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
11/25/1992
RECALLS AND FIELD CORRECTIONS: November 25, 1992
FOODS -- CLASS I
92-48
PRODUCT Frozen Crabmeat, in 8 ounce plastic tubs. Recall #F-108-3.
CODE C-286 (marked with sticker label on tub bottom).
MANUFACTURER William Atwood Lobster Company, Spruce Head, Maine.
RECALLED BY Manufacturer, by telephone September 16, 1992, followed by
letter September 17, 1992. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 53 containers were distributed.
REASON The product is contaminated with Listeria monocytogenes.
PRODUCT Crabmeat, in 6, 7, and 8 ounce, 1 and 5 pound plastic tubs, and
in 2 pound plastic bags. Recall #F-109-3.
CODE None.
MANUFACTURER Port Quality Shellfish, Portland, Maine.
RECALLED BY Manufacturer, by telephone September 21-24, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Maine, New Hampshire, New York.
QUANTITY 153 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
PRODUCT Crabmeat in 8 and 16 ounce tubs. Recall #F-113-3.
CODE C-53.
MANUFACTURER D.L. Young Seafood, Company, Jonesport, Maine.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Maine, Massachusetts, Connecticut.
QUANTITY 21 pounds were distributed.
REASON Product is contaminated with Listeria Monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Porcelain Tea Set for Children, 17 pieces, 4" covered teapot,
2" covered sugar bowl, 1-1/4" creamer, and 4 each: 3-1/2"
plates, 1-3/4" cups, 2-1/2" saucers. Recall #F-114-3.
CODE None. Lillian Vernon Catalog item #482589.
MANUFACTURER Zhou Ceramics Wholesale Department, Chaozhou, Peoples Republic
of China.
RECALLED BY Lillian Vernon Corporation, Mount Vernon, New York, by letter
October 21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 33,678 sets were distributed.
REASON The product contains excessive leachable lead.
PRODUCT Earthen Ware Pottery for Food Use, various pieces including
mugs, pitchers, plates, and casserole dishes. Each piece is
hand-painted and highly decorated. Recall #F-115-3.
CODE 036 or 037 on bottom of pottery.
MANUFACTURER The Earthen Vessel, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter November 16, 1992, followed by visit
during the week of November 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Indiana, Tennessee, Michigan, New York.
QUANTITY Approximately 100 to 150 pieces were manufactured.
REASON The product contains excessive leachable lead.
-2-
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Thiamine Hydrochloride Tablets USP. Recall #F-111-3.
CODE Repacker's lot #51568; manufacturer's lot #K1055, EXP 11/93.
MANUFACTURER Life-Line Nutritional Products, Inc., Hayward, California.
RECALLED BY West-Ward Pharmaceutical Corporation, Eatontown, New Jersey, by
letter dated September 4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,448 packages of 100 vitamins were distributed; firm estimates
1,079 packages remain on the market.
REASON Product exceeds USP potency limits.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
PRODUCT IDPN - Intradialytic Parenteral Nutrition. Recall #D-067-3.
CODE 9/21/92, 9/22/92, 9/28/92 (date compounded).
MANUFACTURER Washington Clinic Pharmacy , Washington, D.C.
RECALLED BY Infusion Care Systems, Inc., Mt. Laurel, New Jersey, by visit
or by telephone September 29-30, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Maryland, Michigan, Pennsylvania, Washington, D.C.
QUANTITY 62 units were distributed; firm estimates none remains on the
market.
REASON Non-sterility.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets, Pheresis. Recall #B-042-3.
CODE Unit numbers: 40P13049, 40P13083.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone December 30, 1991, and by letter
January 14, 1992. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood components, held under uncontrolled conditions, were
distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-044/045-3.
CODE Unit numbers: (a) 53J00031, 53J16605, 53J90904; (b) 53G48822,
53G51682, 53H57870, 53J16605, 53J90904, 53J96166.
MANUFACTURER American Red Cross Blood Services, The Greater Chesapeake and
Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by (a) letter dated July 23, 1992; (b) by letter
June 29, 1992. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY (a) 3 units; (b) 6 units.
-3-
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from a donor who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
PRODUCT Platelets. Recall #B-057-3.
CODE Unit #384442.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on or about March 17, 1992.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Platelets labeled with incorrect expiration dates were
distributed.
PRODUCT Red Blood Cells, Deglycerolized. Recall #B-062-3.
CODE Unit #24LS56253.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone March 6, 1992. Firm-initiated
recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration date was
distributed.
PRODUCT Recovered Plasma. Recall #B-066-3.
CODE Unit #1811358.
MANUFACTURER Department of the Army, Dwight David Eisenhower Medical Center
Blood Bank, Fort Gordon, Georgia.
RECALLED BY Manufacturer, by telephone and follow-up letter August 7,
1992. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Recovered Plasma, which tested initially reactive for the
antibodies to human immunodeficiency virus types 1 and 2
(anti-HIV-1/2), was distributed.
PRODUCT Platelets. Recall #B-067-3.
CODE Unit #1395056.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
RECALLED BY Consignee notified manufacturer by telephone April 30, 1992.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect expiration
date was distributed.
-4-
PRODUCT Red Blood Cells. Recall #B-070-3.
CODE Unit 9M-4752.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone October 29, 1991, and November 1,
1991. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit.
REASON Blood product, which was collected from an autologous donor who
tested reactive for the antibody to the hepatitis B core
antigen (anti-HBc) and who was not asked the appropriate donor
screening questions, was distributed for transfusion to the
incorrect autologous donor.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells. Recall #B-054-3.
CODE Unit #9217275.
MANUFACTURER Lorain County Blood Bank, Elyria, Ohio.
RECALLED BY Manufacturer, by telephone August 12, 1992. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration date was
distributed.
PRODUCT Red Blood Cells. Recall #B-055-3.
CODE Unit numbers: 4314253, 4315326, 4315753.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY Manufacturer, by telephone and letter dated May 6, 1992, July
27, 1992, and September 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Florida.
QUANTITY 3 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-058-3.
CODE Unit numbers: 428680, 428786.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by telephone on or about September 8, 1992.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 2 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
-5-
PRODUCT Red Blood Cells. Recall #B-056-3.
CODE Unit #12R23858.
MANUFACTURER American Red Cross, Blood Services. Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone February 20, 1992, followed by
letter February 27, 1992. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, testing initially reactive for the antibody to
the hepatitis B core antigen (anti-HBc), was distributed prior
to completion of all testing.
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis; (c) Recovered
Plasma. Recall #B-063/065-3.
CODE Unit numbers: (a) 55C39934; (b) 55Q00164; (c) 55C39934.
MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY Manufacturer, by telephone December 20, 1990, and March 4,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas.
QUANTITY 1 unit of each component.
REASON Blood products which were either: unlabeled and untested for
viral markers; or negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but collected from
a donor who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
PRODUCT Red Blood Cells. Recall #B-068-3.
CODE Unit #90-24900.
MANUFACTURER Medic, Inc., Knoxville, Tennessee.
RECALLED BY Manufacturer, by telephone February 20, 1992, followed by
letter March 11, 1992. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect expiration
date was distributed.
PRODUCT Red Blood Cells. Recall #B-069-3.
CODE Unit #12GL02391.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY Consignee notified firm April 16, 1992. Firm-initiated recall
complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood product which was labeled with an incorrect expiration
date was distributed.
-6-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Ultramark 8 Digital Beam Forming (DBF) -- an integrated
ultrasound system that provides anatomic and dynamic flow
information for hospital and clinic use for quantitative
analysis of both cardiac and obstetrical imaging;
Ultramark 9 - an integrated ultrasound system that provides
anatomic, dynamic flow, and color flow information for the
hospital and clinic. The suspect PCB assembly, Part
7500-0391-07 is also sold as service stock individually and
suspect boards may have also been used in the following upgrade
kits: (a) Part 8000-0565-01, UM 9 steered CW Upgrade
(domestic/international); (b) Part 8000-0623-01, upgrade PCB UM
9 Colorflow II without steered CW. Recall #Z-038-3.
CODE All units in which a mechanical 2 D acquisition printed circuit
board (PCB), 7500-0391-07, was installed for configuration as a
-05 board.
MANUFACTURER Advanced Technology Laboratories (ATL), Bothell, Washington.
RECALLED BY Manufacturer, by letter March 24, 1992 (domestic) and between
April 28 1992 and June 23, 1992 (international).
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Domestically there were 104 boards, and internationally there
were 29 boards and 14 kits.
REASON Users could be subject to a 10 percent distance measurement
error when using mechanical scan heads. A 2-D measurement may
provide values 10 percent less than actual.
PRODUCT (a) Defibrillator 19E; (b) Defibrillator w/Pacer 20E -- options
used with the escort 300 series full parameter transport
monitor. Recall #Z-082/083-3.
CODE Serial numbers 1002-1008, 1011, 1013 - 1022.
MANUFACTURER Medical Data Electronics, Inc., (MDE), Arleta, California.
RECALLED BY Manufacturer, by telephone January 16, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION California, Colorado, Ohio, Bangkok, Thailand.
QUANTITY 7 units were distributed.
REASON An defective diode caused the device to malfunction and the
defibrillator would not shut off after use when used at 40
degrees F or below.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Agri-Strept, Sterile Penicillin G Procaine and
Dihydrostreptomycin Sulfate Suspension, in 100 ml clear vials.
Recall #V-005-3.
CODE 2293-01 EXP 7/94.
MANUFACTURER Norbrook Laboratories, Ltd., Newry, Northern Ireland.
-7-
RECALLED BY Agri Laboratories, Ltd., St. Joseph, Missouri, by FAX September
24, 1992, and by letter October 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Indiana, Texas, Missouri, Oklahoma, North Carolina.
QUANTITY 276 vials were distributed.
REASON Product is mislabeled as Agri-Cillin instead of Agri-Strept.
-8-
END OF ENFORCEMENT REPORT FOR NOVEMBER 25, 1992. Blank pages may follow.
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