Safety
Enforcement Report for July 12, 2006
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 12, 2006
06-28
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II
______________________________
PRODUCT
Oatmeal - Raisin Frozen Cookie Dough, Net Wt. 3 lbs. packaged under 2 different labels: a) Alantra Oatmeal-Raisin Premium Cookie Dough, Product of USA, UPC 779759-100230; and b) Aunt Betsy's Blue Ribbon Classics Oatmeal-Raisin Frozen Cookie Dough. Recall # F-251-6
CODE
Individual tubs are not coded, however Oatmeal - Raisin Cookie Dough was manufactured between 11/17/2005 and 02/09/2006.
RECALLING FIRM/MANUFACTURER
Royalston Foods dba Royalston Desserts, Saint Paul MN, by telephone on April 14, 2006 and by letter on April 18, 2006. Firm initiated recall is ongoing.
REASON
Foreign material was reported by the Canadian Food Inspection Service as being found inside 2 different containers of Alantra Oatmeal-Raisin cookie dough. The foreign material may pose a choking hazard.
VOLUME OF PRODUCT IN COMMERCE
1541 - 3 lb containers
DISTRIBUTION
IA and Canada
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
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PRODUCT
Mobic (meloxicam), 15 mg. tablets, packaged in 100 tablet bottles, Recall # D-266-6
CODE
Lot ''651237'', expiration date Dec 08; and lot ''651296”, expiration dated Feb 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Roxane Inc., Columbus, OH, by letter on May 24, 2006.
Manufacturer: Promeco S.A. De C.V., Xochimilco, Mexico. Firm initiated recall is ongoing.
REASON
Oversized tablets
VOLUME OF PRODUCT IN COMMERCE
19,521/100 tablet bottles
DISTRIBUTION
Nationwide
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PRODUCT
FIRST AID brand EXTRA STRENGTH NON-ASPIRIN, Acetaminophen 500 mg, 2 tablets per pack, Recall # D-277-6
CODE
Lot 03M847, exp. date 12/06
RECALLING FIRM/MANUFACTURER
Generic Pharmaceutical Services, Inc., Hauppauge, NY, by telephone on May 15, 2006 and by letter dated May 25, 2006.
Manufacturer: PDK Labs, Inc. Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Lot 03M847, exp. date 12/06
VOLUME OF PRODUCT IN COMMERCE
490,733 pouches, 2 tablets per pouch
DISTRIBUTION
Nationwide
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PRODUCT
Extra Strength Pain Relief PM (acetaminophen 500mg and diphenhydramine HCl 25mg) in bottles of 50 caplets, Pain Reliever, Sleep Aid, Recall # D-283-6
CODE
Lot 5ME0438
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter dated May 10, 2006. Firm initiated recall is ongoing.
REASON
Presence of Foreign Particles; acrylic mirror.
VOLUME OF PRODUCT IN COMMERCE
58,920 bottles
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Midrin Capsules (Isometheptene Mucate 65 mg, Dichloralphenazone 100 mg. and Acetaminophen 325 mg.) in bottles of 100 capsules, Rx, Recall # D-285-6
CODE
Lot 50968B, exp. 7/07
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, by letter dated July 3, 2006. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets; the bottles may contain foreign tablets of the NSAID oxyprozin.
VOLUME OF PRODUCT IN COMMERCE
1,023 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
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PRODUCT
Midrin Capsules (Isometheptene Mucate 65 mg, Dichloralphenazone 100 mg and Acetaminophen 325 mg) in bottles of 100 capsules, Rx., Recall # D-284-6
CODE
Lots 50968B, 50969A, 50970A, 51113A, 51166A, 51167A, 51168A, 51169A, 51206A, 51207A and 51308A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd.,Detroit , MI, by telephone on March 15 and April 19, 2006. Firm initiated recall is ongoing.
REASON
The capsules are brittle and may fracture or break
VOLUME OF PRODUCT IN COMMERCE
12,962 bottles
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
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PRODUCT
Source Plasma, Recall # B-1283-6
CODE
Unit NG0083695
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX, by telephone and fax on July 13, 2004. Firm initiated recall is complete.
REASON
Source Plasma, untested for the human immunodeficiency virus by NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
______________________________
PRODUCT
Red Blood Cells, Recall # B-1286-6
CODE
Unit 2024439
RECALLING FIRM/MANUFACTURER
Department of the Army, Moncrief U.S. Army Community Hospital Blood Bank
Columbia, South Carolina, by telephone on November 5, 1998. Firm initiated recall is complete.
REASON
Red Blood Cells, that tested repeatedly reactive for the antibody to hepatitis B core antigen (anti-HBcore), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
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PRODUCT
a) Red Blood Cells, Recall # B-1291-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1292-6;
c) Fresh Frozen Plasma. Recall # B-1293-6
CODE
a) Unit 03LT50304;
b) Units 003GZ46161, 03LL44031, 03LM04858, 03FG19676, 03GK57308, 03FJ60213,
03GK48155;
c) Units 03LL44031, 03GK57308
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone, e-mail, letter and fax on April 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that tested negative for antibody to Hepatitis B core antigen (anti-HBcore), but previously tested repeatedly reactive for anti-HBcore on multiple occasions
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA, PA, NJ and MD
______________________________
PRODUCT
Source Plasma. Recall # B-1295-6
CODE
Units: NG0046551, NG0045950
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1296-6
CODE
Unit: NG 0044520
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma. Recall # B-1297-6
CODE
Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
KY
______________________________
PRODUCT
Source Plasma, Recall # B-1298-6
CODE
Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY
______________________________
PRODUCT
Recovered Plasma, Recall # B-1299-6
CODE
Unit: 4357117
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1301-6
CODE
Units: 9023450 (Split as triple)
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on August 19, 2002. Firm initiated recall is complete.
REASON
Blood products, with platelet concentrations exceeding acceptable limits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
SC
______________________________
PRODUCT
Platelet Pheresis, Recall # B-1302-6
CODE
Unit: 9015457
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on May 11, 2001. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
______________________________
PRODUCT
Source Plasma, Recall # B-1306-6
CODE
Units: 20028609, 20027949, 20027690, 20027302, 20027124, 20026736, 20026506, 20025902, 20025649, 20025027, 20024545, 20024086, 20022921, 20022295, 20022044, 20020729, 20020092, 20019558, 20019080, 20018615, 20015073, 20014638, 20014202, 20013715, 20013265, 20012761, 20012288, 20011740, 20011291, 20010780, 20009845
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Amarillo, TX, by fax on December 8, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had not had an annual physical performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Spain
______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1308-6
CODE
Units: 0844092, 0847216
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on December 22, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with corresponding products that contained clots, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC and NC
______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1310-6
CODE
Units: 0879656, 0693212
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on September 30, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with corresponding products that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and SC
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1325-6
CODE
Unit 012C52747
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on March 15, 2005 and by letter on March 17, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-1), but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Platelets, Recall # B-1371-6
CODE
Units 2464885, 2468534, 2468408, 2468402, and 2465289
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on June 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not manufactured in accordance with current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6;
b) Recovered Plasma, Recall # B-1375-6
CODE
a) and b) unit 2453906
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria
______________________________
PRODUCT
Red Blood Cells, Recall # B-1378-6
CODE
Unit K40972
RECALLING FIRM/MANUFACTURER
Carlisle Regional Medical Center, Carlisle, PA, by fax on December 29, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1397-6;
b) Red Blood Cells Irradiated, Recall # B-1398-6
CODE
a) Units A243582, A243583, A243584, A240409, A240410, 250784, 251831, 250792, 249628, 249605, 250915, 251974, 251949, 251968, 249675, 250731, 249631, 251980, 239519, 243085, 243943, 240063, 239546, 243737, 243773, 243940, 243970, 250984, 250602, 243974, 243929, 250991, 250927, 243982, 243980, 250672, 243641, 250948, 250684, 250954, 250951, 250702, 250686, 250649, 243657, 249609, 249620, 249622, 249616, 249634, 250742, 250732, 249780, 249779, 249774, 243665, 251999, 243700, 249759, 249753, 249775, 249772, 249807, 249748, 249682, 251971, 249810, 243664, 250740, 250726, 249642, 249702, 249699, 249691, 249837, 249801, 251864, 252000, 249606, 249960, 251959, 251956, 249782, 249781, 249709, 249711, and 249808
b) Units 251884, 251997, 250708, 243645, 251810, 250746, 251963, 251986, and 249916
RECALLING FIRM/MANUFACTURER
Aultman Hospital Blood Bank, Canton, OH, by fax on April 13, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
OH
______________________________
PRODUCT
Plasma Frozen, Recall # B-1422-6;
Recovered Plasma, Recall # B-1423-6
CODE
a) Unit 03E42218;
b) Unit 03E38153
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and Switzerland
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1424-6
CODE
Units 03KQ29887 and 03KP23915
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by fax and letter on September 21, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1425-6;
b) Platelets, Recall # B-1426-6;
c) Fresh Frozen Plasma, Recall # B-1427-6
CODE
a) Units 03GK47815, 03GG55083, and 03GF47445;
b) Units 03GG55083 and 03GF47445;
c) Units 03GK47815, 03GG55083, and 03GF47445
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by fax and letter on November 5 and 16, 1999. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1429-6
CODE
Unit 03LF30638
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by fax and letter on September 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1430-6;
b) Platelets, B-1431-6
CODE
a) and b) Unit 1037871
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on April 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and SC
______________________________
PRODUCT
Platelets Pheresis, Recall # B-1432-6
CODE
Unit 1042502
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on October 29, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells, Recall # B-1433-6
CODE
Unit 2018344
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on September 10 and 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1434-6;
b) Platelets, Recall # B-1435-6
CODE
a) Units 4017663 and 3022312;
b) Unit 4017663
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on September 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
______________________________
PRODUCT
Source Plasma, Recall # B-1450-6
CODE
Unit numbers ST0824313 and ST0824764
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
______________________________
PRODUCT
Source Plasma, Recall # B-1452-6
CODE
Unit numbers 0020012950, 0020013855, 0020017701, 0020019061, 0020021230, 0020023014, 0020023706, 0020024885, 0020025798, 0020027293, 0020027575, 0020034015, 0020034296, 0020034575, 0020034809, 0020035096, 0020036226, 0020036468, 0020036809, 0020037196, 0020037406, 0020038447, 0020038681, 0020039397, 0020039634, 0020040086, 0020040418, 0020040786, 0020041112, 0020041505, 0020041860, 0020042210, 0020042564, 0020042965, 0020044022, 0020044369, 0020044765, 0020045161, 0020045561, 0020047531, 0020048176, 0020048546, 0020048955, 0020049334, 0020049739, 0020050092, 0020050483, 0020050856, 0020051295, 0020051684, 0020052132, 0020052573, 0020053010, 0020053406, 0020053816, 0020054210, 0020054651, 0020055011, 0020055428, 0020055839, 0020056290, 0020056690, 0020057087, 0020057468, 0020057889, 0020058281, 0020058697, 0020059109, 0020059529, 0020059944, and 0020060361
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by fax on January 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
CA
______________________________
PRODUCT
Source Plasma, Recall # B-1487-6
CODE
Unit numbers 0200253088, 0200252923, 0200252404, 0200251724, 0200250135, 0200249230, 0200247925, 0200247334, and 0200246446
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Norman, OK, by fax on February 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a tattoo within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
FL
______________________________
PRODUCT
Red Blood Cells, Recall # B-1493-6
CODE
Units 5009054 and 5113121
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on October 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had tested repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc) on two separate donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and SC
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1494-6
b) Cryoprecipitated AHF, Recall # B-1495-6
CODE
a) and b) Unit 5013100
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
______________________________
PRODUCT
Platelets Pheresis, Recall # B-1496-6
CODE
Unit numbers 1044590A, 1044590B, 1042645, 1040797, 1039294A, 1036536A, 1036536B, 1033617, 1032684, and 1031477.
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on February 9, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Lodine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA and SC
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1497-6;
b) Platelets, Recall # B-1498-6
CODE
a) and b) Unit number GL18316
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on January 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1502-6;
CODE
Units: 7079666-1, 7079666-2, 7075067-1, 7075067-2
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on December 9 and 14, 2004 and October 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1550-6;
b) Fresh Frozen Plasma, Recall # B-1551-6
CODE
a) and b) Unit 2395371
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on August 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1552-6;
b) Platelets, Recall # B-1553-6;
c) Fresh Frozen Plasma, Recall # B-1554-6
CODE
a), b) and c) Unit 2438702
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6;
b) Fresh Frozen Plasma, Recall # B-1556-6
CODE
a) and b) Unit 2454970
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1300-6
CODE
Unit: 12FW29648
RECALLING FIRM/MANUFACTURER
Rex Hospital Inc., Raleigh, NC, by telephone on December 25, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1303-6
CODE
Unit: 10746-6021
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on February 3, 2003. Firm initiated recall is complete.
REASON
Blood product, mislabeled Jkb negative, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1304-6
CODE
Units: KY18631-1, KY18631-2
RECALLING FIRM/MANUFACTURER
Rex Hospital Inc., Raleigh, NC, by telephone on June 20, 2005. 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
2 units
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells, Recall # B-1309-6
CODE
Unit: 0209428
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on December 22, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with corresponding products that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
______________________________
PRODUCT
Red Blood Cells, Recall # B-1311-6
CODE
Unit: 0877283
RECALLING FIRM/MANUFACTURER
The Blood Connection Inc., Greenville, SC, by telephone on September 30, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with corresponding products that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1324-6
CODE
Units 107544778 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on June 11, 2003. Firm initiated recall is complete.
REASON
Blood products, for which documentation of an abnormal alarm during apheresis collection was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________
PRODUCT
Recovered Plasma (for non-injectable use), Recall # B-1428-6
CODE
Unit 03LM78045
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by fax or letter on November 5 and 16, 1999. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1499-6;
b) Fresh Frozen Plasma, Recall # B-1500-6
CODE
a) and b) Unit: 10741-8699
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on January 10, 2003 and by letter dated February 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received an Anterior Cruciate Ligament (ACL) transplant within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1504-6
CODE
Unit: 10747-3840
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on February 13, 2003. Firm initiated recall is complete.
REASON
Blood product, which did not have the entire amount of adsol added during component preparation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
______________________________
PRODUCT
Red Blood Cells (Pheresis) Leukocytes, Recall # B-1507-6
CODE
Units: 10747-5331 (split product)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by telephone on February 18, 2003.
REASON
Blood products, not quarantined after an abnormal alarm sounded during the apheresis procedure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1546-6;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1547-6
CODE
a) Units 18P64185 (split unit), 18P64186 (2 units), 18P64189, 18P64191 (2 units),
18P64192, and 18P64193;
b) Platelets Pheresis Leukocytes Reduced Irradiated, unit 18P64185 (split unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by facsimile and letter dated June 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MI
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1548-6
CODE
Units 18N97954, 18N97955, 18N97957, 18N97958, 18N97961, 18N97963, 18N97964, 18N97965, 18N97966, and 18N97967
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI, by telephone on July 12, 2005 and by letter on July 13, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors whose suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
MI
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1549-6
CODE
Units 22FN76058, 22FN76059, and 22FN76079 [3 units]
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Philadelphia, PA, by telephone and letter on November 18, 2005
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
______________________________
PRODUCT
a) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire,
distal balloon, sterile, single use only, material number M00535110; catalog number
3511. Recall # Z-1109-06;
b) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire,
distal balloon, sterile, single use only, material number M00535130; catalog number
3513. Recall # Z-1110-06;
c) Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire,
proximal balloon, sterile, single use only, material number M00535150; catalog
number 3515. Recall # Z-1111-06;
d) Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire,
proximal balloon, sterile, single use only, material number M00535170; catalog
number 3517. Recall # Z-1112-06;
e) Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire,
proximal balloon, sterile, single use only, material number M00535190; catalog
number 3519. Recall # Z-1113-6
CODE
a) All lots. Lots 588218, 7173503, 7907512, 8541152, 6553517, 7209058, 7923845,
8541153, 6573307, 7213538, 7938899, 6593724, 7238048, 7959199, 6628839,
7244918, 7978741, 6650500, 7312261, 7988003, 6663230, 7323058, 8012669,
6684869, 7345074, 8037031, 6684870, 7368731, 8056507, 6710850, 7394062,
8076206, 6731508, 7416357, 8076207, 6745329, 7441769, 8093643, 6762317,
7469187, 8115498, 6783937, 7487245, 8131913, 6798010, 7510076, 8146780,
6811675, 7536508, 8154851, 6832811, 7550048, 8165619, 6834085, 7570081,
8194623, 6843046, 7592340, 8221047, 6870688, 7613897, 8250992, 6893879,
7635034, 8262323, 6896571, 7635532, 8272381, 6917737, 7656406, 8301236,
6919072, 7701169, 8303922, 6939764, 7722952, 8304044, 6946002, 7738501,
8304054, 6965093, 7738922, 8326168, 6979350, 7773671, 8331426, 6988355,
7794744, 8337750, 7005425, 7813723, 8359941, 7037237, 7833511, 8378721,
7049995, 7833512, 8393169, 7052629, 7845564, 8414769, 7076211, 7845565,
8428051, 7096493, 7864321, 8444985, 7121618, 7891878, 8461221, 7143069,
7892977, 8489777, 7163174, 7900869 and 8509967;
b) All lots. Lots 558552, 7739212, 602212, 7753189, 6593723, 7794743, 6632145,
7814338, 6666397, 7836676, 6685227, 7864847, 6713444, 7885211, 6732190,
7938898, 6746552, 7959197, 6787368, 7979136, 6795091, 7997847, 6834079,
8001283, 6846985, 8079834, 6874028, 8119586, 6897533, 8133511, 6900226,
8170294, 6948065, 8203324, 6966289, 8250997, 6987748, 8306742, 6988354,
8306923, 7037239, 8409135, 7052984, 8430041, 7078441, 8459615, 7189065,
8533268, 7213471, 7244925, 7323059, 7351026, 7403584, 7442556, 7485763,
7536756, 7557104, 7656402, 7675613, 7701170 and 7722953;
c) All lots. Lots 603391, 6799504, 7037095, 7403583, 7747718, 8005961, 8358477,
6539142, 6800398, 7049985, 7416358, 7760416, 8017560, 8358478, 6546666,
6817098, 7049986, 7417916, 7761394, 8018138, 8379614, 6553801, 6817103,
7053803, 7435843, 7761853, 8032106, 8388053, 6553902, 6828542, 7066018,
7441770, 7786226, 8032115, 8400748, 6565305, 6828544, 7079432, 7462728,
7786735, 8051884, 8400749, 6573305, 6846542, 7097700, 7462729, 7802332,
8056988, 8422201, 6573599, 6846543, 7097887, 7468203, 7807099, 8071999,
8422445, 6591126, 6854647, 7119562, 7485762, 7814339, 8072078, 8423915,
6600353, 6856256, 7119563, 7490850, 7819437, 8093644, 8428272, 6603310,
6866068, 7135244, 7510077, 7834051, 8098020, 8450926, 6612042, 6866800,
7137004, 7510139, 7836780, 8098242, 8452464, 6622542, 6866801, 7143070,
7529920, 7844585, 8109397, 8465129, 6624628, 6880631, 7162295, 7529921,
7850336, 8109398, 8465132, 6639865, 6880632, 7171662, 7549824, 7852743,
8119584, 8481185, 6639866, 6882924, 7172639, 7561807, 7870482, 8129662,
8481186, 6642282, 6882925, 7194509, 7570701, 7870483, 8129666, 8502291,
6654412. 6882926, 7196785, 7580070, 7874768, 8142554, 8502292, 6654414,
6905787, 7215344, 7596810, 7874769, 8146781, 8529548, 6655006, 6905789,
7226282, 7601687, 7888575, 8151220, 8529873, 6688430, 6928345, 7230675,
7614631, 7889310, 8151399, 8534044, 6688431, 6930039, 7230717, 7622178,
7893150, 8162009, 8551812, 6705783, 6930823, 7240370, 7636172, 7900338,
8165618, 6706029, 6930828, 7255850, 7644297, 7903556, 8185320, 6706030,
6944021, 7255852, 7644959, 7907510, 8206062, 6722148, 6944023, 7281821,
7660740, 7919430, 8206395, 6722149, 6945019, 7283356, 7669404, 7919806,
8229567, 6723458, 6965086, 7298816, 7685490, 7924565, 8229568, 6742385,
6965087, 7309412, 7685991, 7940070, 8241697, 6742386, 6965092, 7321591,
7696885, 7947076, 8241698, 6742387, 6987554, 7321593, 7697518, 7947978,
8262517, 6761469, 6987555, 7343776, 7709157, 7969329, 8272091, 6761470,
7005426, 7344057, 7717440, 7971757, 8307578, 6771563, 7008933, 7367660,
7733590, 7978424, 8319259, 6771840, 7009025, 7367661, 7742542, 7978758,
8331425, 6780209, 7026602, 7392895, 7745771, 7997846, 8341585, 6799502,
7035326, 7392896, 7747717, 8002443 and 8341586;
d) All lots. Lots 6546667, 6602514, 6706832, 6763251, 6811777, 6848204, 6930829,
7022531, 7078442, 7172641, 7283354, 7375263, 7467937, 7620507, 7725395,
7752678, 8037806, 8133510, 8230614, 8331439, 8360757, 8360758, 8384930,
8384931, 8411892, 8411893, 8411894, 8411895 and 8534126;
d) All lots. Lots 224690, 7576902, 6546668, 7701654, 6573600, 7718121, 6603846,
7773069, 6662859, 7803065, 6689054, 7823006, 6706833, 7852755, 6734078,
7865546, 6747479, 7884781, 6763254, 7900823, 6800397, 7918903, 6828545,
7938897, 6874720, 7959841, 6901256, 8012981, 6905390, 8037505, 6930831,
8052326, 6950302, 8114299, 6987742, 8185319, 7037096, 8221046, 7067306,
8251275, 7078440, 8301234, 7121617, 8319260, 7143071, 8360762, 7172640,
8384933, 7215343, 8411896, 7254598, 8415192, 7283355, 8453123, 7309110,
8481169, 7353543, 8533265, 7375265, 7394060, 7418357, 7442997, 7490851,
7544533, 7576853, 7593007 and 7660576;
e) All lots. Lots 6604751, 6689295, 6802779, 6848203, 6905391, 7053955, 7098448,
7189064, 7353544, 7442998, 7592642, 7676907, 7703438, 7802899, 7852756,
7938900, 8002453, 8271737 and 8502059
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter on May 19, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, as the sterile barrier may fail.
VOLUME OF PRODUCT IN COMMERCE
47,750
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Catalog No. 2103PK and 917015PK, Recall # Z-1175-06
CODE
All production codes
RECALLING FIRM/MANUFACTURER
Gyrus Medical, Inc., Maple Grove, MN, by telephone beginning May 15, 2006 and by letter on May 31, 2006. Firm initiated recall is ongoing.
REASON
Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists.
VOLUME OF PRODUCT IN COMMERCE
2971
DISTRIBUTION
Nationwide, Australia, Canada, Netherlands
______________________________
PRODUCT
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301, Recall # Z-1177-06
CODE
Lots 04051142--06121FE2, 04051142--06123FE2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter on June 2, 2006.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo State/Province Puerto Rico, firm initiated recall is ongoing.
REASON
Device for which sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
70,968 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Theratron 780C Cobalt Radiotherapy. Recall # Z-1178-06
b) Theratron 780E Cobalt Radiotherapy. Recall # Z-1179-06
c) Theratron 1000 Cobalt Radiotherapy. Recall # Z-1180-06
d) Theratron 1000E Cobalt Radiotherapy. Recall # Z-1181-6
e) Theratron Phoenix Cobalt Radiotherapy. Recall # Z-1182-06
f) Theratron Elite 80 Cobalt Radiotherapy. Recall # Z-1183-06
g) Theratron Elite 100 Cobalt Radiotherapy. Recall # Z-1184-06
CODE
a) Model Theratron 780C
b) Model Theratron 780E
c) Model Theratron 1000
d) Model Theratron 1000E
e) Model Theratron Phoenix
f) Model Theratron Elite 80
g) Model Theratron Elite 100
RECALLING FIRM/MANUFACTURER
MDS Canada Inc. DBA MDS Nordion, Kanata, Canada, by letter on August 24, 2004. Firm initiated recall is complete.
REASON
The source locking device may not fit properly through the smaller opening in the new field light shield which could prevent the source from being returned manually under emergency conditions.
VOLUME OF PRODUCT IN COMMERCE
4 units in US, 279 units foreign
DISTRIBUTION
FL, KS and Internationally
______________________________
PRODUCT
Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton. Item number MDS108070LT, size 7, Recall # Z-1185-06
CODE
Lot number T502504322
RECALLING FIRM/MANUFACTURER
Terang Nusa Sdn Bhd, Kota Bharu, Malaysia, by letters dated May 23, 2006. Firm initiated recall is ongoing.
REASON
The sterile glove pouches may have an open seal at the bottom of the pouch.
VOLUME OF PRODUCT IN COMMERCE
51 cartons
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071.
Recall # Z-1186-06
b) ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog
Number: OM-8075. Recall # Z-1187-6
CODE
a) 21134
b) 31144
RECALLING FIRM/MANUFACTURER
Arthrocare Corp., San Juan Capistrano, CA, by letter on June 7, 2006. Firm initiated recall is ongoing.
REASON
Potential loss of product sterility due to breach of pouch seal.
VOLUME OF PRODUCT IN COMMERCE
447 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
ambIT Ambulatory Infusion Therapy Intermittent Pump. Catalog Number: 220245, Recall # Z-1188-6
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Medical, Inc., West Jordan, UT, by e-mail and telephone on May 3, 3005. Firm initiated recall is ongoing.
REASON
Intermittent Infusion pump may continually dispense medication under certain conditions.
VOLUME OF PRODUCT IN COMMERCE
39 pumps (Domestic), 33 pumps (International)
DISTRIBUTION
KS, NJ, PA, WA and Internationally
______________________________
PRODUCT
a) Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The
vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle
to the vaporizer, Recall # Z-1189-06;
b) Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane).
The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the
bottle to the vaporizer, Recall # Z-1189-06
CODE
a) Lot numbers: I02156, I07205, I03096, I02286, & I12095
b) Lot Numbers: S07275, S02086, S10215, S08315, S02286, S12095, S12195,
S12215, S02216, & S03096
RECALLING FIRM/MANUFACTURER
Southmedic Inc.,Barrie, Ontario, Canada, by letter on April 21, 2006. Firm initiated recall is ongoing.
REASON
Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics
VOLUME OF PRODUCT IN COMMERCE
255
DISTRIBUTION
FL, NJ and Worldwide
______________________________
PRODUCT
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310. Recall # Z-1191-06
CODE
Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Respironics, Incl, Murrysville, PA, by letter on September 19, 2005.
Manufacturer: Caradyne Ltd., Galway, Ireland. Firm initiated recall is complete.
REASON
Gas input pressures over 62 psi may cause CPAP pressure oscillation.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide and Worldwide
______________________________
PRODUCT
a) Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3
HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK
RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy
Defibrillator (CRT-D). Sterile EO, Recall # Z-1192-06
b) VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO,
Recall # Z-1193-06
c) Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3
AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175),
CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchronization
Therapy Defibrillator. Sterilized using gaseous ethylene oxide. CONTAK RENEWAK
AVT models provide both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-1194-06
CODE
Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Guidant.
RECALLING FIRM/MANUFACTURER
Guidant Corp., Saint Paul, MN, by press release and letter on May 15, 2006. Firm initiated recall is ongoing.
REASON
Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping.
VOLUME OF PRODUCT IN COMMERCE
Estimated less than 1% of the 996 implanted were implanted with the serial numbers facing down.
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee,
Recall # Z-1197-06;
b) Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee,
Recall # Z-1198-06;
c) Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee,
Recall # Z-1199-06;
d) Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee,
Recall # Z-1200-06
CODE
a) Serial numbers: 5787 -- 6207 including the following repaired units outside the
stated range. 5339, 5471, 5478, 5670;
b) Serial numbers: 14466 -- 16053 including the following repaired units outside the
stated range. 12588, 13131, 13216, 13236, 13265, 13363, 13487, 13573, 13598,
13799, 13967, 14028, 14032, 14127, 14143, 14158, 14159, 14370;
c) Serial numbers: 38198 -- 40858 including the following repaired units outside the
stated range. 18989,19232, 27029, 27804, 28629, 28923, 30538, 31033, 31104,
31108, 31110, 31111, 31113, 32040, 32229, 32293, 32352, 32528, 32556, 32704,
32712, 32849, 33016, 33035, 33038, 33435, 33626, 33644, 33770, 33963, 34025,
34032, 34131, 34205, 34257, 34331, 34362, 34448, 34544, 34562, 34578, 34631,
34753, 34756, 34783, 34870, 34926, 34994, 35125, 35257, 35328, 35412, 35755,
35810, 35819, 35845, 35969, 35981, 36157, 36209, 36391, 36636, 36665, 36733,
36871, 36902, 36955, 36960, 37098, 37114, 37128, 37147, 37172, 37243, 37255,
37291, 37310, 37554, 37625, 37717, 37788, 37910, 37987, 38047, 38197;
d) Serial numbers: 6918 -- 7569
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur North America Inc., Aliso Viejo, CA, by press release on March 29, 2006.
Manufacturer: Ossur Engineering, Inc., Albion, MI. Firm initiated recall is ongoing.
REASON
The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
VOLUME OF PRODUCT IN COMMERCE
3382
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic, Recall # Z-1203-06
CODE
Lot 712050.066, expiration date 2007-02-22 and Lot 712050.068, expiration date 2007-03-08.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience Inc., Cincinnati, OH, by letter on June 6, 2006. Firm initiated recall is ongoing.
REASON
The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.
VOLUME OF PRODUCT IN COMMERCE
704 kits
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver, Recall # Z-1202-06
CODE
All systems - each major component has its own serial number
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Incorporated, Issaquah, WA, by letter on May 5, 2006. Firm initiated recall is ongoing.
REASON
Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.
VOLUME OF PRODUCT IN COMMERCE
24 telemetry systems; 1142 transmitters
DISTRIBUTION
Nationwide
______________________________
PRODUCT
3D-I/III Ceiling Stand. Diagnostic x-ray tube mount, Recall # Z-1205-6
CODE
Model numbers 0923/G0923, 1022, 1080, 1212687, 1371970, 1372325, 1654250, 1576164, 8186751, 7388002, 7389489, 1738509, 1738517, 1738525, 7276504, 7276512, 7276520, 7276553, 7465008, 7486822, and 8185530.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by field correction update on April 28, 2006.
Manufacturer: Siemens AG, Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers.
VOLUME OF PRODUCT IN COMMERCE
466 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette, Recall # Z-1206-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc., Palo Alto, CA, by letter on June 6, 2006. Firm initiated recall is ongoing.
REASON
Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds.
VOLUME OF PRODUCT IN COMMERCE
4085 units
DISTRIBUTION
Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
______________________________
PRODUCT
ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3, Recall # Z-860-06
CODE
Lot numbers 33079M200, 33079M201
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on March 8, 2006. Firm initiated recall is ongoing.
REASON
The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.
VOLUME OF PRODUCT IN COMMERCE
135 kits
DISTRIBUTION
Canada, Germany and Australia
______________________________
PRODUCT
Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system, Recall # Z-1172-06
CODE
Serial number ranges A06251 thru A09914, A12012 thru A31198 and A35001 thru 35097 may include devices that are not subject to the correction. Serial number ranges A10000 thru A11087 and A31201 thru A33742 only include devices subject to the correction
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med. Sys. Ultrasound, West Milwaukee, WI, by letter on April 17, 2006.
Manufacturer: Kretziechnik Gesmbh, Zipf, Austria, firm initiated recall is ongoing.
REASON
In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question 'PG Mean' for any diagnostic or therapeutic decision, and 'PG Mean' values should not be included in any patient documentation.
VOLUME OF PRODUCT IN COMMERCE
3936
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) RapidScreen RS-2000D , Medical Image Analyzer, Recall # Z-1173-6;
b) RapidScreen RS-Digital, Medical Image Analyzer, Recall # Z-1174-6
CODE
a) Serial numbers: 39CKM51, 1BCKM51, 25-1034, 4BCKM51, F9CDM51, 25-1011,
25-1012, 25-1013, 25-1015, 25-1017, 25-1021, 25-1025, 25-1028, 25-1029, 25-1023,
25-1024, 25-1027, 25-1033, 25-1030, 25-1031, 25-1035, 25-1036, 25-1032, 25-1037,
25-1038, 25-1039, 25-1041, 25-1042;
b) Serial numbers: 58HVH31, F8HVH31,49HVH31, 87HVH31, 47HVH31, F7HVH31,
H7HVH31, 2RCTH31, 1RCTH31, B8HVH31, GQCTH31, G031M31, C031M31,
3131M31, 8031M31, 1131M31, 2FNNS31, BDNNS31,GDNNS31, FDNNS31,
JDNNS31, GFNNS31, 2433X31, D333X31, F433X31, 5L3R241, 7L3R241, 148HN41,
648HN41, 348HN41, 848HN41, 838HN41, BR5VQ41, 4R5VQ41, JL0VQ41,
JL0VQ41, 3N0VQ41, 2P0VQ41, BPZTQ41, FL0VQ41, 946VQ41, 296VQ41,
9M0VQ41, CL0VQ41, H86VQ41, 1QCWQ41, 1LCWQ41, 5LCWQ41, JNCWQ41,
596VQ41, 4NCWQ41, 9LCWQ41, GM0VQ41, BNCWQ41, 8QCWQ41, DN0VQ41,
F26VQ41, B86VQ41, G96VQ41, 996VQ41, JR5VQ41, 2BCKM51,
F9CKM51,79CKM51, H9CKM51, 39CKM51, C9CKM51, 1BCKM51, 59CKM51,
4BCKM51, 20-168, 20-160, and 7S5VQ41
RECALLING FIRM/MANUFACTURER
Riverain Medical Group, Miamisburg, OH, by letter on May 10, 2006, firm initiated recall is ongoing.
REASON
The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
VOLUME OF PRODUCT IN COMMERCE
101 devices
DISTRIBUTION
Nationwide
______________________________
PRODUCT
ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests), Recall # Z-1204-06
CODE
List numbers 6C11-20, 6C11-25 and 6C11-30; all lots
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by e-mail on June 6, 2006. Firm initiated recall is ongoing.
REASON
Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).
VOLUME OF PRODUCT IN COMMERCE
10,725 kits
DISTRIBUTION
Internationally
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
______________________________
PRODUCT
a) PRO-LAK, bulk weight, Protein Concentrate for Lactating Dairy Animals,
Recall # V-079-6;
b) ProAmino II, FOR PREFRESH AND LACTATING COWS, net weight 50lb (22.6 kg),
Recall # V-080-6;
c) PRO-PAK, MARINE & ANIMAL PROTEIN CONCENTRATE FOR USE IN ANIMAL
FEED, Recall # V-081-6;
d) Feather Meal, Recall # V-082-6
CODE
a) Bulk
b) None
c) Bulk
d) Bulk
RECALLING FIRM/MANUFACTURER
H. J. Baker & Bro., Inc., Albertville, AL, by telephone on June 15, 2006 and by press release on June 16, 2006. Firm initiated recall is ongoing.
REASON
Possible contamination of animal feeds with ruminent derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
10,878.06 tons
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR July 12, 2006
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