June 25, 2003
03-26
_______________________________
PRODUCT
Frozen Dough Cranberry Orange Triangle Scones, 72 Units. Net Weight 19.13 Lbs. Product Number: 60326.
Recall # F-400-3.
CODE
Date/Lot: 017032.
RECALLING FIRM/MANUFACTURER
Titteringtons Old English Bake, Woburn, MA, by fax on March 10, 2003, and by letter and press release on March 12, 2003. Firm initiated recall is complete.
REASON
The product, labeled as Cranberry Orange Scones, actually contained Cranberry Walnut Scones - Undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
112 cases.
DISTRIBUTION
PA, MD, VA, and WV.
_______________________________
PRODUCT
a) GLORY FOODS, Seasoned, Southern Style, KALE GREENS,
Net WT. 27oz. (1 lb-11oz), Slow Simmered for Flavor.
Recall # F-401-3;
b) GLORY FOODS, Seasoned, Southern Style, TURNIP GREENS,
Net WT. 27oz. (1 lb-11oz), Slow Simmered for Flavor.
Recall # F-402-3.
CODE
a) GK25/KGLC and GK22/CGLC;
b) GK25/TGLC.
RECALLING FIRM/MANUFACTURER
McCall Farms, Inc., Effingham, SC, by letters on December 24, 2002, and press release on December 26, 2002. Firm initiated recall is ongoing.
REASON
The product may be post processing contaminated with food pathogens.
VOLUME OF PRODUCT IN COMMERCE
24,733 cases.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Methylene Blue Injection, USP, 1%, lmL, 10 vials per
carton, Rx only. Recall # D-251-3;
b) Myochrysine, Gold Sodium Thiomalate Injection, USP,
50 mg/mL, 1 mL Single Dose Vials and 10 mL Multiple Dose
Vials, Rx only. Recall # D-252-3;
c) Edex Diluent, (bacteriostatic 0.9% sodium chloride
injection preserved with benzyl alcohol 0.945% w/v),
1.2mL syringe, Rx Only. Recall # D-253-3;
d) Sarapin Injection, 50 mL vials. Recall # D-254-3.
CODE
a) Lot 21192, Exp 2/04;
b) Lot 41092, Exp 4 (mL vial) Lots 41082, Exp 4/04 (10mL
vial) and Lot 51242, Exp 5/04 (10mL vial);
c) Lots 61062, 121232;
d) Lots 31272, 41132, 51312.
RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL, by letters on April 3, 2003. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
a) 20,582 vials;
b) 19,168 vials;
c) not supplied;
d) 50,667 vials;
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Cholestyramine for Oral Suspension, USP Powder, 4 grams cholestyramine resin, USP, per packet, 60 single dose packets, Apothecon. Recall # D-259-3.
CODE
Lot no. 1A32512 Exp. Date 2/29/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ, by letters on April 11, 2003.
Manufacturing Firm: Bristol-Myers Squibb Company, Prinston, NJ. Firm initiated recall is ongoing.
REASON
Superpotent (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
2,011 ctns/60 packets ea.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
OxyContin Tablets (oxycodone hydrochloride controlled-release), 10 mg, 25 count unit dose packages, Rx only, For Hospital Use. Recall # D-265-3.
CODE
Lot SG11 exp. 2/28/2006.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by telephone on March 17, and 21, 2003. Firm initiated recall is ongoing.
REASON
NDA Filing Discrepancy; supplement not filed for new supplier of inactive ingredient.
VOLUME OF PRODUCT IN COMMERCE
9,732-25 count blister packs.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Cornea. Recall # B-1044-3.
CODE
ID number 03-097-1.
RECALLING FIRM/MANUFACTURER
Utah Lions Eye Bank, Salt Lake City, UT, by letter on March 20, 2003. Firm initiated recall is complete.
REASON
Cornea that was collected from a donor who was found to test repeatedly reactive for Hepatitis B Core antibody (HbcAb) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
UT.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1135-3;
b) Recovered Plasma. Recall # B-1136-3.
CODE
a) and b) Unit number 50E24218.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by letter and fax on November 26, 2002 or December 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding having tested positive for hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and Switzerland.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1144-3.
CODE
Unit 04C64041.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by electronic mail on December 6, 2002.Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of having tested positive for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1151-3;
b) Platelets. Recall # B-1152-3;
c) Fresh Frozen Plasma. Recall # B-1153-3.
CODE
a), b), and c) Unit number 13FM77147.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letters on January 6, 2003, and February 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-1154-3;
b) Platelets, Irradiated. Recall # B-1155-3.
CODE
a) Unit numbers 13FM88958, 13FM88928, 13FM88948,
and 13FM88956;
b) Unit number 13GM76657.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on January 6, 2003, and by letter on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products were not irradiated but were distributed with labeling that indicated that the units had been irradiated.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1156-3.
CODE
Unit number 13T96271.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated December 16, 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
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1157-3;
Platelets. Recall # B-1158-3.
CODE
a) and b) Unit number 22KT44570.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters dated June 5, 2002, and July 5, 2002. 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
PA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1159-3;
b) Platelets, Leukocytes Reduced. Recall # B-1160-3.
CODE
a), and b) unit number 22FV93238.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region,
Philadelphia, PA, by letters dated May 24, 2002, and June 24, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
PA, and NJ.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1162-3;
b) Platelets, Leukocytes Reduced. Recall # B-1163-3;
c) Recovered Plasma. Recall # B-1164-3.
CODE
a), b) and c) Unit number 22FJ71665.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on March 26, 2002, and letter on March 29, 2002. Firm initiated recall is complete.
REASON
Blood products, that 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
3 units.
DISTRIBUTION
PA, VA, and CA.
_______________________________
PRODUCT
Platelets. Recall # B-1165-3.
CODE
Unit number 22KM75770.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on February 26, 2002, and letter on March 5, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-1166-3.
CODE
Unit number 04L42295.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated November 21, 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
MA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1167-3.
CODE
Unit numbers 04KL72173 and 04KL66070.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter on November 13, 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
2 units.
DISTRIBUTION
VT.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1168-3;
b) Recovered Plasma. Recall # B-1169-3.
CODE
a) and b) Unit number 04GK27366.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by facsimile on December 20, 2002, and by letter on December 24, 2002. Firm initiated recall is complete.
REASON
Blood products tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY, and CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1170-3
CODE
Unit number 50LJ50599.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Western Lake Erie Region, Toledo, OH, by telephone on November 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected using a phlebotomy method that may compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1171-3;
b) Recovered Plasma. Recall # B-1172-3.
CODE
a) and b) Unit number LL75668.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by telephone on February 5, 2001, and by letter dated February 5, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1173-3;
b) Platelets. Recall # B-1174-3.
CODE
a), and b) Unit number 4108271.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and letter dated February 5, 2002. 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
TX, and NY.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1175-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1176-3;
c) Platelets. Recall # B-1177-3.
CODE
a) Unit number 4100696;
b), and c) Unit number 4288465.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and letter dated April 19, 2002. 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
3 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1189-3;
b) Platelets. Recall # B-1190-3.
CODE
a) and b) Unit number 4284534.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile dated January 8, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1192-3;
b) Recovered Plasma. Recall # B-1193-3.
CODE
a), and b) Unit number 18230-1151.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone and facsimile dated January 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY, and Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1194-3;
b) Platelets. Recall #B-1195-3;
c) Fresh Frozen Plasma. Recall # B-1196-3;
d) Cryoprecipitated AHF. Recall # B-1197-3.
CODE
a), b), c), and d) Unit number 3787166.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on February 22, 2002, and by facsimile dated February 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, and SC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1220-3.
CODE
Unit numbers 0020754322, 0020754729, 0020755051, 0020755442, 0020755775, 0020756164,
0020756588, and 0020757359.
RECALLING FIRM/MANUFACTURER
Nabi, Norfolk, VA, by letter on July 11, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not
include questioning regarding risk factors for new variant Creutzfeldt-Jacob
disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1221-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1222-3;
CODE
a) Unit numbers C46090 and KQ29143;
b) Unit number C40796.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letters on June 11, and 26, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from an ineligible donor due to a subsequent report of a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA, and TX.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1223-3;
b) Recovered Plasma. Recall # B-1224-3.
CODE
a), and b) Unit numbers 35FH46064, 35FH52457, and 35GC00421.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Appalachian Region, Roanoke, VA, by facsimile on January 30, 2002, and by letter on February 6, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from an ineligible donor due to a subsequent report of a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
VA, and CA.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1226-3.
CODE
Unit number 53GL13129.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, by facsimile May 20, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1227-3;
b) Plasma. Recall # B-1228-3.
CODE
a), and b) Unit number 29FS84448.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letters on January 24, 2003, and February 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1229-3.
CODE
Unit number 29GF31819.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by letter dated February 5, 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
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes. Recall # B-1231-3;
b) Recovered Plasma. Recall # B-1232-3.
CODE
a), and b) Unit number 27GX40430.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA, by letter dated December 27, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA, and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1243-3.
CODE
Unit number 53GH57572.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters on January 23, 2003, and February 13, 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
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1244-3;
b) Platelets. Recall # B-1245-3.
CODE
a) Unit numbers 4207948 and 4181168;
b) Unit number 4181168.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, 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.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1246-3;
b) Platelets. Recall # B-1247-3.
CODE
a), and b) Unit number 4229251.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on April 19, 2002. 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
TX.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1248-3;
b) Platelets. Recall # B-1249-3.
CODE
a), and b) Unit number 4275066.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on June 11, 2002. 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
TX.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1250-3.
CODE
Unit number 4328690 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on July 26, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1252-3.
CODE
Unit number 4251163.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on April 22, 2002. Firm initiated recall is complete.
REASON
Blood product, that was below the firm's specification for red blood cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1253-3;
b) Recovered Plasma. Recall # B-1254-3.
CODE
a) and b) Unit numbers 6850866, 5433676, 5702938, and 5245809.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by facsimile on February 6, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
LA, TX, FL, CA, and NY.
_______________________________
PRODUCT
Source Plasma. Recall # B-1269-3.
CODE
Unit numbers G-94172-070, G-93996-070, G-93558-070,
G-93297-070, G-92935-070, G-92569-070, G-92302-070,
G-91960-070, G-91657-070, G-90078-070, G-89735-070,
G-89482-070, G-89123-070, G-88896-070, G-88574-070,
G-88329-070, G-87972-070, G-87464-070, G-87263-070,
G-86844-070, G-86632-070, G-86176-070, G-85964-070,
G-85604-070, G-85357-070, G-84973-070, G-84731-070,
G-84307-070, G-84120-070, G-83707-070, G-83511-070,
G-83161-070, G-82968-070, G-81309-070, G-80615-070,
G-80359-070, G-79944-070, G-79633-070, G-79049-070,
G-78830-070, G-78370-070, G-78045-070, G-77651-070,
G-77381-070, G-77010-070, G-76656-070, G-76297-070,
G-75895-070, G-75633-070, G-75246-070, G-74847-070,
G-72379-070, G-71954-070, G-71759-070, G-71320-070,
G-71033-070, G-70559-070, and G-69553-070.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corp., Vancouver, WA, by facsimile on February 13, and 19, 2002. Firm initiated recall is complete.
REASON
Blood products, tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
58 units.
DISTRIBUTION
CA, Spain, and Switzerland.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1161-3.
CODE
Unit number 22KQ67825.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on March 12, 2002, and by letter dated March 29, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Source Plasma. Recall # B-1219-3.
CODE
Unit number 57561622.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Danville, VA, by facsimile on February 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer 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
CA.
_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1225-3.
CODE
53LP37152, 53GK27517, 53GK27513, 53LP37147, 53LF69115, and 53GK27518; and the following unit was distributed as two split products: unit number 53GK27514.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on January 9, 2003, and by letter on January 13, 2003.Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
MD, and Washington, D.C.
_______________________________
PRODUCT
Platelets. Recall # B-1251-3.
CODE
Unit numbers 4391691 and 4391692.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on November 18, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood possibly collected and/or stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and TN.
_______________________________
PRODUCT
Stryker Secure II hospital bed; model 3002.
Recall # Z-0868-03.
CODE
Serial numbers 030415710, 030415711, 030415712, 030415713, 030415714 and 030415729.
RECALLING FIRM/MANUFACTURER
Stryker Medical, Kalamazoo, MI, by on site visits, beginning on May 1, 2002. Firm initiated recall is complete.
REASON
A wire may break at the crimp and present a potential electric shock hazard.
VOLUME OF PRODUCT IN COMMERCE
6
DISTRIBUTION
PA, and KS.
_______________________________
PRODUCT
a) Product is a drill used in dental surgery labeled in
part: OFDR8 OsseoFix Drill 8mm Length 3i. Non Sterile
Contents must be sterilized prior to use. RX only.
Recall # Z-0923-03;
b) Products are surgical drills packaged separately or
included in a surgical kit so two products will be
listed. The second product is the 8mm drill included in
a kit and It is labeled as OFKIT2 OsseoFix System
Complete (Kit)3i. Non Sterile Contents must be
sterilized prior to use. RX only. Recall # Z0924-03.
CODE
a) Lot numbers 126509, 183758, 186315, 188528, 187918,
188867, 190033, 191429, 196769;
b) Lot numbers 127726 and 191427.
RECALLING FIRM/MANUFACTURER
Implant Innovations, Inc., Palm Beach Gardens, FL, by fax and e-mail on May 9, 2003, and by letters on May 12, 2003. Firm initiated recall is ongoing.
REASON
Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.
VOLUME OF PRODUCT IN COMMERCE
200.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6" LL. Model Number 2N9205K. Recall # Z-0925-03.
CODE
Lot D207201.
RECALLING FIRM/MANUFACTURER
Venetec Intl, Inc., San Diego, CA, by telephone on or about May 12, 2003, and by letter on or about May 14, 2003. Firm initiated recall is ongoing.
REASON
Set tubing disconnected from the male luer lock during use on patients. Misassembled.
VOLUME OF PRODUCT IN COMMERCE
500 units.
DISTRIBUTION
CT, IN, PA, and TN.
_______________________________
PRODUCT
Misys Laboratory System. Recall # Z-0926-03.
CODE
Version 5.3.
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by Product Safety Notice issued on May 13, 2003. Firm initiated recall is ongoing.
REASON
Two clients reported Quality Assurance dates could not be entered after 5/19/03.
VOLUME OF PRODUCT IN COMMERCE
466.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) System O2, Portable Humidified Oxygen Delivery System
Over 99% pure humidified oxygen. Box Includes Delivery
system with Clear Base. 4 White Powder refills. 4 Black
Powder refills. Water bottle. Nasal cannula. Medium
concentration mask. Carry Case. Unit is intended
to provide oxygen for emergency use. Recall # Z-0929-03;
b) Rejuv O2 Home Oxygen Spa - 98% + Pure, Non-pressurized
Oxygen for Breathing. Reusable system. Box Includes
Reusable reaction chamber with dome assembly. 4 White
Powder refills. 4 Black Powder refills. Reusable water
bottle. Nasal cannula. Medium concentration mask. Canvas
Carry Bag. This system is designed expressly for
cosmetic and nutraceutical applications. Manufactured by
Oxygen Delivery Systems, LLC, 490 Mathis Airport Road,
Suwanee, GA. Recall # Z-0930-03.
CODE
All units are under recall.
RECALLING FIRM/MANUFACTURER
System O2, Inc., Roswell, GA, by telephone and letter on May 1, 2002. Firm initiated recall is ongoing.
REASON
System 02 oxygen flow rate found to be inadequate and Rejuv 02 Home Oxygen Bar contains 'Adulterated Labeling'.
VOLUME OF PRODUCT IN COMMERCE
2000 units.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Line Powered RePaks, Model Number 1785S. Recall # Z-0931-03.
CODE
Between 04/09/03 and 05/07/03, (Model 1785S) were shipped.
RECALLING FIRM/MANUFACTURER
Rehabilicare, New Brighton, MN, by letters dated May 21, 2003. Firm initiated recall is ongoing,
REASON
If there is a short, excessive heat could be generated in the transformer due to the use of the wrong fuse.
VOLUME OF PRODUCT IN COMMERCE
618 Line Powered RePaks.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Synapse. Recall # Z-0932-03.
CODE
Version 2.2.1 and 2.3.1.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12, 2003. Firm initiated recall is ongoing.
REASON
Synapse Version 2.2.1 and 2.3.1software (Free-Hand Region) may lead to incorrect
density calculations during CT scan.
VOLUME OF PRODUCT IN COMMERCE
54 units.
DISTRIBUTION
Nationwide, Canada, Germany, Isrel, and Japan.
_______________________________
PRODUCT
Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets. Recall # Z-0933-03.
CODE
Catalog #352004 - Lot #s 0060390643, 0060390644,
0060395269, 60395272, 60429525, 0060411651,
0060426960, 0060429525, and 0060430054;
Catalog #352049 - Lot #s 0060381759, 0060384115,
0060386555, 0060388678, 0060391072, 0060392950,
0060397344, 0060399612, 0060405055, 0060406467,
0060408425, 0060410255, 0060411638, 0060412823,
0060419500, 0060421552, 0060426399, 0060429531,
0060430749, 0060435319, 0060437596, and 0060437913;
Catalog #352051 - Lot #s 0060419038 and 0060419039; Catalog #352222 - Lot #s 0060381626, 0060386862,
0060390599, 0060393331, 0060397325, 0060411966,
0060417244, 0060420643, and 0060429830;
Catalog #352223 - Lot #s 0060395209, 0060420353, and
0060432419;
Catalog #352224 - Lot # 0060374720;
Catalog #352225 - Lot #s 0060406237, 0060411540, and
0060417245;
Catalog #352237 - Lot #s0060386868, 0060384090, 0060397352,
006042859, 0060435289 and 0060393337;
Catalog #352238 - Lot #s 0060379443, 0060413601, 0060419352
and 0060397391;
Catalog #352340 - Lot # 0060399651;
Catalog #352341 - Lot #0060419800;
Catalog #352342 - Lot #s 0060385368 and 0060386187;
Catalog #352355 - Lot #s 0060381731, 0060386533, 060405539,
and 0060421540;
Catalog #352356 - Lot #s 0060384095, 0060405753, 060412569,
0060419498, and 0060428603;
Catalog #352362 - Lot # 0060390627;
Catalog #352379 - Lot #s 0060386755 and 0060390530;
Catalog #352393 - Lot #s 0060379061, 0060386808, 060390531,
0060395158, 0060397119, and 0060417162;
Catalog #352396 - Lot #s 0060379062, 0060385889, 060390534,
0060397122, and 0060408823;
Catalog #352406 - Lot #s 0060388274, 0060395165, 060397235,
0060408828, 0060411870, and 0060420593;
Catalog #352409 - Lot # 0060388275;
Catalog #352413 - Lot #s 0060397890, 0060409013, 060411626,
and 0060411975;
Catalog #352420 - Lot #s 0060406524, 0060412700, 060421691,
0060432013, 0060432988, and 0060433472;
Catalog #352421 - Lot #s 0060404049, and 0060411708; Catalog #352422 - Lot #s 0060404062, 006040908, and
0060417538;
Catalog #352423 - Lot # 0060404052;
Catalog #352444 - Lot # 0060417840;
Catalog #352446 - Lot # 0060417838;
Catalog #352455 - Lot # 0060417841;
Catalog #375038 - Lot #s 0060406603 and 0060408468;
Catalog #375084 - Lot #s 0060397187 and 0060422174;
Catalog #375088 - Lot #s 0060381216, 0060386872, and
0060417250;
Catalog #375090 - Lot #s 0060386873, 0060411552, and
0060417251;
Catalog #375100 - Lot #s 0060381725, 0060384081,
0060384082, 0060385182, 0060388670, 0060388671,
0060391024, 0060395171, 0060395185, 0060398414,
0060403467, 0060403471, 0060408406, 0060408407,
0060408408, 0060410249, 0060411025, 0060412517,
0060412992, 0060413598, 0060418255, 0060418257,
0060418455, and 0060421541;
Catalog #375101 - Lot #s 0060386532, 0060395172,
0060399599, 0060406462, 0060410025, 0060418444,
0060426298, 0060427317, and 0060438111;
Catalog #375105 - Lot #s 0060391170, 0060397412,
0060399667, 0060403501, 0060405234, 0060410306,
0060412697, 0060424455, 0060427890, 0060430736, and
0060432994;
Catalog #375135 - Lot # 0060393350;
Catalog #375151 - Lot #s 0060399411, 0060408845, and
0060424446;
Catalog #375155 - Lot #s 0060408847 and 0060419024;
Catalog #472033 - Lot #s 0060373796, 0060373797,
0060373800, 0060378892, 0060378893, and 0060378894; Catalog #473436 - Lot #s 0060385366, 0060386542,
0060395227, 0060423199, 0060424318, 0060425256,
0060425671, 0060428044, and 0060432415;
Catalog #473992 - Lot # 0060432401;
Catalog #474516 - Lot # 0060401098;
Catalog #474577 - Lot #s 0060381183, 0060382531,
0060388314, and 0060411522;
Catalog #474912 - Lot #s 0060398364 and 0060417227;
Catalog #CC1260-SP02 - Lot #s 0060428236, 0060432935,
0060438115, and 0060432936;
Catalog #S5403001N - Lot #s 0060378529, 0060380587,
0060387639, 0060392813, and0060407453;
Catalog #S9903301N - Lot # 0060418246;
Catalog #US1380 - Lot #s 0060391069 and 0060403474;
Catalog #US3115 - Lot #s0060387950, 0060388508, 0060406192,
0060410297, 0060419358, 0060419972, 0060426441, and
0060428624;
Catalog #US3116 - Lot # 0060410763;
Catalog #US3120 - Lot #s 0060386610, 0060397408,
0060406515, 0060410310, 0060413656, 0060424458,
0060427887, and0060435342;
Catalog #US3130 - Lot #s 0060381801, 0060384195,
0060386619, 0060386621, 0060386792, 0060387920,
0060387921, 0060388758, 0060390219, 0060391167,
0060391168, 0060393010, 0060395363, 0060395364,
0060395373, 0060397407, 0060398938, 0060403494,
0060403495, 60405210, 60408590, 0060406071,
0060408480, 0060408485, 0060408590, 0060412691,
0060412692, 0060413650, 0060413651, 0060417595,
0060418182, 0060419378, 0060419381, 0060419384,
0060421685, 0060421687, 0060423935, 0060424451,
0060424452, 0060424453, 0060424459, 0060424460,
0060424699, 0060425148, 0060426360, 0060426361,
0060427884, 0060427885, 006040058, 0060430943,
0060430944, 0060430945, 0060435339, 0060435816,
0060437605, 0060437607, and 0060437609;
Catalog #US3131 - Lot #s 0060385347, 0060385365, and
0060386180;
Catalog #US3169 - Lot #s 0060397410 and 0060413655;
Catalog #US3485 - Lot #s 0060384044, 0060397229,
0060408385, 0060410245, 0060413662, 0060420137,
0060421697, 0060432014, and 0060435399;
Catalog #US3488 - Lot #s 0060386525 and 0060412568; Catalog #US5300 - Lot #s S-0776, S-0777, S-0778, S-0903,
30049, 30096, 30149, and 30150;
Catalog #US6413 - Lot #s 0060381721, 0060397240,
0060403462, 0060411045, 0060411635, 0060412564,
0060418436, and 0060432400;
Catalog #US6415 - Lot #s 0060386526 and 0060412567;
Catalog #V5534-SP02 - Lot #s 0060405704 and 0060417228.
RECALLING FIRM/MANUFACTURER
Braun, B Medical, Inc., Allentown, PA, by letters dated April 14, 2003. Firm initiated recall is ongoing.
REASON
Possible leakage.
VOLUME OF PRODUCT IN COMMERCE
2,577,300 units.
DISTRIBUTION
Nationwide, Germany, Canada, and Spain.
_______________________________
PRODUCT
T-U-R-Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02. Recall # Z-0934-03.
CODE
List number 15252-04-02, lot 940285H.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003. Firm initiated recall is ongoing.
REASON
The irrigation set was mislabeled with the wrong delivery rate of 8 drops/ml when it actually has a delivery rate of ll drops/mL.
VOLUME OF PRODUCT IN COMMERCE
60 units.
DISTRIBUTION
LA.
_______________________________
PRODUCT
Sanarus brand Centrica( Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack). Recall # Z-0935-03.
CODE
Lot # 28090403.
RECALLING FIRM/MANUFACTURER
Sanarus Medical Inc., Pleasanton, CA, by letters on May 13, 2003. Firm initiated recall is ongoing.
REASON
Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.
VOLUME OF PRODUCT IN COMMERCE
83 units.
DISTRIBUTION
MD, TN, TX, OH, and IL.
_______________________________
PRODUCT
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020. Recall # Z-0936-03.
CODE
List number 19020-04-12, lot 941845H.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003.
Manufacturer: Costa Rica, Abbott Laboratories, North Chicago, IL. Firm initiated recall is ongoing.
REASON
The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL.
VOLUME OF PRODUCT IN COMMERCE
4,656 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
a) CryoValve Pulmonary Valve & Conduit.
Recall # Z-0938-03;
b) CryoValve Pulmonary Valve & Conduit. Recall # Z0939-03.
CODE
a) and b) Donor #64108, Serial #7984345, Model #PV00 and
Donor #55416, Serial # 7253418, Model #PV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on May 23, 2003. Firm initiated recall is ongoing.
REASON
Microorganisms detected in associated allografts.
VOLUME OF PRODUCT IN COMMERCE
2 individual heart valve allografts.
DISTRIBUTION
CT.
_______________________________
PRODUCT
LIFEPAK CR Plus defibrillator. Recall # Z-0940-03.
CODE
All serial numbers below 31058753.
RECALLING FIRM/MANUFACTURER
Medtronic Physio Control Corp., Redmond, WA, by letter on May 23, 2003. Firm initiated recall is ongoing.
REASON
Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE
7,095 units.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 8, 10 and 11 French sizes only). Recall # Z-0941-03.
CODE
Catalog Numbers 401811M, 401923M, 401845M, 401935M, 401955M, 401911M, 401823 Also there are 636 specific lot numbers as follows: Catalog number Lot Number 401011M 40102114 401011M 40202950 401011M 40202950 401011M 40302315 401011M 40502170 401011M 41002991 401011M 41101111 401011M 41201721 401011M 41201898 401011M 50102160 401011M 50102160 401011M 50203190 401011M 50203190 401011M 50402054 401011M 50402054 401011M 50402323 401011M 50502275 401011M 51002576 401011M 51002576 401011M A0202879 401011M A0402425 401011M A0402425 401011M A0402809 401011M A0402809 401011M A0702953 401011M A0801019 401011M A0801298 401011M A0802511 401011M A1001609 401011M A1201755 401011M X0102305 401011M X0102305 401011M X0202591 401011M X0302562 401011M X0602226 401011M X0702049 401011M X0702828 401011M X0802394 401011M X0902132 401011M X0902535 401011M X1001444 401011M X1101158 401011M X1101717 401011M X1101717 401011M X1102221 401023M 40103575 401023M 40202378 401023M 40302816 401023M 40302816 401023M 40502368 401023M 40602515 401023M 41001756 401023M 41201511 401023M 50102176 401023M 50103742 401023M 50203192 401023M 50402141 401023M 50402141 401023M A0202574 401023M A0402445 401023M A0402445 401023M A0502351 401023M A0502351 401023M A0702965 401023M A0801240 401023M A0802518 401023M A0901911 401023M A1002290 401023M A1101856 401023M A1102652 401023M A1201677 401023M X0103383 401023M X0202812 401023M X0402634 401023M X0502655 401023M X0602239 401023M X0701056 401023M X0702030 401023M X0702835 401023M X0802402 401023M X0902137 401023M X1001459 401023M X1002715 401023M X1101732 401023M X1102232 401111M 40502481 401111M 40602534 401111M 40702040 401111M 40702040 401111M 41201722 401111M 50402324 401111M 50502276 401111M A0202594 401111M A0302241 401111M A0302241 401111M A0402426 401111M A0402426 401111M A0602559 401111M A0602559 401111M A0802631 401111M A1002395 401111M A1002395 401111M A1002418 401111M A1102643 401111M X0102205 401111M X0102205 401111M X0102205 401111M X0402517 401111M X0702829 401111M X0802395 401111M X0802537 401111M X1002704 401111M X1102222 401123M 40402551 401123M 40702044 401123M 40802500 401123M 41001594 401123M 41201512 401123M 50102177 401123M 50102177 401123M A0402446 401123M A0402838 401123M A0602028 401123M A0602993 401123M A0602993 401123M A1002394 401123M A1202284 401123M X0202203 401123M X0402153 401123M X0702681 401123M X0702685 401123M X0702685 401123M X0802403 401123M X0802538 401123M X1002710 401123M X1101733 401123M X1102233 401805M 40502356 401805M 40502791 401805M 40702534 401805M 41102050 401805M 41102059 401805M 50702455 401805M 51002382 401805M 51102323 401805M A0802599 401805M X0502531 401805M X0802151 401811M 40102003 401811M 40102003 401811M 40102637 401811M 40102866 401811M 40202479 401811M 40202479 401811M 40302143 401811M 40302143 401811M 40302827 401811M 40402550 401811M 40402550 401811M 40602096 401811M 40602369 401811M 40702580 401811M 40802491 401811M 41001442 401811M 41001742 401811M 41002003 401811M 41002796 401811M 41002796 401811M 41002853 401811M 41101500 401811M 41102051 401811M 41102060 401811M 41201547 401811M 41201547 401811M 41201547 401811M 41201901 401811M 41201901 401811M 50102161 401811M 50402539 401811M 50502281 401811M 50702456 401811M 50702492 401811M 51002383 401811M 51002390 401811M 51102324 401811M 51102357 401811M A0203173 401811M A0203181 401811M A0302247 401811M A0302247 401811M A0402306 401811M A0402306 401811M A0402691 401811M A0702331 401811M A0702882 401811M A0802601 401811M A0902986 401811M A0902993 401811M A1002995 401811M A1101812 401811M A1102587 401811M A1102592 401811M A1201316 401811M A1201519 401811M X0102306 401811M X0102306 401811M X0202595 401811M X0402131 401811M X0402900 401811M X0702325 401811M X0802152 401811M X1001304 401811M X1002705 401811M X1101162 401811M X1102150 401823M 40102668 401823M 40202125 401823M 40202125 401823M 40202903 401823M 40302818 401823M 40602519 401823M 40702590 401823M 40802496 401823M 40802501 401823M 40902776 401823M 41002006 401823M 41002011 401823M 41002855 401823M 50702465 401823M 50702470 401823M 50802091 401823M 51002392 401823M 51002393 401823M 51102363 401823M 51102367 401823M A0202456 401823M A0202456 401823M A0302937 401823M A0402096 401823M A0402638 401823M A0402698 401823M A0402698 401823M A0602032 401823M A0602995 401823M A0702891 401823M A0802630 401823M A0902146 401823M A1002291 401823M A1102596 401823M A1102598 401823M X0103288 401823M X0202603 401823M X0202603 401823M X0202814 401823M X0202814 401823M X0402050 401823M X0402050 401823M X0402991 401823M X0502520 401823M X0602242 401823M X0702033 401823M X0802190 401823M X0902537 401823M X1002711 401823M X1102160 401835M 40602372 401835M 40702588 401835M 51102361 401835M A0502826 401835M A0602582 401835M A0902893 401835M A1102593 401835M X0502516 401835M X0802187 401845M 40102666 401845M 40103555 401845M 40302815 401845M 41001775 401845M 41002004 401845M 41102062 401845M 41201510 401845M A0202572 401845M A0302248 401845M A0402697 401845M A0502827 401845M A0502827 401845M A0502827 401845M A0602583 401845M A0702888 401845M X0402161 401845M X0502517 401845M X0702027 401845M X0802953 401855M 51102362 401855M A0302931 401855M A0702341 401855M A0902894 401855M A1102594 401855M X0402162 401855M X0402162 401855M X0402643 401855M X0502518 401855M X0702910 401855M X0802188 401890M 40303594 401890M 40402408 401890M 40802495 401890M A0602584 401890M A0702890 401890M A0902145 401890M A0902895 401890M A1102595 401890M A1102595 401890M X0103287 401890M X0302897 401890M X0402986 401890M X0502519 401911M 40102867 401911M 40402116 401911M 40602535 401911M 40602535 401911M 40702041 401911M 40902061 401911M 41002797 401911M 41002992 401911M 51002560 401911M 51002560 401911M A0502186 401911M A0502868 401911M A0802603 401911M A0802844 401911M A0802846 401911M A0902135 401911M A0902987 401911M A1002281 401911M A1002411 401911M A1102644 401911M A1202285 401911M A1202289 401911M X0202181 401911M X0402617 401911M X0402617 401911M X0402901 401911M X0502340 401911M X0502773 401911M X0602232 401911M X0602759 401911M X0702673 401911M X0702830 401911M X0802396 401911M X0902530 401911M X1101719 401911M X1102151 401923M 40302826 401923M 40502512 401923M 40602520 401923M 40902071 401923M 40902071 401923M 41002308 401923M 41002856 401923M 41002998 401923M 41002999 401923M 41101524 401923M 41201515 401923M 51002563 401923M 51002563 401923M A0202577 401923M A0502530 401923M A0602033 401923M A0702966 401923M A0902996 401923M A1102653 401923M A1102784 401923M A1201681 401923M A1202286 401923M X0102326 401923M X0402636 401923M X0402992 401923M X0702836 401923M X1102161 401935M 40502195 401935M 41001777 401935M 51002562 401935M 51002562 401935M A0402444 401935M A0702964 401935M A1002392 401935M A1101831 401935M A1202287 401935M X0202202 401935M X0202202 401935M X0502654 401935M X0702028 401935M X0802954 401935M X1101753 401945M 40502196 401945M 41201746 401945M 41201746 401945M 41201746 401945M A0602585 401945M A0802847 401945M A1102650 401945M A1202288 401945M X1101580 401955M 40902070 401955M A1102651 401955M X0402633 401955M X0602765 401955M X0802955 MODS11269 K0702051 MODS11269 K0702339 MODS11269 K0902002 MODS12042 K0702262 MODS12042 K0702514 MODS12042 K0902003 MODS12295 K0802187 MODS12295 K0802477 MODS17833 K0802476 MODS17833 K0802476 MODS17833 K0902093 MODS17833 K0902223 SRA0042 0107020177 SRA0042 0107020913 SRA0042 0108021047 SRA0042 0109020185 SRA0042 0109020750 SRA0104 A1202035 SRA0148 A0103819 SRA0148 A0103819 SRA0148 A1102193 SRA0148 X0203846 SRA0149 A1202352 SRAM09555 L0602445 SRAM09555 L0702695 SRAM09555 L0902006 SRAM16514 L0802484 SRAM16514 L0902398
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes, FL, by on site visit and letter dated May 5, 2003 and letter on May 30, 2003. Firm initiated recall is ongoing.
REASON
Reports of broken or separated tips of the catheter sheath introducers.
VOLUME OF PRODUCT IN COMMERCE
49,022.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Temno Chiba Fine Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CH11815, Allegiance, Made in Dominican Republic. Recall # Z-0942-03.
CODE
Catalog number CH11815, lot D03AB0594.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by telephone and letter on June 2, 2003. Firm initiated recall is ongoing.
REASON
The product was shipped prior to being sterilized.
VOLUME OF PRODUCT IN COMMERCE
50 needles
DISTRIBUTION
FL, GA, MN, OK, OH, MO, and Malaysia.
______________________________
PRODUCT
ThinPrep Microscope Slides for Non-Gynecologic Use Size 1" x 3" Reorder Number:
70214-001. Recall # Z-0922-03.
CODE
Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and
0293.
RECALLING FIRM/MANUFACTURER
Cytyc Corp., Boxborough, MA, by letter on January 29, 2003. Firm initiated recall
is ongoing.
REASON
Microscope Slides contaminated with fungal material.
VOLUME OF PRODUCT IN COMMERCE
5,261 units.
DISTRIBUTION
Nationwide.
________________________________
PRODUCT
IVIEW DAB Detection Kit. Catalog Number 760-091.
Recall # Z-0928-03.
CODE
Lot 400566.
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Inc., Tucson, AZ, by telephone and letter on May 6 and 7, 2003. Firm initiated recall is ongoing.
REASON
Kit does not stain tissues properly.
VOLUME OF PRODUCT IN COMMERCE
409.
DISTRIBUTION
Nationwide.
________________________________
PRODUCT
a) ECI DOUBLE DIP 2 Iodine Teat Dip, 0.60% iodine
titratable), sold in 1 gallon, 5 gallon, and 15 gallon
plastic containers and 55 gallon drums.
Recall # V-169-3;
b) ECI DOUBLE DIP Iodine Teat Dip, 0.80% iodine
(titratable), sold in
1 gallon, 5 gallon, and 15 gallon plastic containers and
55 gallon drums. Recall # V-170-3.
CODE
a) All lots within expiration: LEPO21 EXP 4/03;
LPEO21 EXP 4/03; LPLO21 EXP 4/03; PNPL21 EXP 5/03;
PNPY24 EXP 5/03; PNLU21 EXP 5/03; PNLV21 EXP 5/03;
PNLY21 EXP 5/03; LPEU22 EXP 6/03; PLEP31 EXP 7/03;
PYPM23 EXP 7/03;
b) All lots within expiration: POEE22 EXP 4/03;
LPEL21 EXP 4/03; LPPY22 EXP 5/03; LLPY22 EXP 5/03;
LLEN22 EXP 5/03; PEOP22 EXP 5/03; PNLU22 EXP 5/03;
PSE022 EXP 6/03; LEEM21 EXP 7/03; PEEL36 EXP 8/03;
PELL36 EXP 8/03.
RECALLING FIRM/MANUFACTURER
Benbow Chemical Packaging, Inc., Syracuse, NY, by letter dated April 10, 2003. FDA initiated recall is complete.
REASON
Lack of assurance that products meet stability specifications throughout their shelf life.
VOLUME OF PRODUCT IN COMMERCE
6,265 gallons.
DISTRIBUTION
NY, PA, and VT.
_______________________________
PRODUCT
Xylazine Hydrochloride Injection, 100 mg/mL, 50 mL vial.
Recall # V-171-3.
CODE
Product code 2797, lots 121221, 41192.
RECALLING FIRM/MANUFACTURER
Akorn, Inc., Decatur, IL, by letters on April 3, 2003. FDA initiated recall is ongoing.
REASON
Potential non-sterility of aseptically filed injectable drugs.
VOLUME OF PRODUCT IN COMMERCE
38,878 vials.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR JUNE 25, 2003
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