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.

January 15, 1997 97-3

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Mike's Menu Maker Deviled Egg Salad (no
tumeric), in 10 and 30 pound bulk containers.
Recall #F-164-7.
CODE Use by date of November 2, 1996.
MANUFACTURER Harold Food Company, Charlotte, North
Carolina.
RECALLED BY Manufacturer, by telephone on October 16,
1996. Firm-initiated recall ongoing.
DISTRIBUTION North Carolina.
QUANTITY Undetermined.
REASON Product is contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-220/221-7.
CODE Unit #40FF11160.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated June 28, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-222/223-7.
CODE Unit numbers: 40GT50600, 40GS48035,
40GR79312.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated July 3, 1996;
and on July 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION Illinois, New York, California.
QUANTITY 3 units of each component were distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), or were collected
from a donor who previously tested repeatedly
reactive for anti-HIV-1.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-224/225-7.
CODE Unit #40FS04293.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 23, 1996,
followed by letter dated June 3, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) were subjected to
additional retesting.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-227/228-7.
CODE Unit #KR80481.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by letter dated February 8,
1996. Firm-initiated recall complete.
DISTRIBUTION Iowa and Pennsylvania.
QUANTITY 1 unit of each component was distributed.
-2-REASON Blood products were collected from a donor who
traveled to areas designated as endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-229/230-7.
CODE Unit #2000328.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on August 26, 1996,
and by letter dated August 29, 1996. Firm-
initiated recall complete.
DISTRIBUTION Ohio and Massachusetts.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-231/232-7.
CODE Unit numbers: (a) F07097; (b) F07097,
FS00270.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letter dated March 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY (a) 1 unit; (b) 2 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT (a) AS-1 Red Blood Cells; (b) Platelets.
Recall #B-233/234-7.
CODE Unit #50G02486.
MANUFACTURER American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY Manufacturer, by letter dated February 27,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area designated as endemic for
malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-237/238-7.
CODE Unit numbers: (a) 1564228; (b) 6440615.
MANUFACTURER Blood Center of Southeast Texas, Inc.,
Beaumont, Texas.
-3-RECALLED BY Manufacturer, by letter dated March 1, 1996,
and by telephone on October 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION New York and Texas.
QUANTITY 1 unit of each component was distributed.
REASON A unit of Red Blood Cells was incorrectly
labeled as irradiated and a unit of platelets
was prepared from Whole Blood with an extended
collection time.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-258/259-7.
CODE Unit numbers: (a) 42FW27281, 42FG32323,
42FG32310; (b) 42FW27281.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter dated October 6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY (a) 3 units; (b) 1 unit was distributed.
REASON Blood products containing positive antibodies
screen, were labeled as negative for
unexpected antibodies.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT Phoenix PX115 PowerloftTM Alternating Pressure
Pump, a component for the Phoenix Alternating
Air Floatation Mattress System, designed to
provide a combination of alternating pressure
and ventilation air therapy to prevent
pressure sores. Recall #Z-202-7.
CODE Serial numbers 04109381 through 05060219, Part
numbers: PX120 and PX120RP.
MANUFACTURER Cathay Consolidated Inc., Taipei, Taiwan
R.O.C.
RECALLED BY Mason Medical Products, Division of MRC
Industries, Inc., Glendale, New York, by
letter dated November 15, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 4,694 pumps were distributed.
REASON The timing mechanism would freeze up causing
the unit to run continuously until manually
shut off. The diaphragm inside the compressor
part of the pump would rupture or break,
making the unit inoperable.

-4-_______________
PRODUCT Sabratek Model 6060 Homerun Volumetric
Infusion Pump, for the delivery of enteral,
epidural, subcutaneous, arterial, and
intravenous fluids to the patient.
Recall #Z-204-7.
CODE All units with software version 2.0.
MANUFACTURER Sabratek Corporation, Niles, Illinois.
RECALLED BY Manufacturer, by telephone on October 15,
1996, followed by letter dated October 16 and
18, 1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Illinois, Massachusetts, Ohio, Florida, Texas,
Missouri, North Carolina, Pennsylvania,
Indiana, California, Washington state,
Louisiana, Ireland, Brazil, Canada.
QUANTITY 487 units were distributed.
REASON There is a possibility that the device can
bypass the delay delivery mode when the
infusion pump is programmed in the Continuous,
25 Period, Intermittent or Auto-Ramp profile,
delivering the solution as programmed without
the delayed delivery.

_______________
UPDATE Recall #Z-089-7, which appeared in the January
2, 1997 Enforcement Report should read:
PRODUCT: Operator's Manual and Front Panel
Decal for the Medtronix M-300 Talc Sterilizer.
Medtronic was incorrectly named in the report
and is not associated with Medtronix, a
Division of Dentronix, Inc.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Vitros Lipase Slides, for use with Vitros
Chemistry Systems to quantitatively measure
lipase activity in serum and plasma, for in-
vitro diagnostic use. Recall #Z-198-7.
CODE Catalog #1668409, lot numbers: 5919-0082-6895
through 6897.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York.
RECALLED BY Manufacturer, by letter dated November 15,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,355 cartridges (15 slides each) were
distributed; firm estimated that 3,500
cartridges remained on market at time of
recall initiation.

-5-REASON Some cartridges within affected lots may
contain slides that exhibit significant biases
in lipase results.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Tramisol (levamisole resinate), Type A
Medicated Article, in 32 pound drums, for use
in the manufacture of swine and cattle worming
pellets or meal only. Recall #V-023-7.
CODE Lot #5026 EXP May 2001.
MANUFACTURER American Cyanamid, Resende, Brazil.
RECALLED BY Mallinckrodt Veterinary, Mundelein, Illinois,
by letter dated November 21, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Arkansas, Illinois, Kentucky, Georgia,
Alabama, Tennessee, North Carolina, Missouri,
Iowa, Oregon, Texas, Florida.
QUANTITY 55 drums were distributed; firm estimated that
little if any product remained on market at
time of recall initiation.
REASON The label contained typographical error. The
label states 22.7 g/lb instead of 227 g/lb
levamisole hydrochloride. Several values are
also missing from the table in the "mixing
directions" section.

-6-

END OF ENFORCEMENT REPORT FOR JANUARY 15, 1997. BLANK PAGES MAY
FOLLOW.

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