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
02/03/1993

Recalls and Field Corrections:  Foods -- Class I -- 02/03/1993


                                            93-5


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
              
UPDATE         Pride of Alaska Snow Crab Legs and Claws, Recall #F-201-3,       
               which appeared in the January 27, 1993 Enforcement Report        
               should read:
               DISTRIBUTION:  Nationwide.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
              
PRODUCT        Various ice cream and sherbet products:
               (a) Lemon Sherbet, in 3 gallon cardboard cartons;
               (b) Triple Fruit Sherbet, in 3 gallon and 1/2 gallon cardboard   
               cartons;
               (c) Butter Krunch Ice Cream, in 3 gallon cardboard cartons;
               (d) Country Classic Butter Krunch, in 1 gallon plastic cartons;
               (e) Western Family Butter Brickle Ice Cream, in 1 gallon         
               plastic cartons.  Recall #F-203/207-3.
CODE           (a) 8 91; (b) 28992, 24092, 17792 (3 gallon), 41593, 122592,     
               22093, 12393, 22292 (1/2 gallon); (c) 21092;
               (d) 32592, 61192, 62392; (e) 32592.

                                       
MANUFACTURER   Meadow Gold Dairy (a Borden, Inc. company), Great Falls,         
               Montana. 
RECALLED BY    Manufacturer, by memorandum November 6, 1992.  Firm-initiated    
               recall ongoing.
DISTRIBUTION   Montana.
QUANTITY       (a) 84 units; (b) 475 3-gallon units and 9,973 1/2-gallon        
               containers; (c) 71 units; (d) 1,570 units; (e) 144 units were    
               distributed.
REASON         Products contain undeclared FD&C Yellow No. 5.

              
PRODUCT        Cinnamon popcorn, under the following labels and sizes:
               (a) Corn Crib Old Fashioned Cinnamon Popcorn, packed in 9 ounce  
               cello bags; (b) Kernel Glaze Glazed Cinnamon Popcorn, packed in  
               12 ounce cello bags and 22 ounce plastic jugs; (c) Kernel Glaze  
               Gourmet Confetti Popcorn, packed in 6 ounce cello bags for       
               further repacking by the consignee into a corporate gift pack;   
               (d) Red and Green Confetti, packed in a 9 ounce metal tin,       
               under the Pioneer Marketing label.  Recall #F-210/213-3.
CODE           All lots.
MANUFACTURER   Pioneer Marketing, Wichita, Kansas.
RECALLED BY    Manufacturer, by telephone prior to October 31, 1992, and by     
               letter dated October 28, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Kansas, Illinois, New Jersey.
QUANTITY       Approximately (a) 1,553 9-ounce bags; (b) 304 12-ounce bags and  
               81 22-ounce jugs; (c) 91 9-ounce tins; (d) 360 6-ounce bags      
               were distributed.
REASON         Product contains undeclared FD&C Yellow No. 5.


RECALLS AND FIELD CORRECTIONS:  FOODS -  CLASS III
              
PRODUCT        Log Cabin Syrup, made with real maple syrup (2%), in 24 and 36   
               fluid ounce plastic bottles.  Recall #F-176-3.
CODE           2286A* ****/2289A* ****, 2306A* ****/2310A* ****,
               2324A* ****/2326A* ****, 2328A* ****/2329A* **** (24 fluid       
               ounce); 2286A* ****/2353A* ****.  The code consists of a 4       
               digit Julian date followed by an "A" for the plant, then a 1 or  
               2 indicating the shift, and 4 numbers indicating the time of     
               fill.
MANUFACTURER   General Foods USA, Division of Kraft General Foods, Chicago,     
               Illinois.
RECALLED BY    General Foods USA, Division of Kraft General Foods, Northfield,  
               Illinois, by letter December 22, 1992.  Firm-initiated recall    
               ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       165,984 cases were distributed; firm estimates 75 percent of     
               the product remains on the market.
REASON         Product is contaminated with yeast.

                                      -2-
              
PRODUCT        Bumble Bee brand Chunk Light Tuna in Water, packaged in metal    
               cans (307 x 109), 6-1/8 ounces.  Recall #F-209-3.
CODE           CLPCS/ Y6FMB, CLPCS/ Z6N3A, CLPCS/ Z6NDB, CLPCS/ Z6P31,
               CLPCS/ Z6P32, CLPCS/ Z6P41, CLPCS/ Z6P51, CLPCS/ Z6PD1,
               CLPCS/ Z6PD2, CLPCS/ Z6P4A, CLPCS/ Z6P5A, CLPCS/ Z6PDA,
               CLPCS/ Z6PE2, CLPCY/ Y5PD2, CLPCY/ Y5PEB, CLPCY/ Y6ZP2,
               CLPCY/ Y6N52, CLPCY/ Z6N52, CLPCY/ Z9ND2, CLPCY/ Z6NE2,
               CLPCY/ Z6SDB, CLPCY/ Z6T41, CLPCY/ Z6SD2, CLPCY/ Z6T42,
               CLPCY/ Z6TD1, CLPCY/ Z6TD2, CLPCY/ Z6TE2, CLPCY/ Z6TDB,
               CLPCY/ Z6T4B.
MANUFACTURER   Unicord Company, Ltd., Phomprab, Bangkok, Thailand.
RECALLED BY    Bumble Bee Seafoods, Inc., San Diego, California, by letter      
               November 23, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Northeastern United States.
QUANTITY       3,920 cases (48 cans per case) were distributed.
REASON         Product is decomposed.

              
PRODUCT        Shop & Save Tomato Sauce, in 8 ounce cans.  Recall #F-208-3.
CODE           All lots.
MANUFACTURER   Naas Foods, Division of Red Wing Company, Inc., Geneva, Indiana.
RECALLED BY    Supervalu, Inc., Chaska, Minnesota, by memorandum December 3,    
               1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Maryland, Ohio, Pennsylvania, West Virginia.
QUANTITY       Approximately 36,000 cases (48 cans per case) were distributed.
REASON         Product is contained in swollen cans.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
              
PRODUCT        (a) Ben-Aqua 5 Wash, Benzoyl Peroxide, USP 5% a therapeutic      
               cleanser for the control of acne, in 5 fluid ounce plastic       
               cylinder;
               (b) Ben-Aqua 10 wash, Benzoyl Peroxide, USP, 10% a therapeutic   
               cleanser for the control of acne, in 5 fluid ounce plastic       
               cylinder.  Recall #D-104/105-3.
CODE           Lot numbers:  (a) H516 EXP 6/94; (b) H517 EXP 6/94.
MANUFACTURER   Syosset Laboratories Company, Syosset, New York.
RECALLED BY    Manufacturer, by letter January 8, 1993.  Firm-initiated recall  
               ongoing.
DISTRIBUTION   California, Texas, Connecticut, Virginia, Colorado.
QUANTITY       (a) 1,205 containers were distributed; firm estimates 90         
               percent remains on the market; (b) 1,470 containers were         
               distributed; firm estimates 90 percent remains on the market.
REASON         Potential for microbial contamination.

              
PRODUCT        Rifadin Capsules, 300 mg, a Rx drug used to treat tuberculosis   
               and asymptomatic carriers of N. meningitides, in bottles         
               containing 30, 60 and 100 capsules.  Recall #D-106-3.

                                      -3-
CODE           30 count bottles  -  8461YD, 9442YL, 9461YM, 9670AB,
               and 9884AD; 60 count bottles - 8458YD, 8459YD, 8779YF, 9108YH,
               9109YH, 9110YH, 9415YH, 9246YL, 9247YL, 9459YM, 9460YM, 9667AB,
               9668AB, 9669AB, 9841AD, and 9842AD; 100 count bottles - 8455YD,
               8456YD, 8745YF, 9106YH, 9107YH, 9245YL, 9378YL, 9500YM, 9726YN,
               9501YM, 9540AB, 9541AB, 9760AD and 0110AF.
MANUFACTURER   Marion Merrell Dow, Inc., Cincinnati, Ohio.
RECALLED BY    Manufacturer, by telephone during the week of 1/11/93, followed  
               by letter dated January 4, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       62,168 of the 100 count bottles; 118,737 of the 60 count         
               bottles; and 63,932 of the 30 count bottles were distributed.
REASON         Product does not meet dissolution specifications.

              
PRODUCT        Quality Value brand Oral Analgesic Aspirin, 1-1/4 gr, in 1,000   
               tablet bottles.  Recall #D-107-3.
CODE           Lots #7878.
MANUFACTURER   LNK International, Hauppague, New York.
RECALLED BY    Manufacturer, by telephone on or about May 15, 1992.             
               Firm-initiated field correction ongoing.
DISTRIBUTION   Virginia.
QUANTITY       300 bottles were distributed.
REASON         Absence of some dosage directions and lack of conspicuousness    
               of specific caution statements.

              
PRODUCT        Lite-Coat Aspirin Tablets, 325 mg, in bottles of 100, 110, 250,  
               300 and 500, under the following labels:  Bradlees, Freddy's     
               Good Health, Legend, Medic, Pharmor, Pic N Save, Seaway, Shop N  
               Save, Stop N Shop, Sweetlife, Thayer, Wegmans.  Recall #D-109-3.
CODE           Lot numbers:  K1005E, K1006E, K1007E, L1006E.
MANUFACTURER   Pennex Products Company, Inc., Verona, Pennsylvania.
RECALLED BY    Manufacturer, by letter July 22, 1992.  Firm-initiated recall    
               ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       16,351,920 bottles were distributed.
REASON         Possible presence of metal particles.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
              
PRODUCT        Betatar Gel Shampoo, in 8 fluid ounce bottles and 1 fluid ounce  
               bottles (professional sample), therapeutic shampoo for dandruff  
               and seborrheic dermatitis.  Recall #D-108-3.
CODE           Lot #GKA.
MANUFACTURER   Jewett Manufacturing Corporation, San Antonio, Texas.
RECALLED BY    Beta Dermacuticals, Inc., San Antonio, Texas, by telephone       
               January 6, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   Louisiana, Texas.
QUANTITY       120 8-fluid ounce bottles and 144 1-fluid ounce bottles were     
               distributed.
REASON         Formulation not in compliance for dandruff and dermatitis        
               products.
                                      -4-
              
PRODUCT        Bulk Fentanyl Citrate USP, in 17 gram glass bottles, a bulk      
               drug powder.  Recall #D-111-3.
CODE           Lot #0662SHL003.
MANUFACTURER   Mallinckrodt Specialty Chemicals, St. Louis, Missouri.
RECALLED BY    Manufacturer, by letter December 11, 1992.  Firm-initiated       
               recall ongoing.
DISTRIBUTION   Massachusetts.
QUANTITY       17 grams were distributed.
REASON         Use of manufacturing method not currently approved.

              
PRODUCT        CVS brand Timed Release Cold & Allergy Tablets, 15 mg            
               brompheniramine and 75 mg phenylpropanolamine HCl packaged 12    
               tablets per carton, an OTC product.  Recall #D-110-3.
CODE           Lot numbers:  D6073E, J6003E, J6078E.
MANUFACTURER   Pennex Products Company, Inc., Verona, Pennsylvania.
RECALLED BY    Manufacturer, by telephone July 14, 1992, followed by letter     
               July 14, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       2,449 dozen of lot D6073E, 2,336 dozen of lot J6003E, 57 dozen   
               of lot J60783.
REASON         Front label panel incorrectly declares ingredients as 25 mg      
               each.  Rear panel correctly states 12 mg and 75 mg.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
              
PRODUCT        (a) Red Blood Cells; (b) Red Blood Cells, Frozen; (c)            
               Platelets; (d) Fresh Frozen Plasma.  Recall #B-118/121-3.
CODE           Unit numbers:  (a) 1942901, 1947846, 2029606, 2029607;
               (b) 1947845; (c) 1942901, 1947845, 1947846, 2029595, 2029607;
               (d) 2029595, 2029606, 2029607.
MANUFACTURER   The Greater New York Blood Program, New York, New York.
RECALLED BY    Manufacturer, by telephone December 19,1991 and January 14 and   
               15, 1992, and by letters dated January 28 and 29, 1992.          
               Firm-initiated recall ongoing.
DISTRIBUTION   New York.
QUANTITY       (a) 4 units; (b) 1 unit; (c) 5 units; (d) 3 units.
REASON         Blood products, which tested initially reactive for syphilis     
               and were not retested in accordance with the manufacturer's      
               test kit instructions, were distributed.

              
PRODUCT        (a) Whole Blood; (b) Red Blood Cells; (c) Platelets.
               Recall #B-122/124-3.
CODE           Unit numbers:  (a) KC85939; (b) LM96693; (c) KC85940, LM96678,   
               LM96693.
MANUFACTURER   Mid-South Regional Blood Center, Memphis, Tennessee.
RECALLED BY    Manufacturer, by telephone and or letter on various dates        
               between September 11, 1991, and April 24, 1992.  Firm-initiated  
               recall complete.

                                      -5-
DISTRIBUTION   Tennessee, Michigan.
QUANTITY       (a) 1 unit; (b) 1 unit; (c) 3 units.
REASON         Blood products, which were not tested for shyphilis in           
               accordance with the test manufacturer's directions, were         
               distributed.

              
PRODUCT        Source Plasma.  Recall #B-129-3.
CODE           Unit #XT7312.
MANUFACTURER   Sera-Tec Biologicals, Inc., Laredo, Texas.
RECALLED BY    Manufacturer, by letter June 1, 1992.  Firm-initiated recall     
               complete.
DISTRIBUTION   Italy.
QUANTITY       1 unit.
REASON         Source Plasma, which tested negative for the antibody to         
               hepatitis C virus encoded antigen (anti-HCV), but was collected  
               from a donor who previously tested repeatedly reactive for       
               anti-HCV, was distributed.

              
PRODUCT        Recovered Plasma.  Recall #B-130-3.
CODE           Unit numbers:  22FG60981, 22FP90442,
               22FP90444, 22FP90445, 22GE11758, 22GE11824,
               22GE11833, 22GE11838, 22GE11864, 22GE11899,
               22GE12042, 22GE12045, 22GE12055, 22GE12104,
               22GE12112, 22GE12115, 22GE12117, 22GE12232,
               22GE12354, 22GE12430, 22GE12462, 22GE12493,
               22GE12521, 22GE12601, 22GE12710, 22GE12753,
               22GE12852, 22GE12861, 22GE12868, 22GE12870,
               22GE12960, 22GE12983, 22GE12985, 22GE13027,
               22GE13076, 22GE13083, 22GE13105, 22GE13119,
               22GE13185, 22GE13222, 22GE13258, 22GE13272,
               22GE13275, 22GE13309, 22GE13318, 22GE13323,
               22GE13330, 22GE13350, 22GE13423, 22GE13438,
               22GE13448, 22GE13457, 22GE13473, 22GE13475,
               22GE13526, 22GE13578, 22GE13579, 22GE13580,
               22GE13594, 22GE13600, 22GE13617, 22GE13682,
               22GE13704, 22GE13718, 22GE13746, 22GE13785,
               22GE13828, 22GE13842, 22GE13893, 22GE13897,
               22GE13996, 22GE14005, 22GE14058, 22GE14084,
               22GE14219, 22GE14223, 22GE14240, 22GE14248,
               22GE14259, 22GE14314, 22GE14379, 22GE14572,
               22GE14575, 22GE14576, 22GE14578, 22GE14580,
               22GE14586, 22GE14590, 22GE14617, 22GE14637,
               22GE14645, 22GE14649, 22GE14666, 22GE14721,
               22GE14722, 22GE14724, 22GE14732, 22GE14760,
               22GE14764, 22GE14781, 22GE14791, 22GE14798,
               22GE14807, 22GE14830, 22GE14832, 22GE14833,
               22GE14834, 22GE14845, 22GE14853, 22GE14877,
               22GE14918, 22GE14948, 22GE14953, 22GE14954,
               22GE14961, 22GE15001, 22GE15005, 22GE15124,
               22GE15125, 22GE15142, 22GE15151, 22GE15231,

                                      -6-
               22GE15236, 22GE15283, 22GE15300, 22GE15310,
               22GE15430, 22GE15492, 22GE15544, 22GE15551,
               22GE15557, 22GE15558, 22GE15567, 22GE15573,
               22GE15681, 22GE15689, 22GE15690, 22GE15780,
               22GE15827, 22GE15859, 22GE15897, 22GE15908,
               22GE15918, 22GE15992, 22GE16024, 22GE16038,
               22GE16092, 22GE16097, 22GE16149, 22GE16162,
               22GE16247, 22GE16306, 22GJ56714, 22GR83223,
               22GS86261, 22LJ04115, 22LL77397, 22LL77426,
               22LN01397, 22LQ12785, 22LQ12786, 22LQ12924,
               22LQ15274, 22LQ15280, 22LV01215, 22LX83602,
               22LZ07749.
MANUFACTURER   Brandywine Hospital and Trauma Center, Coatesville,              
               Pennsylvania. 
RECALLED BY    Manufacturer, by letter August 12, 1992.  Firm-initiated recall  
               ongoing.
DISTRIBUTION   California, Tennessee, New York, Delaware.
QUANTITY       167 units.
REASON         Blood products, which were collected from donors who were not    
               asked questions designed to exclude donors who are at increased  
               risk for HIV or hepatitis, were distributed for further          
               manufacture.

              
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.     
               Recall #B-134/136-3.
CODE           Unit #L70895.
MANUFACTURER   Aurora Area Blood Bank, Heartland Blood Centers, Aurora,         
               Illinois.
RECALLED BY    Manufacturer, by letter October 13, 1992.  Firm-initiated        
               recall ongoing.
DISTRIBUTION   Illinois.
QUANTITY       1 unit of each component.
REASON         Blood products, which tested negative for the antibody to human  
               immunodeficiency virus type 1 (anti-HIV-1), but were collected   
               from a donor who previously tested repeatedly reactive for       
               anti-HIV-1, were distributed.

              
PRODUCT        Recovered Plasma.  Recall #B-137-3.
CODE           Unit numbers:  39-09128, 39-09142.
MANUFACTURER   Virginia Regional Medical Center, Virginia, Minnesota.
RECALLED BY    Manufacturer, by telephone November 21, 1992.  Firm-initiated    
               recall complete.
DISTRIBUTION   Pennsylvania.
QUANTITY       2 units.
REASON         Recovered Plasma, which tested repeatedly reactive for the       
               antibody to hepatitis B core antigen (anti-HBc), was             
               distributed for further manufacture into non-injectable          
               products without labeling to reflect the anti-HBc reactive       
               results.

                                      -7-
RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
              
PRODUCT        (a) Whole Blood; (b) Whole Blood, Platelets Removed; (c) Red     
               Blood Cells.  Recall #B-125/127-3.
CODE           Unit numbers:  (a) E93019; (b) E95598; (c) LM94727.
MANUFACTURER   Mid-South Regional Blood Center, Memphis, Tennessee.
RECALLED BY    Manufacturer, by telephone and or letter on various dates        
               between September 11, 1991, and April 24, 1992.  Firm-initiated  
               recall complete.
DISTRIBUTION   Tennessee, Michigan.
REASON         Blood products labeled with incorrect expiration dates, were     
               distributed.

              
PRODUCT        (a) Platelets, Pheresis; (b) Granulocytes/Platelets, Pheresis;
               (c) Leukoyctes.  Recall #B-131/133-3.
CODE           Unit numbers:  (a) 12FT24683, 12FT24684, 12FT24685, 12FT24687,   
               12FT24688, 12FT24689, 12FY15110, 12FY15111, 12FY15112,           
               12FY15113, 12FY15114, 12LT05328, 12LT05329, 12LT05330,           
               12LT05331, 12LT05332, 12LT05334, 12T51231, 12T51245, 12T51246,   
               12T51248, 12T51249, 12T51251; (b) 12W04646; (c) 12G95705,        
               12G95706, 12G95707, 12G95708.
MANUFACTURER   American Red Cross Blood Services, Charlotte, North Carolina.
RECALLED BY    Manufacturer, by telephone August 28, 1992, followed by letters  
               August 28 and 31, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 23 units; (b) 1 unit; (c) 4 units.
REASON         Blood products, untested for the antibodies to human             
               immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were       
               distributed.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
              
PRODUCT        EDEC 90c X-ray Controls/high-voltage generators installed in     
               Unicath x-ray systems.  Recall #Z-170-3.
CODE           All serial numbers.
MANUFACTURER   XRE Corporation, Littleton, Massachusetts.
RECALLED BY    Manufacturer.  FDA approved the firm's corrective action plan    
               December 2, 1992.  Firm-initiated field correction ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       50 units.
REASON         Noncompliance with provisions of the performance standards for   
               electronic products requirements for identification and          
               certification.

              
PRODUCT        Latex Examination Gloves:  (a) Catalog #87-9655M;
               (b) Catalog #87-9655L.  Recall #Z-206/207-3.
CODE           Serial numbers:  9655M, 9655L.
MANUFACTURER   Graham-Field, Inc., Hauppauge, New York.
RECALLED BY    Manufacturer, by letter April 20, 1992.  Firm-initiated recall   
               ongoing.
                                      -8-
DISTRIBUITON   Nationwide.
QUANTITY       1,000 cartons were distributed.
REASON         The gloves contained holes.

              
PRODUCT        Alcon/Biophysic Ophthalas AK, SP, Argon and Dye Ophthalmic       
               Lasers.  Recall #Z-247-3.
CODE           Serial numbers:  Unknown.
MANUFACTURER   Alcon Laboratories, Inc., Fort Worth, Texas.
RECALLED BY    Manufacturer.  FDA approved the firm's corrective action plan    
               October 13, 1992.  Firm-initiated field correction ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       473 units were distributed.
REASON         Noncompliance with the performance standards for light-emitting  
               products in that user manuals failed to contain reporductions    
               of required labels and a "caution" statement, units              
               manufactured after October 1989 failed to have certification     
               labels, and schedules and procedures for recalibration of the    
               incorporated measurement systems were not supplied with each     
               unit.

              
PRODUCT        Spacelabs 610 Semi-Automatic Defibrillator.  Recall #Z-250-3.
CODE           Serial numbers:  601 to 1189.
MANUFACTURER   Spacelabs Medical, Inc., Redmond, Washington.
RECALLED BY    Manufacturer, by telephone beginning in September 1990.
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       589 units.
REASON         Failure condition of these units to "latch-up", apparently due   
               to noise in the electrical circuit discharge.

              
PRODUCT        Spacelabs 610 Semi-Automatic Defibrillator.  Recall #Z-251-3.
CODE           Serial numbers:  1672 to 1758.
MANUFACTURER   Spacelabs Medical, Inc., Redmond, Washington.
RECALLED BY    Manufacturer, by letter dated November 18, 1992.                 
               Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide, Canada, Peru, Indonesia, Italy.
QUANTITY       80 units were distributed.
REASON         Excessive arcing may reduce the life of the high voltage relay   
               causing the product to fail.

              
PRODUCT        Retroplegia II Coronary Sinus Cardioplegia Cannula, a            
               polyurethane triple lumen cannula that features a manually       
               inflated/deflated textured polyurethane occlusion balloon with   
               a check valve and pilot balloon at the inflation port.
               Recall #Z-253-3.
CODE           Product code  RC2-012MIB: Lot #73236, 73567, 74109;
               Product code  RC2-102MIBB: Lot #73237, 73484, 73568, 74110.
MANUFACTURER   Research Medical, Inc., Midvale, Utah.
RECALLED BY    Manufacturer, by fax December 4, 1992, followed by letter.       
               Firm-initiated recall ongoing.

                                      -9-
DISTRIBUTION   Illinois, Wisconsin, California, Kansas, Indiana, Georgia,       
               Florida, Pennsylvania, North Carolina, Minnesota, Alabama,       
               Virginia, Michigan, Texas, New York, Canada, England, Belgium,   
               Italy, Japan, Sweden.
QUANTITY       455 units of product RC2-012MIB and 230 units of product code    
               RC2-102MIBB.
REASON         The coronary sinus balloon may fail to maintain proper           
               inflation volume.

SEIZURES:
              
PRODUCT        Various articles of food (92-683-341/355).
CHARGE         Adulterated - The products consist in part of a filthy
               substance.
FIRM           SFC Trading Co., Inc., Los Angeles, California.
FILED          October 16, 1992 - U.S. District Court for the Central
               District of California; Civil #CV92-6243, FDC #66612.
SEIZED         October 26, 1992 - goods valued at approximately $24,000.

              
PRODUCT        Various articles of food (92-567-024).
CHARGE         Adulteration - The products consist in part of a filthy
               substance.
FIRM           Dai Cheong Trading Co., Inc., Los Angeles, California.
FILED          July 24, 1992 - U.S. District Court for the Central
               District of California, Civil #CV92-4054-RMT(JGX);
               FDC #66468.
SEIZED         August 14, 1992 - goods valued at approximately $16,243.

                                     -10-

END OF ENFORCEMENT REPORT FOR FEBRUARY 3, 1993.  BLANK PAGES MAY
FOLLOW.