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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
May 21, 2008
08-21
___________________________________
PRODUCT
Chocolate Covered Espresso Beans in clear plastic bag labeled Chocolate Covered Select Blend Espresso Beans, Net Wt. 8 oz, Recall # F-343-8
CODE
Product is coded with "Best if used by" dates located in the lower right hand corner of the nutrition label on the back of the bag. All products with Best if used by dates after 8/28/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bear Creek Operations, Inc. DBA Harry and David's, Medford, OR, by press release and e-mail on April 4, 2008.
Manufacturer: Sanders Candy Factory Inc., Baldwin, CA. Firm initiated recall is ongoing.
REASON
Undeclared milk in Chocolate covered Espresso Beans.
VOLUME OF PRODUCT IN COMMERCE
66,500 bags
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
a) Nick and Katie Ruffino's Stuffed Italian Artichoke, net wt 16oz, Recall # F-344-8;
b) Nick and Katie Ruffino's Stuffed Crab, net wt. 8 oz, Recall # F-345-8;
c) Nick & Katie Ruffino's Crab Stuffed Mushrooms, net wt. 10oz., Recall # F-346-8;
d) Nick & Katie Ruffino's Crayfish Stuffed Portabella Mushroom, net wt. 10oz,
Recall # F-347-8;
e) Nick & Katie Ruffino's, Stuffed Bell Pepper, 10oz, Recall # F-348-8
CODE
The product is not coded
RECALLING FIRM/MANUFACTURER
Nick & Katie's, Inc., New Orleans, LA, by telephone on February 8, 2008. Firm initiated recall is complete.
REASON
The products contain undeclared soy flour. Additionally the products' labels list ingredients derived from milk and wheat without listing milk and wheat as the source of these ingredients.
VOLUME OF PRODUCT IN COMMERCE
265 dozen units
DISTRIBUTION
LA
___________________________________
PRODUCT
Del Valle Clam Club Tomato and Natural Clam Cocktail beverage, 8.4 oz. glass bottles; UPC #32239 05702; Product of Mexico, Recall # F-349-8
CODE
Best if used by dates prior to 20 APR 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: JUGOS DEL VALLE USA, INC., Houston, TX, by telephone on April 23, 2008 and by press release on April 24, 2008.
Manufacturer: JUGOS DEL VALLE, S.A.B. DE C.V., CALERA DE VICTOR ROSALES, Mexico. Firm initiated recall is ongoing.
REASON
Product labeled as containing clam also contains wheat, fish, milk, shrimp and crab, which are not included in the label.
VOLUME OF PRODUCT IN COMMERCE
197,973 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Bridgford Southern Style Buttermilk Biscuits, Frozen, 100/2.25oz. Biscuits;
net wt. 14 lb. 8 oz. Product #6186; UPC #47500 00471, Recall # F-341-8;
b) Bridgford Old South Round Pre-Proofed Bake-Off Buttermilk Biscuits, 100/2.85oz.
(3 1/4") biscuits and 100/2.25oz. (3") biscuits, Net Wt. 17.5 lbs.; Product #6191
(3 1/4"), UPC #47500 00533 and Product #6193 (3"), Net Wt. 15.38 lbs.,
UPC #47500 00534, Recall # F-342-8
CODE
All date codes which do not bear the statement "contains soy".
RECALLING FIRM/MANUFACTURER
Bridgford Foods, Inc., Dallas, TX, by letter or e-mail on February 27, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
2765 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Birdgford Honey Wheat Ranch Style Rolls, Frozen Ready Dough Tray Pack; 240/1.5
oz. rolls per case, 22.5lbs.; Product #6152; UPC #47500 00260, Recall # F-350-8;
b) Birdgford Bavarian Dark Ranch Style Rolls, Frozen Ready Dough Tray Pack; 240/1.5
oz. rolls per case, 22.5lbs.; Product #6156; UPC #47500 00319, Recall # F-351-8;
c) Birdgford Heat and Serve Honey Wheat Rolls; 15/1.5 oz. rolls per case, 7.0lbs.;
Product #6668; UPC #47500 00740, Recall # F-352-8
CODE
Best used by 08/08/2008
RECALLING FIRM/MANUFACTURER
Bridgford Foods, Inc., Dallas, TX, by telephone on February 15, 2008. Firm initiated recall is ongoing.
REASON
Wheat flour used in manufacturing rolls contains rodent filth.
VOLUME OF PRODUCT IN COMMERCE
435 cases
DISTRIBUTION
AL, FL, MI and TX
___________________________________
PRODUCT
a) Intralipid 10%, a 10% Fat Emulsion for Intravenous Use, 500 mL flexible plastic
container, sterile, Rx only, each 100 mL contains Soybean Oil 10 g, Phospholipids
1.2 g, Glycerin USP 2.25 g, NDC 0338-0518-13, Product code 2B601, Recall #
D-211-2008;
b) Intralipid 20%, a 20% Fat Emulsion for Intravenous Use, 100, 250, 500 mL
flexible plastic containers, sterile, Rx only, each 100 mL contains Soybean Oil 20 g,
Phospholipids 1.2 g, Glycerin USP 2.25 g, NDC 0338-0519-02, 0338-0519-03, 0338-
0519-48, 1) Product code 2B6030: 2) Product code 2B6022: 3) Product code 2B6023:
4) Product code JB6023 (sold in Canada only), Recall # D-212-2008;
c) Intralipid 30%, a 30% Fat Emulsion for Intravenous Use, 500 mL flexible plastic
container, Pharmacy Bulk Package, sterile, Rx only, each 100 mL contains Soybean
Oil 30 g, Phospholipids 1.2 g, Glycerin USP 1.7 g, NDC 0338-0520-03, Product
code 2B6053, Recall # D-213-2008
CODE
a) Lots WB11179, exp. 1/31/09; WD12411, 3/31/09;
b) 1) Lots WB11032, exp. 1/31/09; WB11034, exp. 1/31/09; WB11163, exp. 1/31/09;
WC11686, 2/28/09, WC11688, exp. 2/28/09; WC11690, exp. 2/28/09; WD12645,
exp. 3/31/09; WD12649, exp. 3/31/09; WD12647, exp. 3/31/09; WE13167, exp.
4/30/09; WE13169, exp. 4/30/09; WE13248, exp. 4/40/09; WE13385, exp. 4/30/09;
2) Lots WC11968, exp. 2/28/09; WD12368, exp. 3/31/09;
3) Lots WB11318, exp. 1/31/09; WB11410, exp. 1/31/09; WC11699, exp. 2/28/09;
4) Lot WD12723;
c) Lot WE13010, exp. 4/30/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters on March 11, 2008
Manufacturer: Fresenius Kabi, Uppsala, Sweden. Firm initiated recall is ongoing.
REASON
There is an increased potential for port splitting to occur in the administration port.
VOLUME OF PRODUCT IN COMMERCE
235,140 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Terbutaline Sulfate Injection USP 1 mg/ml, 25 - 1mL Single Use Vial, For Subcutaneous Injection, Rx Only, NDC number 0703-1271-04, Recall # D-209-2008
CODE
Lot numbers 06K128 exp 8/2008 and 07B121 exp 2/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letters on March 19, 2008.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Exceeded Specification for pH (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
152,525 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ThermoGenesis AXP Bag Sets 8-5101, Boxes of 24, manufactured by ThermoGenesis Corporation. Disposable Processing Set for the AXP System, Recall # B-1136-08
CODE
Lot numbers: 25128-0674-05, 25128-0674-04, 25128-0671-03, 25128-0669-02, 25128-0667-01, 24455-0666-04, 24455-0665-03, 24455-0663-02, 24452-0661-05, 24452-0659-04, 24452-0655-02, 24452-0653-01, 24452-0000-03, 24455-0661-01, 22129-0640-04, 22129-0639-03, 22129-0633-01, 22128-0633-04, 22128-0631-03, 22128-0625-01, 22127-0623-04, 22127-0621-03, 22127-0619-02, 22127-0617-01, 21504-0617-03, 21504-0615-02, 21504-0614-01, 20684-0613-16, 20684-0611-15, 20684-0609-14, 20684-0607-13, 20684-0605-12, 20684-0603-11, 20684-0601-10, 20684-0599-09, 20684-0597-08, 20684-0595-07, 20684-0593-06, 20684-0588-02, 20684-0586-01, 20338-0586-02, 20337-0000-03, 20337-0000-02, 20337-0000-01, 19863-0000-04, 19863-0000-03, 19863-0000-02, 19863-0000-01, 19329-0584-03, 19329-0000-06, 19329-0000-05, 19329-0000-04, 19329-0000-03, 18279-0000, 17882-0000, 16988-0000, 16978-0000, 16359-0000, 16357-0000, 15500-0000, 15357-0000, 15118-0000, 15021.00
RECALLING FIRM/MANUFACTURER
Thermogenesis Corp., Rancho Cordova, CA, by letters and telephone on February 20, 2008. Firm initiated recall is ongoing.
REASON
Devices (both empty bags and bags subsequently filled with cord blood) were not properly tested for endotoxin (pyrogen) testing.
VOLUME OF PRODUCT IN COMMERCE
59716 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1188-08
CODE
Unit: 04N65053
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on December 10, 2007 and by letter on December 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which was overweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets, Recall # B-1190-08
CODE
Unit: N77842
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by letter on January 4, 2008. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1331-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1332-08
CODE
a) and b) Unit: 18GQ18227
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on March 16, 2007 and follow-up letter dated March 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1333-08
CODE
Unit: 18GF61564
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on February 9, 2007 and follow-up letter dated February 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1335-08
CODE
Unit: 18GY03182
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on April 30, 2007 and follow-up letter dated June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor, version 6.0.1 and 6.0.2, Recall # B-1337-08
CODE
Blood Bank and Blood Donor, version 6.0.1 distributed with Sunquest Laboratory version 6.1 and 6.2; Blood Bank and Blood Donor, version 6.0.2 distributed with Sunquest Laboratory version 6.3
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on March 26, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
282 units or clients
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1341-08;
b) Red Blood Cells (Apheresis), Recall # B-1342-08;
c) Platelets, Recall # B-1343-08;
CODE
a) KT22768, KH62884, FY00023, FT14039, LV81465, LV80477, LV81038,
FW68633, GR72942, KH63837, KM23706;
b) KM23382 (2 units), KP16385 (2 units);
c) KT22768, KH62884, FY00023, LV81465, FW68633, GR72942, KH63837;
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1345-08
CODE
Unit: T67854
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated February 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Tegison, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1346-08
CODE
Unit: 04C13692
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on January 26, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but was collected from a donor who provided post-donation information regarding two previous positive tests for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1347-08;
b) Red Blood Cells (Apheresis), Recall # B-1348-08
CODE
a) Units: V81524 (2 units), V81468 (2 units), V81471 (2 units), V81496 (2 units),
V81499 (2 units), V81515 (2 units);
b) Units: V81549, V81560, V81562, V81564, V81955, V83302
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on November 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for hemoglobin and hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1349-08
CODE
Unit: 6981600
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on May 19, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets, Irradiated, Recall # B-1350-08
CODE
Unit: J91540
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Saginaw, MI, by facsimile on January 23, 2008.
Manufacturer: Michigan Community Blood Centers, Bay City, MI. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets, Recall # B-1351-08
CODE
Unit: N99817
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on December 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1352-08;
b) Fresh Frozen Plasma, Recall # B-1353-08
CODE
a) and b) Unit: 04Z28833
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on December 8, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
ME, NY
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-1355-08;
b) Platelets, Recall # B-1356-08
CODE
a) and b) Unit: 04J99154
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on December 8, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Platelets, Recall # B-1361-08
CODE
Units: 4071114, 4071108
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on October 30, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors who had taken aspirin within 36 hours of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced, Irradiated, Recall # B-1362-08
CODE
Unit: GW50065 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by letter dated May 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Asacol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1365-08
CODE
Units: UQ008616, UQ008399, UQ008297, UQ004244, UQ004076, UQ003969, UQ003743, UQ003654, UQ003105, UQ002927
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on July 25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-1366-08
CODE
Units: JQ042834, JQ042530, JQ042098, JQ041899, JQ041448, JQ041209, JQ040792, JQ040164, JQ038350, JQ037958, JQ037692
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Jackson, TN, by facsimile on August 14, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred for a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1371-08
CODE
Unit: 4437492
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 27, 2006. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Platelets, Recall # B-1378-08;
b) Fresh Frozen Plasma, Recall # B-1379-08
CODE
a) and b) Unit: GS03659
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on January 22, 2008. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1381-08
CODE
Units: 172069673 and 172070319
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Mcallen, TX, by telephone on July 25, 2006. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an elevated platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25 mg per Vial, Rx NDC 58468-0080-1, Recall # B-1018-08
CODE
Lot Numbers: CG024CAA EXP NOV 09; TH175-05 EXP OCT 09; C7008C01 EXP MAR 2010; C7014C01 EXP MAY 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genzyme, Framingham, MA, by letters on February 12, 2008 and April 8, 2008.
Manufacturer: Genzyme Ireland Ltd., Waterford, Ireland. Firm initiated recall is complete.
REASON
Thymoglubin, in which the product fails stability, for opalescence, was distributed.
VOLUME OF PRODUCT IN COMMERCE
114,562 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cornea in Optisol-GS Media - Tissue Not Sterile, Lions Eye Bank of Wisconsin. SEROLOGY TESTING – NONREACTIVE, Recall # B-1044-08
CODE
Tissue ID # 050494100
RECALLING FIRM/MANUFACTURER
The Lions Eye Bank of Wisconsin, Inc., Madison, WI, by facsimile on November 6, 2005. Firm initiated recall is complete.
REASON
Corneal Tissue, recovered from a donor who tested repeatedly reactive to the Hepatitis B surface antigen screening assay, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 cornea
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1129-08
CODE
Units: 364005948; 364009819; 364011288; 364011966; 364013736; 364013993
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth, TX, by fax on November 11, 2006.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Platelets Leukocytes Reduced Irradiated, Recall # B-1177-08;
b) Fresh Frozen Plasma, Recall # B-1178-08;
c) Platelets Leukocytes Reduced, Recall # B-1179-08;
d) Plasma Frozen, Recall # B-1180-08;
e) Platelets Pooled, Leukocytes Reduced, Recall # B-1181-08
CODE
a) Unit: 22GY16228;
b) Units: 22FX38672, 22FQ46116, 22KC96271, 22GY16228, 22FQ48049, 22GH38597,
22KH16930, 22LP25256, 22FZ40402, 22FQ48711, 22GH57717, 22FP02526,
22KX88960, 22FS56285, 22FZ40413, 22FZ40405;
c) 22KE45624, 22GS33797, 22KX88960, 22KC96271, 22FC59277, 22GH38597,
22GG28543, 22LP25256, 22KH16930, 22GH57717, 22FQ48711, 22FX38672,
22FS56285, 22FQ48049, 22GG28532, 22FQ46116;
d) Unit: 22GG27336;
e) Pool numbers 2921, 2916
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on November 14, 2007 and by letter dated December 12, 2007. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood units that may have had an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
PA, NJ, MD, VA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1334-08
CODE
Unit: 18GF61564
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on February 9, 2007 and follow-up letter dated February 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1336-08
CODE
Unit: 18GY03182
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone and e-mail on April 30, 2007 and follow-up letter dated June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1344-08
CODE
Unit: 22FY71571
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on February 1, 2008. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the E red cell antigen, but was collected from a donor who subsequently tested positive for E antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1354-08
CODE
Unit: FX04350
RECALLING FIRM/MANUFACTURER
ITxM Clinical Services, Pittsburgh, PA, by telephone on December 13, 2007 and facsimile on December 14, 2007. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to antigen phenotype, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1357-08
CODE
Unit: 0353754
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected using automated equipment that did not undergo performance qualification following repair, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1359-08
CODE
Unit: 0353822
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 22, 2007 and fax on April 4, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not have QC testing performed but which was collected during apheresis machine validation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1363-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1364-08
CODE
a) Units: 027KK17272, 027KW07210, 027KL17428;
b) Units: 027KN10308, 027LE97826, 027KK17287, 027LP32381, 027KP10831,
027LY35110, 027KW07225, 027KP10806
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on January 3, 2008 and by letter dated April 2, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis and CVM, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
PA, VA, WV
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1367-08
CODE
Unit: 4475181
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on February 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an invalid result for body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1368-08
CODE
Unit: 4452906
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on January 10, 2007 and by facsimile on January 15, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor without documentation of a hemoglobin or hematocrit test having been performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1370-08
CODE
Units: 032LF71198 (Split), 032LF71198, 032LF71199, 032LF71200, 032LF71201, 032LF71218, 032LF71219, 032LF71220, 032LF72389, 032LF72390, 032LF72391, 032LF72392, 032LF72392 (Split)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on September 21, 2005. Firm initiated recall is complete.
REASON
Blood products, possible exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1372-08
CODE
Unit: 4421202
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by fax on November 2, 2006. Firm initiated recall is complete.
REASON
Blood product, collected during apheresis machine validation but which did not have the required QC testing performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
a) VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive
Version), Recall # Z-0982-2008;
b) VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive
Version), Recall # Z-0983-2008;
c) VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive
Version), Recall # Z-0984-2008;
d) VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version),
Recall # Z-0985-2008;
e) VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with
Compressor Version), Recall # Z-0986-2008
CODE
a) Serial numbers: AGV02302, AEV01757;
b) Serial numbers: AGV01472;
c) Serial numbers: AHV03020, AHV03021, AHV03022, AHV03023, AHV03024,
AHV03025;
d) Serial numbers: AHV03000, AHV03001, AHV03004, AHV03005;
e) Serial numbers: AHV03066, AHV03040, AHV03041, AHV03042, AHV03043,
AHV03044, AHV03045, AHV03046, AHV03047, AHV03049, AHV03095,
AHV03096, AHV03097, AHV03098, AHV03099, AHV03100, AHV03101,
AHV03102, AHV03103, AHV03104, AHV03105, AHV03106, AHV03121,
AHV03123, AHV03124, AHV03129, AHV03134, AHV03136
RECALLING FIRM/MANUFACTURER
Viasys Respiratory Care, Inc. dba Bird Products, Palm Springs, CA, by letters on December 18, 2007. Firm initiated recall is complete.
REASON
Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Firmware Version 2.02.39, Recall # Z-0987-2008
CODE
Serial Numbers: 0107DL001, 0107DL002A, 0107DL003, 0107DL004A, 0107DL005, 0107DL006, 0107DL007, 0107DL008A, 0107DL009, 0107DL010, 0107DL011A, 0107DL012, 0107DL013, 0107DL014, 0107DL015, 0107DL016, 0107DL017, 0107DL018, 0107DL019, 0107DL020, 0107DL021, 0107DL022, 0107DL023, 0107DL024, 0107DL025, 0107DL026, 0107DL027, 0107DL028, 0107DL029, 0107DL030, 0206DL001, 0206DL002, 0206DL003, 0206DL004, 0206DL005, 0206DL006, 0207DL001, 0207DL002, 0207DL003, 0207DL004, 0207DL005, 0207DL006, 0306DL001, 0306DL002, 0306DL003, 0507DL007, 0507DL008, 0507DL009, 0507DL010, 0507DL011, 0507DL012, 0507DL013, 0507DL014, 0507DL015, 0507DL016, 0507DL017, 0507DL018, 0507DL019, 0507DL020, 0507DL021, 0507DL022, 0507DL023, 0507DL024, 0507DL025, 0507DL026, 0507DL027, 0507DL028, 0507DL029, 0507DL030, 0507DL031, 0507DL032, 0507DL033, 0507DL034, 0507DL035, 0507DL036, 0507DL037, 0507DL038, 0507DL039, 0507DL040, 0507DL041, 0507DL042, 0606DL001, 0606DL002A, 0606DL003, 0606DL004, 0606DL005, 0606DL006, 0606DL007, 0606DL008, 0606DL009A, 0606DL010, 0606DL011, 0606DL012A, 0606DL013, 0606DL014A, 0606DL015, 0606DL016, 0606DL017A, 0606DL018, 0606DL019A, 0606DL020, 0606DL021A, 0606DL022A, 0606DL023A, 0606DL024A, 0606DL025A, 0606DL026A, 0606DL027A, 0606DL028, 0606DL029, 0606DL030, 0606DL031, 0606DL032, 0606DL033A, 0606DL034, 0606DL035, 0606DL036, 0606DL037, 0606DL038, 0606DL039, 0606DL040, 0607DL043, 0607DL044, 0607DL045, 0607DL046, 0607DL047, 0607DL048, 0607DL049, 0607DL050, 0607DL051, 0607DL052, 0607DL053, 0607DL054, 0607DL055, 0607DL056, 0607DL057, 0607DL058, 0607DL059, 0607DL060, 0607DL061, 0607DL062, 0607DL063, 0607DL064, 0607DL065, 0607DL066, 0607DL067, 0607DL068, 0607DL069, 0607DL070, 0607DL071, 0607DL072, 0607DL073, 0607DL074, 0607DL075, 0607DL076, 0607DL077, 0607DL078, 0607DL079, 0607DL080, 0607DL081, 0607DL082, 0607DL083, 0607DL084, 0607DL085, 0607DL086, 0607DL087, 0607DL088, 0707DL089, 0707DL090, 0707DL091, 0707DL092, 0707DL093, 0707DL094, 0707DL095, 0707DL096, 0707DL097, 0707DL098, 0707DL099, 0707DL100, 0707DL101, 0707DL102, 0707DL103, 0707DL104, 0707DL105, 0707DL106, 0707DL107, 0707DL108, 0707DL109, 0707DL110, 0707DL111, 0707DL112, 0707DL113, 0707DL114, 0707DL115, 0707DL116, 0707DL117, 0707DL118, 0707DL119, 0707DL120, 0707DL121, 0707DL122, 0707DL123, 0707DL124, 0707DL125, 0707DL126, 0707DL127, 0707DL128, 0707DL129, 0707DL130, 0707DL131, 0707DL132, 0707DL133, 0707DL134, 0707DL135, 0707DL136, 0707DL137, 0707DL138, 0707DL139, 0707DL140, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005A, 1106DL006, 1106DL007A, 1106DL008, 1106DL009, 1106DL010A, 1106DL011, 1106DL012A, 1106DL013, 1106DL014A, 1106DL015A, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1107DL133, 1107DL134, 1107DL135, 1107DL141, 1107DL142, 1107DL143, 1107DL144, 1107DL145, 1107DL146, 1107DL147, 1107DL148, 1107DL149, 1107DL150, 1107DL151, 1107DL152, 1107DL153, 1107DL154, 1107DL155, 1107DL156, 1107DL157, 1107DL158, 1107DL159, 1107DL160, 1107DL161, 1107DL162, 1107DL163, 1107DL164, 1107DL165, 1107DL166, 1206DL001A, 1206DL002A, 1206DL003A, 1206DL004A, 1206DL005A, 1206DL006A, 1206DL007A, 1206DL008A, 1206DL009A, 1206DL010, 1206DL011, 1206DL012A, 1206DL013A, 1206DL014, 1206DL015, 1206DL016A, 1206DL017, 1206DL018A, 1206DL019A, 1206DL020, 1206DL021, 1206DL022A, 1206DL023, 1206DL024, 1206DL025A, 1207DL167, 1207DL168, 1207DL169, 1207DL170, 1207DL171, 1207DL172, 1207DL173, 1207DL174, 1207DL175, 1207DL176, 1207DL177, 1207DL178, 1207DL179, 1207DL180, 1207DL181, 1207DL182, 1207DL183, 1207DL184, 1207DL185, 1207DL186, 1207DL187, 1207DL188, 1207DL189, 1207DL190, 1207DL191, 1207DL192, 1207DL193, 1207DL194, 1207DL195, 1207DL196, 1207DL198, and 1207DL199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated January 4, 2008.
Manufacturer: Cardinal Health 200 Inc dba Cardinal Health, Riverside, CA. Firm initiated recall is ongoing.
REASON
Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min.
VOLUME OF PRODUCT IN COMMERCE
314 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Recall # Z-1103-2008
CODE
Lot Numbers: 51749i2, 51754i2 and 56675i2
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on December 19, 2007. Firm initiated recall is ongoing.
REASON
Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
VOLUME OF PRODUCT IN COMMERCE
3,499 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Recall # Z-1105-2008
CODE
Lot: NYC08
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on February 25, 2005. Firm initiated recall is complete.
REASON
Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.
VOLUME OF PRODUCT IN COMMERCE
293 units total
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043. Material number: 10035829, Recall # Z-1138-2008
CODE
Serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, Inc., Mountain View, CA, by letter dated November 2007. Firm initiated recall is ongoing.
REASON
Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Alcon/Grieshaber Morris ILM Forceps, Direct Action; Manual ophthalmic surgical instrument, Catalog Number: 641.22; Non-sterile/Reusable, Recall # Z-1461-2008
CODE
Lot Numbers: F58834, F60464, F60465 and F60466
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alcon Research, Ltd, Fort Worth, TX, by fax on March 7, 2007.
Manufacturer: Alcon Grieshaber AG, Schaffhausen, Switzerland. Firm initiated recall is ongoing.
REASON
Device corrosion: Forceps are prone to corrosion and possibly premature fracture and/or malfunction.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08, Recall # Z-1462-2008
CODE
Lot Numbers: 59311P100 and 59312P100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on January 21, 2008. Firm initiated recall is ongoing.
REASON
Error Message: If the Positive and Negative Interpretation Cutoff parameters (116/117) are edited after installation of the revised assay file, VRTX error #0002 in Task 40 is generated and the instrument locks up when it attempts to report an AxSYM Amphetamine/Methamphetamine II patient result.
VOLUME OF PRODUCT IN COMMERCE
369 disks – Nationwide and 901 disks - Internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Remel RapID Inoculation Fluid, Microorganism differentiation and identification
device, Packaged in 1-ml tube, Catalog Number: R8325102, 20/pack, Recall #
Z-1624-2008;
b) Remel RapID Inoculation Fluid, Microorganism differentiation and identification
device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Recall #
Z-1625-2008
CODE
a) Lot 518113;
b) Lot 521354
RECALLING FIRM/MANUFACTURER
Remel Inc, Lenexa, KS, by letter on October 23, 2007. Firm initiated recall is complete.
REASON
Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
VOLUME OF PRODUCT IN COMMERCE
500/1-ml. and 554/2-ml. packs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Country Acres Horse Pellet 12, formula number 35DS, item number 0041940.
The product is sold in 50 lb bags, Recall # V-046-2008;
2) Purina Equine Senior, formula number 35J9, item number 0001209.
The product is sold in 50 lb bags, Recall # V-047-2008;
3) Horse Chow 100, formula number 3531, item number 0004984.
The product is sold in 50 lb bags, Recall # V-048-2008;
4) All Stock Sweet 12%, formula number 33VN, item number 0044453.
The product is sold in 50 lb bags, Recall # V-049-2008;
5) Antlermax Deer 20, formula number 59SB, item number 0049801.
The product is sold in 50 lb bags, Recall # V-050-2008;
6) Antlermax RUT & CND Deer 16, formula number 59SD, item number 0049897.
The product is sold in 50 lb bags, Recall # V-051-2008;
7) Antlermax Watershield Deer 20, formula number 59SS, item number 0049802.
The product is sold in 50 lb bags, Recall # V-052-2008;
8) AS 700 Ettes, formula number 0596, item number 0032030.
The product is sold in 50 lb bags, Recall # V-053-2008;
9) Country Acres All Stock 12% Texture, formula number 53Q7, item number
0047133. The product is sold in 50 lb bags, Recall # V-054-2008;
10) Country Acres All Stock 14% Texture, formula number 56AT, item number
0049098. The product is sold in 50 lb bags, Recall # V-055-2008;
11) Country Acres All Stock 16% Texture, formula number 56AZ, item number
0051858. The product is sold in 50 lb bags, Recall # V-056-2008;
12) Country Acres Deer & Elk 20, formula number 54JZ, item number 0049901.
The product is sold in 50 lb bags, Recall # V-057-2008;
13) Country Acres Horse Complete 14, formula number 35EZ, item number 0048193.
The product is sold in 50 lb bags, Recall # V-058-2008;
14) Country Acres Horse Pellet 10, formula number 35DR, item number 0041941.
The product is sold in 50 lb bags, Recall # V-059-2008;
15) Country Acres Horse Pellet 14 (5/32), formula number 35DT, item
number 0041939. The product is sold in 50 lb bags, Recall # V-060-2008;
16) Country Acres Horse Pellet 14 (Ovals), formula number 35DT9, item
number 0055999. The product is sold in 50 lb bags, Recall # V-061-2008;
17) Country Acres Horse Sweet 10, formula number 35DN, item number 0041937.
The product is sold in 50 lb bags, Recall # V-062-2008;
18) Country Acres Horse Sweet 12, formula number 35D9, item number 0041943.
The product is sold in 50 lb bags, Recall # V-063-2008;
19) Country Acres Layer 16%, formula number 6514, item number 0009876.
The product is sold in 50 lb bags, Recall # V-064-2008;
20) Country Acres Wildlife Builder, formula number 54KY, item number 0053498.
The product is sold in 50 lb bags, Recall # V-065-2008;
21) Cattle Finisher 40 W/O, formula number 3923, item number 0009798.
The product is sold in 50 lb bags, Recall # V-066-2008;
22) Cattle Finisher 50 W/O, formula number 3982M, item number 0001273.
The product is sold in 50 lb bags, Recall # V-067-2008;
23) Cattle Finisher 32 W/O, formula number 3895, item number 0009271.
The product is sold in 50 lb bags, Recall # V-068-2008
24) Coarse 14, formula number 3080, item number 0001089.
The product is sold in 50 lb bags, Recall # V-069-2008;
25) Complete Advantage, formula number 3505, item number 0034202.
The product is sold in 50 lb bags, Recall # V-070-2008;
26) CTC 4 gm Ettes , formula number 0982, item number 0032024.
The product is sold in 50 lb bags, Recall # V-071-2008;
27) CU Clearbrook B38 DY CC, formula number 1BT1, item number 0067147.
The product is sold in 50 lb bags, Recall # V-072-2008;
28) CU K&K 18% Calf DQ, formula number 1BSP, item number 0067069.
The product is sold in 50 lb bags, Recall # V-073-2008;
29) Economy Special 14, formula number 1119, item number 0009492.
The product is sold in 50 lb bags, Recall # V-074-2008;
30) Equine Adult, formula number 35V7, item number 0001822.
The product is sold in 50 lb bags, Recall # V-075-2008;
31) Equine Junior, formula number 35G9, item number 0001206.
The product is sold in 50 lb bags, Recall # V-076-2008;
32) Farm Club 15% Rabbit Pellet, formula number 50W5, item number 0001341.
The product is sold in 50 lb bags, Recall # V-077-2008;
33) Homegrown Laying Ration Cr, formula number 65AE, item number 0011563.
The product is sold in 50 lb bags, Recall # V-078-2008;
34) Horse Chow 200, formula number 3532, item number 0005888.
The product is sold in 50 lb bags, Recall # V-079-2008;
35) Horseman's Edge 10:10 TXT HF, formula number 35CZ, item number 0054628.
The product is sold in 50 lb bags, Recall # V-080-2008;
36) Horseman's Edge Complete 14, formula number 35TK, item number 0065331.
The product is sold in 50 lb bags, Recall # V-081-2008;
37) Horseman's Edge Pellet 10:6, formula number 35Y5, item number 0010610.
The product is sold in 50 lb bags, Recall # V-082-2008;
38) Horseman's Edge PLT 12:6 + Lys, formula number 35TG, item number 0065244.
The product is sold in 50 lb bags, Recall # V-083-2008;
39) Horseman's Edge Sweet 14:6, formula number 35TP, item number 0065356.
The product is sold in 50 lb bags, Recall # V-084-2008;
40) Horseman's Edge Sweet 16:6 Mare & Foal, formula number 35TL, item number
0065353. The product is sold in 50 lb bags, Recall # V-085-2008;
41) Horseman's Edge Sweet 12:6 + Lys, formula number 35TM, item number 0065354.
The product is sold in 50 lb bags, Recall # V-086-2008;
42) Nutrisource Deer Feed, formula number 5ZD8, item number 0051579.
The product is sold in 50 lb bags, Recall # V-087-2008;
43) Platform Mare & Foal, formula number 35SD, item number 0062178.
The product is sold in 50 lb bags, Recall # V-088-2008;
44) Platform Mini-Horse & Pony 25#, formula number 35ST, item number 0065838.
The product is sold in 50 lb bags, Recall # V-089-2008;
45) Platform Pleasure Horse, formula number 35SB, item number 0062176.
The product is sold in 50 lb bags, Recall # V-090-2008;
46) Platform Senior Horse, formula number 35SE, item number 0062180.
The product is sold in 50 lb bags, Recall # V-091-2008;
47) Platform Sport Horse, formula number 35SC, item number 0062177.
The product is sold in 50 lb bags, Recall # V-092-2008;
48) Prepare Concentrate 36% E, formula number 12R2, item number 0000066.
The product is sold in 50 lb bags, Recall # V-093-2008;
49) Pure Pride 100, formula number 3516, item number 0001178.
The product is sold in 50 lb bags, Recall # V-094-2008;
50) Show Lamb Ultra Toner 18 F DQ, formula number 31UF, item number 0063592.
The product is sold in 50 lb bags, Recall # V-095-2008;
51) Sow & Pig Builder OTC 50, formula number 35WK, item number 0047869.
The product is sold in 50 lb bags, Recall # V-096-2008;
52) Producer's Pride Haystretche, item number 0004859.
The product is sold in 50 lb bags, Recall # V-097-2008;
53) DuMOR Pleasure Horse 12, item number 0046517.
The product is sold in 50 lb bags, Recall # V-098-2008;
54) Producer's Pride Calf Starte, item number 0009729.
The product is sold in 50 lb bags, Recall # V-099-2008;
55) DuMOR Mare & Foal 16, item number 0046518.
The product is sold in 50 lb bags, Recall # V-100-2008;
56) Producer's Pride 10% Sweet, item number 0009771.
The product is sold in 50 lb bags, Recall # V-101-2008;
57) Producer's Pride Rabbit, item number 0046821.
The product is sold in 50 lb bags, Recall # V-102-2008;
58) Producer's Pride Range Cube, item number 0011011.
The product is sold in 50 lb bags, Recall # V-103-2008;
59) DuMOR Sheep, item number 0047317.
The product is sold in 50 lb bags, Recall # V-104-2008;
60) DuMOR Rabbit Pellet 50/24, item number 0019364.
The product is sold in 50 lb bags, Recall # V-105-2008;
61) Nutrisource Deer Feed, item number 0051579.
The product is sold in 50 lb bags, Recall # V-106-2008;
62) Platform Pleasure Horse, item number 0062176.
The product is sold in 50 lb bags, Recall # V-107-2008;
63) Golden Feed All Stock Dry 12, item number 0045017.
The product is sold in 50 lb bags, Recall # V-108-2008;
64) Platform Sport Horse, item number 0062177.
The product is sold in 50 lb bags, Recall # V-109-2008;
65) DuMOR Performance Horse 14, item number 0046493.
The product is sold in 50 lb bags, Recall # V-110-2008;
66) Platform Mare & Foal, item number 0062178.
The product is sold in 50 lb bags, Recall # V-111-2008;
67) DuMOR Senior Horse 14, item number 0046494.
The product is sold in 50 lb bags, Recall # V-112-2008;
68) Platform Senior Horse, item number 0062180.
The product is sold in 50 lb bags, Recall # V-113-2008
CODE
1) Lot numbers 8JAN24HAR3 and 8FEB06HAR2;
2) Lot number 8FEB01HAR2;
3) Lot number 8JAN11HAR2;
4) Lot numbers 8JAN08HAR2 and 8JAN09HAR3;
5) thru 68) Lot numbers range from 8JAN01HAR to 8FEB08HAR
RECALLING FIRM/MANUFACTURER
Purina Mills LLC d/b/a Land O'Lakes Purina Feed LLC, Camp Hill, PA, by telephone and letter on April 4, 2008 and April 9, 2008. Firm initiated recall is ongoing.
REASON
Elevated aflatoxins levels.
VOLUME OF PRODUCT IN COMMERCE
100,450 bags
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR MAY 21, 2008
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