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
11/10/1993
Recalls and Field Corrections: Foods -- Class I -- 11/10/1993
November 10, 1993 93-45
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT Fresh ready-to-eat cooked crabmeat in 1 pound plastic
containers: (a) Special Crabmeat; (b) Lump Crabmeat.
Recall #F-051/052-4.
CODE None. All crabmeat processed during the period of 8/11/93-
9/10/93.
MANUFACTURER Simonson Seafood Ltd., Warsaw, Virginia.
RECALLED BY Manufacturer, by telephone August 31, 1993 and September
24, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Virginia.
QUANTITY Firm estimates none remains on the market.
REASON Products are contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Nectarines, fresh, raw, US Grades No. 1 and No. 2, packed
in 20 pound cardboard boxes. Recall #F-533-3.
CODE 0817 EOO G 32.
MANUFACTURER Ray Beauleaurer, Beauleaurer Farms, Grandview, Washington
(Grower).
RECALLED BY E.W. Brandt & Sons, Wapato, Washington, by telephone August
31, 1993. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 50 boxes.
REASON Product contained illegal residues of Dimethoate.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Dressings and condiments:
(a) Salad Dressing, in 1 gallon plastic jars;
(b) Lite Salad Dressing, in 32 ounce glass jars;
(c) Tarter Sauce, in 8 ounce glass jars and in 1 gallon
plastic jars;
(d) Cole Slaw Dressing, in 1 gallon plastic jars;
(e) Thousand Island Dressing, in 1 gallon plastic jars;
(f) Ollie Sauce, in 1 gallon plastic jars;
(g) Burger Tarter Sauce, in 8 ounce glass jars.
Recall #F-006/012-4.
CODE Lot numbers: (a) S3522, S3532, S3562, S3572, S3642, S0043,
S0053, S0063, S0083, S0263, S0323;
(b) S0153; (c) S0043; (d) S0063; (e) S3532; (f) S3582,
S0213; (g) S0063.
MANUFACTURER Silver Foods, Corporation, Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone on or around January 1993 -
February 1993. Firm-initiated recall complete.
DISTRIBUTION Illinois, Ohio, Kentucky, Virginia, California, Wisconsin,
Tennessee.
QUANTITY 3,736 cases were distributed; firm estimates none remains
on the market.
REASON Products were contaminated with mold and yeast.
_______________
PRODUCT "Astro for Bison" Lowfat Yogurt and Apple Crisp Granola, in
4.4 ounce plastic containers. Recall #F-013-4.
CODE All code dates up to and including SEP 1 93.
MANUFACTURER Bison Foods Company, Buffalo, New York.
RECALLED BY Manufacturer, by letter dated July 26, 1993, followed by
telephone. Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania, New Jersey, Maryland, Vermont.
QUANTITY 1,808 cases were distributed; firm estimates none remains
on the market.
REASON Product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Atenolol with Chlorthalidone Tablets, 50 mg/25 mg, Rx used
as a combination antihypertensive/diuretic, packaged in
bottles of 100. Recall #D-018-4.
CODE Lot numbers: 25322 EXP 7/95 (Rugby & Mutual), 25323 EXP
7/95 (Mutual, URL & Geneva), 25324 EXP 7/95 (URL, Goldline,
Mutual).
MANUFACTURER Mutual Pharmaceutical Company, Inc., Philadelphia,
Pennsylvania.
-2- RECALLED BY Manufacturer, by letter September 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Lot #25322 -- 1,662 bottles (Rugby), 1,675 bottles
(Mutual); Lot #25323 -- 352 bottles (Mutual), 144 bottles
(URL), 4,320 bottles (Geneva); Lot #25324 -- 288 bottles
(URL), 49 bottles (Goldline), 809 bottles (Mutual).
REASON Product does not meet disintegration specifications.
_______________
PRODUCT Compressed Medical Oxygen, USP, in size E cylinders.
Recall #D-019-4.
CODE 12 cylinders without lot numbers. 11 with the following
serial numbers and one cylinder with an unknown serial
number:
Serial Number Hydrostatic Testing Date
0191A021852 12/16/92
0191A0221819 12/16/92
16694 12/16/92
0890A017230 12/16/92
0191A021903 12/16/92
15642 2/01/93
6293A060712 3/22/93
15015D 7/15/93
0011042 8/09/93
0293A060706 8/25/93
IT5647 9/03/93.
MANUFACTURER County Health Services, Inc., doing business as American
Medical Equipment (AME), Georgetown, Texas.
RECALLED BY Manufacturer, by visit between September 22-28, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Texas.
QUANTITY Firm estimates none remains on the market.
REASON Current good manufacturer practice deficiencies.
_______________
PRODUCT Lacrisert, a sterile Rx 5 mg Hydroxypropyl Cellulose
Ophthalmic Insert and Applicator, indicated in patients
with moderate to severe dry eye syndromes. Recall #D-020-
4.
CODE Lot #W0213.
MANUFACTURER Merck Manufacturing Division, Division of Merck & Company,
Inc., West Point, Pennsylvania.
RECALLED BY Manufacturer, by letters beginning November 4, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,077 units were distributed; firm estimates that very
little if any of the product remains on the market.
REASON Lack of assurance of sterility.
-3- _______________
PRODUCT Cortisone Acetate Tablets USP, 10 mg and 25 mg, in bottles
of 100, used as replacement therapy in adrenocortical
deficiency states. Recall #D-021/022-4.
CODE Lot numbers: 982DF, 733HS (10 mg); 561FD, 616HJ, 535DW
(25 mg).
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letters December 4, 1992 and November 8,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 29,790 bottles of lot numbers 982DF, 733HS, 561FD and 616HJ
and 14,539 bottles of lot numbers 535DW were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Olympus PK 7100 Data Diskettes, used to store data from the
hard drive of the Olympus PK 7100 Automated Pretransfusion
Blood Testing System. Recall #B-032-4.
CODE Catalog #ZM0472; Lot P111.
MANUFACTURER Formats Unlimited, East Farmingdale, New York.
RECALLED BY Olympus America, Inc., Lake Success, New York, by letter
June 2, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 46 diskettes.
REASON Diskettes were defective.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-034/036-4.
CODE Unit #04K34211.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letter September 24, 1992. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Software programs: (a) UPS Version 10.22 DOS; (b) Unix
Systems, used for the re-entering of catheter description
points in the Nucletron Planning System.
Recall #Z-046/047-4.
CODE All Nucletron Planning Systems.
MANUFACTURER Nucletron B.V., Waardegelder 1, The Netherlands.
-4- RECALLED BY Nucletron Corporation, Columbia, Maryland, by sending
Technical Notes to all NPS users on October 15, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Brazil, Canada, West Indies.
QUANTITY 231 units.
REASON In a situation with implants of two or more cathetrs, an
error situation can occur when the catheters are described
with catheter description points.
_______________
PRODUCT Adams Compact II Centrifuge, distributed as a Primary Care
Diagnostic product and through several private label
distributors and clinical laboratories which include:
(a) Catalog #0225 - Becton Dickinson
(b) Catalog #0226 - Allied Clinical Laboratories
(c) Catalog #0230 - Methpath
(d) Catalog #0231 - Roche
(e) Catalog #0232 - Damon Clinical Laboratories
(f) Catalog #0234 - Mawd Medical Laboratories
(g) Catalog #0236 - Eastside Medical Laboratories
(h) Catalog #0237 - Laboratory of Clinical Medicine
(i) Catalog #0238 - Metwest Clinical Laboratories
(j) Catalog #0239 - Clinical Diagnostic Services.
Recall #Z-064/073-4.
CODE Serial numbers: 25101 through 262348.
MANUFACTURER Becton Dickinson, Sparks, Maryland.
RECALLED BY Manufacturer, by letter March 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 13,177 units were distributed; firm estimates
2,215 units remain on the market.
REASON Under certain operating conditions, the rotating tube
shields may contact the wiring within the housing resulting
in abraded insulation or exposed wires.
_______________
UPDATE Dilipan Hygroscopic Cervical Dilator, listed in the
November 3, 1993 Enforcement Report should read Recall #Z-
035-4.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Dermatology laser systems:
(a) Candela SPTL-1a Dermatology Laser System (P/N
9904-10-0300/0302); Candela SPTL-1aG (Germany) Dermatology
Laser System (P/N 9904-10-0302);
(b) Candela SPTL IEC Dermatology Laser System (P/N
9904-0010-0250). Recall #Z-018/019-4.
CODE (a) SPTL-1a (9904-10-0300), Serial Nos. 2106, 2219,
2220, 3109-3149, 3151-3164, 3167, & 3169
SPTL-1aG (Germany) (9904-10-0302), Serial Nos.
3150, 3165, 3166, 3168, 3170, 3171, 3173, 3174;
-5- (b) SPTL IEC (9904-10-0250), Serial Nos. 2217,
2244-2267, 2269-2290.
MANUFACTURER Candela Laser Corporation, Wayland, Massachusetts.
RECALLED BY Manufacturer, by letter March 17, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 64 units; (b) 54 units.
REASON The design allowed for possible internal fires.
_______________
PRODUCT Techmate 1000, an automated immunostaining system for
tissue samples placed on microscope slides.
Recall #Z-061-4.
CODE All serial numbers are prefixed with alphabetic code TMR
followed by 10001, 10006-13, 10015-25, 10027-33, 10035-43.
MANUFACTURER Biotek Instruments Inc., Santa Barbara, California.
RECALLED BY Manufacturer, by letter dated June 24, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION California, Colorado, Connecticut, Illinois, Massachusetts,
Maryland, Michigan, Minnesota, North Carolina, New Jersey,
New York, Ohio, Oregon, Pennsylvania, Texas, Washington,
Vermont, District of Columbia.
QUANTITY 40 units.
REASON The device's mechanical arm will stop after the failure of
an electronic component which senses the position of the
mechanical arm. The component failure is caused by an
improperly designed resistor.
_______________
PRODUCT Bioscan Reagent Strips Dip and Read Test for measuring
glucose, ketone, bilirubin, protein, pH and blood in urine,
in bottles each holding 100 test strips. Recall #Z-062-4.
CODE Lot 28202.
MANUFACTURER Yeong Dong Pharmaceutical Corporation, Seoul, Korea.
RECALLED BY Dia-Screen Corporation, Minneapolis, Minnesota, by letter
September 20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Michigan, Ohio.
QUANTITY 120 bottles.
REASON The test strips are not detecting blood urine in the
specified time. The test strips are intended to detect 5-
15 blood cells per microliter one minute after being dipped
in a positive urine sample.
_______________
PRODUCT Ortho brand, Round Bottom, MRC-5 Human Embryonic Lung
(Diploid) Cell Culture tubes, used for the isolation of
infectious agents and as an indicator system for the
presence of toxins. Recall #Z-063-4.
CODE Product #505050, lot #063050 EXP 7/29/93.
MANUFACTURER Ortho Diagnostic Systems, Inc., Carpinteria, California.
RECALLED BY Manufacturer, by telephone on June 28 & 29, 1993. Firm-
initiated recall complete.
-6- DISTRIBUTION California, Connecticut, Illinois, Maine, Missouri, New
Jersey, New York, Ohio, Oklahoma, Oregon.
QUANTITY 1,995 tubes were distributed; firm estimates none remains
on the market.
REASON Tubes are contaminated with the organism Xanthonas
(pseudomonas) Maltophilia which causes the device not to
function as designed.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Acufex Orthopedic Screwdrivers:
(a) Part #013108, 7 mm Cannulated Driver, Large Handle;
(b) Part #013109, 9 mm Cannulated Driver, Large Handle;
(c) Part #013426, 7 mm Cannulated Driver, Small Handle;
(d) Part #013427, 9 mm Cannulated Driver, Small Handle.
Safety Alert #N-063/064-3 & N-087/088-3.
CODE Lot numbers: (a) LCN 591, LCN 691, LCN 791, LCN 891, LCN 991, LCN
1091, LCN 1191, LCN 1291, LCN 1391, LCN 192, LCN 292, LCN 392, LCN
492, LCN 592, LCN 692, LCN 792, LCN 892, LCN 992, LCN 1092, LCN 1192,
LCN 1292, LCN 1392, LCN 1492.
(b) LCN 391, LCN 491, LCN 591, LCN 691, LCN 791, LCN 891, LCN 192, LCN
292, LCN 392, LCN 492, LCN 592, LCN 692, LCN 792, LCN 892; (c) LCN
491, LCN 591, LCN 691, LCN 791, LCN 891, LCN 991, LCN 1091, LCN 192,
LCN 292, LCN 392, LCN 492, LCN 592, LCN 692, LCN 792, LCN 892, LCN
992, LCN 1092, LCN 1192, LCN 1292, LCN 1392, LCN 1492, LCN 1592, LCN
1692, LCN 1792; (d) LCN 491, LCN 591, LCN 691, LCN 791, LCN 192, LCN
292, LCN 392, LCN 492, LCN 592, LCN 692, LCN 792, LCN 892, LCN 992,
LCN 1092, LCN 1192.
MANUFACTURER Acufex Microsurgical, Inc., Mansfield, Massachusetts.
ALERTED BY Manufacturer, by letter dated October 15, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 1,235 units; (b) 793 units; (c) 734 units; (d) 454.
REASON There is a potential for tip breakage.
SEIZURE:
==================================================================
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PRODUCT Pickled gouramy fish (93-683-331).
CHARGES Adulterated - The article consists in part of a filthy substance by
reason of the presence therein of insects, and rodent, human, and
cat/dog hair.
FIRM Cathay Company, Los Angeles, California.
FILED October 21, 1993; U.S. District Court for the Central District of
California: Civil #93-6380LBG; FDC #66788.
SEIZED November 2, 1993 - goods valued at approximately $25,000.
-7-
END OF ENFORCEMENT REPORT FOR NOVEMBER 10, 1993. BLANK PAGES MAY
FOLLOW.
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