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
01/18/1995
Recalls and Field Corrections: Foods -- Class II -- 01/18/1995
January 18, 1995 95-3
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Enamelware Dinnerware:
(a) Floral Salad Plate, Item #05356-0;
(b) Cowboy Plate, Item #11356-1;
(c) Cowboy Bowl, Item #11354-7. Recall #F-179/181-5.
CODE All lots.
MANUFACTURER Lucky Enamelware Factory Ltd., Tsuen Wan, Hong Kong.
RECALLED BY Midwest of Cannon Falls, Cannon Falls, Minnesota, by letter
dated November 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, France, England.
QUANTITY Firm estimated that: (a) 8,106 units; (b) 13,573 units; (c)
1,747 units remained on market at time of recall initiation.
REASON Product contains excessive levels of leachable lead.
_______________
PRODUCT Ice cream and frozen yogurt in 3 gallon bulk containers:
(a) Rocky Road Ice Cream; (b) Heath Crunch Ice Cream; (c)
Bumpy Road Ice Cream; (d) Heath Frozen Yogurt.
Recall #F-184/187-5.
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 very little if any product remains on the
market.
REASON Product contains undeclared almonds.
_______________
PRODUCT Sathers Sugar Free Taffy, in 1 ounce plastic bags.
Recall #F-188-5.
CODE 39C4 230.
MANUFACTURER Sweet Candy Company, Salt Lake City, Utah.
RECALLED BY Sathers, Inc., Round Lake, Minnesota, by telephone December
7, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Chile.
QUANTITY 322 cases (12 bags per case) were distributed.
REASON Product is labeled as sugar free taffy, but actually
contains regular taffy.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Ice Cream in 3 gallon bulk containers:
(a) Peanut Butter Ripple; (b) Peanut Butter Cup.
Recall #F-182/183-5.
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 very little if any product remains on the
market.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Artane (Trihexyphenidyl HCl), Sequels, 5 mg Sustained
Release Capsules, in bottles of 60, Rx used in the treatment
Parkinsonism. Recall #D-044-5.
CODE Control #374-386.
MANUFACTURER Lederle Labs, Inc., Division of American Cyanamid Company,
Pearl River, New York.
RECALLED BY Manufacturer, by letter December 7, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Chile.
QUANTITY 15,031 bottles were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
_______________
PRODUCT Asendin (Amoxapine) Tablets, 100 mg, in bottles of 100 and
in 10 unit dose strips totaling 100 tablets, Rx indicated
for the relief of symptoms of depression. Recall #D-045-5.
-2- CODE Control numbers: 374-365, 374-366.
MANUFACTURER Lederle Laboratories, Inc., Division of American Cyanamid
Company, Inc., Pearl River, New York.
RECALLED BY Manufacturer, by letter November 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,288 bottles and unit dose strips were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
UPDATE Bulk Naltrexone Hydrochloride Powder, Recall #D-038-5, which
appeared in the December 21, 1994 Enforcement Report listed
a lot number as 1479SMJ064. The correct number is
1479SMJ065.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Positron (Or "Position", These terms seem to be used
interchangeably) Energy Processor Powerboard
(Part #3100128-000) for the ECAT Scanner #953.
Recall #Z-169-5.
CODE Serial numbers: 9301245, 9301255, 9301257.
MANUFACTURER Siemens Medical Systems, Inc., Hoffman Estates, Illinois.
RECALLED BY CTI PET Systems, Inc., Knoxville, Tennessee, October 15,
1993. Firm-initiated recall complete.
DISTRIBUTION Georgia, Sweden, Germany.
QUANTITY 3 units; firm estimates none remain on market.
REASON A component not permitted by the manufacturer's
specifications was used in the manufacture of the
powerboards.
_______________
PRODUCT Transducer Protectors, 0.2 micron filter, used as an in-line
protective device for pressure monitors in high flux
hemodialysis systems: (a) Catalog #SLF 025 PB - Dualex
Plus; (b) Catalog #SLFG 025 UB - Dualex Ultra Sterile
(1000/box), Catalog #SLFG 025 US (50/box).
Recall #Z-233/234-5.
CODE Catalog No. Carton I.D No.:
SLFG 025 UB SF1M 872 H2
Lot No: Lot No:
H3BM 985 80 H3CM 872 H2
H3BM 984 84 H3CM 872 H23
H3CM 989 00 H3CM 872 H24
H3CM 989 36 H3CM 872 H25
H3HM 995 27 H3CM 872 H26
H3HM 995 41 H3JM 872 H2
H3KM 000 02 H3JM 872 H21
-3- H3KM 000 20 H3JM 872 H22
H3KM 999 77 H3JM 872 H23
H4MM 001 54 H3JM 872 H24
Catalog No.: Catalog No.
SF1M 872 H2 SLFG 025 US
Lot No: Lot No:
H3BM 985 35 H3HM 994 99
H3BM 987 00
H3BM 985 48
H3CM 987 51
H3CM 989 35
H3CM 989 65
H3EM 993 35
H3EM 994 10
H3EM 994 31
H3EM 994 54
H3EM 994 66
H3CM 988 33.
MANUFACTURER Millipore Cidra, Inc., Cidra, Puerto Rico.
RECALLED BY Millipore Corporation, Bedford, Massachusetts, by letter
January 27, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3.5 million were distributed.
REASON Product may exhibit air leakage at the female luer lock
connection to the male luer of the hemodialysis machine
under normal operating conditions.
_______________
PRODUCT DiaPure Dissolution System, used in hemodialysis treatment.
Recall #Z-235-5.
MANUFACTURER Fresenius USA, Inc., Walnut Creek, California.
RECALLED BY Manufacturer, by retrofitting with new valves between June
20, 1994 and September 15, 1994. Firm-initiated field
correction complete.
DISTRIBUTION California, Louisiana, Maryland, New Jersey, Oklahoma.
QUANTITY 66 units.
REASON Product does not have an approved application for pre-market
approval or an investigational device exemption in effect.
The device is further adulterated in that the pinch valve
may fail causing the device to report "bag not filling."
_______________
PRODUCT Siemens Linear Accelerators: (a) Digital Mevatron Linear
Accelerators with Therapy Data Management System (TDMS);
(b) Conventional Mevatron Linear Accelerator with TVS
System. Recall #Z-236/237-5.
CODE All serial numbers. All models having TDMS Distal Model TVS
for conventional models.
MANUFACTURER Siemens Medical Systems, Inc., Oncology Care Systems,
Concord, California.
RECALLED BY Manufacturer, by letter September 15, 1994. Firm-initiated
field correction ongoing.
-4- DISTRIBUTION Nationwide and international.
QUANTITY 110 units were distributed.
REASON The TDMS software and hardware versions 3.3 and 3.5 were not
adequately validated before release.
_______________
PRODUCT Aequitron Ventilators: (a) Model LP6 V Volume Ventilators;
(b) LP10 Volume Ventilators; (d) Drager Model EV 801
Electronic Ventilators, used to provide continuous
respiratory support for patients with respiratory
insufficiencies: Recall #Z-264/266-5.
CODE Serial numbers: (a) 131104, 131106-131111, 131113,
131115-131126, 131128, 131131, 131134-131141, 131143,
131154, 131155, 131160-131169, 131171-131174, 131179-131195,
131197, 131198, 131219, 131223-131236, and 131242-131245.
(b) 102344, 102348, 102355, 102356, 102359, 102360, 102361,
102364, 102365, 102367-102377, 102381, 102390,
102393-102407, 102409, 102410, 102414, 102417-102439,
102442-102445, 102448-102469, 102471-102481, 102503-102506,
102508-102527, 102529-102531, 102534-102539, 102543,
102547-102550, 102609-102651, 102653-102663, 102702-102711,
102714, 102716, 102718, 102719, 102740, and 102743.
(c) ARHC-0001 through ARHC-0041, ARHC-0044 through
ARHC-0060, ARHE-0001 through ARHE-0020, ARHE-0042 through
ARHE-0046, ARHE-0048 through ARHE-0051, ARHE-0053,
ARHE-0054, ARHE-0056, CRHA-0011 through CRHA-0015, NRHF-0001
through NRHF-0007, NRHF-0010.
MANUFACTURER Aequitron Medical, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter December 9, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan, Germany.
QUANTITY (a) 85 units; (b) 248 units; (c) 102 units were distributed.
REASON Device malfunctions could result because of a failure to
apply adhesive to bearings in the connecting arm assemblies
of the ventilators.
_______________
PRODUCT Silicone Suction Reservoir, 100 cc, wound drainage system.
Recall #Z-287-5.
CODE Product #215-20. Lot #93310146.
MANUFACTURER Sil-Med Corporation, Taunton, Massachusetts.
RECALLED BY Stryker Instruments, Division of Stryker Corporation,
Kalamazoo, Michigan, by letter May 23, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 30 boxes (10 units per box) were distributed.
REASON Seals on the pouches containing the devices were broken, and
the sterility of the devices had been compromised.
_______________
PRODUCT 5 French Pigtail and Selective Angiographic Catheters.
Recall #Z-288/296-5.
-5- CODE Model Numbers Lot Numbers
08526-40 B25205, B27971, B32833, B32876
08526-41 B28843, B29044, B30341, B30540, B30994,
B32549, B32834,
08526-42 B27970
08526-117 B29743
08526-121 B32501
08526-142 B29744, B33581
08526-146 B27527, B32502
08526-300 B27622, B27960, B29591, B30105, B30331,
B30537, B31210, B31611, B32822
08526-301 B27623, B27959, B29590, B30715, B30898,
B32185.
MANUFACTURER Scimed Life Systems, Inc., Maple Grove, Minnesota.
RECALLED BY Manufacturer, by fax and by telephone November 8, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,944 units were distributed.
REASON The distal tip of the devices can separate during use.
Should the distal tip separate, there is a potential for
lodging of the distal tip in an area of the cerebra
circulation, perhaps resulting in a stroke.
_______________
PRODUCT Pulsemaster Dental Surgery Laser System. Recall #Z-298-5.
CODE Model 1000.
MANUFACTURER Incisive Technologies, Inc., San Carlos, California.
RECALLED BY Manufacturer. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Germany, Japan.
QUANTITY 39 units were distributed.
REASON The device was found to have a defective design in that
certain heat exchangers that had been distributed were non-
passivated exchangers that corrode easily resulting in
decreased laser output power.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Olympus Disposable Snares, used for polypectomy procedures:
(a) Model SD-14L; (b) Model SD-14U; (c) Model SD-15L;
(d) Model SD-15U. Recall #Z-242/245-5.
CODE All lots.
MANUFACTURER Shiraku Olympus Company, Ltd., Odakura Nishigo-Mura,
Fukushima, Japan.
RECALLED BY Olympus America, Inc., Lake Success, New York, by letter
November 4, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,396 units were distributed.
REASON The snare wire could separate from the interconnection to
the handle during the removal of polyps.
-6- _______________
PRODUCT Stratus hLH Fluorometeric Enzyme Immunoassay which is an
automated procedure for the quantitative determination of
HLH in serum and plasma samples. Recall #Z-267-5.
CODE Catalog #B5700-52S, lot #KXLH-14S EXP 5/16/94.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter dated
February 1994. Firm-initiated recall complete.
DISTRIBUTION Colorado, Florida, Iowa, Kansas, Texas.
QUANTITY 6 kits were distributed in January 1994.
REASON An incorrect checksum value was calculated by using the tab
expiration date instead of the kit expiration date.
_______________
PRODUCT Stratus-hFSH Fluorometric Enzyme Immunoassay, an automated
procedure for the quantitative determination of hFSH levels
in serum and plasma samples. Recall #Z-268-5.
CODE Catalog #B5700-51, lot KXFH-799M EXP 1/29/94.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter dated
November 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Venezuela.
QUANTITY 37 kits were distributed from September 1993 to December
1993.
REASON An incorrect checksum value was provided for the analyzer
employed by this test.
_______________
PRODUCT Polypectomy Snare, 7 French, in small, medium and large
sizes. Recall #Z-269-5.
CODE Lot numbers beginning 111493 through 020994.
MANUFACTURER Wiltek Medical, Inc., Rural Hall, North Carolina.
RECALLED BY Manufacturer, by letter. Firm-initiated recall complete as
of August 1, 1994.
DISTRIBUTION California, Connecticut, Georgia, Michigan, Missouri, New
York, Pennsylvania, Virginia.
QUANTITY 3,541 snares were distributed.
REASON The snare head may become detached from the cable.
_______________
PRODUCT Stockert Heater/Cooler Units, used to warm/cool patient's
blood during open heart surgery:
(a) Model 16-02-20 Heater-Cooler, base unit;
(b) Model 16-12-01 Heater-Cooler II - 115v, base unit plus
controller;
(c) Model 16-21-01 Heater-Cooler with Mast, base unit plus
controller. Recall #Z-284/286-5.
CODE Serial numbers: 16F3114 - 16F3117, 16F3147 - 16F3149,
16F3150 - 16F3152, 16F3178, 16F3179, 16F3182, - 16F3184,
16F3232, 16F3233, 16F3366 (on hand at Sorin), 16F3367,
16F3396, 16F3418, 16F3489, 16F3649 - 16F3651, 16F3693.
MANUFACTURER Stockert Instrumente GmbH, Munich, Germany.
-7- RECALLED BY Sorin Biomedical, Inc., Irvine, California, by issuing a
"Sorin Biomedical Product Bulletin" on October 24, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION California, Indiana, Ohio, Pennsylvania, Texas, Washington
State.
QUANTITY 25 units were distributed.
REASON The devices fail to heat or cool during use. Should the
device fail to cool, the immediate consequences would be
that the patient would require a higher pump perfusion rate
that may increase trauma to blood components.
_______________
PRODUCT Stratus CK-MB Fluorometric Enzyme Immunoassay, an automated
procedure for the quantitative determination of CK-MB levels
in serum and plasma samples. Recall #Z-297-5.
CODE Catalog B5700-60, lot numbers: KXMB-1635 EXP 1/28/94, KXMB-
1636 EXP 1/28/94, KXMB-1637 EXP 1/28/94, KXMB-1640 2/13/94.
MANUFACTURER Baxter Diagnostic of PR, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by telephone
initiated December 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 802 kits were distributed from December 1993 to January
1994.
REASON Products are being recalled due to kit cross configurations
with one or more components being assigned the same lot
number.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Sterile Prednisone Suspension Veterinary, (Meticorten), 40
mg/ml, 50 ml, intramuscular, indicated for conditions
requiring an anti-inflammatory agent. Recall #V-011-5.
CODE Lot #4-ABC-1 EXP MARCH 1996.
MANUFACTURER Schering Plough Products, Inc., Manati, Puerto Rico.
RECALLED BY Manufacturer, by letter October 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,950 vials were distributed.
REASON Syringeability problems when product is used with small
diameter needles.
SEIZURES:
=================================================================
_______________
PRODUCT Liquid Oxygen, USP (94-682-964).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, processing,
packaging, and holding do not conform to and are not
operated and administered in conformity with current good
manufacturing practice requirements.
LOCATION Coastal Surgical, Lake Worth, Florida.
-8- FILED December 1, 1994; U.S. District Court for the Southern
District of Florida; Civil #94-08695-CIV-MORENO; FDC #67028.
SEIZED December 30, 1994 - goods valued at approximately $3,000.
_______________
PRODUCT Various topical cream and gel prescription drugs (94-628-308
et al).
CHARGES New Drugs - There are no approved new drug applications
filed for the products. Misbranded - The products' labels
fail to bear adequate directions for use and the established
names of the drugs. The articles have not been duly listed
as required. The articles are prescription drugs and their
labels fail to bear the legend, "Caution: Federal law
prohibits dispensing without a prescription."
LOCATED Tex International Corporation, Miami Lakes, Florida.
FILED November 23, 1994; U.S. District Court for the Southern
District of Florida; Civil #94-2507-CIV-MARCUS; FDC #67030.
SEIZED December 1, 1994 - goods valued at approximately $33,600.
_______________
PRODUCT Canned Mushroom Stems and Pieces (94-742-475/80).
CHARGES Adulterated - The article (can code "S1 109/940107/8052")
contains an added poisonous and deleterious substance,
staphylococcal enterotoxin, which may render it injurious to
health; and the article (both can codes) has been prepared
and packed under conditions whereby it may have been
rendered injurious to health.
LOCATION Coborn's, Inc., St. Cloud, Minnesota.
FILED December 29, 1994; U.S. District Court for the District of
Minnesota; Civil #3-94-1629; FDC #67041.
SEIZED January 9, 1995 - goods valued at approximately $33,617.
MASS SEIZURE:
=============================================================
_______________
PRODUCTS Anesthetic medicated ointments, hemorrhoidal ointments, and
their raw material components (94-670-115/6).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Hydrosal Manufacturing Company, also doing business as
Merchandise, Inc., Miamitown, Ohio.
FILED January 5, 1995; U.S. District Court for the Southern
District of Ohio; Civil #C-1-95-007; FDC #66966.
SEIZED January 6, 1995 - goods valued at approximately $15,000.
-9-
END OF ENFORCEMENT REPORT FOR JANUARY 18, 1995. BLANK PAGES MAY
FOLLOW.
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