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.

October 8, 1997 97-41

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Surimi Crab Spread (2 flavors), imitation crab, in 8 ounce containers: (a) Silver
Creek brand Surimi Crab Spread; (b) Silver Creek brand Surimi Crab Spread with
Jalapeno. Recall #F-001/002-8.
CODE 9/07/97.
MANUFACTURER Silver Creek Farms, Twin Falls, Idaho.
RECALLED BY Manufacturer, by telephone on August 25, 1997, by press release on
August 29, 1997, by fax on September 4, 1997, and by letter mailed on
September 5, 1997. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Utah, Idaho, Tennessee, Arkansas, Mississippi, Kentucky,
Alabama.
QUANTITY (a) 158 pounds; (b) 134 pounds were distributed.
REASON The product contains an undeclared egg based ingredient, undeclared wheat based
ingredients, and undeclared fish which can pose a hazard to individuals sensitive to
eggs, wheat or fish.

_______________
PRODUCT Master Choice Dark Bittersweet Chocolate Bar.
Recall #F-003-8.
CODE All codes between production date and code of 8-27-96, code L3240 through 4-8-97,
code L3598 UPC 1114-00315.
MANUFACTURER Wissoll Exporting Company, Germany.
RECALLED BY The Great Atlantic & Pacific Tea Company, Inc., Montvale, New Jersey,
by fax on June 26, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Eastern half of the United States
QUANTITY Undetermined.
REASON Product contained undeclared nuts which may be either peanuts or tree nuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT "Cock" Brand Chinese Noodles in plastic bags, net weight 16 ounces (454 g), 50
bags per carton. Recall #F-836-7.
CODE None.
MANUFACTURER Hong Thai Foods Corporation, Brooklyn, New York.
RECALLED BY Manufacturer, by letter April 30, 1997. Ongoing recall resulted from
sample analysis and followup by the New York State Department of
Agriculture Markets.
DISTRIBUTION New York, Massachusetts, New Jersey.
QUANTITY 48 cartons were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Dietary Supplements: (a) Dietary Supplement in a white plastic bottle labeled in
part; "Herbal Drops Energy 1/9 fluid ounce/3 CC***" DOC 97-413-020
(b) Dietary Supplement in a white plastic bottle labeled in part: "Herbal Drops fat
burner***" DOC 97-713-349.
Recall #F-830/831-7.
CODE Lot numbers: 0729962 EXP 2/97, 4794 EXP 7/98.
MANUFACTURER EFS-Herbal Drops, San Diego, California.
RECALLED BY Manufacturer, by letter during the period of September 6-9, 1996, and
September 18-20, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 5,747 bottles; b) 5,225 bottles were distributed.
REASON The labels are illegible.

-2-_______________
PRODUCT Ice Milk Mixes: (a) KAN-PAK Vanilla Softserve Mix in 64 fluid ounce
polyethylene pouches
(b) CHICK-FIL-A IceDream Mix packaged in 64 ounce polyethylene pouches.
Recall #F-833/834-7.
CODE (a) 7D01C; (b) 7D01B.
MANUFACTURER Kansas Food Packers, Inc., Arkansas City, Kansas.
RECALLED BY Manufacturer, by telephone on April 8, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY (a) 100 cases; (b) 759 cases were distributed.
REASON The products are unfit for food due to swollen and leaking pouches.

_______________
PRODUCT Country Sorghum Cane Molasses.
Recall #F-835-7.
CODE Uncoded.
MANUFACTURER Rachel Syrup Farm, Dekalb, Mississippi.
RECALLED BY Kenneth Hawks Produce, Cana, Virginia, by telephone during the week of
August 24, 1997. Ongoing recall resulted from sample analysis and
followup by the North Carolina Department of Agriculture.
DISTRIBUTION North Carolina.
QUANTITY 15 cases were distributed.
REASON The product, falsely labeled as "Country Sorghum Cane Molasses", is misbranded
as it was found to contain maltose, which is associated with corn syrup and not
molasses.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Clonazepam Tablets, USP, 0.5 mg, in bottles of 100, used in the treatment of
seizures, under the Lemmon label. Recall #D-189-7.
CODE Lot numbers: 357016 EXP 7/98, 357017 EXP 7/98, 357018 EXP 7/98, 357020 EXP
7/98.
MANUFACTURER TEVA Pharmaceutical Industries, Ltd., Jerusalem.
RECALLED BY TEVA Pharmaceuticals USA, Inc., (Lemmon Company), Sellersville,
Pennsylvania, by letters on May 12, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that little if any product remained on market at time of recall
initiation.
REASON Product failed dissolution specifications.

-3-______________
PRODUCT Medical Oxygen, USP, in 31 and 41 liter cryogenic home units (vessels).
Recall #D-280-7.
CODE All lot numbers manufactured prior to 6/28/97.
MANUFACTURER Redeemer Nazareth Medical Supply, Inc., Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by visit completed on July 17, 1997. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON Failure to assay product.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Clemastine Fumarate syrup, 0.5mg/5ml, in 4 fluid ounce and 16 fluid ounce
bottles, indicated for the relief of symptoms associated with allergic rhinitis.
Recall #D-279-7.
CODE Lot No. Size EXP Date
268D203 16 oz. May 1998
268D205 16 oz. May 1998
268D213 4 oz. Aug. 1998.
MANUFACTURER Copley Pharmaceutical Inc., Canton, Massachusetts.
RECALLED BY Manufacturer, by letter dated September 3, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Lot 268D203 - 3274 Units
Lot 268D205 - 3532 Units
Lot 268D213 - 13,174 Units were distributed.
REASON Subpotent.

_______________
PRODUCT Viaquin Forte Cream, 4% Hydroquinone, USP, packed in 1 ounce aluminum
tubes, Rx drug for topical application used for the gradual bleaching of
hyperpigmented skin conditions.
Recall #D-281-7.
CODE All lot numbers within expiration date (27).
MANUFACTURER ICN Pharmaceuticals, Inc., Bryan, Ohio.
RECALLED BY Manufacturer, by fax on September 17, 1997, followed by mail. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 80,651 tubes were distributed; firm estimated that 14,085 remained on market at
time of recall initiation.
REASON The tubes may exhibit leaking at the crimp end.

-4-_______________
PRODUCT Oxygen USP, packaged in D & E High Pressure Cylinders. Recall #D-282-7.
CODE All cylinders filled from July 25, 1996 through June 3, 1997, and on June 7, June 15, July
21, and July 25, 1997.
MANUFACTURER American Homepatient, doing business as Shugarman Surgical Supplies,
Maumee, Ohio.
RECALLED BY Manufacturer, by memorandum on August 18, 1997, followed by visit.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Michigan.
QUANTITY 225 cylinders were distributed.
REASON Current good manufacturing practice deviations.

_______________
PRODUCT Aristocort Suspension Intralesional (Triamcinolone Diacetate), 5 mg/ml, 5 ml per
vial, used for the treatment of rheumatoid arthritis. Recall #D-002-8.
CODE Lot #391-800.
MANUFACTURER Lederle Parenterals, Carolina, Puerto Rico.
RECALLED BY Manufacturer, by letter dated July 31, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Illinois and South Africa.
QUANTITY 5,666 vials were distributed.
REASON Superpotency (stability-nine months).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1123/1124-7.
CODE Unit 50X05716.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone on July 14, 1997 and by letter dated July 18,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose arm inspection and skin
disease status had not been documented.

_______________
PRODUCT Red Blood Cells. Recall #B-1125-7.
CODE Unit #40GT10864.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.

-5-RECALLED BY Manufacturer, by telephone on September 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel
to an area designated as endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1126/1127-7.
CODE Unit #49LJ17159.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated August 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug methotrexate.

_______________
PRODUCT a) Platelets For Further Manufacturer; b) Red Blood Cells; c) Red Blood Cells,
Leukocytes Removed; d) Fresh Frozen Plasma; e) Platelets; f) Cryoprecipitated
AHF; g) Recovered Plasma .
Recall #B-1237-7 & B-1422/1427-7.
CODE Red Blood Cells Units: 0426549, 0428667, 0433762, 0437685, 0440720, 0446247,
0449855, 0451333, 0530508, 0532024, 0536178, 0537187, 0537425, 0538984, 0539778,
0540575, 0542083, 0542769, 0543644, 0543849, 0544447, 0545074, 0555156, 0633134,
0633847, 0634130, 0635343, 0638093, 0639659, 0640812, 0642266, 0647263, 0648363,
0649449, 0650555, 0655795, 0718444, 0800248, 0807332, 0813338, 0815577
Red Blood Cells, Leukocytes Removed Units: 0444405 and 0541417
Fresh Frozen Plasma Units: 0426549, 0428667, 0433762, 0440720, 0444405, 0449855,
0451333, 0530508, 0532024, 0536178, 0537187, 0537425, 0538984, 0539778, 0540575,
0541417, 0542769, 0543644, 0543849, 0544447, 0633134, 0633847, 0634130, 0635343,
0638093, 0639659, 0640812, 0643049, 0802266, 0807332
Platelets Units: 0433762, 0437685, 0444405, 0449855, 0532024, 0536178, 0537187,
0537425, 0538984, 0540575, 0544447, 0555156, 0633847, 0634130, 0635343, 0638093,
0640812, 0642266, 0647263, 0649449, 0655795, 0807332
Platelets For Further Manufacture Units: 0440720, 0446247, 0451333, 0539778,
0542769, 0543644, 0543849, 0639659.
-6- Cryoprecipitated AHF, Units 0545074 and 0800248
Recovered Plasma Units: 0437685, 0446247, 0484137, 0545074, 0555156, 0638878,
0642266, 0647263, 0648363, 0649449, 0650555, 0655795, 0718444, 0800248, 0815577,
0813338.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas.
RECALLED BY Manufacturer, by letter on either February 19, 1997, March 4, 1997, April
1, 1997, April 14, 1997, and September 11, 1997. Firm-initiated recall
complete.
DISTRIBUTION Alaska, California, Colorado, Indiana, Kentucky, Massachusetts, Michigan,
New York, Pennsylvania, Tennessee, Texas.
QUANTITY a) 8 units; b) 41 units; c) 2 units; d) 30 units; e) 22 units; f) 2 units; g) 16 units
were distributed.
REASON Blood products were collected from donors with a history of cancer.

_______________
PRODUCT PathNet HNA Clinical Systems Software, release 306. Recall #B-1462-7.
CODE HNA release 306.
MANUFACTURER Cerner Corporation, Kansas City, Missouri.
RECALLED BY Manufacturer, by letter dated June 6, 1997. firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 275 software units were distributed.
REASON Computer software, containing a design defect which could
result in the assignment of incorrect ABO and Rh groups.

_______________
PRODUCT PathNet HNA Clinical Systems Software Applications: Blood Bank
Transfusion, releases 302, 303, 304, 305, 306 Worksystem Transfusion, releases
302, 303, 304, 305, 306 Blood Bank Donor, releases 303, 304, 305, 306 Blood
Center, releases 303, 304, 305, 306.
Recall #B-1463-7.
CODE HNA release 303, 304, 305, and 306 for all above applications.
HNA release 302 for the Blood Bank Transfusion and Worksystems Transfusion
applications.
MANUFACTURER Cerner Corporation, Kansas City, Missouri.
RECALLED BY Manufacturer, by letters dated May 16, 1997, and in June and July 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-7-QUANTITY Approximately 275 software units were distributed.
REASON Computer software, that contains programming error which (1) could potentially
result in the release of unsuitable blood products, (2) improperly update donor and
unit information files, and (3) could result in the assignment of incorrect ABO/Rh
types in donor files.

_______________
PRODUCT Source Plasma. Recall #B-1464-7.
CODE Unit #66622369.
MANUFACTURER NABI BioMedical Center, Wichita, Kansas.
RECALLED BY Manufacturer, by telephone on June 11, 1997. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for the antibody to the hepatitis C virus
encoded antigen (anti-HCV).

_______________
PRODUCT Platelets. Recall #B-1466-7.
CODE Unit #56148.
MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY Manufacturer, by visit on July 31, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for the antibody to the Hepatitis B core
antigen (anti-HBc).

_______________
PRODUCT Platelet Pheresis. Recall #B-1467-7.
CODE Split unit #29445-1528 (02).
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on June 2, 1997, and by letter dated July 9,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF, Pooled; c) Recovered Plasma.
Recall #B-1469/1471-7.
CODE Unit numbers: a) 4668095, 4707426; b) 4664705; c) 4668095, 4707426.
MANUFACTURER BloodCare, Dallas, Texas.

-8-RECALLED BY Manufacturer, by letter dated September 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Virginia, Texas, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON Blood products, collected from a donor with a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-1476-7.
CODE Unit #40GF13003.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on July 4, 1997, and by letter on July 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area
designated as endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1481/1482-7.
CODE Unit numbers: a) 40FE39461, 40FE33621, 40FE25205, 40LZ00880; b) 40FE25205,
40LZ00880.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on July 14, 1997, and by letter dated July 23 or
24, 1997, and by additional notices on August 14 and 25, 1997, and
September 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Missouri, California, Alabama, Illinois.
QUANTITY a) 4 units; b) 2 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area
designated as endemic for malaria.

_______________
PRODUCT Human Tissues for Transplant: Corneal Human Tissue. Recall #B-1483-7.
CODE Donor # 95-143, 95-144.
MANUFACTURER Lions Hi-Plains Eye Bank, Amarillo, Texas.
RECALLED BY Manufacturer, by letter dated February 1, 1997. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania and Indiana.
QUANTITY 2 units.
REASON Human Tissues for Transplant, in which proper documentation and donor
screening was performed improperly, were distributed.

-9-_______________
PRODUCT a) Allergenic Extracts: Epidermal Mix;
b) Allergenic Extracts: Weed Mix.
Recall #B-1485/1486-7.
CODE Epidermal Mix Lot # L87E2818
Weed Mix Lot # F77D1070.
MANUFACTURER Bayer Corporation, Bayer Pharmaceutical Division, Allergy Products,
Spokane, Washington.
RECALLED BY Manufacturer, by letter on August 29, 1997. Firm-initiated recall
complete.
DISTRIBUTION Alabama, California, Connecticut, Georgia, Massachusetts, Maryland,
Michigan, Minnesota, Missouri, New Jersey, Ohio, Pennsylvania, Texas.
QUANTITY (a) 16 vials; (b) 6 vials were distributed.
REASON Allergenic extract products were mislabeled due to missing components from the
combined product.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1489/1491-7.
CODE Unit numbers: a) M47941, M46733; b) M47941, c) M47941, M46733.
MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY Manufacturer, by letter September 11, 1997. Firm-initiated recall
complete.
DISTRIBUTION Oregon.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON Blood products were collected from a donor who received ear piercing within
twelve months of donation.

_______________
PRODUCT Source Plasma. Recall #B-1499-7.
CODE Unit numbers: 80308966, 81060399, 81061471.
MANUFACTURER Bio-Blood Components, Inc., Hammond, Indiana.
RECALLED BY Manufacturer, by fax on May 21, 1997. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood product, which was collected from a donor with a history of body piercing
within twelve months of donation.

_______________
PRODUCT Platelets. Recall #B-1503-7.
CODE Unit 10520-2235.
MANUFACTURER United Blood Services, Scottsdale, Arizona.

-10-RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter on December 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product, collected from a donor whose body temperature had not been
documented.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1504/1506-7.
CODE Unit numbers: a) 28026-7909, 28027-9189, 28022-5865, 28023-9440; b) 28023-9440,
28026-7909, 28027-9189; c) 28027-9189, 28022-5865, 28023-9440, 28026-7909.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 10, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Tennessee, Massachusetts, Florida, North Carolina.
QUANTITY a) 4 units; b) 3 units; c) 4 units were distributed.
REASON Blood products tested negative for the hepatitis B surface antigen (HBsAg), but
were collected from a donor who was previously deferred for a history of liver
disease, hepatitis, or a positive test for hepatitis.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1511/1513-7.
CODE Unit #11048-8484.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated June 18, 1997,
and July 10, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Texas and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was previously deferred for high
risk behavior.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1516/1517-7.
CODE Unit #10487-7640.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 30, 1997.
Firm-initiated recall ongoing.

-11-DISTRIBUTION Arizona and Illinois.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who was deferred for receiving a
tattoo within 12 months of donation.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1518/1519-7.
CODE Unit #10485-8755.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated August 25, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, which were collected from a donor who was deferred for ear
piercing within 12 months of donation.

________________
UPDATE Recall #B-1112/1115-7, blood products recalled by LifeSource, Glenview, Illinois,
which appeared in the August 6, 1997, Enforcement Report has been extended to
include unit numbers 1800905 and 1820061 for Red Blood Cells, and Unit
#4002374 for Recovered Plasma.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1393/1394-7.
CODE Unit #16035-3068.
MANUFACTURER United Blood Services, Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION Mississippi and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for syphilis, but were collected from a donor who
previously tested reactive for syphilis on two separate occasions.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-1395/1397-7.
CODE Unit numbers: a) 20027-1512 and 20261-6869;
b) 20261-6869; c) 20027-1512, 20042-6425, 20261-6869.
MANUFACTURER United Blood Services, Lafayette, Louisiana.

-12-RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 19, 1997
or April 9, 1997, and July 7, 1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Illinois, North Carolina, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 3 units were distributed.
REASON Blood products tested negative for syphilis, but were collected from a donor
who previously tested reactive for syphilis.

_______________
PRODUCT Source Plasma. Recall #B-1484-7.
CODE Unit Numbers: X11680, X11423, X11161, X10660, X10425, X10226, X10002, X09734.
MANUFACTURER Flint Plasma Company, Flint, Michigan.
RECALLED BY Manufacturer, by fax dated April 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 8 units were distributed.
REASON Blood product was untested for syphilis.

_______________
PRODUCT Red Blood Cells. Recall #B-1498-7.
CODE Unit #10515-4457, 10515-2740.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter on September 24, 1996.
Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 2 units were distributed.
REASON Blood Products had been tested for hemoglobin S from segments
which were more than 14 days old.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c) Fresh Frozen Plasma;
d) Recovered Plasma. Recall #B-1507/1510-7.
CODE Unit numbers: a) 15021-0644; b) 15033-0854, 15022-9534,
15029-2174, 15028-3270, 15019-4770; c) 15028-3270;
d)15019-4770, 15033-0854, 15029-2174.
MANUFACTURER United Blood Services, Lubbock, Texas,
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 1 unit; b) 5 units; c) 1 unit; d) 3 units were distributed.

-13-REASON Blood products, which tested negative for the hepatitis B surface antigen
(HBsAg), but were collected from a donor who previously tested repeatedly
reactive for HBsAg.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT a) Precision Electrometer/Dosemeter, Model 530; b) Precision
Electrometer/Dosemeter, Model 530SI. Recall #Z-906/907-7.
CODE a) Serial Nos. 101-250; b) Serial Nos. 101-128.
MANUFACTURER Victoreen, Inc., Cleveland, Ohio.
RECALLED BY Manufacturer, by letter dated April 10, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 149 units were distributed.
REASON A crack in the ceramic resistor network could divert the signal and
cause the device to read the wrong calibration factor.

_______________
PRODUCT HDI-1000 Ultrasound System. Recall #Z-942-7.
CODE All units with software version below 20.3.
MANUFACTURER Advanced Technology Laboratories, Inc., Bothell, Washington.
RECALLED BY Manufacturer, by letter dated August 27, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 110 units were distributed.
REASON There is a potential mismatch of scaling and image information when used under
certain conditions.

_______________
PRODUCT Shielded disposable obturator and trocars, used in conjunction with either
disposable or reusable trocar cannula for laparoscopic surgical procedures:
a) Model No. CO701, 11mm Safety shielded Obturator;
b) Model No. CO702, 12mm Safety Shielded Obturator;
c) Model No. CON01, Convertible Trocar Procedure Pack;
d) Model No. CON02, Convertible Trocar Procedure Pack;
e) Model No. CON03, Convertible Trocar Procedure Pack. Recall #Z-001/005-8.
CODE All lots with lot number prefixes as follows: 95, R5, E4, R6B, E5, 96B. E6C.

-14-MANUFACTURER Applied Medical Resources, Laguna Hills, California.
RECALLED BY Manufacturer, by telephone and fax or letter on or before March 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 100 boxes of 20 each are estimated to be in distribution channels.
REASON Sterility may be compromised because of a micropoint puncture which may
occur at the package fold under certain shipping conditions.

_______________
UPDATE Recall #Z-912/914-7, Lead Aprons, Collars and Gonadal Shields,
and Recall #Z-915/941-7, Ultra-Flex Adult Anesthesia Breathing Circuits,
which appeared in the October 1, 1997 Enforcement Report are
Class II recalls.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT CSI Clarity (Crofilcon A) Toric Contact Lens. Recall #Z-911-7.
CODE Lot #CGXJJ.
MANUFACTURER PBH/Wesley Jessen (Barnes-Hind), San Diego, California.
RECALLED BY Manufacturer, by telephone on July 22, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Hong Kong, Mexico, Australia, Canada.
QUANTITY 28 lenses were distributed; firm estimated that 12 remain in the marketplace
as of July 30, 1997.
REASON Some Contact Lenses were labeled with incorrect diopter values that did not
reflect the measured value of the product.

_______________
PRODUCT Bartels Herpes Simplex Virus 1 IgM Enzyme Immunoassay,
Catalog No. B1029-345.
Recall #Z-006-8.
CODE Lot No. 2097.
MANUFACTURER Bartels, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by letter dated September 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California, Kentucky, Mississippi, Ohio, Australia, Puerto Rico.
QUANTITY 16 vials were distributed.

-15-REASON The conjugate is losing stability resulting in absorbance values for the positive
control that are lower than the limits in the product insert.

_______________
PRODUCT Bartels Herpes Simplex Virus Type-Specific Fluorescent Monoclonal
Antibody Test and Herpes Simplex Virus Typing Control Slides,
in-vitro diagnostic products used by health care personnel:
a) B1029-44 Herpes Simplex Virus Typing Kit,
b) B1029-44C Herpes Simplex Virus Typing Control Slides.
Recall #Z-007/008-8.
CODE Lot Numbers: a) 7E363; b) 7E364.
MANUFACTURER Bartels, Inc., The Diagnostics Division of Intracel Corporation,
Issaquah, Washington.
RECALLED BY Manufacturer, by letter on August 12, 1997, and by fax.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY a) 66 kits; b) 63 kits were distributed.
REASON The Herpes Simplex Virus-2 control slide contained non-infected cells in the
negative control well instead of infected cells.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III =========
________________
PRODUCT Formula V Products CliniCare Feline Liquid Diet. Recall #V-046-7.
CODE Lot #6K8C EXP 11/98.
MANUFACTURER Pet Ag, Inc., Hampshire, Illinois.
RECALLED BY Manufacturer, by letter dated March 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,853 cases were distributed.
REASON Suspension failure - fat separation which would not go back
into suspension after shaking.

-16-

END OF ENFORCEMENT REPORT FOR OCTOBER 8, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for