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.

December 11, 1996 96-50

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Apple Cider (unpasteurized) under the
following labels: The Notch Store and Cider
Mill, and Hickory Hill Orchards, in 1/2 gallon
and 1 gallon plastic containers.
Recall #F-071-7.
CODE Not coded. All product.
MANUFACTURER The Notch Store and Cider Mill, Cheshire,
Connecticut.
RECALLED BY Manufacturer and the Department of Public
Health and Department of Consumer Protection,
State of Connecticut, by telephone October 18
and 19, 1996, and by press release.
Completed recall resulted from epidemiological
investigation and followup by the Connecticut
Department of Consumer Protection.
DISTRIBUTION New York, Massachusetts, Connecticut, Rhode
Island.
QUANTITY 9,000 gallons.
REASON Product was epidemiologically linked with an
outbreak of E. coli 0157:H7 infection.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Extract of Vanilla in 4 and 8 fluid ounce
containers: (a) Clear (uncolored); (b) Dark -
contains caramel color, also in 1 ounce
containers. Recall #F-118/119-7.
CODE None.
MANUFACTURER Albany Drug Company, Albany, Georgia.
RECALLED BY Manufacturer, by telephone on July 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Georgia and Florida.
QUANTITY 50 bottles of each size, approximately 250
total were distributed.
REASON Product contains coumarin which was prohibited
for addition to human foods in 1954.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Tribe of Two Sheiks Hummus, two varieties, in
8 ounce containers: (a) With Garlic; (b) With
Red Peppers. Recall #F-046/047-7.
CODE (a) 5-9-96; (b) 6-2-96.
MANUFACTURER Rite Foods, Inc., Boston, Massachusetts.
RECALLED BY Key Food Stores Cooperative, Inc., Brooklyn,
New York, by letter dated June 6, 1996.
Completed recall resulted from sample analysis
and followup by the New State Department of
Agriculture and Markets.
DISTRIBUTION New York.
QUANTITY (a) 45 cases (12 containers per case); (b) 35
cases (12 containers per case) were
distributed. Firm estimates none remains on
the market.
REASON Product is unfit for food due to being in
swollen containers.

_______________
PRODUCT Minute Maid Apple Juice, in 90 and 169 fluid
ounce containers. Recall #F-124-7.
CODE 90 fluid ounce case code: Apple 06501
M15488 D 102496 Y
M15488 E 102596 Y
90 fluid ounce container code: 6298 M
6299 M
169 fluid ounce case code: Apple 06583
M15488 D 102496 Y
M15488 E 102596 Y
90 fluid ounce container code: 6298 M
6299 M.
MANUFACTURER The Minute Maid Company, Dunedin, Florida.

-2-RECALLED BY The Minute Maid Company, Houston, Texas, by
telephone on or about November 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 5,936 cases were distributed.
REASON Product was represented as apple juice but
actually contained a mixture of apple and pear
juice.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I ========
_______________
PRODUCT Albumin (Human) 5%. Recall #B-003-7.
CODE Lot #6.231.026.0 EXP 3-8-99.
MANUFACTURER Central Laboratory Blood Transfusion Service,
Swiss Red Cross, Bern, Switzerland.
RECALLED BY Alpine Biologics, Inc., Blauvelt, New York, by
letters of September 30, 1996, October 1 and
24, 1996. Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, Virginia, Florida,
Indiana, South Dakota, Colorado, Washington
state, Arizona, California.
QUANTITY 4,468 vials were distributed.
REASON Biological product associated with multiple
episodes of severe hypotension subsequently
found in a post-release test to have elevated
levels of plasma Pre-Kallikrein Activator
(PKA).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-635/637-6.
CODE Unit numbers: (a) 02G71203, 02F80204,
02G67297, 02F80422; (b) 02F80204, 02F80422;
(c) 02G71203, 02F80204, 02G67297, 02F80422.
MANUFACTURER American Red Cross, Wichita, Kansas.
RECALLED BY Manufacturer, by letters dated between June 5,
1995, and October 11, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kansas, Alabama, California, Switzerland.
QUANTITY (a) 4 units; (b) 2 units; (c) 4 units were
distributed.
REASON Blood products tested initially reactive for
anti-HIV, HBsAg, and HTLV-III with no
confirmatory tests.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma. Recall #B-013/017-7.

-3-CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1191 for individual unit numbers recalled.
MANUFACTURER Blood Bank of San Bernardino and Riverside
Counties, San Barnardino, California.
RECALLED BY Manufacturer, by letter dated August 30, 1993,
or September 24, 1993. Firm-initiated recall
complete.
DISTRIBUTION California, New York.
QUANTITY (a) 23 units; (b) 7 units; (c) 3 units; (d) 3
units; (e) 11 units were distributed.
REASON Blood products were collected from a donor who
tested positive for syphilis within one year
of donation.

_______________
PRODUCT Red Blood Cells. Recall #B-048-7.
CODE Unit #53GR06079.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated January 25,
1996. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-057-7.
CODE Unit #40GT08753.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 13,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-060/061-7.
CODE Unit numbers: (a) 16LN01378, 16LN03210; (b)
16LN01378.
MANUFACTURER American Red Cross Blood Services, Columbus,
Ohio.
RECALLED BY Manufacturer, by telephone on August 2 and 5,
1996, followed by letter dated August 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY (a) 2 units; (b) 1 unit was distributed.

-4-REASON Blood products were collected from a donor who
traveled in an area considered endemic for
malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-062-7.
CODE Unit numbers: 53P62831, 53P62235.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated April 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, Maryland.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
with a history of testing repeatedly reactive
for the antibody to the hepatitis C virus
encoded antigen (anti-HCV).

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-063/065-7.
CODE Unit #26144 2782.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by letter dated May 16, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma, Texas, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that
could compromise the sterility of the
collection.

_______________
PRODUCT Red Blood Cells, Leukocyte reduced.
Recall #B-082-7.
CODE Unit #0362989.
MANUFACTURER Blood Bank of Delaware, Inc., Newark,
Delaware.
RECALLED BY Manufacturer, by telephone on August 16, 1995.
Firm-initiated recall complete.
DISTRIBUTION Delaware.
QUANTITY 1 unit.
REASON Blood products untested during anti-HCV test
were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-108-7.
CODE Unit #20KM07573.
MANUFACTURER American Red Cross Blood Services, Boise,
Idaho.
RECALLED BY Manufacturer, by letter dated August 21, 1995.
Firm-initiated recall complete.
DISTRIBUTION Idaho.
QUANTITY 1 unit was distributed.
-5-REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Fluogen (Influenza Virus Vaccine, Trivalent,
Types A & B). Recall #B-117-7.
CODE Syringe lot numbers: 00576P, 00586P, 00676P,
00686P, 00786P, 00886P, 00986P, 01066P;
Vial lot numbers: 00176P, 00276P, 00966P.
MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile
Products Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letters
of November 1 and 6, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,790,808 units
REASON Parke-Davis Fluogen showed a decrease in
potency of one component of the vaccine after
distribution.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-049-7.
CODE Unit #53GR06079.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letters dated January 17,
1996, February 21, 1996 and March 13, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
reported a history of cancer.

_______________
PRODUCT Recovered Plasma. Recall #B-058-7.
CODE Unit #40GT08753.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated September 13,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
a history of cancer.

_______________
PRODUCT Irradiated Whole Blood Modified, Leukocytes
Removed. Recall #B-059-7.
CODE Unit #N86959.
-6-MANUFACTURER The Blood Center of Southeastern Wisconsin.
RECALLED BY Manufacturer, by telephone on June 28, 1995.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an incorrect
expiration date.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-088/089-7.
CODE Unit #40FG08031.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated May 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1).

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-110/111-7.
CODE Unit numbers: (a) 1224869, 1224874, 1224887,
1224890, 1224892, 1224901, 1224902, 1224907,
1707044, 1707051, 4110892, 4807672, 5123428,
5223156, 7168976, 7168978, 7168979, 7168991,
7168994, 7168997, 7168998, 7168999, 8144661,
8241829, 7168985
(b) 1224871, 1224874, 1224885, 1224887,
1224890, 1224896, 1500727, 1500728, 1500729,
1500730, 1900421, 2605831, 2605832, 2605833,
2605834, 3500346, 3500347, 3500348, 4110887,
4110888, 4500376, 4500377, 5123435, 7168984.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on September 9,
1996, followed by letter on September 26,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 25 units; (b) 24 units were distributed.
REASON Blood products were incorrectly tested for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV).

_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-112-7.
CODE Unit 21GF68421.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.

-7-RECALLED BY Manufacturer, by letter dated March 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
an unacceptable length of time.

_______________
PRODUCT Platelets. Recall #B-113-7.
CODE Unit numbers: L24999, L25048, L25023, L24995.
MANUFACTURER H.C.S.C. Blood Center, trading as Miller
Memorial Blood Center, Bethlehem,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on August 25, 1995.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 4 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
PRODUCT Red Blood Cells. Recall #B-114-7.
CODE Unit numbers: 23131-7808 and 23131-7805.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Manufacturer, by letters dated November 14,
1995, and January 15, 1996. Firm-initiated
recall complete.
DISTRIBUTION Montana.
QUANTITY 2 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-115/116-7.
CODE Unit #L27781.
MANUFACTURER H.C.S.C. Blood Center, Bethlehem,
Pennsylvania.
RECALLED BY Manufacturer, by letter on October 11, 1995.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for
anti-HBc.

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT 3M Model 300 Modular Infusion Pump.
Recall #Z-147-7.

-8-CODE The serial numbers are arranged in columns
below "Adapter Sleeve", "Interlocking Track"
or "both." "Adapter Sleeve" means that a
problem with the adapter sleeve needs to be
corrected and "Interlocking Track" means that
a problem with interlocking track needs to be
corrected. Devices identified by serial
numbers in the first two columns have only one
of the two problems and devices with serial
numbers in the third column are affected by
both problems.
Adapter Sleeve Interlocking Track Both
30012897-30012980 30005706-30005755 30013194-30013293
30012894-30012991 30005756-30005767 30013294-30013393
30012966 30005844-30005955 30013394-30013493
30012918-30012993 30006020-30006129 30013494-30013593
30013012-30013089 30005768-30005800 30013595-30013693
30013002-30013093 30005801-30005810 30013609
30013004-30013091 30005811-30005843 30013602-30013672
30012937-30013061 30005956-30005961 30013613
30013023 30005962-30005986 30013623
30002306-30003100 30005987-30006019 30013694-30013717
30013094-30013193 30014619-30014678 30013719-30013723
30015078-30015175 30014714-30014720 30013734-30013748
30015082-30015172 30014679-30014713 30013749-30013848
30015076-30015167 30016130 30013849-30013853
30015095-30015162 30016131-30016151 30013854-30013953
30006472-30006474 30006272-30006291 30013955-30014053
30015276-30015295 30006153-30006268 30014054-30014153
30015296- 30015305 30006292-30006294 30014154-30014253
30006485-30006514 30006156-30006396 30014254-30014453
30015306-30015318 30014454-30014553
30015331-30015410 30014502
30014504
30014509
30014515
30014528
30014562-30014603
30014604-30014608
30014554-30014602
30014555-30014601
30014721-30014889
30014821-30014825
30014721-30014781
30014876
30014882-30014925
30014876-30014924
30014874-30014920
30014926-30014975
30006397-30006416
310000046-9
30014976-30015054

-9- 30014981
30015003
30015047
30006417-30006436
30014918-30015073
30015000
30014977-30015075.
MANUFACTURER 3M Infusion Therapy (was purchased by Graseby
Medical), Arden Hills, Minnesota.
RECALLED BY Graseby Medical, Inc., Arden Hills, Minnesota,
by letter on October 21, 1996. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,381 interlocking female tracks and 2,717
activator arms.
REASON The pump has the potential to fall apart due
to an incompatibility between the original and
new modular connection system and out of
tolerance with female interlocking tracts of
the modular connection system.

_______________
PRODUCT 3M Sarns Perfusion System 8000 Roller Pump
Power Supply Cables:
(a) 115 Volt Roller pump, Catalog #16402, Part
98-0702-0647-3;
(b) 220 Volt roller pump, Catalog #16407, Part
98-0702-0648-1. Recall #Z-150/151-7.
CODE Serial numbers (a) 10002-10086, 10090, 10092-
10096, 10098, 10099, 10100, 10110, 6231, 6248,
6251-6253, 6255-6257, 6259, 6260, 6281-6283,
6285-6291, 6296-6302, 6347-6351; (b) Serial
numbers 6276-6280, 6303-6305, 6307-6318, 6324-
6324-6328, 6334-6338.
MANUFACTURER Undetermined.
RECALLED BY 3M Health Care, Ann Arbor, Michigan, by letter
October 29, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 186 units were distributed.
REASON The power supply cable assemblies used may
contain an improperly sized resistor which may
not achieve maximum specified blood flow.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Immulite brand Progesterone Kits, a diagnostic
device test kit:
(a) Catalog No. LKPG1, 100 Test Kit
(b) Catalog No. LKPG5, 500 Test Kit.
Recall #Z-157/158-7.

-10-CODE Lot Numbers: (a) 131, 132, 133;
(b) 131, 132, 133.
MANUFACTURER Diagnostic Products Corporation, Los Angeles,
California.
RECALLED BY Manufacturer, through publication of technical
bulletin #1083 for domestic customers and
#2098 for international customers, followed by
letters. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,999 kits were sold; firm estimates none
remains on the market.
REASON The device had a low bias on patient samples,
and was found to be unstable after 30 days of
the 6 month labeled expiration date.

_______________
PRODUCT Diamedix Corp. brand of Anti-RNP Microassay,
Catalog No. 783-270, Catalog No. 783-270, for
in-vitro diagnostic use, 96 Test Set.
Recall #Z-159-7.
CODE Lot No. 31126, EXP Dec 96.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on August 5, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 166 kits were distributed.
REASON The test results for the positive control are
above the assigned control range.

-11-

END OF ENFORCEMENT REPORT FOR DECEMBER 11, 1996. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for