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.
February 11, 1998 98-06
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT 7 C's Stuffed Crabs in Natural Shells, 72-2 oz.,
net wt. 9 lbs,. Recall #F-246-8.
CODE "1111397".
MANUFACTURER C. B. Caroon Crab Co., Inc., Southport, North
Carolina.
RECALLED BY Manufacturer, by telephone on December 12,1997.
Ongoing recall resulted from sample analysis and
follow-up by the North Carolina Department of
Agriculture.
DISTRIBUTION North Carolina and South Carolina.
QUANTITY 65 cases were distributed.
REASON Product was found contaminated with Salmonella.
_______________
PRODUCT Dews Research C-500 Chewable Vitamin C mixed fruit
flavor wafers in 100 count boxes:
a) Dews Research C-500 Chewable Vitamin C mixed
fruit flavor wafers in 100 count boxes
b) Red Arrow Distributing Lemon & Cream of Tarter
with sulfur wafers in 30 count boxes
c) Bald Mountain Herbal Syrup in 4 and 16 fl.
1oz. bottles. Recall #F-247/249-8.
CODE All lots manufactured prior to October 23,
1997: a) Lot 31232; b) Lot 10714;
c) Lot 70470.
MANUFACTURER Dews Research Associates, Mineral Wells, Texas.
RECALLED BY Twenty First Century Products, Mineral Wells,
Texas, by letter mailed between approximately
October 20 and November 3, 1997. Ongoing
recall resulted from sample analysis and
follow-up by the Texas Department of Health.
DISTRIBUTION Nationwide.
QUANTITY a) 24 100-wafer boxes; b) 19 30-wafer boxes;
c) 32 4-fluid ounce and 28 16-fluid ounce
bottles were distributed.
REASON Products contain undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Janet Lee Apple Cider, in 128 ounce rigid
plastic bottles. Recall #F-071-8.
CODE Best Used by OCT 12 98 P2 and Best Used by
OCT 12 98 Q2.
MANUFACTURER Hi Country Foods Corporation, Selah,
Washington.
RECALLED BY Manufacturer, by memorandum on November 7,
1997. Firm-initiated recall complete.
DISTRIBUTION Utah.
QUANTITY 2,304 cases (4 bottles per case) were
distributed.
REASON Product appears cloudy and fermented and
unfit for food.
_______________
PRODUCT Frozen Yellowfin Tuna Steaks, individually
frozen-vacuum packed, skinless and boneless,
in 4 ounce, 8 ounce and 10 ounce sizes,
packed in 1 10-pound master carton.
Recall #F-250-8.
CODE Contract No.: ICM-2006A, all date codes.
MANUFACTURER P.T. Tirta Raya Mina, Jakarta, Indonesia.
RECALLED BY Slade Gorton & Company, Inc., Boston,
Massachusetts, by fax on January 15, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Bermuda.
QUANTITY 350 cartons (4 oz), 1,050 cartons (6 oz),831
cartons (8 oz), and 350 cartons (10 oz) were
distributed.
REASON Product is adulterated due to decomposition.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Recovered Plasma. Recall #B-308-8.
CODE Unit numbers: 832205 and 835753.
MANUFACTURER University of Texas, M.D. Anderson Cancer
Center, Houston, Texas.
RECALLED BY Manufacturer, by letter dated January 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products were not properly tested for
HIV-p24 antigen.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated, AHF;
c) Recovered Plasma. Recall #B-480/482-8.
CODE Unit numbers: 47Q01183, 47T35211, 47S02258,
47T36762, 47E28421, 47S03964, 47K53416,
47J47690; b) 47S02258, 47S03964
c)47E26962, 47Q01183, 47T35211, 47S02258,
47T36762, 47E28421, 47S03964, 47K53416,
47J47690.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letters dated September 1, 1997,
and October 1 and 24, 1997. Firm-initiated recall
complete.
DISTRIBUTION Missouri, Iowa, Illinois, California.
QUANTITY a) 8 units; b) 2 units; c) 9 units were
distributed.
REASON Blood products were collected from a donor
who had previously tested initially reactive for
the antibody to the human immunodeficiency
virus type 1 (HIV-1), but was not retested in
duplicate.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-516/517-8.
CODE Unit #50F52006.
MANUFACTURER American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY Manufacturer, by telephone on July 7, 1997,
and by letter dated either July 10 or 25,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as
endemic for malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-548-8.
CODE Unit #29446-9849.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated January 20,
1998. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to a malarial endemic area.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Source Plasma. Recall #B-223-8.
CODE Unit numbers: 0560382788 and 0560382844.
MANUFACTURER NABI (Miami Testing Lab), Miami, Florida.
RECALLED BY NABI Corporate Offices, Boca Raton, Florida, by
fax on December 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors who
tested initially reactive for HIV-1-p24, and
not re-tested in duplicate as required by the
manufacturer's instruction.
_______________
PRODUCT Red Blood Cells. Recall #B-380-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance
(301) 827-6220 for individual unit numbers
recalled.
MANUFACTURER American Red Cross, Waco, Texas.
RECALLED BY American Red Cross, Tulsa, Oklahoma, by letter
on August 20, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 40 units were distributed.
REASON Failure to quarantine blood products which
were shipped at unacceptable temperatures.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-522/523-8.
CODE Unit #03GM39283.
MANUFACTURER American Red Cross Blood Services,
Miami, Florida.
RECALLED BY Manufacturer, by letter dated October 10,
1997, by telephone on October 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood products were prepared from a unit of
Whole Blood with an extended collection time.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-525/526-8.
CODE Unit #03GG41810.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on January 17,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood products were prepared from a unit of
Whole Blood which may have had an extended
collection time.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-527-8.
CODE Unit #29445-9036.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on October 27,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood with an extended collection time.
_______________
PRODUCT a) Red Blood Cells; b)Platelets, Pheresis,
c) Lymphocytes; d) Recovered Plasma.
Recall #B-528/531-8.
CODE Unit numbers: a) LM93930, LM93931
b) Contact FDA, Center for Biologics
Evaluation and Research, Office of Compliance
(301) 827-6220 for individual unit numbers
recalled.
c) unit LH38387; d) units LM93930, LM93931.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone on September 16,
1996, and letters dated September 17, 1996,
and October 24, 1997. Firm-initiated recall complete.
DISTRIBUTION Wisconsin, Ohio, Rhode Island, California.
QUANTITY a) 2 units; b) 34 units; c) 1 unit; d) 2 units
were distributed.
REASON Blood products incorrectly tested for the
antibody to the hepatitis B core antigen
(anti-HBc).
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-545-8.
CODE Unit #29442-4190.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on September 29,
1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
Whole Blood designated as a difficult
collection.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT IMED GEMINI PC-1 and PC-2 INFUSION PUMPS:
a) IMED Gemini PC-1 Infusion pumps
b) IMED Gemini PC-2 Infusion pumps.
Recall #Z-247/248-8.
CODE a) All software versions 6.55 or lower
b) All devices.
MANUFACTURER Alaris Medical Systems, Inc. (formerly IMED
Corp.), San Diego, California.
RECALLED BY Alaris Medical Systems, Inc., San Diego,
California, by letter on May 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 34,192 units; b) 36,480 units were
distributed.
REASON The pumps batteries may overheat, causing a
discharge of hydrogen gas which may cause the
pumps to burst.
_______________
PRODUCT Powered Scooters: a) Action CAT Powered
Scooter; b) Action FLYER Powered Scooter.
Recall #Z-295/296-8.
CODE Scooters with serial number prefixes 96C,
96D, 96E, 9F, 96G, and 96H, manufactured
between March 1996, and August 1996.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated January 31,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 529 scooters were distributed.
REASON There is a potential failure condition whereby
the motorlock could become disabled and could
shut the controller off, resulting in the
scooter losing power and braking ability.
_______________
PRODUCT Bipolar Hip Implants. Bipolar Head and
Locking Ring Assembly of the Consensusr
Bipolar System, in 21 sizes, and 42mm to 62mm,
a component of the Consensusr Bipolar System.
Recall #Z-303-8.
CODE Catalog No and Product Name:
1014-0-0042 Bipolar Head, CoCr, Size 42
1014-0-0043 Bipolar Head, CoCr, Size 43
1014-0-0044 Bipolar Head, CoCr, Size 44
1014-0-0045 Bipolar Head, CoCr, Size 45
1014-0-0046 Bipolar Head, CoCr, Size 46
1014-0-0047 Bipolar Head, CoCr, Size 47
1014-0-0048 Bipolar Head, CoCr, Size 48
1014-0-0049 Bipolar Head, CoCr, Size 49
1014-0-0050 Bipolar Head, CoCr, Size 50
1014-0-0051 Bipolar Head, CoCr, Size 51
1014-0-0052 Bipolar Head, CoCr, Size 52
1014-0-0053 Bipolar Head, CoCr, Size 53
1014-0-0054 Bipolar Head, CoCr, Size 54
1014-0-0055 Bipolar Head, CoCr, Size 55
1014-0-0056 Bipolar Head, CoCr, Size 56
1014-0-0057 Bipolar Head, CoCr, Size 57
1014-0-0058 Bipolar Head, CoCr, Size 58
1014-0-0059 Bipolar Head, CoCr, Size 59
1014-0-0060 Bipolar Head, CoCr, Size 60
1014-0-0061 Bipolar Head, CoCr, Size 61
1014-0-0062 Bipolar Head, CoCr, Size 62.
MANUFACTURER U.S. Medical Products, Inc., Austin, Texas.
RECALLED BY Hayes Medical, Inc. (HMI), Sacramento,
California, by letter on January 21, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,979 units were distributed.
REASON Nonconformance of the internal locking ring of
the product which may contribute to a failure
of the ring to meet its design specification.
_______________
PRODUCT Powered Wheelchairs: a) Power 9000;
b) P7E; c) Ranger II Storm Series;
d) Power Tiger. Recall #Z-304/307-8.
CODE Serial Numbers prefixed: "95J through 95L"
and "96A through 96E", manufactured between
October 1995, and May 1996.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated July 31, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 4,002 units were distributed.
REASON The bolts which secure the rear wheels to the
drive shaft may loosen with time, and the wheel
could potentially fall off, which could cause the
user to fall out of the wheelchair.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT Action CAT Powered Scooters, a three-wheeled
scooter. Recall #Z-287-8.
CODE All serial numbers beginning with 97H or 97I.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated September 25,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 150 scooters were distributed.
REASON Two wires became interchanged due to a
manufacturing error, resulting in the
inability to recharge the battery.
_______________
PRODUCT Powered Wheelchairs: a) Action Arrow;
b) Action Torque; c) Ranger X.
Recall #Z-308/310-8.
CODE Serial numbers prefixed: 97F, 97G, 97H,
97I manufactured between June 1997, and
September 1997.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated November 4,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 4,192 units were distributed.
REASON The brushes within the motor that drives
the wheelchair are failing prematurely
which may cause the user to be stranded.
MEDICAL DEVICE SAFETY ALERTS: ===============================
_______________
PRODUCT Pediatric Cribs, with security tops, all brand
names and models including, but not limited
to, Midmark C-374 Pediatric Cribs and Security
Tops. These cribs were manufactured and
sold by a number of companies including:
InterRoyal Corporation (Hurlco), Hill-Rom
Company, Inc., Cambridge Scientific Industries,
General Medical (Whittaker) Manufacturing
Company and Midmark Corporation. The cribs
were marketed under the following names:
Tabbert or "Tab" Crib Model C-374 (mfr'd by
Midmark, Cambridge, and General Medical),
Hill-Rom Model 249 (Hill-Rom), and TODAY Crib
Model C-374 (mfr'd by InterRoyal).
Safety Alert #N-003-8.
CODES All serial numbers of Midmark's Model C-374
Pediatric Cribs manufactured by Midmark from
1982 to 1986, are subject to the firm's
intended "Safety Alert". The serial numbers
for the Midmark Model C-374 cribs are as
follows: TP001000 - TP001651. The Serial
Numbers for those pediatric beds with security
tops manufactured by the other referenced firms,
subject to this Safety Alert, are unknown at
this time.
MANUFACTURER Various.
ALERTED BY Midmark Corporation, Versailles, Ohio. by letter
dated January 23, 1998.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,361 cribs were distributed.
REASON Problems resulting when the security top is
lowered after the siderails are raised resulting
in one or both of the security top latches not
being engaged. When this happens, a child can
push the security top up and out far enough to
place his or her head over the siderail. Then
when the security top is returned to its lowered
position, the childs neck can be caught between
the security top and the siderail resulting in
strangulation.
END OF ENFORCEMENT REPORT FOR FEBRUARY 11, 1998. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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