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U.S. Department of Health and Human Services

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Enforcement Report for June 28, 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 28, 2006
06-26

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

______________________________
PRODUCT
Publix Key Lime Pie - whole, half, and single-serve slices, Recall # F-212-6
CODE
2-95448-90679, 2-91098-30449 and 2-92717-10188
RECALLING FIRM/MANUFACTURER
Recalling Firm: Publix Super Markets Inc, Lakeland, FL, by e-mail and press release on December 28, 2005.
Manufacturer: Foxtail Foods #3, Fairfield, OH, firm initiated recall is ongoing.
REASON
Publix Key Lime Pie (including whole, half, and slice) contained undeclared eggs. The pies were sold between December 13 and December 27, 2005.
VOLUME OF PRODUCT IN COMMERCE
150
DISTRIBUTION
FL, GA, AL, TN and SC

______________________________
PRODUCT
Beef Gravy Mix (foodservice gravy mix) contained in a 12 oz. white plastic bag. Item code is1270, Recall # F-213-6
CODE
E04A1
RECALLING FIRM/MANUFACTURER
Schreiber, R.L. Inc., Pompano Beach, FL, by press release, telephone, email and letter on May 19, 2006. Firm initiated recall is ongoing.
REASON
Product contains ingredients derived from milk and soy that are not declared on product label.
VOLUME OF PRODUCT IN COMMERCE
1091 units
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
a) Seafood Salad, packaged in: 5lb plastic containers (Southern Style),
2 per case (wholesale packaging), 12oz plastic containers 12 per
case (Kroger), Recall # F-214-6;
b) Gourmet Sea Salad, packaged in: 12oz plastic containers 12 per case,
Recall # F-215-6;
c) Tuna Salad, packaged in: 5lb plastic containers (Mrs. Gerry’s,
Dairy Fresh, Southern Style), 2 per case (wholesale packaging),
1-10lb bag in a box (Southern Gourmet Foods), 1 per case, 12oz
plastic containers 12 per case (Kroger), 1-20Lb bag in a box (House of
Thaller), and 14 oz plastic containers (Mrs. Gerry's), Recall # F-216-6;
d) Deli Tuna Salad, packaged in 5 lb plastic containers (House of
Thaller, Southern Style), 2 per case (wholesale packaging),
Recall # F-217-6;
e) SM Tuna Salad, 20 lbs packaged in plastic bags, 1 per case
(Mrs. Gerry’s Super Mom’s) (wholesale packaging), Recall # F-218-6;
f) Seafood Salad Mix, packaged in 5lb plastic containers (House of Thaller),
2 per case (wholesale packaging), Recall # F-219-6;
g) Shrimp Salad, packaged in 12oz plastic containers 12 per case (Kroger),
Recall # F-220-6;
h) Artichoke Shrimp Dip, packaged in 7.5 oz containers-12 per case
(Kroger), Recall # F-221-6;
i) Crab Dip, packaged in 7.5 oz containers-12 per case (Kroger),
Recall # F-222-6;
j) Cajun Style Crab Dip, packaged in 7.5 oz containers-12 per case
(Kroger), Recall # F-223-6;
k) Pea Salad Mix, packaged in 5lb plastic containers, 2 per case
(Southern Style) (wholesale packaging), Recall # F-224-6
CODE
a) 06 JUN 2006A L3, 13 JUN 2006A L3, 13 JUN 2006B L3,
16 JUN 2006A LN2, 20 JUN 2006B L3, 23 JUN 2006B LN2,
26 JUN 2006A L3, 26 JUN 2006B L3, 29 JUN 2006A LN2;
b) 17 JUN 2006A L3, 24 JUN 2006A L3, 01 JUL 2006A L3,
01 JUL 2006B L3, 01 JUL 2006C L3;
c) 08 JUN 2006A LN2, 13 JUN 2006A LN2, 13 JUN 2006A L3,
15 JUN 2006B LN2, 16 JUN 2006A LN2, 20 JUN 2006A LN2,
20 JUN 2006A L3, 20 JUN 2006B L3, 23 JUN 2006A LN2,
23 JUN 2006B LN2, 27 JUN 2006A LN1, 27 JUN 2006A LN2,
27 JUN 2006B L3, 28 JUN 2006B LN2, 28 JUN 2006Z LN2,
01 JUL 2006A LN2, 01 JUL 2006A L3, 02 JUL 2006A LN1,
07 JUL 2006A LN1, 08 JUL 2006B LN1, 11 JUL 2006A LN2;
d) 14 JUN 2006A LN2, 16 JUN 2006A LN2, 21 JUN 2006A LN2,
23 JUN 2006B LN2, 27 JUN 2006B LN2, 27 JUN 2006Z LN2,
02 JUL 2006A LN2;
e) 06 JUN 2006A LN2, 13 JUN 2006A LN2, 01 JUL 2006A LN2,
13 JUN2006A LN3;
f) 14 JUN 2006A LN2, 24 JUN 2006B LN2;
g) 31 MAY 2006A L3, 05 JUN 2006B L3, 07 JUN 2006A L3;
h) 31 MAY 2006A L3, 04 JUN 2006B L3;
i) 06 JUN 2006A L3, 10 JUN 2006B L3, 13 JUN 2006A L3,
17 JUN 2006B L3, 01 JUL 2006A L3, 01 JUL 2006B L3;
j) 17 JUN 2006A L3, 21 JUN 2006B L3, 01 JUL 2006A L3;
k) 04 JUL 2006A LN2
RECALLING FIRM/MANUFACTURER
House Of Thaller, Inc., Knoxville, TN, by telephone, fax and email on May 11, 2006 and May 19, 2006. Firm initiated recall is ongoing.
REASON
Products were manufactured using a canned celery ingredient which was inadequately acidified to prevent the growth of pathogens.
VOLUME OF PRODUCT IN COMMERCE
118,822,375 lbs.
DISTRIBUTION
FL, IN, MI, MN, OH, TN, and TX
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Glyburide and Metformin Hydrochloride tablets, 2.5 ng/500 mg,
(10X10) 100 unit dose tablets, Rx only, NDC 0172-5711-10,
Recall # D-270-6;
b) Glyburide and Metformin Hydrochloride tablets, 5 mg/500 mg,
(10X10) 100 unit dose tablets, Rx only, NDC 0172-5712-10,
Recall # D-271-6
CODE
a) Lot 133750, Exp. 4/06;
b) Lot 133749, Exp. 5/06;
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Inc., Miami, FL, by letters on March 31, 2006.
Manufacturer: IVAX Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Failed specification for one impurity.
VOLUME OF PRODUCT IN COMMERCE
20,042/100 total packages
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Propoxyphene Napsylate and Acetaminophen Tablets USP, 100 mg/650, 1000 tablets per bottle, Rx only, NDC 0172-4980-80, Recall # D-269-6
CODE
Lot 134402A, Exp.12/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Inc., Miami, FL, by letters on May 4, 2006.
Manufacturer: IVAX Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Failed dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE
957/1000 tablet bottles
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Fresh Frozen Plasma, Recall ## B-1254-6
CODE
Unit: 71N27833
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
Recovered Plasma, Recall # B-1312-6
CODE
Unit: KY14213
RECALLING FIRM/MANUFACTURER
Rex Hospital Inc., Raleigh, NC, by telephone on October 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not tested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1317-6
CODE
Unit: 06KT32913
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by telephone on October 1, 2004 and by letter dated October 5, 2004. 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
Red Blood Cells, Leukocytes Reduced, Recall # B-1318-6
CODE
Unit: 6437246
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by telephone on April 22, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was not questioned regarding travel to areas at risk for human immunodeficiency virus (HIV-1) group O, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1326-6;
b) Fresh Frozen Plasma, Recall # B-1327-6
CODE
a) Units: 28LS13188, 36FC11588:
b) Unit: 28LS13188
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter dated August 9, 2000. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and SC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1343-6
CODE
Unit: 2585604
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who indicated living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1344-6
CODE
Unit: 12FS02226
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, by letter on December 20, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who indicated living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1345-6
CODE
Units: 2530782 and 2575324
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile July 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1346-6
CODE
Unit: 2391836
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile January 20, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Platelets, Leukocytes Reduced, Recall # B-1348-6;
b) Platelets Irradiated, Recall # B-1349-6
CODE
a) Units: 18FJ68645, 18FJ68651, 18FJ68652, 18FJ68653, 18FJ68654, 18FJ68655, 18FJ68657, 18FJ68658, 18FJ68659, 18FJ68661, 18FJ68789, 18FJ68807, 18FJ68813, 18FJ68818, 18FJ68835, 18FJ68839, 18FJ68843, 18FJ68847, 18FJ68848, 18FJ68866, 18FJ68867, 18FJ68871, 18FJ68879, 18FJ68882, 18FJ69019, 18FJ69020, 18FJ69022, 18FJ69030, 18FJ69031, 18FJ69033, 18FJ69034, 18FJ69036, 18FJ69037, 18FJ69038, 18FJ69044, 18FJ69047, 18FJ69069, 18FJ69070, 18FJ69072, 18FJ69074, 18FJ69078, 18FK83321, 18FK83322, 18FK83325, 18FK83327, 18FK83328, 18FK83330, 18FK83331, 18FK83332, 18FK83530, 18FK83532, 18FK83537, 18FK83819, 18FK83820, 18FK83824, 18FK83828, 18FK83830, 18FK83838, 18FK83839, 18FK83840, 18FK83841, 18FK83935, 18FN10544, 18FN10547, 18FN10549, 18FN10550, 18FN10551, 18FN10552, 18FN10553, 18FN10554, 18FN10561, 18FN10562, 18FN10565, 18FN10566, 18FN10567, 18FN10568, 18FN10569, 18FN10570, 18FN10572, 18FN10574, 18FN10575, 18FN10578, 18FN10581, 18FN10588, 18FN10589, 18FN10591, 18FN10595, 18FN11281, 18FN11291, 18FN11550, 18FN11551, 18FN11553, 18FN11555, 18FN11556, 18FN11557, 18FN11558, 18FN11560, 18FN11563, 18FN11566, 18FN11568, 18FN11569, 18FN11570, 18FN11572, 18FN11574, 18FN11581, 18FN11582, 18FN11584, 18FN11585, 18FN11586, 18FN11587, 15FN11588, 18FN11592, 18FN11593, 18FN11596, 18FN11597, 18FN11600, 18FN11601, 18FN11602, 18FN11603, 18FN11604, 18FN11605, 18FN11608, 18FN11614, 18FN11615, 18FN11619, 18FN11627, 18FN11628, 18FN11629, 18FN11631, 18FN11633, 18FN11635, 18FN11637, 18FN11647, 18FN11649, 18FN11650, 18FQ92787, 18FQ92792, 18FQ92799, 18FQ92800, 18FQ92801, 18FQ92803, 18FQ92805, 18FQ92806, 18FQ92807, 18FQ92808, 18FQ92809, 18FQ92810, 18FQ92889, 18FQ92890, 18FQ92893, 18FQ92894, 18FQ92895, 18FQ92896, 18FQ92898, 18FQ92901, 18FQ92902, 18FQ92904, 18FQ93370, 18FQ93411, 18FQ93413, 18FQ93416, 18FQ93418, 18FQ93421, 18FQ94326, 18FQ94328, 18FR87628, 18FR87629, 18FR87630, 18FR87633, 18FR87634, 18FR87635, 18FR87638, 18FR87639, 18FR87641, 18FR87642, 18FR87644, 18FR87645, 18FR87693, 18FR87700, 18FR87712, 18FR87716, 18FR87749, 18FS80075, 18FS80081, 18FS80083, 18FS80085, 18FS80086, 18FS80087, 18FS80090, 18FS80091, 18FS80094, 18FS80097, 18FS80098, 18FS80103, 18FS80104, 18FS80230, 18FS80235, 18FT84140, 18FT84146, 18FT84149, 18FT84162, 18FT84163, 18FT84178, 18FT84185, 18FT84201, 18FT84202, 18FT84215, 18FT84216, 18FT84218, 18FT84220, 18FT84221, 18FT84222, 18FT84223, 18FT84224, 18FT84225, 18FT84226, 18FT84229, 18FT84230, 18FT84232, 18FT84233, 18FT84234, 18FT84235, 18FT84238, 18FT84240, 18FT84241, 18FT84242, 18FT84243, 18FT84248, 18FT84249, 18FT84250, 18FT84251, 18FT84252, 18FT84253, 18FT84254, 18FT84257, 18FT84258, 18FT84259, 18FT84261, 18FT84263, 18FT84265, 18FT84266, 18FT84267, 18FT84269, 18FT84270, 18FT84273, 18FT84275, 18FT84276, 18FT84278, 18FT84279, 18FT84281, 18FT84291, 18FT84293, 18FT84299, 18FT84300, 18FT84304, 18FT84307, 18FT84308, 18FT84309, 18FT84310, 18FT84314, 18FT84321, 18FT84329, 18FT84333, 18FT84335, 18FT84336, 18FT84337, 18FT84338, 18FT84353, 18FT84416, 18FT84490, 18FT84491, 18FT84492, 18FT84494, 18FT84498, 18FT84499, 18FT84500, 18FT84501, 18FT84504, 18FT84508, 18FT84510, 18FT84512, 18FT84513, 18FT84514, 18FT84516, 18FT84518, 18FT84521, 18FT84526, 18FT84547, 18FT84550, 18FT84554, 18FT84556, 18FT84557, 18FT84558, 18FT84560, 18FT84561, 18FT84566, 18FT84568, 18FT84569, 18FT84572, 18FT84573, 18FT84576, 18FT84577, 18FT84580, 18FT84582, 18FT84585, 18FT84588, 18FT84589, 18FT84590, 18FT84591, 18FT84592, 18FT84598, 18FT84601, 18FT84603, 18FT84605, 18FT84608, 18FT84609, 18FT84610, 18FT84612, 18FT84626, 18FT84638, 18FT84646, 18FT84679, 18FT84682, 18FT94685, 18FT84689, 18FT84716, 18FT84724, 18FT84726, 18FT84732, 18FT84737, 18FT84750, 18FT84761, 18FT84762, 18FT84763, 18FT84765, 18FT84766, 18FT84771, 18FT84775, 18FT84782, 18FT84783, 18FT84784, 18FT84785, 18FT84789, 18FT84791, 18FT84795, 18FT84797, 18FT84799, 18FT84802, 18FT84803, 18FT84809, 18FT84845, 18FT84846, 18FT84851, 18FT84852, 18FT84853, 18FT84855, 18FT84856, 18FT84857, 18FT84858, 18FT84859, 18FT84860, 18FT84861, 18FT84862, 18FT84863, 18FT84864, 18FT84867, 18FT84868, 18FT84871, 18FT84873, 18FT84881, 18FT84882, 18FT84885, 18FT84886, 18FT84887, 18FT84889, 18FT84897, 18FT84898, 18FT84899, 18FT84901, 18FT84906, 18FT84908, 18FT84913, 18FT84915, 18FT84916, 18FT84919, 18FT84920, 18FT84924, 18FT84925, 18FT84926, 18FT84927, 18FT84929, 18FT84931, 18FT84932, 18FT84936, 18FT84937, 18FT84940, 18FT84959, 18FT84963, 18FT84968, 18FT84970, 18FT84974, 18FT84979, 18FT84981, 18FT84994, 18FT85010, 18FT85022, 18FT85034, 18FT85036, 18FT85043, 18FT85044, 18FT85048, 18FT85108, 18FT85110, 18FT85111, 18FT85114, 18FT85117, 18FT85121, 18FT85123, 18FT85124, 18FT85125, 18FT85128, 18FT85129, 18FT85131, 18FT85132, 18FT85159, 18FT85162, 18FT85169, 18FT85170, 18FT85173, 18FT85175, 18FT85180, 18FT85181, 18FT85182, 18FT85187, 18FT85192, 18FT85199, 18FT85224, 18FT85294, 18FT85302, 18FT85312, 18FT85402, 18FT85403, 18FT85404, 18FT85405, 18FT85408, 18FT85410, 18FT85411, 18FT85413, 18FT85415, 18FT85416, 18FT85419, 18FT85421, 18FT85422, 18FT85426, 18FT85428, 18FT85429, 18FT85434, 18FT85435, 18FT85437, 18FT85438, 18FT85443, 18FT85447, 18FT85452, 18FT85459, 18FT85461, 18FT85464, 18FT85467, 18FT85472, 18FT85473, 18FT85474, 18FT85476, 18FT85477, 18FT85478, 18FT85479, 18FT85480, 18FT85484, 18FT85486, 18FT85492, 18FT85497, 18FT85498, 18FT85511, 18FT85512, 18FT85517, 18FT85520, 18FT85525, 18FT85584, 18FT85588, 18FT85606, 18FT85612, 18FT85613, 18FT85617, 18FT85619, 18FT85620, 18FT85627, 18FT85629, 18FT85640, 18FT85642, 18FT85645, 18FT85646, 18FT85654, 18FT85658, 18FT85660, 18FT85661, 18FT85666, 18FT85669, 18FT85672, 18FT85674, 18FT85743, 18FT85745, 18FT85748, 18FT85751, 18FT85752, 18FT85753, 18FT85755, 18FT85756, 18FT85758, 18FT85760, 18FT85761, 18FT85763, 18FT85768, 18FT85769, 18FT85770, 18FT85776, 18FT85779, 18FT85780, 18FT86007, 18FT86008, 18FT86009, 18FT86010, 18FT86011, 18FT86012, 18FT86014, 18FT86016, 18FT86018, 18FV56852, 18FV56853, 18FV56854, 18FV56855, 18FV56857, 18FV56858, 18FV56862, 18FV56864, 18FV56865, 18FV56866, 18FV56869, 18FV56870, 18FV56871, 18FV56874, 18FV56875, 18FV56876, 18FV56877, 18FV56880, 18FV56881, 18FV56882, 18FV56884, 18FV56886, 18FV56891, 18FV56894, 18FV56904, 18FV56908, 18FV56927, 18FW49522, 18FW49524, 18FW49527, 18FW49528, 18FW49531, 18FW49534, 18FW49535, 18FW49536, 18FW49541, 18FW49543, 18FW49545, 18FW49546, 18FW49669, 18FW49671, 18FW49673, 18FW49674, 18FW49675, 18FW49678, 18FW49679, 18FW49680, 18FW49681, 18FW49683, 18FW49685, 18FW49686, 18FW49688, 18FW49689, 18FW49694, 18FW49695, 18FW49697, 18FW49699, 18FW49700, 18FW49704, 18FW49766, 18FW49769, 18FW49771, 18FW49776, 18FX57729, 18FX57730, 18FX57731, 18FX57733, 18FX57734, 18FX57736, 18FX57739, 18FX57746, 18FX57747, 18FX57748, 18FX57749, 18FX57750, 18FX57751, 18FX57752, 18FX57835, 18FX57838, 18FX58456, 18FX58457, 18FX58459, 18FX58460, 18FX58461, 18FX58462, 18FX58463, 18FX58464, 18FX58465, 18FX58466, 18FX58467, 18FX58468, 18FX58469, 18FX58470, 18FX58471, 18FX58472, 18FX58473, 18FY15141, 18FY15147, 18FY15149, 18FY15152, 18FY15153, 18FY15154, 18FY15155, 18FY15156, 18FY15157, 18FY15158, 18FY15159, 18FY15160, 18FY15161, 18FY15162, 18FY15163, 18FY15197, 18FY15198, 18FY15200, 18FY15201, 18FY15202, 18FY15204, 18FY15206, 18FY15208, 18FY15209, 18FY15214, 18FY15215, 18FY15218, 18FY15219, 18FY15222, 18FY15225, 18FY15226, 18FY15253, 18FY15257, 18FY15258, 18FY15263, 18FY15267, 18FY15270, 18FY15311, 18FY15316, 18FY15317, 18FY15319, 18FY15348, 18FY15544, 18FY15547, 18FY15549, 18FY15550, 18FY15552, 18FY15553, 18FY15554, 18FY15644, 18FY15645, 18FY15647, 18FY15648, 18FY15651, 18FY15656, 18FY15657, 18FY15658, 18FY15659, 18FY15660, 18FY15662, 18FY15664, 18FY15665, 18FY15666, 18FY15667, 18FY15669, 18FY15671, 18FY15675, 18FY15676, 18FY15678, 18FY15809, 18FY15811, 18FY15812, 18FY15814, 18FY15815, 18FY15824, 18FY15826, 18FY15832, 18FZ42292, 18FZ42294, 18FZ42299, 18FZ42693, 18FZ42700, 18GF47191, 18GF47252, 18GF47253, 18GF47254, 18GF47256, 18GF47259, 18GF47260, 18GF47261, 18GF47262, 18GF47263, 18GF47266, 18GF47267, 18GF47269, 18GF47270, 18GF47271, 18GF47273, 18GF47559, 18GF47775, 18GF47776, 18GF47783, 18GF47784, 18GG63550, 18GG63554, 18GG63561, 18GG63571, 18GG63574, 18GG63576, 18GG63579, 18GH96722, 18GH96725, 18GH96727, 18GH96729, 18GH96730, 18GH96733, 18GH96734, 18GH96736, 18GH96739, 18GH96850, 18GH96856, 18GH96857, 18GH96859, 18GH97355, 18GH97357, 18GH97358, 18GH97360, 18GH97362, 18GH97383, 18GH97384, 18GH97385, 18GH97393, 18GH97394, 18GH97396, 18GH97403, 18GH97405, 18GH97407, 18GH97409, 18GH97412, 18GH97416, 18GK34127, 18GK34129, 18GK34130, 18GK34136, 18GK34138, 18GK34139, 18GK34141, 18GK34142, 18GK34146, 18GK34218, 18GK34219, 18GK34221, 18GK34225, 18GK34230, 18GM08428, 18GM08429, 18GM08430, 18GM08432, 18GM08433, 18GM08436, 18GM08437, 18GM08438, 18GM08443, 18GM08449, 18GM08450, 18GM08451, 18GM08455, 18GM08460, 18GM08462, 18GM08463, 18GM08465, 18GM08466, 18GM08467, 18GM08469, 18GM08470, 18GM08472, 18GM08474, 18GM08476, 18GM08478, 18GM08479, 18GM08480, 18GM08481, 18GM08482, 18GM08485, 18GM08486, 18GM08487, 18GM08488, 18GM08490, 18GM08492, 18GM08493, 18GM08494, 18GM08495, 18GM08498, 18GM08499, 18GM08702, 18GM08704, 18GM08705, 18GM08707, 18GM08708, 18GM08709, 18GM08710, 18GM08713, 18GM08715, 18GM08717, 18GM08723, 18GM08724, 18GM08730, 18GM08732, 18GM08733, 18GM08735, 18GM08737, 18GM08809, 18GM08810, 18GM08813, 18GM08814, 18GM08818, 18GM08820, 18GM08835, 18GM08836, 18GM08837, 18GM08839, 18GM08840, 18GM08843, 18GM08844, 18GM08845, 18GM08850, 18GM08852, 18GM08854, 18GM08857, 18GM08858, 18GM08859, 18GM08860, 18GN29182, 18GN29203, 18GN29204, 18GN29206, 18GN29208, 18GN29210, 18GN29211, 18GN30019, 18GN30028, 18GN30033;

b) Units: 18FJ68868, 18FJ69055, 18FJ69057, 18FJ69071, 18FJ69076, 18FQ92791, 18FS80100, 18FS80228, 18FS80229, 18FS80232, 18FS80233, 18FS80237, 18FS80239, 18FT84247, 18FT84497, 18FT84502, 18FT84528, 18FT84536, 18FT84562, 18FT84564, 18FT84565, 18FT84770, 18FT84935, 18FT84953, 18FT84958, 18FT84960, 18FT84966, 18FT84977, 18FT84982, 18FT84984, 18FT85066, 18FT85068, 18FT85069, 18FT85096, 18FV56901, 18FV56906, 18FV56925, 18FV56933, 18FW49690, 18FW49693, 18FW49759, 18FW49768, 18FW49773, 18FW49774, 18FW49775, 18FY15817, 18GF47558, 18GG63558, 18GG63559, 18GH96728, 18GH96731, 18GH96737, 18GH96738
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 20, 2004, or by facsimile on February 24, 2004, and letter dated February 25, 2004. Firm initiated recall is complete.
REASON
Platelets, lacking appropriate quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
925 units
DISTRIBUTION
GA, MI, OK, and PR

______________________________
PRODUCT
Leukotrap SC RC Leukocyte Reduction Filtration System for Red Blood Cells with Pall BPF4Ô High Efficiency Filter, Recall # B-1354-6
CODE
Reorder Code 430-41: Lots 0450520, 0450560, 0450583, 0450613, 0450630, 0450650, 0450672, 0450673, 0450674, 0450684, 0450685, 0450690, 0450707, 0450708, 0450712, 0490006; Reorder Code 430-50: Lots 0450574, 0450626, 0450661, 0450665, 0450668, 0450710, 0450714, 0450737; Reorder Code BPFB: Lot 0450615.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomedical Products Corp., East Hills, NY, by letters on December 9, December 17, 2004, and February 23, 2005.
Manufacturer: Pall Biomedical, Inc., Fajardo, PR. Firm initiated recall is ongoing.
REASON
Numerous reports of potential Hemolysis in Red Blood Cells and Whole Blood, Leukocyte Reduced products manufactured with the Pall BPF4 Filter.
VOLUME OF PRODUCT IN COMMERCE
276,080 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Source Plasma, Recall # B-1361-6
CODE
Unit: 7080066680
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Scottsdale, AZ, by e-mail on April 4, 2002 and by letter dated April 16, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated ALT result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
England

______________________________
PRODUCT
Source Plasma, Recall # B-1364-6
CODE
Units: 006739, 006373, 031249, 021576, 029135, 034687, 035939, 031514, 034024, 002341, 012687, 005773, 041449, 019195, 030860, 029827, 030995, 030137, 029862, 026188, 030433, 030460, 030849, 028846, 031409, 028534, 012052, 026367, 035614, 016284, 030365, 035485, 023372, 024162, 028050, 025256, 035907, 007010, 035133, 017998, 034065, 027173, 028168, 033774, 025950, 029090, 034467, 030209, 026817, 035908, 025570, 020122, 009968, 010520, 036177, 033683, 032496, 035815, 035663, 029953, 011280, 024391, 033945, 013396, 035619, 033029, 035749, 035409, 035988, 021721, 033771, 035046, 021542, 022718, 027941, 035111, 024810, 016915, 017045, 036001, 027567, 030079, 020595, 016191, 022978, 035733, 030350, 027448, 035676, 021795, 033618, 035995, 029937, 035162, 030346, 036033, 025562, 034342, 032270, 035164, 009659, 034244, 020748, 030746, 029224, 034371, 020218, 029427, 030402, 036096, 024292, 022314, 032915, 030580, 009065, 036029, 018097, 035661, 035358, 002341, 001197, 003783, 002178, 004225, 000807, 002924, 000962, 000562, 000794, 004288, 001334, 002889, 003717, 004651, 004704, 003561, 002215, 000254, 000436, 002888, 000451, 003777, 004368, 000767, 004373, 012687, 012423, 011897, 015038, 020518, 047067, 043174, 049623, 052548, 012984, 014853, 049930, 034210, 029353, 044750, 049629, 053173, 047139, 037176, 050138, 044404, 001588, 051259, 052988, 032034, 052452, 052626, 045386, 032251, 052866, 051588, 049492, 050679, 052203, 005773, 041449, 004195, 001471, 000584, 002137, 006408, 004199, 007002, 006915, 006991, 003370, 007127, 004192, 007112
RECALLING FIRM/MANUFACTURER
Talecris Biotherapeutics, Inc, Raleigh, NC, by letter dated July 30, 1999. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
194 units
DISTRIBUTION
CO, FL, IL, LA, MO, OR, PA, and WI

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1365-6
CODE
Unit; 9013567
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on January 25, 2001. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1366-6;
b) Platelets, Recall # B-1367-6
CODE
a) Units: 11GQ31740 and 11GQ44322;
b) Unit: 11GQ31740
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St Louis, MO, by telephone on April 1, 2005 and by letter dated April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL, MO, and AR

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1368-6
CODE
Unit: 2484646
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1370-6
CODE
Unit: 2436070
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 11, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1372-6
CODE
Unit: 7072558
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on March 3, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received a body piercing within twelve months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1373-6
CODE
Unit: 11GS44084
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on March 10, 2005 and by letter dated April 1, 2005. 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
GA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1383-6
CODE
Unit: 06FC13128
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone and by letter on December 1, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1384-6
CODE
Unit: 06GM30092
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone and letter on December 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1385-6
CODE
Unit: 06FE77079
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone on January 24, 2005 and by letter dated January 26, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1386-6
CODE
Units: 102942958 (2 parts)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on July 22, 2004 and by letter dated August 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

_______________________________________
PRODUCT
Platelets, Recall # B-1387-6
CODE
Unit: T22046
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on March 30, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from whole blood in which the associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1390-6
CODE
Unit: 2594418
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on September 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1391-6;
b) Recovered Plasma, Recall # B-1392-6
CODE
a) and b) Unit: 2454690
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 21, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and FL

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1393-6;
b) Fresh Frozen Plasma, Recall # B-1394-6
CODE
a) and b) Unit: 2495327
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on September 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of malignant melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1395-6
CODE
Unit: 2508139
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 2, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of Hodgkin’s Lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1396-6
CODE
Unit: 16KK13923
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by telephone on November 2, 2005 and by letter dated November 3, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1399-6;
b) Fresh Frozen Plasma, Recall # B-1400-6
CODE
a) and b) Units: 2441695
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 31, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1401-6;
b) Platelets, Recall # B-1402-6;
c) Fresh Frozen Plasma, Recall # B-1403-6
CODE
a), b), and c) Units: 2353386
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 14, and December 11, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1406-6
CODE
Unit: 6904309
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 5, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1409-6
CODE
Unit: 2463323
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 11, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1410-6;
b) Recovered Plasma, Recall # B-1411-6
CODE
a) and b) Units: 2518603
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 29 and 31, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1412-6;
CODE
Unit: 06GM30888
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone and by letter dated February 5, 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
CA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1415-6;
b) Cryoprecipitated AHF, Recall # B-1416-6;
c) Plasma Cryoprecipitate Reduced, Recall # B-1417-6
CODE
a) b) and c) Units: L65359
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by facsimile on March 30, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received the rabies vaccine within one year of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0804-6
CODE
Unit: KY10840
RECALLING FIRM/MANUFACTURER
Rex Hospital Inc., Raleigh, NC, by telephone on June 7, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1314-6
CODE
Units: 8466929 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by facsimile on July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count as required by the firm’s standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1315-6
CODE
Units: 0223931, 0892185, 0892153, 0223942
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc, Greenville, SC, by telephone on November 29, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date and product code, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
SC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1316-6
CODE
Unit: 9049917
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on December 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count as required by the firm’s standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Recovered Plasma, Recall # B-1328-6
CODE
Unit: 36FC11588:
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by letter dated August 8, 2000. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested reactive for the antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1329-6
CODE
Unit: K35912
RECALLING FIRM/MANUFACTURER
Regional Health Resource Center, Urbana, IL, by telephone on January 19, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not prepared in accordance with the firm’s specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1360-6
CODE
Unit: 3876094
RECALLING FIRM/MANUFACTURER
Maimonides Medical Center, Brooklyn, NY, by telephone and by letter dated November 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1362-6;
b) Fresh Frozen Plasma Pheresis, Recall # B-1363-6
CODE
a) Units: 13GT06710 (3 units), 13GV61907 (3 units), 13FC63032, 13FR76622 (3 units),
13GS16587 (3 units);
b) Units: 13X06647 (2 units), 13X08434, 13X09212 (3 units), 13X10340, 13X04573
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone beginning December 8, 2005 and by letters dated December 21, 2005 or December 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within the appropriate time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
MI

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1369-6
CODE
Units: 2428032 and 2428714
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by telephone on February 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1404-6;
b) Fresh Frozen Plasma, Recall # B-1405-6
CODE
a) and b) Units: 06FM27982
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by letter dated September 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose body temperature was not determined at the time of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1407-6;
b) Fresh Frozen Plasma (Apheresis), Recall # B-1408-6
CODE
a) Units: 12FF38330, 12FF38331, 12FF38332, 12FF38333, 12FF38334,
12FF38335, 12FF38336, 12FF38337, 12FF38338, 12FF38339, 12FF38340,
12FF38341, 12FF38342, 12FF38343, 12FF38344, 12FF38345, 12FF38346,
12FF38347, 12FF38348, 12FF38349, and 12FF38350;
b) Units: 12W01753, 12W01761, and 12W01766
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone and facsimile on May 6, 2005 and by letter dated May 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which lacked assurance of shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
CA, NC, SC, GA, and MO

______________________________
PRODUCT
Plasma, Recall # B-1413-6
CODE
Unit: 06GM30888
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone and by letter dated February 5, 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
CA
 

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part 972200, catalog # 972211, 972212, 972213, 972214, 972215 and 972216; Recall # Z-1106-06
CODE
Serial numbers 205199 through 205786, except for 205213, 205236, 205237, 205238, 205239, 205240, 205242, 205243, 205247, 205307, 205308, 205309, 205465, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205677, 205678, 205684, 205703, 205708, 205719, 205732, 205736, 205754, 205756, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784. Also included in the recall are serial numbers 201784, 202804, 205179, 205790, 205806, 205808, 205818, 205842, 205866, 206076, 206078, 206079, 206080, 206081, 206096, 206125, 206131, 206137, 206138, 206140, 206162, 206164, 206175, 206177, 206180, 206216, 207511, 207518, 207520, 207521, 207522
RECALLING FIRM/MANUFACTURER
MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by press release and letters on June 15, 2006. Firm initiated recall is ongoing.
REASON
The Welch Allyn AED 20 Defibrillators may display a “Defib Comm” error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
VOLUME OF PRODUCT IN COMMERCE
580 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
LADARVision Excimer Laser System, Recall # Z-1147-06
CODE
CustomCornea software only. System serial numbers with prefix L4N and L4U
RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Orlando, FL, by letter dated August 1, 2005. Firm initiated recall is ongoing.
REASON
A software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal reference line will negate compensation for cyclotorsion on Custom Cornea procedures, possibly adversely affecting clinical outcomes.
VOLUME OF PRODUCT IN COMMERCE
436 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with printed polyurethane catheter and 9 French Introducer Kit Catalog Number: 120021 Recall # Z-1148-06
b) Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120025. Recall # Z-1149-06
c) Auto Suture ChemoSite Catheter 9FR Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120039. Recall # Z-1150-06
d) Auto Suture ChemoSite Implantable Venous Kit Access System with 9FR Introducer Kit Catalog Number: 120045. Recall # Z-1151-06
e) Auto Suture ChemoSite Catheter Introducer Kit with 9FR Peel-Away Sheath Catalog Number: 120049. Recall # Z-1152-06
f) Auto Suture ChemoSite Implantable Venous Access System with 9FR Introducer Kit with Silicone Catheter Catalog Number: 120066. Recall # Z-1153-06
CODE
a) Lot Numbers: N5M40, N6B01;
b) Lot Numbers: N5M160, N6B268;
c) Lot Numbers: N5L380, N5M159, N6B02, N6B45;
d) Lot Numbers: N5M90, N6A546, N6B147, N6B351, N6C127, N6C331;
e) Lot Number: N5M255;
f) Lot Numbers: N5L338, N5M232, N6B266, N6C11
RECALLING FIRM/MANUFACTURER
Recalling Firm: United States Surgical, North Haven, CT, by letter dated May 22, 2006.
Manufacturer: B. Braun Medical, Inc., Allentown, PA, firm initiated recall is ongoing.
REASON
The 9F device may contain a 10 F sheath instead of the 9F.
VOLUME OF PRODUCT IN COMMERCE
2,524 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Stericover/ Sterile Disposable Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96'', Recall # Z-1154-06
CODE
Lots: 0796316, 0796319 and 0796320
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Spine, Austin, TX, by telephone on May 15, 2006
Manufacturer: Sterimed, Inc., Cartersville, GA, firm initiated recall is ongoing.
REASON
Non-sterility-Distributor testing of outside manufacturer's product (Sterimed, Inc) revealed positive sterility test results.
VOLUME OF PRODUCT IN COMMERCE
326 drapes
DISTRIBUTION
Nationwide

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PRODUCT
Stryker Trio Mobile Surgery Platform; Model 1033, Recall # Z-1155-06
CODE
Serial numbers 0412060619, 0501073240, 0501073241, 0501073327, 0501073328, 0501073329, 0501073330, 0408062292, 0408062293, 0502069215, 0504072232, 0409062008, 0409062003, 0409062004, 0409062005, 0409062006, 0410065050, 0502069214, 0410058767, 0409062001, 0409062274, 0512070516, 0602079782, 0602079817, 0602079818, 0602079819, 0408062389, 0408062390, 0408062391, 0409062007, 0411060535, 0506071242, 0410065046, 0501073064, 0501073065, 0501073066, 0501073084, 0501073085, 0501073086, 0501073087, 0501073188, 0501073189, 0501073190, 0602079542, 0506071118, 0510071070, 0510071071, 0510071072, 0605087579, 0504072089, 0602079541, 0505069588, 0502069314, 0502069315, 0510071241, 0511071674, 0511071675, 0511071676, 0511071677, 0511071678, 0511071679, 0511071680, 0504072088, 0512070514, 0512070515, 0412060744, 0412060745, 0412060746, 0412060855, 0412060856, 0412060857, 0501073001, 0501073002, 0501073003, 0502069148, 0601084043, 0507070537, 0510071069, 0502069034, 0502069035, 0502069036, 0502069150, 0502069151, 0502069152, 0502069153, 0510071243, 0410058765, 0507070691, 0507070692, 0507070693, 0507070694, 0507070695, 0507070696, 0507070697, 0507070698, 0507070699, 0507070700, 0603084573, 0409062002, 0410058766, 0502069149, 0503068501, 0503068502, 0503068503, 0506071116, 0506071117, 0506071241, 0603084574, 0410065049, 0501073373, 0501073374, 0501073375, 0501073376, 0502069032, 0502069033, 0502069313, 0603084672, 0411060618, 0411060619, 0411060620, 0411060621, 0411060802, 0411060803, 0411060804, 0412060504, 0412060505, 0412060506, 0412060616, 0412060617, 0412060618, 0505069589, 0505069590, 0505069591, 0505069592, 0410065047, 0509069501, 0509069502, 0505069749, 0505069750, 0502069216, 0410065045, 0410065048, 0411060801, 0408062151, 0409062273, 0409062275, 0502069312, 0503068633, 0503068634, 0503068635, 0503068636, 0511071540, 0511071541, 0511071542, 0511071543 and 0503068637
RECALLING FIRM/MANUFACTURER
Stryker Medical Div. of Stryker Corporation, Portage, MI, by telephone on May 15, 2006. Firm initiated recall is ongoing.
REASON
An incorrect pin may have been used during assembly and therefore the device may give way during use.
VOLUME OF PRODUCT IN COMMERCE
156 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR June 28, 2006

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