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U.S. Department of Health and Human Services

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Enforcement Report for June 14, 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.

June 14, 2006
06-24

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I
______________________________

PRODUCT
FORTUNE STAR brand WHITE FUNGUS, Net. Wt. 3 oz. (85g), Product of China. The product is packed in a flexible plastic package. UPC barcode # 6 644601 04083, Recall # F-200-6
CODE
No coding other than the UPC barcode.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ho's Trading Inc., Brooklyn, NY, by press release, telephone and letters dated March 13, 2006.
Manufacturer: Sinojet Development Ltd., Hong Kong, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (3073 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
16 cases (100 -- 3 oz. packages per case)
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
______________________________

PRODUCT
Acetaminophen 500 mg Tablets, OTC, distributed in bottles of 100 tablets and 1000 tablets or in bulk form. (1) NDC 0677-1784-10 --- URL brand ACETAMINOPHEN TABLETS, USP --- 500 mg --- EXTRA STRENGTH --- 1000 TABLETS --- (2) NDC 0904-1988-80 --- MAJOR brand EXTRA STRENGTH Mapap TABLETS --- 1000 ACETAMINOPHEN TABLETS --- 500 MG. EACH --- (3) NDC 62107-050-01 --- HealthSen$e brand TACTINAL Tablets --- Extra Strength - 500mg --- Acetaminophen --- 500 mg each --- 100 Tablets. The product was also sold to 1 account as bulk tablets, Recall # D-259-6
CODE
Lot 03M847 (exp. 12/06)
RECALLING FIRM/MANUFACTURER
PDK Labs, Inc., Hauppauge, NY, by fax and letters dated May 10, 2006. Firm initiated recall is ongoing.
REASON
Firm received a complaint of spotted (discolored) tablets due to mold contamination.
VOLUME OF PRODUCT IN COMMERCE
4.5 Million tablets
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0701-6;
b) Platelets Leukocytes Reduced, Recall # B-0702-6
CODE
a) and b) Unit number: LL24568
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, DBA Rhode Island blood Center, Providence, RI, by letter on February 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA and RI
______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0867-6;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0868-6;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0869-6;
d) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0870-6;
e) Plasma Frozen Cryoprecipitate Reduced, Recall # B-0871-6;
f) Cryoprecipitated AHF, Recall # B-0872-6;
g) Recovered Plasma, Recall # B-0873-6
CODE
a) Units: 12 FV22498, 12FY92543, 12GF13319, 12GY67376, 12KP82111, 12LW87682, 12V 38895;
b) Unit numbers: 12KL58931(2 units), 12KR46287 (2 units);
c) Unit numbers: 12KJ05484, 12KJ06104 (2 units), 12W 84617 (2 units), 12W 86287;
d) Unit number: 12 W86287;
e) and f) Unit numbers: 12FV22498, 12FY92543;
g) Unit numbers: 12GF13319, 12GY67376, 12KP82111, 12LW87682
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Blood Service Region, Charlotte, NC, by telephone, electronically and letter on March 19, 2004, continuing through April 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
OK, NC, GA, CA, TN, PR, and Switzerland
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0874-6
CODE
Unit number: 8504053
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on March 31, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1131-6
CODE
Unit numbers: 17GX43325, 17GX43326
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Carolina Region, St. Paul, MN, by telephone and letter on June 25, 2004. Firm initiated recall is complete.
REASON
Blood products, which may have been leukocyte reduced twice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN and MA
______________________________

PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1147-6
CODE
Unit numbers: 10742-8299 Parts 1 and 2
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by letter on April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1148-6
CODE
Unit numbers: 10744-6042, 10740-7992
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Scottsdale, AZ, by letter on April 4, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1149-6
CODE
Unit number: 004LJ29600
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and letter on February 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VT
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1152-6
CODE
Unit number: 9104035
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on June 21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1153-6
CODE
Unit number: 9010749
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on June 21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1154-6
CODE
Unit number: 33GY99000
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and letter on February 7, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CT
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1155-6
CODE
Unit number: 9007549
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________

PRODUCT
Red Blood Cells, Recall # B-1156-6
CODE
Unit number: 9009615
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 18, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1157-6
CODE
Unit number: 9073600
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 31, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
______________________________

PRODUCT
Source Plasma, Recall # B-1158-6
CODE
Unit numbers: NG0049022, NG0049602, NG0050070, NG0050305, NG0050701, NG0051112, NG0051372, NG0051749, NG0052003, NG0052405, NG0052773, NG0053160, NG0053465, NG0053757, NG0054197, NG0054559, NG0054772, NG0055021
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on January, 16, 2003. 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
18 units
DISTRIBUTION
KY
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1159-6
CODE
Unit number: 9014761
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on July 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________

PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1160-6
CODE
Unit number: 6919328
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 27, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
______________________________

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1161-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1162-6
CODE
a) Unit numbers: 06FH15632, 06FH17842;
b) Unit number: 06KL33064
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by telephone and letter on November 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1165-6
CODE
Unit number: 8611585
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by fax on August 10, 2004. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1167-6
CODE
Unit numbers: 4932104 (distributed as split product)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 1, 2003. Firm initiated recall is complete.
REASON
Blood products, with platelet yields below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
______________________________

PRODUCT
Recovered Plasma, Recall # B-1209-6
CODE
Unit number: 1008433
RECALLING FIRM/MANUFACTURER
Aultman Hospital Blood Bank, Canton, OH, by telephone, facsimile, and letter on October 5, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1221-6
CODE
Unit number: 17FX76089
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on July 8, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with Pseudomonas fluorescens and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1223-6
CODE
Unit number: 003FK46986
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on November 4, 2005 and by letter dated November 25, 2005. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________

PRODUCT
a) Red Blood Cells, Recall # B-1224-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1225-6;
c) Red Blood Cells, Pheresis, Leukocytes Reduced, Recall # B-1226-6;
d) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1227-6;
e) Platelets, Recall # B-1228-6;
f) Cryoprecipitated AHF, Recall # B-1229-6;
g) Fresh Frozen Plasma, Recall # B-1230-6;
h) Fresh Frozen Plasma Pheresis, Recall # B-1231-6;
i) Plasma, Cryoprecipitate Reduced, Recall # B-1232-6
CODE
a) Unit number: 20033-0049;
b) Unit numbers: 20033-0573, 20033-0717, 20033-6816, 20033-6822, 20030-7116,
20032-7095, 20032-7096, 20032-7097, 20032-7098, 20032-7099, 20032-7100,
20032-7101, 20032-7102, 20032-7103, 20032-7107, 20032-7108, 20032-7109,
20032-7112, 20032-7113, 20032-7114, 20032-7115, 20032-7117, 20032-7118,
20032-7119, 20032-7120, 20032-7121, 20032-7538, 20032-7539, 20032-7540,
20032-7554, 20032-7555, 20032-7556, 20032-7557, 20032-7564, 20032-7565,
20032-7567, 20032-7569, 20032-7573, 20032-9334, 20032-9338, 20032-9342,
20033-0043, 20033-0044, 20033-0048, 20033-0581, 20033-0661, 20033-0947,
20033-0948, 20033-0949, 20033-0950, 20033-0951, 20033-0952, 20033-5763,
20033-5764, 20033-5765, 20033-5767, 20033-5771, 20033-5774, 20033-5775,
20033-5778, 20033-5908, 20033-5915, 20033-5920, 20033-6051, 20033-6053,
20033-6054, 20033-6055, 20033-6061, 20033-6062, 20033-6063, 20033-6064,
20033-6089, 20033-6094, 20033-6095, 20033-6100, 20033-6107, 20033-6108,
20033-6112, 20033-6130, 20033-6135, 20033-6136, 20033-6289, 20033-6290,
20033-6291, 20033-6293, 20033-6294, 20033-6310, 20033-8048, 20033-8052,
20033-8058, 20033-8059, 20033-8079, 20033-8081, 20033-8082, 20033-8083,
20033-8094;
c) Unit numbers: 20032-7546 (part 1 & 2), 20032-7559 (part 1 & 2), 20032-7566
(part 1 & 2), 20032-9329 (part 1 & 2), 20033-5766 (part 1 & 2), 20033-6060
(part 1 & 2), 20033-6084 (part 1 & 2), 20033-6303 (part 1 & 2), 20033-8084 (part 2);
d) Unit numbers: 20032-9328, 20033-6045;
e) Unit numbers: 20033-6289, 20033-6290, 20033-6291, 20033-6293, 20033-6294,
20033-6295, 20033-8079, 20033-8081, 20033-8082, 20033-8083, 20033-8086,
20033-8094, 20033-8096, 20033-8097, 20033-8098;
f) Unit numbers: 20030-3558, 20030-3559, 20030-3560, 20030-4175, 20031-8064,
20031-8066, 20031-8067, 20031-8726, 20031-8734, 20031-8735, 20031-9123,
20032-7088, 20032-8427;
g) Unit numbers: 20030-3470, 20030-5457, 20030-5458, 20030-5459, 20030-5460,
20030-5473, 20030-5850, 20030-5856, 20030-6277, 20031-6505, 20031-6508,
20031-6742, 20031-6743, 20031-6746, 20031-6750, 20031-6812, 20031-6816,
20031-6822, 20031-6849, 20031-6912, 20031-6913, 20031-6932, 20031-7152,
20031-7405, 20031-7454, 20031-7455, 20031-7597, 20031-8051, 20031-8052,
20031-8065, 20031-8159, 20031-8162, 20031-8470, 20031-8474, 20031-8476,
20031-8478, 20031-8480, 20031-8482, 20031-8483, 20031-8484, 20031-8633,
20031-8662, 20031-8675, 20031-8859, 20032-0242, 20032-0244, 20032-0252,
20032-0255, 20032-0257, 20032-0261, 20032-0264, 20032-0265, 20032-2714,
20032-2985, 20032-2996, 20032-3057, 20032-3060, 20032-3061, 20032-3063,
20032-3343, 20032-3368, 20032-3383, 20032-3386, 20032-3388, 20032-3635,
20032-3637, 20032-3639, 20032-3641, 20032-3656, 20032-3658, 20032-3659,
20032-3660, 20032-7005, 20032-7012, 20032-7013, 20032-7101, 20032-7538,
20032-7539;
h) Unit numbers: 20030-6256 (split 1 & 2), 20033-5968;
i) Unit number: 20030-3653
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 27, 2003.
Manufacturer: Blood Systems, Inc., Baton Rouge, LA. 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
226 units
DISTRIBUTION
AZ, LA, MS, NM, TN, and TX
______________________________

PRODUCT
Source Plasma, Recall # B-1233-6
CODE
Unit numbers: LYT110, LYR760, LYR375, LYR290, LYP705, LYP372, LYP245, 1RU518, 1MT162, JPY444, JPY958, JPY874, JNV900, JNY977, JNY337, JNY212, JNY973, JCR864, JCR418, JCR328, JCP889, JCP815, JCP624, JCP507, JCP267, JCP175, JCN995, JCN681, JCN433, JCN291, JCN165, JCN015, JOA116, JOA040, 8057GH, 2933BC, 0430BC, 0195BC, 08152X, 07294X, 07022X, 06656X, 37209U, 37015U, 36121U, 35716U, 35624U, 34454U, Y81112, Y80598, Y79888, Y79159, V78465, V91945, V91420, V90651, V90521, V90089, V90019, V89617, V89445, V88266, H30887, R84533, R83427, R82644, C47918, C47534, C47201, C46956, C46519, C46302, C45499, C45086, D15635, D15564, D15236, YHA861, YHA753, YHB409, YHD402, YHD274, WRD822, WRD683
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Montgomery, AL, by facsimile on September 22, 1999. 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 was previously deferred for testing positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
NC
______________________________

PRODUCT
Source Plasma, Recall # B-1239-6
CODE
Unit numbers: NG0046355, NG0046660, NG0046936, NG0047193, NG0047669, NG0048726, NG0049215, NG0049590, NG0049865, NG0050332, and NG0053478
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by facsimile and telephone on December 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
KY
______________________________

PRODUCT
Source Plasma, Recall # B-1241-6
CODE
Unit numbers: 20049036, 20049126, 20049837, 20049901, 20050593, 20050727, 20051369, and 20051553
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1242-6
CODE
Unit number: 8835585
RECALLING FIRM/MANUFACTURER
NBAH Blood Center, New Brunswick, NJ, by facsimile on August 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
NJ
______________________________

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1243-6;
b) Fresh Frozen Plasma, Recall # B-1244-6
CODE
a) and b) Unit numbers: 8835584
RECALLING FIRM/MANUFACTURER
NBAH Blood Center, New Brunswick, NJ, by facsimile dated August 8, 2005. 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
NJ
______________________________

PRODUCT
Source Plasma, Recall # B-1246-6
CODE
Unit numbers: 0440594567, 0440594387, 0440593801, 0440592886, 0440592638, 0440586312, 0440585421, 0440583630, 0440582802, 0440582163, 0440581945, 0440581575, 0440554700, 0440554344, 0440579372, 0440578241, 0440577894, 0440575435, 0440576972, 0440572145, 0440567000, 0440566804, 0440565152, 0440564673, 0440564494, 0440561276, 0440560995, 0440560708, 0440560327, 0440559996, 0440559796, 0440559190, 0440559106, 0440558254, 0440558029, 0440557194, 0440556676, 0440553205, 0440552877, 0440552551, 0440545112, 0440544891, 0440544009, 0440543448, 0440543209, 0440542819, 0440539697, 0440539286, 0440539079, 0440538604, 0440538357, 0440529867, 0440529391, 0440528669, 0440528061, 0440527085, 0440526514, 0440526360, 0440587800, 0440587436, 0440584839, 0440584644, 0440584279, 0440583391, 0440583204, 0440581639, 0440581165, 0440580423, 0440580276, 0440574982, 0440574489, 0440574296, 0440573957, 0040573061, 0440572447, 0440572280, 0440571868, 0440571666, 0440571326, 0440571129, 0440570552, 0440569239, 0440569000, 0440568746, 0440568557, 0440568334, 0440568161, 0440567885, 0440567681, 0440567388, 0440567157, 0440566912, 0440566654, 0440566367, 0440566107, 0440565830, 0440565852, 0440565497, 0440565276, 0440564998, 0440564729, 0440564443, 0440564156, 0440563905, 0440563587, 0440563360, 0440562999, 0440562784, 0440562397, 0440562199, 0440561799, 0440561629, 0440557896, 0440557720, 0440557385, 0440557174, 0440556825, 0440556691, 0440555645, 0440555235, 0440554726, 0440554569, 0440553944, 0440552840, 0440551041, 0440550713, 0440550331, 0440550145, 0440549776, 0440549575, 0440549219, 0440549021, 0440548361, 0440547519
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Charleston, SC, by facsimile on August 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION
NC
______________________________

PRODUCT
Fresh Frozen Plasma, Recall # B-1255-6
CODE
Unit number: 71N293749
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
______________________________

PRODUCT
Fresh Frozen Plasma, Recall # B-1256-6
CODE
Unit number: 71N060653
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
______________________________

PRODUCT
Fresh Frozen Plasma, Recall # B-1257-6
CODE
Unit number: 71N060585
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery, AL, by facsimile on November 22, 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
______________________________

PRODUCT
a) Red Blood Cells, Recall # B-1258-6;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1259-6;
c) Platelets, Recall # B-1260-6;
d) Platelets Pheresis Leukocytes Reduced; Recall # B-1261-6;
e) Platelets Pheresis Leukocytes Reduced Irradiated,
Recall # B-1262-6;
f) Fresh Frozen Plasma, Recall # B-1263-6
CODE
a) Unit numbers: 1279803, 1279820, 1279821, 1363777, 1363819, 1511840;
b) Unit number: 1279826;
c) Unit number: 1363777;
d) Unit numbers: 1411036 - part 2, 1411041, 1411047-1&2, 1411048,
8574658 -- part 2, 8574661-1&2, 8574717, 8574739- 1&2, 8574742;
e) Unit numbers: 1411036- part 2, 4968568, 8574651, 8574656;
f) Unit numbers: 1279803, 1279820, 1279821, 1279826, 1363777, 1363819
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by telephone on April 24, 2003, and letters dated April 28 and 29, 2003. Firm initiated recall is complete.
REASON
Blood products, collected using expired arm cleansers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
NY, NJ, CA, MS, and D.C.
______________________________

PRODUCT
a) Fresh Frozen Plasma, Recall # B-1264-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1265-6
CODE
a) Unit number: 8504628;
b) Unit number: 8504628 (split unit)
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on April 4, 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
3 units
DISTRIBUTION
GA
______________________________

PRODUCT
Fresh Frozen Plasma, Recall # B-1267-6
CODE
Unit numbers: 0307633, 0872087, and 0869837
RECALLING FIRM/MANUFACTURER
Blood Connection, Inc, Greenville, SC, by telephone on June 30, 2005. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood in which the associated blood components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and SC
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1268-6
CODE
Unit number: 12GN59461
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Asheville, NC, by letter dated February 19, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
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PRODUCT
Autologous Whole Blood, Recall # B-0820-6
CODE
Unit number: 6350850
RECALLING FIRM/MANUFACTURER
NBAH Blood Center, New Brunswick, NJ, by facsimile dated October 28, 2003. Firm initiated recall is complete.
REASON
Whole Blood, collected from an ineligible autologous donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1150-6
CODE
Unit numbers: 10743-9240, 10743-8714
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on March 3, 2003. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of acceptable temperatures during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
______________________________

PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1151-6
CODE
Unit numbers: 10772-3234, 10772-3235, 10772-3238, 10772-3239
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 29, 2003. Firm initiated recall is complete.
REASON
Blood products, in transit longer than 24 hours and without constant agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AZ
______________________________

PRODUCT
Source Plasma, Recall # B-1222-6
CODE
Unit number: FGDCBG
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Montgomery, AL, by facsimile on March 2, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
______________________________

PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1266-6
CODE
Unit number: 246332262
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by letter dated June 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with acceptable specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SD
______________________________

PRODUCT
a) Red Blood Cells, Recall # B-1269-6;
b) Fresh Frozen Plasma, Recall # B-1270-6
CODE
a) Unit number: V24469 ad V24472;
b) Unit number: V24472
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Community Blood Center of Carolinas, Charlotte, NC, by letter dated November 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
______________________________

PRODUCT
a) Red Blood Cells, Recall # B-1271-6;
b) Fresh Frozen Plasma, Recall # B-1272-6;
c) Cryoprecipitated AHF, Recall # B-1273-6
CODE
a) Unit numbers: 0204148, 0204339, and 0829853;
b) Unit numbers: 0686901 and 0832697;
c) Unit numbers: 0205138
RECALLING FIRM/MANUFACTURER
Blood Connection, Inc., Greenville, SC, by telephone on August 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood in which the associated blood components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
PA, NC, GA, NY, and SC
______________________________

PRODUCT
Source Plasma, Recall # B-1274-6
CODE
Unit numbers: G43249097, G43452097, G44250097, G44548097, G45210097, G46095097, G46336097, and G47061097
RECALLING FIRM/MANUFACTURER
Alpha Therapeutics Corp., San Diego, CA, by facsimile on June 18, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had surgery within 12 months prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Spain
______________________________

PRODUCT
a) Red Blood Cells, Recall # B-1275-6;
B) Red Blood Cells Leukocytes Reduced, Recall # B-1276-6
CODE
a) Unit numbers: 0789511, 0594815, 07799769, 0802461, 0596840, 0597205,
0596624, 0801896, 0803855, 0598306, 0802500, 0598326, 0805435, 0597091,
0597570, 0598053, 0598110, 0597581, 0805094, and 0806130;
b) Unit number: 0597606
RECALLING FIRM/MANUFACTURER
Blood Connection, Inc., Greenville, SC, by telephone on December 11, 2003. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood in which the associated blood components contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
GA, and SC

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
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PRODUCT
Discovery ST PET/CT imaging system with gantry model number 5105797. Catalog Identifiers: S9114LA/LB/MA/MN, S9118LA/LB/MA/MN, S9116LA/MA. Recall # Z-0588-06
CODE
617243PETCT, 203688DST, ALLIANCEPETCT30, 203863DST, 973989DST, 908979DST, 212535DST, 412942DST, 814366CTPET, 202715PTCT, 443663DST, 850863FWPET, 863680DST, 251343DST, 832237EHDST, 0002584305, 574535PET, 763257DST, DMSIPCO7, EPHCPASRW1, 801408DST, 949417DST, 406255PET, 805546CT1, 415222CL1, 503692PETCT, 360SALPET, 425228DST, 402390DST1, 201996DST, AH4001PE01, 2558941, 082445040002, 082445160009, 082445160006, 082445160010, 514340DST, 423468PE01, 10495DST01, A4194408, 10094PTM70, 00060DST01, 00060DST02, A5138110, C5123618, A5215931, A99263302, A5111228, A5808512, A5279305, A5645908, YE0010, YE0009, 81DST2547033, ZWL0470, PER10934, 732292DST, ALLIANCEPCT41, DMSIPC15, 763463PC14, ALLIANCEPETCT28, ALLIANCEPETCT29, 972867DST, 082445040003, 2585577DISCPET, A5645911, YE0100, YE0113, YE0404, YE0403, 0834450002, 787269PETCT, 0002592878
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, LLC, Waukesha, WI, by letter dated November 10, 2005. Firm initiated recall is ongoing.
REASON
The LightSpeed CT Technical Reference Manual was omitted from the document kit shipped with the PET/CT system.
VOLUME OF PRODUCT IN COMMERCE
74 units
DISTRIBUTION
Nationwide and Internationally
______________________________

PRODUCT
Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY*** ***.'' Catalogue number 200-04-45, Recall # Z-0927-06
CODE
Serial number range 0730621-07306351; Lot number 452500
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by letter on December 19, 2005. Firm initiated recall is ongoing.
REASON
An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
VOLUME OF PRODUCT IN COMMERCE
14 implants
DISTRIBUTION
AL, LA, Spain, Germany and Greece
______________________________

PRODUCT
Gliding Nail Radiolucent Guide instrument set, Model Number: GNRADIOLUCENTGUIDE, instrument set that contains one unit of each of the following instrument: 1130020-A: GNp Carbon Targeting Handle 1130021-A: GN Adapter Screw for Handle SW 10 1130022-A: GN Targeting Guide Carbon 125° 1130023-A: GN Targeting Guide Carbon 135° 1130060-A: GNp Drill Guide Locking No. 3 1133158-A: GN Centering Sleeve Recall # Z-0928-06
CODE
Revision A Serial Number: None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone beginning February 22, 2006.
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
VOLUME OF PRODUCT IN COMMERCE
5 sets
DISTRIBUTION
CA, ID and NY
______________________________

PRODUCT
Anestar and Anestar Plus Anesthesia System. Recall # Z-0929-06
CODE
Serial Numbers starting with 4600: A51083; C51104; C51116; C51117; C51120; C51121; C51125; E41025; G30143; L41062; L41063; L41064; L41065; L41071; L41075; 010001; 010002; 010008; 010010; A20024; A51076; A51077; A51078; A51081; A51084; B20027; B30076; B30077; B30078; B30081; B30082; B30083; B41005; B51087; B51088; B51089; B51092; B51096; C30087; C30092; C30093; C30094; C30095; C30096; C30097; C30098; C30099; C30102; C41014; C41015; C41017; C41020; C51114; C51118; D20035; D20036; D20037; D20038; D20042; D20043; D20044; D30100; D30101; D30103; D30104; D30105; D30106; D30107; D30108; D30109; E30112; E30113; E30115; E30116; E30117; E30118; E41029; F30120; F30128; F30129; F30131; F30132; F30133; F30134; F30135; G30136; G30137; G30138; G30139; G30140; G30142; H20045; H20047; H20051; H20052; I10010; I41031; I41035; I41036; I41038; I41041; I41042; I41043; I41044; I41045; I41046; I41047; I41048; I41049; I41050; J20055; J20056; J20057; J20059; J20060; J20061; J20063; J20064; K41057; L41066; L41073; A20018; A20023; A30069; A30070; B20026; B20028; B20030; B30084; B30086; C41031; C41018; D20014; I41034; I41037; K41060; L30162; L41068; C51101; C51103; C51111; C51113; D51131; F30122US; F30127; H30149; I41033; I41039; I41040; 010007; E30114; H30144; H30145; H30146; H30147; H30148; H30150; H30151; H30152; H30153; H30155; A30066; A30067; A30071; A51080; A51082; A51085; B41002; B51086; B51090; B51097; C41011; C41061; C41091; C51105; C51108; C51115; C51123; D51127; D51129; D51132; D51135; E41022; E41023; E41024; E41026; F30130; H20048; I41032; K41051; K41052; K41053; K41054; K41059; L41069; A51079; B41004; B41009; A30072; A30073; A30074; A30075; D20039; D20040; E30119; H30154; 010012; A20020; A20034; K41055; K41056; K41058; L30156; L30157; L30159; L30160; L30161; L41067; L41070; L41074; A30068; B51091; B51093; B51094; B51095; C30088; C30089; C30090; C30091; D10005; E41021; E41027; E41028; E41030; L30163; L30167; B51098; C51112; B20032; D51126; D51130; D51133; D51134; L30164; L30166; F30121; F30123; A20015; A20016; A20022; B10001; B20029; B20031; B20033; B30079; B30080; B41001; B41003; B41006; B41007; B41008; B41010; C51102; C51107; C51109; C51110; F30124; F30125; F30126; G30141; H20046; H20049; H20050; H20053; H20054; I10008; I10013; J20058; J20062; L30158; L40161; A20021; L41072. Serial Numbers starting with AF0: 1040-L5; 1045-A6; 1043-L5; 1029-K5; 1037-L5; 1005-I5; 1032-K5; 1036-L5; 1035-L5; 1034-L5; 1033-L5; 1032-L5; 1031-K5; 1030-K5; 1028-K5; 1027-K5; 1026-K5; 1025-K5; 1024-K5; 1023-K5; 1022-K5; 1021-K5; 1020-K5; 1019-K5; 1018-K5; 1017-K5; 1016-K5; 1015-K5; 1014-J5; 1013-J5; 1012-J5; 1011-J5; 1009-I5; 1008-I5; 1007-I5; 1004-I5; 1003-I5; 1001-I5; 1055-A6; 1051-A6; 1048-A6; 1046-A6; 1042-L5; 1010-I5; 1044-A6; 1041-L5; 1038-L5; 1006-I5; 1053-A6; 1052-A6; 1049-A6; 1047-A6; 1039-L5.
RECALLING FIRM/MANUFACTURER
Datascope Corp, Mahwah, NJ, by letter on March 17, 2006. Firm initiated recall is ongoing.
REASON
The Anestar and Anestar Plus Anesthesia System may produce periods of high Positive End-Expiratory Pressure (PEEP), in both manual and mechanical ventilation mode due to an issue with the Applied Pressure Limit (APL) valve.
VOLUME OF PRODUCT IN COMMERCE
337 UNITS
DISTRIBUTION
Nationwide and Australia, El Salvador, and Venezuela.

PRODUCT
a) CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #: LA5IMAA, Recall # Z-0930-06;

b) CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model # LA5JL40A, Recall # Z-0931-06;

c) CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model #LA5JR40A, Recall # Z-0932-06;

d) CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Model#LA5SR30, Recall # Z-0933-06;

e) CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR35, Recall # Z-0934-06;

f) CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR40, Recall # Z-0935-06;

g) CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA5SR50A, Recall # Z-0936-06;

h) CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number:LA63DRC, Recall # Z-0937-06;

i) CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL10A, Recall # Z-0939-06;

j) CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL20A, Recall # Z-0940-06;

k) CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6AL30A, Recall # Z-0941-06;

l) CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU35A, Recall # Z-0942-06;

m) CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU40A, Recall # Z-0943-06;

n) CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6EBU45A, Recall # Z-0944-06;

o) CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number : LA6HSIA, Recall # Z-0945-06;

p) CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL35A, Recall # Z-0946-06;

q) CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL405, Recall # Z-0947-06;

r) CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40A, Recall # Z-0948-06;

s) CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40SHA, Recall # Z-0949-06;

t) CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL45A, Recall # Z-0950-06;

u) CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL50A, Recall # Z-0951-06;

v) CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40A, Recall # Z-0952-06;

w) CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40SHA, Recall # Z-0953-06;

x) CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR50A, Recall # Z-0954-06;

y) CATHETER LA6MB1A LA 6F 110CM M Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6MB1A, Recall # Z-0955-06;

z) CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30, Recall # Z-0956-06;

aa) CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR30SH, Recall # Z-0957-06;

bb) CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35, Recall # Z-0958-06;

cc) CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR35SH, Recall # Z-0959-06;

dd) CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40,
Recall # Z-0960-06;

ee) CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:
LA6SR40A, Recall # Z-0961-06:

ff) CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR40SH, Recall # Z-0962-06;

gg) CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45, Recall # Z-0963-06;

hh) CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR45SH, Recall # Z-0964-06;

ii) CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50, Recall # Z-0965-06;

jj) CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA6SR50SH, Recall # Z-0966-06;

kk) CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60, Recall # Z-0967-06;

ll) CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6SR60SH, Recall # Z-0968-06;

mm) CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA73DRC, Recall # Z-0969-06;

nn) CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7IMAA, Recall # Z-0970-06;

oo) CATHETER LA7MB1A LA 7F 110CM M CATHETER LA7MB1A LA 7F 110CM MB Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7MB1A, Recall # Z-0971-06;

pp) CATH. GUIDE 7F SR3.0 LAUNCHER CATHETER LA7SR30 LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR30, Recall # Z-0972-06;

qq) CATH. GUIDE 7F SR3.0 W/SH LAUN CATHETER LA7SR30SH LA 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR30SH, Recall # Z-0973-06;

rr) CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR35 LA7SR35, Recall # Z-0974-06;

ss) CATH. GUIDE 7F SR3.5 W/SH LAUN CATHETER LA7SR35SH LA 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR35SH, Recall # Z-0975-06;

tt) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40, Recall # Z-0976-06;

uu) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, Recall # Z-0977-06;

vv) CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA7SR40, Recall # Z-0978-06;

ww) CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR40SH, Recall # Z-0979-06;

xx) CATH. GUIDE 7F SR5.0 LAUNCHER CATHETER LA7SR50 LA 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7SR50, Recall # Z-0980-06;

yy) CATH. GUIDE 8F 3DRC LAUNCHER CATHETER LA83DRC LA 8F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA83DRC, Recall # Z-0981-06;

zz) CATH. GUIDE 8F 3DRC W/SH LAUNC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA83DRCSH, Recall # Z-0982-06;

aaa) CATH.GUIDE 8F EBU 4.0 110CM CATHETER LA8EBU40SHA LA 8F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU40SHA, Recall # Z-0983-06;

bbb) CATH.GUIDE 8F EBU 4.5 SH 110CM CATHETER LA8EBU45SHA LA 8F 110CM EB45 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8EBU45SHA,Recall # Z-0984-06;

ccc) CATH.GUIDE 8F EBU 5.0 SH 110CM CATHETER LA8EBU50SHA LA 8F 110CM EB50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8EBU50SHA, Recall # Z-0985-06;

ddd) CATH. GUIDE 8F SR3.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30, Recall # Z-0986-06;

eee) CATH. GUIDE 8F SR3.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR30SH, Recall # Z-0987-06;

fff CATH. GUIDE 8F SR3.5 LAUNCHER CATHETER LA8SR35 LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35, Recall # Z-0988-06;

ggg) CATH. GUIDE 8F SR3.5 W/SH LAUN CATHETER LA8SR35SH LA 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR35SH, Recall # Z-0989-06;

hhh) CATH. GUIDE 8F SR4.0 LAUNCHER CATHETER LA8SR40 LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40, Recall # Z-0990-06;

iii) CATH. GUIDE 8F SR4.0 W/SH LAUN CATHETER LA8SR40SH LA 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR40SH, Recall # Z-0991-06;

jjj) CATH. GUIDE 8F SR5.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50, Recall # Z-0992-06;

kkk) CATH. GUIDE 8F SR5.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA8SR50SH, Recall # Z-0993-06;

lll) CATH. GUIDE 8F SR6.0 LAUNCHER Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60, Recall # Z-0994-06;

mmm) CATH. GUIDE 8F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA8SR60SH, Recall # Z-0995-06;

nnn) CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRC, Recall # Z-0996-06;

ooo) CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SA63DRCSH, Recall # Z-0997-06;

ppp) CATHETER SA6SR35 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR35, Recall # Z-0998-06;

qqq) CATHETER SA6SR40 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR40, Recall # Z-0999-06;

rrr) CATHETER SA6SR50 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SA6SR50, Recall # Z-1000-06;

sss) CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB63DRC, Recall # Z-1001-06;

ttt) CATHETER SB63DRCSH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB63DRCSH, Recall # Z-1002-06;

uuu) CATHETER SB6SR30 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR30, Recall # Z-1003-06;

vvv) CATHETER SB6SR35 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR35, Recall # Z-1004-06;

www) CATHETER SB6SR35SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR35SH, Recall # Z-1005-06;

xxx) CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: SB6SR40, Recall # Z-1006-06;

yyy) CATHETER SB6SR40SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR40SH, Recall # Z-1007-06;

zzz) CATHETER SB6SR50 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB6SR50, Recall # Z-1008-06;

aaaa) CATHETER SB73DRCSH SB 7F 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: SB73DRCSH, Recall # Z-1009-06;

bbbb) CATHETER Z26AL10A Z2 6F 110CM AL10 Z26 AL10 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL10A, Recall # Z-1010-06;

cccc) 6F Z2 AL 2.0 110CM CATHETER Z26AL20A Z2 6F 110CM AL20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL20A, Recall # Z-1011-06;

dddd) 6F Z2 AL 3.0 110CM CATHETER Z26AL30A Z2 6F 110CM AL30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AL30A, Recall # Z-1012-06;

eeee) 6F Z2 AR 2.0 110CM CATHETER Z26AR20A Z2 6F 110CM AR20 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26AR20A, Recall # Z-1013-06;

ffff) CATHETER Z26EBU35A Z2 6F 110CM EB35 Z26 EBU35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26EBU35A, Recall # Z-1014-06;

gggg) CATHETER Z26EBU40A Z2 6F 110CM CATHETER Z26EBU40A Z2 6F 110CM EB40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26EBU40A, Recall # Z-1015-06;

hhhh) 6F Z2 FL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z26FL40A, Recall # Z-1016-06;

iiii) 6F Z2 JL 4.0 110CM CATHETER Z26JL40A Z2 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JL40A, Recall # Z-1017-06;

jjjj) 6F Z2 JR 4.0 110CM CATHETER Z26JR40A Z2 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40A, Recall # Z-1018-06;

kkkk) CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26JR40SHA, Recall # Z-1019-06;

llll) CATH GUIDE 6F MB2 110CM Z2 CATHETER Z26MB2A Z2 6F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MB2A, Recall # Z-1020-06;

mmmm) 6F Z2 MP1 110CM CATHETER Z26MP1A Z2 6F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26MP1A, Recall # Z-1021-06;

nnnn) 6F Z2 GUIDING CATHETER SR3.0 CATHETER Z26SR30 Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30, Recall # Z-1022-06;

oooo) 6F Z2 GUIDING CATH SR3.0 SH CATHETER Z26SR30SH Z2 6F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR30SH, Recall # Z-1023-06;

pppp) 6F Z2 GUIDING CATHETER SR3.5 CATHETER Z26SR35 Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35, Recall # Z-1024-06;

qqqq) 6F Z2 GUIDING CATH SR3.5 SH CATHETER Z26SR35SH Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35SH, Recall # Z-1025-06;

rrrr) 6F Z2 GUIDING CATHETER SR4.0 CATHETER Z26SR40 Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR40, Recall # Z-1026-06;

ssss) 6F Z2 GUIDING CATH SR4.0 SH CATHETER Z26SR40SH Z2 6F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR40SH, Recall # Z-1027-06;

tttt) 6F Z2 GUIDING CATHETER SR5.0 CATHETER Z26SR50 Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50, Recall # Z-1028-06;

uuuu) 6F Z2 GUIDING CATH SR5.0 SH CATHETER Z26SR50SH Z2 6F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z26SR50SH, Recall # Z-1029-06;

vvvv) 7F Z2 FR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27FR40A, Recall # Z-1030-06;

wwww) 7F Z2 JL 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27JL40A, Recall # Z-1031-06;

xxxx) 7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A, Recall # Z-1032-06;

yyyy) 7F Z2 MB2 110CM CATHETER Z27MB2A Z2 7F 110CM MB2 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code:Z27MB2A, Recall # Z-1033-06;

zzzz) 7F Z2 MP1 110CM CATHETER Z27MP1A Z2 7F 110CM MP1 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27MP1A, Recall # Z-1034-06;

aaaaa) 7F ZUMA 2 SR3.0 100CM CATHETER Z27SR30 Z2 7F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR30, Recall # Z-1035-06;

bbbbb) 7F ZUMA 2 SR3.5 100CM CATHETER Z27SR35 Z2 7F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35, Recall # Z-1036-06;

ccccc) 7F ZUMA 2 SR3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR35SH, Recall # Z-1037-06;

ddddd) 7F ZUMA 2 SR4.0 100CM CATHETER Z27SR40 Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40, Recall # Z-1038-06;

eeeee) 7F ZUMA 2 SR4.0 SH 100CM CATHETER Z27SR40SH Z2 7F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: Z27SR40SH, Recall # Z-1039-06;

fffff) 7F ZUMA 2 SR5.0 100CM CATHETER Z27SR50 Z2 7F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27SR50, Recall # Z-1040-06;

ggggg) CATH. GUIDE 8F AR1.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28AR10SHA, Recall # Z-1041-06;

hhhhh) CATH. GUIDE 8F EBU3.5 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU35SHA, Recall # Z-1042-06;

iiiii) CATH. GUIDE 8F EBU4.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product code: Z28EBU40SHA, Recall # Z-1043-06;

jjjjj) CATH. GUIDE 8F EBU5.0 W/SH 110 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28EBU50SHA, Recall # Z-1044-06;

kkkkk) CATH. GUIDE 8F FR4.0 W/SH 110C Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28FR40SHA, Recall # Z-1045-06;

lllll) CATH. GUIDE 8F MB1 W/SH 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28MB1SHA, Recall # Z-1046-06;

mmmmm) 8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30, Recall # Z-1047-06;

nnnnn) 8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35, Recall # Z-1048-06;

ooooo) 8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH, Recall # Z-1049-06;

ppppp) 8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40, Recall # Z-1050-06;

qqqqq) 8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH, Recall # Z-1051-06;

rrrrr) 8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50, Recall # Z-1052-06;

sssss) 8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH, Recall # Z-1053-06;

ttttt) 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR30, Recall # Z-1054-06;

uuuuu) ZM5SR35 5F ZUMA SR3.5 CATHETER ZM5SR35 Z2 5F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR35, Recall # Z-1055-06;

vvvvv) 5F ZUMA SR4.0 CATHETER ZM5SR40 Z2 5F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR40, Recall # Z-1056-06;

wwwww) 5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR50, Recall # Z-1057-06;

xxxxx) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, Recall # Z-1058-06;

yyyyy) 6F ZUMA AL1.0 W/110CM LENGTH CATHETER ZM6AL10A ZM 6F 110CM AL1.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AL10A, Recall # Z-1059-06;

zzzzz) 6F ZUMA AR2.0 CATHETER ZM6AR20A ZM 6F 110CM AR2.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6AR20A, Recall # Z-1060-06;

aaaaaa) 6F ZUMA DC3.5 W/110CM LENGTH GUID CATH 6F ZUMA DC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC35A , ZM6DC35A00, Recall # Z-1061-06;

bbbbbb) 6F ZUMA DC4.0 W/110CM LENGTH GUID CATH 6F ZUMA DC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Codes: ZM6DC40A ,ZM6DC40A00, Recall # Z-1062-06;

cccccc) 6F ZUMA EBU3.5 W/110CM LENGTH CATHETER ZM6EBU35A ZM 6F 110CM EB35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU35A, Recall # Z-1063-06;

dddddd) 6F ZUMA EBU4.0 W/110CM LENGTH GUID CATH 6F ZUMA EBU4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6EBU40A, ZM6EBU40A00, Recall # Z-1064-06;

eeeeee) ZM6JL40A 6F ZUMA JL40 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A, Recall # Z-1065-06;

ffffff) 6F ZUMA JL40 110CM CATHETER ZM6JL40A ZM 6F 110CM JL4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL40A, Recall # Z-1066-06;

gggggg) CATH, GUIDE 6F JL6.0 110CM ZUM CATHETER ZM6JL60A ZM 6F 110CM JL60 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JL60A, Recall # Z-1067-06;

hhhhhh) ZM6JR40A 6F ZUMA JR4.0 110CM CATHETER ZM6JR40A ZM 6F 110CM JR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR40A, Recall # Z-1068-06;

iiiiii) 6F ZUMA JR5.0 110CM CATHETER ZM61JR50A ZM 6F 110CM JR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6JR50A, Recall # Z-1069-06;

jjjjjj) 6F ZUMA MAC 3.5 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC35A, Recall # Z-1070-06;

kkkkkk) 6F ZUMA MAC 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6MAC40A, Recall # Z-1071-06;

llllll) 6F ZUMA SL5.0 CATHETER ZM6SL50 ZM 6F 100CM SL5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SL50, Recall # Z-1072-06;

mmmmmm) 6F ZUMA SR3.0 CATHETER ZM6SR30 ZM 6F 100CM SR3.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR30, Recall # Z-1073-06;

nnnnnn) 6F ZUMA SR3.5 CATHETER ZM6SR35 ZM 6F 100CM SR3.5 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR35, Recall # Z-1074-06;

oooooo) 6F ZUMA SR4.0 CATHETER ZM6SR40 ZM 6F 100CM SR4.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR40, Recall # Z-1075-06;

pppppp) 6F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM6SR50, Recall # Z-1076-06
CODE
a) Lot number: 0000037028;
b) Lot number: 210764;
c) Lot Numbers: 0000030082 0000044305 210763;
d) Lot Number: 0000027006 0000048626 208415;
e) Lot Numbers: 0000115257 207343 216125;
f) Lot Numbers: 0000013715 0000019773 0000026008 0000027691
0000065807 0000107195 0000114884 0000142208 0000143695 207344
209792 214174 215929 216117 220685;
g) Lot Numbers: 0000106474 180319 180320;
h) Lot Numbers: 0000001683 0000006399 0000010421 0000012409 0000013716
0000017342 0000021394 0000021447 0000023244 0000026985 0000029266
0000029705 0000032466 0000035432 0000037924 0000042889 0000042890
0000043999 0000044001 0000044002 0000044005 0000046318 0000047374
0000051910 0000057225 0000057226 0000057227 0000058402 0000064594
0000064609 0000064622 0000064623 0000064642 0000064644 0000068966
0000068967 0000072109 0000072110 0000074335 0000074336 0000077688
0000077689 0000077723 0000077724 0000080001 0000080002 0000085367
0000088937 0000092144 0000093108 0000095216 0000099873 0000099874
0000100931 0000100932 0000102659 0000106195 0000109513 0000113247
0000118398 0000124586 0000125088 0000132238 0000133516 0000137092
0000149960 0000151195 0000170064 0000173689 0000174400 0000174416
0000175222 0000175235 0000189059 175016 178826 182733 184962 185864
188187 200447 200786 202877 203553 204960 211561 213101 214919
217583 219366 222386 222387;
i) Lot Numbers: 0000188518;
j) Lot Numbers: 0000038283;
k) Lot Numbers: 0000067485 0000072512;
l) Lot Numbers: 0000040827 0000053734 0000171573;
m) Lot Numbers: 0000012692 0000017476 0000052795;
n) Lot Numbers: 0000032526 0000171583;
o) Lot Numbers: 0000025149;
p) Lot Numbers: 0000179184 178473 209767;
q) Lot Number: 0000004678;
r) Lot Numbers: 0000055719 0000085923 178472 205603;
s) Lot Numbers: 0000099411;
t) Lot Numbers: 0000025151;
u) Lot Numbers: 0000032873 0000067482 0000182743;
v) Lot Numbers: 0000064092 0000065235 0000068445 0000077285 0000108383
0000152174 208918 212420;
w) Lot Numbers: 0000099374 0000175190 0000180266;
x) Lot Numbers: 213798 215373;
y) Lot Numbers: 0000079570;
z) Lot Numbers: 0000029246 0000041244 0000090303 0000116131 204579
213554 223848;
aa) Lot Numbers: 0000005088 0000051700 0000059797;
bb) Lot Numbers: 0000001696 0000005659 0000009476 0000042018 0000044719
0000045231 0000064050 0000068017 0000068397 0000082398 0000084406
0000085999 0000095233 0000104293 0000104342 0000115247 0000123723
0000125309 0000138086 0000150459 0000169173 0000176133 176535
186865 201667 204626 205350 211785 213371 214942 220436;
cc) Lot Numbers: 0000021624 0000048665 0000053776 0000060280 0000068019
0000070770 0000077718 0000128585 204128 210659 214624 217180
221581;
dd) Lot Numbers: 0000001691 0000002401 0000004678 0000006402
0000008033 0000008086 0000011110 0000011142 0000011890 0000015012
0000015797 0000017345 0000017357 0000020446 0000024950 0000029702
0000030830 0000033785 0000034253 0000036895 0000037331 0000041204
0000041290 0000043403 0000048659 0000053294 0000054630 0000056728
0000057232 0000062274 0000064619 0000065904 0000069371 0000069790
0000073906 0000075670 0000077725 0000078996 0000082350 0000082375
0000091519 0000098746 0000099570 0000099926 0000100520 0000101996
0000104796 0000106153 0000109527 0000109551 0000118394 0000120012
0000124096 0000125633 0000126524 0000130020 0000132240 0000143671
0000145703 0000151226 0000151733 0000154411 0000155713 0000159964
0000167213 0000171494 0000177092 0000178653 0000181909 0000182745
0000201295 177302 179227 180264 182327 182713 184240 187927 201562
201589 204546 205579 206975 209482 209483 213369 214129 215438
218112 220078 221415 223122 223880;
ee) Lot Number: 0000050710;
ff) Lot Numbers: 0000009467 0000017356 0000018656 0000041210
0000051080 0000060714 0000071655 0000074794 0000077721
0000080996 0000082769 0000083088 0000085997 0000093521 0000096040
0000120776 0000152164 178392 186228 201560 201587 212067 214648
218835;
gg) Lot Numbers: 0000025988 0000064093 0000067488 0000094788
0000095147 0000107152 0000109547 0000123657 0000151228 204043
206494;
hh) Lot Numbers: 0000045233 0000049060 0000095236 213485 219799;
ii) Lot Numbers: 0000064051 0000070414 0000077756 0000151229 217661;
jj) Lot Numbers: 0000051701 0000057224 0000059774 206376;
kk) Lot Numbers: 0000025483 0000041243 0000046316 0000059735
0000116132;
ll) Lot Number: 0000072934;
mm) Lot Numbers: 0000006813 0000009012 0000009040 0000015848 0000031930
0000043653 0000043655 0000055236 0000055686 0000060347 0000068443
0000068446 0000074855 0000074857 0000079601 0000081441 0000083822
0000091563 0000097895 0000101072 0000101074 0000105403 0000115013
0000117385 0000123711 0000133675 0000138054 0000144973 0000149842
0000153958 0000160711 0000170645 0000174447 0000175189 0000187845
181734 184271 185910 187134 188547 201685 203306 205597 207631
208906 211159 214999 216576 218842 219217 221352;
nn) Lot Numbers: 0000139499;
oo) Lot Numbers: 0000139502 0000139540;
pp) Lot Numbers: 0000070357 0000077811 203438 217381;
qq) Lot Numbers: 201000;
rr) Lot Numbers: 0000021160 0000029786 0000043949 0000053303
0000056316 0000056336 0000072554 0000075701 0000084463
0000094761 0000106079 0000121475 0000139067 183010 207282
212415 219669 222953;
ss) Lot Numbers: 0000002638 0000003429 0000078989 0000088047 0000161204
211158 213868 218547;
tt) Lot Numbers: 0000009532 0000013672 0000019809 0000022777 0000044800
0000045282 0000050729 0000056338 0000075247 0000076693 0000083944
0000096010 0000107906 000123126 0000132923 175760 178292 180185
181735 182416 182417 183000 188007 203620 206606 212408 213693
219667;
uu) Lot Numbers: 0000005212 0000043605 0000053798 0000056337 0000068436
0000068560 0000071683 0000076651 0000108452 0000137727 0000164243
176812 208561 212698 213441 217363;
vv) Lot Numbers: 0000009532 0000013672 0000019809 0000022777 0000044800
0000045282 0000050729 0000056338 0000075247 0000076693 0000083944
0000096010 0000107906 0000123126 0000132923 175760 178292 180185
181735 182416 182417 183000 188007 203620 206606 212408 213693 219667;
ww) Lot Numbers: 0000005212 0000043605 0000053798 0000056337 0000068436
0000068560 0000071683 0000076651 0000108452 0000137727 0000164243
176812 208561 212698 213441 217363;
xx) Lot Numbers: 0000046310 0000174582 200307 217387 200307 217387;
yy) Lot Numbers: 0000004701 0000014620 0000021416 0000025411 0000029777
0000045286 0000055307 0000064166 0000068034 0000069020 0000073860
0000076117 0000076118 0000093491 0000097927 0000098637 0000105371
0000120165 0000124169 0000140820 0000158119 200877 208238 214166
219232 221749 223371;
zz) Lot Numbers: 0000010532 0000010592 0000025412 0000042510
0000042512 0000064172 0000076113 0000081546 0000083017 0000094114
0000097316 0000098646 0000108373 0000132346 175818 186369 201732
201960 204235;
aaa) Lot Numbers: 182211;
bbb) Lot Numbers: 182212;
ccc) Lot Numbers: 182213;
ddd) Lot Number: 0000028228 0000106504 0000187129;
eee) Lot Numbers: 0000028244 0000126527;
fff) Lot Numbers: 0000008114 0000056825 0000065756 0000068482
0000099448 0000149030 216757 218174;
ggg) Lot Numbers: 0000052427 0000063888 0000099509 220162 222827 224805;
hhh) Lot Numbers: 0000005106 0000019230 0000020662 0000021409
0000022601 0000022850 0000023102 0000024790 0000050764 0000064169
0000082447 0000084632 0000104324 0000126514 0000173027 207120
211660 214574;
iii) Lot Numbers: 0000022920 0000060990 0000099507 0000124687
0000172308 203668 211659 215934 216087;
jjj) Lot Numbers: 0000117602 0000150334 220682;
kkk) Lot Numbers: 0000059849 0000126533;
lll) Lot Numbers: 0000028261 0000126532;
mmm) Lot Numbers: 0000059850 0000118491;
nnn) Lot Numbers: 0000040400 0000047046 0000054305 0000054306
0000063145 0000063184 0000071797 0000075774 0000082018
0000094143 0000098747 0000100009 0000106139 0000116560;
ooo) Lot Numbers: 0000047113 0000055826 0000055827 0000063161
0000063162 0000063163 0000063187;
ppp) Lot Numbers: 0000155875;
qqq) Lot Numbers: 0000155328;
rrr) Lot Number: 0000038960;
sss) Lot Numbers: 0000055758 0000055759 0000055760 0000070849
0000071307 0000071309 0000073024 0000073025 0000075756
0000080599 0000082939 0000093035 0000096718 0000097929
0000100993 0000103729 0000110816 0000113625 0000114979
0000126421 0000130789 0000134456 0000141335 0000148442
0000149211 0000154614 0000173136 0000173875 0000175333;
ttt) Lot Numbers: 0000055801 0000055802 0000063121 0000063122
0000063123;
uuu) Lot Number: 0000045678;
vvv) Lot Numbers: 0000045369 0000071809;
www) Lot Numbers: 0000045084 0000167550;
xxx) Lot Numbers: 0000045356 0000055781 0000063100 0000098654
0000159338;
yyy) Lot Numbers: 0000063472;
zzz) Lot Numbers: 0000045684;
aaaa) Lot Numbers: 0000136356;
bbbb) Lot Numbers: 0000021993;
cccc) Lot Numbers: 0000024748;
dddd) Lot Numbers: 0000080580;
eeee) Lot Numbers: 0000114946 217167;
ffff) Lot Numbers: 0000013651 224840;
gggg) Lot Numbers: 0000013652;
hhhh) Lot Number: 0000050786;
iiii Lot Numbers: 0000036905 0000038771 0000040866 0000088875
0000146906 217168;
jjjj) Lot Numbers: 0000043735 208961 218172;
kkkk) Lot Number: 224554;
llll) Lot Numbers: 0000087118 0000087255;
mmmm) Lot Numbers: 0000007859 0000087103 0000087253 0000091588
0000092982 0000103702 0000142221 0000148507 0000182815;
nnnn) Lot Numbers: 0000026950 0000033974 0000156729 180318 211049 214903;
oooo) Lot Numbers: 0000048764;
pppp) Lot Numbers: 0000021424 0000044133 0000059944 0000061632
0000080591 0000106158 0000125305 0000134506 177556 203498
207021 209062 209425 215419 221286;
qqqq) Lot Numbers: 0000032871 0000058520 0000138126 0000149130 177525
224420;
rrrrr) Lot Numbers: 0000002433 0000006514 0000012046 0000027687
0000028673 0000033680 0000033718 0000043780 0000046956 0000067140
0000072965 0000076643 0000080168 0000081106 0000085973 0000095150
0000106493 0000134505 0000172339 178512 182950 186089 202512 205561
208500 211542 214599 215763 221279 222892;
ssss) Lot Numbers: 0000011190 0000011209 0000046897 0000050822
0000058465 0000059945 0000076641 0000091580 0000104403
0000120202 0000134918 0000156721 179670 208478 214319;
tttt) Lot Numbers: 0000060403 0000065850 0000140267 179669
209039 211282;
uuuu) Lot Numbers: 0000047798 206499;
vvvv) Lot Numbers: 0000072581 0000077802 0000174555;
wwww) Lot Number: 0000035239;
xxxx) Lot Numbers: 0000120798;
yyyy) Lot Numbers: 0000087257 0000090981;
zzzz) Lot Numbers: 0000076629 0000087109 0000087254;
aaaaa) Lot Numbers: 0000050020 0000054722;
bbbbb) Lot Numbers: 0000026381 208835;
ccccc) Lot Numbers: 0000033365 0000076630;
ddddd) Lot Numbers: 0000002247 0000008188 0000015219 0000015885
0000057268 0000075237 0000103319 0000151685 0000176359
212367 221319;
eeeee) Lot Numbers: 0000027588 0000027596 0000028599 0000183448;
fffff) Lot Numbers: 213488 215327;
ggggg) Lot Number: 206715;
hhhhh) Lot Numbers: 215377;
iiiii) Lot Number: 206732;
jjjjj) Lot Number: 0000083439;
kkkkk) Lot Number: 0000083434;
llll) Lot Number: 206745;
mmmmm) Lot Numbers: 0000050014 0000102672;
nnnnn) Lot Numbers: 0000011215 0000032531 0000040323 0000064232
184861 209079 213092;
ooooo) Lot Numbers: 0000044125 0000050795 209041;
ppppp) Lot Numbers: 0000010657 0000021552 0000075807 215424;
qqqqq) Lot numbers: 0000002224 208965 213818;
rrrrr) Lot Numbers: 0000170203 220956;
sssss) Lot Number: 216303;
ttttt) Lot Number: 0000097904;
uuuuu) Lot Numbers: 0000004321 0000016470;
vvvvv) Lot Numbers: 0000031314 0000120842 0000171203 0000176191
0000183404 212571 214571;
wwwww) Lot Numbers: 0000033244 0000049489 0000143877 215963;
xxxxx) Lot Numbers: 0000096756;
yyyyy) Lot Numbers: 0000162767 144574 155445;
zzzzz) Lot Numbers: 0000111382 0000162772 203444;
aaaaaa) Lot Numbes: 128977 130210;
bbbbbb) Lot Numbers: 128977 130210;
cccccc) Lot Number: 128977;
dddddd) Lot Numbers: 188392 209053 212288;
eeeeee) Lot Numbers: 0000109164 128977 130210;
ffffff) Lot Numbers: 0000109164 128977 130210;
gggggg) Lot Number: 0000129379;
hhhhhh) Lot Number: 0000162769;
iiiiii) Lot Number: 136251;
jjjjjj: Lot Number: 0000080611;
kkkkkk) Lot Number: 0000080610;
llllll) Lot Number: 128283;
mmmmmm) Lot Number: 0000080967;
nnnnnn) Lot Numbers: 0000005115 0000012614 0000014791 0000021492
0000049651 0000052460 0000102704 0000203280 129920 136399 138569;
oooooo: Lot Numbers: 0000000770 0000002134 0000028207 0000043814
0000090410 0000103759 0000125699 0000137834 0000151268
0000164481 127482 128283 128616 128988 130040 130595 132042 134208
135297 136396 138223 139414 141461 145170 223496;
pppppp) Lot Number: 0000178091
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Danvers, MA, by letter on April 5, 2006. Firm initiated recall is ongoing.
REASON
Potential for non-sterility due to loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
10,493 units
DISTRIBUTION
Nationwide and Internationally
______________________________

PRODUCT
Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT), Recall # Z-1078-06
CODE
Serial Number: CXR46201-46213 PC 46002-36011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter 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 affects the system's ability to create Multiplanar Reconstructions (MPR). Some images from the resulting series do not display correctly, or display at all, when MPR was run on them.
VOLUME OF PRODUCT IN COMMERCE
15 devices
DISTRIBUTION
Nationwide
______________________________

PRODUCT
Hitachi Emission Computed Tomography System Hitachi CX-4 CT (including SceptreP3 PET-CT). Recall # Z-1079-06
CODE
CXR46201-46214 PC46002-46011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on February 21, 2006.
Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The device has a software anomaly which causes blank images to be created during Multiplanar Reconstruction processing or results in an inherent filming error in which a reference scale is improperly sized.
VOLUME OF PRODUCT IN COMMERCE
16 devices
DISTRIBUTION
Nationwide
______________________________

PRODUCT
a) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part F#1010563, Recall # Z-1080-06;
b) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564, Recall # Z-1081-06;
c) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565, Recall # Z-1082-06;
d) Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566, Recall # Z-1083-06;
e) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567, Recall # Z-1084-06;
f) ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568, Recall # Z-1085-06
CODE
a) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010563; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
b) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010564; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
c) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010565; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
d) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010566; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
e) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010567; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100
f) All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010568; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
RECALLING FIRM/MANUFACTURER
Guidant Endovascular Solutions, Inc., Temecula, CA, by letter dated April 3, 2006. Firm initiated recall is ongoing.
REASON
Design: increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.
VOLUME OF PRODUCT IN COMMERCE
Approximately 38,203 units
DISTRIBUTION
Nationwide
______________________________

PRODUCT
St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308, Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304. Recall # Z-1086-06
CODE
Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
RECALLING FIRM/MANUFACTURER
St. Jude Medical / Daig Division, Minnetonka, MN, by letter dated April 13, 2006. Firm initiated recall is ongoing
REASON
St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced into the patient with resultant embolism.
VOLUME OF PRODUCT IN COMMERCE
2,489 devices
DISTRIBUTION
Nationwide and Internationally
______________________________

PRODUCT
Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gycolide and 10%L-lactide. Recall # Z-1087-06
CODE
Product Codes/Product Lot Numbers-Expiration Dates: J774D/SB2371-01/2008; JB725/SB2416-01/2008; J864D/SB2426-01/2008.
RECALLING FIRM/MANUFACTURER
Ethicon, Inc., Somerville, NJ, by letter on May 4, 2006. Firm initiated recall is ongoing.
REASON
Misalignment of packaging sealing platform created open seals and/or open channels in the packaging seal causing degradation of the sutures
VOLUME OF PRODUCT IN COMMERCE
1,157 dozen sutures
DISTRIBUTION
Nationwide, Japan, Canada, and Taiwan

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
______________________________

PRODUCT
Amplatz Goose Neck Microsnare Kit, Model SK400 (175 cm length x 4mm loop snare x .018'',0.46mm) and SK701 (200 cm length x 7mm loop snare x 0.18'' x 0.46mm) ev3, 4600 Nathan Lane North, Plymouth, Minnesota, 55442-2920 USA. For one time use only. Sterilization with Ethylene Oxide gas. Do not resterilize. The Amplatz Goose Neck Microsnare Kit contains one Amplatz Goose Neck Microsnare, one Microcatheter, one Microsnare Introducer and one torque device. Recall # Z-0894-06
CODE
Lot number 277755; Lot number 575327
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MA, by letter on December 29, 2005. Firm initiated recall is complete.
REASON
ev3 has determined that one test unit from each of two lots did not meet minimum tensile strength requirements and therefore the entire lots are being recalled.
VOLUME OF PRODUCT IN COMMERCE
58
DISTRIBUTION
Nationwide and Canada, Germany and Japan

END OF ENFORCEMENT REPORT FOR June 14, 2006

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