Mississippi, Missouri, Illinois, Massachusetts, New York, Ohio, Idaho, Arizona, international.
QUANTITY 57 units were distributed.
REASON Software anomaly causes the isocenter shift to be labeled incorrectly.

PRODUCT VACUTAINER Brand Sodium Citrate Tubes
a) Catalog No. 366392, 0.105M Buffered Sodium Citrate Tube with Conventional Stopper, 1.8mL draw;
b) Catalog No. 366393, 0.105M Buffered Sodium Citrate Tube with Conventional Stopper, 2.7mL draw;
c) Catalog No. 369711, 0.105M Buffered Sodium Citrate Tube with HEMOGARD Closure, 1.8mL draw;
d) Catalog No. 367712, 0.105M Buffered Sodium Citrate Tube with HEMOGARD Closure, 2.7mL draw;
e) Catalog No. 366394, 0.129M Buffered Sodium Citrate Tube with Conventional Stopper, 1.8mL draw;
f) Catalog No. 366395, 0.129M Buffered Sodium Citrate Tube with Conventional Stopper, 2.7mL draw;
g) Catalog No. 369700, 0.129M Buffered Sodium Citrate Tube with HEMOGARD Closure, 1.8mL draw;
h) Catalog No. 367703, 0.129M Buffered Sodium Citrate Tube with HEMOGARD Closure, 2.7mL draw.
CODE a) All lots beginning with 7 and all lots beginning with 8C or 8D;
b) All lots beginning with 7 and all lots beginning with 8A, 8B, or 8D;
c) Lot Nos. 7B856, 7E836, 7H878, 7C823, 7G830, and 7J834;
d) Lot Nos. 7B851, 7F854, 7H865A, 7K801A, 7C816, 7G821, and 7J823;
e) All lots beginning with 6, all lots beginning with 7, and All lots beginning with A or 8D;
f) All lots beginning with 6, all lots beginning with 7, and all lots beginning with 8A, 8B, 8C, or 8D;
g) All lots beginning with 6, all lots beginning with 7, and all lots beginning with 8A, 8B, 8C, or 8F;
h) All lots beginning with 6, all lots beginning with 7, and all lots beginning with 8A, 8B, 8C, or 8E.
MANUFACTURER Becton Dickinson VACUTAINER Systems, Franklin Lakes, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 90,801,500 tubes were distributed; firm estimates none remain on the market.
REASON The devices may produce lowered coagulation results for PTís and aPTTís.

SAFETY ALERT:

PRODUCT Amicus Separator Apheresis Kits for Extended Platelet Storage and Plasma Collection:
a) Fenwal Amicus Apheresis Kit - Double Needle
b) Fenwal Amicus Apheresis Kit - Single Needle.
CODE  Lot Numbers: a) N99E03013, N99E05034, N99E17021, N99E19019, N99E24019, N99E24027, N99E26014, N99E26022, N99E27012, N99F01015, N99F03011, N99F07020, N99F09018, N99F11014, N99F14018, N99F14034, N99F16039, N99F21021, N99F22011, N99G01021, N99G06038, N99G08018, N99E13020, N99E24043, N99E10026, N99F03029, N99F07038, N99E03039, N99E04011, N99E10034, N99E12030, N99E17039, N99E26030, N99E28010, N99F02013, N99F03037, N99F04019, N99F07012, N99F21039
b) N99E03021, N99E05018, N99E07014, N99E10018, N99E12014, N99E13038, N99E17013, N99E19027, N99E24035, N99F04027, N99F09026, N99F11022, N99F18019, N99F23027, N99F28018, N99F30022, N99G08026, N99G16029, N99G19015, N99E12022, N99F01031, N99F14026, N99E07022, N99E14010, N99E21015, N99F01023, N99F11048, N99F25014.
MANUFACTURER Baxter Healthcare Corporation, San German, Puerto Rico.
ALERTED BY Baxter Healthcare Corporation, Fenwall Division, Deerfield, Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY The firm distributed 43,500 units in the United States, 7,410 units in Europe and 14,400 units in Japan
REASON Lumen-to-lumen leaks within the umbilicus of the kit allow red blood cells in the plasma line and in the platelet product.
 

WEEK ENDING JANUARY 21

PRODUCT X-Ray Fluorescence Spectrometers, used for the qualitative and quantitative elemental analysis of material composition and thickness by X-ray fluorescence spectroscopy:
a) Model No. 0700; b) Model No. 770; c) Model No. 771; d) Model No. 0750.
CODE Model Numbers 0700, 770, 771, and 0750.
MANUFACTURER Kevex Instruments, Inc., Sunnyvale, California.
DISTRIBUTION Nationwide.
QUANTITY 309 units were distributed.
REASON These analytical X-ray systems are defective as defined by 21 CFR 1003.2. The relay controlling the interlock for the sample chamber, indicator light, and X-ray power can potentially fail.

PRODUCT 6.5 mm Cannulated Tap for proximal hip pin, used to tap a hole in the bone prior to the placement of a hop pin (screw).
CODE Part #311.720, Lot Numbers: 1002 and 1008.
MANUFACTURER Stratec Medical, Oberdorf, Switzerland.
RECALLED BY Synthes (USA), Paoli, Pennsylvania
DISTRIBUTION California, Connecticut, Illinois, New Jersey, Canada.
QUANTITY 10 units were distributed.
REASON Product does not meet hardness specifications.

PRODUCT Depuy LCS Total Knee System Rotating Platform:
a) Size STD/LG, Part No. 1278-46-025, b) Size STD+/LG, Part No. 1278-51-025.
CODE Lot Numbers: a) 051799001; b) 051799002.
MANUFACTURER Depuy Orthopaedics Inc., Warsaw, Indiana.
DISTRIBUTION Alabama, California, Colorado, Florida, Georgia, Illinois, Iowa, Massachusetts, Michigan, Montana, Missouri, New York, Tennessee, Utah, Virginia, England.
QUANTITY 50 units were distributed.
REASON Two lots were mixed during manufacturing. The difference between the devices is a slight mismatch between the curvature of the femoral and tibial insert (approximately 5mm).

PRODUCT Swan-Ganz Bipolar Pacing Catheter Model 97K125F5, designed for temporary transvenous right ventricular endocardial pacing.
CODE Lot Numbers: 219HC569, 219HC570, 219HC571, 219HC572 and 219HC573.
MANUFACTURER Baxter Healthcare Corporation, Anasco, Puerto Rico.
RECALLED BY Baxter Healthcare Corporation, Irvine, California
DISTRIBUTION 716 individual units were distributed.
QUANTITY Nationwide and international.
REASON The labeling on the box and tray indicates that the product is for femoral insertion rather than for Superior Vena Cava (SVC) insertion.

PRODUCT Management Systems, intended to provide continuous infusion of a local anesthetic directly into an intra-operative site for postoperative pain management: a) ON-Q Pain Management System; b) Pain-Buster Pain Management System.
CODE All lot numbers.
MANUFACTURER I-Flow Corporation, Lake Forest, California.
DISTRIBUTION Nationwide.
QUANTITY a) Approximately 5,169 cases (5 units per case); b) 25,250 units were distributed.
REASON The devices contain natural rubber latex components and the label fails to declare, "Caution: This product contains natural rubber latex which may cause an allergic reaction."

PRODUCT Philips BV26 Mobile C-Arm Stand Mobile C-Arm Fluoroscope. The unit consists of a mobile C-arm stand with X-ray generator, medical imaging chain and control.
CODE Philips Medical Systems Model BV26 with Serial Numbers: CBxxxx, CDxxxx, CGxxxx.
MANUFACTURER Philips Medical Systems Nederland B.V., Best Netherlands.
RECALLED BY Philips Medical Systems North America, Inc., Shelton, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 70 units.
REASON The wheel plates may fail causing the BV26 to fall.

PRODUCT Series 200 5 French Angiographic Balloon Catheter, designed for use in right heart catherization for cardiac angiography, and pulmonary angiography: a) Model No. 252-50; b) Model No. 252-60; c) Model No. 252-80.
CODE Lot Numbers:
a) 2021, 172963, 144951; b) 1449151, 50922; c) 1449111, 172961, 172962, 172964, 172965, 116951, 116981, 116982, 307821, 013911, 013921.
MANUFACTURER J-Lloyd Medical, Inc., West Berlin, New Jersey.
DISTRIBUTION Texas, Canada, England.
QUANTITY 419 units were distributed.
REASON The catheter tip may break just proximal to the balloon.

PRODUCT ES 4007 Universal Cord, a reusable device that combines the function of a standard electrosurgical active cord with the electroshield cable in one cable. This allows the user to make a single termination of the ESU/EM equipment and a single termination at the surgical instrument.
CODE Lot Codes BI, BIA, BIB, BJ, CB, CBA, CBB, DA, DB, DG, DGA, DGB, DGC.
MANUFACTURER Electroscope, Inc., Boulder, Colorado.
DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY 1,361 cords were distributed.
REASON A fatigued active conductor could result in a spark and burning of the cord insulation.

PRODUCT TECAN Genesis Disposable 1000ul Filter DiTi Tips, Catalog No. 71-705.
CODE Lot Numbers: 15169, 16169, 17169, 11179, 25169, 26169, 27169, 35169, 36169, and 37169.
MANUFACTURER Eppendorf, Barkhausenweg-1, Germany.
RECALLED BY Tescan U.S., Inc., Durham, North Carolina
DISTRIBUTION Arizona, California, Florida, Illinois, Wisconsin.
QUANTITY 2,720 boxes were distributed.
REASON The device delivers incorrect volumes.

PRODUCT Fresenius Kidney Euro-Collins Perfusion Set, 1 liter.
CODE Catalog #2398001, Lot #9NR816.
MANUFACTURER Fresenius Medical Care, North America, CD Reynosa Tamps, Mexico.
RECALLED BY Fresenius USA Manufacturing, Inc., Lexington, Massachusetts
DISTRIBUTION Arkansas, Arizona, Kansas, Indiana, Louisiana, Michigan, New York, Oregon, Pennsylvania, Texas, Utah.
QUANTITY 61 units.
REASON Outer case label has extended expiration date.

MEDICAL DEVICE SAFETY ALERT:

PRODUCT Endopath ETS45 Endoscopic Linear Cutter, used in general, gynecologic, thoracic, and urologic surgery to deliver staples while simultaneously dividing tissue between rows.
CODE All Endoscopic Linear Cutters, Model ETS45, manufactured since January 1999.
MANUFACTURER Ethicon Endo-Surgery, Inc, Cincinnati, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 49,163 units.
REASON Surgeons are using the device for tissue thickness beyond the specified range.
 

CODE All devices with serial numbers less than 9C12980*, with the following exceptions:
9C12261 T 9C12596 T 9C12605 T 9C12825 T 9C12928 T 9C12955 T 9C12273 T 9C12597 T 9C12608 T 9C12827 T
9C12929 T 9C12956 T 9C12275 T 9C12598 T 9C12609 T 9C12831 T 9C12930 T 9C12957 T 9C12276 T 9C12599 T
9C12610 T 9C12832 T 9C12931 T 9C12958 T 9C12490 T 9C12600 T 9C12611 T 9C12894 T 9C12932 T 9C12567 T
9C12601 T 9C12762 T 9C12895 T 9C12953 T 9C12595 T 9C12604 T 9C12823 T 9C12898 T 9C12954 T
* The last character is an Alpha character and is not part of the serial number sequence.
MANUFACTURER Guidant Corporation, Cardiac & Vascular Surgery Group, Menlo Park, California.
QUANTITY 287 units.
 

WEEK ENDING JANUARY 28

PRODUCT Toshiba Powervision 6000 Diagnostic Ultrasound Device.
CODE Model Number SSA-37OA. Only those units which have the optional equipment of the wheel casters (Part #UZCK-370A) are being recalled.
MANUFACTURER Toshiba Corporation, Otawara-Shi, Tochigi-Ken, Japan.
RECALLED BY Toshiba America Medical Systems, Inc., Tustin, California
DISTRIBUTION Nationwide.
QUANTITY 60 units were distributed.
REASON The wheel caster welds can fail causing the caster to fall off, resulting in the machine tilting and/or falling.

PRODUCT VasoSeal ES (tm) (Extravascular Security) Device Sterile-Nonpyrogenic.
CODE Code: 06309241; Expiration Date: 07-01 Sterilization Date: 07-99; Catalog No. 76000.
MANUFACTURER Datascope, Collagen products Division, Montvale, New Jersey.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,165 devices were distributed; firm estimates none remains on the market.
REASON Some units may contain out of specification locator components.