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.

April 2, 1997                                          97-14

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II ===========
_______________
PRODUCT        Eggnog Cheesecake, net weight 3 pounds 1
               ounce.  Recall #F-270-7.
CODE           None.
MANUFACTURER   Moonstruck Chocolatier, Portland, Oregon.
RECALLED BY    Manufacturer, by telephone beginning on
               November 27, 1996.  Firm-initiated recall
               complete.
DISTRIBUTION   Nationwide.
QUANTITY       100 cakes were distributed between October and
               November.
REASON         The products contain undeclared FD&C Yellow
               No. 5, FD&C Yellow No. 6, FD&C Blue No.1 and
               FD&C Red No.3.

_______________
PRODUCT        Chewsey Fruits Candy, in 8 ounce packages. 
               Recall #F-273-7.
CODE           None.
MANUFACTURER   Rayge Candy Company, Bricktown, New Jersey.
RECALLED BY    Manufacturer, by letter dated November 1,
               1996, followed by visit by November 8, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   New Jersey.
QUANTITY       5 cases were distributed; firm estimates none
               remains on the market.
REASON         Product contains undeclared certified colors,
               FD&C Yellow No. 5 & 6.

_______________
PRODUCT        Pork & Beans in Tomato Sauce, in 16 ounce cans
               distributed under Phillips and Gibbs labels. 
               Recall #F-276-7.
CODE           Product is marked with a two line code on The
               top line the involved are 36262 HPBS and 46262
               HPSB and the second line has a military time
               between 15:00 and 23:00 SEPT 98. 
MANUFACTURER   Hanover Foods Corporation, Hanover,
               Pennsylvania.
RECALLED BY    Manufacturer, by telephone on January 10,
               1997.  Firm-initiated recall complete.
DISTRIBUTION   Virginia, North Carolina, Pennsylvania,
               Maryland.
QUANTITY       Firm estimates none remains on the market.
REASON         Some cans of product contain a small amount of
               undeclared corn.

________________
PRODUCT        Nations Winners brand Spark of Life "Multi-
               Nutritional Drink with Whole Leaf Aloe Vera
               Vitamins, Minerals, Enzymes, and Herbs", in 32
               fluid ounce plastic containers.  
               Recall #F-278-7.
CODE           Batch 3844 on bottom of containers.
MANUFACTURER   Aloe Pro International, Farmers Branch, Texas.
RECALLED BY    Manufacturer, by letter dated November 7,
               1996.  Firm-initiated recall ongoing.
DISTRIBUTION   Georgia.
QUANTITY       2,383 bottles were distributed.
REASON         Product contains undeclared FD&C Yellow No. 5
               and bears an incorrect Vitamin C label
               declaration. 

_______________
PRODUCT        Joe's Bakery Cookies, in 16 ounce hard plastic
               containers.  Recall #F-279-7.
CODE           None.  Product has a short shelf life.
MANUFACTURER   Carcione, Guiseppe & Costello, Maria, doing
               business as Joe's Bakery, Brooklyn, New York.
RECALLED BY    Manufacturer, by telephone on January 29,
               1997, and February 5, 1997.  Completed recall
               resulted from sample analysis and followup by
               the New York State Department of Agriculture
               and Markets.
DISTRIBUTION   New York.
QUANTITY       Firm estimates none remains on the market.
                             -2-REASON         Product contains the undeclared colors FD&C

               Yellow No. 5 and FD&C Red 40.

_______________
PRODUCT        Naturally Wholesome Banana Cake, in 2-1/2
               ounce cellophane packages.
               Recall #F-280-7.
CODE           All codes including Jan 2 97.
MANUFACTURER   Neighborhood Bakery, Inc., also known as Payoo
               Industries, Inc., Brooklyn, New York.
RECALLED BY    Manufacturer, by letter followed by visit . 
               Completed field correction (relabelling)
               resulted from sample analysis and followup by
               the New York State Department of Agriculture
               and Markets.
DISTRIBUTION   New York.
QUANTITY       Firm estimates none remains on market.
REASON         Product contains undeclared FD&C Yellow No. 5.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III ==========
_______________
PRODUCT        Libby's Juicy Juice: (a) Tropical flavor; (b)
               Grape flavor; (c) Cherry flavor;
               (d) Punch flavor; (e) Variety Pack (Punch,
               Grape and Cherry flavors).  
               Recall #F-246/250-7.
 CODE          (a) Product code 28000-39110, date codes
               5-Aug-97 and 6-Aug-97, 250 ml tetra pak,
               27/case
               (b) Product code 28000-39210, date code
               6-Aug-97, 250 ml tetra pak, 27/case
               (c) Product code 28000-39410, date codes
               7-Aug-97 and 8-Aug-97, 250 ml tetra pak,
               27/case product code 28000-39960, date codes
               4-Aug-97 and 5-Aug-97, 125 ml tetra pak,
               44/case
               (d) Product code 28000-39610, date codes
               4-Aug-97, 5-Aug-97, and 8-Aug-97, 250 ml tetra
               pak, 27/case 
               (e) Product code 28000-39920, date codes
               6-Apr-97, 27-Apr-97, 28-Apr-97, 30-Apr-97,
               1-May-97, 19-Jun-97, Jul-97 (all dates 07
               through 31), and Aug-97 (all dates 01 through
               31) 
MANUFACTURER   Sweet Ripe Drinks Ltd., Ontario, Canada
               (finished product); Resero Company, Argentina
               (juice concentrate). 
RECALLED BY    Nestle Beverage Company, San Francisco,
               California, by letter faxed on December 13,
               1996.  Firm-initiated recall ongoing.

                             -3-DISTRIBUTION   Maryland, Pennsylvania, Florida, New Jersey,
               New York, Connecticut, Virgin Islands, North
               Carolina, Virginia, Ohio, Maryland, Georgia,
               Maine, Alabama.
QUANTITY       50,230 cases (27 per case) were distributed.
REASON         One of the juice concentrates used as an
               ingredient in these products was found to
               contain added sweetener.

_______________
PRODUCT        Stop & Shop Fruit Punch from Concentrate, in
               8.5 fluid ounce containers.  
               Recall #F-274-7.
CODE           EXP AUG 5/97 stamped at apex of container.
MANUFACTURER   Fisher Brothers Brands Ltd., Quebec, Canada.
RECALLED BY    The Stop & Shop Supermarket, North Quincy,
               Massachusetts, by E-mail on February 28, 1997,
               follow-up notification was sent on March 4,
               1997.  Firm-initiated recall ongoing.
DISTRIBUTION   Massachusetts, Connecticut, Rhode Island, New
               York, New Jersey.
QUANTITY       110 cases (8 3-packs per case) were
               distributed.
REASON         Product is contaminated with mold.

_______________
PRODUCT        Hunter brand Smoked Oysters in cottonseed oil,
               in 3.75 ounce (105g) metal cans.
               Recall #F-277-7.
CODE           OYSO BY2 5413 and 0YSO BY2 5421.
MANUFACTURER   Shinjin Moolsan Company, Ltd., Kyungnam,
               Korea.
RECALLED BY    Consolidated Stores Corporation, Columbus,
               Ohio, by E-Mail message sent on January 31,
               1997, and February 3 and 21, 1997.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       318 cases (24 cans per case) were distributed.
REASON         Oysters were found to be decomposed.

_______________
PRODUCT        Carbonated Soft Drinks:
               1. Pepsi Cola (10 fl. ozs., 12 fl. ozs., 20
               fl. ozs., 1 Liter, 2 Liter, 3 Liter)
               2. Caffeine Free Pepsi (12 fl. ozs., 2 Liter)  
               3. Diet Pepsi (10 fl. ozs., 12 fl. ozs., 20
               fl. ozs., 2 Liter, 3 Liter)
               4. Diet Caffeine Free Pepsi (12 fl. ozs., 2
               Liter) 
               5. Josta (20 fl. ozs.)   
               6. Mountain Dew (10 fl. ozs., 12 fl. ozs., 20
               fl. ozs., 1 Liter, 2 Liter, 3 Liter)

                             -4-               7. Diet Mountain Dew (12 fl. ozs., 20 fl.
               ozs., 2 Liter, 3 Liter)   
               8.  Caffeine Free Mountain Dew (12 fl. ozs.,
               20 fl. ozs., 2 Liter)
               9.  Diet Caffeine Free Mountain Dew (2 Liter)
               10.  Orange Slice (12 fl. ozs.)
               11.  Dr. Pepper (12 fl. ozs., 20 fl. ozs., 2
               Liter)
               12.  Diet Dr. Pepper (12 fl. ozs., 2 Liter) 
               13.  7-Up (12 fl. ozs., 20 fl. ozs., 2 Liter)
               14.  Diet 7-Up (12 fl. ozs., 20 fl. ozs., 2
               Liter)
               15.  Cherry 7-Up (2 Liter)
               16.  Sunkist Orange (12 fl. ozs., 2 Liter) 
               17.  Canada Dry Club Soda (10 fl. ozs.) 
               18.  Canada Dry Ginger Ale (10 fl. ozs.)
               19.  Canada Dry Tonic (10 fl. ozs.)     
               20.  All Sport Blue Ice (20 fl. ozs., 32 fl.
               ozs.,  64 fl. ozs.)
               21.  All Sport Cherry Slam (20 fl. ozs., 32
               fl. ozs., 64 fl. ozs.)
               22. All Sport Fruit Punch (12 fl. ozs., 20 fl.
               ozs., 32 fl. ozs., 64 fl. ozs.)
               23.  All Sport Grape (12 fl. ozs., 20 fl.
               ozs., 32 fl. ozs., 64 fl. ozs.)     
               24-7  All Sport Lemon Lime (12 fl. ozs., 20
               fl. ozs., 32 fl. ozs., 64 fl. ozs.)
               25.  All Sport Orange (12 fl. ozs., 20 fl.
               ozs., 32 fl. ozs., 64 fl. ozs.)     
               26. Pepsi Cola Premix
               27. Diet Pepsi Premix
               28. Mountain Dew Premix
               29. Dr. Pepper Premix.  Recall #F-281/309-7.
CODE           1.  10 fl. ozs.     xxxxTS021273
                   12 fl. ozs.     xxxxTS020771
                                   xxxxTS021271
                   20 fl. ozs.     xxxxTS020673, xxxxTS021073
                   1 Liter         xxxxTS021373
                   2 Liter         xxxxTS020672
                                   xxxxTS020772, xxxxTS021072
                                   xxxxTS021272, xxxxTS021372
                   3 Liter         xxxxTS021372
               2.  12 fl. ozs.     xxxxTS021071
                   2 Liter         xxxxTS021072
               3.  10 fl. ozs.     xxxxTS021273
                   12 fl. ozs.     xxxxTS021071, xxxxTS021471
                   20 fl. ozs.     xxxxTS020673, xxxxTS021173
                   2 Liter         xxxxTS021172
                   3 Liter         xxxxTS021372
               4.  12 fl. ozs.     xxxxTS020671, xxxxTS021071
                   2 Liter         xxxxTS021072
               5.  20 fl. ozs.     xxxxTS021173

                             -5-               6.  10 fl. ozs.     xxxxTS021273
                   12 fl. ozs.     xxxxTS020671, xxxxTS021171
                                   xxxxTS021371
                   20 fl. ozs.     xxxxTS020673, xxxxTS021073
                                   xxxxTS021173
                   1 Liter       xxxxTS021373
                   2 Liter       xxxxTS021272, xxxxTS021372
                   3 Liter       xxxxTS021372
               7.  12 fl. ozs.   xxxxTS021071, xxxxTS021471
                   20 fl. ozs.   xxxxTS020673, xxxxTS021173
                   2 Liter       xxxxTS020672, xxxxTS021172
                   3 Liter       xxxxTS021372
               8.  12 fl. ozs.   xxxxTS021271
                   20 fl. ozs.   xxxxTS021173
                   2 Liter       xxxxTS021272
               9.  2 Liter       xxxxTS021172
               10. 12 fl. ozs.   xxxxTS020671, xxxxTS021171
               11. 12 fl. ozs.   xxxxTS021171
                   20 fl. ozs.   xxxxTS021173
                   2 Liter       xxxxTS020672, xxxxTS021172
               12.  12 fl. ozs.  xxxxTS021271
                    2 Liter      xxxxTS020672
               13.  12 fl. ozs.  xxxxTS021171
                    20 fl. ozs.  xxxxTS021173
                    2 Liter      xxxxTS020672, xxxxTS021172
                                 xxxxTS021272
               14. 12 fl. ozs.   xxxxTS021171
                   20 fl. ozs.   xxxxTS021073
                   2 Liter       xxxxTS020772, xxxxTS021172
               15. 2 Liter       xxxxTS020772
               16. 12 fl. ozs.   xxxxTS020671, xxxxTS021271
                   2 Liter       xxxxTS021072
               17. 10 fl. ozs.   xxxxTS021273
               18. 10 fl. ozs.   xxxxTS021273
               19. 10 fl. ozs.   xxxxTS021273
               20. 20 fl. ozs.  xxxxTS020873, xxxxTS021473
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS021473
               21. 20 fl. ozs.  xxxxTS020873, xxxxTS021473
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS020873
               22. 12 fl. ozs.  xxxxTS020771, xxxxTS021471
                   20 fl. ozs.  xxxxTS020873
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS020873, xxxxTS021473
               23. 12 fl. ozs.  xxxxTS020771
                   20 fl. ozs.  xxxxTS020873
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS020873, xxxxTS021473
               24. 12 fl. ozs.  xxxxTS020771, xxxxTS021471
                   20 fl. ozs.  xxxxTS020873, xxxxTS021473
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS020873
                             -6-               25. 12 fl. ozs.  xxxxTS021471
                   20 fl. ozs.  xxxxTS020873
                   32 fl. ozs.  xxxxTS020873
                   64 fl. ozs.  xxxxTS021473
               26. Nov 17, 97
               27. May 26, 97
               28. Aug 18, 97
               29. Nov 10, 97.
MANUFACTURER   PepsiCo South, Knoxville, Tennessee.
RECALLED BY    Manufacturer, by visit to be completed by
               close of business on February 21, 1997.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Tennessee and Georgia.
QUANTITY       Approximately 137,000 cases (all sizes and
               package types) were distributed; firm
               estimated that the majority of these cases
               would have been consumed prior to the
               initiation of recall.
REASON         Products have an off-odor and off taste.

_______________
PRODUCT        America's Choice Thick and Chunky Hot Salsa,
               packed in 26 ounce glass jars. 
               Recall #F-314-7.
CODE           "B7B19 41 stamped on jar caps, B7B19 stamped
               on shipping cases.
MANUFACTURER   Torbitt & Castleman Company, Buckner,
               Kentucky.
RECALLED BY    Manufacturer, by mail on March 14, 1997. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Georgia, Vermont, New Jersey.
QUANTITY       55 cases (12 jars per case) were distributed;
               firm estimates none remains on the market.
REASON         Product was under processed, causing it to
               ferment and pop lids off of the product.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II ===========
_______________
UPDATE         UDL Laboratories (Rockford, Illinois),
               Cefaclor Capsules, USP, 250 mg and 500 mg,
               Recall #D-130/131-7, which appeared in the
               March 26, 1997, Enforcement Report should
               read:  Product is unit dose packaged in 10
               strips of 10 capsules per shelf carton. 


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II =======
_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh
               Frozen Plasma; (d) Recovered Plasma.  
               Recall #B-291/294-7.

                             -7-CODE           Unit numbers:  (a&b) 1117668, 1136572,
               1214792; (c) 1117668, 1214792; (d) 1136572.
MANUFACTURER   Central Kentucky Blood Center, Lexington,
               Kentucky.
RECALLED BY    Manufacturer, by letter dated May 24, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   Kentucky, Ohio.
QUANTITY       (a) 3 units; (b) 3 units; (c) 2 units; (d) 1
               unit was distributed.
REASON         Blood products were collected from a donor who
               initially tested HCV reactive was not deferred
               nor properly reentered.

_______________
PRODUCT        Red Blood Cells.  Recall #B-487-7.
CODE           Unit numbers:  53Q55219, 53Q54223, 53Q53198.
MANUFACTURER   American Red Cross Blood Services, Baltimore,
               Maryland.
RECALLED BY    Manufacturer, by letter dated October 7, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   Maryland, Pennsylvania, District of Columbia.
QUANTITY       3 units were distributed.
REASON         Blood products were collected from a donor who
               reported travel to an area considered endemic
               for malaria.

_______________
PRODUCT        Red Blood Cells.  Recall #B-478-7.
CODE           Unit numbers:  M38039, M37526, M36994, M36262.
MANUFACTURER   Tri-Counties Blood Bank, Inc., Santa Barbara,
               California.
RECALLED BY    Manufacturer, by letter dated January 20,
               1995.  Firm-initiated recall complete.
DISTRIBUTION   California.
QUANTITY       4 units were distributed.
REASON         Blood products were collected from a donor who
               traveled to an area considered endemic for
               malaria.

_______________
PRODUCT        Red Blood Cells.  Recall #B-492-7.
CODE           Unit #26146-0328.
MANUFACTURER   Blood Systems, Inc., Rogers, Arkansas.
RECALLED BY    United Blood Services, Fort Smith, Arkansas,
               by telephone on July 19, 1996.  Firm-initiated
               recall complete.
DISTRIBUTION   Arkansas.
QUANTITY       1 unit was distributed.
REASON         Blood product was collected from a donor who
               reported a history of cancer.

                             -8-_______________
PRODUCT        Red Blood Cells.  Recall #B-493-7.
CODE           Unit numbers:  12LF01581, 12LF04609,
               12LF06740, 12LZ06324, 12LZ08584, 12LZ11633,
               12LF12388, 12LF16806, 12LF18747, 12LF21411,
               12LC19144, 12FZ11305, 12FZ13413, 12FZ20291,
               12FZ22623, 12FZ24416, 12FZ15942, 12FZ18198.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 1, 3, 1996,
               or July 5, 1995.  Firm-initiated recall
               complete.
DISTRIBUTION   North Carolina.
QUANTITY       18 units were distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), but were collected from a donor
               who previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Whole Blood; (b) Red Blood Cells; (c)
               Fresh Frozen Plasma.  Recall #B-496/498-7.
CODE           Unit numbers:  12C55093, 12E61490, 12GE10063,
               12E70173, 12GH46339, 12GC31099, 12GH52169,
               12GE23620, 12GH60568. 
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 10, 1996 or
               May 21, 1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 1 unit; (b) 8 units; (c) 1 unit was
               distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), were collected from a donor who
               previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Red Blood Cells; (b) Fresh Frozen Plasma. 
               Recall #B-499/500-7.
CODE           Unit #12FL83579.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letters dated January 22 and
               23, 1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       1 unit of each component was distributed.

                             -9-REASON         Blood products tested negative for the
               antibody to the hepatitis C virus encoded
               antigen (anti-HCV), were collected from a
               donor who previously tested repeatedly
               reactive for anti-HCV.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c)
               Recovered Plasma.  Recall #B-501/503-7.
CODE           Unit numbers:  (a & b) 12LJ02816; (c)
               12FV35378.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated January 22,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina and California.
QUANTITY       1 unit of each component was distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis C virus encoded
               antigen (anti-HCV), were collected from a
               donor who previously tested repeatedly
               reactive for anti-HCV.

_______________
PRODUCT        Red Blood Cells.  Recall #B-505-7.
CODE           Unit #12LJ18563.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated June 17, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       1 unit was distributed.
REASON         Blood product was collected from a donor who
               emigrated from an area considered endemic for
               malaria.

_______________
PRODUCT        Red Blood Cells.  Recall #B-506-7.
CODE           Unit #12GE20198.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated January 31,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       1 unit was distributed.
REASON         Blood product tested negative for the antibody
               to the hepatitis B core antigen (anti-HBc),
               but were collected from a donor who previously
               tested repeatedly for anti-HBc on two separate
               occasions.

                            -10-_______________
PRODUCT        Red Blood Cells.  Recall #B-508-7.
CODE           Unit #12GC27932.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 15, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   South Carolina.
QUANTITY       1 unit was distributed.
REASON         Blood product tested negative for the antibody
               to the hepatitis B core antigen (anti-HBc),
               but was collected from a donor who previously
               tested repeatedly for anti-HBc on two separate
               occasions.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh
               Frozen Plasma.  Recall #B-509/511-7.
CODE           Unit numbers:  (a) 12E77883, 12R54653; 
               (b&c) 12E77883.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 1, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 2 units; (b&c) 1 unit was distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), but were collected from a donor
               who previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Whole Blood; (b) Red Blood Cells.
               Recall #B-512/513-7.
CODE           Unit numbers:  (a) 12FF72206; (b) 12GC43841,
               12FC45478.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letters dated April 18, 19,
               or 25, 1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 1 unit; (b) 2 units were distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc) were collected from a donor who
               previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets, Pheresis. 
               Recall #B-514/515-7.

                            -11-CODE           Unit numbers:  (a) 12LJ18519; (b) 12GP03643,
               12GP03842.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 29, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 1 unit; (b) 2 units were distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), but were collected from a donor
               who previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh
               Frozen Plasma.  Recall #B-516/518-7.
CODE           Unit numbers:  (a) 12LC05579, 12L98175,
               12L12938; (b&c) 12LC05579.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated July 9 or 18,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 3 units; (b & c) 1 unit was distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), but were collected from a donor
               who previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh
               Frozen Plasma.  Recall #B-519/521-7.
CODE           Unit numbers:  (a) 12FH60303, 12FP00085,
               12FX19419; (b) 12FH60303; (c) 12FH60303,
               12FX19419.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letters dated July 8, 10, or
               12, 1996.  Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       (a) 3 units; (b) 1 unit; (c) 2 units were
               distributed.
REASON         Blood products tested negative for the
               antibody to the hepatitis B core antigen
               (anti-HBc), but were collected from a donor
               who previously tested repeatedly reactive for
               anti-HBc on two separate occasions.

_______________
PRODUCT        Platelets, Pheresis.  Recall #B-522-7.
CODE           Unit #1314-1275-02.
                            -12-MANUFACTURER   United Blood Services, El Paso, Texas.
RECALLED BY    Manufacturer, by telephone on July 15, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   Texas.
QUANTITY       1 unit was distributed.
REASON         Blood product was labeled with an extended
               expiration date.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  
               Recall #B-524/525-7.
CODE           Unit numbers:  53Q55615, 53Q54322, 53Q53223.
MANUFACTURER   American Red Cross Blood Services, Baltimore,
               Maryland.
RECALLED BY    Manufacturer, by letter dated October 7, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   Maryland and District of Columbia.
QUANTITY       3 units of each component were distributed.
REASON         Blood products were collected from a donor who
               reported travel to an area considered endemic
               for malaria.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  
               Recall #B-526/527-7.
CODE           Unit #49S53709.
MANUFACTURER   American Red Cross Blood Services, Tulsa,
               Oklahoma.
RECALLED BY    Manufacturer, by letter dated December 27,
               1996.  Firm-initiated recall complete.
DISTRIBUTION   Oklahoma.
QUANTITY       1 unit of each component was distributed.
REASON         Blood products were collected from a donor who
               reported travel to an area considered endemic
               for malaria.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III ======
_______________
PRODUCT        (a) Red Blood Cells; (b) Recovered Plasma. 
               Recall #B-494/495-7.
CODE           Unit #KE49457.
MANUFACTURER   Virginia Blood Services, Richmond, Virginia.
RECALLED BY    Manufacturer, by letter on June 3, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   Virginia, California.
QUANTITY       1 unit of each component was distributed.
REASON         Blood products were collected from a donor
               whose donor history screening was inadequately
               performed.

                            -13-_______________
PRODUCT        Red Blood Cells.  Recall #B-504-7.
CODE           Unit #12FZ30252.
MANUFACTURER   American Red Cross Blood Services, Charlotte,
               North Carolina.
RECALLED BY    Manufacturer, by letter dated May 8, 1996. 
               Firm-initiated recall complete.
DISTRIBUTION   North Carolina.
QUANTITY       1 unit was distributed.
REASON         Blood product was stored at unacceptable
               temperature.

_______________
PRODUCT        Red Blood Cells.  Recall #B-523-7.
CODE           Unit #26146-4190.
MANUFACTURER   United Blood Services, Fort Smith, Arkansas.
RECALLED BY    Blood Systems, Inc., Scottsdale, Arkansas, by
               letter dated October 16, 1996.  Firm-initiated
               recall complete.
DISTRIBUTION   Arkasas.
QUANTITY       1 unit was distributed.
REASON         Blood product may have remained at room
               temperature for an unacceptable length of
               time.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II =========
_______________
PRODUCT        7200 Series Ventilators System with Pulsed
               Alarm Option and Pulsed Alarm Kits.  
               Recall #Z-349-7.
CODE           Lot numbers 704 and 729.
MANUFACTURER   Nellcor Puritan Bennett, Carlsbad, California.
RECALLED BY    Manufacturer, by telephone and by fax dated
               August 22, 1996.  Firm-initiated recall
               complete.
DISTRIBUTION   Nationwide, France, New Zealand, Canada.
QUANTITY       70 units were distributed.
REASON         The optional pulsed alarm was not loud enough
               for the user facilities to hear.

_______________
PRODUCT        Airway Modules with Optional Spirometry
               Functions used with the AS/3 Anesthesia
               Monitor:
               (a) Model G-AOV, Measure C02, N20, 02
               Anesthetic Agent with Side Stream Spirometry;
               (b) Model No. G-AiOV, Measure C02, N20, 02
               Anesthetic Agent Side Stream Spirometry. 
               Recall #Z-350/351-7.
CODE           Modules: G-AOV, G-AiOV
MANUFACTURER   Datex-Engstrom Division, Helsinki, Finland.

                            -14-RECALLED BY    Datex-Engstrom, Inc., Tewksbury,
               Massachusetts, by letter dated January 10,
               1997.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       (a) 26 units; (b) 760 units were distributed.
REASON         A defective tantalum capacitor (C17) on the
               PVX Board (pressure and volume measurement)
               partly burned and short-circuited, resulting
               in the spread of fire to the tubing and some
               plastic parts inside the module.

_______________
PRODUCT        Fluoroscan I and III Promotional Videotape,
               with a 1992 copyright at the end of the tape. 
               Recall #Z-353-7.
CODE           All tapes distributed prior to August 1996.
MANUFACTURER   FluoroScan Imaging Systems, Inc., Northbrook,
               Illinois.
RECALLED BY    Manufacturer, by undated letter sent on March
               14, 1997.  Firm-initiated field correction
               ongoing.
DISTRIBUTION   Undetermined.
QUANTITY       Undetermined.
REASON         The device has indications that extend the use
               of the device beyond extremity imaging.

_______________
PRODUCT        ImmunoCard H. pylori, Catalog #710030, used 
               for the detection of IgG antibodies to
               Helicobacter pylori in human serum and plasma.
               Recall #Z-354-7.
CODE           Lot #710030.024.
MANUFACTURER   Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY    Manufacturer, by telephone on February 25,
               1997.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and Italy.
QUANTITY       206 kits were distributed.
REASON         The enzyme conjugate reagent causes false
               positive results with patient specimens and
               the negative control.


_______________
PRODUCT        Hewlett Packard Ultrasound Transducers,
               transducer frequencies are available for a
               variety of imaging applications, including
               abdominal and cardiac, fetal imaging and
               neonatal head.  Recall #Z-355/374-7.
CODE           Model   Serial        Description
               21200C  3412AOO651    2.5 MHz transducer
                       3412AO6749
                       3412AO6961

                            -15-               21202A  3412AO5578    2.5 NHz / 2.0 MHz
                       3412AO5594    transducer
               21205C  3412AO2644    3.5 MHz transducer
                       3412AO2667
               21210B  3412AO2731    5.0 MHz medium focus
                                     transducer
               21211B  3412AO2761    5.0 MHz short focus
                       3412AO2812    transducer
                       3412AO2840
                       3412AO2927
               21215A  3425AOI301    2.5 MHz / 2.0 MHz
                                     transducer
               21253A  3412AOO531    3.5 MHz CLA transducer
               21253B  3519AOO278    3.5 MHz CLA transducer
                       3519AOO2807
                       3519AOO285
                       3519AOO301
                       3519AOO304
                       3519AOO459
                       3519AOO478
                       354OA00123
                       354OA00131
                       3542AOO373
               21255B  3412AOO497    4.5 MHz / 3.5 MHz
                                     trapezoidal transducer
               21958B  3507AOO962    7.5 MHz / 5.5 MHz
                       3507AOII69    trapezoidal linear array
                       3507AOI365    transducer
                       3507AOI366
                       3507AO1402
                       3507AO1419
                       3542AO1786
                       3542AO1799
                       3542AO1911
               21275A  3434AO1447    7.5 MHz / 5.5 MHz
                                     transducer
               21302A  3426AOO215    2.5 MHz/ 2.0 MHz
                                     transducer
               21358B  3507AOO275    7.5 MHz / 5.5 MHz
                       3507AOO292    trapezoidal linear array
                                     transducer
               21363A  3412AOO577    5.0 MHz Biplane TEE
                                     transducer
               21370A  3441AOO1O4    7.5 MHz / 5.0 MHz
                       3441AOO125    Endovaginal transducer
                       3441AOO191
                       3441AOO195
                       3441AOO201
                       3441AOO204
                       3441AOO217
                       3441AOO265
                       3441AOO283
                            -16-                       3441AOO285
                       3441AOO413
               21372A  3551AOO138    7.5 MHz 5.0 MHz Small
                       3618AOO206    Parts CLA transducer
                       3618AOO210
               21373A  3513AOO225    5.0 MHz Curvilinear 
                       3513AOO250   transducer
                       3513AOO290
                       3513AOO356
               21402A  2917AO3855    2.5 MHz CW/I Sonos 100 
                       3312AO2631   transducer
                       3312AO3058
                       3312AO9754
                       3312AO9762
                       3312AO9763
                       3312AO9764
                       3312AO9766
                       3312AO9768
                       3312AO9769
                       3312AO9771
                       3312AO9824
                       3312A10478
                       3312A11946
                       3312A11965
                       3312A12480
               21415A  3312AO8809     7.5 MHz Sonos 100
                       3312A11035     imaging transducer
                       3312A11440
               21445A  3104AO4865     10MHZ imaging
                                      transducer
MANUFACTURER   Hewlett Packard Company, Andover,
               Massachusetts.
RECALLED BY    Manufacturer, by letter dated January 27,
               1997.  Firm-initiated field correction
               ongoing.
DISTRIBUTION   California, Colorado, Florida, Georgia,
               Kentucky, Minnesota, Montana, New York, Ohio,
               international.
QUANTITY       86 transducers were distributed.
REASON         There may be slight image degradation.

_______________
PRODUCT        Argyle Turkel Safety Toracentesis System and
               Procedure Tray: 
               (a) Argyle Turkel Safety Thoracentesis System,
               Catalog No. 8888-566034, 
               (b) Argyle Turkel Safety Thoracentesis
               Procedure Tray, Catalog No. 8888-566059. 
               Recall #Z-375-376-7. 
CODE           Lot Numbers:  (a) WO80333A, WO80334A,
               WO80335A, WO81348A, WO81349A, WO83279A,
               WO85088A, WO85089A, WO86537A, WO86538A, 
                            -17-               WO86539A, WO86540A, WO87939A, WO87938A,
               WO87937A, WO99165A, WO99167A, WO102803A,
               WO99166A, WO102804A, WO99168A, WO93348A,
               WO105541A, WO105540A, WO93349A, WO106947A,
               WO106949A, WO102802A, WO105539A, WO106948A;
               (b) 899874, 800151, 800555, 800812, 800811,
               801090, 801353, 801658, 802195.
MANUFACTURER   Boston Scientific Company, Miami, Florida
               (single device).
RECALLED BY    Sherwood Davis & Geck, St. Louis, Missouri, by
               letter dated February 14, 1997.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       (a) 13,789 systems; (b) 20,447 trays were
               distributed between 1/18/96-2/4/97.
REASON         The one-way safety ball valve in the devices
               may malfunction allowing air leakage into the
               pleural space.

_______________
PRODUCT        Solar 7000/8000 Patient Monitors, used with
               Solar ECG/12SL Modules, to display
               physiological data from modules which monitor
               the patient for ECG, blood pressure, etc. 
               Recall #Z-377-7.
CODE           All versions of software prior to Version 3.
MANUFACTURER   Marquette Electronics, Inc., Milwaukee,
               Wisconsin.
RECALLED BY    Manufacturer, by letter sent on February 14,
               1997.  Firm-initiated field correction
               ongoing.
DISTRIBUTION   Maryland, Minnesota, Texas, Italy, India.
QUANTITY       48 Solar ECG/12SL Modules were distributed. 
               Only the Solar 7000/8000 Patient Monitors used
               with Solar ECG/12SL Modules are affected and
               the software in these monitors is to be
               replaced.
REASON         The device produces output which is incorrect.
               (The data from one patient lead replaces the
               data from another patient lead.)

_______________
PRODUCT        Abbott TestPack Strep A, in-vitro diagnostic
               enzyme immunoassay for the rapid detection and
               confirmation of group A Streptococci from
               throat specimens: List #1301-22, 40 Tests,
               List #1301-82, 80 Tests.  Recall #Z-378-7.
CODE           Lot numbers:  21937M200 (40 tests); 
               22515M300 (80 tests).
MANUFACTURER   Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY    Manufacturer, by telephone on January 16, 17,
               1997, followed by letter dated January 1997. 
               Firm-initiated recall complete.
                            -18-DISTRIBUTION   Nationwide, Italy, Germany.
QUANTITY       231 40-test kits and 123 80-test kits were
               distributed.
REASON         Devices can cause false positive results with
               patient specimens and the negative controls.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III ========
_______________
PRODUCT        Paragon Screw-Vent Implant (SVA-16), a dental
               screw-type implant, packaged in a clear vial. 
               Recall #Z-352-7.
CODE           Lot #074-10/99.
MANUFACTURER   Core BioEngineering Calabasas, California and
               Core-Vent Corporation, Las Vegas, Nevada.
RECALLED BY    Core-Vent Corporation, Las Vegas, Nevada, by
               telephone on January 31, 1997, followed by
               letter.  Firm-initiated recall ongoing.
DISTRIBUTION   Wisconsin, Connecticut, Pennsylvania, New
               York, Utah, Massachusetts, Colorado, Ohio,
               California, Indiana, Maryland, Florida.
QUANTITY       401 units were distributed.
REASON         Some Screw-Vent dental implants were labeled
               with incorrect dimensions and part numbers
               that did not reflect the actual measured
               values of the product.

_______________
PRODUCT        Clintec Model 2200 Enteral Feeding Pump, used
               in the administration of all enteral feeding
               formulas.  Recall #Z-348-7.
CODE           Serial numbers:  16304 through 16603.
MANUFACTURER   Elan Pharma Inc., Smithfield, Rhode Island.
RECALLED BY    Manufacturer, by letters on March 23, 1995,
               May 3 and 10, 1995.  Firm-initiated field
               correction complete.
DISTRIBUTION   Nationwide.
QUANTITY       299 pumps were distributed.
REASON         The pumps may have been manufactured with the
               incorrect instruction labels.

                            -19-

END OF ENFORCEMENT REPORT FOR APRIL 2, 1997.  BLANK PAGES MAY
FOLLOW.

                                  ####
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