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
04/02/1991
FDA Enforcement for the week of 4/3/91
FDA ENFORCEMENT REPORT
FOR APRIL 3, 1991
April 3, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NOTE: Publix brand Frozen, Grade A, Fancy Leaf Spinach, in
10 ounce boxes, Recall #F-255-1 which appeared in the
March 6, 1991 Enforcement Report is a completed recall.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II
Product: Chloral Hydrate Syrup, USP 500 mg/5 ml, an Rx schedule IV
controlled narcotic sedative; 5 ml unit dose cups,
10 cups per tray, 10 trays per case. Recall #D-288-1.
Code: Catalog #01910-9, Lot #004022 EXP 4/92.
Manufacturer: UDL Laboratories, Inc., Largo, Florida.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
March 4, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,781 cases of 100 unit dose cups were distributed; firm
estimates 37% of the product remains on the market.
Reason: Some of the unit dose cups were found to be overfilled.
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Product: Platelets. Recall #B-147-1.
Code: Unit #33KM65338.
Manufacturer: American Red Cross Blood Services, Farmington, Connecticut.
Recalled by: Manufacturer, by telephone July 2, 1990. Firm-initiated
recall complete.
Distribution: Connecticut.
Quantity: 1 unit.
Reason: Blood component collected from donor who contracted
measles was distributed.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-148/149-1.
Code: Unit numbers: (a) 04FS97075, 04GF79802, 04T62576,
04T65267; (b) 04FS97075, 04GF79802, 04T62576, 04KF70076,
04T65267.
Manufacturer: American Red Cross Blood Services, Dedham, Massachusetts.
Recalled by: Manufacturer, (a) by telephone October 18, 1990 followed by
letter October 30, 1990; (b) by telephone November 6,
1990 followed by letter November 27, 1990. Firm-initiated
recall ongoing.
Distribution: California, New York, Massachusetts.
Quantity: (a) 4 units; (b) 5 units.
Reason: Blood products which tested non-reactive for hepatitis
B surface antigen (HBsAg), but were collected from donors
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who had previously tested repeatably reactive for (HBsAg),
were distributed.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-150/152-1.
Code: Unit #42W97180.
Manufacturer: American Red Cross Blood Services, Cleveland, Ohio.
Recalled by: Manufacturer, (a) by telephone March 30, 1990 followed by
letter April 2, 1990; (b) by letter September 7, 1990;
(c) by telephone April 11, 1990. Firm-initiated recall
ongoing.
Distribution: (a) Ohio; (b) New York; (c) California.
Quantity: 1 unit of each component.
Reason: Blood products collected from a donor with high risk
behavior or which tested RPR positive but labeled RPR
negative, were distributed.
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Product: (a) Red Blood Cells and (b) Recovered Plasma.
Recall #B-156/157-1.
Code: Units numbers: 40FF22119, 40FF22542, 40GL33072, 40GL30802.
Manufacturer: American Red Cross Blood Services, Peoria, Illinois.
Recalled by: Manufacturer, by letter November 29, 1990 and by FAX
November 16, 1990. Firm initiated recall ongoing.
Distribution: Illinois, California.
Quantity: 4 units of each component.
Reason: Blood components, collected from donors who had
experienced needle sticks within 12 months prior to
donation, were distributed.
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Product: Platelets. Recall #B-158-1.
Code: Unit #28H24547.
Manufacturer: American Red Cross Blood Services, Savannah, Georgia.
Recalled by: Manufacturer, by telephone June 26, 1990; firm-initiated
recall complete.
Distribution: South Carolina.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
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Product: Red Blood Cells. Recall #B-159-1.
Code: Unit #6611354.
Manufacturer: Med-Lab, Inc., Tuscaloosa, Alabama.
Recalled by: Manufacturer, by telephone on November 6 1990; firm-
initiated recall ongoing.
Distribution: Pennsylvania.
Quantity: 1 unit.
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Reason: Red Blood Cells, which tested repeatably reactive for
the antibody to the Human Immunodeficiency Virus Type 1
(anti-HIV-1), were distributed.
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Product: (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells
Frozen; (d) Platelets; (e) Fresh Frozen Plasma;
(f) Cryoprecipitated AHF; (g) Recovered Plasma.
Recall #B-160/166-1.
Code: Unit # (a)33KR55112; (b) 33G36593, 33G39218, 33H33028,
33J87717, 33K25161, 33K29500, 33KE01605, 33KF10465,
33KF11579, 33KF13054, 33KF19658, 33KG06403, 33KG21430,
33KG48347, 33KG53615, 33KG57949, 33KG67477, 33KH05575,
33KH06090, 33KH35349, 33KH45916, 33KH64834, 33KJ11685,
33KJ20701, 33KJ23049, 33KJ30905, 33KJ38935, 33KJ70576,
33KK04801, 33KK13756, 33KK18262, 33KK21748, 33KK25746,
33KK31786, 33KK52268, 33KL22436, 33KM00201, 33KM01581,
33KM49098, 33KN22893, 33KN38101, 33KN40997, 33KN54033,
33KR07645, 33KR08729, 33KR15609, 33KR20486, 33KR24830,
33KR28873, 33KR42087, 33KR48379, 33KR52212, 33KS02145,
33KS17506, 33KS31111, 33KT15439, 33KT31259, 33KT45657,
33KT62657, 33KT66752, 33KT78923, 33KV02028, 33KV03248,
33KV04778, 33KV05968, 33KV07478, 33KV08957, 33KV10300,
33KV11774, 33KV12982, 33KV14310, 33KV15409, 33KV16582,
33KV20035, 33KV21610, 33KW02541, 33M52372, 33M52725,
33T19136, 33T23389;
(c) 33KJ16861;
(d) 33KE01605, 33KF10465, 33KF11579, 33KF13054, 33KG67477,
33KH05575, 33KH35349, 33KH45916, 33KH64834, 33KJ20701,
33KK04801, 33KK21748, 33KK31786, 33KM01581, 33KM49098,
33KN22893, 33KR08729, 33KR15609, 33KR20486, 33KR24830,
33KR28873, 33KR42087, 33KR48379, 33KT15439, 33KT31259,
33KT79298;
(e) 33KG67477, 33KH05575, 33KH35349, 33KH45916, 33KK04801,
33KM01581, 33KM49098, 33KN22893, 33KN55312, 33KR08729,
33KR24830, 33KT15439, 33KT31259, 33KT66752, 33M52372;
(f) 33KG48347, 33KL62546, 33KR07645, 33KR52212, 33KY10030;
(g) 33G36593, 33G39218, 33H33028, 33J87717, 33K25161,
33K29500, 33KF10465, 33KF11579, 33KF13054, 33KF19658,
33KG06403, 33KG21430, 33KG31145, 33KG48347, 33KG53615,
33KG57949, 33KH06090, 33KJ11685, 33KJ16861, 33KJ18443,
33KJ20701, 33KJ23049, 33KJ30905, 33KJ38935, 33KK13756,
33KK18262, 33KK25746, 33KK31786, 33KK52268, 33KK64834,
33KL22436, 33KM00201, 33KN38101, 33KN54033, 33KR07645,
33KR15609, 33KR20486, 33KR28873, 33KR52212, 33KS02145,
33KS17506, 33KS31111, 33KT62657, 33KV02028, 33KV03248,
33KV04778, 33KV05968, 33KV07478, 33KV08957, 33KV10300,
33KV12982, 33KV14310, 33KV15409, 33KV16582, 33KV20035,
33KV21610, 33KW02541, 33M52725, 33T19136, 33T23389.
Manufacturer: American Red Cross Blood Services, Farmington, Connecticut.
Recalled by: Manufacturer, by telephone on August 14, 1990, followed by
letters August 15, 1990, September 12, 1990 and or October
10, 1990 by letter. Firm-initiated recall ongoing.
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Distribution: Connecticut, California, Kentucky, New York, New Jersey,
Maryland, Massachusetts, and Illinois.
Quantity: (a) 1 unit; (b) 80 units; (c) 1 unit; (d) 26 units;
(e) 15 units; (f) 5 units; (g) 60 units.
Reason: Blood products which tested non-reactive for the
antibody to the Human Immunodeficiency Virus Type 1
(anti-HIV-1), but were collected from donors who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
Product: Prolastin Alpha-1 Proteinase Inhibitor. Recall #B-169-1.
Code: Lot # 01G024 EXP 9/7/91.
Manufacturer: Miles Laboratories, Inc., Berkeley, California.
Recalled by: Manufacturer, by letter dated November 9, 1989.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 2,331 vials were distributed.
Reason: Product initiates adverse, possibly pyrogenic,
reactions in recipients.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-171/172-1.
Code: Unit # 95130.
Manufacturer: Memorial Blood Center of Minneapolis, Inc., Minneapolis,
Minneasota.
Recalled by: Manufacturer, by telephone on October 31, 1990 and by letter
November 5, 1990. Firm-initiated recall complete.
Distribution: Minneasota.
Quantity: 1 unit.
Reason: Blood components, which tested repeatably reactive for the
antibody to the human immunodeficiency virus, type 1
(anti-HIV-1) were distributed.
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Product: Recovered Plasma. Recall #B-173-1.
Code: Units from donors with a past or current history of cancer:
SW 081076, SW 081084, SW 081098, SW 081314, SW 081546,
SW 081554, SW 081566, SW 081599, SW 081724, SW 081739,
SW 081849, SW 081905, SW 081963, SW 081989, SW 082025,
SW 082031, SW 082067, SW 082086, SW 082171, SW 082232,
SW 082293, SW 082444, SW 082661, SW 082756, SW 082808,
SW 082817, SW 082860, SW 082862, SW 082974, SW 082982,
SW 083134, SW 083168, SW 083171, SW 084838, SW 084960,
SW 085123, SW 085136, SW 085192, SW 085268, SW 085269,
SW 085301, SW 085357, SW 085358, SW 085363, SW 085372,
SW 085436, SW 085444, SW 085515, SW 085517, SW 085520,
SW 085545, SW 085616, SW 085653, SW 085732, SW 085782,
SW 085787, SW 085853, SW 086104, SW 086128, SW 086394,
SW 086513, SW 086514, SW 086623, SW 086711, SW 086745,
SW 086852, SW 086895, SW 086905, SW 086950, SW 086986,
-5-
SW 087036, SW 087045, SW 087051, SW 087250, SW 087399,
SW 087518, SW 087550, SW 087630, SW 087661, SW 087736,
SW 087740, SW 087933, SW 087964, SW 087966, SW 087976,
SW 087988, SW 088020, SW 088034, SW 088261, SW 088278,
SW 088323, SW 088357, SW 088362, SW 088411, SW 088432,
SW 088482, SW 088488, SW 088507, SW 088520, SW 088522,
SW 088533, SW 089047, SW 089049, SW 089059, SW 089077,
SW 089135, SW 089172.
Units collected from donors with a history of or
exposure to hepatitis:
SW 081534, SW 081685, SW 081828, SW 081981, SW 082356,
SW 082578, SW 082903, SW 085190, SW 085274, SW 085336,
SW 085416, SW 085462, SW 085493, SW 085640, SW 085772,
SW 085879, SW 086017, SW 086234, SW 086430, SW 086920,
SW 087096, SW 087200, SW 087211, SW 087258, SW 087269,
SW 088056, SW 089163.
Units collected from donors who had 2 or more of the
following conditions that might be indicative of AIDS
(i.e. night sweats, diarrhea, swollen lymph nodes, blue
spots under skin and white spots in the mouth:
SW 082787, SW 085210, SW 085270, SW 085445, SW 086069,
SW 086113, SW 087003, SW 088054, SW 088374, SW 088384.
Units collected from donors with a history of drug addiction:
SW 067694, SW 067695, SW 085250, SW 087366.
Manufacturer: Scott and White Memorial Hospital, Temple, Texas.
Recalled by: Manufacturer, by letters of April 12, 1991 and
May 8, 1991. Firm-initiated recall ongoing.
Distribution: Florida, Texas.
Quantity: 148 units.
Reason: Recovered plasma, collected from donors with: 1) a history
of cancer; 2) history of exposure to hepatitis; 3) history
of drug addiction; or 4) signs and/or symptoms of AIDS were
distributed.
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Product: Recovered Plasma. Recall #B-192-1.
Code: Unit #8204333.
Manufacturer: The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
Recalled by: Manufacturer, by fax January 23, 1991, and by letter
dated January 24, 1991. Firm-initiated recall ongoing.
Distribution: New Jersey, New York.
Quantity: 1 unit.
Reason: Blood component, which tested repeatably reactive for the
hepatitis B surface antigen (HBsAg), was distributed.
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Class III -
Product: Milk of Magnesia, in pint and gallon size plastic bottles,
an OTC drug. Recall #D-280-1.
-6-
Code: Lot numbers: 72037, 82354, 92777, 72254, 82582, 03182,
72447, 92090, 03361, 72659, 92361, 03509, 82148, 92569.
Manufacturer: Barre National, Inc., Baltimore Maryland.
Recalled by: Manufacturer, by letter January 28, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 252,234 bottles were distributed; firm estimates 9,498
bottles remain on market.
Reason: Product does not meet stability requirements and does not
have proper suspension characteristics.
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Product: Meperidine HCl Injection, TUBEX, 22 gauge 1-1/4 inch
needle 50 mg/ml, 1 mg fill in 2 ml vial, an Rx product
for IM, SC and IV administration. Recall #D-283-1.
Code: Lot #2901535 EXP 11/91.
Manufacturer: Wyeth-Ayerst Labs, West Chester, Pennsylvania.
Recalled by: Wyeth-Ayerst Labs, St. Davids, Pennsylvania, by letter
March 7, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 686,380 Tubex were distributed; firm estimates 1,500
packages remain on the market.
Reason: Product contains particulate matter.
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Product: (a) Bacitracin Ointment, 500 units per gram, in lithographed
tubes of 1/2 oz or 1 oz; (b) Triple Antibiotic Ointment,
in lithographed tubes of 1/2 ounce and 1 ounce, an OTC
first aid ointment for external use only.
Recall #D-285/286-1.
Code: Lot numbers: (a) 12578, 14754 (1/2 oz); 14386, 14015,
12678, 12428 14874 (1 oz); (b) 12680, 14615, 14384, 12679,
14946 (1/2 oz); 14241, 14616, 14384, 14016, 14792 (1 oz).
Manufacturer: Biocraft Laboratories, Inc., Fair Lawn, New Jersey.
Recalled by: Manufacturer, by telephone on January 14-16, 1991 and by
letters on March 1-6, 1991 first class with return receipt.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 29,962 (1/2 oz) tubes, 45,942 (1 oz) tubes;
(b) 93,202 (1/2 oz) tubes, 65,181 (1 oz.) tubes were
distributed.
Reason: Products do not comply with labeling requirements for
first aid antibiotic drug products.
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Product: Kramer Laboratories brand Yohimex, 5.4 mg. Yohimbine HCl
Tablet, in amber glass bottles of 100 tablets or in
physician packets of 9 tablets, an Rx product used to treat
erectile impotence. Recall #D-289-1.
Code: Lot #A91052.
-7-
Manufacturer: Jones Medical Industries, Inc., Canton, Ohio and Mikart,
Inc., Atlanta, Georgia; Lex, Inc., Medley, Florida
(repacker).
Recalled by: Kramer Laboratories, Inc., Miami, Florida, by phone
March 8, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 183,365 tablets were distributed; firm estimates 43,535
tablets remaining in bulk.
Reason: Lot A91052 contains both Yohimbine HCl tablets manufactured
by Mikart, Inc. and Jones Medical.
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Product: Beef-Iron and Wine Liquid, 120 mg iron for each 45 ml in
16 ounce plastic bottle, an OTC product used as a
hematinic. Recall #D-292-1.
Code: Lot #900316 EXP 3/93.
Manufacturer: Lex, Incorporated, Medley, Florida.
Recalled by: Manufacturer, by visit March 8, 1991. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: Approximately 507 bottles were distributed; firm estimates
300 bottles remain on the market.
Reason: Iron ingredient is subpotent.
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Product: Gentian Violet Solution, in 1 ounce amber glass bottle, an
OTC anti-infective for external use only. Recall #D-293-1.
Code: Lot #900802 EXP 8/93.
Manufacturer: Lex, Incorporated, Medley, Florida.
Recalled by: Manufacturer, by visit. Firm-initiated recall complete
November 1990.
Distribution: Florida.
Quantity: Firm estimates none remains on the market.
Reason: The label for the product indicates that the product
contained alcohol instead of isopropyl alcohol.
----
Product: Mercurochrome Antiseptic 2% Aqueous Merbromin Solution,
in 1 ounce bottles, an OTC antiseptic for external use only.
Recall #D-294-1.
Code: Lot #900318 EXP 3/94.
Manufacturer: Lex, Inc., Medley, Florida.
Recalled by: Manufacturer, by visit beginning March 8, 1991.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 6,000 bottles were distributed; firm estimates 250 bottles
remain on the market.
Reason: Subpotent.
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-8-
Product: Buffex brand Buffered Aspirin Analgesic Tablets, in
2 tablet packages, 500 packages per box, an OTC product.
Recall #D-305-1.
Code: Lot numbers B-011 EXP 2/91, B-105 EXP 10/91.
Manufacturer: Mallard, Inc., Detroit, Michigan.
Recalled by: Manufacturer, by letter January 4, 1991. Firm-initiated
recall ongoing.
Distribution: Georgia.
Quantity: 960 boxes (1,000 tablets each) and 2,000/4 tablet sample
envelopes were distributed.
Reason: Product does not meet USP specifications for buffering
capacity.
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Product: Red Blood Cells. Recall #B-153-1.
Code: Unit #42J57510.
Manufacturer: American Red Cross Blood Services, Cleveland, Ohio.
Recalled by: Manufacturer, by telephone March 1, 1990. Firm-
initiated recall ongoing.
Distribution: Ohio.
Quantity: 1 unit.
Reason: Blood product collected from a donor with high risk
behavior or which tested RPR positive but labeled RPR
negative, was distributed.
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Product: Red Blood Cells. Recall #B-154-1.
Code: Unit #2820994.
Manufacturer: Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
Recalled by: Manufacturer, by relabeling product on or about
September 24, 1990. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit .
Reason: Blood product labeled with the incorrect expiration date was
distributed..
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MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Laerdal Heartstart Defibrillation Electrode:
(a) Part #90-24-00; (b) Part #90-24-01; (c) Part #90-24-02,
used with the Heartstart 1000, 2000 and 3000 Defibrillators.
Recall #Z-360/362-1.
Code: Lot numbers: Y070990, Y070290, Y070590. They are also
coded "Use before 07-92".
Manufacturer: Katecho, Inc., Des Moines, Iowa.
Recalled by: Laerdal Manufacuring Corporation, Tualatin, Oregon, by
letter November 15, 1990. Firm-initiated recall ongoing.
-9-
Distribution: Nationwide.
Quantity: 1,595 pairs were distributed.
Reason: The electrodes were manufactured with an apparently
nonconductive liner on the conductive metal layer within
the electrode pad.
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Class II -
Product: EBNA ACIF Kit Anti-Complement Immunofluorescence (ACIF)
Test, an in-vitro diagnostic test kit. Recall #Z-333-1.
Code: Lot numbers: 143166, 143205, 143207, 143208.
Manufacturer: Organon Teknika, Durham, North Carolina.
Recalled by: Manufacturer, by letter November 16, 1990. Firm-initiated
recall complete.
Distribution: Nationwide, France, West Germany, Italy, Canada, Norway,
Greece, Yugoslavia.
Quantity: 1,399 kits were distributed; firm estimates that little
of the product remains on the market.
Reason: Possible loss of stability in that some slides exhibit
less than the expected number of fluorescent cells.
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Product: (a) Raspberry; (b) Licorice; (c) Orange; (d) Strawberry
Flavored Condoms, for novelty use only, not for birth
control or disease control usage. Recall #Z-458/461-1.
Code: Not coded.
Manufacturer: Soplex Health Care Ltd., Sussex, United Kingdom.
Recalled by: Dynamed Development Corporation, Commack, New York, by
telephone January 3, 1991 followed by letter January 31,
1991. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 44,064 pieces were distributed.
Reason: Product contains an unacceptable level of holes.
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Product: AMK Tibial Insert, a component of a knee prosthesis.
Recall #Z-462-1.
Code: Catalog #1488-32, Lot #840820.
Manufacturer: MacDee, Inc., Chelsea, Michigan.
Recalled by: DePuy of Boehringer Mannheim Corporation, Warsaw,
Indiana, by letter January 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Colombia, Brazil, Taiwan, Japan, Australia.
Quantity: 39 pieces were distributed.
Reason: The device may be slightly oversized. When inserted into
the metal tibial plateau there is a possibility that it
will not fit properly.
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-10-
Product: Scientific lasers:
(a) Model No YG 601; (b) Model No. YG 660;
(c) Model No. YG 680; (d) Model No. RGA 60;
(e) Model No. Vertex; (f) Model TDL 60;
(g) Model No. RGA 540; (h) Model No. RGA 840;
(i) Model No. RGA 1000. Recall #Z-463/471-1.
Code: Undetermined.
Manufacturer: Continuum Electro-Optics, Inc., Santa Clara, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 28, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 277 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that they do not have multiple microswitches
in place in the event of an interlock failure.
----
Product: (a) Adult Circle Breathing Circuit, non-conductive,
single use; (b) Vital Packs containing Adult Circle
Breathing Circuit, single use. Recall #Z-476/477-1.
Code: Finished goods lot numbers 3529 and 0080.
Catalog numbers for lot 0080:
5020A 5020MK 5030AJMO 5035FEMO 5037FA
5020AAMO 502OMO 5030AJX 5035KXI 5037FE
5020AEH 5021JIMO 5030AJXI 5036 5037FMA
5020AJ 5021JMXI 5030AK 5036AEF 5037FMO
5020AJP 5022 5030AMEH 5036AP 5040
5020AMH 5022AEHM 5030AMOP 5036E 5112AFE
5020AMO 5022JI 5030E 5037A 5112M
5020AMOJ 5023MOXI 5030JXI 5037AE 5112AMOE
5020AXJI 5030 5030JXIO 5037AEFM 5133IMPV
5020E 5030A 5030M 5037AFJ 5237FMXI
5020EAM 5030AAE 5030MA 5037AFJX 5236AEFO
5020HAJ 5030AE 5030MAJ 5037AGH 5372AJXI
5020HM 5030AEMO 5030ME 5037AKI 5372F
5020MAGH 5030AGHM 5030MO 5037AME 5372FAME
5020MJI 5030AGXM 5031MJXR 5037F 5372FAOJ
5020MJX 5030AJ 5035AE
Vital Pak Catalog Numbers for lot 0800 packaged 10/case:
91UY075B, 92FL022B, 93G0062B, 93GV062B, 95F0069A.
Firm did not compile catalog numbers for lot 3529.
Manufacturer: Vital Signs, Inc., Totowa, New Jersey.
Recalled by: Manufacturer, by letter January 30, 1990 and February
15, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Spain.
Quantity: 1,699 cases (20 circuits/case) were distributed;
firm estimates none remains on the market.
Reason: The "y" piece may be occluded.
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-11-
Product: 14F Cath-Seal PCI with 3-Way Stopcock catheter
Introducer Set. Recall #Z-478-1.
Code: Lot #130801, Sterilized 1/91, Catalog #1200-90-3003.
Manufacturer: Universal Medical Instruments Corporation, Ballston Spa,
New York.
Recalled by: Manufacturer, by telephone February 1 and 4, 1991 and
by letter February 4, 1991. . Firm-initiated recall
ongoing.
Distribution: Illinois, New York, California, Tennessee, North Carolina,
Florida, Washington, D.C., Italy, England.
Quantity: 70 units were distributed.
Reason: The introducer sheaths were manufactured with 10F
instead of 14F sheath. The introducer will not
accept a 14F a dilator, and is rendered unusable.
----
Product: Ritter M8 and M8+ Easyclave Self-Contained Steam Sterilizer,
a bench top autoclave. Recall #Z-480/481-1.
Code: All units distributed prior to February 1, 1991.
Manufacturer: Prestige Medical, Surrey, England.
Recalled by: Midmark Corporation, Versailles, Ohio, by letter
January 16, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,086 units were distributed.
Reason: Failure of the safety feature intended to prevent the
sterilizer from pressurizing when the lid is not
fully engaged.
----
Product: Hydrajust III Urological Tables, used to support
patients during urological procedures, Models:
IAFXS, IAFXR, IATXS, IATXR, IAFES, IAFER, IATES, IATER,
IAFJS, IAFJR, IATJS, AND IATJR. Recall #Z-494-1.
Code: Identified by the digits 1000 through 1790 in the
first for digits of the serial number.
Manufacturer: Liebel-Flarsheim Company, Cincinnati, Ohio.
Recalled by: Manufacturer, by letter October 11, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 448 tables containing the defective
circuit boards were distributed.
Reason: The table may unexpectedly tilt. This unexpected
movement is caused by a defective circuit board.
----
CORRECTION: Software Version 3.1 for Sophy Cameras DS7 and DSX,
Recall #Z-293/294-1 which appeared in the March 13, 1991
Enforcement Report should read:
Quantity: 128 cameras were distributed. Firm-initiated
field correction was completed November 19, 1990.
----
-12-
Class III -
Product: (a) Blastomyces Immunodiffusion Antigen, 1 ml;
(b) Blastomyces EXO-Reference Antigen, 0.6 ml;
(c) Blastomyces Immunodiffusion Antigen, 0.2 ml.
Recall #Z-329/331-1.
Code: Catalog No. Lot No. Code
(a) 1D1012 10WB3 877
40WB3 886
70WB3 897
(b) B30010 20WB3 877
50WB3 889
80WB3 897
(c) B30000 60WB3 88A
90WB3 897
Manufacturer: Immuno-Mycologics, Inc., Washington, Oklahoma.
Recalled by: Manufacturer, by letter December 8, 1989.
Firm-initiated recall complete.
Distribution: Texas, Missouri, California, Virginia, Oklahoma, Indiana,
Illinois, Ohio, Colorado, Kentucky, Florida,
Pennsylvania, Tennessee, Mississippi, Wisconsin,
Louisiana.
Quantity: 543 vials were distributed.
Reason: Product may lose its potency.
----
Product: Lifepak 10 Defibrillator/Monitor. Part numbers affected
are: 804200-14, 804200-16, 8004200-18, 804200-19,
804200-23, 804200-24. Recall #Z-455-1.
Code: Serial numbers are noncontinuous starting with 4517 and
ending with 6510.
From Part #804200 To Part #804200-999.
From Serial No. To Serial No.
006503 006507
004517 004524
005359 005364
005378 005381
005914 005917
005863 005910
005926 005949
005956 005999
006070 006141
006168 006184
006186 006234
006236 006252
006272 006275
006278 006281
006284 006286
006475 006479
005398
005719
005726
005732
-13-
006264
006267 006269
006473
006481 006482
006484
006486
006482
006488 006490
006492
006494 006495
006497
006499 006501
006510.
Manufacturer: Physio Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by issuing Technical Service Update 153
November 15, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 246 units are affected.
Reason: An internal trace is missing on the main circuit board
which could result in internal arcing when the
defibrillator is charging.
----
Product: Glucose HK Reagent, a diagnostic kit used for quantitative
determination of serum glucose. Recall #Z-456-1.
Code: Lot #G47LK or G48LK.
Manufacturer: Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by telephone between August 9 and 13, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 30 kits (10 vials/kit) were distributed.
Reason: Reagent vials correctly labeled as 250 ml size were used
to prepare kits labeled as containing 50 ml size reagent
vials.
----
Product: Model 1220 Absorbance Standard-Used in a Stasar
Spectrophotometer. Recall #Z-457-1.
Code: Standards are identified with a calibration date
ranging from September 11, 1989, to December 29, 1989.
Manufacturer: Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letters dated April 13, 1990 and
May 8, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 344 standards were distributed; firm estimates 233
standards remain on the market.
Reason: During a quality assurance check the firm discovered
that the standards were drifting outside the absorbance
accuracy specificaiton of +1% by up to +2%.
----
-14-
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Banminth-48 Type A Medicated Article, 48 grams/lb,
in 50 pound bags, anthelmintic for swine used in the
prevention of internal parasites. Recall #V-069-1.
Code: K01103516.
Manufacturer: Pfizer, Inc., Lee's Summit, Missouri.
Recalled by: Manufacturer, by telephone December 14, 1990. Firm-
initiated recall complete.
Quantity: 98 bags were distirubted.
Reason: Product is subpotent.
----
Seizure Actions Filed:
Product: Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl
for Oral Suspension (89-503-753 et al).
Charge: Adulterated - Noncompliance with current good
manufacturing practice regulations.
Firm: Alra Laboratories, Gurnee, Illinois.
Filed: March 19, 1991 - U.S. District Court for the
Northern District of Illinois, Eastern Division.
Civil #91C1648, FDC #66064.