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.
October 13, 1999 99-41
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Ruffles WOW Original Potato Chips, in 5 ounce bags.
Recall #F-001-0.
CODE
Pull Date Code OCT 26; Plant Code 473306H.
MANUFACTURER
Frito-Lay, Inc., Jonesboro, Arkansas.
RECALLED BY
Frito-Lay, Inc., Plano, Texas, by computer message sent on
September 22, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Arkansas, Kentucky, Louisiana, Mississippi, Missouri,
Oklahoma, Tennessee.
QUANTITY
2,500 packages were distributed; firm estimated that between 50
and 100 bags remained on market at time of recall initiation.
REASON
The bags labeled as "original" variety actually contain "cheddar
and sour cream" variety. The "cheddar and sour cream" variety
contains dairy ingredients, FD&C Yellow No. 5 Lake and FD&C
Yellow No. 6 Lake which are not on the label of the "original"
variety.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Source Leukocytes. Recall #B-1164-9.
CODE
Unit #11R38444.
MANUFCTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on January 23, 1998. Firm-initiated
recall complete.
DISTRIBUTION
New Jersey.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected in a manner that could compromise the
sterility of the product.
________
PRODUCT
Platelets, Pheresis. Recall #B-1196-9.
CODE
Unit #24203-4626.
MANUFACTURER
United Blood Services, Rapid City, South Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated June 8,
1999. Firm-initiated recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 unit was distributed.
REASON
Blood product was not stored in a sufficient amount of plasma to
support the platelet count.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1208/1209-9.
CODE
Unit #17KX33294.
MANUFACTURER
American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter or fax dated April 17, 1998, and a second
by letter dated May 29, 1998. Firm-initiated recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected in a manner that could compromise
the sterility of the products.
________
PRODUCT
Red Blood Cells. Recall #B-1210-9.
CODE
Unit #17KJ72020.
MANUFACTURER
American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated May 14, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who was taking the drug
Methotrexate at the time of donation.
________
PRODUCT
Red Blood Cells. Recall #B-1211-9.
CODE
Unit Numbers: 17KL56716 and 17KH61058.
MANUFACTURER
American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by telephone on July 14, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota.
QUANTITY
2 units were distributed.
REASON
Blood products were not tested for CMV, were labeled CMV negative
and distributed.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1212/1213-9.
CODE
Unit #17GJ70231.
MANUFACTURER
American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated September 9, 1998, and by fax on
September 3, 1998. Firm-initiated recall complete.
DISTRIBUTION
Michigan and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products which 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. Recall #B-1214-9.
CODE
17KJ61161, 17KJ61164, and 17KJ61165.
MANUFACTURER
American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by telephone on June 1, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and Wisconsin.
QUANTITY
3 units were distributed.
REASON
Blood products were collected in a manner that could compromise
the sterility of the products.
________
PRODUCT
Red Blood Cells. Recall #B-1215-9.
CODE
Unit #21GM96984.
MANUFCTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated June 25, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area
considered endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-1216-9.
CODE
Unit #21KL06219.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated June 25, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Oregon.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area
considered endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-1217-9.
CODE
Unit numbers: 21370-6845 and 21370-6843.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October
9, 1998. Firm-initiated recall complete.
DISTRIBUTION
North Dakota.
QUANTITY
2 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
Red Blood Cells. Recall #B-1220-9.
CODE
Unit #21369-6719.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated August
21, 1998. Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area
considered endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-1221-9.
CODE
Units Numbers: 21370-9975-01, 21370-9975-02, 21371-4437-01,
21370-9941-01, 21370-9941-02, 21371-4366-02, 21371-4437-02.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January
26, 1999. Firm-initiated recall complete.
DISTRIBUITON
North Dakota.
QUANTITY
7 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
Platelets, Pheresis. Recall #B-1222-9.
CODE
Unit #21370-1211.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Manufacturer, by letter dated September 22, 1998. Firm-initiated
recall complete.
DISTRIBUTION
North Dakota.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1224/1225-9.
CODE
Unit #6552383.
MANUFACTURER
New York Blood Services (Center West), a Division of New York
Blood Center, Inc., (NYBC), New York, New York.
RECALLED BY
Manufacturer, by letter dated February 24, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-1226-9.
CODE
Unit #LS29253.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 2, 1999, and by letter dated
July 6, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c)
Platelets, Pooled. Recall #B-1227/1229-9.
CODE
Unit Numbers: a) LS20953; b) LS23641; c) FP92127.
MANUFCTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on June 5, 1998, and July 2, 1999, and
by letters dated July 6 and 7, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-1230-9.
CODE
Unit #LS23908.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on April 10, 1998, and by letter dated
August 11, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose hematocrit had not
been determined.
________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall #B-1231-9.
CODE
Unit numbers: FJ47423, KM17514, LH48638.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 2, 1999, and by letters on
July 6 and 8, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
3 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall #B-1232-9.
CODE
Unit #LW66431.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 8, 1999, and by letter on July
6 and 8, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-1233-9.
CODE
Unit #LS21551.
MANUFACTURER
The Blood Center of Southeastern Wisconsin.
RECALLED BY
Manufacturer, by telephone on August 10, 1999, and by letter
dated August 11, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF,
Pooled. Recall #B-1234/1235-9.
CODE
Unit Numbers: a) GP86336; b) FP78864.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 2 and 7, 1999, and by letter
dated July 6 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug
Cytotec (misoprostol).
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-1237-9.
CODE
Unit Numbers: LH46042, LH46244, LH46397
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 2, 1999, and by letter dated
July 6, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from a donor taking the drug
Piroxicam.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1238/1239-9.
CODE
Unit #42FY03478.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated July 20, 1999, or by telephone on
June 29, 1999. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug
Acyclovir.
________
PRODUCT
Corneas. Recall #B-1240-9.
CODE
Lot Numbers 006-99-351, 006-99-352.
MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, Tennessee.
RECALLED BY
Manufacturer, by telephone on June 21 and 27, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Tennessee and Florida.
QUANTITY
2 units were distributed.
REASON
Corneas were from a donor who tested repeatedly reactive for
HBsAg
________
PRODUCT
Red Blood Cells. Recall #B-1241-9.
CODE
Unit #11FF48063.
MANUFACTURER
American Red Cross, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on May 14, 1998, and by letter dated
May 18, 1998. Firm-initiated recall complete.
DISTRIBUTION
Georgia.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-1242-9.
CODE
Unit #11LS12517B.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on March 11, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Missouri.
QUANTITY
1 unit was distributed.
REASON
Blood product was not leukoreduced, was labeled as leukoreduced
and distributed.
________
PRODUCT
Red Blood Cells. Recall #B-1243-9.
CODE
Unit #11GS24405.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by letter dated December 4, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Missouri.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area
considered endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1244/1245-9.
CODE
Unit #01Q28075.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated November 23, 1998. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who traveled to an
area considered endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-1246-9.
CODE
Unit #01P40175.
MANUFACTUER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on January 16, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1247/1248-9.
CODE
Unit #FQ00476.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on February 23, 1999, or by letter
dated February 25, 1999. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected in a manner that could compromise
the sterility of the products.
________
PRODUCT
Platelets, Pheresis. Recall #B-1250-9.
CODE
Unit numbers: LH47856 and LH47866.
MANUFACTURER
The Blood Center of Southeastern Wisconsin.
RECALLED BY
Manufacturer, by telephone on December 16, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Illinois and Kentucky.
QUANTITY
2 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Platelets, Pheresis. Recall #B-1251-9.
CODE
Unit #LH47383-2.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on October 22, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1252/1253-9.
CODE
Unit #LW73582.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 2, 1999, or by letter dated
December 24, 1998. Firm-initiated recall complete.
DISTRIBUTION
Wisconsin and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported a blood
exposure within 12 months of donation.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1255/1256-9.
CODE
Unit #0639181.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter dated April 19, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose donor history
screening was incomplete.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF;
d) Plasma. Recall #B-1258/1261-9.
CODE
Unit #0628498
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter dated February 3, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose donor history
screening was incomplete.
_________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-1262/1264-9.
CODE
Unit #0541726.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letters dated February 12, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota 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.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1265/1266-9.
CODE
Unit numbers: a) 9899846; b) 9956517.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated June 26, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component was 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) Platelets. Recall #B-1267/1268-9.
CODE
Unit #9884566.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated October 12, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Platelets. Recall #B-1269-9.
CODE
Unit #9927324.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated August 10, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-1270-9.
CODE
Unit #9901181.
MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter dated October 5, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1271/1272-9.
CODE
Unit #01KK46334.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated February 8, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who was taking the
drug Valtrex.
________
PRODUCT
Red Blood Cells. Recall #B-1273-9.
CODE
Unit #11LV24886.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by telephone on October 8, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kansas.
QUANTITY
1 unit was distributed.
REASON
Blood products tested negative for the human T lymphotropic virus
types I and II (anti-HTLV-I/II), but were collected from a donor
who previously tested indeterminate for HTLV-I/II.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma; c) Source Leukocytes for
Manufacture. Recall #B-1276/1278-9.
CODE
Unit #0706297.
MANUFACTURER
Bergen Community Regional Blood Center, Paramus, New Jersey.
RECALLED BY
Manufacturer, by letter dated January 18, 1999, or by fax dated
January 7, 1999. Firm-initiated recall complete.
DISTRIBUTION
New Jersey and New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had a tattoo
within 12 months of donation.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1279/1280-9.
CODE
Unit #11FC48766.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by letter dated November 23, 1998. Firm-initiated
recall complete.
DISTRIBUTION
New York and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
Red Blood Cells. Recall #B-1282-9.
CODE
Unit #L59278.
MANUFACTURER
Healthcare Provider Services, Inc., doing business as Rhode
Island Blood Center, Providence, Rhode Island.
RECALLED BY
Manufacturer, by telephone on July 24, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Rhode Island.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported a history
of Babesiosis and Lyme Disease.
________
PRODUCT
Platelets, Pheresis. Recall #B-1283-9.
CODE
Unit Numbers: W88673, X11087, X11137, X11249, X11281, X11339,
X11340.
MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora,
Illinois.
RECALLED BY
Manufacturer, by letter dated July 30, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
7 units were distributed.
REASON
Blood products were collected from donors whose suitability was
not adequately determined.
________
PRODUCT
Platelets. Recall #B-1286-9.
CODE
Unit #49LH38956.
MANUFACTURER
American Red Cross Blood Services, Waco, Texas.
RECALLED BY
American Red Cross Blood Services, Tulsa, Oklahoma, by telephone
on June 14, 1999. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of clotted red blood cells.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1287/1288-9.
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. Firm-initiated recall complete.
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 were distributed.
REASON
Blood products were collected from donors whose donor history
screening was inadequately performed.
________
PRODUCT
a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma.
Recall #B-1294/1296-9.
CODE
Unit Numbers: a) Q85686; FP82338; c) Q85686.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on February 24, 1998 or August 10,
1999, and by letters dated April 20, 1998 or August 11, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Mississippi and Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug
Cytotec (misoprostol).
________
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 letter dated March 31, 1999, or by telephone on
March 22, 1999. Firm-initiated recall complete.
DISTRIBUTION
District of Columbia.
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
Immune Globulin Intravenous (Human) Venoglobulin-S 10%.
Recall #B-1153-9.
CODE
Lot Numbers 5 Gram Vials (11):
GR8041A GR8041AB GR9008A
GR8050A GR8050AB GR9014A
GR8066A GR8067A GR9019A
GR9026A GR9027A
10 GRAM Vials (43):
GR8042A GR8056A GR9002A
GR8042AB GR8057A GR9003A
GR8043A GR8057AB GR9009A
GR8045A GR8061A GR9010A
GR8046A GR8061AB GR9011A
GR8047A GR8063A GR9013A
GR8048A GR8064A GR9015A
GR8049A GR8065A GR9018A
GR8052A GR8069A GR9020A
GR8052AB GR8070A GR9021A
GR8053A GR8073A GR9022A
GR8053AB GR8083A GR9024A
GR8053AC GR8084A GR9034A
GRGR8055A GR9001A GR9035A
GR8055AB
20 GRAM VIALS (23):
GR8044A GR8062AB GR9007A
GR8044AB GR8062AC GR9012A
GR8051A GR8068A GR9016A
GR8051AB GR8071A GR9023A
GR8054A GR8072A GR9025A
GR8054AB GR9004A GR9029A
GR8054AC GR9005A GR9036A
GR8062A GR9006A.
MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, California.
RECALLED BY
Manufacturer, by fax dated July 1, 1999, followed by letter on
July 2, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Guam.
QUANTITY
128,127 vials were distributed; firm estimated that 32,032 vials
remained on market at time of recall initiation.
REASON
Blood products were labeled with expiration dates that exceeds
product stability.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1206/1207-9.
CODE
Unit #22LY51913.
MANUFACTURER
American Red Cross Blood Services, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by letters dated February 16, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Pennsylvania, New Jersey.
QUANTITY
1 unit of each component was distributed.
REASON
Blood product was collected from a donor whose arm inspection
prior to phlebotomy was not documented.
________
PRODUCT
Red Blood Cells. Recall #B-1218-9.
CODE
Unit Numbers: 21372-1733, 21372-1818, 21372-2047, 21372-2049,
21372-2213, 21372-3440.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March
3, 1999. Firm-initiated recall complete.
DISTRIBUTION
North Dakota.
QUANTITY
6 units were distributed.
REASON
Blood products remained at room temperature for an unacceptable
length of time during shipment.
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-1219-9.
CODE
Unit #21368-0149.
MANUFACTURER
United Blood Services, Fargo, North Dakota.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October
13, 1998. Firm-initiated recall complete.
DISTRIBUTION
North Dakota.
QUANTITY
1 unit of each component was distributed.
REASON
Blood product failed the requirement for red blood cell recovery.
________
PRODUCT
Red Blood Cells. Recall #B-1223-9.
CODE
Unit #Q97861.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by letter dated July 6, 1999, and by telephone on
July 7, 1999. Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood products were distributed in interstate
commerce.
________
PRODUCT
Recovered Plasma. Recall #B-1236-9.
CODE
Unit #GP86336.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by letter dated December 17, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the drug Cytotec
(misoprostol).
________
PRODUCT
Platelets, Pheresis. Recall #B-1249-9.
CODE
Unit #LH47902-1.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on December 23, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable white blood count was
distributed labeled as leukoreduced.
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-1254-9.
CODE
Unit #KZ34632.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee,
Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 6, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood product.
________
PRODUCT
Recovered Plasma. Recall #B-1274-9.
CODE
Unit #11LV24886.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by fax on October 12, 1998. Firm-initiated recall
complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood products tested negative for the human T lymphotropic virus
types I and II (anti-HTLV-I/II), but were collected from a donor
who previously tested indeterminate for HTLV-I/II.
________
PRODUCT
Platelets. Recall #B-1281-9.
CODE
Unit #22KJ34493.
MANUFACTURER
American Red Cross Blood Services, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on May 19, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
Blood product with a positive antibody screen, was distributed,
labeled as negative for unexpected antibodies.
________
PRODUCT
Red Blood Cells. Recall #B-1284-9.
CODE
Unit #X31125.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by telephone on June 14, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with extended expiration date.
________
PRODUCT
Red Blood Cells, Washed. Recall #B-1285.
CODE
Unit #22395-2131.
MANUFACTURER
United Blood Services, Las Vegas, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
September 2, 1997. Firm-initiated recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration time.
________
PRODUCT
Recovered Plasma. Recall #B-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. Firm-initiated recall complete.
DISTRIBUTION
California, Florida, New York, Texas, Alabama, Arkansas,
Massachusetts, Mississippi, New Jersey, North Carolina, North
Dakota, South Carolina, South Dakota, Texas, and Switzerland.
QUANTITY
392 units were distributed.
REASON
Blood products were collected from donors whose donor history
screening was inadequately performed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________
PRODUCT
CryoValve Allograft Heart Valve. Recall #Z-004-0.
CODE
Model PV05, Serial #3985652,
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter sent on September 13, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit.
REASON
The firmís Quality Assurance has identified Donor 23718, received
prior to 1/26/98, who does not meet the current guidelines
regarding serodilution of plasma because of the amount of
transfused/infused fluids administered.
________
PRODUCT
CryoValve Allograft Heart Valve: a) Model AVOO; b) Model PVOO
Recall #Z-005/006-0.
CODE
Serial Numbers: a) 3924564; b) 3924556.
MANUFACTURER
CryoLife, Inc., Kennesaw, Georgia.
RECALLED BY
Manufacturer, by telephone on August 12, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Maine and Utah.
QUANTITY
2 valves.
REASON
Additional donor information on donor number 20995, not available
at the time of release of the allografts, revealed that the
donorís mother had tested positive for Hepatitis B Surface
Antigen.
________
PRODUCT
Precision Current Source Device, used in the dental field to
stimulate bone growth and to act as an antibacteria agent.
Recall #Z-009-0.
CODE
Serial Numbers: 101, 103 through 109.
MANUFACTURER
T.H. Charters, Inc., Beaverton, Oregon.
RECALLED BY
Manufacturer, by letter dated September 14, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Texas.
QUANTITY
8 units were distributed.
REASON
Product was distributed without a 510(k) or PMA.
________
PRODUCT
Oxygen Concentrators: Models AS005-xx and AS006-xx
NOTE: "xx" = any 2-digit number. Recall #Z-010/011-0.
CODE
Serial Numbers: 060000 thru 178885 for 120 v, 60 Hz units
Serial Numbers: 900000 thru 916792 for 220 v, 50/60 Hz units.
MANUFACTURER
Airsep Corporation, Buffalo, New York.
RECALLED BY
Manufacturer, by letter dated September 27, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
135,470 units were distributed.
REASON
The plastic capacitor may overheat, posing a fire hazard in the
unit.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
ARCHITECT LH Reagent Kit; a chemiluminescent microparticle
immunoassay for quantitative determination of human leutenizing
hormone in human serum and plasma for the prediction of
ovulation, in the evaluation of infertility, and diagnosis of
pituitary and gonadal disorders. Recall #Z-026-0.
CODE
List 6C25-20 (400 test kits) and 6C25-25 (100 test kits);
Lots 47384M200, 47384M202, 47384M210, 47384M212, 47384M201,
47384M203
MANUFACTURER
Abbott Diagnostics, Division of Abbott Laboratories, Abbott Park,
Illinois.
RECALLED BY
Manufacturer, by telephone on September 8, 1999, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
274 100-test kits and 503 400-test kits were distributed.
REASON
Results generated with these lots may exhibit an over recovery.
END OF ENFORCEMENT REPORT FOR OCTOBER 13, 1999.
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