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.

November 19, 1997 97-47

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Hummus and Baba Ganouch under the following
labels:
Tribe of Two Sheiks label:
1. Classic Hummus
2. Lemon Hummus
3. Hummus with Cracked Chili Peppers
4. Hummus with Roasted Garlic
5. Scallion Hummus
6. Hummus with Roasted Red Peppers
7. Hummus with 40 Spices
8. Hummus with Calamata Olives
9. Hummus for Bagels
10. Hummus
11. Curry Hummus
12. Dill Hummus
13. Orange Hummus
14. Olive Hummus Sicilian Green
15. Olive Hummus Calamata Smooth
16. Olive Hummus Calamata Chunky
17. Olive Hummus French Nicoise
18. Olive French Picholine
19. Olive Hummus Moroccan Cured
20. Olive Hummus Greek Nafpelion
21. Baba Ganoush
"Max Bean" label:
22. Hummus Oven Roasted Garlic
23. Hummus Mediterranean Classic
23. Hummus Roasted Red Pepper
24. Hummus Cucumber & Dill
25. Hummus Lemon & Black Pepper
"Bruegger's" label:
26. Original Hummus. Recall #F-093/119-8.
CODE "Use By" date up to and including "12 15 97":
packed in 2 oz., 8 oz., 16 oz., and 64 oz.,
plastic containers.
MANUFACTURER Rite Foods, Inc., Boston, Massachusetts.
RECALLED BY Manufacturer, by fax on or about August 28,
1997, by telephone followed by fax on
September 17, 1997, and by press release on
September 17, 1997. Firm-initited recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The product may be contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Fresh Marlin. Recall #F-090-8.
CODE None.
MANUFACTURER Inland Seafood, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone, followed by letter
dated May 28, 1997. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Georgia, North Carolina, South
Carolina, Tennessee, Virginia.
QUANTITY Approximately 847 pounds were distributed.
REASON Product contains excessive levels of
histamine.

_______________
PRODUCT Kroger Deluxe Ice Cream: a) Neopolitan Ice Cream;
b) Neopolitan Fat Free Ice Cream.
Recall# F-091/092-8.
CODE a) Dec 31 97DL; b) 29 Nov 97ZC.
MANUFACTURER a) Southern Ice Cream Specialties, Marietta,
Georgia; b) Springdale Ice Cream and Beverage,
Cincinnati, Ohio.
RECALLED BY The Kroger Company, Cincinnati, Ohio,
by telephone followed by E-Mail, on October 4,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia, Alabama, South Carolina, North Carolina,
Indiana, Illinois, Missouri, Ohio, Kentucky, West
Virginia, Michigan, Virginia, Tennessee.

-2-
QUANTITY a) 6,652 2-gallon containers; b) 23,728 2-gallon
containers were distributed.
REASON The product were processed from strawberry lots
that were associated with an illness outbreak of
Hepatitis A.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT 100% Orange Juice From Concentrate packed in
64 fluid ounce paper cartons and 96 fluid ounce
plastic jugs - some product contains pulp,
distributed under the following labels:
1) America's Choice 100% Orange Juice From
Concentrate, 64 fluid ounces distributed by
Compass Foods Montvale, NJ
2) Best Yet 100% Pure Orange Juice From
Concentrate, 64 ounces, packed for Scrivner, Inc.
Oklahoma City, OK
3) Orchard Harvest 100% Juice Unsweetened Orange
Juice From Concentrate, 64 fluid ounces,
distributed by: BI-LO Inc., Mauldin, SC
4) Buehler's 100% Pure Orange Juice From
Concentrate 64 fluid ounces, distributed by
Buehler's Inc., Wooster, OH
5) FARMERS VALU Orange Juice From Concentrate,
Net Weight 64 fluid ounces, distributed by H&H
Sales Norcross, GA
6) Flavorite 100% Pure From Concentrate Orange
Juice, 64 fluid ounces, distributed by Preferred
Products, Inc., Eden Prairie, MN
7) Flavorite 100% Pure Old Fashioned With More
Juicy Bits of Orange, from concentrate, 64 fluid
ounces, distributed by Preferred Products, Inc.
Eden Prairie, MN
8) Flavorite 100% Pure Orange Juice From
Concentrate Unsweetened, 96 fluid ounces,
distributed by Preferred Products, Inc., Chaska,
MN
9) Food Club 100% Pure Orange Juice From
Concentrate pulp added, 64 fluid ounces,
distributed by Topco Associates, Inc., road,
Skokie, IL
10) Food Club 100% Pure Orange Juice From
Concentrate 96 fluid ounces, distributed by Topco
Associates, Inc., Skokie, IL
11) Foodland 100% Orange Juice 64 fluid ounces,
distributed by Preferred Products, Inc., Eden
Prairie, MN
12) Four Winds 100% Pure Orange Juice From
Concentrate 64 fluid ounces distributed by:
Staff Supermarket Assoc., Inc., Norcross,GA
-3-
13) Country Style Orange Juice From Concentrate High
Pulp 64 fluid ounces, distributed by Staff Supermarket
Associates, Inc., Norcross, GA
14) Four Winds Farm 100% Pure Orange Juice From
Concentrate 96 fluid ounces, distributed by Staff
Supermarket Associates, Inc., Norcross, GA
15) Great Value 100% pure Orange Juice from Concentrate
64 fluid ounces, marketed by Wal Mart Stores, Inc.
Bentonville, AR
16) Great Value Orange Juice From Concentrate net
96 fluid ounces, marketed by Wal Mart Stores, Inc.,
Bentonville, AR
17) Hyde Park 100% Pure Orange Juice From Concentrate,
64 fluid ounces, distributed by Fleming Companies,
Oklahoma City, OK
18) Harvey's Supermarkets 100% Orange Juice From
Concentrate distributed by Harveys Supermarkets,
Noashville, GA, 64 fluid ounces
19) Harvey's Supermarkets Country Style with more juicy
bits of orange, 100% orange juice from concentrate,
64 fluid ounces, distributed by Harvey's Supermarkets,
Nashville, GA
20) IGA Orange Juice 100% Pure From Concentrate 64 fluid
ounces, distributed by IGA, Inc., Chicago, IL
21) IGA Country Style 100% Pure Orange Juice From
Concentrate 64 fluid ounces, distributed by IGA, Inc.
Chicago, IL
22) Janet Lee 100% Pure Orange Juice From Concentrate
Unsweetened 96 fluid ounces distributed, by Albertson's
Inc., Boise, ID
23) Janet Lee Country Style Orange Juice From
Concentrate with juicy bits of orange distributed by
Albertson's Inc. Boise, ID
24) Jus Squeezd 100% Orange Juice From concentrate
64 fluid ounces distributed by Lykes Pasco, Inc.
Dade City, FL
25) Kash N Karry 100% Pure Orange Juice From Concentrate
64 fl ounces proudly distributed by: Kash 'N Karry Food
Stores, Inc. Tampa, FL
26) Kingston 100% Pure Orange Juice From Concentrate 64
fluid ounces, packed for Kingston Marketing Co., Skokie,
IL
27) Meijer 100% Pure Unsweetened Orange Juice From
Concentrate 64 fluid ounces, distributed by Meijer, inc.
Grand Rapids, MI
28) Meijer 100% Pure Unsweetened Orange Juice From
Concentrate 96 fluid ounces, distributed by Meijer, Inc.
Grand Rapids, MI
-4-
29) Nature's Best 100% Pure Orange Juice From Concentrate 64
fluid ounces, distributed by Preferred Products, Inc. Eden
Prairie, MN
30) Nature's Best 100% Pure Orange Juice Country Style with
more juicy bits of orange, distributed by Preferred Products
Inc. Eden Prairie, MN
31) Nature's Nectar 100% Pure Orange Juice From Concentrate,
64 fluid ounces, distributed by Aldi, Inc. Batavia, IL
32) Old South 100% Orange Juice From Concentrate, 64 fluid
ounces, distributed by Lykes Pasco, Inc., Dade City, FL
33) Old South Country Style 100% Pure Orange Juice From
Concentrate, 64 fluid ounces, distributed by Lykes Pasco,
Inc., Dade City, FL
34) Old South 100% Pure From Concentrate Orange Juice, 96
fluid ounces distributed by: Lykes Pasco, Inc., Dade City,
FL
35) Old Time 100% Pure Unsweetened Orange Juice From
Concentrate 64 fluid ounces, distributed by Roundy's Inc.,
Milwaukee, WI
36) Our Family 100% Pure Orange Juice From Concentrate
Unsweetened, 64 fluid ounces, distributed by Nash Finch
Company Minneapolis, MN
37) Piggly Wiggly 100% Pure Orange Juice From Concentrate
Unsweetened 64 ounces, distributed by Piggly Wiggly Corp.,
Memphis, TN
38) Red and White 100% Pure Orange Juice From Concentrate
Unsweetened, 64 fluid ounces, packed for Federated Group
Inc., Arlington Heights, IL
39) Seaway 100% Pure Orange Juice From Concentrate, net 64
fluid ounces, distributed by American Seaway Foods, Inc.,
Cleveland, OG
40) Shurfresh brand Orange Juice From Concentrate, 64 fluid
ounces, distributed by Shurfine International Inc.
Northlake, IL
41) Shurfresh brand Orange Juice From Concentrate, 64 fluid
ounces, Country Style, distributed by Shurfine Int., Inc.,
Northlake, IL
42) Shurfresh Orange Juice From Concentrate, 96 fluid
ounces, distributed by Shurfine International, Inc.,
Northlake, IL
43) Signal 100% Pure Orange Juice From Concentrate with
added pulp, The Atlantic Signal Company, Inc. Stellarton,
N-E BOK 1S0 44) Signal Pura 100% Jus D'Orange Avec Pulpe
Ajoutee 1.89 L, The Atlantic Signal Company, Inc.
Stellarton, N-E Box 1S0
-5-
45) Signal 100% Pure Orange Juice From Concentrate, 1.89L,
The Atlantic Signal Company, Inc., Stellarton, N-E Box 1SO.
46) Signal Pura 100% Jus D'Orange, 1.89L, Atlantic Signal
Company, Inc., Stellarton, N-E Box 1s0.
47) Spartan 100% Pure Orange Juice From Concentrate, 64
fluid ounces, distributed by Spartan Stores, Inc., Grand
Rapids, MI
48) Spartan 100% Pure Orange Juice From Concentrate
Unsweetened, 96 fluid ounces, distributed by Spartan Stores,
Inc. Grand Rapids, MI
50) Utimate Choice Orange Juice From Cocncentrate, 64 fluid
ounces, distributed by SSI, North Lake, IL
51) Western Family 100% Pure Orange Juice From Concentrate,
1.89 L Western Family Foods Vancouver, B.C. V684e4.
52) Western Family Jus D'Orange Fait de Concentrate
1.89L
53) Western Family 100% Pure Orange Juice From
concentrate
1.89L, prepared for Western Family foods vancouver, b.C.
54) Jus D'Orange 100% Pur Fait de Concentrate 1.89L
Recall #F-087-8.
Code 08 OCT, 15 OCT, 22 OCT, 29 OCT, 05 NOV, 12 NOV,
19 NOV, 26 NOV.
MANUFACTURER Lykes Pasco, Inc., Dade City, Florida.
RECALLED BY Manufacturer, by telephone on September 24 and 29,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 350,000 cases were distributed.
REASON The product is contaminated with yeast, exhibiting
effervescence, and emitting an off odor.
_______________
PRODUCT Pastry shells distributed in gift boxes labeled
"Holiday Appetizers" which include 3 one-half
pound Incredible Spreadable for filling the pastry
shells (only the Croustades pastry shells are
being recalled).
Recall #F-088-8.
CODE All product is being recalled.
MANUFACTURER Pastry Shoppe Bakery, Glenwood, Minnesota.
RECALLED BY Swiss Colony, Monroe, Wisconsin, by telephone
during the period from October 3-5, 1997, and
by mailgram and letter dated October 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 73 boxes of Croustades in 73 gift packs were
distributed.
REASON The product was packed under insanitary
conditions.
_______________
PRODUCT Pure Honey. Recall #F-089-8.
CODE 075364-123153 (6.8 ounce bottles),
075364-123160 (25.3 ounce bottles).
MANUFACTURER Robins Products, Hormigueros, Puerto Rico.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 150,000 6.8-ounce bottle and 5,000 25.3
ounce-bottles were distributed.
REASON The product, falsely labeled as "Pure Honey",
is adulterated as it was found to contain
sugars of cane or corn origin.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT Platelets Pheresis. Recall #B-044-8.
CODE Unit numbers: 535085, 535093, 535122
MANUFACTURER United Blood Services, Hot Springs, Arkansas.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter
dated September 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arkansas.
QUANTITY 3 units were distributed.
REASON Blood products either (1) tested repeat
reactive for anti-HIV-1, Western Blot negative
or (2) tested negative for the antibody to the
human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor
who previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.

_______________
PRODUCT Platelets, Pheresis. Recall #B-095-8.
CODE Unit #3074513.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by letter dated December 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had
sexual contact with someone who had lived in an
HIV Group O risk area.

_______________
PRODUCT Red Blood Cells. Recall #B-119-8.
CODE Unit #18FQ20766.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
-7-
RECALLED BY Manufacturer, by telephone on July 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c)Platelets;
d) Fresh Frozen Plasma; e) Cryoprecipitated AHF;
f) Plasma, Cryoreduced.
Recall #B-120/125-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Products Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on February 26, 1997,
March 3 or 21, 1997, and or by letters dated march
7 or March 21, 1997. Firm-initiated recall
complete.
DISTRIBUTION New Jersey and Pennsylvania.
QUANTITY a) 8 units; b) 27 units; c) 1 unit; d) 6 units;
e) 7 units; d) 4 units were distributed.
REASON Blood products were incorrectly tested for CMV
antibody.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Cryoprecipitated AHF; e) Recovered
Plasma. Recall #B-131/135-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letters dated July 10, 11, 14, or
29, 1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky, Indiana, South Carolina.
QUANTITY a) 27 units; b) 20 units; c) 8 units; d) 3 units;
e) 19 units were distributed.
REASON Blood products were collected from a donor taking
the drug, Amantadine.

______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-148/149-8.
CODE Unit #3144673.
MANUFACTURER Florida Blood Services, Inc., Tampa, Florida.

-8-
RECALLED BY Manufacturer, by letter (fax) on April 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood products tested initially reactive for the
antibody to the human immunodeficiency virus type
1-2 (anti-HIV 1-2) with no duplicate repeat
testing performed.

_______________
PRODUCT Platelets. Recall #B-152-8.
CODE Unit #29444-9518.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated October 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood identified as a difficult draw.

________________
PRODUCT Red Blood Cells. Recall #B-156-8.
CODE Unit #30001226.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc.,
Tyler, Texas.
RECALLED BY Manufacturer, by telephone on November 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for syphilis, but
was collected from a donor who was deferred for
testing positive for syphilis within one year of
donation.

_______________
PRODUCT Source Plasma. Recall #B-157-8.
CODE Unit numbers: 72162033 and 72165782.
MANUFACTURER American Biologicals, Inc., Waco, Texas.
RECALLED BY Manufacturer, by fax on November 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Blood products tested negative for the HIV-1 p24
antigen, but were collected from a donor who
previously tested repeatedly reactive for the
HIV-1 p24 antigen.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma;
c) Recovered Plasma. Recall #B-163/165-8.
CODE Unit numbers: a) 10193-9811, 10204-9865
b) 10204-9865; c) 10193-9811.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
-9-
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated August 25, 1997, and by fax on August
26, 1997. Firm-initiated recall complete.
DISTRIBUTION Arizona and Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit was distributed.
REASON Blood products were collected from a donor who
had been deferred for intimate contact with a
person who had hepatitis.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma. Recall # B-166/168-8.
CODE Unit #29114-7854.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated September 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had
been deferred for an accidental blood exposure.
______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-169/170-8.
CODE Unit #20020-1063.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALL BY Blood Systems, Inc., Scottsdale Arizona, by
letters dated July 30, 1997 and August 22,
1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1) but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative.
______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma
c) Platelets. Recall #B-183/185-8.
CODE Unit #03KL03714.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on October 11,
1996, and by letter on October 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
-10-
REASON Blood product were collected form a donor with
a history of hepatitis.

______________
PRODUCT Fresh Frozen Plasma. Recall # B-186-8.
CODE Unit # 03V04270.
MANUFACTURER American Red Cross Blood Services, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on December 26, 1996,
and by letter on January 9, 1997. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood
Cells that was returned due to clotting.

_______________
PRODUCT a) Red Blood Cells; b) Platelets, irradiated unit.
Recall # B-187/188-8.
CODE Unit #3KS03882.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by telephone on May 14, 1997 and by
letter dated May 22, 1997. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were mislabeled as CMV antibody
negative.

_______________
PRODUCT Platelets. Recall # B-189-8.
CODE Unit #03R01717.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by letter on September 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted
Red Blood Cells.

______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-190/191-8.
CODE Unit #03R02085
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by letter on September 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component.

-11-
REASON Blood product corresponded to a unit of clotted
Red Blood Cells.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Frozen Plasma.
Recall #B-192/195-8.
CODE Unit numbers: a) KE56032, KQ27938, b) KE56032; c) KE56032;
d) KQ27038.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone and by letter dated
August 3, 1997. Firm-initiated recall complete.
DISTRIBUTION Virginia and California.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit was
distributed.
REASON Blood products were collected from a donor with a
history of cancer.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-196/198-8.
CODE Unit #KN11462.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated July 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of cancer.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-126/128-8.
CODE Unit numbers: a) units 49FM27056, 49LF32126, 49LF32143, 49LK07336, 49W19289, 49W19661
b) 49W19661; c) 49FM27056, 49LF32126,
49W19289, 49W19661, 49LF32143.
MANUFACTURER American Red Cross Blood Services, Waco, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa,
Oklahoma, by letters dated June 19, 1997, and by
letter dated July 18 and 30, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas, Oklahoma, California, Massachusetts,
Switzerland.
QUANTITY a) 6 units; b) 1 unit; c) 5 units were
distributed.
REASON Blood products were collected from donors with no
documentation that the arm inspection was
performed.
-12-
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-129/130-8.
CODE Unit #18FS06345.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letters dated April 10 and 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who had
no arm inspection documented.

_______________
PRODUCT Red Blood Cells. Recall #B-139-8.
CODE Unit #10508-1323.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by telephone on March 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for the E antigen was
labeled E negative.

_______________
PRODUCT Washed Red Blood Cells. Recall #B-140-8.
CODE Unit numbers: 3031060 and 3077935.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by telephone on February 21, 1997,
and by letter dated September 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-141-8.
CODE Unit numbers: 26149-7757, 26149-7758, 26149-7759,
26149-7761, 26149-7763, 26149-7766, 26149-7767,
26149-7769, 26149-7771, 26149-7772, 26149-7773,
26149-7775, 26149-7776, 26149-7777, 26149-7780.
MANUFACTURER United Blood Services, Fort Smith, Arkansas.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
telephone on August 22, 1997, and by letter on
October 6, 1997. Firm-initiated recall complete.
DISTRIBUTION Arkansas.
QUANTITY 15 units were distributed.
-13-
REASON Blood products were not frozen within eight hours
of whole blood collection.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-144-8.
CODE Unit #10506-6732.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 16, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood with an extended collection time.

_______________
PRODUCT Recovered Plasma. Recall #B-145-8.
CODE Unit #18FS06047.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by letter on April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products corresponded to a unit of Red Blood
Cells that was returned due to clotting.

_______________
PRODUCT Platelets. Recall #B-154-8.
CODE Unit numbers: 16LS22449, 16LW16009, 16LY30428,
16LL27089, 16LW16003.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by telephone on August 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 5 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-155-8.
CODE Unit #13000279.
MANUFACTURER W.E. and Lela I Stewart Blood Center, Inc., Tyler,
Texas.
RECALLED BY Manufacturer, telephone on November 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.

-14-
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-176/178-8.
CODE Unit #17181-6785.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated August 26, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas and New York.
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 occasions.

_______________
PRODUCT Washed Irradiated Red Blood Cells.
Recall #B-201-8.
CODE Unit numbers 26150-6977 and 26150-7198.
MANUFACTURER United Blood Services, Fort Smith, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on July 2, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arkansas.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with an extended
expiration date.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
==========
_______________
PRODUCT Horizon/Horizon Modular Nxt Infusion Pumps.
Recall #Z-039/040-8.
CODE Various serial numbers.
MANUFACTURER B.Braun McGaw Medical, Carrollton, Texas.
RECALLED BY Manufacturer, by letter on October 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Kansas, Pennsylvania, Virginia, California,
Georgia, Massachusetts, New Jersey, Nevada,
Montana, Florida.
QUANTITY 391 pumps were distributed.
REASON The detection air-in-line pump could not
consistently alarm when a .1 ml air bubble is
passed through the pump for infusion rates greater
than 350 ml/hr.

_______________
PRODUCT EZ-Flow 480 Ambulatory Infusion Pump.
Recall #Z-047-8.
CODE All serial number with software version 2.3.
MANUFACTURER Gish Biomedical, Inc., Irvine, California.
RECALLED BY Manufacturer, by fax on September 30, 1997,
October 1 and 2, 1997. Firm-initiated field
correction ongoing.
-15-
DISTRIBUTION Nationwide.
QUANTITY 1,058 devices of all serial numbers.
REASON Defective software may cause over infusion when
using the PCA mode

_______________
PRODUCT a) TAS PT Test Card; b) TAS PT-ONE Test Card,
especially suited for professional use in
decentralized areas of tsting near the site of
patient case, as well as for use in the more
traditional clinical laboratory.
Recall #Z-166/167-8.
CODE a) Catalog #1001, Lot Nos. 302069701, 302079701,
302079702, 302079703, and 302079704
b) Catalog #1018, Lot Nos. 30101701, 30101702,
30101703, 30102701, 30102702, 30102703, 30102704,
301049703, 301049704, 302049705, 301049706,
301059701, 301069701, 301079701, 301079703,
301079705, and 301079706.
MANUFACTURER Cardiovascular Diagnostics, Inc., Raleigh, North
Carolina.
RECALLED BY Manufacturer, by letter on September 17 and 23,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY a) 562 units; b) 1,837 units were distributed.
REASON A change in the test instructions in a technical
bulletin included incorrect mean normal
prothrombin times and these values could produce
incorrect International Normalized Ratio results.

_______________
UPDATE King Systems Ultra-Flex Adult Anesthesia Breathing
Circuits which appeared in the November 5, 1997,
Enforcement Report as Recall #Z-049/153-8, is
being changed to Recall #Z-049/-152-8. (Z-153-8
will be reassigned to another recall.)
The following are corrections to the listing of
the various product recalls:
Product 5213F-6154 should be product 51213F-6154.
Product 5613B-80X. Lot 06737H7 should be lot
0637H7.
Product 61213F-6154 should be product 51213F-6154.
Product 6753F-61. Add lot 1560G7.
Product 8412B-61. Lot 01416G7 should be 1416G7.
Product 8613B-61. Lot 0887G7 should be 0887H7.
Product 8613F-61. Add lot 0614G7 and Delete lot
1360G7.
-16-
Product 8613F-61X. Delete lot 0614G7.
Product 8613F-164E. Add lot 1360G7.
Product 8613F-84 should be product 8613F-80.
Product 8753B-61. Add lot 0505F7.
Product 90316. Add lot 0262J7.
Product 90353. Lot 507F7 should be 1507F7.

-17-

END OF ENFORCEMENT REPORT FOR NOVEMNER 19, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for