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U.S. Department of Health and Human Services

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Enforcement Report for September 15, 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 15, 2004
04-37

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Kraft Reduced Fat Parmesan Style Grated Topping, 8 oz. plastic jars, 12 per case; UPC 21000-61480. Recall # F-425-4.
CODE
23 DEC 04 W, 24 DEC 04 W, 30 DEC 04 W.
RECALLING FIRM/MANUFACTURER
Kraft Inc., Northfield, IL, by visiting retail stores on July 21, 2004. Firm initiated recall is ongoing.
REASON
The grated cheese topping is unfit for food due to off-odor and off-taste.
VOLUME OF PRODUCT IN COMMERCE
16,025 cases.
DISTRIBUTION
Nationwide and PR.

 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Zyprexa Tablets, (Olanzapine), 20 mg, 60 count bottles, Orally Disintegrating Tablets, Rx only, Eli Lilly & Company, Indianapolis, IN 46285, NDC 0002-4420-60. Recall # D-252-4.
CODE
Lot 7AA79A, exp Mar 1, 2005 Lot 7EF34A, exp Aug 1, 2005.
RECALLING FIRM/DISTRIBUTOR
Top Rx, Bartlett, TN, by fax and letter dated May 4, 2004. Firm initiated recall is complete.
REASON
Adulterated; presence of foreign tablets from sources other than the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
9 bottles.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Non Drowsy Vicks Formula 44 Cough Relief, 4 fl oz.(118mL). Recall # D-269-4.
CODE
4010SG2 Exp. DE/05.
RECALLING FIRM/MANUFACTURER
Procter & Gamble Manufacturing Co, Greensboro, NC, by telephone and letter on August 18, 2004. Firm initiated recall is ongoing.
REASON
Shelf cartons labeled as Vicks Formula 44 Cough Relief may contain bottles of Vicks Formula 44, Multi-Symptom Relief.
VOLUME OF PRODUCT IN COMMERCE
33 cases with 24 bottles per case.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
fougera? TipTapToe (Tolnaftate Solution USP, 1%), NET 10.8 mL, CONTAINS: 72 Liquid Filled Swabs --- Athlete's Foot Solution in a unique delivery system --- with swab+plus? technology LIQUID FILLED COTTON SWABS, OTC, E. FOUGERA & CO., a division of Altana Inc., MELVILLE, NY 11747, NDC 0168-0009-72. Recall # D-270-4.
CODE
Lot M447, EXP. 7/05.
RECALLING FIRM/MANUFACTURER
Altana Inc. Melville, NY, by letters on August 30, 2004. Firm initiated recall is ongoing.
REASON
Subpotent: Potential for tolnaftate solution to migrate into the swab tip during storage thereby producing inconsistent assay results.
VOLUME OF PRODUCT IN COMMERCE
13, 207 packages.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1713-4.
CODE
Unit number: 6703829.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter, dated May 1, 2003. Firm initiated recall is complete.
REASON
Blood product, untested for CMV, but labeled as CMV negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK.

_______________________________
PRODUCT
Platelets. Recall # B-1716-4.
CODE
Unit number: LJ75284.         
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated September 5, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose spouse engaged in behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1811-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated. Recall
# B-1812-4;
c) Platelets, Leukocytes Reduced. Recall # B-1813-4;
d) Fresh Frozen Plasma. Recall # B-1814-4;
e) Recovered Plasma. Recall # B-1815-4.
CODE
a) Units 38C11045, 38C11047, 38C11048, 38C11072, 38C11073,
38C11081, 38E05749, 38E05751, 38E05754, 38E05756, 38E05758, 38E05770, 38E05772, 38E05957, 38E05969, 38FH20830, 38FH20838, 38FH20839, 38FH20842, 38FH20848, 38FK29656, 38FK29658, 38FK29662, 38FK29663, 38FK29676, 38FV09255, 38FV09262, 38FV09266, 38FV09268, 38FV09286, 38FV09294, 38FV09296, 38FV09339, 38FV09341, 38FV09355, 38FV09358, 38FV09365, 38FV09366, 38FV09375, 38FV09378, 38FV09851, 38FV09852, 38FV09858, 38FV09862, 38FV09873, 38FV09880, 38FV09882, 38FV09888, 38FV09889, 38FV09894, 38FV09926, 38FV09928, 38FV09932, 38FV09945, 38FV09951, 38FV09960, 38FV09962, 38FV09982, 38FV09991, 38FV09992, 38FV09997, 38FV10004, 38FV10005, 38FV10008, 38FV10009, 38FV10010, 38FV10014, 38FV10027, 38FV10029, 38FV10031, 38FV10051, 38FV10074, 38KT09820, 38KT09827, 38KT09828, 38KT09831, 38KT09838, 38KT09874, 38KT09885, 38KT09891, 38KT09896, 38KT09898, 38KT09936, 38KT09945, 38KT09948, 38KT09951, 38KT09955, 38KT09985, 38KT09992, 8KT10028, 38KT10036, 38KT10052, 38KT10055, 38KT10695, 38KT10698, 8KT10727, 38KT10733, 38KT10735, 38KT10740, 38KT10762, 38KT10764, 8KT10766, 38KT10778, 38LC69698, 38LC69705, 38LC69730, 38LC69733, 38LC69736, 38LC69737, 38LC69755, 38LC69759, 38LC69761, 38LC69763, 38LC69779, 38LC69818, 38LC69821, 38LC69824, 38LC69829, 38LC69834, 38LC69836, 38LC69853, 38LC69858, 38LC69861, 38LC69866, 38LC69887, 38LC69896, 38LC70135, 38LC70138, 38LC70163, 38LC70170, 38LC70171, 38LC70191, 38LC70196, 38LC70197, 38LC70340, 38LC70343, 38LC70347, 38LC70351, 38LC70391, 38LC70394, 38LC90432, 38LC70456, 38LC70469, 38LC70537, 38LC70544, 38LC70547, 38W31284, 38W31285, 38W31288, 38W31289, 38W31290, 38W31291, 38W31295, 38W31300, 38LC69894;
b) Unit 38FV10036;
c) Units 38C11045, 38C11047, 38C11072, 38FV09962,
38FV09982, 38FV09991, 38FV09992, 38FV09997, 38FV10004,
38FV10005, 38FV10008, 38FV10009, 38FV10010, 38FV10027,
38FV10029, 38FV10031, 38FV10036, 38KT09843, 38KT10052,
38KT10055, 38KT10695, 38KT10698, 38KT10727, 38KT10733,
38LC69705;
d) Units 38C11045, 38C11047, 38C11048, 38C11073, 38E05761,
38FV09962, 38FV09982, 38FV10005, 38FV10008, 38FV10010,
38FV10031, 38FV10036, 38FV10051, 38KT09820, 38KT09828,
38KT09831, 38KT09843, 38KT09987, 38KT10028, 38KT10036,
38KT10052, 38KT10055, 38KT10698, 38KT10733, 38KT10735,
38KT10740, 38LC69698, 38LC69705, 38LC69829, 38W31295,
38W31300;
e) Units 38C11072, 38C11081, 38E05749, 38E05750, 38E05751,
38E05754, 38E05756, 38E05758, 8E05770, 38E05772,
38E05957, 38E05969, 38FH20830, 38FH20838, 38FH20839,
38FH20842, 38FH20848, 38FK29656, 38FK29658, 38FK29662,
38FK29663, 38FK29676, 38FV09255, 38FV09262, 38FV09266,
38FV09268, 38FV09286, 38FV09294, 38FV09296, 38FV09339,
38FV09341, 38FV09355, 38FV09358, 38FV09365, 38FV09366,
38FV09375, 38FV09851, 38FV09852, 38FV09858, 38FV09862,
38FV09873, 38FV09880, 38FV09882, 38FV09888, 38FV09889,
38FV09894, 38FV09926, 38FV09928, 38FV09932, 38FV09945,
38FV09951, 38FV09960, 38FV09991, 38FV09992, 38FV09997,
38FV10009, 38FV10014, 38FV10029, 38FV10074, 38KT09827,
38KT09838, 38KT09874, 38KT09885, 38KT09891, 38KT09896,
38KT09898, 38KT09936, 38KT09945, 38KT09948, 38KT09951,
38KT09955, 38KT09985, 38KT09992, 38KT10695, 38KT10727,
38KT10762, 38KT10764, 38KT10766, 38KT10778, 38LC69730,
38LC69733, 38LC69736, 38LC69737, 38LC69755, 38LC69759,
38LC69761, 38LC69763, 38LC69779, 38LC69818, 38LC69821,
38LC69824, 38LC69834, 38LC69836, 38LC69853, 38LC69858,
38LC69861, 38LC69866, 38LC69887, 38LC69896, 38LC70129,
38LC70135, 38LC70138, 38LC70163, 38LC70171, 38LC70191,
38LC70196, 38LC70197, 38LC70340, 38LC70343, 38LC70347,
38LC70351, 38LC70391, 38LC70394, 38LC70456, 38LC70458,
38LC70466, 38LC70469, 38LC70535, 38LC70537, 38LC70544,
38LC70547, 38W31284, 38W31285, 38W31288, 38W31289,
38W31290, 38W31291, 38LC69894.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on December 9, 2003, and May 25, 2004, or by facsimile transmissions dated December 9, 2003 or May 25, 2004, and by letter, dated January 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
340 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
NucliSens? Automated Isolation Reagents. Recall # B-1837-4.
CODE
Lot number: 04031904.
RECALLING FIRM/MANUFACTURER
Recalling Firm: bioM?rieux, Inc., Durham, NC, by letter, dated May 17, 2004.
Manufacturer: bioM?rieux bv, Boxtel, Netherlands. Firm initiated recall is complete.
REASON
Components of the NucliSens? Automated Isolation reagents, containing a raw material, which affected the sensitivity and accuracy of down stream assays, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
NY, FL, DC, and CA.

_______________________________
PRODUCT
In-vitro Diagnostic Tests of the following type:
a) MTS Anti-IgG CardTM ;
b) MTS A/B/D Monoclonal and Reverse Grouping CardTM.
Recall # B-1847-4.
CODE
a) Lot 082203001-14, Expiration 15 July 04
(Microtube #1 from left to right with the barcode facing
forward);
b) Lot 111903037-11, Expiration 23 Oct 04 (Anti-D
Microtube);
RECALLING FIRM/MANUFACTURER
Micro Typing Systems, Inc., Pompano Beach, Florida, by letters, dated February 19, 2004, April 23, 2004, May 12, 2004, and June 3, 2004. Firm initiated recall is complete.
REASON
In-vitro diagnostic test cards, which may contain a microtube without any gel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,124 boxes, each containing 48 cards.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Reagent Red Blood Cells, 0.8% SELECTOGEN. Recall # B-1861-4.
CODE
Lot # 8S243, exp. 1/13/2004.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc, Raritan, NJ, by letters and e-mail dated December 23, 2003. Firm initiated recall is complete.
REASON
Reagent Red Blood Cells, manufactured with cell concentrations that were out of specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,883.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) ACF Spacer;
b) C/C Chips 1.7-10mm 30cc;
c) Cancellous Chips 1.7-10mm 15cc;
d) Cancellous chips;
e) Dowel 13mm (Diam)
f) Fascia Lata (medium);
g) Iliac Crest Wedge;
h) Ilium Tricortical Strip;
i) Patella Wedge;
j) Achilles Tendon w/Calc.;
k) Femoral head 44mm;
l) Demin. Cort. Powder. Recall # B-1868-4.
CODE
a) Unit numbers: 007333011001, 007333011002, 007333011003,
007333011004, 007333011005, 007333011006, 007333011007,
007333011008, 007333011009, 007333011010, 007333011011,
007333011012, 007333011014, 007333011015, 007333011016,
007333011017, 007333011018, 007333011019, 007333011020;
b) Unit numbers: 5007333010063, 007333010064,
007333010065, 007333010066, 007333010067;
c) Units 00733310033, 00733310034, 00733310035,
00733310036, 00733310037, 00733310038, 00733310039,
00733310040, 00733310041, 00733310042, 00733310043,
00733310044, 00733310045, 00733310046, 00733310047;
d) Units: 007333010031, 007333010032;
e) Units: 007333010049, 007333010050;
f) Units: 007333010005, 007333010006;
g) Units: 007333010059, 007333010060, 007333010061,
007333010062;
h) Units: 007333010053, 007333010054;
i) Units: 007333010068, 007333010069;
j) Units: 007333010007, 007333010008;
k) Units: 007333010029, 007333010030;
l) Units: 007333010502.
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation, Edison, NJ, recall by telephone on May 19, 2004. Firm initiated recall is complete.
REASON
Human tissues for transplantation, procured from a donor who tested negative for antibody to Hepatitis C virus (anti-HCV), but was subsequently found to be reactive using HCV RNA (TMA) testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
192 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1878-4.
CODE
Units 33GK38931, 33LQ33988, 33GS36753.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by letter dated December 24, 2002. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that were implicated in a transfusion reaction and found to be contaminated with Streptococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1879-4.
CODE
Units 33GY69919, 33GH69987, 33GS43398, 33GS43397.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by telephone on September 25, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that were implicated in a transfusion reaction and found to be contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1905-4.
CODE
Tissue numbers IA-2003-01-021R1 and IA-2003-01-021L1.
RECALLING FIRM/MANUFACTURER
Iowa Lions Eye Bank, Iowa City, IA, by telephone on June 17, 2004, and July 7, 2004, and by letter July 8, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis, but was procured from a donor that previously tested reactive for hepatitis, was distributed
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
IA, and NJ.

_______________________________
PRODUCT
Source Plasma. Recall # B-1906-4.
CODE
Unit numbers: 4VI065 O, 4VI101 O, VI129 O, 4VI169 O
4VI201 O, 4VI234 O, 4VI258 O, 4VI284 O, 4VI311 O, 4VI365 O,
4VI398 O, BSGNDM O, BSGNGJ O, BSGNHZ O, BSGNKY O, BSGNMH O,
BSGNPC O, BSGNRW O, 97S233 O, 97S376 O, 97S619 O, 97S773 O, BSCJKM O, BSCJSW O, BSCKLZ O, BSCKWM O, BSCQMQ O, BSCQQX O, BSCRKR O, BSCRTS O, BSCSQF O, BSCSYD O, BSCTPS O, BSCTZZ O, BSCVLQ O, BSCWCH O, BSGNTX O, BSGPGZ O, BSGPKC O, BSGPLZ O, BSGPPJ O, BSGPRF O, BSGPSS O, BSGPVH O, BSFNNC O, BSFNXN O, BSFPPN O, BSFPVX O, and BSFQMN O.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, St. Paul, MN, by letters, dated November 1, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units.
DISTRIBUTION
IL, and Germany.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-
1907-4;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1908-4.
CODE
a) Unit numbers: 9181266 (2 units), 6950880 (2 units),
6950881 (2 units), 6951100 (2 units), 4802472, 4802476,
4802674 (2 units), 4802676, and 4802707;
b) Unit number: 4803017.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by facsimile and by letter, between May 7, and May 18, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced but were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 Units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1912-4;
b) Red Blood Cells, Leukocytes Removed, Irradiated.
Recall # B-1913-4;
c) Platelets, Leukocytes Removed. Recall # B-1914-4.
CODE
a) Unit number: 49GN26214;
b) Unit number: 49GE04511;    
c) Unit numbers: 49GN26214, 49GE04511.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by facsimile on March 3, 2004, and by letter, dated April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, and OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1915-4.
CODE
Unit number: 49LH47809.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Southwest Region, Tulsa, OK, by letter, dated July 14, 2003.
Manufacturer: American Red Cross, Southwest Region, College Station, TX. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1917-4.
CODE
Unit 182348827.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 17, 2004.
Manufacturing Firm:  Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1919-4.
CODE
Unit numbers: 0040996, 0041273. 0041657, and 0042031.
RECALLING FIRM/MANUFACTURER
DCI Biologicals Bryant, LLC, Bryan, TX, by letter, dated February 16, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a body piercing within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1920-4.
CODE
Unit number: 40LS21668.
RECALLING FIRM/MANUFACTURER
American Red Cross, Heart of America Region, Peoria, IL, by telephone on July 9, 2004, and by letter, dated July 14, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided a history of non-Hodgkin's lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1921-4.
CODE
Unit 030GF43641.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Ashley, PA, by telephone, and by letter dated June 6, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the medication Coumadin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1922-4;
b) Platelets. Recall # B-1923-4;
c) Cryoprecipitated AHF. Recall # B-1924-4.
CODE
Unit 030GJ35956.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Ashley, PA, by telephone, and by letter dated May 6, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who tested negative for the antibody to hepatitis B core antigen (anti-HBc) but tested repeatedly reactive for anti-HBc on two previous occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1925-4.
CODE
Unit number: 49KM05621.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Southwest Region, Tulsa, OK, by telephone on January 22, 2004.
Manufacturer: American Red Cross, Southwest Region, Farmers Branch, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1926-4.
CODE
Unit numbers 004FV31913 and 004FR73871.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on January 23, 2004, and by letter on January 30, 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
NY, and ME.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1927-4.
CODE
Unit numbers 004GL67386 and 004KE41974 (both units distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on June 1, 2004, and by letter on June 7, 2004. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MA, and NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1928-4.
CODE
Unit numbers U00076667 and U00085610.
RECALLING FIRM/MANUFACTURER
York Hospital Donor Center, York, PA, by telephone on November 26, 2003, and by letter on December 4, 2003. 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
PA.

_______________________________
PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1931-4.
CODE
Tissue number 03-1099.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX, by telephone on December 4, 2003. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested reactive for antibodies to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1933-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1934-4;
c) Red Blood Cells (Apheresis), Leukocytes Reduced. Recall
# B-1935-4;
d) Fresh Frozen Plasma. Recall # B-1936-4;
e) Fresh Frozen Plasma (Apheresis). Recall # B-1937-4.
CODE
a) Unit number 31134-4265 (distributed as three split
products);
b) Unit numbers 31134-1230, 31134-1231, 31134-1233, 31134-
1239, 31134-1240, 31134-1243, 31134-1247, 31134-1255,
31134-1260, 31134-1263, 31134-1275, 31134-1277, 31134-
1279, 31134-1281, 31134-1285, 31134-1286, 31134-1288,
31134-1292, 31134-1296, 31134-1299, 31134-1301, 31134-
1303, 31134-1308, 31134-1310, 31134-1312, 31134-1313,
31134-1315, 31134-1316, 31134-1317, 31134-1320, 31134-
1321, 31134-1322, 31134-1325, 31134-1331, 31134-1333,
31134-1343, 31134-1347, 31134-1351, 31134-1357, 31134-
1359, 31134-1362, 31134-2040, 31134-2046, 31134-2053,
31134-2054, 31134-2060, 31134-2062, 31134-2063, 31134-
2164, 31134-2168, 31134-2173, 31134-2177, 31134-2179,
31134-2183, 31134-2189, 31134-2193, 31134-2198, 31134-
2784, 31134-2787, 31134-2789, 31134-2800, 31134-2831,
31134-2899, 31134-2901, 31134-2909, 31134-2910, 31134-
2916, 31134-2920, 31134-2922, 31134-2995, 31134-2997,
31134-3274, 31134-3277, 31134-3279, 31134-3285, 31134-
3288, 31134-3290, 31134-3296, 31134-3298, 31134-3300,
31134-3304, 31134-3307, 31134-3315, 31134-3318, 31134-
3321, 31134-3609, 31134-3612, 31134-3614, 31134-3620,
31134-3621, 31134-3625, 31134-3626, 31134-3631, 31134-
3663, 31134-3667, 31134-3671, 31134-3675, 31134-3687,
31134-3688, 31134-3693, 31134-3694, 31134-3702, 31134-
3703, 31134-3704, 31134-3746, 31134-4101, 31134-4104,
31134-4106, 31134-4116, 31134-4120, 31134-4129, 31134-
4131, 31134-4133, 31134-4135, 31134-4136, 31134-4142,
31134-4147, 31134-4149, 31134-4154, 31134-4156, 31134-
4169, 31134-4176, 31134-4179, 31134-4182, 31134-4220,
31134-4222, 31134-4263, 31134-4449, 31134-4469, 31134-
4470, 31134-4472, 31134-4963, 31134-4966, 31134-5037,
31134-5039, 31134-5046, 31134-5050, 31134-5054, 31134-
5060, 31134-5071, 31134-5075, 31134-5077, 31134-5079,
31134-5612, 31134-5617, 31134-5618, 31134-5621, 31134-
5628, 31134-5630, 31134-5693, 31134-5698, 31134-5703,
31134-5866, 31134-5870, 31134-5873, 31134-5874,
e) Unit numbers 31134-2791, 31134-2905, 31134-2906,
31134-3317, 31134-4224, and 31134-4272; and the following units were distributed as two split products: unit numbers 31134-2913, 31134-1228, 31134-1242, 31134-1250, 31134-1290, 31134-1294, 31134-1306, 31134-1314, 31134-1318, 31134-1337, 31134-1345, 31134-1352, 31134-1354, 31134-1363, 31134-1398, 31134-2036, 31134-2042, 31134-2047, 31134-2050, 31134-2169, 31134-2186, 31134-2999, 31134-3251, 31134-3266, 31134-3306, 31134-3601, 31134-3689, 31134-4117, 31134-4127, 31134-4138, 31134-4155, 31134-4184, 31134-4189, 31134-4270, 31134-4453, 31134-5088, 31134-5091, 31134-5601, 31134-5627, 31134-5691, 31134-5871, 31134-5930, 31134-5931, and 31134-5943;
d) Unit numbers 31132-1374, 31132-1383, 31132-1750,
31132-3252, 31132-4103, 31132-4401, 31132-4444, 31132-4986, 31132-4989, 31132-5075, 31132-6214, 31132-6402, 31132-6449, 31132-6451, 31132-6456, 31132-6458, 31132-6461, 31132-7528, 31132-7533, 31132-7540, 31132-8328, 31132-8330, 31132-8335, 31132-8886, 31132-8888, 31132-8899, 31133-0048, 31133-0366, 31133-0368, 31133-0371, 31133-0376, 31133-0381, 31133-0388, 31133-0392, 31133-3737, 31133-3740, 31133-3748, 31133-5305, 31133-5433, 31133-5449, 31133-5455, 31133-5665, 31133-5682, 31133-5691, 31133-5693, 31133-5796, 31133-8417, 31133-8418, 31133-8419, 31133-8422, 31133-8423, 31133-8425, 31133-8427, 31133-9042, 31133-9045, 31133-9050, 31133-9054, 31133-9066, 31133-9071, 31133-9073, 31133-9307, 31134-0147, 31134-0149, 31134-0150, 31134-0154, 31134-0155, 31134-0156, 31134-0159, 31134-0161, 31134-0164, 31134-0165, 31134-0305, 31134-0311, 31134-0322, 31134-0554, 31134-0562, 31134-0564, 31134-0570, 31134-0575, 31134-0577, 31134-0579, 31134-0752, 31134-0753, 31134-0754, 31134-0755, 31134-1986, 31134-1987, 31134-2217, 31134-2219, 31134-2221, 31134-2410, 31134-2413, 31134-2417, 31134-2421, 31134-2429, 31134-2432, 31134-2434, and 31134-2436;
e) Unit number 31134-2906; and the following units were
distributed as two split products: unit numbers 31132
7993, 31133-4048, 31133-4054, 31133-4063, 31133-9867,
and 31134-0764.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on March 7, 2003.
Manufacturer:  Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were improperly questioned concerning the use of certain medications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
370 units.
DISTRIBUTION
MS, AL, and TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1938-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1939-4.
CODE
a) Unit 11GX76525;
b) Units 11GX76319, 11FJ10350, 11GP14939, 11FJ10239,
11FJ10296.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by letter dated April 26, 2004. Firm initiated recall is complete.
REASON
Blood products, possibly collected from unreliable donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MO.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1940-4;  
b) Cryoprecipitated AHF. Recall # B-1941-4;
c) Cryoprecipitated AHF, Pooled. Recall # B-1942-4;
d) Platelets. Recall # B-1943-4;
e) Plasma, Cryoprecipitate Reduced. Recall # B-1944-4;
f) Fresh Frozen Plasma. Recall # B-1945-4   
g) Recovered Plasma. Recall # B-1946-4.
CODE
a) Units 18FK79385, 18FK79392, 18FS76888, 18FS76898,
18FS76901, 18FS76908, 18FW45920, 18FW45925, 18FW45930, 18FW45941, 18FY11086, 18FY11092, 18FY11097, 18FY11108, 18GC12460, 18GC12464, 18GC12473, 18GC12476, 18GM02367, 18GM02370, 18GM02374, 18GM02404, 18GM02571, 18GM02572, 18GM02581, 18GM02588, 18GM02589, 18N88571, 18N88572, 18N88576, 18N88580, 18N88582;
b) Unit 18GM02370;
c) Unit 18GM02367;
d) Units 18GM02409, 18GM02571, 18GM02572, 18GM02581,
18GM02588;
e) Unit 18GM02367;
f) Units 18FS76901, 18FS76908, 18GM02570, 18GM02571,
18GM02572, 18GM02581, 18GM02588;
g) Units 18FK79392, 18FS76888, 18FS76898, 18FW45920,
18FW45925, 18FW45930, 18FW45941, 18GC12460, 18GC12464,
18GC12473, 18GM02370, 18GM02374, 18GM02404, 18GM02409,
18N88571.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on September 2, and September 3, 2003, by e-mail on September 3, 2003, or by letter dated September 4, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
62 units.
DISTRIBUTION
CA, MI, NY, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1947-4;
b) Plasma. Recall # B-1948-4;
c) Recovered Plasma. Recall # B-1949-4.
CODE
a) Units 011LY33525 and 011LY21015;
b) Unit 011LY33525;
c) Unit 011LY21015.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone or e-mail on September 9, 2003, and by letter dated September 19, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of testing positive for the hepatitis C virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MO, IL, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1950-4.
CODE
Units 2100823 and 2500696.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated July 24, 2003. 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
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1951-4;
b) Platelets. Recall # B-1952-4.
CODE
a) Units 9071342 and 9066889;
b) Unit 9066889.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated June 27, 2003. 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
3 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1953-4.
CODE
Units 2403776 and 2409074.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated July 10, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1954-4.
CODE
Units 9547222 and 2101429.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated July 18, 2003. 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
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1955-4;
b) Platelets. Recall # B-1956-4.
CODE
a) and b) Unit 9527509.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated June 13, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1958-4.
CODE
Unit 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile and by letter on November 13, 2003. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor who was taking the medication Methotrexate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1960-4.
CODE
Units 2026683, 2024471, 2016775, and 2015315.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated February 20, 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
4 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1961-4.
CODE
Unit numbers: 9WY598, 9WY602, 9WY612, 9WY618, FLBTMJ, FLBTMR, FLBTNH, FLBTNL, FLBTQN, FLBTVF, FLBTVG, FLBTVR, FLBTWG, FLBTWL, FLBTXB, FLBTXH, FLCJHC, FLCJJX, FLCJKC, FLCJKQ, FLCJKY, FLCJLX, FLCJNB, FLCJNK, FLCJNX, FLCJPK, FLCJQP, FLCJQW, FLCJRQ, FLCJSW, FLCJSY, FLCJWR, FLCJWV, FLCJXC, FLCJXG, FLCJXM, FLCJXV, FLCJXX, FLCJYH, FLCJYM, FLCJYS, and FLCJYZ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Waco, TX, by facsimile on November 5, 2002. 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
42 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1962-4.
CODE
Unit number 2023959.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated August 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-1964-4.
CODE
Units 0141107409, 0141108210, 0141108897, and 0141109503.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tulsa, OK, by facsimile dated June 18, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk of exposure to new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1965-4.
CODE
Unit number: KE89063.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile on September 30, 2002. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1967-4.
CODE
Unit number 2411148.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on February 16, 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1968-4.
CODE
Unit number 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 28, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1969-4.
CODE
Unit number 2315645.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on September 8, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1970-4.
CODE
Unit number 2022659.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on September 19, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1971-4.
CODE
Unit number 2602476.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on June 12, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1972-4.
CODE
Unit number 2200237.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on June 23, 2003. 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
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1973-4.
CODE
Unit numbers 2507390, 2504211, and 2010137.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 21, 2003. 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
3 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1976-4.
CODE
Unit number 2022036A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on April 17, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1977-4.
CODE
Unit number 2025315A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on July 15, 2003. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-1978-4.
CODE
Unit number 2028718.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on September 3, 2003. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1979-4;
b) Platelets. Recall # B-1980-4;
c) Liquid Plasma. Recall # B-1981-4.
CODE
a), b), and c) Unit number 7769415.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 59th Medical Wing/MTLLB, Lackland AFB, TX, by telephone and facsimile on May 12, 2003 and April 12, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, and TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1988-4;
b) Platelets, Leukocytes Reduced. Recall # B-1989-4;
c) Plasma. Recall # B-1990-4.
CODE
a), b), and c) Unit number 011GR32159.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on July 24, 2003, and by letter on July 31, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MO, and PR.

_______________________________
PRODUCT
Source Plasma. Recall # B-1991-4.
CODE
Unit numbers 00156875, 00156646, 00149990, and 00146876.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lansing, MI, by facsimile on April 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that tested reactive for hepatitis C virus (HCV) by the polymerase chain reaction (PCR) assay, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Diptheria and Tetanus Toxoids Adsorbed.
Recall # B-1993-4;
b) Albumin (Human) 25%. Recall B-1994-4;
c) Albumin 25% for diagnostic use only. Recall # B-1995-4.
CODE
a) Lot number DT4177;
b) Lot number HA1215;
c) Lot number HA1208.
RECALLING FIRM/MANUFACTURER
BioPort Corporation, Lansing, MI, by telephone on September 1, 2000, and by letter on September 6, 2000. Firm initiated recall is complete.
REASON
Products were manufactured during a period where microbiological control of the manufacturing operation could not be assured.
VOLUME OF PRODUCT IN COMMERCE
3 lots.
DISTRIBUTION
FL, MA, and MI.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1996-4;
b) Recovered Plasma. Recall # B-1997-4.
CODE
a) and b) Unit number 31134-1727.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, by letter on June 25, 2003.
Manufacturer:  Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS, and Switzerland.

_______________________________
PRODUCT
a) Cryoprecipitated AHF. Recall # B-2000-4;
b) Recovered Plasma. Recall # B-2001-4.
CODE
a) Unit 1794010;
b) Unit 4015236.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center,  San Antonio, TX, by facsimile dated August 17, and September 25, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at an increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-2005-4.
CODE
Unit number 16KF41945.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone and letter on May 28, 2004. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
IMOVAX Rabies, Rabies Vaccine, (Human Diploid Cell), Single Dose Vial (1mL). Recall # B-1675-4.
CODE
Lots W1419-2, W1419-3, X0667-2, X0667-3.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Pasteur, Inc. Swiftwater, Pennsylvania, by letter dated April 5, 2004, and May 17. 2004.
Manufacturer: Aventis Pasteur SA, 69007 Lyon Cedex, France. Firm initiated recall is complete.
REASON
IMOVAX Rabies Vaccine, manufactured during the same campaign as a bulk lot (not distributed) that failed the test for inactivation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 lots. 45,161 doses.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Baxter ALYX Component Collection System. Recall # B-1876-4.
CODE
Product code: 4R5707, 4R5707R (refurbished).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL, by letter, dated June 10, 2004.
Manufacturing Firm: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is complete.
REASON
Automated Blood Cell Separator (ALYX Component Collection System), designed to collect red blood cells by centrifugation, may spin uncommanded after the centrifuge door is opened.
VOLUME OF PRODUCT IN COMMERCE
174 instruments.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1899-4;
b) Red Blood Cells, Deglycerolized. Recall # B-1900-4.
CODE
a) Units 03K03660, 03K03767, 03K03844;
b) Unit 03K03826.
RECALLING FIRM/MANUFACTURER
National Institutes of Health, Warren Grant Magnuson Clinical Center, Bethesda, MD, by telephone on November 7, 2003, and by letter dated February 10, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1909-4.
CODE
Unit number: 49KC05145.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by facsimile on April 6, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1918-4.
CODE
Unit 182348827.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by e-mail on June 17, 2004.
Manufacturing Firm:  Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1929-4.
CODE
Unit number OG0019078.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on January 3, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-1930-4.
CODE
Unit number OG0019372.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, TX, by facsimile on December 21, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1932-4.
CODE
Unit numbers 030GP32669, 030GP32679, 030GP32681, 030GP32684, 030GP32696, 030GP32716, 030GP32724, 030GP32726, 030GP32731, 030GP32758, 030GP32760, 030GP32771, 030GP32774, 030GP32776, 030GP32786, 030GP32794, 030GP32797, 030GP32799, 030GP32815, 030GP32825, 030GP32826, 030GP32830, 030GP32834, 030GP32885, 030GP32899, 030GP32919, 030GP32936, 030GP32949, 030GP33082, 030GP33104, 030GP33113, 030GP33118, 030GP33125, 030GP33131, 030GP33148, 030GP33175, 030GP33214, 030GP33275, and 030GP33288; and the following units were distributed as two split products: unit numbers 030GP33111, 030GP32664, 030GP32698, 030GP32708, 030GP32763, 030GP32785, 030GP32811, 030GP32852, 030GP32952, 030GP32981, 030GP32996, 030GP33079, 030GP33085, 030GP33099, 030GP33100, 030GP33127, 030GP33141, 030GP33189, 030GP33219, 030GP33246, 030GP33282, and 030GP33298.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on December 19, 2003, and by letter on December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected during a period when quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
83 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1957-4.
CODE
Unit 2037977.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on February 6, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from an autologous donor but was labeled for allogeneic use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1959-4.
CODE
Unit 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile and by letter on November 13, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking the medication Methotrexate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1963-4.
CODE
Unit numbers 030GF43777, 030GF43784, and 030GF43792.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on March 25, 2004, and by letter on March 30, 2004. Firm initiated recall is complete.
REASON
Blood products, that were not tested for hematocrit as required by the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1966-4.
CODE
Unit number: KE89063.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by facsimile on September 27, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1974-4.
CODE
Unit number 2606708.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and letter on March 2, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1975-4.
CODE
Unit number 2017118.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on January 8, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced. Recall # B-1985-4;
b) Fresh Frozen Plasma. Recall # B-1986-4.
CODE
a) and b) Unit 16GJ24707.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone, and letter dated June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, which were prepared from a whole blood unit with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Source Plasma. Recall # B-1992-4.
CODE
Unit numbers 470000121 and 470000165.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by telephone on June 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer all medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Source Plasma. Recall # B-1998-4.
CODE
Unit number DSKZCG.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile on September 18, 2003.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-2004-4.
CODE
Unit numbers FGFDJR and FGFDCH.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Boca Raton, FL, by facsimile on April 8, 2003.
Manufacturer: Aventis Bio-Services, Inc., Montgomery, AL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Irradiated. Recall # B-2006-4.
CODE
Unit numbers 42KF11846, 42KF11852, and 42KW20978.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on May 21, 2004, and by letter on May 25, 2004. Firm initiated recall is complete.
REASON
Blood products that were removed from controlled storage for more than allowed were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.

 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
The probes involved have been part of the Nellcor? CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time. Recall #Z-1414-04.
CODE
All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Pleasanton, CA, by letters on August 24, 2004, telephone on August 25, 2004, and by press release on August 27, 2004. Firm initiated recall is ongoing.
REASON
The product is contaminated with Burkholderia cepacia (formally known as Pseudomonas cepacia), based on the Texas Health Department analysis and also firm's analysis.
VOLUME OF PRODUCT IN COMMERCE
14,120 units.
DISTRIBUTION
Nationwide and Europe.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
ProlieveO Thermodilatation System, Model number
M0068808000. Recall # Z-1339-04.
CODE
CEL0204AK, CEL0204BK, CEL0204CK, CEL0204DK, CEL0204EK, CEL0204FK, CEL0204GK, CEL0204HK, CEL0204IK, CEL0204JK, CEL0604AK, CEL0604BK, CEL0604CK, CEL0604DK, CEL0604EK, CEL0604FK, CEL0604GK, CEL0604HK, CEL0604IK, CEL0604JK, CEL0604KK, CEL0604LK, CEL0604MK, CEL0604NK, CEL0604OK, CEL0604PK, CEL1904AK, CEL9404BK.
RECALLING FIRM/MANUFACTURER
Celsion Corporation, Columbia, MD, by visit on June 25, 2004 and letter on July 19, 2004. Firm initiated recall is ongoing.
REASON
Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
VOLUME OF PRODUCT IN COMMERCE
28 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Harmony MIS Life Instruments, Lumbar Spacer Systems. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30, 2851-4-31, 2851-5-01, 2851-5-30, 2852-2, 2852-4, 2854-1, 2857-1, 2857-2, 2858-1, 2859-1, 2861-5, and 2862-1. Recall # Z-1343-04.
CODE
Lot number 18YH, 18YJ, 18YK, 18YL, 18YM, 18YP, 18YQ, 18YR, 18YS, 18YT, 18YW, 18YX, 18YZ, 18YY, 18ZA, 18ZB, 18ZC and 18ZD.
RECALLING FIRM/MANUFACTURER
Spinal Concepts, Inc., Austin, TX, by telephone on April 1, 2004. Firm initiated recall is complete.
REASON
Handle becomes loose after repeated use.
VOLUME OF PRODUCT IN COMMERCE
646 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog
number 4427. Recall # Z-1345-04;
b) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 17 Fr, steerable stylet, ribbed balloon; catalog
number 4428. Recall # Z-1346-04;
c) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 17 Fr, malleable stylet, ribbed balloon; catalog
number 4429. Recall # Z-1347-04;
d) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 17 Fr, malleable stylet, ribbed balloon; catalog
number 4430. Recall # Z-1348-04;
e) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 13 Fr, steerable stylet, ribbed balloon; catalog
number 5578. Recall # Z-1349-04;
f) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 13 Fr, malleable stylet, ribbed balloon; catalog
number 5579. Recall # Z-1350-04;
g) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog
number 5580. Recall # Z-1351-04;
h) Sarns brand Retrograde Cardioplegia Cannulae, auto,
inflate, 13 Fr, malleable stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5584. Recall # Z-
1352-04;
i) Sarns brand Retrograde Cardioplegia Cannulae, auto,
inflate, 13 Fr, steerable stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5585. Recall # Z-
1353-04;
j) Sarns brand Retrograde Cardioplegia Cannulae, auto,
inflate, 13 Fr, rigid stylet, ribbed balloon, standard
length, 12" (30.5 cm) long; catalog number 5586. Recall # Z-
1354-04;
k) Sarns brand Retrograde Cardioplegia Cannulae, auto,
inflate, 13 Fr, rigid stylet, ribbed balloon, extended
length, 14" (35 cm) long; catalog number 5587. Recall # Z-
1355-04;
l) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 15 Fr, guidewire stylet, smooth balloon; catalog
number 7270. Recall # Z-1356-04;
m) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 15 Fr, steerable stylet, smooth balloon; catalog
number 7271. Recall # Z-1357-04;
n) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 15 Fr, guidewire stylet, ribbed balloon; catalog
number 7272. Recall # Z-1358-04;
o) Sarns brand Retrograde Cardioplegia Cannulae, manual,
inflate, 15 Fr, steerable stylet, ribbed balloon; catalog
number 7273. Recall # Z-1359-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letters on July 7, and July 29, 2004. Firm initiated recall is ongoing.
REASON
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
VOLUME OF PRODUCT IN COMMERCE
40,895 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor CT/NG CT Detection Kit. Recall #
Z-1360-04;
b) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor CT/NG NG Detection Kit. Recall #
Z-1361-04;
c) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor HCV Detection Kit, v2.0. Recall #
Z-1362-04;
d) Amplicor (3) AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate.) Kit: Amplicor HCV Detection Kit, 96 test. Recall
# Z-1363-04;
e) Amplicor (3) AV-HRP. Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: AmpliCap HCV Monitor Test, Export, RUO.
Recall # Z-1364-04;
f) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor IC Detection Kit, Export, IVD/CE.
Recall # Z-1365-04;
g) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor M. avium Detection Kit, Export,
RUO. Recall # Z-1366-04;
h) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor MTB Detection Kit, Gen 2 Export,
IVD/CE. Recall # Z-1367-04;
i) Amplicor (3) AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG
Conjugate. Kit: Amplicor NG Detection Kit, Export, IVD/CE.
Recall # Z-1368-04.
CODE
a) Lot No. E09569 found in kit lot: Lot No. E12231, Material No.
2075932018, Exp. 2/2005;
b) Lot No. E09560 found in kit lot: Lot No. E12647, Material No.
20759406018, Exp. 2/2005;
c) Lot No. E09569 found in kit lot: Lot No. F01023, Material No.
21118439018, Exp. 5/2005;
d) Lot No. E09569 found in kit lot: Lot No. E09554, Material No.
2075952018, Exp. 5/2005;
e) Lot No. E09569 found in kit lot: Lot No. E09193, Material No.
21111337018, Exp. 8/2004;
f) Lot No. E09569 found in kit lot: Lot No. E13115, Material No.
20763306122, Exp. 7/2005;
g) Lot No. E09569 found in kit lot: Lot No. E12990, Material No.
20759880018, Exp. 11/2004;
h) Lot No. E09569 found in kit lot: Lot No. E13307, Material No.
20757462122, Exp. 9/2004;
i) Lot No. E09569 found in kit lot: Lot No. E10894, Material No.
20744026122, Exp. 2/2005.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ, by letters on June 24, 2004 and July 6, 2004. Firm initiated recall is ongoing.
REASON
An increased frequency of "blue foci" that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
VOLUME OF PRODUCT IN COMMERCE
11,842 kits.
DISTRIBUTION
Nationwide, Germany, Canada and Japan.

_______________________________
PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-1371-04.
CODE
All units using software version 3.03.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letter dated August 6, 2004. Firm initiated recall is ongoing.
REASON
A hardware/software problem will result in low elution volumes and bias sample results for various protocols.
VOLUME OF PRODUCT IN COMMERCE
192.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Abbott Clinical Chemistry AEROSET/ARCHITECT c8000 Creatinine. List No. 7D64-20. Recall # Z-1377-04.
CODE
Lot 14032HW00 Exp: November 17, 2005 and lot 17054HW00 Exp: November 17, 2005.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letters on July 27, 2004. Firm initiated recall is ongoing.
REASON
Precipitate formed in product.
VOLUME OF PRODUCT IN COMMERCE
3,800.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
SYNCHRON Clinical Systems Enzyme Validator Kit. Recall # Z-1378-04.
CODE
M310400.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter sent July 29, 2004. Firm initiated recall is ongoing.
REASON
Incorrect Calibration Acceptance Limits.
VOLUME OF PRODUCT IN COMMERCE
771 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Otto Bock 3R90 and 3R92 Modular Knee Joint with Friction Brake. Recall # Z-1379-04.
CODE
No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004.
RECALLING FIRM/MANUFACTURER
Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by telephone on July 15, 2004. Firm initiated recall is ongoing.
REASON
Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the breaking performance of the knee to malfunction.
VOLUME OF PRODUCT IN COMMERCE
437 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode part number: 8900-2065. Recall # Z-1380-04.
CODE
Lot numbers: 3103, 3203, 3303, 3403, 3503, 3603, 3703, 3803, 3903, 4003, 4103, 4203, 4303.
RECALLING FIRM/MANUFACTURER
Bio-Detek, Inc., Pawtucket, RI, by letter dated July 28, 2004. Firm initiated recall is ongoing.
REASON
Pads may fail due to excessive corrosion of the electrode prior to the expiration date.
VOLUME OF PRODUCT IN COMMERCE
9,971 pairs.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) ADP2.1 Adapter, non-sterile reusable Model Number:
30-802-1, an accessory used with the TissueLink BiPolar
Floating Device. Recall # Z-1415-04;
b) ADP 3.2 Adapter, non sterile reusable Model Number:
30-801-1, an accessory used with the TissueLink Bipolar
Floating Device. Recall # Z-1416-04.
CODE
a) Lot Numbers: TLK113A0, TLL113A0, TLL29300, TLL293A0,
TLL293B0, TLC18400;
b) Lot Numbers: TLK17300, TLB02400.
RECALLING FIRM/MANUFACTURER
TissueLink Medical, Inc., Dover, NH, by visit on July 22, 2004. Firm initiated recall is ongoing.
REASON
Adapter when connected to a generator may short circuit resulting in lack of power and/or thermal warming of the ADP housing.
VOLUME OF PRODUCT IN COMMERCE
164 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Allegiance Laminated Wood Crutches, item 74151-010,
Large Adult , 51" , 64"; 1 pair individually shrink
wrapped, 10 pairs per case; catalog #74151-010, all
product labeled Made in China. Recall # Z-1417-04;
b) Allegiance Laminated Wood Crutches, item 74151-020,
Adult , 47" , 57"; 1 pair individually shrink wrapped,
10 pairs per case; catalog #74151-020, all PRODUCT
labeled, Made in China. Recall # Z-1418-04;
c) Allegiance Laminated Wood Crutches, item 74151-030,
Medium , 43" , 53"; 1 pair individually shrink wrapped,
10 pairs per case; catalog #74151-030, all PRODUCT
labeled Made in China. Recall # Z-1419-04;
d) Allegiance Laminated Wood Crutches, item 74151-040,
Youth , 35" , 43"; 1 pair individually shrink wrapped,
10 pairs per case; Made in China, catalog #74151-040.
Recall # Z-1420-04;
e) Allegiance Laminated Wood Crutches, item 74151-050,
Child , 28" , 36"; 1 pair individually shrink wrapped,
10 pairs per case; Made in China, catalog #74151-050.
Recall # Z-1421-04.
CODE
All product labeled Made in China.
RECALLING FIRM/MANUFACTURER
Duro-Med Industries, Inc., Jesup, GA, by letters dated August 4, 2004 and August 18, 2004. Firm initiated recall is ongoing.
REASON
The crutches were labeled as latex free, but contain rubber in the hand grips, tips and underarm padding of the crutches.
VOLUME OF PRODUCT IN COMMERCE
4,768 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Telesheath Left Atrial Introducer System Right Superior.
Telesheath Catheter Two-Piece Introducer Kit with
Hemostasis Valve. Right Superior Reorder #407900. The
product is packaged in an open, semi-rigid plastic tray,
which is then placed in a sterile barrier pouch
consisting of Tyvek on one side and a clear plastic film
on the other. This pouch is then heat sealed prior to
sterilization. Recall # Z-1425-04;
b) Telesheath Left Atrial Introducer System Right Superior.
Telesheath Catheter Two-Piece Introducer Kit with
Hemostasis Valve. Left Lateral Reorder #407901. The
product is packaged in an open, semi-rigid plastic tray,
which is then placed in a sterile barrier pouch
consisting of Tyvek on one side and a clear plastic film
on the other. This pouch is then heat sealed prior to
sterilization. Recall # Z-1426-04.
CODE
a) 1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date:
05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp
Date: 06/2007;
b) 1063074 - Exp Date: 03/2007, 1075104, - Exp. Date:
05/2007, 1076753 - Exp. Date: 06/2007.
RECALLING FIRM/MANUFACTURER
St. Jude Medical/Daig Division, Minnetonka, MN, by visit and letters starting August 4, 2004. Firm initiated recall is ongoing.
REASON
St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
VOLUME OF PRODUCT IN COMMERCE
347 kits.
DISTRIBUTION
US, Canada, Belgium, Hong Kong, and Japan.

_______________________________
PRODUCT
a) Roche/Hitachi 747 - 100 clinical chemistry analyzer;
catalog number 04009223680. Recall # Z-1428-04;
b) Roche/Hitachi Modular Analytical D Module clinical
chemistry analyzer; catalog number 03739023001. Recall
# Z-1429-04;
c) Roche/Hitachi Modular Analytical D Module DAT clinical
chemistry analyzer; catalog number 04429338160. Recall #
Z-1430-04;
d) Roche/Hitachi Modular Additional D Module DAT clinical
chemistry analyzer; catalog number 04429389160. Recall #
Z-1431-04;
e) Roche/Hitachi 747 - 200 clinical chemistry analyzer;
catalog number 04009223680. Recall # Z-1432-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated August 6, 2004.Firm initiated recall is ongoing.
REASON
A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.
VOLUME OF PRODUCT IN COMMERCE
392 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-1433-04.
CODE
Software versions 1A and 1A2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter, dated August 12, 2004. Firm initiated recall is ongoing.
REASON
Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and/or print an erroneous result or an incorrect dilution factor with a predilute sample result.
VOLUME OF PRODUCT IN COMMERCE
222 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
AxSYM Total B-hCG Reagent Pack. Recall # Z-1436-4.
CODE
Lot numbers: 17202Q100 (expiration date 09/23/2004), 17556Q100 (expiration date 10/17/2004), and 17387Q100 (France) (expiration date 08/23/2004).
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letters dated July 7, 2004. Firm initiated recall is ongoing.
REASON
For failing calibrations.
VOLUME OF PRODUCT IN COMMERCE
3,220 kits.
DISTRIBUTION
NY, WI, CA, SC, FL, MO, and Internationally.

_______________________________
PRODUCT
Deflectable Tip Catheter for cardiac mapping. Mfg Part # Catalog # EU Part # D-1078-35-S 107835S SW1078-035; D-1078-63-S D5S06AL252RT 36A-07Q; D-1078-78-S 107878S N/A; D-1097-511-S 1097511S SW1097-511; D-1097-554-S D708DL002RT 36F-32Q. Recall # Z-1437-04.
CODE
112 lots.
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc, Irwindale, CA, by letter on August 16, 2004. Firm initiated recall is ongoing.
REASON
Potential that product is incorrectly assembled with monel wire attached to the tip dome rather than copper wire.
VOLUME OF PRODUCT IN COMMERCE
848.
DISTRIBUTION
Nationwide and Japan, Europe, and Uruguay.

_______________________________
PRODUCT
Optima Spinal System and Spinal Hook System, set screw component. Part number SP3020 (revision 6). Recall # Z-1438-04.
CODE
Lot # 04D033.
RECALLING FIRM/MANUFACTURER
U&I America, Murray, UT, by letter on August 10, 2004. Firm initiated recall is ongoing.
REASON
Threads on a set screw, as a component of a spinal fixation system, may break off during use.
VOLUME OF PRODUCT IN COMMERCE
60 screws.
DISTRIBUTION
CA.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

 

_______________________________
PRODUCT
a) Sheep Blood, Defibrinated , Catalog Number 211946, Unit 100
ml. Recall # Z-1316-04;
b) Sheep Blood, Defibrinated , Catalog Number 212391, Unit 250
Recall # Z-1317-04;
c) Sheep Blood, Defibrinated , Catalog Number 212389, Unit 30
Recall # Z-1318-04;
d) Sheep Blood, Defibrinated , Catalog Number 211947, Unit 500
Recall # Z-1319-04;
e) Sheep Blood, Defibrinated , Catalog Number 211945, Unit 15
Recall # Z-1320-04;
f) Sheep Blood, Defibrinated , Catalog Number 212390, Unit 100
ml. Recall # Z-1321-04;
g) BBL Brain Heart Infusion Agar w/10% Sheep Blood , Catalog
Number 297655. Recall # Z-1322-04;
h) BBL TSA II w/5% Sheep Blood, Spacesaver , Catalog Number
292537. Recall # Z-1323-04;
i) BBL Columbia C.N.A. Agar w/5% Sheep Blood/Levine EMB ,
Catalog Number 295618. Recall # Z-1324-04;
j) BBL Brain Heart Infusion Agar CC w/ Sheep Blood , Catalog
Number 296178. Recall # Z-1325-04;
k) BBL Columbia C.N.A. Agar w/5% Sheep Blood, , Catalog Number
297831. Recall # Z-1326-04.
CODE
a) Lot number: 4155326 and Expiration date: June 29, 2004;
b) Lot number: 4155341 and Expiration date: June 29, 2004;
c) Lot number: 4155337 and Expiration date: June 29, 2004;
d) Lot number: 4155332 and Expiration date: June 29, 2004;
e) Lot number: 4155324 and Expiration date: June 29, 2004;
f) Lot number: 4155328 and Expiration date: June 29, 2004;
g) Lot number: 4146359 and Expiration date: August 02, 2004;
h) Lot number: 4153582 and Expiration date: September 09, 2004;
i) Lot number: 4153593 and Expiration date: August 26, 2004;
j) Lot number: 4153588 and Expiration date: September 23, 2004;
k) Lot number: 4154491 and Expiration date: August 19, 2004.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by facsimile on July 2, 2004. Firm initiated recall is ongoing.
REASON
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
VOLUME OF PRODUCT IN COMMERCE
9510.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) P.F.C. ® -- Knee System 7f Fluted Femoral Stem 18mmX125mm
REF 96-1703. Recall # Z-1369-04;
b) P.F.C. ® -- Knee System 7f Fluted Femoral Stem 18mmX130mm
REF: 96-1731. Recall # Z-1370-04.
CODE
a) Lot Number: 226436R;
b) Lot Number: 226287R.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN, by verbal contact on December 23, 2003. Firm initiated recall is complete.
REASON
The collar was incorrectly etched for the R (Right) and L (Left) orientation.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY.

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PRODUCT
ProSpecT Campylobacter Microplate Assay. Catalog #2476096. Recall # Z-1372-04.
CODE
Lot #910718.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter on July 15, 2002. Firm initiated recall is complete.
REASON
A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
VOLUME OF PRODUCT IN COMMERCE
382.
DISTRIBUTION
Germany.

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PRODUCT
ProSpecT Shiga Toxin E. coli (STEC) Microplate Assay. Catalog # 2474048 (48 well plate) and 2474096 (96 well plate). For qualitative detection of Shiga toxins (STX1 & STX2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. Recall # Z-1373-04.
CODE
918706 918707.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter on July 18, 2002. Firm initiated recall is complete.
REASON
A potential contamination was noted and the particulate in the conjugate may cause the dropper tip to become plugged.
VOLUME OF PRODUCT IN COMMERCE
83.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496. Recall # Z-1374-04.
CODE
926230.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter on November 21, 2002. Firm initiated recall is complete.
REASON
The conjugate may have become contaminated during filing. The particulates in the contamination may cause the dropper tips to become plugged.
VOLUME OF PRODUCT IN COMMERCE
12.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ProSpecT Giardia Cryptosporidium Microplate Assay. Catalog # 2458496. Recall # Z-1375-04.
CODE
944755.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter on December 10, 2002. Firm initiated recall is complete.
REASON
The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
VOLUME OF PRODUCT IN COMMERCE
127.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ProSpecT Cryptosporidium Microplate Assay. Catalog # 2454096. Recall # Z-1376-04.
CODE
910717 912101.
RECALLING FIRM/MANUFACTURER
Remel, Inc, Lenexa, KS, by letter on May 16, 2002. Firm initiated recall is complete.
REASON
The Positive Control may NOT perform as intended through its expiration date and may invalidate an otherwise acceptable run.
VOLUME OF PRODUCT IN COMMERCE
388.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
P.F.C.? Modular Knee System Modular Plus Tibial Wedge 10f HEMI x 8.5MM HEIGHT Product Code: 86-0178. Recall # Z-1382-04.
CODE
Lot Umber: 330722.
RECALLING FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN, by verbal contact on January 15, 2004. Firm initiated recall is complete.
REASON
Screw size included in system was incorrect.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IA.

_______________________________
PRODUCT
a) Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the
Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number
1877470 (11877470216). Recall # Z-1434-04;
b) Roche/Hitachi AST (ASAT/GOT) Reagent Kit for use on the
Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number
1928511 (11928511216). Recall # Z-1435-04.
CODE
a) All lots expiring on or before 11/05;
b) All lots expiring on or before 7/05.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letters dated August 20, 2004. Firm initiated recall is ongoing.
REASON
Rotation of the instrument reagent compartment can cause a bubble to form in the neck of the reagent bottle causing premature liquid level detection and short sampling of the reagent, resulting in falsely low or zero patient results.
VOLUME OF PRODUCT IN COMMERCE
1,485.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR September 15, 2004

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