Enforcement Report

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.

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June 7, 2006
06-23

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Retavase Half-Kit (Reteplase recombinant) with 1 single-use vial Retavase powder (10 unit vial; 10.4 U strength), Rx only, NDC 67286-040-02, Recall # D-256-6
CODE
Lot numbers: 767174E (exp. 12/06), 767174F (exp. 12/06), 767486B (exp. 3/07), 767486D (exp. 3/07);
RECALLING FIRM/MANUFACTURER
Recalling Firm/Manufacturer: Pdl Biopharma, Freemont, CA, by letter on May 15, 2006. Firm initiated recall is ongoing.
Packager/Labeler: Cardinal Health Packaging Services, Philadelphia, PA.
REASON
Kit may contain unlabeled vial of drug product.
VOLUME OF PRODUCT IN COMMERCE
5,908 half-kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0767-6
CODE
Unit number: 7111357
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated February 3, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken the medication Tegison, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Source Plasma, Recall # B-0768-6
CODE
Unit numbers: DBCMCQ, DBCMFK, DBCVNL, DBCVRM, DBCVVW, DBCVZX, DBCWDX, DBCWKQ, DBCWPB, DBDCHB, DBDCLL, DBDCQH, DBDDNS, DBDDXG, DBDHWN, DBDKKG, and DBDYDL.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Savannah, GA, by facsimile on January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Germany and TN

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0824-6
CODE
Unit number: 36LE05370
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by telephone on May 25, 2000. Firm initiated recall is complete.
REASON
Blood product, which was overweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0964-6
CODE
Unit number: 12FM06591 (double unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on June 1, 2005 and by letter dated June 14, 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
2 units
DISTRIBUTION
NC and TN

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PRODUCT
Source Plasma, Recall # B-0984-6
CODE
Unit numbers: 20008610, 20016932, 20022230, and 20023202.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

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PRODUCT
Fresh Frozen Plasma, Recall # B-1166-6
CODE
Unit number: 1914498
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers Inc., Orlando, FL, by telephone on December 19, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the drug Plaquenil, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

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PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-1175-6
CODE
Unit number: 6964511
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 27, 2005. 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
CO

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PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-1176-6
CODE
Unit number: 06GJ77559
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letter on July 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-1177-6
CODE
Unit numbers: 9027539 and 6703241
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO., by facsimile on August 9, 2005. 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
CO

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PRODUCT
Red Blood Cells, Recall # B-1178-6
CODE
Unit number: 4900044
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by facsimile on June 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1179-6;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-1180-6
CODE
a) Unit number: 10744-5109;
b) Unit numbers: unit numbers 10744-5109, 10744-5030, 10744-4966, 10743-4029 and
10741-5870
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter on May 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ

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PRODUCT
Source Plasma, Recall # B-1186-6
CODE
Unit numbers: AMN010290, AMN010098, AMN009781, AMN009624, AMN009349, AMG004360, AMG004282, AMN002889, AMN002857, 0G0015747, 0G0015573, 0G0015245, 0G0015077, 0G0015006, 0G0014838, 0G0014754, 0G0014581, 0N0006418, 0N0006376
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on August 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Spain

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PRODUCT
Source Plasma, Recall # B-1187-6
CODE
Unit numbers: 20012317, 20012583, 20017867, 20020098, 20025638, 20026210
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on May 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Spain

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1189-6
CODE
Unit numbers: 10717-7042, 10714-0414
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated June 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

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PRODUCT
Source Plasma, Recall # B-1191-6
CODE
Unit numbers: 0020001522, 0020001937, 0020011292, 0020011783, 0020012217, 0020012695, 0020013549, 0020014191, 0020014595, 0020015077, 0020015486, 0020016053, 0020016491, 0020017047, 0020017849, 0020018322, 0020018714, 0020019136, 0020019626
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on March 21, 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
19 units
DISTRIBUTION
Spain

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PRODUCT
Source Plasma, Recall # B-1192-6
CODE
Unit numbers: 0020006972, 0020008114, 0020033417, 0020033534
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on January 20, 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
4 units
DISTRIBUTION
Spain

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1193-6
CODE
Unit number: W045005915223
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on November 21, 2005. Firm initiated recall is complete.
REASON
Platelets, contaminated with Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KS

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PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1194-6
CODE
Unit number: 5579252
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on December 6, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in a manner in which the sterility of the collection system was compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1195-6
CODE
Unit number: 7046568
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 9, 2004 and by facsimile on December 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
Skin Tissue, AlloDerm/Repliform Regnerative Tissue Matrix, Recall # B-1197-6
CODE
Lot B9411: 028, 004, 018, 021, 022, 009, 023, 024, 031, 029, 010, 012, 019, 020, 025, 034, 032
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeCell Corporation, Branchburg, NJ, by letter dated January 30, 2006.
Manufacturer: Life Alaska, Inc., Anchorage, Alaska. Firm initiated recall is on going.
REASON
Skin Tissue, that was subsequently found to test repeatedly reactive for antibodies to Hepatitis B Core Total (IgM/IgG) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
17 allografts
DISTRIBUTION
Nationwide

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PRODUCT
Bair Hugger Ranger High Flow Blood/Fluid Warming Disposable Sets, Recall # B-1198-6
CODE
Lots H2057 through H2182
Part Numbers 24350, 24355, 24365, 24370
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arizant, Inc., Eden Prarie, MN, by letter dated April 26, 2006.
Manufacturer: Biotest Laboratories, Inc., Minneapolis, MN. Firm initiated the recall is on going.
REASON
Blood warmers, manufactured with an inverted bubble trap, were distributed.
VOLUME OF PRODUCT IN COMMERCE
90,346 sets
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1199-6;
b) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1200-6
CODE
a) Unit numbers: 7219025 and 4963825;
b) Unit number: 7219025
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on July 12, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA and AR

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1234-6;
b) Recovered Plasma, Recal # B-1235-6,
CODE
a) and b) Unit number 06LC79662
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by facsimile on September 17, 2003 and by letter on October 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

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PRODUCT
Recovered Plasma, Recall # B-1236-6
CODE
Unit number: 1404421
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile on April 28, 2003. Firm initiated recall is complete.
REASON
Blood product, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

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PRODUCT
a) Cryoprecipitated, AHF, Recall # B-1237-6;
b) Recovered Plasma, Recall # B-1238-6
CODE
a) and b) Unit number: 9905472
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Orlando, FL, by telephone on April 22, 2003 and by facsimile on April 28, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and Austria

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1248-6
CODE
Unit number: 71W637488
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Huntsville, AL, by facsimile on July 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1249-6
CODE
Unit number: 71W729608 (split product)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Huntsville, AL, by facsimile on August 10, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

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PRODUCT
Fresh Frozen Plasma, Recall # B-1250-6
CODE
Unit number: 71N332466
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery, AL, by facsimile on November 5, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

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PRODUCT
Fresh Frozen Plasma, Recall # B-1251-6
CODE
Unit number: 71N86421
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery, AL, by facsimile on October 29, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

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PRODUCT
Fresh Frozen Plasma, Recall # B-1252-6
CODE
Unit number: 71M739834
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery, AL, by facsimile on August 4, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

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PRODUCT
Fresh Frozen Plasma, Recall # B-1253-6
CODE
Unit number: 71N286421
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Birmingham, AL, by facsimile on December 5, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0817-6;
b) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0818-6;
c) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0819-6
CODE
a) Unit numbers: 22FC25213, 22FN70870, 22FS29504, 22FS31685, 22FS33988,
22FX12560, 22GH11170, 22GL20516, 22GS11235, 22KE12632, 22KF55143,
22KL18824, 22KV74427, 22KY88734, 22LC18668, 22LC19221, 22LW79321,
22LZ05143, 22FN73316, 22FT97846, 22FS35725, 22KL22816, 22GL18850,
22FL08315, 22LC21758, 22FC29375, 22FQ28297, 22KE12362, 22KW60774,
22KW61254, 22KV70059, 22FC27715, 22KZ70891, 22LW77711, 22KN62203,
22FQ22011, 22GQ09311, 22GS14385, 22FS35873, 22KL13343, 22KL13226,
22GQ05660, 22KX68953, 22LP05620, 22KY86884, 22LC17440, 22KE20785,
22FQ27690, 22LZ03402, 22GQ03917, 22KX70162, 22FS31118, 22LC17396,
22GQ05336, 22FN68150, 22GL25492;
b) Unit numbers: 22KC73557, 22FN67843, 22FZ08262;
c) Unit numbers: (2 units) 22KK67428
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on September 26, 2005. Firm initiated recall is complete.
REASON
Blood products, for which antigen testing was performed incorrectly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
DE, NJ, OK, and PA

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PRODUCT
Source Plasma, Recall # B-1100-6
CODE
Unit numbers: 00269711, 00282185, 00308281, 00312295, 00318723, 00385343, 00401968, 00413107, 00415873, 00421027, 00423137, 00429788, 00433464, 00442473 00445375
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lansing, MI, by facsimile on November 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1132-6
CODE
Unit number: 12LE06052
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone and follow-up letter on May 19, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with hemochromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1140-6
CODE
Unit number: 71R12673-7
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Dunwoody, GA, by facsimile on February 3, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a unit Fresh Frozen Plasma that contained fibrin strands, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

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PRODUCT
a) Red Blood Cells, Recall # B-1181-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1182-6;
c) Fresh Frozen Plasma, Recall # B-1183-6
CODE
a) Unit numbers: 0811198, 0599335, 0817525, 0193594, 0817817, 0813394,
0200709, 0819895, 0201646, 0201591, 0201649, 0201752, 0201256, 0599936,
0825694, 0826943, 0827348;
b) Unit numbers: 0820430, 0820883
c) Unit numbers: 0817879, 0686104, 0822648, 0825158, 0825159, 0824875
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on April 10, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with units of Fresh Frozen Plasma or Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
FL, GA, MO, NY, NC, and SC

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1184-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1185-6
CODE
a) Unit numbers: 0858632, 0215096, 0862185, 0862337, 0862184;
b) Unit numbers: 0862148
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with units of Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
AL, MA, NJ, and SC

______________________________
PRODUCT
Source Plasma, Recall # B-1188-6
CODE
Unit numbers: 03DILA0446, 03DILA0457, 03DILA0490, 03DILA0689, 03DILA1358, 03DILA1471, 03DILA1511, 03DILA1533, 03DILA1824, 03DILA3288, 03DILA3889, 03DILA4338, 03DILA4545, 03DILA4868, 03DILA4920, 03DILA5046, 03DILA5047, 03DILA5471, 03DILA5590, 03DILA5593, 03DILA5685, 03DILA5832, 03DILA5841, 03DILA5864, 03DILA6360, 03DILA7309, 03DILA8492, 03DILA9159, 03DILA9533, 03DILA9552, 03DILA9937, 03DILA9983, 03DILB0187, 03DILB0683, 03DILB1016, 03DILB1342, 03DILB1698, 03DILB1794, 03DILB1798, 03DILB1854, 03DILB2083, 03DILB2638, 03DILB2743, 03DILB2745, 03DILB2849, 03DILB3185, 03DILB3692, 03DILB3940, 03DILB4003, 03DILB4478, 03DILB4517, 03DILB5110, 03DILB5206, 03DILB5224, 03DILB5260, 03DILB5265, 04DILA0358, 04DILA0361, 04DILA1281, 04DILA1714, 04DILA3137, 04DILA3281, 04DILA3358, 04DILA3514, 04DILA3518, 04DILA3741, 04DILA3951, 04DILA4728, 04DILA4859, 04DILA4920, 04DILA5817, 04DILA6420, 04DILA6640, 04DILA6995, 04DILA8196, 04DILA8789, 04DILA9143, 04DILA9449, 04DILB0687, 04DILB1222, 04DILB1736, 04DILB1901, 04DILB1908, 04DILB2366, 04DILB2409, 04DILB2413, 04DILB3506, 04DILB4035, 04DILB4089, 04DILB4368, 04DILB4685, 04DILB5090, 04DILB5307, 04DILB5507, 04DILB6113, 04DILB6430, 04DILB7895, 04DILB7916, 04DILB8180, 04DILB8185, 04DILB8469, 04DILB9505, 04DILB9514, 04DILB9615, 04DILC0511, 04DILC0941, 04DILC1344, 04DILC1739, 04DILC2248, 04DILC2407, 04DILC2653, 04DILC3151, 04DILC4624, 04DILC4905, 04DILC5006, 04DILC5319, 04DILC5440, 04DILC6447, 04DILC7178, 04DILC7637, 04DILC7668, 04DILC7942, 04DILC8165, 04DILC8329, 04DILC8420, 04DILC8716, 04DILC9120, 04DILC9200, 04DILC9510, 04DILD0420, 04DILD0794, 04DILD1639, 04DILD2633, 04DILD2961, 04DILD2966, 04DILD2994, 04DILD3166, 04DILD3892, 04DILD4098, 04DILD4456, 04DILD4754, 04DILD4821, 04DILD4896, 04DILD5919, 04DILD6567, 05DILA0024, 05DILA1080, 05DILA1923, 05DILA2124, 05DILA2276, 05DILA2658, 05DILA2781, 05DILA3162, 05DILA3725, 05DILA4380, 05DILA4981, 05DILA5175, 05DILA5714, 05DILA6222, 05DILA6375, 05DILA6977, 05DILA8385, 05DILA8894, 05DILA9584, 05DILA9724, 05DILA9913, 05DILB0054, 05DILB0403, 05DILB1343, 05DILB1352, 05DILB1814, 05DILB4102, 05DILB4123, 05DILB4259, 05DILB4284, 05DILB4301, 05DILB4586, 05DILB4591, 05DILB4622, 05DILB5054, 05DILB5385, 05DILB5566, 05DILB5615, 05DILB5769, 05DILB5869, 05DILB6348, 05DILB6391, 05DILB7756, 05DILB8310, 05DILB8620, 05DILB9443, 05DILC1221, 05DILC1729, 05DILC2958, 05DILC3584
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., DeKalb, IL, by facsimile on October 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
CA and MD

______________________________
PRODUCT
Recovered Plasma, Recall # B-1190-6
CODE
Unit numbers: 10714-0414, 10717-7042
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated June 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1196-6
CODE
Unit numbers: 0886849, 0887099, 0887098, 0886465
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on October 14, 2005. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes during leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
SC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1208-6
CODE
Unit number: 8367889
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on May 8, 2003. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as being negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1220-6
CODE
Unit numbers: WN0056261, WN0056262, WN0056264, WN0056265, WN0056275, WN0056278, WN0056281, WN0056292, WN0056312, WN0056318, WN0056327
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington, LLC, Wilmington, NC, by telephone on September 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which were untested for viral markers by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC

______________________________
PRODUCT
Recovered Plasma, (non-injectable use), Recall # B-1240-6
CODE
Unit number E29448
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St. Augustine, FL, by facsimile on April 8, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1247-6
CODE
Unit number: 7121540 (2 parts)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on December 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. *
StarBurst™ Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R *
Catalog # 700-102846-RITA® *, Recall # Z-0887-06;
b) XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. *
StarBurst™ Xli enhanced with tubing set * * REF/Catalog: 700-103027 * 4-7 cm
Diameter * 12cm Length * Sterile/R * RITA® * , Recall # Z-0888-06
CODE
a) Lot number: 25969;
b) Lot number: 25952
RECALLING FIRM/MANUFACTURER
Rita Medical Systems, Inc., One Horizon Way, Manchester, GA., by telephone on May 2, 2006 and by letter and email on May 3, 2006. Firm initiated recall is ongoing.
REASON
Misbranding: Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide and Italy

______________________________
PRODUCT
Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide, Recall # Z-0907-06
CODE
All codes. MH2548, MH2549, MH2550, MH2744, MH2745, MH7477, MH7478, MH7479, MH7481, MH7482, MH7495, MH7636, MH7637, MH7638, MH7703R, MH7708, MH7709, MH7710, MJ2180, MJ2181, MJ2182, MJ2213, MJ2214, MJ2739, MJ2740, MJ2741R, MJ2742R, MJ2743R, MJ2789, MJ7119, MJ7120, MJ7121R, MJ7330, MJ7331, MJ7332, MJ7363, MJ7364, MJ7365, MJ7706, MJ7707, MJ7826, MJ7827, MJ7886, MJ7900R, MJ7901R, MJ7902R, MJ7969, MJ7970, MJ7971, MJ7975, MJ7976, MJ7978, MJ7979, MJ7980, MJ7981, MJ7982, MJ7983, MJ7984, MJ7985, MJ7986, MJ7990, MJ7991, MJ7993, MJ7994, MJ8013, MJ8018, MJ8019, MJ8020R, MJ8021, MJ8022R, MJ8023R, MK2185, MK7186, MK7269, MK7343, MK7344, MK7376, MK7468, MK7469, MK7471, MK7472, MK7473, MK7474, MK7477, MK7478, MK7479, MK7480R, MK7481, MK7482, MK7483, MK7484, MK7486, MK7487, MK7501, MK7502, MK7503, MK7504, MK7505, MK7506, MK7507, MK7564, MK7565, MK7566, MK7567, MK7634, MK7822, MK7824, MK8014, MK8015, MK8016, MK8017, MK8023, MK8024, ML2020, ML2191, ML2941, ML7175R, ML7250, ML7424, ML7430, ML9750, ML9767, MM2056, MM2080, MM2581, MM2797, MM2798, MM2799, MM2800, MM2803, MM2804, MM2807, MM2810, MM7207, MM7589, MM7677, MM9729, MM9740, MM9750, MM9755, MM9891, MM9896, MM9897, MP2094, MP2403, MP2426, MP2474, MP2551, MP2601, MP2602, MP2603, MP2817, MP2840, MP2841, MP7251, MP7252, MP7351, MP7367, MP7644, MP7704, MP7761, MP7828, MP7829, MP7849, MP9702, MP9734, MP9759, MP9762, MP9772, MP9876, MP9916, PA2258, PA2259, PA2260, PA7254, PA7255, PA7256, PA7381, PA7400, PA7700, PA7702, PA7703, PA7742, PA7806, PA7807, PA7924, PA9717, PA9719, PA9729, PA9730, PA9749, PA9771, PA9776, PA9872, PA9873, PA9897, PB2421, PB2473, PB2474, PB2483, PB2545, PB2548, PB2555, PB2672, PB2673, PB2718, PB2755, PB2774, PB2795, PB2838, PB2861, PB2862, PB2874, PB7150, PB7345, PB7346, PB7633, PB7634, PB7637, PB7638, PB7639, PB7640, PB7641, PB7772, PB7773, PB7909, PB7910, PB9711, PB9712, PB9729, PB9739, PB9741, PB9743, PB9887, PB9926, PB9944, PB9951, PB9984, PC2042, PC2043, PC2057, PC2066, PC2104, PC2408, PC2459, PC2471, PC2481, PC2508, PC2509, PC2537, PC2598, PC2805, PC2814, PC2815, PC2829, PC2866, PC2924, PC2925, PC7126, PC7149, PC7323, PC7324, PC7325, PC7326, PC7327, PC7329, PC7392, PC7393, PC7394, PC7395, PC7770, PC7864, PC7904, PC7905, PC9700, PC9717, PC9756, PC9757, PC9776, PC9790, PC9792, PC9793, PC9803, PC9963, PC9966, PC9967, PD2091, PD2092, PD2183, PD2418, PD2420, PD2446, PD2463, PD2480, PD2481, PD2482, PD2494, PD2721, PD2723, PD2772, PD2774, PD2796, PD7290, PD7291, PD7331, PD7428, PD7544, PD7697, PD7698, PD7699, PD7732, PD7745, PD7746, PD7747, PD7767, PD7799, PD7899, PD9711, PD9719, PD9724, PD9725, PD9732, PD9743, PD9754, PD9755, PD9763, PD9766, PD9767, PD9889, PD9899, PD9913, PD9914, PD9933, PE2073, PE2185, PE2435, PE2552, PE2553, PE2558, PE2559, PE2586, PE2587, PE2603, PE2607, PE2612, PE2619, PE2896, PE2896S, PE2980, PE7565, PE7566, PE7567, PE7600, PE7627, PE7685, PE7686, PE7830, PE7879, PE7879S, PE9712, PE9730, PE9742, PE9754, PE9766, PE9817, PE9818, PE9825, PE9830, PG2011S, PG2132, PG2133, PG2159, PG2160, PG2161, PG2413, PG2451, PG2454, PG2456, PG2554, PG2624, PG2625, PG2629, PG2635, PG2636, PG2661, PG2662, PG2663, PG2694, PG2695, PG2702, PG2703, PG2780, PG2977, PG7131, PG7132, PG7383, PG7384, PG7474, PG7475, PG7488, PG7595, PG7620, PG7621, PG7717, PG7754, PG7755, PG7851, PG7852, PG7998, PG9708, PG9710, PG9730, PG9744, PG9748, PG9749, PG9750, PG9753, PG9757, PG9758, PG9849, PG9850, PG9884, PH2015, PH2410, PH2414, PH2423, PH2424, PH2427, PH2428, PH2429, PH2430, PH2431, PH2442, PH2446, PH2447, PH2449, PH2451, PH2477, PH2481, PH2742, PH2747, PH2774, PH2981, PH7180, PH7389, PH7390, PH7407, PH7408, PH9734, PH9735, PH9751, PH9756, PH9886R, PH9903, PJ2036, PJ2036D, PJ2037, PJ2037D, PJ2078, PJ2078D, PJ2220, PJ2221, PJ2413, PJ2418, PJ2419, PJ2420, PJ2422, PJ2430, PJ2478, PJ2479, PJ2484, PJ2485, PJ2500, PJ2505, PJ2508, PJ2631, PJ2650, PJ2650D, PJ2655, PJ2679, PJ2680, PJ2681, PJ2681D, PJ2682, PJ2682D, PJ2749, PJ2749D, PJ2750, PJ7245, PJ7246, PJ7247, PJ7255, PJ7255D, PJ7259, PJ7259D, PJ7440, PJ7549, PJ7577, PJ7578, PJ7584, PJ7584D, PJ7588, PJ7589, PJ7590, PJ7599D, PJ7599S, PJ7600, PJ7600D, PJ7601, PJ7606, PJ7606D, PJ7695, PJ7710, PJ9703, PJ9704D, PJ9704S, PJ9705, PJ9711, PJ9720, PJ9740, PJ9855, PJ9856, PJ9857, PJ9860, PJ9861, PJ9861D, PJ9866, PJ9866D, PJ9867, PJ9901, PJ9902, PK2198, PK2199, PK2244, PK2292, PK2405, PK2407, PK2409, PK2414, PK2441, PK2501, PK2522, PK2578, PK2583, PK2590, PK2644, PK2650, PK2654, PK2672, PK2689, PK2704, PK2705, PK2707, PK2734, PK2746, PK2748, PK2790, PK2803, PK2804, PK2806, PK2807, PK2837, PK7354, PK7381, PK7383, PK7384, PK9715, PK9715D, PK9717, PK9718, PK9720, PK9721, PK9733, PK9744, PK9746, PK9746D, PK9747, PK9748, PK9763, PK9782, PK9783, PK9784, PK9850, PK9851, PK9867, PK9885, PL2099, PL2196, PL2196D, PL2197, PL2197D, PL2198, PL2199, PL2199D, PL2200, PL2200D, PL2407, PL2412, PL2417, PL2417D, PL2418, PL2424, PL2424D, PL2448, PL2449, PL2505, PL2534, PL2538, PL2539, PL2572, PL2583, PL2597, PL2597D, PL2598, PL7126, PL7510, PL7594, PL7595, PL7705, PL7706, PL7799, PL7799D, PL9702, PL9709, PL9710, PL9713, PL9741, PL9741D, PL9745, PL9746, PL9756, PL9820, PL9837, PL9861, PM2071, PM2072, PM2140, PM2142, PM2423, PM2424, PM2465, PM2515, PM2762, PM2763, PM2764, PM7259, PM7448, PM7449, PM7450, PM7533, PM7534, PM7763, PM7763D, PM7764, PM7764D, PM9702, PM9704, PM9715, PM9717, PM9732, PM9734, PM9747, PM9748, PP2048, PP2410, PP2491, PP2536, PP2576, PP2578, PP2715, PP7163, PP7183, PP7184, PP7408S, PP7453, PP7454, PP9707, PP9708, PP9722, PP9723, PP9724, PP9735, PP9750, PP9835, QA2074, QA2075, QA2174, QA2236, QA2311, QA2413, QA2455, QA2486, QA2486D, QA2487, QA2491, QA2576, QA2590, QA2598, QA2609, QA2613, QA2636, QA7249, QA7250, QA7251, QA7956, QA7997, QB2040, QB2041, QB2075D, QB2075S, QB2076S, QB2087, QB2088, QB2121, QB2393, QB7120, QB7120D, QB7121, QB7122, QB7122D, QB7257, QB7703, QB7704, QB7854, QB7973, QB7974, QB9005, QB9006, QB9008, QB9009, QB9033, QB9047, QB9109, QB9134, QB9140, QB9269, QB9272, QB9282, QB9282D, QB9294, QB9340, QB9341, QB9344, QB9345, QB9347, QB9348, QB9373, QB9373D, QB9395, QB9405, QB9406, QB9415, QC2008, QC2015, QC2093, QC2121, QC2267, QC2294S, QC2468, QC2469, QC7139, QC7140, QC7141, QC7142, QC7161, QC7240, QC7241, QC7242, QC7324, QC8025, QC8026, QC9002, QC9004, QC9012, QC9089, QC9095, QC9102, QC9135, QC9252, QC9253, QC9256, QC9257, QC9264, QD2063S, QD2211, QD7624, QD7630, QD7752, QD9002, QD9021, QD9026, QD9029, QD9081, QD9093, QD9093D, QD9095, QD9111, QD9119, QD9120, QD9214, QD9251, QE2132, QE2402, QE2403, QE2404, QE7324, QE7655, QE7828, QE7829, QE9014, QE9016, QE9028, QE9029, QE9043, QE9136, QE9204, QE9233, QE9272, QG2412, QG2424, QG2439, QG2567, QG2568, QG7919, QG8133, QG9067, QG9096, QG9108, QG9130, QG9382, QG9393, QG9425, QG9428, QG9510, QH2040, QH2252, QH7484, QH7899, QH7900, QH7916, QH7918, QH7919, QH7920, QH7921, QH9006, QH9015, QH9017, QH9019, QH9021, QH9022, QH9039, QH9040, QH9041, QH9054, QH9055, QH9056, QH9066, QH9067, QH9073, QH9089, QH9093, QH9105, QH9107, QH9123, QH9141, QH9147, QH9184, QH9217, QH9437, QH9441, QH9446, QJ2017, QJ2263, QJ7337, QJ7504, QJ7614, QJ7938, QJ7976, QJ7977, QJ7978, QJ8014, QJ8015, QJ8033, QJ9004, QJ9019, QJ9033, QJ9058, QJ9059, QJ9075, QJ9081, QJ9082, QJ9135, QJ9136, QJ9161, QJ9162, QJ9195, QJ9208, QJ9252, QJ9275, QJ9357, QJ9366, QK2087, QK2234, QK2235, QK2258, QK2447, QK2456, QK2469, QK2475, QK7504, QK7571, QK7581, QK7592, QK7643, QK7644, QK8012, QK8209, QK8236, QK8257, QK8258, QK9016, QK9066, QK9067, QK9077, QK9088, QK9089, QK9115, QK9119, QK9120, QK9141, QK9152, QK9154, QK9169, QK9213, QK9215, QK9216, QK9248, QK9256, QK9257, QK9258, QK9259, QK9263, QK9280, QK9281, QK9315, QK9371, QK9399, QK9411, QK9427, QL2459, QL2462, QL2489, QL7504, QL7505, QL7703, QL7960, QL7961, QL8056, QL9026, QL9061, QL9062, QL9081, QL9139, QL9157, QL9238, QL9273, QL9306, QL9309, QL9313, QL9324, QL9347, QL9348, QL9356, QL9364, QL9365, QL9373, QL9374, QL9375, QL9384, QL9385, QL9394, QL9397, QL9408S, QL9424, QM2021, QM2056, QM2057, QM2084, QM2085, QM7357, QM7448, QM7794, QM7983, QM9020, QM9073, QM9083, QM9092, QM9161, QM9162, QM9163, QM9177, QM9199, QM9204, QM9205, QM9230, QM9249, QM9251, QM9269, QM9312, QM9317, QM9352, QP2050, QP2056, QP2070, QP2072, QP2083, QP2110, QP2111, QP2126, QP2127, QP2157, QP2167, QP2169, QP2182, QP2185, QP2227, QP2228, QP2406, QP7568, QP7579, QP7775, QP7960, QP8017, QP8018S, QP9364, QP9392, QP9452, RA2026, RA2038, RA2414, RA2560, RA7572, RA8206, RA9010, RA9034, RA9035, RA9039, RA9040, RA9059, RA9063, RA9102, RA9141, RA9163, RA9164, RA9172, RA9223, RA9363, RA9390, RA9393, RA9426, RB2214, RB2215, RB2258, RB7053, RB7489, RB7687, RB7912, RB9015, RB9016, RB9063, RB9083, RB9087, RB9092, RB9094, RB9095, RB9096, RB9128, RB9150, RB9161, RB9175, RB9201, RB9206, RB9240, RB9251, RB9274, RB9283, RB9290, RC2163, RC2419, RC2420, RC7331R, RC7477, RC7498, RC7499, RC7644, RC8146, RC9009, RC9014, RC9015, RC9055, RC9073, RC9098, RC9123, RC9136, RC9137, RC9138, RC9144, RC9158, RC9173, RC9174, RC9189, RC9202, RC9226, RC9227, RC9233, RC9234, RC9246, RC9248, RC9258, RC9295, RC9299, RC9307, RC9324, RC9371, RC9373, RC9384, RC9385, RC9386, RD2090, RD2164, RD2173, RD2268, RD2304, RD2338, RD7914, RD7978, RD9045, RD9046, RD9047, RD9061, RD9117, RD9144, RD9156, RD9166, RD9196, RD9218, RD9230, RD9285, RD9286, RD9440, RD9443, RE2051, RE2084, RE2106, RE2107, RE2144, RE7827, RE8006, RE8108, RE8127, RE8303, RE8352, RE9010, RE9055
RECALLING FIRM/MANUFACTURER
Ethicon, Inc., Somerville, NJ, by letter on March 28, 2006. Firm initiated recall is ongoing.
REASON
The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.
VOLUME OF PRODUCT IN COMMERCE
1,061,712 sutures
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Magnetic Resonance Imaging Device, Recall # Z-0910-06
CODE
L001-L223 C002-C765 Hoo2-H733
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visits beginning on February 21, 2006.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The device has a software anomaly which causes the operating system to lock up and data to become corrupted during service procedures.
VOLUME OF PRODUCT IN COMMERCE
1,054 units
DISTRIBUTION
Nationwide

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PRODUCT
ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon. Model number BXB35-05-17-120 and Model number BXB35-06-17-120, Recall # Z-0912-06
CODE
Lot 1049856; Lot 1049864
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by visits on April 12, 2006. Firm initiated recall is ongoing.
REASON
A Primus device labeled (pouch and box) as a BXB35-05-17-120 contained a 6mm x 20mm catheter instead of the intended 5mm x 20mm catheter.
VOLUME OF PRODUCT IN COMMERCE
29 systems
DISTRIBUTION
Nationwide

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PRODUCT
Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an outer cannula with an attached female luer lock hub, and inner stylet with an attached male luer lock hub, and a flexible slip rink depth stop, Recall # Z-0913-06
CODE
Lot number: REP JO196
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Peripheral Vascular, Inc., Tempe, AZ, by letters on May 1, 2006.
Manufacturer: Bard Reynosa S.A. De C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
REASON
Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected.
VOLUME OF PRODUCT IN COMMERCE
225 units
DISTRIBUTION
CA, FL, NJ, MO, and TX

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PRODUCT
EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchscreen portable PC controlling a two channel dedicated EP stimulator. The stimulator is capable of single channel, simultaneous and sequential stimulation at programmed output settings using built-in protocols, and includes an emergency stimulation function, Recall # Z-0914-06
CODE
Model number: EP-4-02 and EP-4-04. EP40312-001 through 010; EP40403-001 through 014; EP40406-001 through 042; EP40408-001 through 039; EP40410-001 through 040; EP40411-001 through 040; EP40504-001 through 040; EP40506-001 through 040; EP40508-001 through 020; EP40510-001 through 020; EP40511-001 through 040
RECALLING FIRM/MANUFACTURER
EP Medsystems, West Berlin, NJ, by letter on April 4, 2006. Firm initiated recall is ongoing.
REASON
Under certain circumstances the device may exhibit the following behaviors: 1)-Initiation of a rapid stimulation train without command, when the device is in use in conjuction with an electrosurgical unit or RF ablation unit-2)-Presence of a DC offset voltage on an output channel-3)-Inability to synchronize with a non-EP MedSystems recording system.
VOLUME OF PRODUCT IN COMMERCE
187 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Endopath Probe Plus II, Hook Electrode, 5 mm Shaft, 34 cm length,
hollow tip electrdode, Product Code EPS01, Recall # Z-0915-06;
b) Endopath Probe Plus II, Foot-Controlled PistolGrip Handle, Product Code EPH01,
Recall # Z-0916-06;
c) Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02,
Recall # Z-0917-06;
d) Endopath Probe Plus II, Hand Controlled PencilGrip Handle, Product Code EPH04,
Recall # Z-0918-06;
e) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS02, Recall # Z-0919-06;
f) Endopath Probe Plus II, Right Ange Electrode, 5 mm shaft, 34 cm length, hollow tip
electrode, Product Code EPS03, Recall # Z-0920-06;
g) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 34 cm length, hollow
tip electrode, Code EPS04, Recall # Z-0921-06;
h) Endopath Probe Plus II, Spatula Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS06, Recall # Z-0922-06;
i) Endopath Probe Plus II, Curved Dissector Electrode, 5mm shaft, 29cm length,
hollow tip electrode, Code EPS08, Recall # Z-0923-06;
j) Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip
electrode, Code EPS09, Recall # Z-0924-06;
k) Endopath Probe Plus II, Open End Suction/Irrigation Canula, 10mm shaft, 34 cm
length, Code EPS11, Recall # Z-0925-06;
l) Endopath Probe Plus II, Flexible Fiber Canula, 5mm shaft, 29cm length, Code EPS13,
Recall # Z-0926-06
CODE
a) Lot numbers: C4D111, C4DD09, C4DD0H, C4DE5L, C4DK67, C4DM01, C4DM03,
and C4DN03;
b) Lot numbers: C4DG34 and C4DN1J;
c) Lot numbers: C4DG7H and C4DL5W;
d) Lot numbers: C4DF27. C4DL5U;
e) Lot numbers: C4DK34 and C4DK9L;
f) Lot numbers: C4DD4K, C4DJ5E, C4DK9M, and C4DN5E;
g) Lot numbers: C4DK66 and C4DL7N;
h) Lot numbers: C4DK35, C4DL86, and C4DN7U;
i) Lot number: C4DN1K;
j) Lot number: C4DN7V;
k) Lot number: C4DL3J;
l) Lot number: C4DL5V
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on April 24, 2006.
Manufacturer: Ethicon Endo-Surgery, Inc., S.A. de C.V. Planta II, Ciudad Juarez, Mexico. Firm initiated recall is ongoing.
REASON
There is a possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device.
VOLUME OF PRODUCT IN COMMERCE
1,627 cases/6 devices per case
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Zinnanti Injector -- 2.0; Size 2.0 mm, Length 23 cm, latex free, single-use, sterile. For in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin’s test. REF TMI1153, Recall # Z-1077-06
CODE
Lot number: M20772
RECALLING FIRM/MANUFACTURER
Catheter Research, Inc., Indianapolis, IN, by letter dated April 24, 2006. Firm initiated recall is ongoing.
REASON
The uterine stop component was not included with the device.
VOLUME OF PRODUCT IN COMMERCE
660 units
DISTRIBUTION
MN and Spain

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case, Recall # Z-0861-06
CODE
NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S, NFD622542S, NFD622564S, NFD622629S, NFD622664S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN, by letter on March 2006.
Manufacturer: Medtronic Puerto Rico Operations Co, MedRel, Juncos, PR. Firm initiated recall is ongoing.
REASON
A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
VOLUME OF PRODUCT IN COMMERCE
24 devices
DISTRIBUTION
CA, OR, PA, Belgium, France, Germany, Italy, Spain, Switzerland, and United Kingdom

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PRODUCT
Medtronic Paceart 2004 Second Edition & Paceart 2005 First Edition versions of the Paceart Gateway Software. The Medtronic Paceart System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station, Recall # Z- 0911-06
CODE
Paceart 2004 second edition and Paceart 2005 first edition
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc., Cardiac Rhythm Management, Minneapolis, MN, by telephone and/ or letter in February 2006.
Manufacturer: Medtronic Paceart, Arden Hills, MN. Firm initiated recall is ongoing.
REASON
The Paceart System could inappropriately insert data from a patient’s Medtronic CareLink transmission into another patient’s Paceart record. An issue associated with the automated batch transfer of implanted cardiac device data from the Medtronic CareLink network to the Paceart System exists.
VOLUME OF PRODUCT IN COMMERCE
210 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR June 7, 2006

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