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U.S. Department of Health and Human Services

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Enforcement Report for January 7, 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.


January 7, 2004
04-01

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0421-4.
CODE
Unit number: 8526251.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Center, Beaumont, TX, by telephone on December 18, 2002, and by letter, dated January 2, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor who reported traveling to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0422-4.
CODE
Unit number: FBCMKK, FBCMFD, FBCLVC, FBCLQG, FBCLGK, FBCLBT, FBCKSZ, FBCKPG, FBCKGL, FBCKCR, FBCJXD, FBCJSF, FBCJLG, FBCJGX.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by facsimile, dated July 16, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who was previously deferred for high risk IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Units.
DISTRIBUTION
IL, and Germany.

_______________________________
PRODUCT
Red Blood Cells Deglycerolized. Recall # B-0423-4.
CODE
Unit numbers: 1726544, 1727147, 1726668, 1708423.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter, dated May 3, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for residual glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 Units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells Deglycerolized. Recall # B-0424-4.
CODE
Unit numbers: 1727026, 1744890.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter, dated May 1, 2002. Firm initiated recall is complete.
REASON
Blood products, which were not tested for residual glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-0441-4.
CODE
Unit numbers: 26-BLKBFR-B, 26-BLKBKH-B, 26-BLKBNG-B,
26-BLKBSG-B, 26-BLKBWV-B, 26-BLKCSN-B, 26-BLKCWX-B,
26-BLKDTQ-B, 26-BLKDWR-B, 26-BLKFDC-B, 26-BLKFHB-B,
26-BLKFNS-B, 26-BLKFSD-B, 26-BLSGGP-B.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Rock Island, IL, by facsimile, dated June 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated within the past twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0454-4.
CODE
Unit number L23159.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on July 10, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to recent ingestion of an aspirin-like medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0455-4.
CODE
Unit number NF186435.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Nutterfort, WV, by facsimile on December 6, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of post donation information from the donor related to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Platelets, Pheresis. Recall # B-0456-4.
CODE
Unit 55P38913.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR, by telephone on May 23, 2002, and by letter dated May 24, 2002. Firm initiated recall is complete.
REASON
Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Removed. Recall # B-0458-4.
CODE
Unit number: 20GR14912 Part 1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on May 15, 2002.
Manufacturer: American Red Cross Blood Services, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was diagnosed with a post donation kidney infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0459-4;
b) Fresh Frozen Plasma. Recall # B-0460-4;
c) Liquid Plasma. Recall # B-0461-4.
CODE
a) Unit numbers: 1811748, 1797093;
b) Unit number: 1797093;
c) Unit number: 1811748.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by letter, dated March 27, 2001, or by facsimile on March 28, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for all viral markers, but were collected from an ineligible donor due to a reported history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 Units.
DISTRIBUTION
MS, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells Rejuvenated Deglycerolized. Recall # B-0463-4.
CODE
Unit number: 9408760.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by letter, dated November 12, 2001. Firm initiated recall is complete.
REASON
Blood product, manufactured using an expired 1.6% saline solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0466-4;
b) Platelets. Recall # B-0467-4;
c) Fresh Frozen Plasma. Recall # B-0468-4'
d) Recovered Plasma. Recall # B-0469-4.
CODE
a) Units 55KR00469, 55F23591;
b) Unit 55KR00469;
c) Unit 55F23591;
d) Unit 55KR00469.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arkansas Region, Little Rock, AR, by letter dated May 21, 2003. ARC National Headquarters was forwarded a "Questionable Plasma Inquiry" on May 23, 2003, which they forwarded to their California consignee, on May 29, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous self-exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AR.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0436-4;
b) Platelets Leukocytes Removed. Recall # B-0437-4;
c) Platelets Pheresis Leukocytes Removed. Recall # B-0438-4;
d) Fresh Frozen Plasma. Recall # B-0439-4.
CODE
a) Units 38FE93687, 38FE93682, 38FC92913 (2 units),
38FC92900, 38FE93676, 38FE93702, 38LC52505 (2 units),
38LC52555 (2 units), 38LC52510 (2 units), 38FE93685,
38FE93681, 38FE93688, 38FE93695 (2 units), 38FE93693
(2 units), 38LC52550 (2 units), 38LC52540 (2 units),
38LC52560 (2 units), 38FC92903, 38FE93699 (2 units),
38FE93698, 38FE93689, 38FC92908 (2 units), 38FE93713,
38FE93711, 38FE93707, 38LC52599 (2 units), 38LC52515,
38LC52535 (2 units), 38FC92918 (2 units), 38LC52572,
38LC52545 (2 units), 38LC52571, 38FC92916 (2 units),
38FE93708, and 38FE93696 (2 units);
b) Units 38FC92902, 38FC92900, 38FC92909, 38FC92903,
38FC92901, 38P78680 and 38FC92907;
c) Units 38P78679 (2 units) and 38P78678 (2 units);
d) Units 38P78678, 38FC92900, 38FC92909 and 38FC92911.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Indiana-Ohio Region, Fort Wayne, by telephone on December 17, 2002. Firm initiated recall is complete.
REASON
Blood products, which were tested incorrectly by NAT upon initial testing but were negative upon subsequent re-testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 53 Units;
b) 7 Units;
c) 4 Units;
d) 4 Units.
DISTRIBUTION
IN, and OH.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0449-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0450-4;
c) Platelets. Recall # B-0451-4;
d) Platelets, Irradiated. Recall # B-0452;
e) Fresh Frozen Plasma. Recall # B-0453-4.
CODE
a) Unit numbers T25121, R51206, and T46866;
b) Unit number T42906;
c) Unit numbers T25121, R51206, and T46866;
d) Unit number K62019;
e) Unit numbers K62019, R51220, and R51206.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Virginia Blood Services, Richmond, VA, by letter on August 7, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 Units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0457-4.
CODE
Unit number: 4005003.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by telephone on December 12, 2000, and by letter, dated January 8, 2001. Firm initiated recall is complete.
REASON
Platelets, without a platelet count being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells Washed. Recall # B-0462-4.
CODE
Unit number: 1840879.
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Jackson, MS, by letter, dated June 5, 2001. Firm initiated recall is complete.
REASON
Blood product, manufactured using an expired processing set, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-0465-4.
CODE
ZA916, 464327, 469928, CDCNSH, CDCSCR, 7ZD768, CDBLLC, CDFBSP, CDDDYQ, CDCCXZ, CDDFFD, CDDFCM, CDJWDF, CDJKKZ, CDJJSV, CDJHXP, CDJHDX, CDLRTF, CDJMRW, CDHCJK, CDKHJC, CDGHHW, CDCKVL, 8PU901, 9TE166, 9TG183, 9TG126, 9TE797, 9TF193, 9TF175, 9TF505, 921256, CDGBXC, 921801, 9ZA540, CDCQHF, CDBKPP, CDFLRC, CDDMKW, 922608, CDCDDC, CDDJBB, CDFYVG, CDGCVJ, CDGDQF, CDJKCV, CDKCQL, CDHXNQ, CDHXVP, CDHXZG, CDHYNP, CDLMDV, CDJRGJ, CDLHBK, 9TJ512, CDHSYJ, CDHXSJ, CDFXGL, CDBYDF, CDHVGW, CDBQQD, 9N2319, 8DV636, CDHFTF, CDBWNX, CDBGSY, 8PV083, CDCMMZ, CDBHNG, CDKBSL, CDHYMG, CDLPCK, 7ZD727, 7ZD901, 8PU944, 8PV630, 8PV839, 8PV947, 921127, 921432, 921496, 921597, 921600, 921683, 921790, 921856, 922010, 922171, 922258, 922400, 922409, 922548, 922948, 923228, 923280, 923468, 976650, 977075, 977198, 9N1275, 9N2250, 9N2343, 9N2438, 9R0741, 9RP819, 9TE051, 9TE220, 9TE221, 9TE457, 9TE780, 9TF016, 9TF019, 9TF043, 9TF167, 9TF332, 9TF334, 9TF819, 9TF984, 9TG168, 9TG314, 9TG484, 9TI022, 9TI382, 9TI471, 9TI866, 9TJ426, 9TJ438, 9TJ679, 9TJ972, 9TK296, 9TK404, 9TK632, 9TI703, 9ZA059, 9ZA062, 9ZA430, 9ZA533, 9ZA566, 9ZA988, 9ZA997, CDBBJB, CDBBRJ, CDBCQF, CDBDHX, CDBDNL, CDBDWZ, CDBDXM, CDBFGS, CDBFXY, CDBFZK, CDBFZN, CDBHBS, CDBHJP, CDBHXP, CDBHYC, CDBJRF, CDBJRH, CDBJVL, CDBJXB, CDBJXM, CDBJXT, CDBKCY, CDBKDD, CDBKPH, CDBLCH, CDBLGF, CDBLQN, CDBLZP, CDBNRV, CDBQHM, CDBQZN, CDBRRP, CDBSDN, CDBSXX, CDBVBT, CDBWRD, CDBYKP, CDCCKD, CDCCLG, CDCFYD, CDCHGT, CDCLQB, CDCMWD, CDCNKS, CDCNRP, CDCPYH, CDCRYS, CDCRYT, CDCSFL, CDCTHH, CDCWXD, CDCXJX, CDCXQB, CDCXQD, CDCXQH, CDCXQM, CDCXQY, CDCYVK, CDCZDN, CDDBPC, CDDCRY, CDDFMG, CDDGMJ, CDDHGG, CDDJDB, CDDKCC, CDDKFP, CDDKTR, CDDLCX, CDDMKY, CDDRCS, CDDTDC, CDDTDK, CDDVCH, CDDVMS, CDDVSD, CDDWNV, CDDWXF, CDDYHJ, CDDYSP, CDDZHH, CDFCRG, CDFDGX, CDFDNQ, CDFGQN, CDFGRB, CDFGWJ, CDFJLY, CDFKTN, CDFKYJ, CDFLJD, CDFQZL, CDFTNL, CDFTZN, CDFXJJ, CDFYDH, CDFZHS, CDFZYM, CDGBFC, CDGCKB, CDGDYR, CDGFDZ, CDGFNH, CDGFNL, CDGFRJ, CDGFRX, CDGGSX, CDGHJJ, CDGMBF, CDCZDG, CDHCBV, CDHDHB, CDHDMN, CDHDRS, CDHFTG, CDHFYT, CDHGKZ, CDHGLG, CDHGMQ, CDHGQK, CDHJHR, CDHKBZ, CDHSMK, CDHXDQ, CDHYBB, CDHZMN, CDHZNQ, CDJBSQ, CDJCCH, CDJCZK, CDJDHM, CDJDYC, CDJDYJ, CDJFRY CDJGDL, CDJHBC, CDJHDW, CDJJCX, CDJKBL, CDJLZT, CDJMZZ, CDJNWM, CDJQMH, CDJQSG, CDJRBL, CDJRTN, CDKDBV, CDKDCG, CDKDJW, CDKDLC, CDKFDG, CDKHLQ, CDKHZL, CDKJDZ, CDKKRK, CDLBYN, CDLHDM, CDLHQD, CDLHSW, CDLJWS, CDLKSG, CDLLLB, CDLLLX, CDLLTB, CDLNFZ, CDLNTD, CDLPWF, CDLPYJ, CDLQLR, CDLRMV, CDLSHD, CDFMLX, CDFQYY, CDLSDL.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Little Rock, AR, by facsimile dated September 5, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
314 units.
DISTRIBUTION
MA, CA, IL, Germany, and Switzerland.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Lorad M-IV and Lorad M-IV Platinum mammography systems.
Mammographic X-Ray systems to conduct mammography.
Model Number: M-IV and M-IV Platinum.
Recall # Z-0148/0149-04.
CODE
None.
RECALLING FIRM/MANUFACTURER
Lorad, Danbury, Connecticut, by CPA letter December 23, 2003. Firm initiated recall is ongoing.
REASON
System failed to meet the mAs accuracy specifications at low mAs values.
VOLUME OF PRODUCT IN COMMERCE
4,206.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR January 7, 2004

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