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
12/04/1990
FDA Enforcement for the week of December 5, 1990
FDA ENFORCEMENT REPORT
FOR DECEMBER 5, 1990
December 5, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Various brands of tuna salad:
(a) Jack's Tuna Salad, 7 ounces, 12 pack;
(b) Kinsers Tuna Salad, 12/6 pack;
(c) Kinsers Tuna Salad, 12 ounces, 24 pack;
(d) Kinsers Tuna Salad, 24 ounces, 6 pack;
(e) Giles Tuna Salad, 2 pound container;
(f) Pocahontas Tuna Salad, 5 pound container;
(g) Seaboard Homestyle Tuna, 5 pound, 2 pack;
(h) Giles Homestyle Tuna Salad, 5 pounds, 2 pack;
(i) Kinsers Tuna Salad, 5 pound container.
Recall #F-693-0.
-1-
Code: Pull date 4/25/90.
Manufacturer: Mrs. Giles Country Kitchen, Inc., Lynchburg, Virginia.
Recalled by: Campbells Soup Company, Camden, New Jersey, by
telephone April 16, 1990. Firm-initiated recall ongoing.
Distribution: Virginia, Kentucky, Florida, Alabama, Tennessee, Georgia,
South Carolina, North Carolina.
Quantity: 426 cases of various sizes and weights were distributed.
Reason: Product is contaminated with Listeria monocytogenes.
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Product: (a) Old Fashioned Fruit Sherbet, Orange Flavored;
(b) Lite Vanilla Flavored Ice Milk;
(c) Chocolate Ice Cream. Recall #F-721/723-0.
Code: Lot numbers: (a) 902190; (b) 904040; (c) 906210.
Manufacturer: J.J. Schmidt, Inc., Cincinnati, Ohio.
Recalled by: Sterling Ice Cream Company, Cincinnati, Ohio, by
telephone June 12, 1990 and by letter June 22, 1990.
Firm-initiated recall complete.
Distribution: Indiana, Kentucky, Ohio, Michigan.
Quantity: Firm estimates none remains on the market.
Reason: Product was contaminated with Listeria monocytogenes.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Internal Defibrillation Handle Set, used with the
Lifepak 9 Defibrillator/Monitor for internal
defibrillation. Recall #Z-072-1.
-2-
Code: Date codes: 3-90 and 90-15.
Manufacturer: Physio Control, Redmond, Washington.
Recalled by: Manufacturer, by telephone beginning June 12, 1990
followed by letter June 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 142 units with code 3-90 and 106 units with code 90-15
were distributed.
Reason: An incorrect pin configuration in the cable that attaches
the internal defibrillation hand set to the defibrillator
adapter causes the Lifepak 9 unit to operate as if were
configured for external defibrillation.
----
Class II -
Product: Radiological Therapy Planning (RTP) System
(a) Version 3A1; (b) Version 3B1. Recall #Z-107/108-1.
Code: Serial numbers:
RTP 5000 RTP 5000 RTP 5100 RTP 5200 RTP 5300
2104-3016A 2104-3106B 2104-3020A 2104-3021A 2104-3022A
112001 207016 311001 407010 408005
112002 303029 406005 409008 503008
202004 303030 409008
204015 410009
211025 411010
RTP 5400 RTP XL-23 RTP XL-23/73 RTP XL-73
2104-3023A 2104-3025 2104-3025D 2104-3026A
311006 702003 801005 511004
311007 805008 512006
311008 712002 512007
311010 508001
506002
RTP XL73 RTPXL73 RTP-XL73 RTP-XL172 RTP-XL
2104-3026B 2104-3026C 2104-3026D 2104-3030A 2104-3032A
603001 708001 709001 808001 808002
603002 708002 709002 809002
603003 708003 711003 809003
603005 708004 801006 810004
604006 801007 810005
605007 802007 901006
607008 802008 901008
603008 802009 904009
605010 802010 906012
606011 803011 906014
701013 804012 907016
702015 804013 906011
703016 712005
-3-
RTP-XL
2104-3033A
807001
807002
906004.
Manufacturer: ADAC Laboratories, Milpitas, California.
Recalled by: Manufacturer, by letter October 30, 1989. Firm-initiated
field correction complete.
Distribution: Nationwide, Thailand.
Quantity: 76 systems were distributed.
Reason: The software program contains a calculation error which
may not provide user with all required information.
----
Product: PolySafe Implantable Endocardial Pacing Leads
(a) Model BV-317, Ventricular biopolar, trabeculok
fixation connector; (b) Model SV-309, Ventricular unipolar
trabeculok fixation connector. Recall #Z-109/110-1.
Code: (a) All serial numbers; (b) All leads with serial
numbers prefaced by 309L.
Manufacturer: Cardiac Control Systems, Palm Coast, Florida.
Recalled by: Manufacturer, by telephone and letter September 19, 1990.
Firm-initiated recall ongoing.
Distribution: (a) Texas, New Jersey, Oklahoma, Florida, Maine,
Louisiana, New York, Michigan, Pennsylvania, Connecticut;
(b) Texas, New Jersey, New York, Florida, Louisiana,
Arkansas, Massachusetts.
Quantity: (a) 74 units; (b) 33 units were distributed.
Reason: The lead connector that attaches the proximal end of the
lead to the pulse generator unit is too big in diameter.
Excess adhesive was used to affix the connector to the
silicon seal between the sheath and connector.
----
CORRECTION: Lastac System, Model 1025 Laser Product, Recall #Z-022-1
which appeared in the November 7, 1990 Enforcement
Report should read:
Reason: Noncompliance with performance standard for laser
products in that it lacks a Class IV warning logo-type
label adjacent to the laser output aperture on the
Model 1025 Control Monitor.
----
-4-
Class III -
Product: Coulter JT2 and Coulter JT3 Automated Hematology
Analyzer, instruments needed in clinical and hospital
labs for hematology studies on human blood.
Recall #Z-101/102-1.
Code: Catalog numbers: 664073, 6604123, 6604124, 6604125,
6604142, 6604143, 6604144, 6604145. Part numbers:
6704765, 6704816, 6701817, 6704820, 6704874, 6704875,
6704876, 6704877. Serial numbers: 0 through S35590.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
Recalled by: Manufacturer, by letter September 7, 1990. Firm-
initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: (a) 166 units; (b) 248 units were distributed.
Reason: The device has the potential to dilute patient samples
and also to loose pre-set calibration factors under
certain conditions such as power interruption.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Phoenix Pharmaceutical brand Mineral Oil Light USP, in
1 gallon brown plastic containers, a pharmaceutic aid for
veterinary use only. Recall #V-050-1.
Code: Lot #590.
Manufacturer: Tab Chemical, Chicago, Illinois.
Recalled by: Hydrox Chemical Company, Elk Grove Village, Illinois;
by telephone October 29, 1990. Firm-initiated recall
ongoing.
Distribution: Florida, Maryland, Pennsylvania.
Quantity: 56 cases were distributed; FDA estimates 25 percent
remains on market.
Reason: Some of the oil is contaminated with propylene glycol.
----
Class III -
NONE
Injunction Action Filed:
Against: Richards Bros., Inc., Mountain Grove, Missouri.
Product: Multiple Foods (90-553-185/193).
Charge: Adulterated -- Products were held for sale in a warehouse
infested with insects and rodents.
-5-
Filed: November 27, 1990 - U.S. District Court for the Western
District of Missouri, Southern Division;
Civil #90-3514-CV-S-4, INJ #1244.
----
Seizure Actions Filed:
Product: Various Articles of Food (91-575-474).
Charge: Adulterated -- Products were held for sale in a warehouse
infested with insects and rodents.
Firm: Indian Groceries and Spices, Inc., Skokie, Illinois.
Filed: November 26, 1990 - U.S. District Court for the
Northern District of Illinois, Eastern Division;
Civil #90C6819, FDC #65974.
----
Product: Dessicated Coconut (90-609-718).
Charge: Adulterated - Product was held under insanitary
conditions whereby it may have become contaminated
with filth.
Firm: Virmurco, Medina, Ohio.
Filed: November 26, 1990 - U.S. District Court for the
Northern District of Ohio, Eastern Division;
Civil #5:90CV2098, FDC #65961.