• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for September 8, 2004

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.

September 8, 2004
04-36

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Assorted Old Fashioned Candies; 16 pieces per box; 7.6 oz.
Recall # F-426-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Dulzura Borincana, Moca, PR, by store visit beginning on April 21, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared colors - FD&C Yellow # 5, FD&C Yellow #6, and Red # 40.
VOLUME OF PRODUCT IN COMMERCE
24 cases/12 bowls/16 pieces.
DISTRIBUTION
PR.

_______________________________
PRODUCT
John Frieda brand Sheer Blonde Curvaceous Blonde Curl-Defining Styler, Curls Swirls Brightens Blond Hair, packaged in 6.7 fl. Oz. plastic bottles with pump sprayer, 6 bottles per case. Item/SKU #7-17226-00502-2; Order No. 0723859. Recall # F-427-4.
CODE
Lots: # S001AW037 and #S001AW040.
RECALLING FIRM/MANUFACTURER
Andrew Jergens Co, Cincinnati, OH, by email, fax, and letter on March 22, 2004. Firm initiated recall is complete.
REASON
The product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
104 cases.
DISTRIBUTION
PA.

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Guava filled cakes (?Panetela de Guayaba?), packaged in plastic bags of 12 pieces and plastic container of 24 pieces. Recall # F-428-4.
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Carla?s Sweets, Bayamon, PR, by visit beginning on April 12, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared color additive, FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
8,928 units.
DISTRIBUTION
Local supermarkets, chain stores, and department stores.

 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) 5% Benzoyl Peroxide Gel packaged in 1-oz. tubes, 12 per
case, OTC, under the following private labels:
Schnucks; 2) Harris Teeter; and 3) Finast.
Recall # D-266-4;
b) Invisible Acne Cream (Benzoyl Peroxide 10%), 1-oz.
tubes, 12 per case, OTC, under the following private
labels: 1) Western Family Maximum Strength Invisible
Acne Cream; 2) Meijer Invisible Acne Cream Maximum
Strength, 3) Stop & Shop Maximum Strength Invisible
Acne Cream; 4) Best Yet Absolute Elements Maximum
Strength Invisible Acne Cream; 5) Premier Value Maximum
Strength Invisible Acne Cream; 6) Finast Maximum
Strength Invisible Acne Cream; 7) Personal Expressions
Vanishing Acne Cream; 8) HyVee Maximum Strength
Invisible Acne Cream. Recall # D-267-4.
CODE
a) Lot #3J21D and 3L18D;
b) Lot #3J16B, Exp. Oct 2005; 3J16C, Exp. Oct 2005; 3J16D,
Exp. Oct 2005; 3K18B, Exp. Nov 2005; 4A22B, Exp. Jan
2006; 4A22C, Exp. Jan 2006; 4A28A, Exp. Jan 2006; 4B12B,
Exp. Feb 2006; 4B25C, Exp. Feb 2006; 4C03C, Exp. Mar
2006; 4D03A, Exp. Apr 2006; and 4D07A, Exp. Apr 2006.
RECALLING FIRM/MANUFACTURER
Quailis, Inc., Des Moines, IA, by letter on July 16, 2004 and July 22, 2004. Firm initiated recall is ongoing.
REASON
Bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
48,588 tubes.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.45 mg/1.5 mg tablets, Rx only, 1 EZ-DIAL Dispenser of 28 tablets, NDC #0046-0937-09. Recall # D-268-4.
CODE
A46796, Exp. March 2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters dated August 12, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
24,871 units.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Whole Blood. Recall # B-1531-4;
b) Red Blood Cells. Recall # B-1532-4;
c) Red Blood Cells, Leukocytes Reduced. Recall # B-1533-4;
d) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall
# B-1534-4;
e) Platelets. Recall # B-1535-4;
f) Platelets, Irradiated. Recall # B-1536-4;
g) Fresh Frozen Plasma. Recall # B-1537-4;
h) Cryoprecipitated AHF. Recall # B-1538-4.
CODE
a) Unit numbers: 24FC19939, 24FC19981, 24FC20405,
24FC20850, 24FC21029, 24FC21033, 24FC21035, 24FC21053,
24FC21438, 24FC21442, 24FC21456, 24FC21473;
b) Unit numbers: 24FC18821, 24FC18878, 24FC18973,
24FC18974, 24FC18978, 24FC18989, 24FC19023, 24FC19039,
24FC19278, 24FC19309, 24FC19315, 24FC19380, 24FC19925,
24FC19959, 24FC19975, 24FC20016, 24FC20817, 24FC20826,
24FC20839, 24FC21037, 24FC21184, 24FC21199, 24FC21206,
24FC21301, 24FC21440, 24FC21466
c) Unit numbers: 24FC18818, 24FC18822, 24FC18824,
24FC18826, 24FC18829, 24FC18848, 24FC18852, 24FC1885
24FC18860, 24FC18864, 24FC18865, 24FC18901, 24FC18920,
24FC18923, 24FC18925, 24FC18931, 24FC18963, 24FC18972,
24FC18982, 24FC18995, 24FC18998, 24FC19005, 24FC19010,
24FC19012, 24FC19013, 24FC19289, 24FC19290, 24FC19293,
24FC19295, 24FC19296, 24FC19297, 24FC19299, 24FC19313,
24FC19314, 24FC19326, 24FC19327, 24FC19328, 24FC19330,
24FC19390, 24FC19392, 24FC19393, 24FC19394, 24FC19409,
24FC19412, 24FC19414, 24FC19930, 24FC19961, 24FC19972,
24FC19992, 24FC19993, 24FC20001, 24FC20012, 24FC20013,
24FC20014, 24FC20023, 24FC20024, 24FC20026, 24FC20028,
24FC20037, 24FC20042, 24FC20043, 24FC20044, 24FC20048,
24FC20050, 24FC20054, 24FC20067, 24FC20068, 24FC20069,
24FC20074, 24FC20075, 24FC20090, 24FC20092, 24FC20094,
24FC20096, 24FC20358, 24FC20360, 24FC20377, 24FC20378,
24FC20386, 24FC20388, 24FC20520, 24FC20539, 24FC20540,
24FC20544, 24FC20700, 24FC20735, 24FC20987, 24FC20988,
24FC21002, 24FC21003, 24FC21116, 24FC21131, 24FC21132,
24FC21133, 24FC21135, 24FC21147, 24FC21149, 24FC21183,
24FC21185, 24FC21196, 24FC21292, 24FC21300, 24FC21312,
24FC21313, 24FC21317, 24FC21322, 24FC21324, 24FC21325,
24FC21458, 24FC21474, 24FC21484, 24FC20565, 24FC20572,
24FC20574, 24FC20577, 24FC20584, 24FC20820, 24FC20829,
24FC20830, 24FC20833, 24FC20834, 24FC20837, 24FC20848,
24FC20859, 24FC20860, 24FC20861, 24KG56510, 24KG58159,
24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH95846,
24KH95847, 24KH95848, 24KH95851, 24KH95871, 24KH95875,
24KH95877, 24KH95878, 24KH95881, 24KH95882, 24KH96472,
24KJ69126, 24KJ69127, 24KJ69129, 24KJ69142, 24KJ69143,
24KJ69146, 24KJ70003, 24KJ70004, 24KJ70050, 24KJ70051,
24KJ70052, 24KJ70054, 24KJ70058, 24KJ70073, 24KJ70078,
24KJ70090, 24KJ70091, 24KJ70092, 24KJ70093, 24KJ70106,
24KJ70108, 24KJ70113, 24KJ70114, 24KJ70128, 24KJ70129,
24KJ70130, 24KJ70140, 24KJ70316, 24KJ70320, 24KJ70325,
24KJ70339, 24KJ70340, 24KJ70341, 24KJ70343, 24KJ70346,
24KJ70349, 24KJ70351, 24KJ70353, 24KM83399, 24KM83400,
24KM83406, 24KM83411, 24KM83414, 24KM83467, 24KM83469,
24KM83474, 24KM83475, 24KQ56116, 24KQ56117, 24KQ56132,
24KQ56133, 24KQ56142, 24KQ56146, 24KR21873, 24KR21874,
24KR21880, 24KR21881, 24KR21882, 24KR21884, 24KR21885,
24KR21890, 24KR21891, 24KR21892, 24KR21895, 24KR21896,
24KR21900, 24KR21902, 24KS56066, 24KS56067, 24KS56068,
24KS56071, 24KS56074, 24KS56075, 24KS56077, 24KS56078,
24KS56081 24FC18636, 24FC19021, 24FC19022, 24FC19040,
24FC19041, 24FC19051, 24FC19053, 24FC19259, 24FC19260,
24FC19261, 24FC19270, 24FC19272, 24FC19273, 24FC19345,
24FC19347, 24FC19356, 24FC19358, 24FC19360, 24FC19379,
24FC19381, 24FC19385, 24FC19731, 24FC19751, 24FC19752,
24FC19758, 24FC19767, 24FC19768, 24FC19776, 24FC19778,
24FC19779, 24FC19913, 24FC19924, 24FC19937, 24FC19944,
24FC19945, 24FC19947, 24FC19948, 24FC19956, 24FC19962,
24FC19963, 24FC20097, 24FC20149, 24FC20151, 24FC20153,
24FC20631, 24FC20635, 24FC20657, 24FC20659, 24FC20670,
24FC20672, 24FC20674, 24FC20677, 24FC20682, 24FC21021,
24FC21026, 24FC21051, 24FC21056, 24FC21057, 24KC33488,
24KC33489, 24KC33490, 24KC33492, 24KC33495, 24KC33504,
24KC33505, 24KH93842, 24KH93844, 24KH93846, 24KH93849,
24KH93851, 24KH93859, 24KH94851, 24KH94852, 24KH94853,
24KH94854, 24KH94861, 24KH95010, 24KH95450, 24KH95451,
24KH95453, 24KH95459, 24KH95467, 24KH95492, 24KH95494,
24KH95498, 24KH96442, 24KH96444, 24KJ70008, 24KJ70016,
24KJ70019, 24KJ70020, 24KJ70032, 24KJ70033, 24KJ70034,
24KJ70039, 24KJ70040, 24KJ70043, 24KJ70046, 24KJ70049,
24KL65170, 24KL65171, 24KL65173, 24KL65184, 24KL65185,
24KM83145, 24KM83148, 24KM83154, 24KM83160, 24KM83163,
24KM83164, 24KM83172, 24KQ56162, 24KQ56482, 24KQ56501;
d) Unit numbers: 24FC20566, 24FC20573, 24FC19036,
24FC19037, 24FC20099, 24FC20630, 24FC20632, 24KC33486,
24KH95009, 24FC18912, 24FC18928, 24FC18983, 24FC19312,
24FC19966, 24FC20000, 24FC20045, 24FC20401, 24FC20714,
24FC21004, 24FC21118, 24FC21120, 24FC21146, 24FC21210,
24FC21461, 24FC21475;
e) Unit numbers: 24FC19021, 24FC19036, 24FC19037,
24FC19050, 24FC19051, 24FC19345, 24FC19347, 24FC19379,
24FC19385, 24FC19731, 24FC19767, 24FC19768, 24FC19776,
24FC19778, 24FC19913, 24FC19924, 24FC19937, 24FC19944,
24FC19945, 24FC19947, 24FC19956, 24FC19962, 24FC20632,
24FC20657, 24FC20659, 24FC20670, 24FC20672, 24FC20674,
24FC20677, 24FC20682, 24FC21026, 24FC21051, 24FC21052,
24FC21057, 24KC33486, 24KC33489, 24KC33505, 24KH93846,
24KH93849, 24KH93851, 24KH93859, 24KH94851, 24KH94852,
24KH94861, 24KH95451, 24KH95453, 24KH95467, 24KH95494,
24KH95498, 24KH96442, 24KJ70016, 24KJ70020, 24KJ70032,
24KJ70033, 24KJ70034, 24KJ70039, 24KJ70040, 24KJ70046,
24KL65170, 24KL65173, 24KL65184, 24KL65185, 24KM83148,
24KM83154, 24KM83160, 24KM83163, 24KM83164, 24KQ56162,
24KQ56499, 24KQ56501;
f) Unit numbers: 24FC19948, 24FC19963, 24KC33488,
24KC33490, 24KC33492, 24KH93842, 24KH93844, 24KH95010,
24KM83145;
g) Unit numbers: 24FC19021, 24FC19024, 24FC19036,
24FC19037, 24FC19041, 24FC19050, 24FC19051, 24FC19053,
24FC19345, 24FC19347, 24FC19356, 24FC19358, 24FC19359,
24FC19360, 24FC19379, 24FC19381, 24FC19385, 24FC19731,
24FC19752, 24FC19758, 24FC19776, 24FC19778, 24FC19779,
24FC19913, 24FC19924, 24FC19937, 24FC19944, 24FC19945,
24FC19947, 24FC19948, 24FC19956, 24FC19962, 24FC19963,
24FC20151, 24FC20153, 24FC20572, 24FC20630, 24FC20632,
24FC20635, 24FC20657, 24FC20659, 24FC20670, 24FC20672,
24FC20674, 24FC20677, 24FC20682, 24FC20833, 24FC20834,
24FC20848, 24FC20859, 24FC20860, 24FC20861, 24FC21021,
24FC21026, 24FC21051, 24FC21052, 24FC21056, 24FC21057,
24FC21062, 24KC33486, 24KC33488, 24KC33489, 24KC33490,
24KC33492, 24KC33495, 24KC33505, 24KG58159, 24KG58161,
24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH93842,
24KH93844, 24KH93846, 24KH93849, 24KH93851, 24KH93859,
24KH94852, 24KH94853, 24KH94854, 24KH95010, 24KH95451,
24KH95459, 24KH95467, 24KH95494, 24KH95498, 24KH96442,
24KH96444, 24KH96472, 24KJ69126, 24KJ69127, 24KJ69142,
24KJ69143, 24KJ69146, 24KJ70078, 24KJ70129, 24KL65170,
24KL65171, 24KL65173, 24KL65184, 24KL65185, 24KM83160,
24KM83163, 24KM83164, 24KQ56162, 24KQ56499, 24KQ56501;
h) Unit numbers: 24KH95875, 24KH95877, 24KH95878,
24KM83467, 24KM83474, 24KM83475.
RECALLING FIRM/MANUFACTURER
American Red Cross, River Valley Region, Louisville, KY, by facsimile on August 24, 2003, and by letters, dated September 3, 2003 and October 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm preparations were not adequately prepared, were distributed.
VOLUME OF PRODUCT IN COMMERCE
589 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Source Plasma. Recall # B-1615-4.
CODE
Unit numbers: 7G2898, 8MW310, 8MW498, 95D691, 95D796, 95D967, 95E040, 95E289, 95E349, 95E539, 95E578, 95E716, 95F464, 9NS158, 9NS265, 9NS594, 9SW771, 9SW999, 9V5741, 9V5801, BJBZNC, BJCDLK.            
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK, by facsimile dated April 20, 2001 and by email on May 16, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been permanently deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
IL, and Germany.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1645-4.
CODE
Unit number: 04KM46478.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letters dated April 13, 2004, and May 4, 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
VT.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukoreduced. Recall # B-1764-4.
CODE
Units 301878101, 301878107, 301878159.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND, by letter on December 19, 2003.
Manufacturer: United Blood Services, Bismarck, ND. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised their sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units from 3 doubles.
DISTRIBUTION
CA, NJ, and ND.

_______________________________
PRODUCT
Platelet Pheresis, Leukoreduced. Recall # B-1774-4.
CODE
Units: 5479032A, 5479032B, 5479032C, 5479080A, 5479080B, 5479080C.
RECALLING FIRM/MANUFACTURER
Coral Blood Services Inc. Bangor, ME, by telephone on May 11, 2004 and letter on May 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
ME.

_______________________________
PRODUCT
Source Plasma. Recall # B-1796-4.
CODE
Units DPDCDL, DPDCGV, DPDCWT, DPDDCZ, DPDDXW, DPDDRY.
RECALLING FIRM/MANUFACTURER
International Bio Resources, LLC, Milwaukee, WI, by facsimile dated September 25, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1798-4.
CODE
Unit number: G98916.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on June 4, 2004. Firm initiated recall is complete.
REASON
Blood product, contaminated with coagulase-negative Staphylococcus, was distributed.   
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
a) Platelets. Recall # B-1821-4;
b) Platelets, Leukocytes Removed. Recall # B-1822-4;
c) Platelets, Irradiated. Recall # B-1823-4;
d) Fresh Frozen Plasma. Recall # B-1824-4;
e) Plasma, Frozen. Recall # B-1825-4.
CODE
a) Unit numbers: 49Y67247, 49F97629, 49F97919, 49S74852,
49Y46256, 49L86761, 49GF08210, 49L86831, 49G75024, 49S77099, 49S78483, 49LJ36776, 49Y66975, 49Y68019, 49LR07035, 49M29798, 49LF47660, 49S88013, and 49G97186;
b) Unit numbers: 49LR25697, 49GF65893, 49M40747, 49GF66168,
49GF66163, 49GG08274, 49GG08288, 49Y83947, 49LR23218,
49LR23574, 49GG07218, 49LR26552, 49Y88280, 49M43638, and
49GG08308;
c) Unit number: 49GG06960;
d) Unit numbers: 49LW09875, 49LR25697, 49M40654, 49GF65893,
49M40747, 49GF65928, 49LW10123, 49GF66168, 49GF66163,
49Y86783, 49Y86768, 49GF66283, 49GG08274, 49GG08308,
49GG08288, 49GF66711, 49Y43034, 49G67557, 49GF02183,
49GF02368, 49S74472, 49GF12916, 49S77778, 49LJ36776,
49LG35118, 49GF32092, 49Y68019, 49LR05986, 49X74064,
49S88013, 49Y70271, 49GF44164, 49M33702, 49GF59138,
49GF59374, 49GG03425, 49Y83947, 49M37476, 49GF62809,
49LR23218, 49LR23574, 49M38005, 49M37999, 49M37998,
49GF64155, 49GG06960, 49S97285, 49GG07218, 49GG07494,
49GG07480, 49W37522, 49M40192, 49Y88280, 49GF68833,
49M43638, 49GF70875, 49Y89926, 49GF71467, 49GF72747, and
49GN14868;
e) Unit numbers: 49LJ41837.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by telephone on April 10, 2003 and by letters dated April 16, 18, 21, and May 20, 2003, and by facsimile dated July 2, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
96 units.
DISTRIBUTION
UT, IL, OK, and TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1858-4.
CODE
Units 9NS964, 82P211, 82O863, 82O161, 82N548, 82J462, 82J334, 82J270, 82I921, 82I853, 8ZI158, 8ZH186, 8ZH080, 8ZG902, 8ZG807, 8ZG379, 8ZG293, 8ZG021, 8ZF932, 8ZE634, 8I5722, 8I5566, 8I5394, 8I5140, 8I5037, 8I4627, 8I3735, 8I3603, 8I3444, 8I2822, 8I2768, 8I2552, 8I2381, 8I2166, 8I2025, 8I1615, 8I1499, 8I1080, 71A482, 71A387, 709879, 709421, 7CY967, 7CY849, 7CY746, 6CV867, 6CV756, 6CV552, 6CU454, 6CU311, 6CU227, 6CU008, 6CT900, 6CT664, 6CT570, 6CS303, 6CR529, 6CQ220, 04L394, 04L213, 04L106, 04K740, 04K379, 04K012, 04J363, 04J165, 04J055, 04I723, 04I429, 04H960, 04H848, 04H498, 04H324, 04H196, 04G627, 04G323, 04D951, 04D774, 04D053, 04C584, 04C404, 04C326, 04C054, 04B922, 04B810, 04B691, 04B571, 04B493, 04B223, 04B170, 04A989, 04A918, 04A386, 04A140, 04A070, 038429, 038146, YFU655, YFU568, YFU336, YFU148, YFU022, YFQ795, YFQ662, YFQ439, YFQ249, YFQ048, YFT956, YFO756, YFN863, YFN721, YFM886, YFM745, YFL980, V07334, V07175, V06914, V06763, V06332, V06010, V05370, V05239, V04958, V04820, V04566, V04463, V03972, V03858, V03596, V00914, UG0107, UGZ800, UGZ578, UGZ364, UGY603, UGY517, RLS382, RLS104, RLR352, RLR151, RLQ885, RLQ566, RLQ451, RLP664, UGT030, UGS796, UGS671, UGS399, UGS232, UGS006, UGR245, UGQ309, RLP223, RLP117, RLO745, RLO595, S3P848, S3N929, S3N666, S3N371, S3N146, S3M426, S3M215, S3M018, S3L422, S3L285, S3K939, S3K134.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK, by letters dated September 26, and September 27, 2001. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who engaged in high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
168
DISTRIBUTION
NC, France, and Germany.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1860-4.
CODE
Unit numbers: 38H84546, 38FE77835.
RECALLING FIRM/MANUFACTURER
American Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on April 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.  
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1864-4.
CODE
Unit 21K21241.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on May 23, 2003, and by letter dated June 2, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had an unacceptable hemoglobin at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1865-4.
CODE
Unit 20GR16226.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on February 21, 2003, and by letter dated March 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had received the typoid vaccination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1873-4.
CODE
unit numbers 23149-4917 (distributed as two split units) and 23149-4931.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 7, 2003.
Manufacturer:  Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.

_______________________________
PRODUCT
Platelets. Recall # B-1875-4.
CODE
Units 4229844, 4229846, 4229850, 4229880.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated December 9, 2002. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AK.

_______________________________
PRODUCT
Red Blood Cells Frozen. Recall # B-1882-4.
CODE
unit 71Z69719-8
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on December 23, 2003. Firm initiated recall is complete.
REASON
Blood product, which was manufactured using expired glycerol solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1883-4;
b) Platelets, Recall # B-1884-4;
c) Fresh Frozen Plasma. Recall # B-1885-4.
CODE
a) Units 11GK17618 and 11GK11191;
b) Unit 11GK17618;
c) Units 11GK17618 and 11GK11191.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on April 29, 2003, or by letter dated April 28,2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MO, and CA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1886-4.
CODE
Unit 11GQ51677.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by facsimile on February 20, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was at increased risk for Creuztfeldt Jakob Disease (CJD) due to having lived in Europe between 1984 - 1987, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1888-4. CODE
Unit number 04FP70069.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on May 8, 2004, and by letter dated May 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in an apheresis collection kit that had exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1889-4;
b) Platelets, Leukocytes Reduced. Recall # B-1890-4;
c) Recovered Plasma. Recall # B-1891-4.
CODE
a), b), and c) unit number 33GE80466.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by facsimile on April 28, 2004, telephone on May 28, 2004, and letter on June 2, 2004. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT, and CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1892-4;
b) Fresh Frozen Plasma. Recall # B-1893-4.
CODE
a) and b) Unit number 4227074.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated November 25, 2002. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AK.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1894-4.
CODE
Unit number KC51510.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by telephone on January 23, 2004, and by letter on February 2, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with an unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1902-4;
b) Fresh Frozen Plasma. Recall # B-1903-4.
CODE
a) and b) Unit number 11GJ26528.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by letter on February 3, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and PR.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1910-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1911-4.
CODE
a) Unit 49FF51189;
b) Unit 49FF50655.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Southwest Region, Tulsa, OK, by facsimile on November 14, 2003.
Manufacturing Firm: American Red Cross Blood Services,
Southwest Region, College Station, TX. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK, and TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1916-4.     
CODE
Units FLHSHK , FLDRWN, FLDRVJ, FLDRQG, FLDRPH , FLDRBK, FLDQLL, FLDQJX, FLDQHY , FLDQGB, FLDQDM, FLDPSC, FLDPRC, FLCPTM, FLCPRV, FLCPRC, FLCPBM, and FLCNWF.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Waco, TX, by letter dated March 21, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
IL.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Human Corneal Tissue. Recall # B-1714-4.
CODE
2004-040OS, 2004-040OD.
RECALLING FIRM/MANUFACTURER
Great Plains Lions Eye Bank, Inc., Lubbock, TX, by letter dated June 7, 2004. Firm initiated recall is complete.
REASON
Human tissues for transplantation, procured from a donor whose next of kin was not asked multiple questions regarding high-risk behavior questions during the Medical/Social History Interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MO.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1820-4.
CODE
Unit number: 49LF47704.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by telephone on April 10, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1862-4;
b) Red Blood Cells Leukocytes Reduced. Recall # B-1863-4.
CODE
a) Unit 2421944401;
b) Unit 242192958.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone on April 2, 2003. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for the presence of red cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1866-4.
CODE
Unit XG0013823.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1867-4.
CODE
Unit XN0002165.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Source Plasma, Recall # B-1869-4.
CODE
Unit number XG0019114.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. 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
Spain.

_______________________________
PRODUCT
Source Plasma, Recall # B-1870-4.
CODE
Unit number XA0002443.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. 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
Spain.

_______________________________
PRODUCT
Source Plasma, Recall # B-1871-4.
CODE
Unit number XA0002340.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. 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
Spain.

 

_______________________________
PRODUCT
Source Plasma, Recall # B-1872-4.
CODE
Unit number XG0011720.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX, by facsimile on April 16, 2001. 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
Spain.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1887-4.
CODE
Unit number 04GR22891 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on June 18, 2004, and by letter dated June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Platelets. Recall # B-1901-4.
CODE
Unit number 6034421.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter on May 28, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
Minerva Patient Lift, model ML-20; this lift has a passive lifting unit. Recall # Z-1381-04.
CODE
Model ML-20: serial numbers 952056, 952057, 952112, 952113, 952114, 952115, 952116, 952117, 962118, 952119, 952120, 952121, 962214, 962215, 962216, 962217, 962218, 962235, 962236, 962238, 962239, 962240, 962241, MPBX 97052M563, MPBX97052M564, MPBX97052M565, MPBX97052M566, MPBX97052M567, MPBX97052M568, MPBX97052M569, MPBX97052M570, MPBX97052M571, MPBX97052M572, MPBX97052M573, MPBX97052M574, MPBX97052M575, MPBX97052M576, MPBX97052M577, MPBX97052M578, MPBX97052M579, MPBX98022M649, MPBX98022M650, MPBX98022M651, MPBX98022M652, MPBX98022M653, MPBX98022M676, MPBX98022M677, MPBV00032M1013, MPBV00072M1074.
RECALLING FIRM/MANUFACTURER
Medibo N.V., Hanmont, Achel, Belgium, by letters dated August 6, 2004. Firm initiated recall is ongoing.
REASON
The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.
VOLUME OF PRODUCT IN COMMERCE
64 units.
DISTRIBUTION
CA, FL, LA, MA, NH, NJ, NY, OH, OR and PA.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
STS-T Mobile x-ray system used with the STS-T lithotripter. Model STS-T. Recall # Z-0884-04.
CODE
None provided.
RECALLING FIRM/MANUFACTURER
Medstone International, Inc., Aliso Viejo, CA, by letter on June 11, 2004. Firm initiated recall is complete.
REASON
Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square centimeters or less as required.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands. Recall # Z-1383-04.
CODE
Catalog No.?s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (?VIN?s): 020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302.
RECALLING FIRM/MANUFACTURER
Independence Technology LLC, Warren, NJ, by telephone on July 2, 3, & 4, 2004 and by letters from July 5, 6, & 8, 2004. Firm initiated recall is ongoing.
REASON
IBOT Mobility System may tip over due to malfunction in power base.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide, UK, Ireland, and New Zealand.

_______________________________
PRODUCT
The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK. Recall # Z-1384-04.
CODE
CS0293.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by letter on July 23, 2004. Firm initiated recall is ongoing.
REASON
The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the sterile tray are the correct components for a Model 8540 Catheter Access Port kit. The issue is limited to one lot of product: CS0293.
VOLUME OF PRODUCT IN COMMERCE
405 kits.
DISTRIBUTION
Nationwide and New Zealand.

_______________________________
PRODUCT
a) Weck Hemoclip Traditional Ligating Clips, Ref No. 523170
Hemoclip, 15 Large Tantalum Clips/Cartridge and Ref. No.
523370 Hemoclip 10 Large Tantalum Clips/Cartridge.
Recall # Z-1385-04;
b) Weck Atrauclip Ligating Clips, Ref. No. 121505
Atrauclip, 15 Large Titanium Clips/Cartridge and Ref.
No. 121506 Atrauclip, 10 Large Titanium Clips/Cartridge.
Recall # Z-1386-04;
c) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523770 Hemoclip, 15 Large Titanium Clips/Cartridge, and
Ref. No. 523870 Hemoclip 10 Large Titanium
Clips/Cartridge. Recall # Z-1387-04;
d) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523171 Hemoclip, 10 Large Tantalum Clips/Cartridge (Non-
Sterile) and Ref. No. 523371 Hemoclip, 15 Large Tantalum
Clips/Cartridge (Non-Sterile). Recall # Z-1388-04;
e) Weck Hemoclip Traditional Ligating Clips, Ref. No.
523771 - Hemoclip, 15 Large Titanium Clips/Cartridge
(Non-Sterile) and Ref. No. 523871- Hemoclip, 10 Large
Titanium Clips/Cartridge (Non-Steile). Recall # Z-1389-
04;
f) Weck Hemoclip Traditional Ligating Clips, Ref No. 523470
Hemoclip, 15 Large Stainless Steel Clips/Cartridge and
Ref. No. 523670 Hemoclip, 10 Large Stainless Steel
Clips/Cartridge. Recall # Z-1390-04;
g) Weck Hemoclip Plus Ligating Clips, Ref. No. 533702
Hemoclip Plus, 25 Medium Titanium Clips, No Tape; Ref.
No. 533737 Hemoclip Plus, 25 Small Titanium
Clips/Cartridge, No Tape and Ref. No. 533872 Hemoclip
Plus, 10 Large Titanium Clips/Cartridge, No Tape.
Recall # Z-1391-04;
h) Weck Hemoclip Plus Ligating Clips, Ref. No. 533735 and
534735 Hemoclip Plus, 25 Small Titanium Clips,
Cartridge; Ref. No. 533870 Hemoclip Plus, 10 Large
Titanium Clips/Cartridge and Ref. No. 533700 Hemoclip
Plus, 25 Medium Titanium Clips/Cartridge. Recall # Z-
1392-04.
CODE
a) All lots manufactured between 2001-8 through 2002-12 for
the 15 and 10 Large Tantalum Clips and additional Lots
763010, 763011, 769345 and 831864 for the 10 Large
Tantalum Clips;
b) All lots manufactured between 2001-8 through 2002-12;
c) All lots manufactured between 2001-8 through 2002-12 for
the 15 and 10 Large Titanium Clips and additional lots
799983, 816529, 826816, and 840190 for the 10 Large
Titanium Clips;
d) All lots manufactured between 2001-8 through 2002-12 for
the 10 and 15 Large Tantalum Clips and lot 763013 for
the 15 Large Tantalum Clips;
e) All lots manufactured between 2001-8 throught 2002-12
for the 15 and 10 Large Titanium Clips and lots 880608
and 944135 for the 10 Large Titanium Clips;
f) All lots manufactured between 2001-8 thorugh 2002-12 for
15 Large and 10 Large Stainless Steel Clips and lot
809026 for the 10 Large Stainless Steel Clips;
g) All lots manufactured between 2001-8 thorugh 2002-12 for
all three products and lot 763100 for 25 Medium Titanium
Clips, lots 763102 and 949861 for 25 Small Clips and lot
814007 for 10 Large Titanium Clips;
h) All lots manufactured between 2001-8 through 2002-12 for
all three products and lots 738967, 763871 and 714124
for 25 Small Titanium Clips; lots 703251, 722666 and
825952 for 10 Large Titanium Clips and lots 738966,
754641 and 824238 for 25 Medium Titanium Clips.
RECALLING FIRM/MANUFACTURER
Weck, NC, by letter beginning October 24, 2003. Form initiated recall is complete.
REASON
Hole in the sterile unit blister pack that could compromise sterility.
VOLUME OF PRODUCT IN COMMERCE
91,869 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) SMV FX-40 Nuclear Camera. Recall # Z-1393-04;
b) SMV FX-80 Nuclear Camera. Recall # Z-1394-04.
CODE
a) 00000000000194, 00000000000222, 0070090040-100,
0070090040-101, 0070090040-105, 0070090040-111, 0070090040-113, 0070090040-114, 0070090040-117, 0070090040-120, 0070090040-122, 0070090040-128, 0070090040-129, 0070090040-131, 0070090040-132, 0070090040-133, 0070090040-134, 0070090040-136, 0070090040-137, 0070090040-139, 0070090040-144, 0070090040-147, 0070090040-148, 0070090040-149, 0070090040-151, 0070090040-154, 0070090040-156, 0070090040-157, 0070090040-159, 0070090040-160, 0070090040-166, 0070090040-171, 0070090040-175, 0070090040-177, 0070090040-182, 0070090040-183, 0070090040-185, 0070090040-189, 0070090040-190, 0070090040-192, 0070090040-193, 0070090040-195, 0070090040-196, 0070090040-197, 0070090040-198, 0070090040-199, 0070090040-200, 0070090040-201, 0070090040-202, 0070090040-204, 0070090040-205, 0070090040-206, 0070090040-207, 0070090040-208, 0070090040-210, 0070090040-211, 0070090040-212, 0070090040-213, 0070090040-215, 0070090040-216, 0070090040-217, 0070090040-219, 0070090040-221, 0070090040-222, 0070090040-939;
b) 00000000000172, 00000000000173, 00000000000188,
00000000000203, 00000000000209, 00000000000214,
00000000000223, 0070090080-103, 0070090080-106,
0070090080-107, 0070090080-112, 0070090080-115,
0070090080-116, 0070090080-123, 0070090080-124,
0070090080-125, 0070090080-126, 0070090080-127,
0070090080-138, 0070090080-141, 0070090080-146,
0070090080-150, 0070090080-152, 0070090080-158,
0070090080-161, 0070090080-162, 0070090080-163,
0070090080-164, 0070090080-165, 0070090080-167,
0070090080-168, 0070090080-170, 0070090080-172,
0070090080-173, 0070090080-179, 0070090080-180,
0070090080-188, 0070090080-203, 0070090080-209,
0070090080-96, 0070090080-P298.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by Field Modification Instruction beginning on March 23, 2004. Firm initiated recall is ongoing.
REASON
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial drive assembly. (3) Mounting bolts on the radial drive assembly may become loose, fail, or back out.
VOLUME OF PRODUCT IN COMMERCE
96 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Magnetom Avanto MRI System, Model 7391167. Recall # Z-
1395-04;
b) Magnetom Harmony MRI System Model number 7106714. Recall
# Z-1396-04;
c) Magnetom Harmony MRI System Model number 5751438, Recall
# Z-1397-04;
d) Magnetom Symphony MRI System, Model 7106557. Recall # Z-
1398-04;
e) Magnetom Symphony MRI System, Model 7104594. Recall # Z-
1399-04;
f) Magnetom Sonata MRI System, Model 7388148. Recall # Z-
1400-04;
g) Magnetom Sonata MRI System, Model 7104719. Recall # Z-
1401-04;
h) Magnetom Sonata MRI System, Model 7106425. Recall # Z-
1402-04;
i) Magnetom Trio MRI System, Model 7106441. Recall # Z-
1403-04;
j) Magnetom Trio MRI System, Model 7387074. Recall # Z-
1404-4.
CODE
a) Serial numbers 25001 , 25129;
b) Serial number 10502;
c) Serial number 15002;
d) Serial numbers 14018 and 14108;
e) Serial numbers 22009, 22016, and 22081;
f) Serial numbers 16502 and 16509;
g) Serial numbers 21151 and 21223;
h) Serial numbers 21921;
i) Serial numbers 20500, 20502, and 20507;
j) Serial numbers 20554, 20561, and 20569.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern PA, by letter on July 28, 2004. Firm initiated recall is ongoing.
REASON
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Guardian' Distal Femur Axial Pin. Recall # Z-1405-04.
CODE
Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074.
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc, Arlington, TN, by letter dated July 14, 2004. Firm initiated recall is ongoing.
REASON
Potential for self-locking axial pin to dislodge and ?back out?.
VOLUME OF PRODUCT IN COMMERCE
44 units.
DISTRIBUTION
Nationwide, Ontario, and Taiwan, ROC.

_______________________________
PRODUCT
a) Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone
wound drain; a sterile, single use only, Rx device,
individually packaged, 10 drains per box, 8 boxes per
case; catalog #JP-HUR880; catalog #JP-HUR880, Recall #
Z-1406-04;
b) Jackson-Pratt Reservoir, 400 mL suction reservoir;
a sterile, single use only, Rx device used as a
component of the wound drain system, individually
packaged, 10 reservoirs per case, catalog #SU130-1000;
Recall # Z-1407-04.
CODE
a) Lot 1040909;
b) Lots 1040877, 1040879, 1040991, and 1040992.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL, by telephone and letters on July 28, 2004. Firm initiated recall is ongoing.
REASON
The products labeled as sterile are not sterile.
VOLUME OF PRODUCT IN COMMERCE
170 cases.
DISTRIBUTION
FL, AZ, NJ, and Canada.

_______________________________
PRODUCT
a) Peritoneal Lavage Kits, Model number AK-09000. Recall #
Z-1408-04;
b) Peritoneal Lavage Kits, Model number AK-09001. Recall #
Z-1409-04.
CODE
a) Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06,
RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp.
8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06,
RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592
exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp.
12/06;
b) Lot numbers: RF3111152 exp. 5/08, RF3121739 exp. 8/06,
RF4012282 exp. 7/08, RF4012530 exp. 7/08, RF4034376 exp.
10/06, RF4034554 exp. 11/08, RF4045029 exp. 11/08, and
RF4066325 exp. 1/09.
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA, by letter on August 9, 2004. Firm initiated recall is ongoing.
REASON
Wrong introducer needle in some kits.
VOLUME OF PRODUCT IN COMMERCE
8,090 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Esophageal Z-Stent? Fully Coated or Uncoated Flanges, Endoprosthesis Systems with the Z Speed Introducer, Disposable - Single Use Only, Rx Only, Sterile EO, Order Number EZSP-25-10-FC. Recall # Z-1410-04.
CODE
Lot Number R1688574.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC, by visit on January 30, 2003. Firm initiated recall is complete.
REASON
Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CT, HI, LA, MO, and PA.
____________________________
PRODUCT
Heat Loop cautery instrument, EO sterile - single use only; Arthrotek Ref. No. 905414 and Biomet Ref. No. 450026. Recall # Z-1411-04.
CODE
Arthrotek lots 049130, 300470, 278290 and 452840. Biomet lots 300450 and 228320.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letters dated July 12, and July 15, 2004. Firm initiated recall is ongoing.
REASON
The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.
VOLUME OF PRODUCT IN COMMERCE
130 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) ConMed Stealth Coated Laparoscopic Electrodes with
3/32? pin (60-5158 series) as follows: Cat. #60-5158-027
Spatula 5 mm x 27 cm; Cat #60-5158-032 - Spatula 5 mm
x 32 cm; Cat. #60-5158-044 - Spatula 5 mm x 44 cm; Cat
#60-5158-127 - L Hook 5 mm x 27 cm; Cat #60-5158-132 - L Hook, 5 mm x 32 cm; Cat #60-5158-144 - L Hook 5 mm x 44 cm; Cat #60-5158-232 - J Hook 5mm x 32 cm; Cat. #60-5158-244 - J Hook 5mm x 44 cm; Cat #60-5158-927 - Needle 5 mm x 27 cm; Cat #60-5158-932 - Needle 5 mm x 32 cm; Recall # Z-1412-04;
b) ConMed Stealth Coated Laparoscopic Electrodes with 4mm
pin (60-5158 series) as follows: Cat. #60-5158-034 ,
Spatula, 5 mm x 32 cm; Cat #60-5158-432 , ?L? Hook 5 mm
x 32 cm; Cat #60-5158-934 - Needle 5mm x 32 cm. Recall
# Z-1413-04.
CODE
a) Lot #s 0309121, 0310301, 0401051, 0404271, 0405031;
Lot #s 0309011, 0309111, 0401121, 0402031, 0402271, 0404131, 0405031, 0406071;
Lot #s 0309151, 0403121;
Lot #s 0309021, 0309151, 0310301;
Lot #s 0308071, 0308211, 0310081, 0311031, 0311101, 0401051, 0402031, 0402271, 0403121, 0404131;
Lot #s 0308261, 0310061, 0310081, 0311101, 0402031, 0403031, 0403121, 0406071;
Lot #s 0309121, 0310301, 0402181, 0404301;
Lot #s 0309121, 0310081, 0402271, 0404301;
Lot # 0309021;
Lot #0308111, 0309021, 0310081, 0311101, 0401121, 0402181, 0403121;
b) Lot #s 0309121; Lot #s 0308071, 0309021, 0309151, 1121;
Lot #s 0309111.
RECALLING FIRM/MANUFACTURER
ConMed Corporation, Utica, NY, by letters dated August 9, 2004. Firm initiated recall is ongoing.
REASON
Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
VOLUME OF PRODUCT IN COMMERCE
6,472 units.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR September 8, 2004

###