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
12/16/1992
RECALLS AND FIELD CORRECTIONS: December 16, 1992
FOODS -- CLASS III
92-51
PRODUCT Happy Valley Springs Pure Drinking Water, in 2-1/2 gallon
plastic liqui-boxes with handi-tap valve;
(b) Food Club Pure Drinking Water, in 2-1/2 gallon plastic
liqui-boxes with handi-tap valve. Recall #F-118/119-3.
CODE Happy Valley and Food Club Brands dated with a pull date of AUG
28 93, SEP 3 93, SEP 4 93, and SEP 11 93.
MANUFACTURER Happy Valley Springs Inc., Kentwood, Louisiana (water);
Liqui-Box Corpporation, Houston, Texas (bottles).
RECALLED BY Happy Valley Springs, Inc., Kentwood, Louisiana, by telephone
during week of September 14, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Mississippi, Louisiana, Alabama.
QUANTITY 10,296 bottles of Food Club brand and 2,448 bottles of Happy
Valley Springs brand were distributed.
REASON The products have an off-odor.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
PRODUCT Cucumber Cleansing Cream, in 6 ounce plastic jars.
Recall #F-131-3.
CODE 246R4.
MANUFACTURER Kolmar Laboratories, Inc., Port Jarvis, New York.
RECALLED BY Del Labs, Farmingdale, New York, by telephone and follow up
letter October 16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,529 jars were distributed.
REASON Product is contaminated with Pseudomonas cepacia.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT (a) Corn-Stick, 5.10 grams, corn/callus remover; (b) Wart
Stick, 5.10 grams, wart remover. Recall #D-076/077-3.
CODE All lots.
MANUFACTURER Balassa Laboratories, Inc., Port Orange, Florida.
RECALLED BY Manufacturer, by letter August 25, 1992. Firm-initiated recall
complete.
DISTRIBUTION Colorado, New York, Illinois.
QUANTITY Firm estimates none remains on the market.
REASON Products are not formulated in accordance with OTC monograph
for wart/corn remover drugs.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT SEBRA Mini Sealer Model 2380 portable tube sealer with
rechargeable battery pack, indicated for sealing tubing in
blood banks. Recall #B-041-3.
CODE Serial numbers: 0001, 0002, 0015, 0016, 0017, 0019, 0020,
0021, 0022, 0023, 0024, 0100 through 0247, 0249 through 0268,
0270 through 0299, 0301 through 0324, 0326 through 0338, 0340
through 0365, 0367 through 0375, 0377, 0378, 0380 through 0386,
0389 through 0394, 0396, 0397.
MANUFACTURER Engineering & Research Associates, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter March 18, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Alabama, Arizona, California, Colorado, Florida, Illinois,
Louisiana, Maryland, Minnesota, Mississippi, North Carolina,
New Hampshire, New Mexico, Nevada, New York, Oregon, South
Carolina, Tennessee, Texas, Virginia, Vermont, Washington
state, Wisconsin, Argentina, Austria, Brazil, Canada, England,
France, Greece, Hong Kong, Italy, Korea, Netherlands, Spain,
Sweden, Taiwan.
QUANTITY 298 units were distributed.
REASON The battery pack of the portable tubing sealer has a design
flaw which may cause electrical short or overheating of the
device.
-2-
PRODUCT Platelets. Recall #B-079-3.
CODE Unit #C80156.
MANUFACTURER Nueces County Medical Society Community Blood Bank, Corpus
Christi, Texas.
RECALLED BY Consignee notified firm by telephone November 15, 1991.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Platelets labeled with the incorrect expiration date were
distributed.
PRODUCT (a) Platelets; (b) Cryoprecipitated AHF. Recall #B-082/083-3.
CODE Unit #KM14767.
MANUFACTURER Richmond Metropolitan Blood Services, Inc., Richmond, Virginia.
RECALLED BY Manufacturer, by telephone July 9, 1992. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus types 1/2
(anti-HIV-1/2), were distributed.
PRODUCT Platelets. Recall #B-085-3.
CODE Unit #0974123.
MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, Kentucky.
RECALLED BY Consignee notified firm by telephone March 27, 1992.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration date was
distributed.
PRODUCT Platelets. Recall #B-087-3.
CODE Unit #49H93111.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone August 14, 1992. Firm-initiated
recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit.
REASON Blood product untested for syphilis was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-080/081-3.
CODE Unit numbers: (a) KM16322, KM16326; (b) KC17053.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
-3-
RECALLED BY Consignee notified firm by telephone September 29, 1992 and
October 2, 1992. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY (a) 2 units; (b) 1 unit.
REASON Blood products, labeled with incorrect expiration dates were
distributed.
PRODUCT Red Blood Cells. Recall #B-084-3.
CODE Unit #F42773.
MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina.
RECALLED BY Manufacturer, by letter dated July 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Red Blood Cells, collected from a donor who had traveled to
areas endemic for malaria and taken prophylactic anti-malarial
medication less than three years prior to donation, were
distributed.
PRODUCT Whole Blood. Recall #B-086-3.
CODE Unit #9165126.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY Consignee notified firm by telephone October 29, 1991.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Multipolar Bioplar Acetabular Cups, for use with femoral stems
in hip replacement operations:
(a) Product #5000-54-32; (b) Product #5000-55-28.
Recall #Z-053/054-3.
CODE Lot numbers: (a) 78964100; (b) 79214100.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by telephone August 26, 1992, and letter August
28, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Germany.
QUANTITY (a) 19 pieces; (b) 20 pieces were distributed.
REASON Device labeled as containing a 28 mm liner was found to contain
a 32 mm liner, and vice versa.
-4-
PRODUCT Accuflate Tourniquet System, a medical device which employs
ambient air for cuff inflation and pressure regulation and is
used during emergency and elective cases when it is necessary
to reduce the flow of blood and/or when greater visualization
of the operative field is desired or imperative.
Recall #Z-089-3.
CODE Serial numbers: 0001S1 through 49S1 and 51S1 through 56S1.
(Serial #50S1 was never manufactured or shipped).
MANUFACTURER Instrumed, Inc., Bothell, Washington.
RECALLED BY Manufacturer. All units were returned on or about June 27,
1992. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 55 units were distributed.
REASON Some of the units tested did not meet the firm's specifications.
PRODUCT Biological Test Pack and Culture Service Program, a spore
autoclave sterilization indicator. Recall #Z-116-3.
CODE All lot numbers. Catalog/reorder #269067.
MANUFACTURER Propper Manufacturing Company, Inc., Long Island City, New York.
RECALLED BY Manufacturer, by letter February 10, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 153 boxes were distributed.
REASON The device lacks an approved 510(k) to be marketed for use as
sterilization indicators for chemical vapor sterilization
(chemiclave).
PRODUCT Valleylab Sterile, Disposable Laparoscopic Electrodes.
Recall #Z-117-3.
CODE Catalog #E2771-28, lot #B-0871.
MANUFACTURER Valleylab, Inc., Pfizer Hospital Products Group, Boulder,
Colorado.
RECALLED BY Manufacturer, by letter dated November 2, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 112 cases (1,120 packages) were distributed. This quantity
includes 7 cases incorrectly shipped under catalog #E2783, Lot
#N-0579.
REASON A single lot of the product had inadequate seals which could
compromise the sterility of the device.
PRODUCT Diascan Blood Glucose Monitoring Test Strips, for the
determination of glucose in whole blood. Recall #Z-128-3.
CODE Lot numbers/EXP Dates: DC104A/May 2, 1993, DC104B/May 4, 1993,
DC104C/May 4, 1993; DC105A/May 22, 1993.
MANUFACTURER Home Diagnostics, Inc., Ft. Lauderdale, Florida.
RECALLED BY Home Diagnostics, Inc., Eatontown, New Jersey, by letter June
24, 1992. Firm-initiated recall ongoing.
-5-
DISTRIBUTION Nationwide, Canada.
QUANTITY 19,667 units of lot DC104A, 24,490 units of lot DC104B, 3,839
units of lot DC104C, and 13,373 units of lot DC105A were
distributed.
REASON The product could provide falsely low glucose readings.
PRODUCT Ocean Pacific Med Tec 2nd Generaton Opal Non-Powdered Latex
Medical Examination Gloves. Recall #Z-155-3.
CODE Item Numbers Lot Numbers
115 (small) 22-6, 23-6
215 (medium) 22-5, 23-5
315 (large) 21-4, 22-7, 23-4.
MANUFACTURER A.P. Rubber Company, Hatyai, Songkhla, Thailand.
RECALLED BY Shepard Medical Products, Melrose Park, Illinois, by letters of
September 2, 1992, and November 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Colorado, Illinois, New York, Texas, Pennsylvania.
QUANTITY 163 cases (100 gloves per carton, 10 cartons per case) were
distributed.
REASON The gloves failed to comply with regulations, with respect to
patient examination gloves leakage defects.
PRODUCT Argyle Left Ventricular Sump Vent Catheter with Cath-Lok and
Sentinel Line, 14 FR, a Rx device. Recall #Z-156-3.
CODE Reorder #8888-590208, Lot #443955.
MANUFACTURER Sherwood Medical Argyle, New York.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by telephone
beginning November 4, 1992, followed by letter. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,770 units were distributed.
REASON Some of the packages may not be completely sealed.
PRODUCT Cross Cut Fissure Carbide Bur, a cutting accessory for
orthopedic bone saw:
(a) Part No. 296-100-216, 1.6 mm; (b) Part No. 296-100-221, 2.1
mm. Recall #Z-157/158-3.
CODE Lot numbers: (a) 92080321; (b) 92070311.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION (a) Illinois, Ohio, Virginia, California, Florida, Georgia; (b)
Nationwide, Canada, United Kingdom.
QUANTITY (a) 12 boxes; (b) 571 boxes were distributed.
REASON Devices labeled as containing a 296100-216 bur may contain a
296-221 bur, and vice versa.
-6-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Medium Adult Airway, single-use, used to maintain an
oropharynageal airway on persons while under anesthesia.
Recall #Z-122-3.
CODE Catalog #32068-540, lot #042491.
MANUFACTURER Gierco Company, Inc., Barnegat, New Jersey.
RECALLED BY Manufacturer, by letter August 12, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 408 dozen units were distributed; firm estimates none remains
on the market.
REASON Some devices labeled as Medium Airways contained Small Airways.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT T-LUX Shampoo, in 8 fluid ounce plastic containers, an OTC
veterinary drug used for antiseptic cleansing for the control
of dandruff, seborrhea, and eczema for dogs. Recall #V-006-3.
CODE Lot numbers: B-EEG and B-EACG.
MANUFACTURER A & I Laboratory, Inc., Arlington, Texas.
RECALLED BY Allerderm, Inc., subsidiary of Virbac, Inc., Fort Worth, Texas,
by telephone August 19, 1992, followed by letter August 25,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 32,647 containers of lot B-EEG and 32,303
containers of lot B-EACG were distributed.
REASON Product is subpotent in coal tar.
SEIZURES:
PRODUCT Frozen scallops (92-669-899).
CHARGE Adulterated - The product consists in whole or in part of a
decomposed substance.
FIRM David's Buffet, Cincinnati, Ohio.
FILED October 5, 1992; U.S. District Court for the Southern District
of Ohio, Western Division; Civ. #C-1-92-785; FDC #66617.
SEIZED October 13, 1992 - goods valued at approximately $900.
PRODUCT Frozen pollock fish portions (92-669-900).
CHARGE Adulterated - The product consists in whole or in part of
decomposed seafood, or is otherwise unfit for food because it
is rancid.
FIRM Interstate Cold Storage, Inc., Columbus, Ohio.
FILED October 2, 1992; U.S. District Court for the Southern District
of Ohio, Eastern Division; Civ. #C2-92-908; FDC #66618.
SEIZED October 6, 1992 - goods valued at approximately $19,500.
-7-
PRODUCT Frozen lobster tails (92-658-381/2).
CHARGE Misbranded - The products are food in a package form and fail
to bear a label containing an accurate statement of net
quantity of contents.
FIRM Arnies Meat and Seafood, Austin, Minnesota.
FILED November 5, 1992; U.S. District Court for the District of
Minnesota; Civ. #4-92-1086; FDC #66631.
SEIZED November 17, 1992 - goods valued at approximately $2,900.
PRODUCT IQ-9110, IQ-TUTOR+, IQ-TUTOR, IQ-Jr. Personal Brainwave
Synchronizers (92-603-792/794).
CHARGE Adulterated - The devices are class III devices for which no
approved premarket approval application is in effect.
Misbranded - The devices' labeling fails to bear adequate
directions for use for the purposes for which they are
intended; and, the devices were manufactured, prepared,
propagated, compounded, or processed in an establishment not
duly registered and were not included in a list as required.
FIRM The Sharper Image, Little Rock, Arkansas.
FILED November 4, 1992; U.S. District Court for the Eastern District
of Arkansas, Western Division; Civ. #LRC-92-693; FDC #66633.
SEIZED November 4, 1992 - goods valued at approximately $300,000.
-8-
END OF ENFORCEMENT REPORT FOR DECEMBER 16, 1992. BLANK PAGES MAY
FOLLOW.
###