FDA

Enforcement Report FOR OCTOBER 20, 1999

October 20, 1999                                               99-42

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Stop & Shop Chocolate Rugalah packaged in 16 ounce clear plastic 
container.  Recall #F-005-0.
CODE
All date codes.
MANUFACTURER
Dadd’s Continental Bakery, Inc., Lodi, New Jersey.
RECALLED BY
The Stop & Shop Supermarket Co., Quincy, Massachusetts, by E-mail 
and press release on September 7, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Connecticut, Massachusetts, New York, Rhode Island.
QUANTITY
144 cases (24 1-pound cases) were distributed.
REASON
Product contains undeclared walnuts.

________
PRODUCT
Pinna Ricotta Salata Cheese labeled as ANCO Foods, packaged as 
net wt. 8 ounce. wedges and 0.6 lb. bulk wheels.  Product of 
Italy.  Recall #F-006-0.
CODE
SEP 18 99 (8 ounce wedges; AUG 22 99 (8 ounce wedges;
SEP 04 99 (8 ounce wedges); SEP 15 99 (8 ounce wedges);
DATA SCAD 18/07/99 (bulk wheel).
MANUFACTURER
Pinna, Thesi, Italy.
RECALLED BY
Schratter Foods Inc., (ANCO Foods, Division of), Fairfield, New 
Jersey, by letter, fax and press release on May 25, 1999.  
Ongoing recall resulted from sample analysis and follow-up by the 
North Carolina Department of Agriculture and Consumer Services.
DISTRIBUTION
Florida, Massachusetts, Georgia, North Carolina, New Jersey, New 
York, South Carolina, Tennessee, Pennsylvania, Delaware, 
Connecticut, Maryland, Nebraska, New Hampshire, Indiana, 
Virginia.
QUANTITY
164 cases were distributed.
REASON
The product is contaminated with Listeria monocytogenes.
________
PRODUCT
Banzai Giant California Roll Sushi, approximate net weight 7 
ounces  Recall #F-007-0.
CODE
Consume by Aug. 23 ‘99 and earlier.
MANUFACTURER
Entrees, Inc., Seattle, Washington.
RECALLED BY
Manufacturer, by press release on August 20, 1999. Firm-initiated 
recall complete.
DISTRIBUTION
Washington State, Oregon. 
QUANTITY
Approximately 150 seven-ounce packages were distributed.
REASON
The product contains undeclared egg whites, snow crabmeat, 
pollock, and wheat starch.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
2% Milk in gallons, half gallons, pints, and 5 gallon bulk 
containers, packaged under the Flav-O-Rich, Acme, American Fare, 
Food City, Great Value, Country Fresh, Pinemont Farms, White's, 
IGA, and Pet labels.  Recall #F-002-0.
CODE
Use By Dates are 7/23/99 for gallons and half gallons and 7/25/99 
for pints.
MANUFACTURER
Flav-O-Rich, Inc., Bristol, Virginia.
RECALLED BY
Land-O-Sun Dairies, LLC, Johnson City, Tennessee, by telephone 
and fax on July 13, 1999, and by E-mail if available.  Firm-
initiated recall complete.
DISTRIBUTION
Kentucky, North Carolina, South Carolina, Tennessee, Virginia, 
West Virginia.
QUANTITY
13,751 gallons, 3,948 half gallons, 40 5-gallon bags, and 8,006 
half-pints were distributed.
REASON
Milk was contaminated with a drug residue.
________
PRODUCT
LUNA, Drinks That Work, in 7 fluid ounce bottles.
Recall #F-003-0.
CODE
All product codes.
MANUFACTURER
Di Domenico's Gourmet Product & Custom Packers, Morgan Hill, 
California.
RECALLED BY
Drinks That Work, Davenport, California, by telephone, fax, and 
visit September 14, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 3,480 cases were distributed.
REASON
Product contains undeclared soy milk.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
a) Cefazolin Sodium, USP, Rx, Sterile,10 grams, 100 mL vial;
b) Cefazolin Sodium, USP, Rx, Sterile,1 gram, 100 mL vial, 
c) Ampicillin Sodium, USP, Rx, Sterile, in 10g, 100 mL vial.
Recall #D-001/003-0. 
CODE
a) Lot#  9901006 (Control #9M02727) EXP 12/2000 - 
NDC 0209-1100-52; b) Lot # 9801005 (Control #8M92223) 
EXP 12/99 - NDC 0209-1000-42; c) Lot# 9710002 (Control #7J02055) 
EXP 09/2000, NDC 0209-0450-52.  (Note:  All products are 
identified on the label by the Control Number.  The firm's lot 
number does not appear on the label).
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letters sent on June 7, 1999 and May 17, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Lot# 9801005 (Control #8M92223)- 5,810 trays, 10 vials per tray
Lot# 9901006 (Control No. 9M02727)- 1,151 trays, 10 vials per 
tray
Lot# 9710002 (Control No. 7J02055)- 2,496 trays, 10 vials per 
tray were distributed.
REASON
Potency problems; super and/or subpotent.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Lorazepam Injection, USP, 2 mg/mL, in 10 mL multiple dose vial, 
Rx, indicated in adult patients for preanesthetic medication, 
producing sedation, relief of anxiety, and a decreased ability to 
recall events related to the day of surgery.  Recall #D-004-0.
CODE
Lot# 9806034 (Control #8E02499) EXP 05/2000
NDC 0209-4581-20. (Note:  All products are identified on the 
label by the Control Number.  The firm's lot number does not 
appear on the label).
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter on June 8, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
10,591 cartons, 1 multiple dose vial per carton were distributed.
REASON
Superpotency.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Platelets, Pheresis.  Recall #B-1143-9.
CODE
Unit  #KK00833.
MANUFACTURER
Gateway Community Blood Program, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on March 4, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Missouri.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with an elevated ALT.
________
PRODUCT
Various Human Tissue for Transplant:
a) Femoral Head w/o Cartilage; b) Fascia Lata;
c) Tricortical Ilium Wedge; d) Cancellous Chips; e) Cortical 
Strut Units; f) NA Shaft.  Recall #B-1275-9.
CODE
Unit Numbers a) 990450001, 990450002; b) 990450003, 990450004;
c) 990450006, 990450008, 990450009, 990450010, 990450011;
d) 990450014, 990450015, 990450016, 990450017, 990450018,
   990450019, 990450020, 990450021, 990450022, 990450023, 
   990450024, 990450027, 990450028, 990450032, 990450033;
e) 990450038, 990450039, 990450040, 990450043;
f) 990450044, 990450045.
MANUFACTURER
AlloSource, Denver, Colorado.
RECALLED BY
Manufacturer, by telephone on July 20, 1998, and by letters dated 
August 18, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Colorado, Florida, Illinois, Indiana, Oklahoma, 
Pennsylvania, New York, Texas.
QUANTITY
a) 2 units; b) 2 units; c) 5 units; d) 15 units; e) 4 units; f) 2 
units were distributed.
REASON
The tissues for transplant were collected from a donor who tested 
repeatedly reactive for the antibody to the Hepatitis B core 
antigen (anti-HBC).
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; Recovered Plasma.  
Recall #B-1287/1289-9.
CODE
FDA, Center for Biologics Evaluation and Research, Contact Office 
of Compliance (301) 827-6220 for individual unit numbers 
recalled.
MANUFACTURER
United Blood Services, Bismarck, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone beginning 
on June 2, 1999, followed by letters dated June 18, 21, 23, 28, 
and 30, and July 1, 1999.
DISTRIBUTION
California, Florida, New York, Texas, Alabama, Arkansas, 
Massachusetts, Mississippi, New Jersey, North Carolina, North 
Dakota, South Carolina, South Dakota and Switzerland.
QUANTITY
a) 388 units; b) 2 units; c) 392 units were distributed.
REASON
Blood products were collected from donors whose donor history 
screening was inadequately performed. 
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-1291-9.
CODE
Unit #0102681.
MANUFACTURER
Ashford Blood Bank, Inc., Santurce, Puerto Rico.
RECALLED BY
Manufacturer, by telephone on April 23, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
Puerto Rico.
QUANTITY
1 unit was distributed.
REASON
Blood product containing positive antibodies, but labeled as 
negative for unexpected antibodies.
________
PRODUCT
a) Platelets, Pheresis; b) Platelets Pheresis, Irradiated.  
Recall #B-1292/1293-9.
CODE
a) 10594-2996, 10597-6162; b) 10598-3087, 10602-5101.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale Arizona, by letters dated June 
16, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Nevada, Arizona.
QUANTITY
2 units of each component were distributed.
REASON
Blood products had unacceptable platelet counts.
________ 
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes 
Reduced; c) Platelets, Pooled.  Recall #B-1297/1299-9.
CODE
Unit Numbers: a) LG99113 b) FR01339 c) FP73927, FP79567.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on August 10, 1999, and by letters 
dated August 11, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
a) 1 unit; b) 1 unit; c) 2 units were distributed.
REASON
Blood products were collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Plasma.  Recall #B-1300/1301-9.
CODE
Unit #53KQ53856.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by letters dated March 31, 1999, or by telephone 
22, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Washington, D.C.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-1290-9.
CODE
Unit Number 0103796.
MANUFACTURER
Ashford Blood Bank, Inc., Santurce, Puerto Rico.
RECALLED BY
Manufacturer, by telephone on September 2, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
Puerto Rico.
QUANTITY
1 unit was distributed.
REASON
Blood product was not tested for HIV ½, prior to release, and 
subsequently tested non-reactive for HIV ½.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
BLD PEEP-FLO resuscitator devices:
a) Peep-Flo Positive Expiratory Pressure valve;
b) Pulmanex Manual Resuscitator with a PEEP-FLO Valve
c) CPAP Chsuion-FLEX Mask packaged with BLD’s PEEP-FLO 
ValveValve.  Recall #Z-001/003-0.
CODE
a) PEEP-FLO Valve only
   Product       Number          Lot Number        
   Number        of Lots         Range
   BLD-8870        49           813085/909002
   BLD-8872        28           813085/909002
   BLD-8875        20           815075/850093
   BLD-8876        11           820047/850093
b) BLD PULMANEX Manual Resuscitator with PEEP-FLO Valve
   Product       Number          Lot Number        
   Number        of Lots         Range
   BLD-9007-477    10           816065/909003
   BLD-9007-5477    2           849045/903081
   BLD-9017-477     5           815084/850092
   BLD-9017-5477   30           815083/905048
   BLD-9017-5477V   1           829082
   BLD-9018-5477   13           814095/909000
   BLD-9057-477     9           818040/849046
   BLD-9058-477    10           834071/908104
   BLD-9058-5477   18           823026/908100
   BLD-9147-57     12           825047/906069
   BLD-9154-5477    1           903035
   BLD-9170-5477    4           827048/845055
   BLD-9172-477     2           834055/849052
   BLD-9172-5477    9           818022/909010
   BLD-9178-4837   12           816049/903086
   BLD-9257-477     4           816023/909004
   BLD-9257-977     2           846024/904034
   BLD-9274-477     2           823005/904063
   BLD-9274-5477    3           901061/906003
   BLD-9274-83      1           830087
   BLD-9274-837     3           822040/902071
c) CPAP Chsuion-FLEX Mask with PEEP-FLO Valve
   Product       Number          Lot Number        
   Number        of Lots         Range
   BLD-8897         2           833054/903054
   BLD-8898         3           815099/831016.
MANUFACTURER
BLD Medical Products, Dallas, Texas.
RECALLED BY
Manufacturer, by letters dated August 5, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
A total of 62,018 PEEP-FLO valves were distributed:
a) 10,808 units; b) 51,090; c) 120.
REASON
The PEEP-FLO valve values are out of specification.
________
PRODUCT
Sabraset 560112-L Administration Set with Spike and Cassette for 
use with the Sabratek 6060 Homerun Volumetric Infusion Pump only. 
 Recall #Z-013-0.
CODE
Catalog #560112L; Lot #990356. 
MANUFACTURER
Pacific Device de Mexico, S.A.
Privada EC Edifico E-1, Local B, Parque Industrial
La Mesa, Tijuana, Mexico.
RECALLED BY
Sabratek Corporation, Skokie, Illinois, by telephone on September 
24, 1999, and letter on September 24, 1999.  Firm-initiated 
recall ongoing. 
DISTRIBUTION
Iowa, Arizona, Indiana, Massachusetts, California, Oregon, South 
Carolina, Tennessee, Wisconsin, Virginia, Colorado, Florida, 
Illinois and England.
QUANTITY
2,790 sets were distributed.
REASON
Tubing may separate from the filter.
________
PRODUCT
Arrow Percutaneous Sheath Introducer Kit.
Recall #Z-014/016-0.
CODE
Product #AK07903-AG; Lot Numbers: 9C592C, 9C6697, 9D7005,9E819F, 
9F610E, and 9G807H.
Product #SI-07903-AG: Lot Numbers: MX9030230 and MX9030234. 
Product #JM-07903-AG: Lot Numbers: 9E8181 and 9G8849.
MANUFACTURER
Arrow International, Inc., Reading, Pennsylvania.
RECALLED BY
Manufacturer, by letters dated September 27, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,860 kits.
REASON
Potential for separation of sheath from hemostasis valve body in 
use.
________
PRODUCT
ATS 2000 Pneumatic Tourniquet, intended use is to temporarily 
occlude blood flow in a patient's extremities during surgical 
procedures on those extremities.
Catalog No. 60-2000-101-00.  Recall #Z-027-0.
CODE
The serial numbers contain 8 digits/letters.  The last 6 digits 
are either: '079920' or '089920'.  These numbers are preceeded 
with one of the following sets of letters:  AA, AG, AR, EJ, FE, 
FL, FR, AB, AJ, AS, EK, FF, FM, FS, AC, AL, AT, EN, FH, FN, FT, 
AE, AM, CK, EU, FJ, FP, FU, AF, AQ, EG, EW, FK, FQ, and FW.
MANUFACTURER
Zimmer, Inc., Dover, Ohio.
RECALLED BY
Zimmer Patient Care Inc., Dover Ohio, by letter on August 27, 
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nebraska, Minnesota, Connecticut, California, Maine, Arizona, 
Illinois, Massachusetts, Wisconsin, Washington state, Texas, 
Pennsylvania.
QUANTITY
35 units were distributed.
REASON
The buttons on the touch panel component may stick in position 
during use.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
ABBOTT AXSYM TROPONIN-I Reagent Pack; a microparticle enzyme 
immunoassay (MEIA), to assist in the diagnosis of acute 
myocardial infarction.  Recall #Z-012-0.
CODE
List #3C29-20, Lot numbers: 52735M300, 52735M301, 53053M200, 
53053M201, 53053M202, 53446M100, 53446M101, 53448M100, 53448M101, 
53577M100, 53577M101, 53879M200, 54860M100, 54860M101, 54885M100, 
54885M101, 54886M100, 54886M101, 54887M100, 54887M101, 54889M100, 
54889M101, 55153M200, 55153M201.
MANUFACTURER
Abbott Laboratories, Inc., Abbott Park, Illinois. 
RECALLED BY
Manufacturer, by letters dated September 21, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
47,010 kits were distributed.
REASON
Calibration failures. 

END OF ENFORCEMENT REPORT FOR OCTOBER 20, 1999.  BLANK PAGES MAY FOLLOW.
####