FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
04/14/1993
Recalls and Field Corrections: Foods -- Class II -- 04/14/1993
ENFORCEMENT REPORT FOR APRIL 14, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Vitamin B 6 Sustained Release Tablets, 500 mg, in bottles
of 30, 60, and 400, under the following labels:
DC #56 Sustain B-6, formulated for Dee Cee Laboratories,
and Doctors Weight Loss Sustain B-6. Recall #F-272-3.
CODE Lot numbers: 02010, 08033, 03010, 10023.
MANUFACTURER Rasi Laboratories, Inc., North Brunswick, New Jersey.
RECALLED BY Dee Cee Laboratories, Inc., White House, Tennessee, by
letter and by telephone February 8, 1993, Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 300,000 tablets were distributed; firm
estimates 49,390 tablets remain on the market.
REASON The product contains 25,000 times the Recommended Dietary
Allowance for vitamin B-6 which poses a potential to cause
neurological injury to persons consuming these tablets on a
regular basis.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Delflex brand Peritoneal Dialysis Solution, USP, 2.5%
Dextrose, 2,000 ml, a Rx drug used for the treatment of
problems associated with kidney disorders.
Recall #D-205-3.
CODE Lot #07-067-2K EXP 4/94.
MANUFACTURER Fresenius USA, Inc., Ogden, Utah.
RECALLED BY Freenius USA, Inc., Walnut Creek, California, by telephone
March 10, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 742 bags were distributed.
REASON Some labels incorrectly declared dextrose content as 1.5%
instead of 2.5%.
PRODUCT (a) Diazepam Injection, USP, 5 mg/ml, in 10 ml amber glass
vials, Rx, for intravenous or intramuscular use;
(b) Cyanocobalamin Injection, 1000 mcg/ml, in 10 ml amber
glass vials, Rx, for intramuscular or deep subcutaneous
use. Recall #D-208/209-3.
CODE Lot numbers: (a) 92D640, 92G910, 92H410; (b) 92A590,
92F840.
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Manufacturer, by telephone February 19, 1992, followed by
letter February 26, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 3,970 units; (b) 4,511 vials were distributed.
REASON Some correctly labeled vials of each product may be found
in unit cartons labeled as the other product.
PRODUCT Aluminum Hydroxide Gel, Magnesium Hydroxide and Simethicone
Suspension, double strength, in 5 fluid ounce white plastic
bottles, labeled as: Nu-Med Double Strength Antacid Anti-
Gas, an OTC liquid antacid. Recall #D-210-3.
CODE All lots starting with 1B, 1C, 1D, 1G, 1H, 1J.
MANUFACTURER MAS Laboratories, Inc., East Windsor, New Jersey.
RECALLED BY Manufacturer, by letter dated November 25, 1992. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 11,826 cases were distributed.
REASON Microbial contamination and non-uniform suspension.
PRODUCT (a) Nitrous Oxide Cylinders; (b) Carbon Dioxide Cylinders,
both size E. Recall #D-212/213-3.
CODE Lot numbers: (a) LMB 093G EXP 2/98; (b) LMB 093A EXP 2/98.
MANUFACTURER Liquid Carbonic Specialty Gas Corporation, Lemoyne,
Pennsylvania.
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RECALLED BY Manufacturer, by telephone February 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 16 cylinders were distributed; firm estimates none remains
on the market.
REASON Cylinders were overfilled.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Dicyclomine HCl Tablets, USP, 20 mg, used for the treatment
of functional bowel/irritable bowel syndrome, and for
relieving smooth muscle spasms of the gastrointestinal
tract. Recall #D-203-3.
CODE Lot numbers: 1516-009 EXP 7/93, 1516-010 EXP 7/93.
MANUFACTURER Barr Laboratories, Pomona, New York.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by letter dated
March 17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,125 boxes of 100 blister packs were distributed.
REASON Small degree of superpotency.
PRODUCT Minute Rinse, Sodium Fluoride Oral Mouth Rinse, 0.2% NaF
Dental Solution, in 10 ml packs, 300/10 ml packs per case,
a clear-colored liquid OTC product. Recall #D-204-3.
CODE Lot numbers: 921013, 921014, 921015, 921016, 921018,
921019, 921022, 921023, 921026, 921027, 921028, 92108,
921030, 921002, 921005, 921006, 921109, 921112, 921113,
921116, 921117, 921118, 921119, 921120, 921121, 921123,
921124, 921127, 921201, 921202, 921203, 921204, 122292,
129224, 921228, 921229, 921230, 921231, 930104, 920105,
930106, 930107, 010893, 11193.
All of the above referenced lots were manufactured after
10/5/92.
MANUFACTURER Minute Rinse Labs, Inc., Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated March 29, 1993. Firm-
initiated field correction ongoing.
DISTRIBUTION Kentucky.
QUANTITY 9,155 cases (300 packs per case) were distributed.
REASON Presence of mold.
PRODUCT Cephalexin for Oral Suspension USP, 125 mg/5 ml and 250
mg/5 ml strengths; packaged in 100 ml and 200 ml bottles,
an Rx oral semisynthetic cephalosporin antibiotic for the
treatment of infections when caused by susceptible strains
of Streptococcus and Staphylococcus microorganisms,
distributed under the following labels:
(a) 125 mg/5 ml --
(i) Novopharm, manufactured for Novopharm Inc., Schaumburg,
IL, 100ml;
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(ii) Aligen, distributed by Aligen Independent
Laboratories, Inc., Jackson, Wyoming, 100 ml and 200 ml;
(iii) Biocef, distributed by International Ethical Labs,
Inc., Rio Piedras, PR, 100 ml;
(iv) Danbury, distributed by Danbury Pharmacal Inc.,
Danbury, CT, 100 ml and 200 ml;
(v) GG (Geneva Generics), distributed by Geneva
Pharmaceuticals, Inc., Broomfield, CO, 100 ml and 200 ml;
(vi) Schein, manufactured for Schein Pharmaceutical, Inc.,
Port Washington, NY, 100 ml and 200 ml;
(vii) Seyer, distributed by Seyer Pharmacal, San Juan, PR
100 ml;
(viii) URL, distributed by United Research Laboratories,
Inc., Bensalem, PA, 100 ml and 200 ml;
(b) 250 mg/5 ml --
(i) Novopharm, manufactured for Novopharm Inc.,
Schaumburg, IL, 100 ml;
(ii) Genetco, distributed by Genetco Inc., RonKonKoma, NY;
100 ml;
(iii) GG (Geneva Generics), distributed by Geneva
Pharmaceuticals, Inc., Broomfield, CO, 100 ml,
(iv) Schein, manufactured for Schein Pharmaceutical, Inc.,
Port Washington, NY; 100 ml and 200 ml;
(v) URL, distributed by United Research Laboratories, Inc.,
Bensalem, PA; 100 ml and 200 ml. Recall #D-206/207-3.
CODE (a) 100 ml: 1500140, 1500240, 1597340, 1597440
200 ml: 1500153, 1595453, 1597453;
(b) 100 ml: 0791240, 0791340, 0791440;
200 ml: 0791253.
MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada
RECALLED BY Novopharm Inc., Schaumburg, Illinois (distributor), by
letters dated March 29, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY (a) 20,059 100-ml and 4,193 200-ml bottles; (b) 17,506 100-
ml bottles and 2,181 200-ml bottles were distributed; firm
estimates little, if any, remains on the market.
REASON Sodium benzoate preservative found below ANDA
specification.
PRODUCT Atrovent (Ifratropium bromide) Inhalation Aerosol, supplied
as a metered dose inhaler in a pressurized aerosol
canister, a Rx bronchodilator. Recall #D-211-3.
CODE Lot #920632A.
MANUFACTURER 3M Health Care Specialties Division, St. Paul, Minnesota.
RECALLED BY Boehringer Ingleheim Pharmaceuticals, Inc., Ridgefield,
Connecticut, by letter February 11, 1993. Firm-initiated
field correction comnplete.
DISTRIBUTION Nationwide.
QUANTITY 75,155 canisters were distributed; firm estimates none
remains on the market.
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REASON Shrink wrap label incorrectly declares expiration date of
4/92 instead of 4/94.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Diphtheria and Tetanus Toxoids Adsorbed;
(b) Tetanus and Diphtheria Toxoids Adsorbed for Adult use;
(c) Tetanus Toxoid; (d) Tetanus Toxoid Adsorbed;
(e) Tuberculin, Purified Protein Derivative, Mantoux;
(f) Tuberculin, Purified Protein Derivative, Multiple
Puncture Device. Recall #B-206/211-3.
CODE All lots distributed since 1/1/91.
MANUFACTURER Sclavo, Inc., Siena, Italy.
RECALLED BY Sclavo, Inc., Wayne, New Jersey, by letter September 30,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Virgin Islands, Guam, Palau, Marshall Islands,
Commonwealth of Northern Marana Islands, and Federated
States of Micronesia.
QUANTITY (a) 73,426 vials; (b) 355,001 vials; (c) 6,245 vials;
(d) 140,432 vials; (e) 244,359 vials;
(f) 171,362 vials.
REASON Lack of assurances that products were manufactured in
accordance with the specifications contained in the license
applications.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-218/220-3.
CODE Unit numbers: (a) 14F43159; (b) 14F43159; (c) 14S00283.
MANUFACTURER American Red Cross Blood Service, Yakima, Washington.
RECALLED BY Manufacturer, by letters of June 3 and 11, 1992. Firm-
initiated recall complete.
DISTRIBUTION Florida, Washington state, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested non-reactive for all required
or recommended tests but were collected from donors who 1)
previously tested repeatedly reactive for anti-HIV-1/2; or
2) had an exposure to hepatitis less than 12 months prior
to the donation, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Ortho Coombs Control Reagent Red Blood Cells, in 10 ml
vials. Recall #B-221-3.
CODE Lot #K209.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter October 19, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
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QUANTITY 1,207 vials.
REASON Reagent Red Blood Cells which were found to be hemolyzed
were distributed.
RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS II
PRODUCT BLD PEEP-FLO Positive End Expiratory Pressure Valves, a
non-sterile, single patient use, Rx device designed to
adapt to the LDS Cushion-Flex face mask and the LDS
Pulmanex pulmonary manual resuscitator. Recall #Z-409-3.
CODE Lot #301039.
MANUFACTURER Bird Life Design (BLD) formerly Life Design Systems,
Carrollton, Texas.
RECALLED BY Manufacturer, by letter dated February 10, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 730 units were distributed.
REASON The valve is not adjustable in the lower ranges when used
in the CPAP applications, due to the presence of flash on
the device.
PRODUCT Adult Ground Pad, a single-use disposable, pre-gelled
electrosurgical dispersive electrode with attached cable
that is used during procedures requiring monopolar instru-
mentation. Recall #Z-429-3.
CODE Catalog #809855, lot numbers: 176720, 176720A, 176720B,
179220A.
MANUFACTURER MPI Dupaco, Oceanside, California.
RECALLED BY Weck, Research Triangle Park, North Carolina, by letter
October 16, 1992 and December 15, 1992, followed by
telephone January 28, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm-estimates none remains on the market.
REASON Glue pad may have dried out and may not adhere to the
patient.
PRODUCT Cordis 3.5 Orion Steerable Percutaneous Transluminal
Coronary Angioplasty (PTCA) Balloon Catheters, Catalog
numbers: (a) 515-435 (short); (b) 525-435 (standard); (c)
525-435S (soft). Recall #Z-430/432-3.
CODE Lot numbers 410990XXX and higher.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
RECALLED BY Manufacturer, by written notice dated September 6, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Colombia, Hong Kong.
QUANTITY 825 units were distributed.
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REASON Incorrect version of the instructions for use may lead to
over-inflation of the balloon.
PRODUCT Electrocardiograph electrodes:
(a) Electro Blue Adult Vinyl ECG, Catalog Nos: AV301,
AV303, AV305, AV310;
(b) United Medical Unitrace Ag Adult Vinyl ECG;
(c) Electro Blue Adult Foam ECG, Catalog Nos: AF301,
AF303, AF310, AF330;
(d) ABCO Adult Foam ECG, Catalog Nos: 104303, 104330;
(e) Electro Blue Adult Cloth ECG, Catalog #AC301, AC303,
AC305, AC330;
(f) ABCO Adult Cloth ECG, Catalog #106303.
Recall #Z-433/435-3.
CODE Lot numbers: (a) JJ2G06, JJ2F03; (b) AR1G13;
(c) JJ2F10, JJ2G16; (d) BZ2G1; (e) JJ2F26;
(f) BZ2F26.
MANUFACTURER Labeltape Meditect, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by telephone beginning November 6, 1992, and
by letter Dated November 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 89,200 units of lot AR2G13; 60,300 units of lot JJ2G06;
195,000 units of lot JJ2F03; 195,713 units of lot JJ2F10;
120,000 units of lot JJ2G16; 67,725 units of lot BZ2G21;
108,526 units of lots JJ2F26 and BZ2F26 were distributed.
REASON Corrosion of the metal stud results in wandering baseline
tendencies and direct current offset voltage.
PRODUCT Low Angle Laser Light Scattering Unit, Model PL-LALA, used
for measurment of scattering of light. Recall #Z-436-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Otsuko Electronics (USA), Inc., Ft. Collins, Colorado.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 15, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION California and Massachusetts.
QUANTITY 2 units were distributed.
REASON Noncompliance with performance standards for laser products
in that the levels of laser light emitted through the
incorporated telescope exceeds the specified emission limit
of 0.20uW.
PRODUCT Model 700 Intra-Aortic Balloon Pump with Recorder.
Recall #Z-437-2.
CODE All Model 700 IABP control systems with built-in recorders.
MANUFACTURER Belmot Instruments Corporation, Billerica, Massachusetts.
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RECALLED BY St. Jude Medical, Cardiac Assist Division, Chelmsford,
Massachusetts, by letters dated January 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 288 units were distributed.
REASON The monitor may fail to turn on, resulting in the screen
remaining blank due to a capacitor retaining an excessive
charge after the system has been turned off.
PRODUCT Acoma OTS Overhead Tube Support, a fully counter-balanced
radiographic x-ray tube suspension system used in the above
table radiographic systems. Recall #Z-438-3.
CODE Serial #05011192010, 05011192011, 05011192012, 05011192013,
05011192014, 05011292003, 05011292004, 05011292005,
05011292006, 05011292007.
MANUFACTURER Panel Manufacturing Inc., Addison, Illinois (component).
RECALLED BY Acoma Medical Imaging Inc., Wheeling, Illinois, by
telephone January 9, 1993, followed by fax. Firm-initiated
field correction complete.
DISTRIBUTION Wyoming, Nebraska, Florida.
QUANTITY 10 units were distributed.
REASON A potential welding defect in the bottom tube of the center
section of the OTS could result in the unit falling.
PRODUCT Medic 4 Defibrillator, a portable emergency system designed
to serve the hospital, clinic or physician's office.
Recall #Z-439-3.
CODE 25960, 25961, 25963, 25964, 25966, 25967-25970,
25981-25988, 25990-25992, 25994, 26001, 26006, 26010,
26011, 26041, 26042, 26044-26049, 26054, 26055.
MANUFACTURER Burdick, Inc., Milton, Wisconsin.
RECALLED BY Manufacturer, by verbal instructions January 25, 1993, and
by memorandum January 27, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION California, Florida, Indiana, Louisiana, Maryland,
Minnesota, North Carolina, New York, Ohio, Pennsylvania,
Rhode Island, Tennessee, Texas, Virginia, international.
QUANTITY 35 units were distributed.
REASON Defibrillator failure could be caused by an incorrect type
of capacitor.
PRODUCT AVI Model 220 Standard IV Administration Set.
Recall #Z-447-3.
CODE Lot #AUG92E05.
MANUFACTURER LeiLei Medical, Taipei, Taiwan.
RECALLED BY 3M Infusion Therapy, Arden Hills, Minnesota, by letter
March 8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Florida, Georgia, Illinois, Indiana,
Massachusetts, Minnesota, Missouri, New York, Ohio, Texas.
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QUANTITY 288 cases (40 sets per case) were distributed.REASON
A defect at the tubing to lower y-site connection and/or
the tubing to luer lock connection may cause leakage.
PRODUCT Hawaiian Haze, Floridian and Quality brand Ultraviolet
Sunlamps. Recall #Z-448-3.
CODE None.
MANUFACTURER Quality Lamp, Inc., Canton, Ohio.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan November 18, 1992. Firm-initiated field correction
ongoing.
DISTRIBUTION Ohio, South Carolina.
QUANTITY 7,318 units were distributed
REASON Noncompliance with the performance standards for sunlamp
products in that no initial or model change reports were
submitted for the products, the firm issued certification
which is not based on a test as required, and the firm did
not maintain adequate records of results of tests for
electronic product radiation safety.
PRODUCT Sarns Aortic Arch Cannula, various part numbers:
(a) Aortic Arch Cannula;
(b) Left Heart Vent Catheter;
(c) Vent Catheter; (d) Venous Return Catheter;
(e) High Flow Aortic Arch Cannula;
(f) Two Stage Venous Return Catheter;
(g) D4 Aortic Arch Cannula;
(h) Intracardiac Suckers; (i) Temperature Probe Connector;
(j) Venoatrial Catheter. Recall #Z-449/458-3.
CODE Lot numbers: (a) M156190;(b) M153100; (c) M148940;
(d) M153050, M130750, M154050, M154030;
(e) M158950, M131560, N122260, M156100, M151340;
(f) M153120, M158550; (g) M137560, M158750, M137460,
M158770; (h) M158930, M153110, M156090;
(i) M133950, M137350; (j) M158730.
MANUFACTURER Sarns3/M, Inc., Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter October 13, 1992, and by telephone
October 13-15, 1992. Firm-initiated recall ongoing
DISTRIBUTION Nationwide, Japan, Italy, Scotland, Australia, Taiwan.
QUANTITY 1,648 cases (20 units per case) were distributed.
REASON Nine individual bags (half Tyvek, half Polymylar) from this
lot were found with an open Sarns-made seal, therefore,
rendering the devices unsterile.
PRODUCT T841 4-Towel Pack Sterile Surgical Pack, used during
surgery to cover instrument trays and for other
miscellaneous uses. Recall #Z-464-3.
CODE Lot #01-04-93-03-302.
MANUFACTURER Repack Surgical Enterprises, Inc., Denver, Colorado.
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RECALLED BY Manufacturer, by telephone, followed by visit January 7,
1993, and by letter dated February 2, 1993. Firm-initiated
recall complete.
DISTRIBUTION Colorado.
QUANTITY 239 units were distributed; firm estimates none remains on
the market.
REASON Customers reported that they had received a "wet Pack". A
wet pack is a sterilized pack that, when opened, moisture
is detected on the interior of the wrap, on the item, or in
the towel. (A wet pack does not necessarily mean that
there is a sterility or contamination problem).
PRODUCT MinOX V Pulse Oximeter, cutaneous oxygen monitor, used for
monitoring a patient's functional oxygen via cutaneous
measurement, (finger probe), attached to portable pulse-
oximeter or monitoring device. Recall #Z-465-3.
CODE Serial numbers: A-00028 through A01285 (manufactured at
subsidiary firm, Catalyst Research Systems, Owings Mills,
MD, now closed); A-000H92 through A666A93 were manufactured
by Mine Safety Appliance.
MANUFACTURER Mine Safety Appliance Company, Mars, Pennsylvania.
RECALLED BY Manufacturer, by letter March 8, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe.
QUANTITY Approximately 1,908 units were distributed.
REASON The sensor connector can become damaged and fracture,
causing failures.
PRODUCT Sarns MDX Battery Pack, Part #16345, used to supply power
to Sarns 115 volt equipment that is used for extracorporeal
circulation. Recall #Z-466-3.
CODE Serial numbers: 1001 and 1003-1037.
MANUFACTURER Sarns/3M, Inc., Ann Arbor, Michigan.
RECALLED BY Manufacturer, by memorandum dated October 26, 1992 and by
letter November 3, 1992. Firm-initiated field correction
ongoing.
DISTRIBUTION Domestic and foreign (Canada, Taiwan).
QUANTITY 36 units were distributed.
REASON A circuit breaker may trip into the off position which will
cause the unit to stop supplying power.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Sickle Cell Reagent Set, 100 test kits and 250 test kits,
under the following labels: Ampocor for Alpha Scientific;
MCA (MichClone) for Fisher Scientific; and Columbia for
Columbia Diagnostics. Recall #Z-341-3.
CODE Lot #2132 EXP 5/11/94.
MANUFACTURER MichClone Associates, Inc., Troy, Michigan.
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RECALLED BY Manufacturer, by telephone July 13, 1992, followed by
letter October 23, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Texas, Delaware, Pennsylvania.
QUANTITY 47 100-test kits and 4 250-test kits were distributed.
REASON The product may give false positive results.
PRODUCT 5 French Percutaneous Introducer Kit. Recall #Z-405-3.
CODE Product #0601410, Lot #36KC1470.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone, fax and letter February 18,
1993. Firm-initiated recall ongoing.
DISTRIBUTION West Virginia, Illinois, Wisconsin, Minnesota, California,
Louisiana, Michigan, Colorado.
QUANTITY 37 units were distributed.
REASON This lot contained 8 French introducers instead of the
labeled 5 French.
PRODUCT Linearity Test Kit for Accu-Chek II/IIM/III Systems, used
for testing linearity of "Accu-Chek" blood glucose monitor.
Recall #Z-428-3.
CODE Lot #47584 EXP 7/31/93.
MANUFACTURER Boehringer Mannheim Corporation, Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter March 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 720 kits were distributed.
REASON The test kit solutions may be contaminated, causing low
glucose recovery values.
PRODUCT Oscillating Vitrector, Model 12-01-01, also known as The
"VAC" (Vitreous Aspiration Cutter) with low temperature 6
volt motors, used in cataract eye surgery.
Recall #Z-467-3.
CODE Serial numbers: 141, 128, 100, 121A, 122A, 134, 117A, 102,
129, 120A, 127A, 130A. Only units distributed under the
Staar Surgical logo that have a low temp 6 motor are
affected.
MANUFACTURER B&B Medical Associates, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by correcting all returned VACS' with 6-volt
low temp motors and replacing them with 6-volt high temp
motors. Service records for the subject VACS' range from
January 1992 through September 1992. Firm-initiated recall
complete.
DISTRIBUTION Undetermined.
QUANTITY Approximately 12 to 15 units were distributed.
REASON The low temperature motors fail to function as intended
after high temperature autoclaving.
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MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Cobalt 60 Radiation Therapy Devices, used to treat cancer
patients:
(a) Eldorado Model 76; (b) Eldorado Model 78;
(c) Theratron Model 765; (d) Theratron Model 780;
(e) Theratron Model 780C; (f) Theratron Model 1000;
(g) Phoenix Model. Safety Alert #N-035/041-3.
CODE Serial numbers: (a) 003 and 005; (b) 002, 003, 008, 010,
013, 027, 028, 050, 051, 061, 063, 064, 902, 903;
(c) 007; (d) 003, 004, 005, 007, 008, 010, 011, 016, 017,
019, 021, 024, 026, 027, 028, 029, 033, 037, 040, 042, 049,
051, 052, 056, 057, 058, 059, 060, 064, 067, 068, 073, 074,
075, 082, 083, 086, 089, 097, 098, 101, 113, 114, 116,121,
127, 128, 129, 133, 136, 137, 143, 149, 150, 151, 160, 161,
177, 178, 179, 182, 190, 201, 215, 221, 226, 230, 232, 233,
234, 235, 236, 241, 249, 251, 252, 253, 262, 266, 275, 280,
284, 288, 293, 296, 298, 299, 302, 306, 307, 308, 311, 314,
315, 318, 322, 323, 326, 333, 334, 335, 336, 341, 343, 351,
359, 360, 366, 367, 375, 381, 386, 388, 395, 398, 399, 401,
402, 415, 417, 426, 428, 431, 433, R20, and one unit with
unknown serial number;
(e) 002, 009, 016, 020, 022, 024, 030, 032, 035, 036, 038,
043, 058, 072, 073, 074, 078, 082, 103;
(f) 001, 002, 004, 005, 007, 008, 010, 011, 012;
(g) 001, 003, 005, 008, 010, 012, 014, 017, 018, 020, 023,
032, 036.
MANUFACTURER Theratronics International, Ltd. (formerly Atomic Energy of
Canada, Ltd. (AECL)), Kanata, Ontario, Canada.
ALERTED BY Manufacturer, by User Bulletin CUB-92-12 dated July 14,
1992.
DISTRIBUTION Nationwide.
QUANTITY 185 units were distributed.
REASON User bulletin reminds users that the cord reel must be
replaced every five years as specified in the operator's
manual, contains the installation instructions set forth in
the maintenance manual and advises an improperly installed
cord reel could cause the cord reel to bind which may
result in a source return failure, therefore, the cord reel
or any other component of the source drawer drive
mechanism, must be performed by licensed source handlers.
PRODUCT Infusaid Implantable Infusion Pump:
(a) Model 400, Catalog #36263;
(b) Model M400 Dual Catheter, Catalog #36287;
(c) Model M400 Dual Catheter, Catalog #36328.
Safety Alert #N-042/044-3.
CODE Product distributed between December 21, 1991 through
October 7, 1991.
MANUFACTURER Infusaid, Inc., Norwwod, Massachusetts.
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ALERTED BY Manufacturer, by letter October 23, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 1,247 units were distributed.
REASON Labeling change to advise users not to administer
radiopaque dyes through the sideport.
PRODUCT Blood Cardioplegia Heat Exchanger, used for mixing, cooling
and delivery of oxygenated blood/cardioplegia solution at a
predetermined ratio. Safety Alert #N-045-3.
CODE Lot numbers: M552960, M552970, M562640, M562650, M575440,
M588240, M591920, M593510, M597180, M604670, M579700,
M609590, M585350. These were used in 61 different
products: B7085A, B7095A, B7100A, B7103A, M7112C,
B7114A,B7114B, B7115A, B7115B, B7120F, B7124A, B7127B,
B7132, B7135, B7144, B7159, B7160B, B7169, B7175, B7183,
B7191, B7195, B7197, B7200, B7206, B7207, B7209, B7213,
B7215A, B7216, B7217, B7220, B7222, B7224, B7226, B7228,
B7232, B7235, B7239, B7176, B7250, C8782A, C8821C, C8821D,
C8850B, C8850C, C8870, C8870A, C8870B, C8870C, C8889,
D1079E, D1080A, D1081A, D1082A, D1084A, D1085A, D1086A,
D1087A, P9756.
MANUFACTURER Electromedics, Inc., Englewood, Colorado.
ALERTED BY Manufacturer, by letter February 16, 1993.
DISTRIBUTION Nationwide.
QUANTITY 9,207 units were distributed.
REASON The devices may leak water around the safety vent hole on
the bottom portion of the device due to a crack in the
epoxy.
PRODUCT Infrasonics Microprocessor Infant Star Ventilators,
standard and high frequency models, enables a respiratory
care practitioner to provide a neonatal infant with
ventilatory assistance. Safety Alert #N-046-3.
CODE All units shipped from 1/85 to present.
MANUFACTURER Infrasonics, Inc., San Diego, California.
ALERTED BY Manufacturer, by letter February 19, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 4,500 units were distributed.
REASON Some Baxter breathing circuits with the Star Ventilators
impedes flow of ventilator gases which are detected as flow
restrictions and causes the alarm to go off.
PRODUCT Molded, High Density, Polycarbonate Resin Manifolds,
intended for use in Cardiac Catheterization Procedures, an
extension of the firm's January 27, 1993 Safety Alert which
only included 3-Port Manifolds:
(a) 1-Port Manifold, Catalog Nos. 300132, 300135, 300144,
300147, 310132, 310135, 310144, 310147;
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(b) 2-Port Manifold, Catalog Nos. 300000, 300001, 300002,
300003, 300100, 300101, 300102, 300103, 300148,
300149, 300150, 300151, 310100, 310101, 310102,
310103;
(c) 4-Port Manifold, Catalog Nos. 300112, 300113, 300114,
300115, 300160, 300161, 300162, 300163, 300184,
300185, 300186, 300187, 300190, 300191, 300192,
300193, 310112;
(d) 5-Port Manifold, Catalog Nos. 300118, 300119, 300120,
300121, 300166, 300167, 300168, 300169.
Safety Alert #N-047/050-3.
CODE Manifolds with lot numbers smaller than 011272.
MANUFACTURER L.O.N. Research, Inc., Sanford, Florida.
ALERTED BY Manufacturer, by letter February 18/19, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON These devices are subject to the same design problem as the
3-Port models. Subjecting the manifolds to a "back and
forth" or side-loading force could lead to the introduction
of air into the system which could lead to air embolism in
the patient.
SEIZURES:
PRODUCT White Glutinous Rice Flour (92-668-841).
CHARGE Adulterated - The article consists in part of a filthy
substance.
FIRM Viet Hoa Warehouse, Seattle, Washington.
FILED August 11, 1992 - U.S. District Court for the Western
District of Washington; Civil #C92-1274; FDC #66459.
SEIZED November 19, 1992; goods valued at approximately $6,500.
PRODUCT Ultratherm Fluid Warmer (93-657-112, et al.).
CHARGE Adulterated - The article is a class III device which does
not have in effect the required approved premarket approval
application, and the methods used in, and the facilities
and controls used for, its manufacture, packing, and
storage are not in conformity with current good
manufacturing practice regulations. Misbranded - The
article's labeling fails to bear adequate directions for
use for the purposes for which it is intended, and no
notice or other information was provided as required.
FIRM PMT Corporation, Chanhassen, Minnesota.
FILED March 4, 1993; U.S. District Court for the District of
Minnesota; Civil #4-93-220, FDC #66678.
SEIZED March 9, 1993 - goods valued at approximately $4,500.
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FOLLOW.