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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