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
04/26/1995
Recalls and Field Corrections: Foods -- Class I -- 04/26/1995
April 26, 1995 95-17
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Seafood Spread in a plastic tub, net weight 7 ounces.
Recall #F-601-5.
CODE 4 19 95 2234 on container and APR 19 1995 on case.
MANUFACTURER Alaska King Seafoods, Seattle, Washington.
RECALLED BY Manufacturer, by letter March 14, 1995. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
QUANTITY 40 cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Danish bakery products, individually wrapped frozen Danish
rolls, packaged 24 per case unless otherwise stated:
(a) Apple Danish: Royal Danish Apple, 3 ounces;
Kraft Apple Danish, 3 ounces;
(b) Crown Danish Cherry, 3 ounces;
(c) Raspberry Danish: Item 5435 & 5425, Crown Danish
Raspberry, 3 ounces; Item 557454, Kraft Raspberry Danish, 3
ounces;
(d) Kraft Cheese Danish, 3 ounces;
(e) Cinnamon Roll: Item 5436, Supreme Cinnamon Roll, 4
ounces; Item 54362-W, Cinnamon Roll, 36/4 ounces, Net weight
9 pounds; Item 573816, Kraft Cinnamon Roll, 4 ounces;
(f) Variety Pack (Cheese, Apple, Raspberry); Item 5461 &
5471, Variety Crown Danish, 24/3 ounces, Net weight 4.5
pounds; Item 5465-W, Crown Danish Apple/Raspberry/Cheese,
12 pack, 12/3 ounces Net weight 36 ounces; Item 557447,
Kraft Assorted Danish (Apple, Cheese, Raspberry), 4.5
pounds;
(g) Cheese Coffee Cake, 16 ounces;
(h) Raspberry Coffee Cake, 16 ounces;
(i) Caramel Nut Coffee Cake, 16 ounces.
Recall #F-611/619-5.
CODE All product manufactured between 9/1/94 and 3/10/95.
MANUFACTURER La Francaise Bakery, Northlake, Illinois.
RECALLED BY Manufacturer, by relabeling product on March 9, 1995. Firm-
initiated field correction (relabeling) ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,912 cases were distributed; firm estimated that 20
percent of product remained on market at time of recall
initiation.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Murray brand Peanut Butter Cremes, in 14 ounce packages.
Recall #F-622-5.
CODE All lots.
MANUFACTURER President Baking Company, Augusta, Georgia.
RECALLED BY Manufacturer, by voice mail message November 18, 1994,
followed by letter November 21, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 63,250 cases were manufactured/distributed.
REASON Product contains undeclared sugar.
_______________
PRODUCT Pinahs Crunchy Bagel Chips, cinnamon sugar, net weight 10
ounces. Recall #F-647-5.
CODE All lots.
MANUFACTURER Pinahs Company, Inc., Waukesha, Wisconsin.
RECALLED BY Manufacturer, by telephone March 7, 1995, and by letter
March 15, 1995. Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Nebraska, Idaho.
QUANTITY 10,348 packages were distributed.
REASON Product contains undeclared sugar.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Florida's Natural brand Canned Apple Juice in 11.5 ounce
aluminum cans. Recall #F-522-5.
CODE CEHSI (10/26/94).
MANUFACTURER Citrus World, Inc., Lake Wales, Florida.
RECALLED BY Manufacturer, by letter December 3, 1994. Firm-initiated
recall complete.
-2- DISTRIBUTION Florida, Illinois, Michigan, Missouri, North Carolina,
Virginia, Tennessee, Connecticut.
QUANTITY 851 cases (24 cans per case) were distributed.
REASON Product was under processed and contaminated with mold.
_______________
PRODUCT Fresh Frozen Headless Shrimp, in a generic paper box, net
weight 80 ounces (5 pounds) 2268 grams.
Recall #F-606-5.
CODE All lots distributed between August 8 and November 9, 1994.
MANUFACTURER Tex-Mex Cold Storage, Inc., Brownsville, Texas.
RECALLED BY Manufacturer, by letter November 22, 1994, followed by
telephone. Firm-initiated recall complete.
DISTRIBUTION California, Illinois, Michigan, Texas, Virginia.
QUANTITY Firm estimates none remains on the market.
REASON Product is misbranded. The labels do not bear the name and
address of the manufacturer, packer, or the distributor.
_______________
PRODUCT Ripe Olives: (a) Sliced Ripe Olives, in 2.5 ounce
containers; (b) (b) Chopped Ripe Olives, in 4.5 ounce
containers. Recall #F-620/621-5.
CODE Case codes: (a) 84225A, 84124A, 84125A, 842_4A, 84218A,
84118A, 84119A; (b) 84211A.
MANUFACTURER Tri-Valley Growers, San Francisco, California.
RECALLED BY Manufacturer, by telephone on or about February 1, 1994.
Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Florida, Illinois, Oregon.
QUANTITY 8,4087 cases were distributed.
REASON Product is contained in cans with incomplete seams with high
potential for leakage.
_______________
PRODUCT Haddon House Pre-Sliced Forest Mushrooms, Net weight 1 ounce
(28.3g). Recall #F-623-5.
CODE None.
MANUFACTURER Unknown. Purchased by U.S. distributor from Toyo Flakes
Co., Ltd, Yamatokoriyama City, Nara, Japan.
RECALLED BY Haddon House Food Products, Inc., Medford, New Jersey, by
letter January 25, 1995. Firm-initiated recall ongoing.
DISTRIBUTION South Carolina, Ohio, North Carolina, Louisiana, Texas,
Pennsylvania, Virginia.
QUANTITY 134 packages were distributed.
REASON Product contains undeclared sulfites.
_______________
PRODUCT Adam's Ale Drinking Water, in 8 fluid ounce plastic bottles.
Recall #F-624-5.
CODE 94-190 through 94-244.
MANUFACTURER All Star Bottling Company, Kansas City, Kansas.
RECALLED BY Manufacturer, by telephone September 16, 1994. Firm-
initiated recall complete.
-3- DISTRIBUTION Montana, Texas, Oklahoma, Missouri, Nebraska, Wyoming,
Colorado, North Dakota, Minnesota, Louisiana.
QUANTITY Approximately 1 1/2 - 2 million bottles were distributed;
firm estimates none remains on the market.
REASON Product was contaminated with mold.
_______________
PRODUCT Kraft Macaroni & Cheese Dinner: (a) Kraft Original Macaroni
& Cheese Dinner, in 7.25 ounce boxes, 48 boxes per case also
packaged in 6-packs; (b) Kraft Family Size Macaroni & Cheese
Dinner, in 14.5 ounce boxes, 24 boxes per case; (c) Kraft
Spirals Macaroni & Cheese Dinners, in 5.5 ounce boxes, 24
boxes per case. Recall #F-625/627-5.
CODE Best when purchased by: SEP 28 95 C and all OCT 95 dates
followed by C and JAN 07 96 C, JAN 08 96 C, JAN 09 96 C
(14.5 ounce boxes); JAN 02 96 C (7.25 ounce boxes).
MANUFACTURER Kraft USA, Champaign, Illinois (dinner); Kraft USA, Wausau,
Wisconsin (cheese and sauce).
RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by memorandum
February 28, 1995, followed by visit on or about March 3,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Germany.
QUANTITY 125,679 cases were distributed; firm estimated that less
than 20 percent of product remained on market at time of
recall initiation.
REASON Cheese sauce powder has a rancid odor and taste.
_______________
PRODUCT English Muffins manufactured by Fred Meyer Inc., Bakery on
March 19 and March 20 with the following labels:
Fred Meyer brand 4-count 8 oz. packages:
1. "4 fork-split Regular English Muffins
2. "4 fork-split Sourdough English Muffins
3. "4 fork-split Cinnamon Raisin Muffins
4. "4 fork-split Honey Wheat Muffins
5. "4 fork-split Extra Crispy English Muffins
Country Oven brand 6-count 12 oz. packages:
6. "Original english muffins
7. "Sour Dough english muffins
8. "Raisin english muffins
9. "Honey Wheat english muffins
10. "Extra Crisp english muffins
F.G. Meyer Deli brand 12-count 24 oz. packages:
11. "12 pre-split english muffins
12."12 pre-split sourdough english muffins
Cascade Pride brand 6-count 12 oz. packages:
13. "English muffins 6 muffins
14. "Sour Dough 6 muffins
15. "Honey Wheat 6 muffins
16. "Cinnamon Raisin 6 muffins
Cascade Pride brand 10-count 20 oz. packages:
17. "Extra Crispy 10 muffins. Recall #F-628/644-5.
-4- CODE Fred Meyer, Country Oven, and F.G. Meyer brand English
muffins with sell-by date codes MARCH 25 and MARCH 26.
These products have a six day shelf life. Cascade Pride
English Muffins with sell-by date codes MARCH 27 AND
MARCH 29.
MANUFACTURER Fred Meyer, Inc. Bakery, Clackamas, Oregon.
RECALLED BY Fred Meyer, Inc., Portland, Oregon, by issuing press release
March 21, 1995 and by E-mail message. Firm-initiated recall
complete.
DISTRIBUTION Alaska, Montana, Oregon, Washington State, California,
Nevada, Idaho.
QUANTITY 171,494 muffins were distributed; firm estimates none
remains on the market.
REASON Product may have been contaminated with metal pieces.
_______________
PRODUCT Minute Maid Country Style 100% Pure Orange Juice from
concentrate, in 64 ounce paper and 95 ounce plastic
containers. Recall #F-646-5.
CODE Pull date code MAR22 SI.
MANUFACTURER Super Stores Industries, Turlock, California.
RECALLED BY Coca-Cola Foods, Houston, Texas, by telephone March 14,
1995, followed by visit. Firm-initiated recall complete.
DISTRIBUTION California, Idaho, Montana, Oregon, Washington State.
QUANTITY 1,095 64-ounce and 1,575 95-ounce containers were
distributed; firm estimates none remains on the market.
REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Isoniazid Tablets, USP, 100 mg, unit dose packaged, 100
tablets per box, Rx oral drug for the treatment of
tuberculosis. Recall #D-117-5.
CODE Lot #5A410, 4P184, 4A104, 3K501.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois, by letter April
12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,931 cartons of 100 unit dose tablets were distributed;
firm estimated that 35 percent of product remained on market
at time of recall initiation.
REASON Product does not meet dissolution specifications at the 48
and 60 month test intervals.
_______________
PRODUCT Isoniazid Tablets, USP (a) 100 mg, in bottles of 100 and
1,000; (b) 300 mg, in bottles of 30, 100, and 1,000, Rx oral
drug for the treatment of tuberculosis, under the following
labels: Barr, Aligen, Goldline, UDL. Recall #D-123/124-5.
-5- CODE 100 mg: Lot Number Expiration date
0K066AG November 1995
1B066BZ February 1996
1C066DQ April 1996
1C066DR April 1996
1D066FY June 1996
1D066FZ June 1996
2C066DY April 1997
2E066AT May 1997
2E066AV May 1997
2E066CG May 1997
2F066BG June 1997
2F066BH June 1997
2F066CO June 1997
2G066AT July 1997
2G066AV August 1997
2G066BZ July 1997
2I066AM September 1997
2I066AN September 1997
2I066CK October 1997
300 mg:
0D071EG April 1995
0D071EH May 1995
0G071AP July 1995
0G071AQ July 1995
0G071EE July 1995
0H071EA September 1995
0H071EB September 1995
0I071GC October 1995
01071GD October 1995
0I071GE October 1995
0J071DS October 1995
0J071DT October 1995
0K071CS November 1995
0K071CT November 1995
0L071BI January 1996
0L071BJ January 1996
1A071AP January 1996
1A071AQ January 1996
1B071CD March 1996
1B071CE March 1996
1B071CF March 1996
1B071CG March 1996
1B071CH March 1996
1C071DS April 1996
1C071DT April 1996
1C071DV May 1996
1C071DW May 1996
1D071CA May 1996
1D071CB May 1996
1D071CO May 1996
1D071CP May 1996
-6- 1D071FW May 1996
1D071FX May 1996
1I071BM September 1996.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Manufacturer, by letter April 6, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Virgin Islands, Guam.
QUANTITY 745,264 30-tablet bottles (300 mg only);
352,414 100-tablet bottles (100 and 300 mg);
52,514 1000-tablet bottles (100 and 300 mg) were
distributed; firm estimates little product remains on the
market.
REASON Product does not meet dissolution specifications at the 48
and 60 month test intervals.
_______________
PRODUCT Ultra Strength Muscle Rub, in 3 ounce metal tubes; OTC
topical rub used to relieve pain from sore muscles, under
the following labels: Pathmark, Brite-Life, Good Neighbor,
Treasury, Thrifty. Recall #D-125-5.
CODE LOT # EXP LOT # EXP LOT # EXP
S590 4/96 T920 4/95 T928 4/95
U163 5/95 U171 5/95 U179 5/95
U215 5/95 U218 5/95 U221 5/95
U592 5/95 U602 12/95 W036 7/96
W063 7/96 W155 8/96 W165 8/96
W816 10/96 W826 11/96 W860 11/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed April 17, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Rhode Island, Pennsylvania, Michigan,
Illinois, California, Alabama, Florida, Arkansas.
QUANTITY Approximately 175,678 tubes were distributed.
REASON Premature product separation.
_______________
PRODUCT Hydrocortisone Lotion USP, 0.5%, in 2 ounce and 4 ounce
plastic bottles, OTC used for the temporary relief of
itching associated with minor skin irritations and rashes,
under the Clay Park label and the following private labels:
For 4 fluid ounces:
Rugby Anti-itch Lotion Hydrocortisone Lotion;
Schein Hydrocortisone 0.5% Lotion; Valumed Hydrocortisone
0.5% Lotion, distributed by: H.L. Moore Drug Exchange;
For 2 fluid ounces: Rugby Antipruritic-Anti-itch
Hydrocortisone Lotion 1/2%; Valumed Hydrocortisone Lotion
USP, 0.5%, distributed by H.L. Moore Drug Exchange;
Super D Hydrocortisone Lotion USP, 0.5%, distributed by
Super Drugs, Inc.; Goldline Hydrocortisone Lotion, 1/2%;
Brite-Life Hydrocortisone Lotion USP, 0.5%, distributed by
Bergen Brunswig Drug Company; Good Neighbor Pharmacy
Hydrocortisone Lotion USP, 0.5%, distributed by Bergen
Brunswig Drug Company. Recall #D-126-5.
-7- CODE LOT# EXP LOT# EXP LOT# EXP LOT# EXP
S575 4/95 S821 6/95 S830 6/95 T099 7/95
T210 7/95 T257 7/95 T841 9/95 U019 10/95
U466 12/95 U706 1/96 V145 3/96 V438 4/96
V445 4/96 V921 7/96 W338 8/96 W757 10/96
W766 10/96 X024 11/96 X034 11/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter mailed April 7, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 167,405 2-ounce and 18,386 4-ounce bottles were distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets, Pheresis. Recall #B-240-5.
CODE Unit numbers: P19319 and Q01291.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter June 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood product which tested initially reactive to the
hepatitis C virus encoded antigen (anti-HCV) but tested
negative for anti-HCV on a single repeat test, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-234/235-5.
CODE 13FT60183.
MANUFACTURER American National Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter June 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component.
REASON Blood products, which tested initially reactive for syphilis
and were not retested in accordance with the manufacturer's
test kit instructions, were distributed.
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma. Recall #B-236/239-5.
CODE Unit numbers: (a) 13FL18468; (b) 13FT60117, 13FT60124,
13FT60142; (c) 13FL18486, 13FT60117, 13FT60142; (d)
13FL18486, 13FT60117, 13FT60142.
MANUFACTURER American National Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter June 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION Michigan.
QUANTITY (a) 1 unit; (b) 3 units; (c) 3 units; (d) 3 units.
REASON Blood products which were improperly tested for syphilis
were distributed.
-8- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Platelets,
Pheresis; (d) Recovered Plasma. Recall #B-241/244-5.
CODE Unit numbers: (a) V98251; (b) V98245, V98246, V98247,
V98248, V98249, V98250; (c) P19308, P19309, P19312, P19313,
P19315, P19316, P19317, P19318, P19320, P19321, P19322; (d)
V98245, V98246, V98247, V98248, V98249, V98250.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter June 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY (a) 1 unit; (b) 6 units; (c) 11 units; (d) 6 units.
REASON Blood products were improperly tested for anti-HCV, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Mini 22 Channel Cochlear Implant System, Model C122M.
Recall #Z-642-5.
CODE Batch numbers: 16797, 16814, 16830, 16848, 16854. Serial
numbers: CI14185, CI14323, CI14324, CI14379 (units in
inventory, returned); CI14187, CI14188, CI14322, CI14327,
CI14329, CI14332, CI14333, CI14373 (implanted); 12 units
sold outside U.S. -- CI14113, CI14416, CI14118, CI14120,
CI14270, CI14274, CI14281, CI14114, CI14271, CI14278
(implanted); CI14277, CI14279 (returned).
MANUFACTURER Cochlear Pty Ltd (CPL), Sydney, Australia.
RECALLED BY Cochlear Corporation, Englewood, Colorado, by telephone
December 1994. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, California, Florida, Georgia,
Pennsylvania, Tennessee, Texas, France, Spain, Australia.
QUANTITY 24 units were distributed.
REASON The power supply capacitors were installed incorrectly
causing premature failure of the device.
_______________
PRODUCT IMED Volumetric Infusion Pumps with software versions 4.0
and 4.1, indicated for the delivery of medical/nutritional
fluids to patients: (a) Model 960A, designed for use with
Accuset administration sets; (b) Model 965A, designed for
pediatric/neonatal infusions using "Microset" administration
sets. Recall #Z-680/681-5.
CODE All pumps with software versions 4.0 and 4.1.
MANUFACTURER IMED Corporation, San Diego, California.
RECALLED BY Manufacturer, by letter November 8, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,000 units were distributed.
REASON A software defect may allow the device to "lock up" and
over-infuse fluids or air, without triggering an alarm.
-9- _______________
PRODUCT Digital Spotfilm System (DSS), used in fluoroscopy:
(a) 3.0 Systems, Models 79189-A and 79189-B; (b) IIP 3.0
Systems, Model 79190. Recall #Z-682/683-5.
CODE Serial numbers: 31-020, 32-123, 32-136, 32-141, 32-143,
32-144, 32-154, 32-156, 32-159, 32-161, 32-163, 32-169,
32-170, 33-105, 33-113A, 33-127A, 33-138A, 33-139A, 33-141A,
33-142A, 33-144A, 33-148A, 33-162A, 33-163A, 33-164A,
33-165A, 33-173A, 33-176A, 33-188A, 33-192A, 33-106B through
33-112B, 33-114B through 33-126B, 33-128B through 33-137,
33-140B, 33-145B, 33-146B, 33-149B through 33-161B, 33-166B
through 33-169B, 33-174B through 33-186B, 33-190B through
33-193B, 33-202B through 33-206B, 33-100C.
MANUFACTURER Infimed, Liverpool, New York.
RECALLED BY Picker International, Inc., Cleveland, Ohio, by issuing a
Mandatory Letter #336 dated June 14, 1994. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide, Canada, France, Germany.
QUANTITY 98 units were distributed.
REASON A software bug in version 3.05 software was causing
intermittent image losses.
_______________
PRODUCT Model 8400STi Volume Ventilators, with pressure control and
volume assured pressure support features. Recall #Z-689-5.
CODE All serial numbers.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
RECALLED BY Manufacturer, by letter January 13, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 529 units were distributed.
REASON A software defect results in a false error code indicating
that a breath was not properly delivered, when in fact the
breath was delivered. This false error code requires
removal of the ventilator from service.
_______________
PRODUCT Custom Surgical Kits. Recall #Z-693-5.
CODE Catalog #SCV25BS060, JKK CAD PACK #6.
MANUFACTURER Baxter Custom Sterile, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone and by letter on or about January
30, 1995. Firm-initiated recall complete.
DISTRIBUTION Alabama.
QUANTITY 20 kits were distributed; firm estimates none remains on the
market.
REASON Devices were packaged in the wrong type of pouches for gas
sterilization and that, due to this packaging error, the
firm is unable to assure that the devices were sterilized
properly.
-10- _______________
PRODUCT Endopath Endoscopic Reloadable Linear Cutter with Safety
Lock-Out: (a) Product Code EZ35B; (b) Product Code EZ35W.
Recall #Z-695/696-5.
CODE All lots.
MANUFACTURER Ethicon Endosurgery, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter September 23, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,000 units were distributed.
REASON A component within the handle of the instrument that was
incorrectly molded, may cause the instrument to malfunction.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT In-vitro diagnostic test kits, indicated for the detection
of infectious mononucleosis IgM Heterophile Antibodies in
serum, plasma, or whole blood:
(a) Cards O.S. Mono, Catalog #CR7758 (20 test);
(b) Concise Plus Mono, Catalog #4650 (20 test).
Recall #Z-684/685-5.
CODE Lot number range: (a) 760443.1 through 840018.1;
(b) 780369.1 through 830026.1.
MANUFACTURER Pacific Biotech, Inc. (PBI), San Diego, California.
RECALLED BY Manufacturer, by letter January 17, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 23,754 kits were distributed. On January 26, 1995, firm
estimated that 2,600 kits remained on the market.
REASON Due to a defective raw material, false negative test results
are obtained.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT Glover Farms GRW-FIN, a swine feed mineral supplement in 60
pound bags. Recall #V-026-5.
CODE Product #S2104, Control #412197.
MANUFACTURER Good-Life Feed Additives, Effingham, Illinois.
RECALLED BY Manufacturer, by telephone January 30, 1995. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 40 bags were distributed.
REASON High level of selenium.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT CITE Sulfa Trio Test Kit, Product #06-01667-00.
Recall #V-029-5.
CODE 064KL and 230LL.
-11- MANUFACTURER Idexx Laboratories, Westbrook, Maine.
RECALLED BY Manufacturer, by distributing new conjugates for the test
kits with instructions to replace the conjugate in the kit
on March 6, 1995. Firm-initiated field correction complete.
DISTRIBUTION Nationwide, Taiwan, Argentina.
QUANTITY 433 kits of lot 064KL and 498 kits of lot 230LL were
distributed.
REASON CITE Solution 1 Alkaline Phosphatase Conjugate did not
always activate the positive control of the test membrane
resulting in possible false negative results.
-12-
END OF ENFORCEMENT REPORT FOR APRIL 26, 1995. BLANK PAGES MAY
FOLLOW.
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