FDA

Enforcement Report

February 2, 2000                                   00-05

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
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PRODUCT
Unpasteurized Orange Juice, under the following labels:
a) "Sun Orchard" brand in gallon, pint & 12 oz sizes; 
b) "Sysco" brand in gallon size, 
c) "Aloha" brand in gallon & pint sizes; 
d) "Zupan's" brand in gallon, half-gallon, quart, & pint sizes; 
e) "Epicurean" brand in half-pint size; 
f) Unlabeled gallon containers were distributed to First Season in 
Chicago, Illinois [unknown what eventual label was affixed]
g) Unlabeled half-gallon containers were distributed to Fantasia 
Fresh Juice in Overland, Kansas [unknown what eventual label was 
affixed].  Recall #F-089-0.
CODE
Julian Code:  9306 Enjoy by 11/18/99
Julian Code:  9307 Enjoy by 11/19/99
Julian Code:  9308 Enjoy by 11/20/99
Julian Code:  9309 Enjoy by 11/21/99
Julian Code:  9309 Enjoy by 11/22/99
Julian Code:  9309 Enjoy by 11/23/99.
MANUFACTURER
Sun Orchard, Inc., Strathmore, California.
RECALLED BY
Sun Orchard, Inc., Tempe, Arizona, by telephone on 
November 12, 1999, followed by fax and press release. 
Firm-initiated recall complete. See also FDA press 
releases 99-28, November 16, 1999, and P99-30, November 
19, 1999.
DISTRIBUTION
Arizona, California, Colorado, Kansas, Michigan, New Mexico, 
Oregon, Texas, Utah, Washington state, Canada.
QUANTITY
12,250 gallons were distributed.
REASON
Product is contaminated with Salmonella.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
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PRODUCT
Cryo-Reduced Plasma.  Recall #B-259-0.
CODE
Unit Numbers:  53FE51739, 53FH76584, 53FH76585, 53Q75985, 
53Q75986.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on July 12, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Maryland.
QUANTITY
5 units were distributed.
REASON
Blood products were labeled with extended expiration dates.

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PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets.
Recall #B-313/315-0.
CODE
Unit #KM67343.
MANUFACTURER
Keystone Community Blood Bank, Inc., Reading, Pennsylvania.
RECALLED BY
Manufacturer, by telephone and letter on September 4, 1997.  Firm-
initiated recall complete.

DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
hepatitis. 


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-316-0.
CODE
Unit #21GC68320.
MANUFACTURER
American Red Cross, Pacific Northwest Regional Blood Services, 
Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on September 8, 1999, and by letter 
dated September 17, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Corneas.  Recall #B-317-0.
CODE
99-1905 and 99-1906.
MANUFACTURER
Georgia Eye Bank, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone and letter on December 2, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
2 units were distributed.
REASON
Corneas from a donor who tested repeatedly reactive for HBsAg.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
________
PRODUCT
CryoValve Allograft, Model AVOO and PVOO.  Recall #Z-330-0.
CODE
Serial Numbers 6321836 and 6321844.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter on February 10, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Connecticut and Canada.
QUANTITY
2 valves.
REASON
Donor unsuitability.


________
PRODUCT
AMS Urolume Endoprostheses, stents for recurrent bulbar urethral 
stricture and prostatic obstruction 
secondary to benign prostatic hyperplasia:
a) AMS Urolume Endoprostheses, Models 72402010 (2.0 cm) and 
72402011 (2.5 cm); b) AMS Urolume Endourethral Prosthesis Plus 
Stricture, Models 72401841 (2.0 cm) and 72401843 (3.0 cm); c) AMS 
Urolume Endourethral Prosthesis Plus Prostate, Models 72401800 
(1.5 cm), 72401801 (2.0 cm) and 72401802 (2.5 cm).  Recall #Z-
322/324-0.
CODE
All lots.
MANUFACTURER
Schneider (Europe) A.G., Bulach, Switzerland.
RECALLED BY
American Medical Systems, Inc., Minnetonka, Minnesota, by letter 
dated December 20, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
5,698 units.
REASON
The delivery tool of the devices, which is supposed to place the 
stent in the urethra, could fail to deploy and place the stent in 
position.

________
PRODUCT
Hewlett-Packard Model M1026A Anesthetic Gas Module with Watertrap 
Option, used in operating rooms to measure concentration of 
anesthetic agent and 02 in the breathing circuit to supplement 
indications given on the anesthesia machine and other monitors.  
Recall #Z-326-0.
CODE
All serial numbers.
MANUFACTURER
Hewlett-Packard GMbH, Boeblingen, Baden-WTTBG, Germany.
RECALLED BY
Agilent Technologies (subsidiary of Hewlett-Packard Company), 
Andover, Massachusetts, by letter dated January 10, 2000.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, Mexico, Costa Rica, Brazil, Venezuela.
QUANTITY
1,542 units were distributed.
REASON
Values of CO2 and anesthetic agents may be lower than actual due 
to dilution.

________
PRODUCT
Versys Cemented Hip Stem:  a) Versys Cemented Plus Hip Stem, Size 
15, Catalog No. 00-7852-015-00; b) Versys Cemented Hip Stem, Size 
15, Catalog No. 00-7853-015-01.
Recall #Z-328/329-0.
CODE
a) Lot Nos.  63124100, 63380400, 63380500 and 63491200; 
b) Lot Nos. 62773300, 63491900, 63493600, 63891400, 63893100, 
64223900, 62773200 and 63892900.
MANUFACTURER
Zimmer, Inc., Warsaw, Indiana.
RECALLED BY
Manufacturer, by letter on December 10, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
244 units were distributed.
REASON
An anomaly in the vendor forging die created an intermittent flaw 
in the mid-section region that could reduce the ultimate fatigue 
strength.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Duraflow II Heparin Treated Thin-Flex Single Venous Return  
Cannula Wire Reinforced Open Lighthouse Tip, 
Model No. DII-TF-036-L.  Recall #Z-066-0.
CODE
Lot #93965-9. Use before date of 02/2001.
MANUFACTURER
Baxter Research Medical, Inc., also known as Research Medical, 
Inc., Midvale, Utah.
RECALLED BY
Baxter Healthcare Corporation, Cardiovascular Group, 
Irvine, California, by letter dated December 17, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Kansas, Japan, Belgium.
QUANTITY
316 units were distributed.
REASON
The size 30 French was found in the 36 French package. 
     
END OF ENFORCEMENT REPORT FOR FEBRUARY 2, 2000.