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
05/27/1992

RECALLS AND FIELD CORRECTIONS: MAY 27, 1992

                                   FOODS -- CLASS I
                                                                      92-22
              
PRODUCT        Maplenut Ice Cream, in 1/2 gallon brick style cartons.  Recall   
               #F-300-2.
CODE           All lots.
MANUFACTURER   Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY    Manufacturer, by letters of March 13 and 25, 1992.               
               Firm-initiated recall ongoing.
DISTRIBUTION   Pennsylvania, West Virginia, Ohio, Maryland.
QUANTITY       Approximately 100 cases (2 units/carton) were distributed.
REASON         Product contains undeclared peanuts.

              
PRODUCT        Various chocolate flavored ice cream and ice milk products,      
               packaged in pint cartons, 8 per case; half-gallon round          
               cardboard cartons, 6 per case; and 3 gallon bulk containers:
               (a) Chocolate Ice Cream, under Breyers, Albertsons and Knudsen   
               labels;
               (b) Neapolitan Ice Cream, under Breyers, Albertsons, Knudsen     
               and Stater Bros. Markets labels;
               (c) Heavenly Hash Ice Cream, under Albertsons label;
               (d) Chocolate Chip Ice Cream, under Breyers label;
               (e) Rocky Road Ice Cream, under Knudsen and Stater Bros.         
               Markets labels;
                                       
               (f) Rocky Road with Marshmallow Sauce and Walnuts Ice Cream,     
               under Albertsons label;
               (g) Mocha Almond Fudge Ice Cream, under Stater Bros. Markets     
               label;
               (h) Nice "N" Light Chocolate Ice Milk, under Knudsen label;
               (i) Nice "N" Light Neapolitan Ice Milk, under Knudsen label;
               (j) Nice "N" Light Rocky Road Ice Milk, under Knudsen label.     
               Recall #F-302/311-2.
CODE           Lot numbers:  (a) 13JUN92, 28SEP92, 13JUN92 (Bryers); 10JAN93,   
               20DEC92 (Albertsons); 13AUG92 (Knudsen);
               (b) 28SEP92, 22AUG92 (Breyers); 02DEC92, 24DEC92, 19SEP92        
               (Albertsons); 24DEC92, 08AUG92 (Knudsen); 09JUL92, 16JUL92,      
               08JAN93, 13DEC92, 08AUG92, 02DEC92, 10JUL92 (Stater Bros.        
               Markets);
               (c) 28MAY92, 09JAN93; (d) 28SEP92, 13JUN92; (e) 12AUG92,         
               07JAN93, (Knudsen); 16JUL92, 27DEC92, 18JUN92, 28MAY92 (Stater   
               Bros. Markets); (f) 12JUN92, 16SEP92, 26DEC92; (g) 02JUL92,      
               03JUL92; (h) 11JUN92, 25DEC92; (i) 24DEC92; (j) 23DEC92.
MANUFACTURER   Kraft General Foods, Inc., Los Angeles, California.
RECALLED BY    Kraft General Foods, Inc., Glenview, Illinois, by letter April   
               21, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Alaska, Arizona, California, Colorado, Hawaii, Idaho, New        
               Mexico, Nevada, Oklahoma, Oregon, Montana, Texas, Utah,          
               Washington state, Wyoming.
QUANTITY       63,463 cases were distributed; firm estimates that 33 percent    
               of the product remains on the market.
REASON         Products contain undeclared peanuts.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
              
PRODUCT        Dicyclomine HCl Capsules, USP, 10 mg, in bottles of 100 and      
               1,000, an Rx antispasmodic.  Recall #D-352-2.
CODE           Lot #0A128FH EXP 2/94.
MANUFACTURER   Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY    Barr Laboratories, Inc., Pomona, New York, by letter dated May   
               7, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       Approximately 22,583 bottles of 100 and 1,435 bottles of 1,000   
               capsules were distributed.
REASON         Subpotency.

              
PRODUCT        Hydrogen Peroxide Solution USP 3%, packed in 16 fluid ounce      
               brown plastic bottles, may be used as a mouthwash or as a        
               gargle, under the following labels:  Albertson's, Dominick's,    
               Marquee, May's and Medical Center.  Recall #D-353-2.
CODE           Lot #2041BD1.
MANUFACTURER   Hunt Products Company, Inc., Dallas, Texas.
RECALLED BY    Manufacturer, by letter dated April 27, 1992.  Firm-initiated    
               recall ongoing.
DISTRIBUTION   Illinois, Pennsylvania, Missouri, Tennessee, Texas.
QUANTITY       1,134 cases (12 bottles per case) were distributed.

                                      -2-
REASON         Presence of trace quantities of isopropyl alcohol.

              
PRODUCT        Promotional Pamphlets for Pro-Woman brand All-Natural            
               Multivitamin and Multimineral Supplements.  Pamphlets are        
               titled "PMS:  Understanding and Dealing with Premenstrual        
               Syndrome" and "Pro-Woman Natural Vitamin-Mineral-Supplement      
               Winning the Monthly Battle."  Recall #D-354-2.
CODE           All copies distributed.
MANUFACTURER   Biokin Company, Inc., Arlington, Texas (distributor).
RECALLED BY    Distributor, by letter October 1, 1991.  Firm-initiated recall   
               ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       Unknown.
REASON         Promotional material serves to misbrand the product.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
              
PRODUCT        Platelets.  Recall #B-288-2.
CODE           Units numbers:  07J49087, 07J49088, 07J49093, 07J49094,          
               07J49098, 07J49103, 07J49015, 07J49111.
MANUFACTURER   American Red Cross Blood Services, Tucson, Arizona.
RECALLED BY    Consignee notified firm by telephone May 18, 1991 and follow-up  
               letter May 31, 1991.  Recall complete.
DISTRIBUTION   Arizona.
QUANTITY       8 units.
REASON         Blood products labeled with incorrect expiration date were       
               distributed.

             
PRODUCT        Red Blood Cells.  Recall #B-296-2.
CODE           Unit #J16947.
MANUFACTURER   Texoma Regional Blood Center, Sherman, Texas.
RECALLED BY    Consignee notified firm by telephone November 7, 1991.  Recall   
               complete.
DISTRIBUTION   Texas.
QUANTITY       1 unit.
REASON         Blood product, which tested repeatedly reactive for the          
               antibody to hepatitis B core antigen (Anti-HBc), was             
               distributed. 

              
PRODUCT        Platelets, Pheresis.  Recall #B-297-2.
CODE           Unit #7798070.
MANUFACTURER   The Blood Center for Southeast Louisiana (BCSL), New Orleans,    
               Louisiana.
RECALLED BY    Consignee notified firm by telephone December 5, 1991.  Recall   
               complete.
DISTRIBUTION   Louisiana.
QUANTITY       1 unit.

                                      -3-
REASON         Blood product labeled with the incorrect expiration date was     
               distributed.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
              
PRODUCT        Diagnostic X-Ray Control Generators, Models MS 325 and MS 525,   
               control console used to control the supply of electrical energy  
               to the x-ray tube.  Recall #Z-460/461-2.
CODE           All of the manuals for this device.
MANUFACTURER   Control X, Inc., Columbus, Ohio.
RECALLED BY    Manufacturer, by letter March 4, 1992.  Firm-initiated field     
               correction complete.
DISTRIBUTION   Nationwide, Canary Islands, Zimvablov, Israel, Canada.
QUANTITY       35 units were distributed.
REASON         Noncompliance with the performance standard for x-ray products   
               in that the instruction manual for these devices list the        
               coefficient of variation for linearity and reproductibility as   
               greater than 0.05.

              
PRODUCT        Clinac Medical Linear Accelerators with Accessory Mounts:
               (a) CL 2100; (b) CL 1800; (c) CL 2500; (d) CL 6/100;
               (e) CL 4/100; (f) CL 600C; (g) CL 18; (h) CL 20; (i) CL 12/10.
               Recall #Z-474/482-2.
CODE           Serial numbers:  (a) 1-60; (b) 1-234; (c) 2-31; (d) 1 417;
               (e) 1-77; (f) 1-3; (g) 1-169, 901, 905-908;
               (h) 1-72, 324; (i) 1-10.
MANUFACTURER   Varian Associates, Inc., Palo Alto, California.
RECALLED BY    Manufacturer, by Service Technical Bulletin, July 29, 1991.      
               Firm-initiated field correction ongoing.
DISTRIBUTION   Nationwide, International.
QUANTITY       1,078 units were distributed.
REASON         Accessories can fall out of the accessory mount as the "safety   
               notch tends to deform and fail".

              
PRODUCT        Puritan-Bennett 7200 Series Microprocessor Ventilator, used for  
               the delivery of volumes of gas to patients dependent on          
               artificial respiration.  Recall #Z-484-2.
CODE           All models and all serial numbers ventilators shipped from       
               4/23/83 to 1/10/92.
MANUFACTURER   Puritan Bennett Corporation, Carlsbad, California.
RECALLED BY    Manufacturer, by letter dated January 10, 1992.  Firm-initiated  
               recall ongoing.
DISTRIBUTION   Nationwide, Canada, Europe.
QUANTITY       20,416 units were distributed.
REASON         A design problem may cause the error code 9905 indicating        
               "failed pressure transducer" to be generated during weather      
               conditions that exhibit high atmospheric pressure.  This will    
               cause the device to stop ventilating and alarms will sound.

                                      -4-
              
PRODUCT        Fixed Wing Huber Needle Set, a non-coring needle administration  
               set with a "Y" site, 19 ga, 20 ga, and 22 ga and two needle      
               lengths (3/4 inch and 1 inch).  Recall #Z-485-2.
CODE           Lot numbers:  1A161, 1A191, 1A211.
MANUFACTURER   Nipro Medical Industries, Ltd., Tatebayashi, Gumma, Japan.
RECALLED BY    ACB Medical Suppliers, Inc., Medina, New York, by telephone      
               April 3, 1992, followed by letter April 21, 1992.                
               Firm-initiated recall ongoing.
DISTRIBUTION   Canada.
QUANTITY       19,200 units were distributed.
REASON         Cannula separation can occur.

              
PRODUCT        Huber Infusion Set, Fixed Wing, with non-coring, 90 degree bend  
               needle, used in the treatment of cancer:  Product Codes --
               (a) 26940; (b) 26941; (c) 26944; (d) 26945; (e) 26946;
               (f) 26948; (g) 26949; (h) 26950.  Recall #Z-486/493-2.
CODE           Lot numbers:  91A21, 91B19, 91B28, 91D22, 91D29, 91D18, 91E07,   
               91B25, 91B13.
MANUFACTURER   Nissho Corporation, Osaka, Japan.
RECALLED BY    Excel International, Inc., Culver City, California, by letter    
               April 9, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       52,450 sets were distributed.
REASON         Cannula separation can occur.

              
PRODUCT        Bard Cardiopulmonary division/TMP brand Extracorporeal Tube      
               Packs, Rx, sterile, single-use, custom perfusion tubing pack     
               used in heart bypass surgery:
               (a) Catalog #401284-I; (b) Catalog #H-3767-H;
               (c) Catalog #H-3792-H; (d) Catalog #H-7049-B;
               (e) Catalog #H-7312-E;
CODE           Lot numbers:  (a) 28IBX154; (b) 28IBX165; (c) H 28IBX202;
               (d) 28IBX167; (e) 28HBX162.  Recall #Z-494/498-2.
MANUFACTURER   Surgimedics, Inc./TMP, The Woodlands, Texas.
RECALLED BY    Manufacturer, by memorandum October 29, 1991.  Firm-initiated    
               recall complete.
DISTRIBUTION   California, Kentucky.
QUANTITY       None.  Unknown.
REASON         The sterility of the devices may be compromised due to           
               defective seals.

              
PRODUCT        Vista 0.5T Magnetic Resonance Imaging Systems equipped with      
               surface coil interface boxes.  Recall #Z-499-2.
CODE           MFE, MF1, MF3-13, MF16, MF19, MF22-25, MF27-44, MBI-11,          
               MB13-17, MF20, MB12.
MANUFACTURER   Picker International, Inc., Solon, Ohio.
RECALLED BY    Picker International, Inc., Highland Heights, Ohio.              
               Firm-initiated recall ongoing.

                                      -5-
DISTRIBUTION   Nationwide and international.
QUANTITY       74 units were distributed.
REASON         During MRI scanning induced currents may be generated in         
               surface coil connectors or the interface box, causing heating    
               of the component which may result in burns to patients.

              
PRODUCT        Bard Electrophysiology Intracardiac Electrode Catheters, used    
               for intracardiac procedures:
               (a) Catalog No. 200056, 5F; 1 cm; Cournand; 
               (b) Catalog No. 200060, 5F; 5 mm; Josephson;
               (c) Catalog No. 200150, 4F; 2, 5, 2 mm; Cournand;
               (d) Catalog No. 200151, 4F; 2, 5, 2 mm; Josephson;
               (e) Catalog No. 200152, 4F; 1 mm; Cournand;
               (f) Catalog No. 200153, 4F; 1 mm; Josephson;
               (g) Catalog No. 200472, 6F; 2 mm; Cournand;
               (h) Catalog No. 200473, 6F; 2 mm; Josephson.
               Recall #Z-646/653-2.
CODE           Lot numbers:  (a) 27AC0064, 27JB6687, 27CC0102;
               (b) 27HB9183, 27KB0654, 27AC0065, 27JB7481;
               (c) 27HB3800, 27HB9770, 27AC0069;
               (d) 27IB9599, 27AC0076; (e) 27AC0077;
               (f) 27LB0114, 27AC0078; (g) 27AC0039, 27BC0047, 27CC0096;
               (h) 27AC0040, 27BC0048.
MANUFACTURER   Bard Ventures Division, Bard Electrophysiology, C.R. Bard,       
               Inc., Billerica, Massachusetts.
RECALLED BY    Bard Ventures Division, Bard Electrophysiology, C.R. Bard,       
               Inc., Tewksbury, Massachusetts, by letter April 3, 1992.         
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide, Ireland, France.
QUANTITY       Approximately 437 units were distributed.
REASON         The electrode pin cable assembly was incorrectly labeled, in     
               that the electrode pairs labeled as 1, 2, 3, 4 are actually 3,   
               4, 1, 2 respectively.

              
PRODUCT        10F Judkins Left Coronary Guiding Catheters, used for guiding    
               and supporting the DVI Simpson Coronary Atherocath Catheters     
               utilized in percutaneous transluminal coronary atherectomy, and  
               for guiding and supporting commercial percutaneous coronary      
               angioplasty dilation catheters.  Recall #Z-654-2.
CODE           Catalog Nos.       Lot Nos.
               GC-1080-JL4.0SH    120151
               GC-1080-JL4.5SH    120221
               GC-1080-JLGRFSH    120081.
MANUFACTURER   Devices for Vascular Intervention, Inc., Temecula, California.
RECALLED BY    Devices for Vascular Intervention, Inc., Redwood City,           
               California, by letter February 20, 1992.  Firm-initiated recall  
               ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       7,095 units were distributed.

                                      -6-
REASON         Observed kinks or indentions on the inside curve of the guiding  
               catheter, near the side holes may prevent the advancement of     
               the atherectomy catheter through the guiding catheter.

              
PRODUCT        11F Judkins Left 4.0 Coronary Guiding Catheter, used for         
               guiding and supporting the DVI Simpson Coronary Atherocath       
               Catheters utilized in percutaneous transluminal coronary         
               atherectomy, and for guiding and supporting commercial           
               percutaneous coronary angioplasty dilation catheters.  Recall    
               #Z-699-2.
CODE           Catalog #CG-1190-JL4.OSH, lot numbers 112881, 113112.
MANUFACTURER   Devices for Vascular Intervention, Inc., Temecula, California.
RECALLED BY    Devices for Vascular Intervention, Inc., Redwood City,           
               California, by visit and by letter January 2, 1992.              
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       125 units were distributed.
REASON         There is circumferential urethane cracking in the tip shape on   
               the inner radius of the distal, curved portion and brittle       
               bending behavior of the catheter.


              
UPDATE         Corpak Bower PEG Feeding with Internal Retention Balloon with    
               Elastic Foam, Recall #Z-622/625-2 which appeared in the May 6,   
               1992 Enforcement Report should read:

               CODE:  Any lots produced after A48BA, A03BP, A01BH, A07BD        
               respectively, are not affected.  Lots affected are:
               (a) Reorder #30-5020, lot nos. A01BA through A48BA
               (b) Reorder #30-4020, lot nos. A01BP through A03BP
               (c) Reorder #30-6020, lot nos. A01BH
               (d) Reorder #30-5520, lot nos. A01BD through A07BD.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
              
PRODUCT        CKMB Isoenzyme Control (Human), a calibration control for an     
               in-vitro immunoinhibition test for the Creatine Kinase           
               isoenzyme specific to human heart muscle.  Recall #Z-698-2.
CODE           Catalog #102-S, lot #1004S.
MANUFACTURER   Cala Diagnostics, Los Osos, California.
RECALLED BY    Manufacturer, by letter July 18, 1991, followed by telephone.
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       3,564 kits were distributed.
REASON         Portions of the precautionary statements were omitted from the   
               package insert.


                                      -7-
MEDICAL DEVICE SAFETY ALERTS
              
PRODUCT        Alukart Hemoperfusion Cartridge Devices, used in dialysis:
               (a) Alukart Hemoperfusion Cartridge Device, Catalog #01-6003-6;
               (b) HemoKart Hemoperfusion Cartridge Device, Catalog #01-6004-4;
               (c) HemoKart Ped (Pediatric) Hemoperfusion Cartridge Device,     
               Catalog #01-6006-9.  Safety Alert #M-054/056-2.
CODE           All lots.
MANUFACTURER   National Medical Care, Rockleigh, New Jersey.
ALERTED BY     Manufacturer, by letter February 27, 1992.
DISTRIBUTION   Unknown.
QUANTITY       Unknown.
REASON         Devices may contain an ether residue.


SEIZURES:
              
PRODUCT        CMPK Injection (91-624-693/694).
CHARGES        Misbranded - The product is a veterinary prescription drug that  
               does not bear the required prescription legend, "Caution:        
               Federal law restricts this drug to use by or on the order of a   
               licensed veterinarian."  The product's label also fails to bear  
               adequate directions for use since it fails to indicate all the   
               conditions and purposes for which the drug is intended.
FIRM           Turlock Dairy Supply, Turlock, California.
FILED          January 29, 1992 - U.S. District Court for the Eastern District  
               of California; Civil #CV F92 5050REC, FDC #66330.
SEIZED         February 5, 1992 - veterinary drugs, valued at approximately     
               $1,160.

              
PRODUCT        Caldex CMPK Injection (91-625-203).
CHARGE         Misbranded - The product is a veterinary
               prescription drug that does not bear the required
               prescription legend, "Caution:  Federal law
               restricts this drug to use by or on the order of a
               licensed veterinarian."
FIRM           Veterinary Pharmaceuticals, Inc., Hanford, California.
FILED          December 19, 1991 - U.S. District Court for the Eastern          
               District of California; Civil #CV F-91-285, FDC #66267.
SEIZED         December 19, 1991 - veterinary drugs, valued at approximately    
               $3,550.

              
PRODUCT        Oxygen, USP (92-619-154).
CHARGE         Adulterated - The methods used in, and the facilities or         
               controls used for, their manufacture, processing, packing, and   
               holding do not conform to and are not operated and administered  
               in conformity with current good manufacturing practice           
               regulations.
FIRM           Atlantic Sales and Repair, Myrtle Beach, South Carolina.
FILED          March 25, 1992 - U.S. District Court for the District of South   
               Carolina, Florence Division; Civil #4-92-0888-21, FDC #66368.

                                      -8-
SEIZED         May 13, 1992 - oxygen, in cylinders, valued at approximately     
               $1,600.

              
PRODUCT        Oxygen, USP (92-632-250).
CHARGE         Adulterated - The methods used in, and the facilities and        
               controls used for, their processing, packing, and holding do     
               not conform to and are not operated and administered in          
               conformity with current good manufacturing practice regulations.
FIRM           Concept Care Services, Inc., Trenton, New Jersey.
FILED          April 29, 1992 - U.S. District Court for the District of New     
               Jersey; Civil #92-1831, FDC #66417.
SEIZED         May 12, 1992 - bulk oxygen, and filled and empty liquid and      
               gaseous oxygen cylinders, valued at approximately $40,000.

              
PRODUCT        "Sea-Band" accupressure wristbands (92-609-775).
CHARGE         Adulterated - The products are class III devices which do not    
               have in effect the required approved premarket approval          
               application.
               Misbranded - The labeling fails to bear adequate directions for  
               use for the purposes for which the products are intended         
               because adequate directions cannot be written for such           
               purposes.  In addition, a premarket notification covering the    
               device was not filed as required by regulation.
FIRM           Sportsman's Market, Inc., Batavia, Ohio.
FILED          May 11, 1992 - U.S. District Court for the Southern District of  
               Ohio, Western Division; Civil #C-1-92-397, FDC #66422.
SEIZED         May 14, 1992 - "Sea-Band" accupressure wristbands, valued at     
               approximately $5,500.

              
PRODUCT        Sensor Pad, a round latex rubber bladder that contains           
               silicone, a medical grade lubricant, and is sold                 
               over-the-counter for use as an aid in performing breast          
               self-examination (92-673-358).
CHARGE         The sensor pad is a class III medical device which does not      
               have in effect the required approved premarket approval          
               application.
FIRM           Inventive Products, Incorporated, Decatur, Illinois; and Health  
               Services Medical Corporation, Baldwinsville, New York.
FILED          May 5, 1992 - U.S. District Court for the Northern District of   
               New York, Civil # 92-CV-581, FDC #66420.
SEIZED         May 13, 1992 - sensor pads, valued at $1,000.


MASS SEIZURE:
              
PRODUCT        Cervical Dilators (91-612-926).
FIRM           Gynotech, Inc., Middlesex, New Jersey.

                                      -9-
CHARGE         Adulterated - The products are class III devices which do not    
               have in effect the required approved premarket approval          
               application for the devices, and for any subsequent change       
               affecting the safety or effectiveness of the devices.  In        
               addition, the methods used in, and the facilities and controls   
               used for, their manufacture, packing, and storage are not in     
               conformity with current good manufacturing practice regulations.
               Misbranded - The labeling fails to bear adequate directions for  
               use; and, information required by the Medical Device Reporting   
               regulation was not submitted.
FILED          May 11, 1992 - U.S. District Court for the District of New       
               Jersey; Civ # 91-1894(DRD), FDC #66325.
SEIZED         May 12, 1992 - cervical dilators and in-process raw materials,   
               valued at approximately $1,800,000.

                                     -10-


END OF ENFORCEMENT REPORT FOR MAY 27, 1992.  BLANK PAGES MAY FOLLOW.
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