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.
December 11, 2002
02-49
_____________________________
PRODUCT
ALESSI brand Sun Dried Tomatoes NET WT. 2 OZ. (56 g), IMPORTED FROM ITALY OR TURKEY. Recall # F-094-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Vigo Importing Co., Tampa, FL, by letter on August 20, 2002. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
1800/ 2 oz. plastic bags.
DISTRIBUTION
TX, MA, PA, NJ, FL AND WI.
_____________________________
PRODUCT
Natural Oyster Shell Calcium 500 mg Tablets in 100 count bottles.
The product is shipped in cases that contain 72 of the 100 count bottles. The brand name of the product is Kaiser Permanente. Recall # F-095-3.
CODE
Lot #5235 exp. Jun 04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dixon Shane, Inc., Philadelphia, PA, by telephone on November 19, 2001.
Manufacturer: Vicen Nutritional, Swedesboro, NJ. Firm initiated recall is complete.
REASON
The product was manufactured under conditions whereby it may have been cross-contaminated with amoxicillin.
VOLUME OF PRODUCT IN COMMERCE
5436 bottles.
DISTRIBUTION
CA and OR.
_____________________________
PRODUCT
PINEAPPLE TANGERINE CANDY, net wt. 8 oz. (227G), packaged in a rigid plastic tray inside a sealed plastic bag. Made in Taiwan. Recall # F-096-3.
CODE
All codes including EXP 12 32002.
Barcode #: 719600 001046.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import Inc., Brooklyn, NY, by visit on/about April 16, 2002.
Manufacturer: Chin Yi Foodstuff Factory Hou Li Hsiang, Taichung County. State initiated recall is complete.
REASON
The product contained undeclared Sunset Yellow FCF (certifiable as FD&C Yellow #6).
VOLUME OF PRODUCT IN COMMERCE
10 cases (50 - 8 oz. packages per case).
DISTRIBUTION
NY and MA.
_____________________________
PRODUCT
Pooled Plasma, Solvent/Detergent Treated, Type A, PLAS+SD, Recall # B-0217-3.
CODE
Lot number FW00315.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Corporate Headquarters, V.I. Technologies, Watertown, MA, by letter dated August 31, 2001.
Manufacturer: V.I. Technologies, Melville, NY. Firm initiated recall is ongoing.
REASON
Blood products, containing fibrin like material, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,340 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0251-3.
CODE
Unit number 04M09382.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated September 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0252-3
CODE
Unit number 04FR61607.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter dated September 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0253-3;
b) Recovered Plasma, Recall # B-0254-3.
CODE
a) and b) Unit numbers 04F89674 and 04V85144.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letters on August 8 and 19, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MA and CA.
_____________________________
PRODUCT
a) Red Blood Cells, Recall # B-0255-3;
b) Fresh Frozen Plasma, Recall # B-0256-3;
c) Recovered Plasma, Recall # B-0257-3.
CODE
a)Units 01LS22368, 01LS21230, 01LS20144, 01LS18839,
01LS17613, 01LS16265, 01LS14999;
b) Unit 01LS14999
c) Units 01LS22368, 01LS21230, 01LS20144,
01LS18839, 01LS17613, 01LS16265.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated May 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis B Surface Antigen (HBsAg), but were collected from a donor who previously tested reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0258-3;
b) Recovered Plasma, Recall # B-0259-3.
CODE
a) and b) Unit 01LP40710.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letters dated January 18, 2002 and February 2, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who provided information regarding previously testing positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0260-3;
b) Plateletsm, Recall # B-0261-3;
c) Recovered Plasma , Recall # B-0262-3.
CODE
a); b) and c) Unit 01Y33966.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated January 17, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided
information regarding a history of jaundice, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NY.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0263-3.
CODE
Unit 106043578.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated September 17, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history having tested positive for hepatitis A, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.
_____________________________
PRODUCT
Human bone and tissue for transplantation (various types), Recall # B-0265-3.
CODE
DONOR # 00329204
Item # 550486 Serial # 003292040047 - 003292040049;
Item # 550100 Serial # 003292040001 - 003292040002;
Item # 500060 Serial # 003292040042 - 003292040044
& 003292040050;
Item # 500402 Serial # 003292040038 - 003292040040;
Item # 500730 Serial # 003292040026 - 003292040027;
Item # 500080 Serial # 003292040003 - 003292040007;
Item # 500292 Serial # 03292040045;
DONOR # 00329983
Item # 500530 Serial # 003299830030;
Item # 500046 Serial # 003299830042;
Item # 500209 Serial # 003299830047 - 003299830049;
Item # 500570 Serial # 003299830052 - 003299830054;
Item # 500210 Serial # 003299830060 - 003299830062;
Item # 500402 Serial # 003299830063 - 003299830065;
Item # 500057 Serial # 003299830067 - 003299830071;
Item # 500080 Serial # 003299830003 - 003299830004;
Item # 500410 Serial # 003299830032 - 003299830033;
Item # 500401 Serial # 003299830066;
Item # 550100 Serial # 003299830001 - 003299830002;
DONOR # 00828449
Item # 550495 Serial # 008284490047 - 008284490048;
Item # 550100 Serial # 008284490001 - 008284490002;
Item # 500060 Serial # 008284490040 - 008284490042;
Item # 500220 Serial # 008284490043 - 008284490046;
Item # 500585 Serial # 008284490049 - 008294490050;
Item # 500080 Serial # 008284490003 - 008284490006;
DONOR # 01729322
Item # 150781 Serial # 017293220016 - 017293220020 &
017293220040 - 017293220040;
Item # 100399 Serial # 017293220027 - 017293220030;
Item # 100405 Serial # 017293220023 - 017293220026;
Item # 100585 Serial # 017293220043;
DONOR # 02329525
Item # 550782 Serial # 023295250003 - 023295250005;
Item # 550494 Serial # 023295250046;
Item # 550776 Serial # 023295250037 - 023295250041
023295250002;
Item # 500750 Serial # 023295250023 - 023295250024;
Item # 500051 Serial # 023295250054 - 023295250063;
Item # 500585 Serial # 023295250052 - 023295250053;
Item # 500201 Serial # 023295250042 - 023295250045 &
023295250050 - 023295250051
Item # 500530 Serial # 02329520057;
Item # 500402 Serial # 023295250033 - 023295250034;
DONOR # 02329646
Item # 550100 Serial # 023296460001 - 023296460002;
Item # 550782 Serial # 023296460003 - 023296460005;
Item # 500060 Serial # 023296460037 - 023296460039;
Item # 500410 Serial # 023296460029 - 023296460030;
Item # 500293 Serial # 023296460040 - 023296460041;
Item # 500585 Serial # 023296460047 - 023296460048;
DONOR # 02329773
Item # 550782 Serial # 023297730001 - 023297730002;
Item # 550495 Serial # 023297730034 - 023297730035;
DONOR # 03528533
Item # 100080 Serial # 035285330016 - 035285330021 &
035285330057 - 035285330058;
Item # 150486 Serial # 035285330038 - 035285330040;
DONOR # 03530117
Item # 550495 Serial # 035301170042 - 035301170043;
Item # 550782 Serial # 035301170003 - 035301170004;
Item # 550100 Serial # 035301170001 - 035301170002;
Item # 500750 Serial # 035301170044 - 035301170047;
Item # 500060 Serial # 035301170037 - 035301170039;
Item # 500220 Serial # 035301170023 - 035301170025;
Item # 500410 Serial # 035301170029 - 035301170031;
Item # 500330 Serial # 035301170035;
Item # 500520 Serial # 035301170027;
Item # 500585 Serial # 035301170048;
DONOR # 0382982
Item # 550100 Serial # 038298200001 - 0382982000;
Item # 500060 Serial # 038298200042 - 038298200044;
Item # 500399 Serial # 038298200036 - 038298200037;
Item # 500410 Serial # 038298200032 - 038298200034;
Item # 500580 Serial # 038298200003 - 038298200007 &
038298200059 - 038298200060;
Item # 500209 Serial # 038298200045 - 038298200048;
Item # 500530 Serial # 038298200030 - 038298200031;
Item # 500330 Serial # 038298200040;
DONOR # 02329773 Item # 550782 not available
Item # 550495 not available
DONOR # 00328426 Item # 550486 Serial #: 003284260092
DONOR # 00529695 Item # 550776 not available.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Musculoskeletal Transplant Foundation, Edison Corporate Center, Edison, NJ, by telephone on September 20, 2002 and by letter on September 23, 2002.
Contract Manufacturer: Osteotech, Inc., Eatontown, NJ.
Firm initiated recall is ongoing.
REASON
Human bone and tissues for transplantation that tested negative for microorganisms, but may have been exposed to microbial contamination due to failing 0.24 micron filters, were distributed.
VOLUME OF PRODUCT IN COMMERCE
107 units.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
Human bone and tissue for transplantation--various types, Recall # B-0266-3.
CODE
Units (52 units)
| Donor # | Item # | Product Description | Quantity |
|---|---|---|---|
| F0103410 | 910120 | Cancellous Chips | (7 units) |
| F0103410 | 910300 | Ilium Tricort. Blk s | (1 unit) |
| F0103410 | 910320 | Ilium Tricort. Blk L | (8 units) |
| F0103410 | 910010 | Cortical/Canc Chips | (4 units) |
| F0103410 | 910620 | Canc/Cortical Dowel | (2 units) |
| F0103410 | 911311 | Patellar Blk | (2 units) |
| C0194653 | 319120 | Cancellous Chips | (8 units) |
| E0403318 | 310120 | Cancellous Chips | (7 units) |
| F0103729 | 310120 | Cancellous Chips | (10 units) |
| A0101706 | 920012 | Crushed Cortical/Canc. | (1 unit) |
| D0102654 | 920000 | Cancellous Chips | (1 unit) |
| E0403300 | 910825 | Fibula Shaft | (1 unit) |
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0267-3;
b) Platelets, Leukoreduced, Recall # B-0268-3;
c) Fresh Frozen Plasma, Recall # B-0269-3.
CODE
a); b)and c) Unit 42FS71141.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by telephone on May 22, 2002 and by letter dated June 3, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of
jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0270-3.
CODE
Unit 01GL57919.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY, by letter dated March 8, 2002.
Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0271-3
b) Red Blood Cells, Recall # B-0272-3;
c) Fresh Frozen Plasma, Recall # B-0273-3;
d) Platelets, Recall # B-0274-3;
e) Recovered Plasma, Recall # B-0275-3.
CODE
a) Unit 50E21595;
b) Unit 50F89525, 50F67302, 50H68164;
c) Unit 50E21595;
d) Unit 50H68164;
e) Unit 50F89525, 50F67302, 50H68164.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by letter dated October 29, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding a history of hepatitis and participating in high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
OH, IN and WI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0277-3.
CODE
Units 26172-2009, 26172-2140, 26172-2170.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Ft. Smith, AR, by telephone on May 22, 2002 and by letter dated June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, quarantined due to possible hemolysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AR.
_____________________________
PRODUCT
Blood Grouping Reagents of the following types:
Recall # B-0278-3.
a) ID-Micro Typing System_ MTS ABD Monoclonal and Reverse
Grouping;
b) ID-Micro Typing System_ MTS ABD Monoclonal Grouping;
c) ID-Micro Typing System_ MTS Anti-A (Murine Monoclonal)
Grouping Card.
CODE
a) Lot numbers 110901037-01, 110901037-02, 110901037-03,
110901037-04, 110901037-05, 110901037-06, 110901037-07,
110901037-08, 110901037-09, 110901037-10, 110901037-11,
110901037-12, 110901037-13, 110901037-14, 110901037-15,
110901037-16, 110901037-17, 110901037-18, 110901037-19,
110901037-20, 110901037-21, 050401037-04, 050401037-05,
050401037-06, 050401037-07 071701037-05, 071701037-06,
071701037-07, 071701037-08, 071701037-09, 071701037-10,
071701037-11, 071701037-12, 071701037-13, 071701037-14,
071701037-15, 071701037-16, and 071701037-17;
b) Lot numbers 012102053-01, 012102053-02, 012102053-03;
c) Lot numbers 101901039-01 and 101901039-02.
RECALLING FIRM/MANUFACTURER
Micro Typing Systems, Inc., Pompano Beach, FL, by letter on July 22, 2002. Firm initiated recall is ongoing.
REASON
ABO Blood Grouping Reagents, that exhibited a decreased reactivity with type A2B red blood cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
43 lots.
DISTRIBUTION
Nationwide, Mexico, Spain, Canada and Germany.
_____________________________
PRODUCT
Red Blood Cells, Recall # B-0279-3.
CODE
Unit number 3955774.
RECALLING FIRM/MANUFACTURER
Houchin Community Blood Bank, Bakersfield, CA, by letter dated January 18, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Products from low volume collections:
a) Whole Blood, Recall # B-0282-3;
b) Whole Blood, Irradiated, Recall # B-0283-3.
c) Red Blood Cells, Recall # B-0284-3;
d) Red Blood Cells, Leukocytes, Recall # B-0285-3;
e) Red Blood Cells, Irradiated, Recall # B-0286-3;
f) Platelets, Recall # B-0287-3;
g) Platelets, Irradiated, Recall # B-0288-3;
h) Cryoprecipitated, Recall # B-0289-3.
CODE
a) Unit numbers 2335406, 3425628, 3582615, 4546214,
8060743, 8561359, 9555505, and 9555824;
b) Unit number 4548684;
c) Unit numbers 1492171, 1493680, 1494691, 1495833,
1496366, 1498136, 1498714, 1499385, 1499888, 1767419,
1770418, 1771067, 1771295, 1772367, 1774113, 1774473,
1777786, 1779669, 2158019, 2161408, 2162258, 2162266,
2162272, 2162312, 2165356, 2165802, 2167610, 2170435,
2172447, 2173477, 2174172, 2174262, 2176717, 2178868,
2179075, 2181976, 2182328, 2183366, 2183890, 2185893,
2186055, 2186378, 2186552, 2186825, 2187385, 2187745,
2188872, 2191323, 2193490, 2195234, 2196636, 2196726,
2197897, 2198121, 2198374, 2198406, 2198411, 2198770,
2198853, 2213941, 2216265, 2217806, 2218184, 2220939,
2222027, 2222815, 2222929, 2334548, 2338637, 2339051,
2339258, 2343919, 2345876, 2347650, 2347907, 2348310,
2354461, 2355358, 2355747, 2356036, 2365998, 2427862,
2428144, 2428171, 2428622, 2429013, 2430781, 2434400,
2434415, 2434609, 2436072, 2436083, 2437871, 2443322,
2446268, 2447460, 2447468, 2448739, 2448744, 2449354,
2450503, 2450913, 2450932, 2450943, 2450958, 2452009,
2455522, 2455807, 2456284, 2702617, 2705259, 2706411,
2706674, 2711501, 2713381, 2714499, 3029818, 3030528,
3420284, 3420351, 3420773, 3420788, 3421999, 3422172,
3422592, 3423235, 3423437, 3425310, 3425457, 3426063,
3426189, 3426310, 3426901, 3427956, 3428441, 3428733,
3432198, 3432217, 3432712, 3440369, 3441084, 3583331,
3583856, 3584482, 3585455, 3585935, 3586086, 3587474,
3587934, 3590561, 3592612, 3593775, 3595049, 3597366,
3598798, 3599663, 3901327, 4059774, 4060395, 4061776,
4062961, 4063374, 4064938, 4070372, 4072552, 4075132,
4075679, 4115784, 4116119, 4117569, 4124505, 4124515,
4125391, 4317454, 4317511, 4324467, 4327281, 4327418,
4330077, 4332571, 4417024, 4417212, 4417238, 4417742,
4417994, 4423663, 4424406, 4427351, 4429501, 4430196,
4549596, 4551221, 4552922, 4554502, 4554504, 4555970,
4559558, 4566822, 4567198, 4811225, 4814277, 4816167,
4816591, 4817894, 4820463, 4820820, 5081320, 5082488,
5083471, 5084347, 5085140, 5086125, 5089467, 5089706,
5089955, 5091475, 5091999, 5093042, 5096307, 5098366,
5507085, 5507504, 5507706, 5510564, 5522549, 5528967,
5530278, 5605012, 5705528, 5807121, 5807486, 5808903,
5811048, 5811280, 5815868, 5817540, 5817959, 5822534,
5824058, 5825400, 5825599, 5826840, 5827141, 5828613,
5908634, 5912519, 5913698, 5913962, 5914024, 5914624,
5917173, 6082401, 6082644, 6083327, 6087318, 6087906,
6088101, 6088111, 6089480, 6090076, 6090462, 6093170,
6096270, 6097616, 6099160, 6099867, 6116357, 6119502,
6123599, 6123807, 6124647, 6127236, 6127776, 6129441,
6131813, 6133697, 6133945, 6138031, 6138332, 6138351,
6141504, 6229705, 6230870, 6230923, 6231415, 6231636,
6231667, 6233964, 6234343, 6236412, 6307785, 6310537,
6311614, 6313108, 6314199, 6314379, 6315996, 6317834,
6318018, 6319693, 6321001, 6321011, 6321117, 6401278,
6401495, 6402228, 6404682, 6405147, 6406037, 6407328,
6407492, 6408312, 6607275, 6610250, 6610444, 6610447,
6612218, 6612987, 6617714, 6620088, 6621215, 6909228,
6909737, 6910539, 6911074, 6911962, 6912034, 6915206,
6915279, 6915750, 6915870, 6918514, 6920279, 7047162,
7047335, 7047940, 7049758, 7051551, 7052072, 7052188,
7052191, 7052593, 7056087, 7056772, 7057379, 7057928,
7499231, 7499555, 7537123, 7538033, 7539507, 7540845,
7541000, 7542727, 7544078, 7544905, 7544977, 7545050,
7546264, 7781883, 7782394, 7859612, 7860608, 7860776,
7863528, 7863613, 7863792, 7864641, 7917158, 7917649,
7918534, 7919052, 7920454, 7923259, 7923739, 7925504,
7932280, 7932356, 7932549, 7936184, 7936630, 7937767,
7937989, 7938914, 7939495, 8056087, 8062248, 8063913,
8067084, 8068609, 8069224, 8081694, 8172728, 8177475,
8180159, 8181987, 8182528, 8182538, 8207790, 8208082,
8554924, 8555883, 8571260, 8600581, 8600680, 9036611,
9037716, 9037828, 9038559, 9038608, 9041142, 9041853,
9044116, 9045067, 9046007, 9046344, 9048000, 9048745,
9049100, 9409874, 9549969, 9556291, 9558064, 9565357,
9568361, 9811883, 9812604, 9813033, 9813547, 9814142,
9815070, 9815711, 9815818, 9818823, 9819494, 9820566,
9821226, 9821535, 9821672, 9822030, 2341330, 4116890,
2183057, 3427996, 3583158, and 8208175
d) Unit numbers 4556145, 2442364, 5527866, 6098009,
7863535, 8554912, 8555059, 8556292, 8559734, 8560598,
9549729, 9552960, 9556822, 9557106, 9557113, 9557135,
9557349, 9559368, 9560974, 9562457, 9564731, and
9569555;
e) Unit numbers 2197921, 4816364, 5087931, 6135351, and
8561922;
f) Unit numbers 1492171, 1493680, 1494691, 1495833,
1498136, 1498714, 1767419, 1770418, 2158019, 2161408,
2162258, 2162266, 2162272, 2165802, 2172447, 2173477,
2174262, 2178868, 2182328, 2191323, 2193490, 2213935,
2216265, 2427862, 2428171, 2429013, 2430781, 2434400,
2434415, 2443322, 2446268, 2448739, 2448744, 2449354,
2450913, 2450932, 2450943, 2455807, 2702617, 3422172,
3441084, 3583331, 3585935, 3590561, 3593775, 3595049,
4317454, 4317511, 4327418, 4417212, 4417238, 4417742,
4417994, 4423663, 4424406, 4427351, 4429501, 4549596,
4566822, 4816167, 5082488, 5091475, 5096307, 5807121,
5807486, 5809491, 5811280, 5825400, 5825599, 5826840,
5908634, 5909548, 5914624, 6081605, 6088101, 6088111,
6089480, 6090462, 6116357, 6123807, 6131813, 6229705,
6230870, 6230923, 6231415, 6307785, 6310537, 6311614,
6314199, 6407492, 6408312, 6610250, 6610444, 6610447,
6612218, 6909737, 6911074, 6911962, 6912034, 6915206,
6915279, 6915750, 6920279, 7499555, 7537123, 7538033,
7544078, 7781883, 7782394, 7859612, 7860608, 7860776,
7864641, 7917649, 7918534, 7932280, 8172728, 8182528,
8182538, 8207790, 9037828, 9041142, 9050029, 9549969,
9812604, 9821226, 9821535, and 9822030;
g) Unit numbers 2170435, 6138332, 6612987, 7925504, and
4551221;
h) Unit numbers 1774113, 2179075, 2185893, 2186825,
2196726, 3432217, 6231636, 6404682, 8180159, 9048745,
and 9049100.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by fax on July 19, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood designated as either: 1) low volume collections; or 2) difficult collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 8 units;
b) 1 unit;
c) 446 units;
d) 22 units;
e) 5 units;
f) 128 units;
g) 5;
h) 11.
DISTRIBUTION
IL, WI, GA, RI and NY.
_____________________________
PRODUCT
Source Plasma, Recall # B-0295-3.
CODE
Units 60510389, 62553803, 62556828, 62559027,62561525.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dayton, OH, by fax on April 16, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0077-3.
CODE
Units GK42654, GK42550, GK42599, GK42680, GK42601, GK42597, GK42653.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 4, 2002 and by letter dated July 24, 2002.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA. Firm initiated recall is complete.
REASON
Blood products, collected from donors with inaccurate hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Source Plasma, Recall # B-0249-3.
CODE
Unit 183174.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Springfield, OH, by fax dated August 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for viral markers, but was collected from a donor whose medical history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
Source Plasma, Recall # B-0264-3.
CODE
Unit YA133071.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by letter dated September 4, 2002. Firm initiated recall is complete.
REASON
Blood product, which were collected from donor whose health history was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
_____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0276-3.
CODE
Unit 50FP08281(Part 1 and 2), 50FP08282(Part 2), 50FP08283 (Part 1 and 2),
50FP08284 (Part 1 and 2), 50FP08285, 50FP08287(Part 2).
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by letter dated February 14, 2002. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped at unacceptable temperatures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units.
DISTRIBUTION
CA and NY.
_____________________________
PRODUCT
Source Plasma, Recall # B-0280-3.
CODE
Unit numbers N-65481-139, N-65476-139, N-65386-139, N-65031-139, N-64716-139, and N-64710-139.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Mobile, AL, by fax on July 6, 2001. Firm initiated recall is complete.
REASON
Source Plasma, that was exposed to unacceptable storage temperatures and was not properly relabeled as Source Plasma, Salvaged, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA and Spain.
_____________________________
PRODUCT
Source Plasma, Recall # B-0281-3.
CODE
Unit number 317353.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by fax on September 20, 2002.
Manufacturer: Aventis Bio-Services, Inc., Springfield, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_____________________________
PRODUCT
a) Platelets, Recall # B-0290-3;
b) Platelets, Irradiated, Recall # B-0291-3;
c) Cryoprecipitated AHF, Recall # B-0292-3;
d) Fresh Frozen Plasma, Recall # B-0293-3;
e) Plasma, Recall # B-0294-3.
CODE
a) Unit numbers 1492188, 1492567, 1492902, 1492930,1493254, 1493462, 1493507, 1493605, 1493676, 1493886, 1494528, 1494547, 1495070, 1495123, 1495982, 1497697, 1498445, 1499038, 1765913, 1766069, 1766467, 1766690, 1767579, 1768415, 1769948, 1770301, 1770896, 1772740, 1772955, 1778485, 2160505, 2161860, 2163917, 2164818, 2165453, 2165471, 2165753, 2165806, 2165812, 2168043, 2168156, 2168624, 2168980, 2169967, 2170216, 2170222, 2171067, 2171295, 2174516, 2175553, 2175572, 2175858, 2177066, 2177081, 2177195, 2178101, 2179132, 2179153, 2182392, 2182402, 2185002, 2186073, 2186123, 2187789, 2191948, 2192459, 2192479, 2194509, 2195272, 2198570, 2216225, 2216395, 2217798, 2219439, 2332947, 2336155, 2336157, 2336189, 2336209, 2345149, 2346993, 2352280, 2352426, 2363778, 2425650, 2426126, 2426387, 2426512, 2426591, 2426698, 2427165, 2427208, 2428689, 2430074, 2431658, 2431695, 2432331, 2432496, 2432843, 2433191, 2433248, 2433782, 2433783, 2436390, 2437052, 2437888, 2437942, 2439360, 2439362, 2440436, 2441018, 2441024, 2441047, 2441052, 2441363, 2441812, 2443680, 2444448, 2446272, 2447152, 2449726, 2702712, 2703213, 2704012, 2704215, 2704462, 2709607, 2709919, 2712901, 2713386, 2713389, 2713599, 3423177, 3423178, 3423179, 3426526, 3432021, 3439456, 3579049, 3581469, 3581872, 3582628, 3583345, 3586836, 3587310, 3589982, 3591037, 3591040, 3593075, 3595545, 3596068, 3596257, 3599504, 4058881, 4059559, 4061078, 4061520, 4061726, 4073823, 4077981, 4317398, 4318171, 4320088, 4320226, 4320398, 4320577, 4320974, 4321264, 4321767, 4322222, 4322659, 4323120, 4323121, 4325156, 4326509, 4326510, 4326562, 4326673, 4326758, 4326851, 4326862, 4327004, 4327006, 4413705, 4413706, 4413707, 4413708, 4413709, 4413711, 4413713, 4413715, 4413716, 4413718, 4413719, 4413720, 4413721, 4413722, 4413723, 4413724, 4413726, 4413729, 4413730, 4413731, 4413732, 4413733, 4413736, 4413738, 4413739, 4413741, 4413743, 4413744, 4413913, 4415080, 4415257, 4415686, 4417282, 4417511, 4418331, 4418338, 4419590, 4420532, 4420907, 4421161, 4421833, 4423142, 4423550, 4425134, 4426375, 4427427, 4428733, 4548275, 4549177, 4549320, 4550273, 4556098, 4557344, 5081944, 5083309, 5084235, 5084271, 5085344, 5807275, 5808769, 5809174, 5809746, 5809768, 5810184, 5810887, 5811455, 5811909, 5813749, 5814497, 5814528, 5814552, 5814715, 5815351, 5815961, 5816099, 5819762, 5819813, 5820120, 5820121, 5827459, 5827586, 5907641, 5907799, 5908173, 5908811, 5909555, 5910160, 5910297, 5910914, 5912428, 5912736, 5913743, 5914366, 5914379, 5914705, 5914776, 5914880, 5914921, 5915424, 5915675, 5916932, 5918228, 6085322, 6088357, 6089469, 6090321, 6096742, 6097127, 6116877, 6116898, 6117104, 6117448, 6118044, 6118047, 6119913, 6122161, 6123052, 6123714, 6123790, 6123809, 6124494, 6126325, 6127904, 6127907, 6128109, 6130674, 6131110, 6131849, 6131904, 6136182, 6136183, 6136184, 6137157, 6140859, 6227536, 6227558, 6229444, 6229522, 6229626, 6229692, 6230874, 6231822, 6231852, 6232159, 6232201, 6232304, 6308388, 6309549, 6309600, 6311467, 6313196, 6313580, 6313773, 6313778, 6313780, 6313949, 6314681, 6318267, 6607117, 6607826, 6608178, 6608361, 6608668, 6608756, 6608809, 6608885, 6609339, 6609730, 6610320, 6610553, 6612233, 6613274, 6615524, 6615563, 6615564, 6615568, 6616019, 6616658, 6617159, 6908818, 6909167, 6909296, 6909352, 6909357, 6910249, 6911971, 6912409, 6912474, 6912875, 6912881, 6913000, 6913475, 6913870, 6915276, 6915766, 6915999, 6916002, 6916097, 6916178, 6916190, 6917332, 6918212, 6918652, 6919099, 6919117, 6921034, 7050575, 7497686, 7498565, 7498741, 7538463, 7539015, 7539786, 7540682, 7541639, 7542966, 7542968, 7543676, 7543984, 7544003, 7544123, 7544126, 7544380, 7547498, 7780330, 7780375, 7781132, 7782368, 7782720, 7783346, 7783628, 7783840, 7858044, 7858700, 7858873, 7859394, 7859843, 7860315, 7860475, 7860479, 7860574, 7861243, 7861903, 7864308, 7865292, 7865294, 7865295, 7914518, 7917546, 7917604, 7917761, 7917925, 7918065, 7918067, 7918081, 7918248, 7920206, 7922833, 7923548, 7923732, 7923895, 7924988, 7925653, 7925663, 7925879, 7925895, 7926555, 7926621, 7926909, 7927327, 7929149, 7929346, 7929351, 8172625, 8172794, 8173152, 8175318, 8175581, 8176151, 8176258, 8176447, 8177280, 8177434, 8177522, 8177551, 8178967, 8179011, 8179283, 8179285, 8180011, 8600575, 8600893, 9809533, 9811197, 9812153, 9812269, 9812319, 9813756, 9817357, 9822700, and 2330827
b) Unit numbers 2170447, 4413336, 4413727, 4567570, 5813898, 6120361, 6123446, 6609029, 7498312, 4413725, and 4413742
c) Unit numbers 1774114, 2177571, 2178197, 2179048,
2179546, 2180383, 2182087, 2182257, 2182892, 2182926,
2183017, 2183061, 2184130, 2184262, 2184283, 2184348,
2184636, 2185911, 2187271, 2187596, 2187858, 2188727,
2189324, 2196838, 2196839, 4325989, 6407949, 6615221,
7931612, and 9049824
d) Unit numbers 1492188, 1492567, 1492902, 1493462,
1493507, 1493605, 1495123, 1496580, 1498445, 1766069,
1766467, 1767579, 1770301, 1772740, 1772955, 1778485,
2163917, 2165453, 2165471, 2168156, 2168624, 2168980,
2169967, 2170222, 2170447, 2171067, 2171295, 2171661,
2172527, 2172794, 2172933, 2175553, 2178101, 2178780,
2179153, 2182392, 2182402, 2183057, 2186880, 2188112,
2191948, 2191951, 2192459, 2192479, 2192736, 2198570,
2215163, 2217798, 2218344, 2218598, 2221514, 2221515,
2221517, 2221523, 2330827, 2332626, 2345230, 2352426,
2363778, 2425650, 2426126, 2426387, 2427165, 2428200,
2430074, 2432843, 2433191, 2433248, 2436390, 2437888,
2438399, 2439304, 2441018, 2441024, 2441047, 2441052,
2441607, 2447152, 2449726, 2455864, 2704215, 2709607,
2713032, 2713386, 2713389, 2713599, 3428856, 3431678,
3581469, 3583345, 3587310, 3589982, 3590084, 3591037,
3591040, 3592100, 3594484, 3595233, 4058881, 4061520,
4077462, 4317398, 4318171, 4320226, 4320398, 4321264,
4322659, 4323120, 4323121, 4324433, 4324983, 4325156,
4326509, 4326510, 4326673, 4326758, 4413707, 4413708,
4413709, 4413710, 4413711, 4413713, 4413715, 4413716,
4413718, 4413719, 4413720, 4413721, 4413722, 4413723,
4413724, 4413725, 4413726, 4413727, 4413728, 4413729,
4413730, 4413731, 4413732, 4413736, 4413738, 4413739,
4413741, 4413742, 4413743, 4413744, 4414883, 4415080,
4415162, 4417282, 4417511, 4418338, 4419590, 4420194,
4421833, 4423550, 4425134, 4428733, 4428940, 4556457,
4557344, 5081944, 5808307, 5809746, 5810887, 5811089,
5811455, 5811631, 5811682, 5811909, 5814079, 5814528,
5814552, 5816099, 5817593, 5818802, 5819762, 5820120,
5820121, 5827586, 5907799, 5909555, 5910160, 5910297,
5914880, 5914921, 5915424, 5918228, 6088357, 6089469,
6096042, 6096742, 6097127, 6115711, 6117104, 6117151,
6118044, 6118047, 6119913, 6120361, 6123052, 6123714,
6124494, 6124969, 6127546, 6127574, 6128548, 6130674,
6131101, 6136182, 6136183, 6136185, 6137157, 6140859,
6229522, 6231852, 6232159, 6232201, 6232304, 6308388,
6309549, 6309600, 6313580, 6313949, 6316405, 6318267,
6608178, 6608361, 6608668, 6608885, 6609029, 6615563,
6615564, 6615570, 6616019, 6617159, 6908818, 6909296,
6912409, 6912474, 6913000, 6913706, 6913870, 6915766,
6916178, 6917332, 6918652, 7497686, 7498312, 7498565,
7498741, 7538463, 7539229, 7539786, 7540354, 7541639,
7542966, 7542968, 7543398, 7543676, 7543984, 7544003,
7544380, 7780330, 7780375, 7781132, 7782368, 7782720,
7783346, 7783628, 7783789, 7783840, 7858873, 7859434,
7859843, 7860475, 7862125, 7864308, 7917546, 7917761,
7918065, 7918081, 7918248, 7920206, 7923895, 7925663,
7926895, 7926909, 7926910, 7927833, 7929149, 7929346,
7929351, 7930130, 8067440, 8172625, 8172794, 8175581,
8176151, 8177551, 8179011, 8179283, 8179285, 8179849,
8180011, 9042630, 9810557, 9812153, 9812319, 9817357,
9818364, and 9822700
e) Unit numbers 2177571, 2178197, 2179048, 2179546,
2180383, 2182892, 2183017, 2184262, 2187271, 2187596,
2188727, 2189324, 3435084, 4325989, and 6615221.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by fax on June 19, 2002. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood designated as either: 1) low volume collections; or 2) difficult collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 484 units;
b) 11 units;
c) 30 units;
d) 312 units;
e) 15 units.
DISTRIBUTION
IL, WI, GA, RI and NY.
_____________________________
PRODUCT
Medtronic RF Enhancr SC Single-Curve Steerable Ablation Catheters,Model numbers 11744523, 11745523, 11745533, 19745533, 19746534. Recall # Z-0320-3;
Medtronic RF Enhancr NTC (Non-Thermocouple) Steerable
Mapping/Ablation Catheters, Model numbers 21744523, 21745523, 29745533, 29746534. Recall # Z-0231-3.
CODE
Model 11744523, lot numbers FA11245, FA11256, FA11256A, FA11257, FA11370, FA11606, FA11777, FA11831, FA11895, FA11895A, FA11990, FA12056, FA12104, FA12186, FA12299, FA12378, FA12477, FA12540, FA12726, and FA12908
Model 11745523, lot numbers FA11359, FA11369, FA11660, FA11660B, FA11778, FA11778B, FA11832, FA11832B, FA11991, FA12105, FA12300, FA12423, FA12478, FA12478A, FA12645, and FA12909
Model 11745533, lot numbers FA11243, FA11360, FA11368, FA11609, FA11658, FA11658A, FA11779, FA11833, FA11833C, FA11896, FA11992, FA12057, FA12106, FA12216, FA12256, FA12256A, FA12301, FA12302, FA12302B, FA12379, FA12479, FA12646, FA12727, and FA12910
Model 19745533, lot numbers FA11244, FA11255, FA11255A, FA11367, FA11615, FA11659, FA12058, FA12107, FA12107A, FA12303, FA12303A, FA12480, and FA12728
Model 19746534, lot numbers FA11242, FA11254, FA11364, FA11616; FA11661, FA12059, FA12108, FA12108A, FA12217, FA12257, FA12304, FA12380, FA12541, FA12541A, FA12729, FA12730, and FA12911
Model 21744523, lot numbers FA11361, FA11608, FA12258, FA12258A, FA12424, and FA12731
Model 21745523, lot numbers FA11607, FA11834, FA12055, FA12305, and FA12381
Model 29745533, lot numbers FA11362, FA11617, and FA12306
Model 29746534, lot numbers FA11253, FA11363, FA11897, FA12307, and FA12846.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Minneapolis, MN, by letter dated October 29, 2002.
Manufacturer: Medtronic Puerto Rico, Inc., Villalba, RQ. Firm initiated recall is ongoing.
REASON
In some of the catheters, the catheter manipulator wire detached from the catheter insulating tip anchor during operation of the catheter deflection mechanism and after detachment penetrated the catheter wall and protruded from the shaft.
VOLUME OF PRODUCT IN COMMERCE
500 catheters.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR DECENBER 11, 2002
####
Enforcement Report Index | FDA News Page | FDA Home Page
Office of Public Affairs
Web page created by clb 2002-DEC-10.