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
12/07/1994
Recalls and Field Corrections: Foods -- Class I -- 12/07/1994
December 7, 1994 94-49
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT Rainier Farms brand Oat Bran Bread in 24 ounce plastic bags.
Recall #F-124-5.
CODE All codes manufactured prior to 9/24/94.
MANUFACTURER Snyder's Bakery, Inc., Spokane, Washington.
RECALLED BY United States Bakery, Inc., Portland, Oregon, by notices and
by press release hand delivered on September 24, 1994.
Firm-initiated recall complete.
DISTRIBUTION Washington State.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared hazelnuts.
_______________
PRODUCT Cold Smoked Salmon Fillets, vacuum packed, 1 per package.
Recall #F-125-5.
CODE 0405 printed on label.
MANUFACTURER Sotra Smoked Fish, U.S.A., Inc., Kingston, New York.
RECALLED BY Manufacturer, by telephone of August 19 and 26, 1994,
followed by letter. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 165 pounds were distributed; firm estimates none remains on
the market.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Smoked Atlantic Salmon, sliced sides in various weights.
Recall #F-126-5.
CODE Batch I.D. 873094, Sell by date 091694, Manufacturing lot
0000007.
MANUFACTURER Spence & Company, Ltd., South Easton, Massachusetts.
RECALLED BY Manufacturer, by telephone September 26, 1994, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 6 cases, approximately 50 pounds, were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Various flavored ice cream and sherbet, in 3 gallon bulk
containers: (a) Mint Chocolate Chip Ice Cream;
(b) Pistachio Almondine Ice Cream;
(c) Lime Sherbet; (d) Rainbow Sherbet. Recall #F-106/109-5.
CODE All codes manufactured in the past 6 months.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letter September 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Calcium Tablets, 600 mg, in bottles of 500, under the
Bradlees and FEDCO labels. Recall #F-028-5.
CODE Lot numbers: 104258 EXP 5/96 (Bradlees), 014102 EXP 5/96
(FEDCO).
MANUFACTURER Hall Laboratories, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by letter September 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION California, Massachusetts, Maine, New Hampshire, New Jersey,
Pennsylvania, New York, Connecticut.
QUANTITY 684 bottles of the Bradlees brand and 598 bottles of FEDCO
brand were distributed.
REASON Bottles contain niacin tablets mixed in with the calcium
tablets.
_______________
PRODUCT Ice Cream, yogurt, and sherbet in 3 gallon bulk containers:
(a) Lime Sherbet; (b) Cherry Vanilla Ice Cream;
(c) Strawberry Ice Cream; (d) Rainbow Ice Cream;
(e) Strawberry Fountain Ice Cream;
(f) Black Raspberry Ice Cream;
-2- (g) Strawberry Cheesecake Ice Cream;
(h) Black Cherry Ice Cream; (i) Red Raspberry Sherbet;
(j) Strawberry Frozen Yogurt; (k) Raspberry Frozen Yogurt;
(l) Black Cherry Yogurt;
(m) Strawberry Banana Frozen Yogurt;
(n) Nonfat Strawberry Yogurt. Recall #F-110/123-5.
CODE All codes manufactured in the past 6 months.
MANUFACTURER Kemp's Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by letter September 2, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Delaware, New York, Maryland,
Virginia, Connecticut.
QUANTITY Firm estimates that very little if any product remains on
the market.
REASON Product contains undeclared food colors: Blue #1 and
Red #40.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
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PRODUCT Source Plasma. Recall #B-099-5.
CODE Unit #PG46047.
MANUFACTURER Immuno-U.S., Inc., Columbus, Georgia.
RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by
letter January 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 1 unit.
REASON Blood products, which tested non-reactive for hepatitis B
surface antigen (HBsAg), but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
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PRODUCT (a) Whole Blood Cells; (b) Red Blood Cells; (c) Platelets;
(d) Platelets, Pheresis. Recall #B-100/103-5.
CODE Unit numbers: (a) R24442, R26502;
(b) R19134, R19389, R19406, R19409, R19411, R22333, R22334,
R22343, R22346, R22348, R22350, R22656, R22663, R22690,
R25130, R25132, R25138, R25139, R25140, R25150, R25152,
R25157, R25163, R25164, R25168, R25177, R25194, R28740,
R28742, R28885, R29843, R29925, R31589, R32241, R32251,
R32259, R32263, R32287, R32290, R32295, R32307, R32308,
R32678, R32696, R32705, R32717, R32719, R32725, R32726,
R32729, R32733, R32735, R32736, R33380, R34016, R34041,
R34142, R34153, R34683, R34696, R34735, R35022, R35094,
R35096, R35105, R35106, R35541;
-3- (c) R28736, R31589, R32290, R32293
R32308, R33380, R33701, R33708, R34016, R34044,
R34050, R34454, R34455, R34457, R34459, R34467,
R34504, R34509, R34510, R34511, 534519, R34521,
R34522, R34543, R34546, R34553, R34570, R34671,
R34683, R34684, R34694, R34953, R35053, R35071,
R35102, R35104, R35105, R35107, R35108, R35111,
R35113, R35288, R35538; (d) R35132.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone September 25, 1994, followed by
letter September 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois, Indiana.
QUANTITY (a) 2 units; (b) 67 units; (c) 43 units; (d) 1 unit.
REASON Blood products incorrectly tested for syphilis were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
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PRODUCT BrandtScan 900S, Model 3151, high speed barcode scanner.
Recall #Z-151-5.
CODE Model #3151.
Manufacturer Brandt, Inc., Bensalem, Pennsylvania.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan October 7, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11 units were distributed
REASON Product failed to comply with the Federal laser product
performance standard in that it did not incorporate an
interlock and failed to display all the required labeling.
_______________
PRODUCT Blood Cardioplegia Delivery Sets, indicated for mixing
cooling, and warming of oxygenated blood/cardioplegic
solution and delivering it to the patient:
(a) Model BCD ADV1, individually packaged in trays, 6 per
carton;
(b) Model BCD ADV4, individually packaged in trays, 6 per
carton;
(c) Model BCD ADV C (with shunt), individually packaged in
trays, 6 per carton;
(d) Model D721 (BCD ADV 1 labeled for Dideco Italy),
individually packaged in trays, 6 per carton;
(e) Model D724 (BCD ADV 4 labeled for Dideco, Italy),
individually packaged in trays, 6 per carton;
(f) Model Mono 4116 (kit with BCD ADV 1 and other devices);
(g) Model Mono 3744 (kit with BCD ADV 1 and other devices);
(h) Model SCPS 3898 (kit with BCD ADV 1 and other devices).
Recall #Z-152/159-5.
-4- CODE Lot numbers: (a) 9400234500; (b) 9400246200;
(c) 9400229500; (d) 9400247100; (e) 9400226600, 9400226700;
(f) 9400273600; (g) 9400271200; (h) 9400256500.
MANUFACTURER Halkey Roberts Corporation, St. Petersburg, Florida.
RECALLED BY Sorin Biomedical, Inc., Irvine, California, by letter
October 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Georgia, Louisiana, Michigan,
North Carolina, Pennsylvania, Tennessee, Texas, Washington
State, West Virginia, Canada, Italy, Japan, The Netherlands.
QUANTITY 3,284 units were distributed; firm estimated that 2,000
units remained on market on 10/14/94.
REASON Due to a defective clamp on the crystalloid line, leakage
may occur, resulting in a variation of infused potassium
concentration in the crystalloid solution.
_______________
PRODUCT Abbott RV Pacing Lead, heparin coated transluminal RV pacing
lead for temporary ventricular pacing only.
Recall #Z-160-5.
CODE All lots up to and including 89-391-TS.
MANUFACTURER Abbott Laboratories, Mountain View, California.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by telephone
October 18, 1994, followed by letter October 19, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Taiwan, Switzerland, Argentina, Spain, The
Netherlands, Canada, Japan, Italy, Puerto Rico.
QUANTITY Approximately 5,000 to 6,000 leads were distributed; firm
estimated that 600 leads remained on the market the time the
recall was initiated.
REASON There is a potential for the tip of the pacing lead to break
off and remain in the patient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
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PRODUCT Lipase Test Reagent C 091-0192, Model P1 used with the Model
No. 91 Amylase-Lipase Analysis System, for in-vitro
diagnostic use only. Recall #Z-101-5.
CODE Lot numbers 880218 and 880517.
MANUFACTURER Electro-Nucleonics, Inc., Cranbury, New Jersey.
RECALLED BY Bacharach, Inc., Pittsburgh, Pennsylvania, by letter July 9,
1990. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,089 units were distributed; firm estimates none remains on
the market.
REASON The reagents when used with the Model 91 Amylase-Lipase
analyzer were out of range after calibration.
_______________
PRODUCT Difco DuraPak Media Chocolate Agar, a media plate used for
isolating and cultivating fastidious microorganisms.
Recall #Z-102-5.
-5- CODE Product #4140-22-7, Lot numbers: 17268, 18392, 23715,
24600, 25903.
MANUFACTURER Difco Laboratories, Sun Prairie, Wisconsin.
RECALLED BY Difco Laboratories, Livonia, Michigan, by letters of March
5, 1993, and July 7, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Switzerland, Italy, Spain, France, Uruguay,
Portugal, Finland, Belgium.
QUANTITY Firm estimates none remains on the market. All lots of the
product have been expired since October 1993.
REASON The plates were failing to grow Hemophilus microorganisms
when tested after storage for 2 to 4 months at room
temperature.
_______________
PRODUCT Epstein-Barr Virus IgM Elisa Test. Recall #Z-149-5.
CODE Kit product #EBE150-E; Kit lot #3LLAYE; Negative control
(component) lot #3EEAAQ.
MANUFACTURER Gull Laboratories, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone and by fax on or about February
10, 1994. Firm-initiated recall complete.
DISTRIBUTION California, Illinois, Massachusetts, Maryland, Michigan,
Mississippi, Virginia, Austria, Singapore, South Africa,
Italy, Switzerland, Uruguay.
QUANTITY 105 units were distributed; firm estimates none remains on
the market.
REASON The Negative Control component of the subject device did not
meet the specification of s0.5 times the mean (average)
absorbance value of the reference serum (low positive
control).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
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PRODUCT Listeria Selective Supplement (MOX), a freeze dried
selective supplement for the isolation of Listeria
monocytogenes. Recall #V-002-5.
CODE Catalog #SR157E, lot #95927 EXP 11/95.
MANUFACTURER Unipath Ltd., (under the Oxoid logo), Basingstoke,
Hampshire, England.
RECALLED BY Unipath Division of UL Canada, Inc., Ogdensburg, New York,
by telephone August 9-26, 1994, and by letter dated August
31, 1994. Firm-initiated recall complete.
DISTRIBUTION Washington, D.C., Tennessee, Georgia, Michigan, New Jersey,
Kansas.
QUANTITY 19 boxes (10 vials per box) were distributed.
REASON Failure of test kit to detect Listeria.
-6- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
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PRODUCT Aureozol (chlortetracycline, sulfathiazole and penicillin)
Category II Type A Medicated article, in 50 pound bags,
antibacterial premix for swine feeds. Recall #V-003-5.
CODE All lots.
MANUFACTURER American Cyanamid Company, Wayne, New Jersey.
RECALLED BY Farmland Industries,Inc., Eagle Grove, Iowa, by letter July
29, 1994. Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY 80 50-pound bags were distributed.
REASON Product shipped to firms not holding approved FDA 1900.
-7-
END OF ENFORCEMENT REPORT FOR DECEMBER 7, 1994. BLANK PAGES MAY
FOLLOW.
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