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.

January 29, 1997 97-05

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Parisian French Bread Stuffing, in 12 ounce
cartons. Recall #F-205-7.
CODE Lot #09597.
MANUFACTURER San Francisco French Bread Products Company,
Oakland, California.
RECALLED BY Manufacturer, by visit on December 2, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 212 cases (12 units per case) were
distributed.
REASON Product is contaminated with small pieces of
glass.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Menko Egg Kichel, in 7 ounce cellophane bags.
Recall #F-128-7.
CODE None.
MANUFACTURER Lee Avenue Food Products, Inc., Brooklyn, New
York.
RECALLED BY Manufacturer, by visit on October 7 and 10,
1996. Completed recall resulted from
inspection and followup by the New York State
Department of Agriculture and markets.
DISTRIBUTION New York.
QUANTITY 56.5 dozen bags were distributed.
REASON The product is misbranded as follows:
1) Product does not qualify for the "No
Cholesterol" claim based on a finding of 55 mg
of cholesterol per 30 g serving.
2) The label fails to declare the ingredients
in the enriched flour.
3) The nutrition information does not comply
with the format requirements.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-245/247-7.
CODE Unit #40GT44463.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 7, 1996,
followed by letters dated June 11 and 13,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), and were subjected
to additional retesting.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-255/257-7.
CODE Unit numbers: (a) 40GN11464, 40GW08142,
40GV43592; (b) 40GW08142, 40GV43592;
(c) 40GN11464, 40GW08142, 40GV43592.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 7, 1996,
followed by letters dated June 11, 13, and 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY (a) 3 units; (b) 2 units; (c) 3 units were
distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), and were subjected
to additional retesting, or were collected
from a donor who previously tested repeatedly
reactive for anti-HIV-1.
-2-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-263/264-7.
CODE Unit numbers: (a) 814366, V25076, F06913; (b)
F06913.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letters between the dates of
December 8, 1995 through January 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION South Carolina, Florida, California,
Tennessee.
QUANTITY (a) 3 units; (b) 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-266/268-7.
CODE Unit #KT66899.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by letter dated February 2,
1996. Firm-initiated recall complete.
DISTRIBUTION Iowa, Pennsylvania, California.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor
whose spouse had a history of intravenous (IV)
drug use.

_______________
PRODUCT Red Blood Cells. Recall #B-269-7.
CODE Unit #G09463.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letter dated February 20,
1996. Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had a history of ear piercing within one year
of donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-271/273-7.
CODE Unit #M26418.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letter dated March 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit of each component was distributed.
-3-REASON Blood products were collected from a donor who
had a history of ear piercing within one year
of donation.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-274/275-7.
CODE Unit #M27100.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letter dated February 20,
1996. Firm-initiated recall complete.
DISTRIBUTION South Carolina and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had a history of ear piercing within one year
of donation.

_______________
PRODUCT Red Blood Cells. Recall #B-276-7.
CODE Unit #47C46545.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 18, 1996,
followed by letter dated June 24, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
the antibody to the hepatitis B core antigen
(anti-HBc), and was not retested in duplicate.

_______________
PRODUCT Red Blood Cells. Recall #B-277-7.
CODE Unit #47C47811.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 18, 1996,
followed by letter dated June 24, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
the antibody to the hepatitis B core antigen
(anti-HBc), and was not retested in duplicate.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-282/284-7.
CODE Unit #29135-8563.
MANUFACTURER United Blood Services, Chicago, Illinois.

-4-RECALLED BY Manufacturer, by telephone on July 19, 1996,
and by letter dated August 6, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of hepatitis A.

_______________
PRODUCT (a) Platelets; (b) Recovered Plasma.
Recall #B-288/289-7.
CODE Unit #0561598.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by letters dated April 8, 1996
and May 15, 1996. Firm-initiated recall
complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, with confirmed weaker than
expected Rh testing results when performing D
antigen testing, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-290-7.
CODE Unit #3A28118.
MANUFACTURER W.E. & Lela I. Stewart Blood Center, Inc.,
Tyler, Texas.
RECALLED BY Manufacturer, by telephone on April 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a previous history of hepatitis.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-251/252-7.
CODE Unit #40GS47369.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 23, 1996,
followed by letter dated June 3, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the hepatitis B surface antigen (HBsAg), but
were subjected to additional retesting. The
donor has since met reentry.

-5-_______________
PRODUCT Red Blood Cells. Recall #B-260-7.
CODE Unit numbers: 29134-2563 and 29134-9427.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on June 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 2 units were distributed.
REASON Red Blood Cells had no quality control testing
performed after deglycerolization.

_______________
PRODUCT Cryoprecipitated AHF. Recall #B-261-7.
CODE Unit #53GQ51195.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated August 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time.

_______________
PRODUCT Red Blood Cells. Recall #B-262-7.
CODE Unit #02H46945.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on January 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product may have been shipped at an
unacceptable temperature.

_______________
PRODUCT Recovered Plasma. Recall #B-265-7.
CODE Unit numbers 814366 and F06913.
MANUFACTURER Spartanburg Blood Bank, Inc., Spartanburg,
South Carolina.
RECALLED BY Manufacturer, by letters dated December 8,
1995, and January 2, 1996. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Blood product was collected from a donor who
reported a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-270-7.
CODE Unit #42FJ53189.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
-6-RECALLED BY Manufacturer, by telephone on August 6, 1996,
followed by letter dated August 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT HYATE:C, Antihemophilic Factor (Porcine),
Factor VIII. Recall #B-281-7.
CODE Lot #559.
MANUFACTURER Speywood Biopharm Limited, Wrexham, Wales, UK.
RECALLED BY Speywood Pharmaceuticals, Inc., Milford,
Massachusetts (distributor), by telephone on
December 4, 1996, and by letter dated December
5, 1996. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Louisiana, Iowa, Rhode
Island, Maine, Missouri, New Mexico,
Pennsylvania, Florida, New York, Texas.
QUANTITY 1,019 vials were distributed.
REASON Factor VIII product was positive (adulterated)
for porcine parvovirus (PPV).

_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells;
(c) Recovered Plasma. Recall #B-285/287-7.
CODE Unit numbers: (b&c) 9711351; (a) 9658388.
MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated May 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in expired blood
collection bags.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Kangaroo Entriflush Enteral Feeding Pump, Rx
device used to regulate the flow of enteral
feedings: (a) Catalog #8884-352405 (new); (b)
Catalog #8884-352413 (refurbished).
Recall #Z-208/209-7.
CODE All pumps.
MANUFACTURER Sherwood Davis & Geck, Watertown, New York.
RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by
letter dated December 4, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,954 units were distributed.
REASON The pumps may deliver formula at rates up to
twice the programmed feeding rate.
-7-_______________
PRODUCT Abiomed (R) BVS 5000i Bi-Ventricular Support
System, temporary artificial heart system
consoles. Recall #Z-221-7.
CODE Serial Numbers: 1500-1523.
MANUFACTURER Abiomed, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter on October 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Connecticut, District of Columbia,
Florida, Illinois, Kentucky, Massachusetts,
New York, Ohio, Pennsylvania, Rhode Island,
South Carolina, Texas, West Virginia.
QUANTITY 24 consoles (2 valves each) were distributed.
REASON The transducers may malfunction and result in
several types of device failures. If the
transducer fails during power-up, the BVS
System may fail the self-test. If the
transducer malfunctions during use, the BVS
System may produce erratic or reduced blood
flow.

_______________
PRODUCT Fresenius Hemodialysis Delivery Systems:
(a) Model 2008H/3008; (b) Model 2008E;
(c) Model 2008C/D; (d) Model 2008BSS.
Recall #Z-224/227-7.
CODE All lots.
MANUFACTURER Fresenius USA, Inc., Walnut Creek, California.
RECALLED BY Manufacturer, by visit November 22, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada, Mexico.
QUANTITY 5,172 modules were distributed.
REASON Certain solenoids used in the level detector
module line clamp contain a rubber bumper that
may become gummy, causing the line clamp to
stick open after a blood alarm.

_______________
PRODUCT Xanar Surgical CO2 Lasers, for general surgery
and dermatology:
(a) Model No. XL40; (b) Model No. XL60
(c) Model No. XL55; (d) Model No. XA50.
Recall #Z-228/231-7.
CODE Serial numbers: (a) 207, 111, 189;
(b) 60151, 60172, 60150, 60155, 60194;
(c) 221, 161; (d) 334, 233.
MANUFACTURER Coherent, Palo Alto, California.
RECALLED BY Manufacturer, by fax on May 17, 1996. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 12 units were distributed.

-8-REASON Devices failed to comply with 21 CFR
1040.11(a)(1) in that they may deliver twice
the power requested by the user and
displayed on the terminal.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Richard Allen brand Disposable Endoscopic Clip
Applier, Reflex-ELC with Titanium Clips,
Product No. 530, used in Reflex Brand
Cholecystectomy Kit No. 37001.
Recall #Z-218-7.
CODE Custom Kit Nos. C37200 and C37201, All lots
with Lot No./Expiration Date of 25JAN99 or
earlier.
MANUFACTURER Richard-Allan Medical, Richland, Michigan.
RECALLED BY Manufacturer, by sending technical bulletin
dated February 21, 1994, and by letter dated
March 1, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Clip applier jaw are subject to opening too
far and not being able to contain an unformed
clip, allowing the clip to fall during use.

_______________
PRODUCT Bio-Tek Software Microplate Readers, in-vitro
diagnostic medical device:
(a) Product #ELx800; (b) ELx808.
Recall #Z-219/220-7.
CODE All serial numbers.
MANUFACTURER Bio-Tek Instruments, Inc., Winooski, Vermont.
RECALLED BY Manufacturer, by letter on November 19, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,328 units were distributed.
REASON An error in the device's data reduction
software could produce erroneous results.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ===========
_______________
PRODUCT Pro Lean 18/95 CSP Medicated Starter/Grower
(pelleted swine feed medicated with
chlortetracycline, sulfathiazole and
penicillin). Recall #V-024-7.
CODE Lot numbers: 1N2576 and 1N2616.
MANUFACTURER Growmark, Inc., Nashville, Illinois.
RECALLED BY Manufacturer, by telephone on November 8,
1996. Firm-initiated recall complete.
-9-DISTRIBUTION Illinois.
QUANTITY 5 tons were distributed; firm estimates none
remains on the market.
REASON Subpotency of chlortetracycline and penicillin
ingredients.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III =========
_______________
PRODUCT Baytril (enrofloxacin) Antibiotic Tablets No.
20 and No. 60, for the treatment of bacterial
pathogens in dogs and cats. Recall #V-025-7.
CODE Lot #142139;
Product Codes: Baytril No. 60 - 1882
Baytril No. 20 - 1881.
MANUFACTURER Bayer Corporation, Shawnee, Kansas.
RECALLED BY Manufacturer, by telephone on October 28,
1996, followed by letter on November 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,556 bottles of Baytril No. 60 and 3,041
bottles of Baytril No. 20 were distributed.
REASON A single lot failed content uniformity.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Picker Prism Nuclear Medicine Imaging Systems,
used for diagnostic purposes for SPECT and
body imaging performed in a hospital or clinic
setting:
(a) Model No. 1000S/215003, Model No.
1000XP/210337 and Model No. 1500XP/210502;
(b) Model Nos. 2000S/215000, 2000XP/210336;
(c) N-006-7 - Model No. 3000S/210060 and Model
No. 3000XP/210335. Safety Alert #N-004/006-7.
CODE All models and all serial numbers.
MANUFACTURER Picker International, Inc., Highland Heights,
Ohio.
ALERTED BY Manufacturer, by letter dated November 16,
1996.
DISTRIBUTION Nationwide and international.

-10-QUANTITY 1,112 units were distributed.
REASON Objects should not be placed in the path of
the equipment.

-11-

END OF ENFORCEMENT REPORT FOR JANUARY 29, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for