January 10, 2001 01-02
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Sharp Cheddar Cheese (Black Wax Daisy Wedges) in 16-oz. wedges with black
wax coating wrapped in plastic wrap; the stick-on gold foil paper label
does not have a brand name, just identifies it as Real Wisconsin Cheese,
with an American Flag and USA. The firm cut the wheels of cheese into
wedges which are wrapped and labeled, and then are reassembled into a
wheel/daisy and shipped in cartons that contain 24-1 lb. wedges or 12-1
lb. wedges.
Recall #F-158-1.
CODE
2/28/2001, 3/1/2001, 3/10/2001, 3/11/2001, 3/18/2001, 3/26/2001,
3/27/2001, 3/29/2001, 4/18/2001
MANUFACTURER OF BULK CHEESE
Hill & Valley Cheese, Inc., Cashton, WI
RECALLED BY
The Deli Source, Inc., Antioch, Illinois by telephone and fax November 8,
2000, and by press release November 16, 2000. Firm-initiated recall
ongoing.
DISTRIBUTION
Tennessee, North Carolina, Florida, Virginia, Maryland, Illinois, and
California.
QUANTITY
17,712.34-pounds of cheese were distributed.
REASON
The Sharp Cheddar Cheese was manufactured using bulk cheese that Hill &
Valley Cheese, Inc., Cashton, Wisconsin recalled due to potential
Listeria monocytogenes contamination.
________
PRODUCT
Bench Cured Hoop Cheddar Cheese, red waxed wedges of yellow cheddar
cheese packaged in random sizes ranging in weight from approximately 10-
ounce to 24-ounce wedges.
Recall #F-159-1.
CODE
Sell by dates of August 12, 2000, through February 8, 2001.
MANUFACTURER OF BULK CHEESE
Hill & Valley Cheese, Inc., Cashton, Wisconsin.
RECALLED BY
Swiss-American, Inc., St. Louis, Missouri, by phone on November 1, 2000,
followed by fax on November 3, 2000 and press release on November 9,
2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
33,963.70-lbs. Of random-weight wedges were distributed.
REASON
The Bench Cured Hoop Cheddar Cheese was manufactured using
bulk cheese that Hill & Valley Cheese, Inc., Cashton, Wisconsin recalled
due to potential Listeria monocytogenes contamination.
________
PRODUCT
Cheese sticks labeled as follows:
a) Schneider Snack Cheese Marble Cheese, net weight 1-ounce sticks;
b) Crystal Farms Natural Marble Jack Cheese Sticks (UPC 075925-30168)
single-serve, 1 ounce net weight, labeled as distributed by Crystal
Farms, Minneapolis, Minnesota;
c) Crystal Farms Cheezoids Marble Jack Stick Cheese (UPC 075925-30166),
10-ounce net weight bag of individually wrapped sticks, labeled as
distributed by Crystal Farms, Minneapolis, Minnesota.
Recall #F-160-1.
CODE
a) Schneider Snack Cheese Marble Cheese, Net Weight 1 ounce, use by date
2-21-01;
b) One-ounce, single-serve Crystal Farms Marble-Jack Cheese Sticks, UPC
Code 075925-30168.
DEC 24 00
DEC 25 00
DEC 28 00
DEC 30 00
JAN 7 01
JAN 9 01
MAR 3 01
MAR 11 01
MAR 12 01
c) 10-ounce bags of individually wrapped Crystal Farms Cheezoid Marble-
Jack Cheese Sticks, UPC Code 075925-30166
DEC 28 00
JAN 5 01
MAR 3 01
MAR 12 01
MAR 13 01
MAR 15 01
MAR 20 01
MAR 21 01
MANUFACTURER OF BULK CHEESE
Hill and Valley Cheese, Incorporated, Cashton, Wisconsin.
RECALLED BY
Schneider Cheese, Inc., Waldo, WI (cutter/repacker) by telephone and
letter on November 2, 2000, and by press release November 3, 2000. Firm-
initiated recall ongoing.
DISTRIBUTION
Minnesota and states east of the Rocky Mountains.
QUANTITY
74,302 pounds were distributed.
REASON
The Marble Jack Cheese Sticks were manufactured using bulk cheese that
Hill & Valley Cheese, Inc., Cashton, Wisconsin recalled due to potential
Listeria monocytogenes contamination.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
Reames brand Free Home Style Noodles, Fat Free, Cholesterol Free,
packaged in 12-ounce (340 gms), plastic bags. Recall #F-162-1.
CODE
Lot number 137DO.
MANUFACTURER
Reames Foods, Incorporated, Clive, Iowa.
RECALLED BY
T. Marzetti Company, Columbus, Ohio, by fax on August 29, 2000. Firm-
initiated recall completed.
DISTRIBUTION
Nebraska, Texas, New Mexico, Colorado and Arizona.
QUANTITY
300 case (12 bags per case) were distributed.
REASON
The product is unfit for food because it was stored in a warehouse at
ambient temperature instead of being frozen as specified on the package.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Premarin Conjugated
a) Premarin (r) tablets (conjugated estrogens tablets),0.625 mg, 100 &
1,000 count bottles;
b) Premarin (r) tablets (conjugated estrogens tablets), 1.25mg, 100 &
1,000 count bottles;
c) Premarin (r) tablets (conjugated estrogens tablets, 2.5mg, 100 count
bottles. D-074/076-1.
CODE
STRENGTH: 0.625 mg/100 count bottles/NDC #0046-0867-81:
a) Lot #9990086 Exp. 9/02,
Lot #9990086 Exp. 12/03,
Lot #999029U Exp. 11/03,
Lot #9990585W Exp. 11/03,
STRENGTH: 0.625 mg/1,000 count bottles/NDC #0046-0867-91:
Lot #9990086 Exp. 9/02,
Lot #9980299 Exp. 11/02;
STRENGTH 1.25 mg/100 count bottles/NDC #0046-0866-81:
b) Lot #9980874 Exp. 2/03;
STRENGTH: 1.25 mg/1,000 count bottles/NDC #0046-0866-91:
Lot #9980874 Exp. 2/03;
STRENGTH: 2.5 mg/100 count bottles/NDC #0046-0865-81:
c) Lot #9990175 Exp. 10/03.
MANUFACTURER
Wyeth-Pharmaceuticals Co., Gauyama, Puerto Rico.
RECALLED BY
National Pharmpak Svcs, Incorporated, Zanesville, Ohio, by letter faxed
on October 18, 2000 and December 8, 2000. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and New Mexico, Puerto Rico.
QUANTITY
108,394 bottles were distributed.
REASON
Manufacturer failed to meet USP dissolution specifications for Conjugated
Estrogen.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-236-1.
CODE
Unit numbers: 41GJ8375, 41GJ58382, 41GJ58388, 41GJ58392, 41GJ58396,
41FN49291, 41FN49297, 41FN49305, 41FN49308, 41FN49310, 41FL82454,
41FL82455, 41FL82456, 41FL82457, 41FL82459, 41FL82460, 41FL82461,
41FL82462, 41FL82463, 41FL82464, 41FL82465, 41FN49290, 41LW72975,
41GM34938, 41GM34931, 41FT38934, 41FT38935, 41FT38936, 41LW72976,
41GM34938, 41GM34931, 41FT38934, 41FT38935, 41FT38936, 41FT38937,
41FT38939, 41FT38940, 41FT38941, 41FT38944, 41FT38945, 41FT38946,
41FT38949, 41FT38950, 41FT38953, 41FT38955, 41FT38957, 41FT38958,
41FT38959, 41FT38960, 41FT38961, 41FT38962, 41FT38963, 41FT38964,
41FT38966, 41FT38967, 41FT38968, 41LP18257, 41LP18263, 41GJ58343,
41GJ58344, 41GJ58346, 41GJ58347, 41GJ58348, 41GJ58350, 41GJ58351,
41GJ58352, 41GJ58353, 41GJ58354, 41GJ58355, 41GJ58356, 41GJ58357,
41GJ58358, 41GJ58361, 41GJ58364, 41GJ58366, 41GJ58368, 41GJ58369,
41GJ58370.
MANUFACTURER
The American National Red Cross, Birmingham, Alabama.
RECALLED BY
Manufacturer, by telephone on August 3, 4 and 9, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
73 units were distributed.
REASON
Blood products were inappropriately collected in 450 ml collection sets,
and labeled as having been collected in a 500 ml collection set.
________
PRODUCT
Red Blood Cells. Recall #B-312-1.
CODE
Unit #LX02769.
MANUFACTURER
Inova Health Care Services, Annandale, Virginia.
RECALLED BY
Manufacturer, by letter dated November 23, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Maryland.
QUANTITY
1 unit was distributed.
REASON
tested reactive for syphilis.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Red Blood
Cells, Leukocytes Reduced, Irradiated; d) Platelets; e) Platelets,
Irradiated; f) Platelets, Leukocytes Reduced; g) Platelets, Pheresis; h)
Platelets, Pheresis, Leukocytes Reduced; i) Platelets, Pheresis,
Leukocytes Reduced; j) Cryoprecipitated AHF; k) Cryoprecipitated AHF,
Pooled; l) Fresh Frozen Plasma; m) Plasma Frozen within 24 Hours After
Phlebotomy; n) Plasma, Cryoreduced.
Recall #B-333/340-1.
CODE
Unit numbers:
a) 17KJ85315, 17FS08201, 17FK08202, 17FZ21613, 17KK75471, 17KX54954,
17KX55109, 17KJ85622, 17KL75806, 17FZ21894, 17KK75641, 17KK75673,
17KK75711, 17KK75718, 17KJ85803, 17KW02680, 17KW02202, 17KH81929,
17KW02734, 17KC06828, 17KR67044, 17KR66942, 17FZ22140, 17KC06960,
17KC07041, 17KC07088, 17FZ22319, 17KC07511, 17KP78032, 17KP78039,
17KK76372, 17KK76379, 17KK76394, 17KP78069, 17KC07609, 17GT77989;
b) 17KJ85823, 17FZ22094, 17FW24867, 17FW24927, 17KK76254, 17KK76327,
17KQ37338, 17KK76313, 17KK76407, 17FZ22470, 17FZ22477, 17FZ22478,
17KK76501;
c) 17FZ22308;
d) 17FZ21621, 17KK75471, 17KH81519, 17FZ21785, 17KR66886, 17FZ21894,
17KK75711, 17KJ86098, 17FZ22125, 17FZ22133, 17FZ22140, 17FZ22148,
17FZ22155, 17FZ22162, 17FZ22203, 17FZ22268, 17FZ22276, 17FZ22290,
17FZ22319, 17FZ22334, 17FZ22381, 17FZ22396, 17FZ22403, 17FZ22410,
17FZ22417, 17KP78032, 17KP78039, 17KF90805, 17KP78069, 17KF90823,
17FZ22449, 17FZ22463, 17KC07595, 17KC07602, 17KC07609, 17KP78132,
17KP78163, 17KW03655, 17KW03669, 17FZ22465, 17FZ22468, 17FZ22484;
e) 17FZ21576;
f) 17KQ36795, 17KQ37338;
g) 17FX26371, 17FX26375, 17FX26377, 17FX26382 17FX25838;
h) 17FQ00301, 17FX25847, 17FX25862, 17FX25868, 17FX25869, 17FX25871,
17FX25886, 17FQ00303, 17FQ00306, 17FX25907, 17FX25955, 17FX26158,
17FX26294, 17FX26361, 17FX26368, 17FX26371, 17FX26378, 17FX26387,
17FQ00298, 17FX25837, 17FX25841;
i) (Split units designated by product numbers 12710 and 12750) Units
17FX25870, 17FX25872, 17FX25961, 17FX26021, 17FX26051, 17FX26124,
17FX26134, 17FX26254, 17FX26320, 17FX26343, 17FX26369, 17FX26378,
17FX25834, 17FX25835, 17FX25839;
j) 17KF85315, 17KJ85629, 17KJ85803, 17KJ85823, 17KN61210, 17FZ22396,
17FZ22403;
k)2504, 2458, 2518, 2605, 2564, 2667, 2669, 2630, 2633, 2666;
l) 17FZ21718, 17KH81519, 17FZ21785, 17KJ86091, 17KK76300, 17FZ22469;
m) 17FZ22319;
n) 17KC07088.
MANUFACTURER
American National Red Cross, National Testing Laboratory, Eagan,
Minnesota.
RECALLED BY
American Red Cross, St. Paul Minnesota, by letters dated October 14 and
21, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Georgia, Indiana, Massachusetts, Michigan, Minnesota, and
Wisconsin.
QUANTITY
a) 36 units; b) 13 units; c) 1 unit; d) 42 units; e) 1 unit; f) 2 units;
g) 5 units; h) 21 units; i) 17 units; j) 7 units; k) 10 units; l) 6
units; m) 1 unit; n) 1 unit.
REASON
Blood products were not tested for syphilis in accordance with the
manufacturers instructions.
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-352-1.
CODE
Unit numbers: 16LS69511, 16LV58367, 16LV58376, 16LY86523.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by letter dated October 10, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Ohio.
QUANTITY
4 units were distributed.
REASON
Blood products were not tested for CMV antibody in accordance with the
manufacturers instructions were distributed with labels stating that they
tested negative for CMV.
________
PRODUCT
Various tissue for transplants. Recall #B-372-1.
a) Lateral Meniscus, Bone, Left;
b) Hemi-Patellar Tendon;
c) Saphenous Vein;
d) Pulmonary Hemi-Artery;
e) Ascending Thoracia Aorta.
CODE
Serial numbers: a) 4094417; b) 4094433, 4094441, 4094468, 4094476; c)
6081169, 6081126, 6081177; d) 6081053; e) 6081088.
MANUFACTURER
CryoLife, Incorporated, Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter dated October 17, 2000, and by telephone on
October 23, 2000 or December 4, 2000. Firm-initiated recall complete.
DISTRIBUTION
Arkansas, California, Florida, Illinois, Maryland, South Carolina and
Tennessee.
QUANTITY
a) 1 unit; b) 4 units; c) 3 units; d) 1 unit; e) 1 unit were distributed.
REASON
Various tissue for transplant were collected from donors who had not been
properly evaluated.
________
PRODUCT
Saphenous Vein. Recall #B-373-1.
CODE
Serial numbers: 3832791, 3832805, 3832813.
MANUFACTURER
CryoLife, Incorporated, Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter dated July 21, 2000. Firm-initiated recall
ongoing.
DISTRIBUTION
Maryland.
QUANTITY
3 units were distributed.
REASON
Various tissue for transplant were collected from a donor who had not
been properly evaluated.
________
PRODUCT
Various tissues for transplant. Recall #B-374-1.
a) Saphenous Vein; b) Medial Meniscus, Bone, Right; c) Achilles Tendon.
CODE
Serial numbers: a) 3741141, 3741168; b) 4052552; c) 4052579, 4052587.
MANUFACTURER
CryoLife, Incorporated, Kennesaw, Georgia.
RECALLED BY
Manufacturer, by letter dated October 20, 2000. Firm-initiated recall
completed.
DISTRIBUTION
Connecticut, Georgia, Massachusetts, Michigan and Canada.
QUANTITY
a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON
Various tissue for transplant were collected from a donor who had not
been properly evaluated.
________
PRODUCT
Platelets, Pheresis. Recall #B-384-1.
CODE
Unit #K14809 (Split unit A and B), K14135.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by telephone on September 24 and 29, 1999, and by letter
dated October 29, 1999. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
3 units were distributed.
REASON
Blood products had high platelet counts.
________
PRODUCT
Platelets, Pheresis. Recall #B-385-1.
CODE
Unit #K13427.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by telephone on July 6, 1999, and by letter dated July 27,
1999. Firm-initiated recall complete.
DISTRIBUTION
Iowa.
QUANTITY
1 unit was distributed.
REASON
Blood product had a high platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-415-1.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of
Compliance (301) 827-6202 for individual unit numbers recalled.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland
RECALLED BY
Manufacturer, by fax on July 21, 2000. Firm-initiated recall complete.
DISTRIBUTION
Maryland, Virginia and District of Columbia.
QUANTITY
137 units were distributed.
________
PRODUCT
Red Blood Cells. Recall #B-417-1.
CODE
Unit #09FT23197.
MANUFACTURER
American Red Cross Blood Services, North Platte, Nebraska.
RECALLED BY
American Red Cross Blood Services, Omaha, Nebraska, by letter dated
December 2, 1999. Firm-initiated recall completed.
DISTRIBUTION
Colorado.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to areas designated
endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-418-1.
CODE
Unit #09FP25266.
MANUFACTURER
American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY
Manufacturer, by letter dated November 18, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Colorado.
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
Red Blood Cells. Recall #B-420-1.
CODE
Unit #W77463.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by letter dated April 27, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had traveled to an area
designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-421-1.
CODE
Unit #V83951.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by letter dated January 18, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Virginia.
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-422-1.
CODE
Unit numbers: 03KR06552, 03KR06480.
MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter dated August 25, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Georgia.
QUANTITY
2 units were 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-423/424-1.
CODE
Unit #Y15504.
MANUFACTURER
Aurora Area Blood Bank, Auroa, Illinois.
RECALLED BY
Manufacturer, by telephone on August 28, 2000, and by letters dated
August 28 and 31, 2000. Firm-initiated recall completed.
DISTRIBUTION
Illinois and Louisiana.
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-425-1.
CODE
Unit #04FF16462.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated July 11, 2000. Firm-initiated recall
complete.
DISTRIBUTION
New York.
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
Red Blood Cells. Recall #B-426-1.
CODE
Unit #0614605.
COLLECTION SITE
Blood Centers of the Pacific, Burlinghame, California.
RECALLED BY
Blood Centers of the Pacific, Irwin Center, San Francisco, California, by
letter dated December 21, 1999. Firm-initiated recall complete.
DISTRIBUTION
California.
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
Red Blood Cells. Recall #B-427-1.
CODE
Unit #42FJ85383.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated June 1, 2000. 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
Red Blood Cells. Recall #B-428-1.
CODE
Unit #15007-1679.
MANUFACTURER
United Blood Services, Texas Blood, Lubbock, Texas.
RECALLED BY
Blood Systems, Incorporated, Scottsdale, Arizona, by letter
dated February 1, 2000. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had traveled to an area
designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-433/434-1.
CODE
Unit numbers: a) Y32717, Y12785, X88587, X71539, X22442, W92489, W64461,
W30834; b) W92489.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by letter dated August 18, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Illinois and Indiana.
QUANTITY
a) 8 units; b) 1 unit were distributed.
REASON
Blood products were collected from a donor who had lived in an area
designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-440-1.
CODE
Unit numbers: 18FE67714, 18FK39085, 18FZ02788, and 18FE67761.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY
Manufacturer, by letter dated April 4, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Michigan and Arizona.
QUANTITY
4 units were distributed.
REASON
The blood products failed hematocrit quality control testing.
________
PRODUCT
Platelets, Pheresis. Recall #B-441-1.
CODE
Unit #27P46997.
MANUFACTURER
The American National Red Cross, Johnstown, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on February 8, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
The Platelets Pheresis had an elevated platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-442-1.
CODE
Unit #27P41967.
MANUFACTURER
The American National Red Cross, Johnstown, Pennsylvania.
RECALLED BY
Manufacturer, by letter on March 30, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
The Platelets Pheresis had an elevated platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-443-1.
CODE
27P41990 (split unit).
MANUFACTURER
The American National Red Cross, Johnstown Pennsylvania.
RECALLED BY
Manufacturer, by letter on March 30, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
The Platelets Pheresis had an elevated platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-444-1.
CODE
27GE10486.
MANUFACTURER
The American National Red Cross, Johnstown Pennsylvania.
RECALLED BY
Manufacturer, by telephone on June 1, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
The Platelets Pheresis had an elevated platelet count based on the volume
of product collected.
________
PRODUCT
Platelets, Pheresis. Recall #B-445-1.
CODE
27P47942.
MANUFACTURER
The American National Red Cross, Johnstown Pennsylvania.
RECALLED BY
Manufacturer, by letter dated May 23, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
The Platelets Pheresis had an elevated platelet count based on the volume
of product collected.
________
PRODUCT
Platelets, Pheresis. Recall #B-446-1.
CODE
Unit numbers: 36FP10270 and 36FP10298.
MANUFACTURER
The American National Red Cross, Columbia, South Carolina.
RECALLED BY
Manufacturer, by telephone on October 11, 1999 and by letter on October
25, 1999. Firm-initiated recall complete.
DISTRIBUTION
Puerto Rico and South Carolina.
QUANTITY
2 units were distributed.
REASON
Platelets Pheresis had an elevated platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-447-1.
CODE
Unit #2310266 (split unit).
MANUFACTURER
LifeShare, Inc., Elyria, Ohio.
RECALLED BY
Manufacturer, by letter dated August 24, 2000. Firm-initiated recall
complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Platelets Pheresis with a decreased platelet count were distributed.
________
PRODUCT
Red Blood Cells. Recall #B-453-1.
CODE
Unit #36C53197.
MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY
Manufacturer, by telephone on May 5, 1999 and by letter dated May 19,
1999. Firm-initiated recall complete.
DISTRIBUTION
South Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported having tender lymph
nodes under the arm.
________
PRODUCT
Platelets. Recall #B-454-1.
CODE
Unit #18P42435.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY
Manufacturer, by telephone on April 12, 2000 and by letter dated April
17, 2000. Firm-initiated recall complete.
DISTRIBUTION
Michigan.
QUANTITY
1 unit was distributed.
REASON
The blood product contained a small fibrin clot in the container.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
________
PRODUCT
Tisseal VH Kit, Fibrin Sealant. Recall #B-313-1.
CODE
Lot #K05499J.
MANUFACTURER
Baxter Healthcare Corporation, Vienna, Australia.
RECALLED BY
Baxter Healthcare Corporation, Glendale, California, by fax on August 8,
2000, and by letter on August 9, 2000. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
1,707 kits were distributed.
REASON
The product was subjected to shipping temperatures that were below the
freezing point of one of the kit components.
________
PRODUCT
Platelets, Pheresis. Recall #B-412-1.
CODE
Unit #2330189.
MANUFACTURER
LifeShare, Incorporated, Elyria, Ohio.
RECALLED BY
Manufacturer, by letter dated August 8, 2000. Firm-initiated recall
complete.
DISTRIBUTION
New Jersey.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood product was distributed in interstate commerce.
________
PRODUCT
Fresh Frozen Plasma. Recall #B-413-1.
CODE
Unit #26FF28541.
MANUFACTURER
The American National Red Cross, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on May 27, 1999, and by letter dated June 7,
1999.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood product was distributed in intrastate commerce.
________
PRODUCT
Platelets, Pheresis, Leukoreduced. Recall #B-411-1.
CODE
Unit #09FP18569.
MANUFACTURER
American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY
Manufacturer, by telephone on November 14, 1997. Firm-initiated recall
complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood product was distributed in interstate commerce.
________
PRODUCT
Platelets, Pheresis, Leukoreduced. Recall #B-430-1.
CODE
Unit #LS62039.
MANUFACTURER
Mid-South Regional Blood Center, Memphis, Tennessee.
RECALLED BY
Manufacturer, by telephone on December 29, 1997, and by Y32717, Y12785,
X88587, X71539, X22442, W92489, W64461, W30834 letter dated February 27,
1998. Firm-initiated recall complete.
DISTRIBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving information concerning
a post donation illness.
________
PRODUCT
Platelets, Pheresis. Recall #B-448-1.
CODE
Unit #27P47477.
MANUFACTURER
The American National Red Cross, Johnstown, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on March 20, 1999, requesting return of the
unit. Firm-initiated recall complete.
DISTRIBUTION
Maryland.
QUANTITY
1 unit was distributed.
REASON
Platelets Pheresis were not properly agitated during storage.
________
PRODUCT
Red Blood Cells. Recall #B-449-1.
CODE
Unit numbers: 18GH58030 and 18GH58074.
MANUFACTURER
American Red Cross, Lansing, Michigan.
RECALLED BY
Manufacturer, by telephone on May 22, 2000 and by letter dated May 23,
2000. Firm-initiated recall complete.
DISTRIBUTION
Michigan.
QUANTITY
2 units were distributed.
REASON
Blood products exceeded acceptable storage temperatures.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
________
PRODUCT
Cryovalve Allograft, human heart valve replacement implant. Recall #Z-
143-1.
CODE
Model number PV00, S/N 6790417.
MANUFACTURER
Cryolife, Kennesaw, Georgia.
RECALLED BY
Manufacturer, by telephone on July 11, 2000.Firm-initiated recall
ongoing.
DISTRIBUTION
Missouri.
QUANTITY
1 unit was distributed.
REASON
The donor possessed adenocarcinoma of the prostate.
________
PRODUCT
Dual Stage Venous Cannula, Model No. TF36460.
Recall #Z-144-1.
CODE
Lot number 58107837.
MANUFACTURER
Baxter Research Medical, Inc., Midvale, Utah.
RECALLED BY
Baxter Edwards, Irvine, California, by letter on October 25, 2000. Firm-
initiated recall complete.
DISTRIBUTION
Alabama, California, Florida, and Indiana.
QUANTITY
231 pouches.
REASON
Sterility of the device has been compromised by loss of pouch integrity.
An incomplete seal on the pouch was caused by lack of vents in the
plastic liner, which are needed to properly vent the pouch during EtO
sterilization.
=====SAFETY ALERTS - DEVICES==============================
________
PRODUCT
Gynecare Versapoint Bipolar Electrosurgery Electrodes
and Connector Cables:
a) Resectoscope Electrode (Product Codes 1930, 1939, 1948, 1950, 1980,
1985);
b) Electrode--Spriong Tip, 5 FR (Product Codes 0471, 0472);
c) Electrode--Twizzle Tip, 5 FR (Product Codes 0470, 0467);
d) Electrode--Ball Tip, 5 FR (Product Codes 0466, 0469).
e) RN-001/004-1.
CODE
All lot numbers.
MANUFACTURER
Ethicon, Inc., Somerville, New Jersey.
RECALLED BY
Manufacturer, by letter, dated September 22, 2000. Voluntary safety
alert.
DISTRIBUTION
Nationwide.
QUANTITY
2400 electrodes and 400 hand pieces were distributed.
REASON
The device may cause gas embolism events during hysteroscopic surgery.
END OF ENFORCEMENT REPORT FOR JANUARY 10, 2001.
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