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
08/01/1995
ENFORCEMENT REPORT FOR 08/02/95
August 2, 1995 95-31
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Miniature Four Piece Silver Plated Coffee Set.
Recall #F-688-5.
CODE Style #5095A.
MANUFACTURER Jaunlet Industries, Ltd., Kowloon, People's Republic of
China.
RECALLED BY Godinger Silver Company, Ltd., Brooklyn, New York, by letter
dated April 16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Brazil, Argentina, Canada, Ecuador.
QUANTITY 33,000 sets were distributed.
REASON The products contain excessive levels of leachable lead.
_______________
PRODUCT Clumsy Bear (Mishka) - Wafer bar coated with chocolate.
Recall #F-704-5.
CODE None.
MANUFACTURER Golden Chocolate Company, Brooklyn, New York.
RECALLED BY Manufacturer, by telephone May 2 and 3, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 35 cartons were distributed.
REASON The product contains eggs and eggs are not listed as an
ingredient.
_______________
PRODUCT Alessi brand Basil Pesto Sauce, packaged in 3.5 ounce glass
jars. Recall #F-709-5.
CODE IIE 3Z14.
MANUFACTURER Formec Alimentari S.p.a., Milano, Italy.
RECALLED BY Vigo Importing Company, Inc., Tampa, Florida, by letter May
16, 1995, followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,500 cases (12 jars per case).
REASON Product contains peanuts, a potential allergen, which is not
declared on the label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Piccolo Peppers and Pepper Sorrento:
(a) Asti brand Pepper Salad Sorrento, in 11-1/2 ounce glass
jars; (b) Asti brand Anchovy Stuffed Piccolo Peppers, in 7
ounce glass jars; (c) Asti brand Sliced Hot Cherry Peppers
Sorrento, in 7 ounce glass jars. Recall #F-694/696-5.
CODE All lots produced prior to December 31, 1994.
MANUFACTURER Asti/Salvati Foods, Inc., formerly Pepes Inwood Packing
Company, Inc., Hicksville, New York.
RECALLED BY Manufacturer, by letters dated June 27, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Connecticut,
Massachusetts, Georgia, Florida.
QUANTITY (a) 1,718 jars; (b) 99 jars; (c) 1,550 jars were
distributed.
REASON Products contain undeclared FD&C Yellow No. 5 and Sodium
Benzoate.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Multivitamin Prenatal Tablets - multivitamin/multi-
supplement tablet containing calcium (calcium sulfate) 200
mg, packaged in bulk. Recall #F-684-5.
CODE Lot #4J27702; Code 1890F EXP 10/97.
MANUFACTURER Nutro Laboratories, Inc., South Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter dated February 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 150 bulk cartons each containing 15,000 tablets were
distributed.
REASON Product is mislabeled. Calcium 600 mg plus vitamin D
tablets were labeled as calcium 200mg tablets.
_______________
PRODUCT Land O'Lakes Lightly Salted Butter, in 1 pound cartons, 4
quarters per carton. Recall #F-685-5.
-2-
CODE Various. Pull dates: 9/21/92, 9/26/92, 10/3/92, 11/2/92,
11/12/92, 11/13/92, 11/23/92, 12/1/92, 12/11/92.
MANUFACTURER Madison Dairy Produce Company, Madison, Wisconsin;
Holly Milk Division of Atlantic Dairy Cooperative, Carlisle,
Pennsylvania.
RECALLED BY Land O' Lakes, Inc., Arden Hills, Minnesota, by letter,
telephone, and fax on July 24, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 828,792 pounds were distributed; firm estimates none remains
on the market.
REASON Product contained unapproved food colors (Red #2 and Red
#57:1).
_______________
PRODUCT Flavored Water in 12 ounce glass bottles, in the following
flavors: (a) Apple; (b) Cherry; (c) Peach; (d) Berry.
Recall #F-690/693-5.
CODE SR5111**** and SR5112**** ink jet stamped on bottle neck.
MANUFACTURER Talking Rain Beverage Company, Inc., Preston, Washington.
RECALLED BY Manufacturer, by fax June 5, 1995. Firm-initiated recall
complete.
DISTRIBUTION New York, Massachusetts, Missouri, Maryland, Illinois.
QUANTITY Approximately 5,000 cases (24 bottles per case) were
distributed.
REASON Product is contaminated with yeast.
_______________
PRODUCT Amino Acid L-Lysine 500 mg Tablets, in bottles of 100, a
protein used as a dietary supplement under the following
labels: Rugby, Happy Herman's, URL, Carlisle, Stay-Well
(Medi Mail). Recall #F-700-5.
CODE Lot #2701-4911 EXP 11/97.
MANUFACTURER Tishcon Corporation, Salisbury, Maryland.
RECALLED BY Tishcon Corporation, Westbury, New York, by letter May 31,
1995. Firm-initiated recall ongoing.
DISTRIBUTION New York, Georgia, Pennsylvania, Delaware, Nevada.
QUANTITY Approximately 2,502 bottles were distributed.
REASON The product, Amino Acid L-Lysine 500 mg tablet bottles,
contains Vitamin B6 tablets.
_______________
PRODUCT JBs Finest brand Shucked Clams; Clam Meat; and Clam Strips
in gallon containers, used for clam chowder.
Recall #F-701/703-5.
CODE NSSP certification and permit #7750SP, packed and/or shipped
from May 30, 1995 through June 16, 1995.
MANUFACTURER New Bedford Sea Clam, Inc., New Bedford, Massachusetts
(processor).
RECALLED BY Manufacturer, by telephone and letter June 15, 1995. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts, Rhode Island, New York.
-3-
QUANTITY 994 gallons.
REASON Product was prepared, packed and held under insanitary
conditions.
_______________
PRODUCT Minute Maid 100% Pure Orange Juice from Concentrate:
(a) Pure and Delicious in 64 ounce paper and 96 ounce
plastic containers;
(b) Country Style more juicy bits of orange in 64 ounce
paper containers;
(c) Pulp free no bits of pulp in 64 ounce paper and 96 ounce
plastic containers;
(d) With added calcium calcium rich as much calcium as
milk" in 64 ounce paper and 96 ounce plastic containers.
Recall #F-705/708-5.
CODE Pull date code JUL07.
MANUFACTURER Preston Products, Burkburnett, Texas.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visits beginning June
26, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Colorado, Kansas, Louisiana, Maryland, New Jersey,
Missouri, Mississippi, Oklahoma, Rhode Island, Tennessee,
Texas.
QUANTITY 7,158 cases (6 64-ounce containers) and 8,600 cases (6 96-
ounce containers) were distributed; firm estimates that only
a very small quantity remains on the market.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Chloromycetin Hydrocortisone Ophthalmic, supplied in a
package containing dry ingredients in a 5 ml vial and a 5 ml
vial of distilled water, Rx antibiotic/antiinflammatory.
Recall #D-213-5.
CODE Lot #024D2P, N 0071-3228-36 EXP 10/95.
MANUFACTURER Warner-Lambert Company, Parke-Davis, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, by letter December 2, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 15,737 vials were distributed.
REASON Associated water diluent does not meet stability
specifications.
_______________
PRODUCT 10 g Elase-Chloromycetin Ointment (Fibrinolysin and
Deoxyribonuclease Combined (Bovine) with Chloramphenicol
Ointment), indicated for use in the treatment of infected
lesions. Recall #D-214-5.
CODE Lot #6144, N 0071-4281-10 EXP 2/97.
MANUFACTURER Warner-Lambert Company, Parke-Davis, Rochester, Miami.
-4-
RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, by letter August 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Puerto Rico, The Virgin Islands, The Bahamas, Trinidad, The
Netherlands, Jamaica, St. Maarteen, Antigua, Antilles, West
Indies.
QUANTITY 33,898 units were distributed.
REASON Product does not meet stability specifications.
_______________
PRODUCT Surital (Thiamylal Sodium for Injection, USP), a
barbiturate, intravenous anesthetic agent: (a) 1 g in
packages of 25; (b) 5 g in packages of 10; (c) 10 g in
packages of 10. Recall #D-215/217-5.
CODE Lot numbers and EXP dates: (a) 04730P 11/94, 04350P 03/95,
056N9P 10/94, 035D9P 10/94, 05110P 11/94, 03430P 09/94;
(b) 037N1P 08/94, 03501P 07/94, 019D9P 10/94, 04210P 10/94,
03920P 11/94, 04250P 03/95;
(c) 038N1P 08/94, 020D9P 10/94, 04110P 10/94, 03820P 11/94,
02460P 11/94.
MANUFACTURER Warner-Lambert Company, Sterile Products Division,
Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, by letter August 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 11,451 units were distributed.
REASON Product does not meet stability specifications for potency.
_______________
PRODUCT Nitrostat Sublingual Tablets (nitroglycerin tablets, USP),
0.4 mg, in bottles of 25, indicated for the prophylaxis,
treatment and management of patients with angina pectoris.
Recall #D-218-5.
CODE Lot #05393F5 EXP 8/95.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plains, New Jersey, by letter July 18, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20,691 bottles were distributed.
REASON Product may not meet assay specification through the
expiration date.
_______________
PRODUCT Verapamil Hydrochloride Extended Release Tablets, 240 mg, in
bottles of 500, anti-hypertensive, under the Goldline label.
Recall #D-219-5.
CODE Lot #4I05521 EXP 9/96.
MANUFACTURER Baker Norton Pharmaceuticals, Miami, Florida.
RECALLED BY Manufacturer, by telephone and by letter March 30, 1995.
Firm-initiated recall complete.
-5-
DISTRIBUTION Texas, Oklahoma, Washington state, California, Missouri,
Nevada, Pennsylvania, Florida.
QUANTITY 892 bottles were distributed.
REASON Outer shipping cases declared incorrect 26 month expiration
date. Bottles declared correct 24 month date.
_______________
PRODUCT Collodion, USP, 100 ml plastic bottles, a topical
protectant. Recall #D-220-5.
CODE Lot #J02604.
MANUFACTURER Mallinckrodt Baker, Inc., (formerly J.T. Baker, Inc.),
Jackson, Tennessee (repacker).
RECALLED BY Mallinckrodt Baker, Inc., (formerly J.T. Baker, Inc.),
Phillipsburg, New Jersey, by fax July 21, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Kentucky, Louisiana, Michigan, Mississippi, Ohio,
Texas, Wisconsin.
QUANTITY 109 bottles were distributed.
REASON Container leakage.
_______________
PRODUCT Potassium Chloride products, concentrations of 10% and 20%,
in 16 ounce and/or 128 ounce sizes, under the Cenci, Humco
and URL labels:
(a) Potassium Chloride Solution 10% Red, Cherry Flavored,
Sugar-Free, Alcohol-Free, 16 ounce;
(b) Potassium Chloride Solution 10%, Sugar-Free, Alcohol-
Free, 16 ounces;
(c) Potassium Chloride Solution 10%, Sugar-Free, Alcohol-
Free, Dye-Free, 16 ounces;
(d) Potassium Chloride Solution 20%, Sugar-Free, Alcohol-
Free, Dye-Free, 16 ounce;
(e) Potassium Chloride Oral Solution 10%, Sugar-Free, 16
ounces;
(f) Potassium Chloride Oral Solution 20%, Sugar-Free, 16
ounce. Recall #D-221/226-5.
CODE Lot numbers: (a) 013321, 013323, 013324, 023376, 023377,
023378, 023380, 033441, 042498, 043498, 053520, 063553,
063554, 063555, 083645, and 093705 (16 ounces).
013324 and 093705 (128 ounces).
(b) 033475, 043506, 053525 (16 ounces).
(c) 023380, 044340, 044341, 053527, 063548, 082563, 093710,
093711 (16 ounces).
(d) 044340, 053527, 093710, and 033407 (16 ounces).
(e) 023383, 063544, 083599, 093703, 102709 (16 ounces).
(f) 053519 (16 ounces).
MANUFACTURER H.R. Cenci Laboratories, Fresno, California.
RECALLED BY Manufacturer, by letter June 20, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Connecticut, Illinois, New Mexico, Ohio,
Pennsylvania, Texas.
-6-
QUANTITY Volume in commerce: 16oz. 1 gal.
10%, Red, Sugar-Free, Alcohol-Free*: 51,449 124
10%, Sugar-Free, Alcohol-Free: 11,820 -
10%, Sugar-Free, Alcohol-Free, Dye-Free: 12,504 -
10%, Sugar-Free Oral Solution: 12,073 -
20%, Sugar-Free: 15,416 -
20%, Sugar-Free Oral Solution: 2,038 -
*includes all "Red", not just those labelled "Cherry
Flavored".
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Red Blood
Cells Leukocytes Removed; (d) Red Blood Cells Washed; (e)
Platelets; (f) Platelets, Pheresis; (g) Fresh Frozen Plasma.
Recall #B-469/475-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance (301) 594-1070 for individual unit
numbers recalled.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on December 16, 1994, followed by
letters dated January 31, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois, Iowa, Missouri, Indiana, Texas, Idaho, Minnesota,
Puerto Rico.
QUANTITY (a) 2 units; (b) 1,698 units; (c) 80 units; (d) 5 units; (e)
95 units; (f) 1,465 units; (g) 1 unit.
REASON Blood products which were inadequately irradiated due to the
malfunction of the irradiation device were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-476-5.
CODE Unit #0045821.
MANUFACTURER Baystate Medical Center, Springfield, Massachusetts.
RECALLED BY Manufacturer, by letters dated January 6 and 9, 1995. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Blood products, which were improperly tested for the
antibody to the human immunodeficiency virus types 1 and 2
(anti-HIV-1/2), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-479/480-5.
CODE Unit #20G93688.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by letters dated January 16 and 25, 1995.
Firm-initiated recall complete.
DISTRIBUTION Idaho, California.
-7-
QUANTITY 1 unit of each component.
REASON Blood products which tested negative for 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.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF; (c) Single
Donor Plasma. Recall #B-489/491-5.
CODE Unit numbers: (a) 29114-7785, 29112-1844, 29107-4842,
29105-7348; (b) 29107-4842; (c) 29107-4842.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letters dated October 12, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 4 units; (b) 1 unit; (c) 1 unit.
REASON Blood products, which tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from a donor who previously tested Western blot
indeterminate, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-477/478-5.
CODE Unit numbers: (a) 0044506; (b) 0044700, 0044702, 0044704,
0044708, 0045800, 0045805, 0045819, 0045826, 0045828,
0045832, 0045840, 0046397, 0046401, 0046839, 0046849.
MANUFACTURER Baystate Medical Center, Springfield, Massachusetts.
RECALLED BY Manufacturer, by letters dated January 6 and 9, 1995. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY (a) 1 unit; (b) 15 units.
REASON Blood products, which were improperly tested for the
antibody to the human immunodeficiency virus types 1 and 2
(anti-HIV-1/2), were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-481-5.
CODE Unit #20KF01813.
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer, by letter dated September 7, 1994. Firm-
initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit.
REASON A unit of Red Blood Cells, which was irradiated and labeled
with an incorrect expiration date, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-482-5.
CODE Unit #15285-1694.
-8-
MANUFACTURER Blood Systems, Inc., doing business as United Blood
Services, Lubbock, Texas.
RECALLED BY Manufacturer, by telephone March 7, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON A unit of Red Blood Cells, which was irradiated and labeled
with an incorrect expiration date, was distributed.
_______________
PRODUCT Whole Blood. Recall #B-483-5.
CODE Unit numbers: P32093, P32094, P32095.
MANUFACTURER Sacramento Medical Foundation, Sacramento, California.
RECALLED BY Manufacturer. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units.
REASON Blood products, labeled with an incorrect expiration date,
were distributed.
_______________
PRODUCT (a) Platelets; (b) Platelets, Pheresis.
Recall #B-484/485-5.
CODE Unit numbers: (a) 12FT48690,12FT48691, 12FT48693,
12FT48694, 12FT48695, 12FT48696, 12FT48697, 12FT48698,
12FT48699, 12FT48700, 12FT48702, 12FT48703, 12FT48704,
12FT48705, 12FT48706, 12FT48707, 12FT48710, 12FT48712,
12FT48713, 12FT48714, 12FT48715, 12FT48716, 12FT48717,
12FT48718, 12FT48719, 12FT48720, 12FT48721, 12FT48722,
12FT48723, 12FT48724, 12FT48725, 12FT48726, 12FT48727,
12FT48728, 12FT48729, 12FT48730, 12FT48731, 12FT48732,
12FT48733, 12FT48734, 12FT48735, 12FT48736, 12FT48737,
12FT48738, 12FT48739, 12FT48740, 12FT48742, 12FT48743,
12FT48744, 12FT48745, 12FT48747, 12FT48748, 12FT48749,
12FT48750, 12FT48751, 12FT48752, 12FT48754, 12FT48755,
12FT48756, 12FT48757, 12FT48759, 12FT48760, 12FT48762,
12FT48764, 12FT48765, 12FT48766, 12FT48767, 12FT48768,
12FT48769, 12FT48770, 12FT48771, 12FT48772, 12FT48773,
12FT48775, 12FT48776, 12FT48777, 12FT48778, 12FT48779,
12FT48780, 12FT48781, 12FT48782, 12FT48783, 12FT48784,
12FT48785, 12FT48787, 12FT48788, 12FT48789, 12FT48790,
12FT48791, 12FT48792, 12FW18229, 12FW18230, 12FW18231,
12FW18232, 12FW18233, 12FW18234, 12FW18236, 12FW18237,
12FW18239, 12FW18240, 12FW18241, 12FW18242, 12FW18243,
12FW18244, 12FW18245, 12FW18246, 12FW18248, 12FW18249,
12FW18251, 12FW18252, 12FW18253, 12FW18254, 12FW18256,
12FW18257, 12FW18258, 12FW18259, 12FW18261, 12FW18262,
12FW18263, 12FW18264, 12FW18265, 12FW18267, 12FW18269,
12FW18270, 12FW18271, 12FW18274, 12FW18276, 12FW18277,
12FW18278, 12FW18280, 12FW18281, 12FW18282, 12FW18284,
12FX19702, 12FX19704, 12FX19705, 12FX19706, 12FX19707,
12FX19708, 12FX19709, 12FX19711, 12FX19712, 12FX19714,
12FX19715, 12FX19716, 12FX19717, 12FX19718, 12FX19719,
-9-
12FX19720, 12FX19721, 12FX19722, 12FX19723, 12FX19725,
12FX19726, 12FX19727, 12FX19728, 12FX19729, 12FX19730,
12FX19731, 12FX19732, 12FX19734, 12FX19735, 12FX19736,
12FX19737, 12FX19738, 12FX19739, 12FX19740, 12FX19745,
12FX19746, 12FX19747, 12FX19748, 12FX19750, 12FX19751,
12FX19752, 2FX19753, 12FX19754, 12FX19755, 12FX19756,
12FX19757
(b) 12FL96924, 12FL96926, 12FL96927,
12FM76155, 12LT20709, 12LT20710, 12LT20713, 12LT20714,
12FL96910, 12FL96911, 12FL96913, 12FL96925, 12FL96929,
12FL96932, 12FL96936, 12FM76161, 12LT20704, 12LT20706,
12LT20700, 12LT20716, 12LT20717, 12LT20718, 12LT20698,
12FL96912, 12FL96921, 12FL96923, 12FL96928, 12FL96931,
12FL96933, 12FL96934, 12FL96935, 12FL96937, 12FL96938,
12FL96939, 12FL96940, 12FM76131, 12FM76133, 12FM76135,
12FM76136, 12FM76137, 12FM76138, 12FM76149, 12FM76150,
12FM76151, 12FM76153, 12FM76154, 12FM76157, 12FM76158,
12FM76160, 12FM76162, 12FM76163, 12FM76164, 12LT20678,
12LT20672, 12LT20674, 12LT20680, 12LT20685, 12LT20690,
12LT20699, 12LT20701, 12LT20703, 12LT20707, 12LT20708,
12LT20712, 12LT20719, 12T84362A, 12T84364B.
MANUFACTURER American National Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by letters dated January 4, 1995. Firm-
initiated recall complete.
DISTRIBUTION North Carolina, South Carolina.
QUANTITY (a) 179 units; (b) 67 units.
REASON Blood products, which were exposed to unacceptable storage
temperatures, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-486/488-5.
CODE Unit numbers: (a) 50F63568, 50Z00926; (b) 50F63568; (c)
50F63568, 50Z00926.
MANUFACTURER American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by letters dated June 28, 1994. Firm-
initiated recall complete.
DISTRIBUTION Ohio, California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
REASON Blood products, which were collected from an individual who
admitted to receiving clotting factor concentrates, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Spectra Apheresis System, automated blood cell separator.
Recall #Z-947-5.
CODE Catalog numbers: 950000-000 through 950000-008, 950000-900,
950000-903, 950000-905. All serial numbers.
MANUFACTURER COBE BCT, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by letter June 9, 1995. Firm-initiated field
correction ongoing.
-10-
DISTRIBUTION Nationwide and international.
QUANTITY 1,978 units were distributed.
REASON The software may allow patient hypovolemia under certain
conditions during red blood cell exchange.
_______________
PRODUCT Lincare Portable Liquid Oxygen Reservoirs in the following
models: (a) Lincare 1.2 Portable Liquid Oxygen Unit
w/mechanical gauge, part number 10561987;
(b) Lincare 0.6 Portable Liquid Oxygen Unit
w/Sur-Cal Gauge, part number 10669162;
(c) Lincare 1.2 Portable Liquid Oxygen Unit
w/Sur-Cal Gauge, part number 10678229. Recall #Z-948/950-5.
CODE Serial numbers: (a) 379418001 through 379447004;
(b) 11794402001 through 1179502010;
(c) 1189450001 through 1189506091.
MANUFACTURER Caire, Inc., New Prague, Minnesota.
RECALLED BY Manufacturer, by letters dated March 7, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 846 units; (b) 598 units; (c) 225 units were
distributed.
REASON The units may develop a broken fill tube and release liquid
oxygen during the fill process.
_______________
PRODUCT Siredoc Recorders with Software Versions prior to and
including VH1:
(a) Siredoc 60 (S60) Recorder, a 2 channel strip chart
recorder that prints waveforms, alphanumerics, text, grids
and other graphics from Siemens' bedside and central
monitors;
(b) Siredoc 220 (S220) Recorder, an 8 channel strip chart
recorder. Recall #Z-951/952-5.
CODE (a) 8540403E2509; (b) 8836066E2511.
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter dated April 18, 1995. Firm-
initiated field corrections ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON On rare occasions, the recorders with software versions
prior to and including VH1 may incur communication errors.
This is exhibited by a short recording with an error message
that could occur on either recorder.
_______________
PRODUCT USCI 6F/17cm Input Dilator Products (introducers and build-
to-order angiographic catheter kits), distributed under the
following item numbers:
Introducers - 050013, 060011, 065011, 563311, 663311,
763311, 863311, and 963311; and
-11-
Catheter Kits - 258418, 258443, 258445, 388407, 550028,
550029, 558418, 558419, 558420, 558443,
558445, 558447, 558448, 758422, 850002,
850003, 850004, 858418, 858420, 858443,
and 858445. Recall #Z-956-5.
CODE All lots manufactured from 4/1/93 through 11/25/94.
MANUFACTURER USCI Manufacturing Facility, Galway, Ireland.
RECALLED BY USCI Division, C.R. Bard, Inc., Billerica, Massachusetts, by
letters of January 11, 1995 and April 18, 1995, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Ireland.
QUANTITY 162,465 units (USA), 66,465 units (Ireland) were
distributed.
REASON The devices may contain loose particulate debris in their
inner lumens.
_______________
PRODUCT SoloPak Extension Set with Air Eliminating Filter and
Clamp, a sterile, Rx fluid pathway for the administration of
I.V. fluids: (a) Catalog #73300, Extension Set with .22
Micron Filter and Clamp, NDC #59747-733-00;
(b) Catalog #73301, Extension Set with 1.2 Micron Filter and
Clamp, NDC #59747-733-01. Recall #Z-1002/1003-5.
CODE Lot numbers: (a) DC1194A, DC1194B, DC1294A;
(b) DB1194A, DB1294A.
MANUFACTURER Venusa, Ltd., Juarez, Mexico (contract manufacturer).
RECALLED BY SoloPak Medical Products, Inc., Elk Grove Village, Illinois,
by letters dated June 30, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 127,800 sets were distributed; firm estimated that less than
10 percent remained on market at time of recall initiation.
REASON Solvent bond failures at the tubing to filter junction could
cause a fluid leak when used with extended periods of high
pressure such as with an infusion pump.
_______________
PRODUCT Micro Diagnostics in-Vitro diagnostic prepared culture media
plates, 10 plates per package, a selective medium for the
isolation of Haemophilus species from respiratory specimens
containing normal oropharyngeal flora;
(a) Haemophilus Isolation Agar, Product #M1106;
(b) Columbia CNA Agar with 5% Sheep Blood, Product #M1014.
Recall #Z-1011/1012-5.
CODE Lot numbers: (a) 4286 EXP 4/16/94; (b) 4284 EXP 5/1/94.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone April 1 and 4, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Georgia.
QUANTITY (a) 180 plates; (b) 190 plates were distributed.
REASON Some of the media plates labeled as Haemophilus Isolation
Agar actually contained Columbia CNA Agar with 5% Sheep
Blood.
-12-
_______________
PRODUCT Steam/Ethylene Oxide Sterilizeable Pouch, Catalog #10933.
Recall #Z-1017-5.
CODE Lot #042895.
MANUFACTURER Anchor Continental, inc., Columbia, South Carolina (tape).
RECALLED BY OnGard Systems, Inc., Denver, Colorado, by telephone on June
27, 1995, followed by letter dated June 30, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 305 cases.
REASON A change in the vendor's adhesive formulation for the
sealing tape will not accept sterilization temperatures,
causing seal failures which may compromise sterility.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Bipolar Endoprosthesis (hip replacement) Catalog #BP-2854.
Recall #Z-795-5.
CODE Lot numbers: EX90B, EX91B, EX146C, EX170C.
MANUFACTURER Exactech, Inc., Gainesville, Florida.
RECALLED BY Manufacturer, by letter January 30, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, California, Florida, Massachusetts, New Jersey,
Oklahoma, Maryland, Colorado, Texas, Minnesota, Greece,
Korea.
QUANTITY 30 units were distributed.
REASON The inner label contained an error (28 mm x 44 mm), instead
of the correct 28 mm x 54 mm.
_______________
PRODUCT ConMed/Andover Medical 1910-100 Fastrace 3 Resting
Electrodes used for EKG's. Recall #Z-957-5.
CODE Lot codes: 27 OCT 96F, 03 NOV 96A, 03 NOV 96B.
MANUFACTURER ConMed/Andover Medical, Haverhill, Massachusetts.
RECALLED BY Manufacturer, by letter April 28, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 351,000 units were distributed.
REASON The product is incorrectly labeled with an incorrect
expiration date of 22 months, when it should have shown a
shelf life of 9 months.
_______________
PRODUCT Dade Thromboplastin-IS, a lyophilized acetone-dehydrated
rabbit brain thromboplastin, calcium ions, buffers and
stabilizers, for use in prothrombin time (PT) determination
and prothrombin time based assays: (a) Catalog #B4213-50;
(b) Catalog #281053. Recall #Z-980/981-5.
CODE (a) Lot #TPS-81; (b) None.
MANUFACTURER Dade International of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by letter dated
May 1995. Firm-initiated recall ongoing.
-13-
DISTRIBUTION Nationwide and international.
QUANTITY 6,142 packages were distributed from 10/27/94 to 2/17/95.
REASON The device may show vial to vial variability, resulting in
PTT testing results higher than expected for a given
specimen.
_______________
PRODUCT Dade Actin Activated Cephaloplastin Reagent (APAC), for use
in the determination of activated partial thromboplastin
time and other coagulation procedures requiring an activated
partial thromboplastin reagent: (a) Catalog #291010; (b)
Catalog #B4218-1; (c) Catalog #291011; (d) B4218-999.
Recall #Z-982/985-5.
CODE Lot numbers: (a) APAC-610A and APAC-610E;
(b) APAC-610B; (c) APAC-610C; (d) APAC-610D.
MANUFACTURER Dade International of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by letter dated
June 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,236 packages were distributed from 3/31/95 to 5/19/95.
REASON The device may show PTT testing results higher than expected
for a given specimen.
_______________
PRODUCT Storz Deluxe Posterior Vitrectomy Pack, sterile, single
patient use, Catalog #DP4800, used in ophthalmic surgery.
Recall #Z-986-5.
CODE 0195BF.
MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letters dated May 23, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 212 6-pack cases were distributed between 3/22/95 and
5/1/95.
REASON The anterior collection cassettes (blue-colored) were found
to have been packaged in some of the packages instead of the
posterior collection cassettes (yellow-colored).
_______________
PRODUCT Micro Diagnostics in-vitro diagnostic prepared culture media
plates, 10 plates per package:
(a) Columbia CNA Agar with 5% Sheep Blood, Product #M1014;
(b) Bi-Plate Blood Agar/MacConkey, Product #B3036;
(c) Bacti-Urine Plate, Product #PS100;
(d) Bacti-General Plate, Product #PS400;
(e) Mueller Hinton Agar with 5% Sheep Blood, Product #L2034.
Recall #Z-1005/1009-5.
CODE Lot numbers: (a) 5401; (b) 5405; (c) 5414; (d) 5415; (e)
5456.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone July 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Michigan, Illinois, Wisconsin, Missouri, Georgia, Iowa.
-14-
QUANTITY (a) 220 plates; (b) 70 plates; (c) 1,770 plates; (d) 610
plates; (e) 50 plates were distributed.
REASON Bacterial contamination.
_______________
PRODUCT Bi Plate CNA/MacConkey Agar Prepared Culture Media Plates, a
selective and differential medium used in the isolation and
identification of gram-negative bacilli from stool, urinary
and other specimens harboring these organisms, packaged 10
plates per package. Recall #Z-1010-5.
CODE Product #B3101, lot #4955 EXP 7/12/94.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois, by telephone
June 24, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 40 bi-plates were distributed.
REASON The sheep blood in the media hemolyzed prior to the
expiration date.
_______________
PRODUCT Streptococcus Selective Agar Jembec Prepared Culture Media
Plates, a primary medium for the selective isolation of
streptococci from clinical specimens, 10 plates per package.
Recall #Z-1013-5.
CODE Lot #8090 EXP 3/26/95.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone on February 16 and 21, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 150 plates were distributed.
REASON The sheep blood in the media hemolyzed prior to the
expiration date.
_______________
PRODUCT Micro Diagnostics In-vitro diagnostic prepared culture media
plates, 10 plates per package:
(a) Streptococcus Selective Agar, Product #M1028;
(b) Mueller Hinton Agar with 5% Sheep Blood, Product #L2034.
Recall #Z-1014/1015-5.
CODE Lot numbers: (a) 8044 EXP 3/20/95; (b) 8008 EXP 4/1/95.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone on February 2, 3, 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Ohio.
QUANTITY (a) 700 plates; (b) 15 plates were distributed.
REASON The sheep blood in the media hemolyzed prior to the
expiration date.
_______________
PRODUCT Haemophilus Isolation Agar Prepared Culture Media Plates, a
selective medium for the isolation of Haemophilus species
from respiratory specimens containing normal oropharyngeal
flora. Recall #Z-1016-5.
CODE Lot #6832 EXP 11/13/94.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
-15-
RECALLED BY Manufacturer, by telephone October 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 250 plates were distributed.
REASON The horse blood in the media hemolyzed prior to the
expiration date.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Amprolium 1.25% Crumbles Medicated, in 50 pound bags,
labeled for Feed Specialties, used as an aid in prevention
of coccidiosis. Recall #V-037-5.
CODE 8859.
MANUFACTURER MFA, Inc., Columbia, Missouri.
RECALLED BY Manufacturer, by telephone June 6, 1995. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 14 bags were distributed; firm estimates none remains on the
market.
REASON Product is subpotent. Amprolium 1.25% was inadvertently
used. 25% Amprovine should have been used.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Physostigmine Sulfate Ophthalmic Ointment (Eserine Sulfate
1/4%, under the Pharmaderm label. Recall #V-036-5.
CODE Lot #2537 EXP 4/96.
MANUFACTURER Altana, Inc., Melville, New York.
RECALLED BY Manufacturer, by letter June 2, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,528 tubes were distributed.
REASON Subpotent for active ingredient.
-16-
END OF ENFORCEMENT REPORT FOR AUGUST 2, 1995. BLANK PAGES MAY
FOLLOW.
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