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U.S. Department of Health and Human Services

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Enforcement Report for July 21, 2004

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.


July 21, 2004
04-29

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Frico brand Chevrette Goat's Milk Cheese, Imported from Holland. Product is sold in bulk wheels of approximately 9 lbs. each, and in retail packages weighing approx. 8 oz. each. --- Labeling on bulk cheese wheel: Frico brand Chevrette. Labeling of 8 oz. product: Frico brand Mild & Tangy Flavor CHEVRETTE Goat's Milk CHEESE. KEEP REFRIGERATED. Recall # F-290-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Schratter Foods, Inc., Fairfield, NJ, by press release on May 26, 2004, and letters dated May 25, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg white lysozyme.
VOLUME OF PRODUCT IN COMMERCE
9 lb. wheels: 4735 cases (42,615 lbs. total); 8 oz.: 5284 cases (26,420 lbs. total).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
River Ranch brand Popeye Caf? Parisian Complete Salad Kit in 16 oz. packages. UPC number 45388-81023. Recall # F-291-4.
CODE
Use By Date June 2, 2004 and prior.
RECALLING FIRM/MANUFACTURER
River Ranch Fresh Foods Llc, Salinas, CA, by letters, telephone, email and press release on May 18, 2004. Firm initiated recall is complete.
REASON
Products contain undeclared walnuts and pecans.
VOLUME OF PRODUCT IN COMMERCE
7912 cases.
DISTRIBUTION
WA, OR, AK, ID, MT, UT, NV, NM and AZ.

_______________________________
PRODUCT
Raw Whole Almonds, packaged in 5 lb. Plastic jugs. Recall # F-292-4.
CODE
Products are identified with the firm's item number #65002 and #65004. The products in question were sold during the dates of 10/23/03 to 06/01/04.
RECALLING FIRM/MANUFACTURER
International Gourmet Food Inc., Springfield, VA, by letter on June 4, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
1,000 lbs.
DISTRIBUTION
MD, VA, D.C, and NC.

_______________________________
PRODUCT
Borracchini Foods brand Whole Raw Almonds in 5 lb. poly lined box. Recall # F-293-4.
CODE
The firm does not code product. The firm recalled product distributed between August 19, 2003 through October 31, 2003.
RECALLING FIRM/MANUFACTURER
Borracchini Foods. Seattle, WA, by fax on May 26, 2004. FDA initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
30/5 lb. Boxes.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Baja Bob's brand Bloody Mary Mix in 32 fl. oz. glass bottle. Recall # F-294-4.
CODE
BBBM001SPF BEST USED BY 2/11/05 and BBBM001SPF BEST USED BY 2/14/05.
RECALLING FIRM/MANUFACTURER
Side Pocket, Cottage Grove, OR, by press release and fax on May 24, 2004. FDA initiated recall is complete.
REASON
Bloody Mary mix contains undeclared anchovy paste, a sub-ingredient of the Worcestershire sauce.
VOLUME OF PRODUCT IN COMMERCE
631 cs/12/32 oz. bottles.
DISTRIBUTION
OR, MI, TX, CA, WA, NY and Canada.

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Fortune Cookies labeled as Rose Brand Fortune Cookies NET WT 4 OZ. and NET WT 1 LB. Packaged in clear plastic bags. Product is also packaged in a 10. oz plastic container, 10 LB. box and 4-2.5 LB. plastic bags per box. Recall #F-297-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Tsue Chong Co., Inc., Seattle, WA, by letter dated May 21, 2004. FDA initiated recall is ongoing.
REASON
Product contains undeclared color ? FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
1000 cases/ 1000 pounds.
DISTRIBUTION
WA and ID.

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Jenny's Cuisine Chocolate Chip Bites Crisp Cookies with Chocolate Drops, 1 oz bags. Recall # F-296-4.
CODE
best before date of 11/17/04.
RECALLING FIRM/MANUFACTURER
Jenny Craig, Carlsbad, CA, by telephone, fax and e-mail on July 2, 2004. Firm initiated recall is ongoing.
REASON
Packages labeled as ?cookies? may actually contain a different product, chicken flavor snack crackers with MSG.
VOLUME OF PRODUCT IN COMMERCE
55,920 pkgs.
DISTRIBUTION
Nationwide.

 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Aspirin, Enteric Coated Tablets, 81 mg, 120 count bottles, Adult Low Strength Pain Reliever, BROOKS brand. Also sold under the following brand names: GOOD SENSE brand, Perrigo, NDC 0113-0535-76; Longs brand, NDC 12333-9537-1; Perfect Choice brand, NDC 41226-535-76; SAFEWAY brand, NDC 21130-535-76; Shop Rite brand; Equate brand, NDC 0113-1535-76; FOOD LION brand, NDC 55316-535-76; Brite-Life brand, NDC 24385-535-76; Good Neighbor Pharmacy brand, Distributed by Bergen Brunswig Drug, NDC 24385-535-76; Valu-Rite brand, NDC 49348-756-53; Family Pharmacy brand, NDC 52735-761-23; and Leader brand. Recall # D-215-4.
CODE
Lot numbers 2DE0148 and 2DE0584; EXP. 01/05.
RECALLING FIRM/MANUFACTURER
Perrigo Co., Allegan, MI, by letter dated June 25, 2004. Firm initiated recall is ongoing.
REASON
Dissolution failure; Enteric coating.
VOLUME OF PRODUCT IN COMMERCE
99,252 bottles.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1305-4;
b) Recovered Plasma. Recall # B-1306-4.
CODE
a) and b) Unit numbers: 49N32683, 49LK39235.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by facsimile on January 24, 2003 and by letter, dated January 30, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a repeatedly reactive HIV-p24 antigen, Western Blot indeterminate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD, TX, Switzerland, and Israel.

_______________________________
PRODUCT
Source Plasma.Units. Recall # B-1563-4.
CODE
0520272204, 0520271809, 0520271325, 0520269987, 0520271128, 0520269666, 0520269134, 0520268929, 0520232140, 0520231353.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by fax on June 6, 2002.
Manufacturing Firm: ZLB Bioplasma Inc., Memphis, TN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
United Kingdom.

_______________________________
PRODUCT
Source Plasma. Recall # B-1564-4.
CODE
Units: 67692606, 67689804, 67682942, 67679102, 67676088, 67672714, 67669592, 51863753, 51757854, 51752866.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by fax on March 12, 2002.
Manufacturing Firm: Plasma Biological Services Inc., Johnson City, TN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1568-4.
CODE
Units: 67893843, 67889457.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by fax on August 7, 2002.
Manufacturing Firm: Plasma Biological Services Inc., Johnson City, TN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1570-4.
CODE
Units: 63639735, 63635461, 63632552, 63626537, 63624533, 63619690, 63614954, 63612615, 63608885, 63603514, 63599374, 63595345, 63590012, 63583649, 63581379.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL, by fax on January 31, 2002.
Manufacturing Firm: ZLB Bioplasma Inc., Baton Rouge, LA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam had not been performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1581-4;
b) Recovered Plasma. Recall # B-1582-4.
CODE
a) and b) Unit number 49K56260.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letters on May 20 and 22, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1583-4.
CODE
Unit numbers 49FF50224, 49FF49108, and 49LQ45615.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by letter on April 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX and OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1584-4.
CODE
Unit numbers 53GE80761, 53GV54236, and 53Y01505.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by facsimile and letter on February 5 and 6, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD and VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1585-4.
CODE
Unit numbers 53FC33385, 53FC31641, and 53FC27941.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters on January 20, 2004, and February 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD and DC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1586-4.
CODE
Unit number 53Y05184.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD by letter on March 15, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1587-4.
CODE
Unit number 8731397.
RECALLING FIRM/MANUFACTURER
Union Memorial Hospital Blood Bank, Baltimore, MD, by letter on January 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Source Plasma. Recall # B-1591-4.
CODE
Unit numbers: 450001386, 450001670, 450002036, 450002333, 450003085, 450004477, and 450005153.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Hampton, VA, by facsimile on February 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1592-4.
CODE
Unit number: 53FX94889.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter, dated March 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who has a history of Sarcoidosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1597-4;
b) Platelets. Recall # B-1598-4;
c) Plasma, Frozen. Recall # B-1599-4;
d) Plasma Frozen, Cryoprecipitate Reduced. Recall # B-1600-4;
e) Cryoprecipitated AHF. Recall # B-1601-4;
f) Red Blood Cells, For Further Manufacturing into Injectables.
Recall # B-1602-4.
CODE
a) Unit numbers: 53G42341, 53GE44107, 53L28828;
b) Unit numbers: 53G42341, 53GE44107;
c) Unit numbers: 53G48235, 53G42341, 53GE44107, 53L28828;
d) e) and f) Unit number: 53GN39869.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters, dated July 24 and August 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a subsequent disclosure of previous positive Hepatitis B testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
MD, CT, FL, MI, and D.C.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-1603-4.
CODE
Units: 53LT81231, 53LT80755, 53LT81189, 53LT81143 (split)
53LT81101 (split), 53LT80069.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Baltimore, MD, by phone on February 6, 2004 and by letter on February 13, 2004. Firm initiated recall is complete.
REASON
Blood Products, labeled ?leukoreduced? but which were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1606-4.
CODE
Unit number: L09275.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter, dated March 15, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided post donation information of having Hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1607-4.
CODE
Unit number: 49LL12935.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by telephone on February 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1608-4.
CODE
Unit number: 49LQ25365.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by letter, dated July 26, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had resided in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1609-4.
CODE
Unit number 2055126.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by visit on March 8, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1610-4.
CODE
Unit number 042X90236.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on March 29, 2004, and by letter on March 31, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Platelets. Recall # B-1612-4.
CODE
Unit number K96110.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on February 25, 2004, and by letter on April 8, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1613-4.
CODE
Unit number K99667.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on February 20, 2004, and by letter on February 24, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1614-4.
CODE
Unit numbers: OT093053, OT089436, OT088102.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Odessa, TX, by letter, dated September 7, 2001. Firm initiated recall is complete.
REASON
Blood products, that were not properly quarantined after the receipt of
repeatedly reactive anti-HCV, RIBA indeterminate results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA._______________________________
PRODUCT
Red Blood Cells Leukoreduced. Recall # B-1616-4.
CODE
Unit: 49GQ34075.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Tulsa, OK, by letter dated February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had resided in a malarial endemic area within the past three years, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1617-4;
b) Fresh Frozen Plasma. Recall # B-1618-4;
c) Recovered Plasma. Recall # B-1619-4.
CODE
a) Units: 1770435, 8070190;
b) Unit: 1770435;
c) Unit: 8070190.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 19, 2004, and by fax on April 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had had previously been permanently deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
IL and Scotland.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1620-4.
CODE
Unit 2472056.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 5, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets and Red Blood Cells that were contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1622-4.
CODE
Units 040P98472-1, 040P98472-2.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on March 29, 2004 and letter on April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced, but which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1623-4;
b) Platelets. Recall # B-1624-4;
c) Fresh Frozen Plasma. Recall # B-1625-4.
CODE
a), b), and c) Unit: 6152287.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on April 14, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for all viral markers, but which were collected from a donor who reported a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1626-4;
b) Source Leukocytes for Further Manufacturing of Non-Injectable.
Recall # B-1627-4.
CODE
a) and b) Unit 4380836.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile dated January 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1628-4;
b) Recovered Plasma for Further Manufacture of Non-Injectables.
Recall # B-1629-4.
CODE
a) and b) Units 49X55421, 49G70461.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter dated May 22, 2002, and a ?Questionable Plasma Inquiry? on August 15, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
OK and MA.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1638-4.
CODE
Unit: 49GQ33293.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on October 8, 2001. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1640-4.
CODE
Unit 71W43194-4 (split #1).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 20, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1641-4.
CODE
Unit 71W58014-X (split #2).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on April 6, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-1646-4.
CODE
Unit: 71 W57537-4.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by fax on January 20, 2004. Firm initiated recall is complete.
REASON
Blood Product, prepared in insufficient plasma to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit split product).
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-1647-4.
CODE
Unit: 71 W58273-4.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by fax on January 6, 2004. Firm initiated recall is complete.
REASON
Blood Products, prepared in insufficient plasma to support the platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units, (split product).
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1648-4.
CODE
Unit FQ41761.
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by phone on January 20, 2003 and by letter dated January 15, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1649-4.
CODE
Unit number: 49KL00694.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by letter, dated February 19, 2003.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1650-4.
CODE
Unit number: FQ43674.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on January 17, 2003, and by letter, dated February 4, 2003.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1651-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1652-4.
CODE
a) Unit number: KC05000;
b) Unit number: LS90153.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by letters, dated June 6, 2003, and February 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI and PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1653-4;
b) Recovered Plasma. Recall # B-1654-4.
CODE
a) and b) Unit 49LV03322.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on March 27, 2003, by letter dated April 9, 2003, or by facsimiles on March 28, 2003, April 8, 2003, and April 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1655-4.
CODE
Unit 33GY77132.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by letter dated April 30, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1657-4;
b) Platelets, Leukocytes Reduced. Recall # B-1658-4.
CODE
a) and b) Unit FG81282.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., DBA Rhode Island Blood Center
Providence, RI, by letter dated April 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA and RI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1660-4.
CODE
Unit 7793801.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on April 6, 2004. Firm initiated recall is complete.
REASON
Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1276-4;
b) Platelets. Recall # B-1277-4.
CODE
a) GR46907, KE64714, KE64717, KK6752, KK67526, KK67528,
LK26089, LK26096, LR50338, LR50339, LR50340, LR50341,
LR50342, LR50344, LR50348, LR50349, LR50350, GR46897;
b) GR46906, GR46907, GR46908, GR46909, KE64713, KE64714,
KE64715, KE64717, KE64718, KK67522, KK67523, KK67524,
KK67525, KK67526, KK67527, LK26089, LK26093, LK26096,
LK26098, LR50337, LR50339, LR50340, LR50341, LR50342,
LR50348, LR50350, GR46897.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on August 19, 2003. Firm initiated recall is complete.
REASON
Blood products, that were not tested for NAT-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1307-4.
CODE
Unit number: 2076206.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on February 25, 2004.
Manufacturing Firm: Tacoma Pierce County Blood Bank, dba Cascade Regional Blood Services, Tacoma, WA. Firm initiated recall is complete.
REASON
Blood product, which was bacterially contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Platelets. Recall # B-1525-4.
CODE
Unit number: W90171.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by telephone on December 22, 2003. Firm initiated recall is complete.
REASON
Blood Product, collected from a donor who reported having a headache with fever during the week before donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-1573-4.
CODE
Unit number: 6055465.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by telephone on June 5, 2003, and by letter, dated June 13, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1590-4.
CODE
Unit numbers: 29GV56388, 29GV56389, 29GV56390, 29GV56392, 29GV56394, 29GV56397, 29GV56398, 29GV56408, 29GV56413, 29GV56416, 29GV56417, 29GV56419, 29GV56420, 29GV56421, 29GV56424, 29GV56425, 29GV56427, and 29GV56429.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on March 2, 2004, and by letter, dated March 4, 2004. Firm initiated recall is complete.
REASON
Blood products, collected using trip scales that lacked quality control documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
VA and NC.

_______________________________
PRODUCT
a) Platelet pheresis, leukoreduced. Recall # B-1604-4;
b) Platelet pheresis, leukoreduced, irradiated. Recall # B-1605-4.
CODE
a) Units: 29FP92590, 29FP92578 (split);
b) Units: 29FP95282, 29FP92578 (split).
RECALLING FIRM/MANUFACTURER
American National Red Cross, Norfolk, VA, by letter on February 26, 2004. Firm initiated recall is complete.
REASON
Blood Products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA, NC and PA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1611-4.
CODE
Unit number FJSZWZ.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, (formerly Aventis Bio-Services), Roanoke, VA, by facsimile on December 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1621-4.
CODE
Units 49GN15128, 49GM01458, 49GN16396, 49GC02349, 49GW00301, 49GC02363, 49GC02365, 49GC01694, 49GM01457, 49GW04222, 49GW04149, 49GN15129, 49GW03899, 49GW03897, 49GW03898.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letters dated February 11, 2003 and March 18, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
OK and TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1642-4.
CODE
Unit numbers: FT05124, FT05125, FT05127, FT05128, GP54711, GV50346, GV50363, GV50364, KC68892, KC68904, KC68915, KC68931, KH44770, KJ56017, KJ56019, KJ56020, KM08189, KM08190, KM08191, KM08192, KM08193, KM08196, KM08198, LR43493, LR43495, LR43496, LR43498, LR43501, LR43504, LR43505, LR43508, LR43511, LR43512, LR43513, LR43527, LR43532, LR43535, LR43536, LR43542, LV32119, LV32128, LV32130, and LV32133.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on December 16 and 17, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured without the entire quantity of additive solution added, were distributed.
VOLUME OF PRODUCT IN COMMERCE
43 units.
DISTRIBUTION
WV, OH, and PA.

 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm); and
TAXUS Express Paclitaxel-Eluting Over-The-Wire Coronary Stent Systems (2.75 x 12mm). Recall # Z-1052-04.
CODE
MONORAIL Lot number: 6365192 (Exp date July 2004);
Over-the-wire Lot number: 6294706 (Exp date June 2004).
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by website and letter on July 2, 2004. Firm initiated recall is ongoing.
REASON
On a few occasions the balloon has failed to deflate within one minute after deployment of the stent.
VOLUME OF PRODUCT IN COMMERCE
208 Stent Systems.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Vitros Immunodiagnostic Products TROPONIN I Reagent Packs, (Lot 1110 and 1130 REF #194 9882 and Lot 2510 and 2530 REF #680 1857). Each reagent pack contains 100 coated wells. Recall # Z-1053-04.
CODE
Lot 1110 and Lot 2510 with exp. date of 8/11/04. EXPANDED 6/30/04 to include Lot 1130 and Lot 2530 with exp. date of 9/8/2004.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by telephone on June 7-8, 2004, and July 1, 2004, by letters on June 7, and July 2, 2004, and by e-mail on June 7, and June 30, 2004. Firm initiated recall is ongoing.
REASON
Random occurrence of false positive test results.
VOLUME OF PRODUCT IN COMMERCE
5,185 reagent packs (6/7/04) & 1,507 reagent packs (6/30/04).
DISTRIBUTION
Nationwide and Internationally.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

______________________________
PRODUCT
Stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D. Recall # Z-1075-04.
CODE
Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026.
RECALLING FIRM/MANUFACTURER
Orbus Medical Technologies Inc, Fort Lauderdale, FL, by letter on March 19, 2004. Firm initiated recall is ongoing.
REASON
Balloons have longer than expected deflation times.
VOLUME OF PRODUCT IN COMMERCE
22.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Dispersive Electrodes packaged in an 8x10 plastic container. Recall # Z-1076-04.
CODE
Lot codes affected: Y110503-1 and Y103003-2.
RECALLING FIRM/MANUFACTURER
Rita Medical Systems, Mountain View, CA, by letters during the week of June 21, 2004. Firm initiated recall is ongoing.
REASON
Inaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.
VOLUME OF PRODUCT IN COMMERCE
468 sets (each set consists of two pads).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
GemStar? I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271. Recall # Z-1077-04.
CODE
95-156-5H, 05-027-5H, 09-208-5H.
RECALLING FIRM/MANUFACTURER
Abbott Labs, Morgan Hill, CA, by letters on May 11, 2004. Firm initiated recall is ongoing.
REASON
The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25?C (77? F).
VOLUME OF PRODUCT IN COMMERCE
18,432 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x ?? Reference Number: 4313. Recall # Z-1078-4.
CODE
Lot Number: K527299.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by telephone on June 29, 2004. Firm initiated recall is ongoing.
REASON
Sterility of product is not assured.
VOLUME OF PRODUCT IN COMMERCE
180 CASES (400/CS).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system. Recall # Z-1082-04.
CODE
Lot 412410 printed on carton.
RECALLING FIRM/MANUFACTURER
Dynex Technologies, Inc., Chantilly, VA, by letters on June 11, 2004 and June 24, 2004. Firm initiated recall is ongoing.
REASON
An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.
VOLUME OF PRODUCT IN COMMERCE
1749 cartons.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
VSP Shock Module (as part of a prosthetic foot). Recall # Z-1083-04.
CODE
RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
RECALLING FIRM/MANUFACTURER
Ossur North America Inc, Aliso Viejo, CA, by telephone and letter on June 15, 2004. Firm initiated recall is ongoing.
REASON
Flawed shock module might cause breakage causing patient to fall.
VOLUME OF PRODUCT IN COMMERCE
37 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Linear accelerator workstation software suite. Recall # Z-1084-04.
CODE
MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by telephone beginning May 27, 2004 and by letters on June 3, 2004. Firm initiated recall is ongoing.
REASON
An anomaly occurs in the software suite (Millennium MLC Workstation v 6.3 and 6.4, Integrated Treat v.6.5) when used in combination with the standard series MLC controller software v 5.0 or 5.1.
VOLUME OF PRODUCT IN COMMERCE
155 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG
(Coronary Sinus Guide)/BCor-90/09. These sheaths
packaged in 5 individual boxed kits per case carton.
Recall # Z-1085-04;
b) SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and
CSG (Coronary Sinus Guide) KR/BCor-90.09. These
sheaths are packaged in 5 individual boxed kits per
case carton. Recall # Z-1086-04;
c) SafeSheath CSG (Coronary Sheath Guide) Multisite
(MSP)-00-6.5 and CSG (Coronary Sheath Guide)
Multisite-00.09. Recall # Z-1087-04;
d) SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD;
CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG
(Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus
Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/
L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/
L/BCor-1-09/Long. Recall # Z-1088-04.
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc, Malvern, PA, by letter on June 11, 2004. Firm initiated recall is ongoing.
REASON
Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.
VOLUME OF PRODUCT IN COMMERCE
39,605 kits.
DISTRIBUTION
CA and PA.

_______________________________
PRODUCT
The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. Recall # Z-1089-04.
CODE
Lot numbers S000121, S000122, 300748, 300783, 300784, 300792, and 300822.
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Minneapolis, MN, by letter on May 21, 2004. Firm initiated recall is ongoing.
REASON
The marker band in guidewire lumen could move from the manufactured location during clinical use.
VOLUME OF PRODUCT IN COMMERCE
1010.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Hill-Rom brand TotalCare Bed System; Model P1900. Recall # Z-1090-04.
CODE
All beds built during April and May of 2004.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letters dated June 28, 2004. Firm initiated recall is ongoing.
REASON
An incorrect warning label was placed on these beds. Warning should say, ?do not use for life sustaining equipment.....?.
VOLUME OF PRODUCT IN COMMERCE
180 beds.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
ReFORM/SilverHawk Peripheral Atherectomy Catheters, packaging currently unknown. Recall # Z-1091-04.
CODE
Lot codes 04052414 and 04052608.
RECALLING FIRM/MANUFACTURER
Fox Hollow Technologies, Redwood City, CA, by telephone and letter on June 18, 2004. Firm initiated recall is ongoing.
REASON
Gram positive Rod organisms were detected in samples after lab analysis.
VOLUME OF PRODUCT IN COMMERCE
127 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Introcan Safety IV Catheter 22G x 1? PUR with Wings. Catalog Number 4253540 - Catalog Number 4253540. Recall # Z-1092-04.
CODE
Lot number 3G26258U02, Lot number 3G27258U02.
RECALLING FIRM/MANUFACTURER
Braun B Medical Inc., Allentown, PA, by letter on March 19, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. Recall # Z-1093-04.
CODE
8XRJ.
RECALLING FIRM/MANUFACTURER
Bausch & Lomb Surgical, Inc., Clearwater, FL, by telephone on February 27, 2004 and March 2004. Firm initiated recall is ongoing.
REASON
Lens may be labeled with incorrect diopter size.
VOLUME OF PRODUCT IN COMMERCE
33 units.
DISTRIBUTION
Nationwide and Puerto Rico.

_______________________________
PRODUCT
Fischer SenoScan True View Digital Mammography System. Recall # Z-1094-04.
CODE
Product number 94829G-1, 94830G-1, 94830G-2.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp, Denver, CO, by telephone and letter on May 21, 2004. Firm initiated recall is complete.
REASON
Existing software may allow Image data to be truncated in the margin of the breast on processed patient images.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
FL, NC, NY, OK, WI, and France.

_______________________________
PRODUCT
Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163. Recall # Z-1095-04.
CODE
All software associated with Image Navigator feature in Magic View.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letters on April 1, 2004. Firm initiated recall is ongoing.
REASON
The Image Navigator feature in the MagicView 300 VA42A or VA42B software may not be imported accurately to certain CT or MR images.
VOLUME OF PRODUCT IN COMMERCE
70 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Disetronic brand 3.15 ml glass cartridges used with
H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin
pens in 10 x 10 box (10 cartidges per blister pack;
10 blister packs per box; catalog number 150.0157.
Recall # Z-1096-04;
b) Disetronic brand 3.15 ml glass cartridges used with
H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin
pens in box of 25 cartridges, 25 needles; catalog number
300.0419. Recall # Z-1097-04;
c) Disetronic brand 3.15 ml glass cartridges used with
H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin
pens, 1 cartridge; catalog number 150.0042. Recall #
Z-1098-04;

e) Disetronic brand 3.15 ml glass cartridges used with
H-tron, H-tron plus, Panomat C, Panomat P, Panomat T,
Panomat V and Dahedi Infusion pumps and Pen 10 insulin
pens, 1 cartridge; catalog number 150.0272. Recall #
Z-1100-04;
f) Disetronic brand 5 ml. glass cartridges used with the
Panomat C, Panomat P, Panomat T and Panomat V infusion
pumps, box of 25; catalog number 300.0420. Recall
# Z-1101-04;
g) Disetronic brand 5 ml. glass cartridges used with the
Panomat C, Panomat P, Panomat T and Panomat V infusion
pumps, 1 cartridge; catalog number 150.0051. Recall
# Z-1102-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated May 17, 2004. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
208 lots.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Boston Scientific/MEDI-TECH brand Fascial Dilator,
8 FR(2.7 mm), sterile, single use only, model
M001481541; Catalog No. 48-154. Recall # Z-1104-04;
b) Boston Scientific/MEDI-TECH brand Fascial Dilator,
10 FR (3.3 mm), sterile, single use only, model
M001482501, REF/Catalog No. 48-250. Recall # Z-1105-04.
CODE
a) Lots 6015906, 6028660, 6048137 and 6048138;
b) Lot 6015888.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letters dated June 16, 2004. Firm initiated recall is ongoing.
REASON
Labeling mix-up as to product size; 8FR may be labeled 10FR and vice versa.
VOLUME OF PRODUCT IN COMMERCE
2,590.
DISTRIBUTION
Nationwide and Netherlands.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

PRODUCT
d) Disetronic brand 3.15 ml glass cartridges used with
H-tron, H-tron plus, Panomat C, Panomat P, Panomat
T, Panomat V and Dahedi Infusion pumps and Pen 10
insulin pens in box of 25; catalog number 3001061.
Recall # Z-1099-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated May 17, 2004. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
208 lots.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue. a) catalog #TFS30; b) catalog #TFR60. Recall # Z-1073-04.
CODE
a) Lot number 002419 and b) lot number 002441.
RECALLING FIRM/MANUFACTURER
Lifecore Biomedical, Inc., Chaska, MMN, by letter on June 3, 2004. Firm initiated recall is ongoing.
REASON
Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
VOLUME OF PRODUCT IN COMMERCE
255.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Emission Computed Tomography System. Recall # Z-1079-04.
CODE
Model number 2163-3000A, 2163-3000B; 510K K011611.
RECALLING FIRM/MANUFACTURER
Adac Labs, Milpitas, CA, by letter on June 21, 2004. Firm initiated recall is ongoing.
REASON
Software problems may cause the detector head to drift unexpectedly.
VOLUME OF PRODUCT IN COMMERCE
483 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
FDP Plasma kit provides reagents for the detection and semi-quantitation of fibrin/fibrinogen degradation products (FDP) in plasma through the use of latex particles coated with monoclonal antibodies to FDP. The kit contains: 1 x1.3 mL vial of Reagent 1 (Latex), 1 x 20mL bottle of Reagent 2 (Buffer), 1 x 0.5mL vial of Reagent 3 (Negative Control), 1 x 0.5mL vial of Reagent 4 (Positive Control) and 10 test cards with mixing rods packaged in a predominantly white cardboard unit container. Recall # Z-1080-04.
CODE
Lot 012823 Exp October 2003.
RECALLING FIRM/MANUFACTURER
Diagnostica Stago, Inc., Parsippany, NJ, by letter dated December 4, 2002. Firm initiated recall is complete.
REASON
The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.
VOLUME OF PRODUCT IN COMMERCE
965.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Reagent 1 (STA Heparin Control 2) and 6 x 1 mL of Reagent 2 (STA Heparin Control 5) packaged in a white cardboard unit container. Recall # Z-1081-04.
CODE
Lot number 02019. Exp. 1/31/2004.
RECALLING FIRM/MANUFACTURER
Diagnostica Stago, Inc., Parsippany, NY, by letter dated 12/20/2002. Firm initiated recall is complete.
REASON
Incorrect assay ranges on the assay value insert for Heparin Control 5.
VOLUME OF PRODUCT IN COMMERCE
523.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885. Recall # Z-1106-04.
CODE
Lots 6030323, exp. 01-Nov-06; 6348004, exp. 01-Mar-07 and 6313957, exp 01-Mar-07.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter on June 30, 2004. Firm initiated recall is complete.
REASON
Mislabeled as to size; 10FR are labeled as 8FR.
VOLUME OF PRODUCT IN COMMERCE
32.
DISTRIBUTION
MO.

 

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

_______________________________
PRODUCT
a) Bulk whole corn. Recall # V-150-4;
b) Bulk rolled corn. Recall # V-151-4;
c) Bulk rolled corn with added fat. Recall # V-152-4.
CODE
No coding information is used.
RECALLING FIRM/MANUFACTURER
Fresno Farming LlC, Traver, CA, by letters on June 30, 2004. Firm initiated recall is ongoing.
REASON
Corm for feed may be contaminated with ruminant meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Unknown.
____________________________
PRODUCT
a) Fort Dodge Amiglyde-V Injection, Amikacin Sulfate,
Veterinary Injection, Equivalent to 50 mg. Amikacin
per mL, packaged in 50-ml. vials, 48 vials per case,
RX, NADA 127-892, NDC 0856-2326-20. Recall # V-153-4;
b) Fort Dodge Cal-Dextro No. 2 Sterile Solution,
packaged in 500-ml. bottles (12 per case), each mL
contains 16.84 mg. (8.42 g/500mL) calcium (as gluconate
salt), 9.8 mg. (4.9 g/500 mL) phosphorus, 3.84 mg.
(1.92 g/500 mL) magnesium, and 165 mg. (82.5 g/500 ml)
dextrose, RX, NDC #0856-0263-01. Recall # V-154-4;
c) Fort Dodge Cal Dextro Special Sterile Solution, packaged
in 500-mL bottles (12 per case), each mL contains 22 mg.
(11 g/500/mL) calcium (as glucontate salt), 1.022 mg.
(511 mg/500 mL) phosphorus, 0.402 mg. (201 mg/500 mL)
magnesium, and 150 mg. (75 g/500 mL) dextrose, RX,
NDC 0856-0271-01. Recall # V-155-4;
d) Fort Dodge Factrel, Gonadorelin Hydrochloride, 50 mcg/mL
Sterile Solution, packaged in 20 mL and 50 mL multidose
vials (24 per case), RX, NADA 139-237, NDC 0856-4311-02.
The product is also distributed to Canada under the
Ayerst Factrel label. Recall # V-156-4;
e) Fort Dodge Flucort Flumethasone Solution, Sterile, each
mL contains 0.5 mg. flumethasone, packaged in 100-mL
multidose vials (72 per case), RX, NADA 030-414,
NDC 0856-0820-20. The product is also distributed to
Canada under the Ayerst Flucort Flumethasone Injection
Label. Recall # V-157-4;
f) Ketamine Hydrochloride Injection, USP, packaged under
the Fort Dodge Vetalar and Fort Dodge Ketaset labels,
100 mg/mL, packaged in 10-mL vials (144 vials per case),
RX, NADA 045-290, NDC 0856-2012-01. The product is also
distributed to Canada under the Ayerst Ketaset label.
Recall # V-158-4;
g) Fort Dodge ProHeart 6 (moxidectin) Sustained Release
Injectable for Dogs, packaged in 5-packs (20/5-packs per
case) and 10-packs (10/10 packs per case), RX, NADA 141-
189, NDC 0856-3670-25 (5-pack), NDC 0856-3670-20
(10-pack). Foreign distribution is made to Canada under
the Ayerst ProHeart 6 label, and to Italy under the Fort
Dodge Guardian SR label. Recall # V-159-4;
h) Fort Dodge PromAce Injectable, Acepromazine Maleate
Injection, USP, equivalent to 10 mg/mL Acepromazine
Maleate, USP, packaged in 50-mL multiple dose vials
(24 per case), RX, NADA 015-030, NDC 0856-3020-01.
The product is also distributed under the following
foreign label for Canadian distribution: Ayerst Atravet
10 mg. Injectable. Recall # V-160-4;
i) Fort Dodge Torbugesic Butorphanol Tartrate Veterinary
Injection containing 10 mg. butophanol base per mL as
butorphanol tartrate, USP, packaged in 10-ml and 50-ml.
vials (24/10-ml. per case and 48/50-ml per case), RX,
NADA 135-780, NDC 0856-2033-20. Foreign distribution is
made to: (1) Canada under the Wyeth Torbugesic label;
(2) United Kingdom under the Fort Dodge Torbugesic
Injection label. (3) Denmark under the Fort Dodge
Torbugesic Vet label. Recall # V-161-4.
CODE
a) Lot 410206;
b) Lots 263952, 263953, 263954,263955, 263956, 263957,
263958,263959, and 263960;
c) Lot 271749;
d) Lots 431334 and 431336 (50?mL only);
e) Lots 005529, 005230, and 005231;
f) Ketaset - Lots 440641, 440642, 440643, 440644, 440645,
440646, and 440647; Vetalar - Lot 440642;
g) Lots 367162220, 367162221, 367164223, and 367164224;
h) Lots 020118 and 020119;
i) Lots 454416, 454417 (10-mL only), and 454418.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories Inc, Fort Dodge, IA, by e-mail and letters dated May 13, 2004. FDA initiated recall is ongoing.
REASON
GMP deviations cited during an inspection cause the sterility of the products to be questionable.
VOLUME OF PRODUCT IN COMMERCE
443,096 vials.
DISTRIBUTION
Nationwide and Internationally.
 

END OF ENFORCEMENT REPORT FOR JULY 21, 2004

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