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
07/30/1994
Recalls and Field Corrections: Foods -- Class I -- 07/30/1994
July 20, 1994 94-29
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT Smoked Nova Chips, 5 pounds. Recall #F-736-4.
CODE None.
MANUFACTURER Springfield Smoked Fish Company, Inc., Springfield,
Massachusetts.
RECALLED BY Manufacturer, by telephone June 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Connecticut.
QUANTITY 5 pounds were distributed.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Shark Cartilage Powder, bulk, 4.2 Kg. Recall #F-388-4.
CODE M-2368.
MANUFACTURER Pharmline, Inc., Florida, New York.
RECALLED BY Manufacturer, by letters of May 24 and 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION California, Canada, Japan.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with Salmonella.
_______________
PRODUCT Various flavors of Estee Snack Crisps, waffle-shaped baked
snacks packaged in both a small 0.66 ounce; 0.70 ounce for
White Cheddar flavor only, and large 4.75 ounce flexible
plastic bag: (a) Chocolate; (b) Apple Cinnamon; (c) Lemon;
(d) Ranch; (e) White Cheddar. Recall #F-724/728-4.
CODE All lots/date codes of products manufactured from 11/1/93
through 3/15/94.
MANUFACTURER The Estee Corporation, Parsippany, New Jersey.
RECALLED BY Manufacturer, by letters dated March 17 and 21, 1994, and
May 4, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Mexico.
QUANTITY (a) 4,454 cases; (b) 4,502 cases; (c) 5,005 cases; (d) 3,509
cases; (e) 238 cases were distributed. As of 4/22/94, firm
estimated that less than 3% of product remained on the
market.
REASON Products may contain metal fragments.
_______________
PRODUCT Dark Chocolate and Milk Chocolate Non Pareils in 8 ounce
boxes. Recall #F-729/730-4.
CODE None.
MANUFACTURER Criterion Chocolates, Inc., Eatontown, New Jersey.
RECALLED BY Manufacturer, by letter January 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 816 boxes were distributed.
REASON Products contain undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Various butter products:
(a) Level Valley 47-cut Lightly Salted Butter, single
serving size;
(b) Monarch 47-cut Lightly Salted Butter, single serving
size;
(c) Level Valley Fresh Sweet Cream Butter, 4 quarters, 16
ounces;
(d) Kroger Lightly Salted Butter, 4 quarters, 16 ounces;
(e) Shur Fresh Lightly Salted Sweet Cream Butter, 4
quarters, 16 ounces. Recall #F-731/735-4.
CODE (a) Recalled codes begin with 482; (b) Recalled codes begin
with 483; (c) Pull date 5/4/94, churn number embossed on the
end of the package is 483; (d) Pull date 5/7/94, churn
number 483; (e) Pull date 5/7/94, churn number 483.
MANUFACTURER Level Valley Dairy Company, West Bend, Wisconsin.
RECALLED BY Manufacturer, by letter March 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, Florida, Georgia, North Carolina, South Carolina.
QUANTITY (a) 558 cases (17 pounds per case); (b) 558 cases (17 pounds
per case); (c-e) 228 cases (36 pounds per case) of the 16
ounce packages of butter quarters.
-2- REASON Products contain dieldrin at a level greater than the
established tolerance.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
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PRODUCT Lindane Lotion, USP 1%, Rx topical, used for the treatment
scabies, in 1 pint bottles sold under the following labels:
Pennex, PBI, Goldline, GG, Major, Qualitest, Rugby, Schein.
Recall #D-327-4.
CODE Lot numbers: 19490A, 19490E, 19516A, 19806A, 19806C,
19806E, 19806F, 19866A, 19866C, 19878P, 19878R, 19878T,
19878X.
MANUFACTURER Pennex Pharmaceuticals, Inc., formerly known as
Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter dated June 29, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 28,856 bottles were distributed; firm estimates 25% of the
product remains on the market.
REASON Lots 19490, 19516 and 19806 do not meet content uniformity
specification. Lots 19866 and 19878 are superpotent.
_______________
PRODUCT Salsalate Tablets, USP: (a) 500 mg, in 100 and 1000 count
bottles; (b) 750 mg, in 100 and 1000 count bottles.
Recall #D-328/329-4.
CODE Lot numbers: (a) 3FE01A, 3FE01B, 3AP02A, 3AP02B; (b)
3FE02A, 3FE02B, 3AP01A, 3AP01B.
MANUFACTURER Caraco Pharmaceutical Laboratories, Inc., Detroit, Michigan.
RECALLED BY Manufacturer, by letter July 20, 1993. Firm-initiated
recall complete.
DISTRIBUTION Colorado, Missouri, Arkansas, Illinois, Michigan, Tennessee,
Louisiana, Florida.
QUANTITY (a) 85 bottles of 100 of lots 3FE01B and 3AP02B; 26 bottles
of 1,000 of lot 3FE01A; (b) 62 bottles of 100 of lot 3FE02B;
and 316 bottles of 1,000 of lots 3AP01A and 3FE02A.
REASON Products do not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Blood Bank Information System (BBIS) Computer Software.
Recall #B-316-4.
CODE All versions released prior to version 4.
MANUFACTURER Collaborative Medical Systems, Inc., Waltham, Massachusetts.
RECALLED BY Manufacturer, by letters of June 25 and 30, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Iowa, Massachusetts, Oklahoma.
QUANTITY 5 systems.
-3- REASON Software, that contained programming errors which could
potentially result in the release of unsuitable blood
products, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT (a) EF Synergy Quad Plated Media, used as a predictor of
synergy of an aminoglycoside and penicillin when testing
enterococci isolates;
(b) Chocolate Agar Mono Plated Media, used in the culturing
of Pathogenic Neisseria and Haemophilus.
Recall #Z-954/955-4.
CODE Lot numbers: (a) 2721 EXP 8/31/93, Catalog #02-454; (b)
3540 EXP 11/12/92, Catalog #01-302.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone September 29, 1992. Firm-
initiated recall complete.
DISTRIBUTION (a) Arkansas, Maine, Massachusetts, New Hampshire, New York,
Rhode Island, California, Ohio, Michigan, Utah, Nebraska,
Missouri, Florida, Virginia, Pennsylvania; (b) California,
Utah, New Mexico.
QUANTITY (a) 660 plates; (b) 1,700 plates were distributed. Firm
estimates none remains on the market.
REASON The control quadrant for the EF Synergy Quad Plated Media
failed to support the growth of the challenge organisms used
as positive controls; and the quality control organism,
Haemophilus influenzae, for the Chocolate Agar Mono Plated
Media did not grow on this lot of product.
_______________
PRODUCT Pro-Lok Beech brand, Shielded Needle Connector, Needle
Housing with Removable Needle, 18GA x 5/8 (16 mm), sterile:
(a) Catalog #01-9018; (b) Catalog #01-9020.
Recall #Z-983/984-4.
CODE All lots with prefix AE through CC, which represents all
lots manufactured between 5/91 and 3/93.
MANUFACTURER VLV Associates, Inc., East Hanover, New Jersey.
RECALLED BY Beech Medical Products, Newtown, Pennsylvania, by letter
August 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Maryland, New York, Massachusetts, Illinois,
Texas, Michigan, California, Ohio, Colorado, Missouri,
Washington state, Minnesota, Indiana.
QUANTITY Approximately 2 million plus units were distributed; firm
estimates none remains on the market.
REASON The female luer of the Pro-Lok housing cracks and may leak
when used with certain IV solutions.
_______________
PRODUCT CardioPump ACD (Active Compressed/Decompression)
Resuscitator both prototype and production models.
Recall #Z-1078-4.
-4- CODE All codes including lot numbers 262237 and 262242.
MANUFACTURER Ambu International A/S, Glostrup, Denmark.
RECALLED BY Ambu, Inc., Linthicum, Maryland, by telephone and letter
April 19, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Minnesota, New York.
QUANTITY 506 devices.
REASON The firm was using data from an unapproved clinical
investigation on human subjects to support a 510(k)
application.
_______________
PRODUCT Storz Intraocular Lens, Model P010UV. Recall #Z-1080-4.
CODE Serial numbers: 1G1705, 1G1710, 1G1717 through 1G1719,
1G1721 through 1G1727, 1G1730, 1G1731, 1G1733, 1G1734,
1G1737, 1G1740, 1G1745, 1G1747, 1G3811.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter April 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Florida, California, Singapore, Germany, Brazil,
Guatemala.
QUANTITY 21 lenses remain in commerce that may still be unimplanted.
REASON The lenses were mislabeled with the incorrect refractive
index.
_______________
PRODUCT Microvasive Ablaser Side-Firing Laser Guide, a laser
delivery guiding catheter, indicated for use for soft tissue
ablation and hemostasis treatment in urological conditions.
Recall #Z-1088-4.
CODE Catalog #800-102, lot numbers: EM02061 EXP 12/95, 118340
EXP 2/96, 118165 EXP 2/96, 118566 EXP 2/96, 119078 EXP 2/96,
119062 EXP 2/96.
MANUFACTURER Boston Scientific Corporation, Milford, Massachusetts.
RECALLED BY Boston Scientific Corporation, Watertown, Massachusetts,
March 22, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, California, Missouri, Mississippi, Illinois, New
York, Kentucky, Virginia, Tennessee, Alabama, Indiana,
Massachusetts, Pennsylvania, Colorado, Florida, Georgia,
Washington, D.C.
QUANTITY 179 units were distributed; firm estimates none remains on
the market.
REASON The gold plated catheter tip may detach during surgery
causing the tip to remain within the body or the laser
reflecting mirror in the tip may char and burn tissue.
_______________
PRODUCT Disposable reservoir bags for Infumed and Walkmed infusion
pumps:
(a) IPR-86 Reservoir Bag, 65 ml;
(b) IPR-150 Reservoir Bag, 150 ml;
(c) IPR-250 Reservoir Bag, 250 ml;
(d) MF-65 Reservoir Bag, 65 ml;
(e) PR-70 Reservoir Bag, 65 ml Recall #Z-1089/1093-4.
-5- CODE: Lot numbers: (a) MF91435, MF91483, MF91487, MF91505,
MF911516, MF92011, MF92069, MF92077, MF92088, MF92114,
MF92138, MF92186, MF92441E, MF92273E, MF92274E, MF922851 and
MF92328;
(b) MF91421, MF91513, MF92013, MF92033, MF92065, MF92080,
MF92117, MF92125, MF92159, MF92204E, MF92243E and MF922761;
(c) MF91454, MF91510, MF92015, MF92067, MF92210E, MF92244E,
MF922791 and MF92330;
(d) MF91445, MF92017 and MF92091;
(e) MF92024.
MANUFACTURER Medex, Inc., Duluth, Georgia.
RECALLED BY Manufacturer, by letter June 11, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, United Kingdom, Germany.
QUANTITY 171,010 bags.
REASON The female luer lock will crack when being used preventing
administration of proper amount of prescribed fluids.
_______________
PRODUCT Baxter/Travenol Fenwal Blood Warmer, used to warm blood
products and intravenous fluids before administration to
reduce complications associated with the infusion of cold
solutions: (a) Product #4R4305 - 115 volts (U.S.
distribution); (b) Product #4R4306 - 220 volts
(international distribution). Recall #Z-1094/1095-4.
CODE Serial numbers 15821 through 19320, and those units which
have had their housing replaced with blue housings with
black EMI coating on the inside.
MANUFACTURER Panlmatic Company, Elk Grove Village, Illinois.
RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois, by
letter June 15, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Colombia, Brazil, Venezuela, United
Kingdom.
QUANTITY An estimated 3,500 units are affected and remain on the
market. These affected units were distributed between May
1985 and September 1987.
REASON There is a potential for electrical shock if the wiring were
to come loose and contact the electrical magnetic
interference (EMI) coating inside the housing.
_______________
PRODUCT CCS Maestro II Models 231, 232, 325, and 333 Cardiac
Pacemakers. Recall #Z-1099/1102-4.
CODE All serial numbers.
MANUFACTURER Cardiac Control Systems, Inc., Palm Coast, Florida.
RECALLED BY Manufacturer, by letter March 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arkansas, California, Connecticut, Florida, Louisiana,
Massachusetts, Maine, Montana, North Carolina, New Jersey,
New York, Ohio, Pennsylvania, Rhode Island, South Carolina,
Tennessee, Texas, Wisconsin.
-6- QUANTITY 416 pacers were distributed domestically. Of those, 284
were implanted and 132 were recovered (per final report). A
total of 574 pacers were distributed internationally and all
were implanted.
REASON An intended future safety feature included in the hybrid
circuitry of the present device design can be spontaneously
activated in some units, causing the device to act as an
asynchronous single-chamber pacer. The likely result of
such an event would be that the pacer would revert to an 80
pulses per minute (ppm) mode, which may not be a
satisfactory default if the mode persists.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Beta Lysin Reagent, 5 ml, a liquid microbial reagent for the
identification of Strep. agalactiae. Recall #Z-956-4.
CODE Catalog #21-022, lot #4111 EXP 10/31/94.
MANUFACTURER Remel Limited partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone January 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Colorado, Illinois, Oklahoma.
QUANTITY 15 units were distributed from 10/11/93 to 1/20/94.
REASON The expected positive QC reaction, an enhanced crescent of
beta hemolysis with Strep. Agalactiae, was not occurring.
_______________
PRODUCT McFarland Equivalence Turbidity Standards 4.0, used as
standards in adjusting densities of bacterial suspensions.
Recall #Z-957-4.
CODE Catalog #20-414, Lot #0154 EXP 4/4/94.
MANUFACTURER Scientific Device Lab., Glenview, Illinois.
RECALLED BY Remel Limited Partnership, Lenexa, Kansas, by telephone
October 20, 1993. Firm-initiated recall complete.
DISTRIBUTION Oklahoma, Texas, Florida, New Jersey, Washington state,
Michigan, Kansas, Missouri, Illinois, Colorado, New Mexico,
New York, Nebraska, Guam, Canada.
QUANTITY 37 units were distributed.
REASON The individual tubes were incorrectly labeled.
_______________
PRODUCT Piperacilin 100 mcg Susceptibility Test Disks, for in-vitro
diagnostic use. Recall #Z-958-4.
CODE Catalog #30-813, Lot #2830 EXP 7/31/94.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone and letter May 7, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 386 units were distributed; firm estimates
none remains on the market.
REASON The individual cartridge labeled Piperacillin was
incorrectly labeled.
-7- _______________
PRODUCT Virocult ENT, in-vitro diagnostic collection and transport
system. Recall #Z-959-4.
CODE Catalog #61-9755, Lot #3811 EXP 2/28/95.
MANUFACTURER Medical Wiring & Equipment, Sparta, New Jersey.
RECALLED BY Remel Limited Partnership, Lenexa, Kansas, by letter January
20, 1994. Firm-initiated recall complete.
DISTRIBUTION New York, Ohio, Kansas.
QUANTITY 8 units of 125 swabs were distributed.
REASON The product had an incorrect expiration date printed on the
label of the outer container.
_______________
PRODUCT Remel RPR Liquid Controls, to be used with the Remel RPR
Card Test Kit. Recall #Z-960-4.
CODE Catalog #16-307, Lot #3083 EXP 4/30/94.
MANUFACTURER Ampcor, Camden, New Jersey.
RECALLED BY Remel Limited Partnership, Lenexa, Kansas, by telephone May
27, 1993. Firm-initiated recall complete.
DISTRIBUTION Illinois, Missouri, Iowa, Tennessee, Michigan, Alabama.
QUANTITY 20 units were distributed.
REASON The reactive control contained black specs and turbidity.
_______________
PRODUCT Contact I Sabouraud Dextrose Agar with Polysorbate 80 with
Lecithin, used in the detection and enumeration of
microorganisms present on surfaces of sanitary importance.
Recall #Z-961-4.
CODE Catalog #11-1306, Lot #3641 EXP 12/9/93.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone October 19 0r 20, 1993. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 500 plates were distributed; firm estimates none remains on
the market.
REASON The product was incorrectly labeled as TSA instead of SAB-
DEX.
_______________
PRODUCT Linvatec Cannuloc, threaded cannula, used during orthoscopic
surgery to introduce various surgical instruments into the
surgical site. Recall #Z-1079-4.
CODE Catalog #9822, Lot #47855.
MANUFACTURER Linvatec, Division of Bristol-Myers Squibb, Largo, Florida.
RECALLED BY Manufacturer, by letter April 6, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Massachusetts, Minnesota, Maine, Denmark, Canada.
QUANTITY 24 boxes of 10 were distributed.
REASON 75 mm Cannuloc Threaded Cannulas were labeled as 50 mm
Cannuloc Threaded Cannulas.
-8- _______________
PRODUCT Wall Mount Brackets, ABS construction, part #008-0046-00, an
accessory item for PROPAQ Patient Monitor, Models 102, 104,
and 106. Recall #Z-1083-4.
CODE All brackets with part #008-0046-00 ABS plastic
construction.
MANUFACTURER Protocol Systems, Inc., Beaverton, Oregon.
RECALLED BY Manufacturer, by letters in January/February 1993, and
May/June 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 196 units were distributed.
REASON An environment of high vibration or severe force could cause
fracture of the plastic portion of the bracket.
_______________
UPDATE 2FR V-Cath Introducer Needle, Recall #Z-683-4, manufactured
by HDC Corporation, which appeared in the April 27, 1994,
Enforcement Report should be identified as Product #350-20,
Lot #1013.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT (a) Organic Iodide with Dextrose, in 1 pound and 25 pound
containers; (b) Organic Iodide with Saline, in 1 pound and
25 pound containers. Recall #V-054/055-4.
CODE Lot numbers: (a) WAB50575, WAB50580; (b) WAB50590,
WAB50595.
MANUFACTURER Chem-Tronics, Inc., Leavenworth, Kansas.
RECALLED BY The Butler Company, Dublin, Ohio, by letter April 21 and 25,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,152 units were distributed.
REASON Labeled directions for use in cattle for ethylenediamine
dihydroiodide (EDDI) exceeds the daily recommended dietary
requirements for cattle.
-9-
END OF ENFORCEMENT REPORT FOR JULY 20, 1994. BLANK PAGES MAY FOLLOW.
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