Enforcement Report

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.

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February 28, 2007
07-09

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

___________________________________
PRODUCT
Lucky Doll Brand Frozen Tuna Steaks, 6oz. vacum packed, Labeled: ''*** TUNA (Thunnus albacares) 6 oz *** Packed for: CROCKER & WINSOR SEAFOOD, INC. *** PRODUCT OF INDONESIA ***''. They were further packed in a cardboard carton labeled in part as ''*** LUCKY DOLL BRAND PRODUCED BY: PT. DHARMA SAMUDERA FISHING INDUSTRIES, Tbk INDONESIA *** WILD CAUGHT PRODUCT OF INDONESIA NET WT: 10 Lbs ***'', Recall # F-128-7
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Crocker & Windsor, Boston, MA, by telephone and fax on January 17, 2007.
Manufacturer: PT Dharma Samudera Fishing Industries TBK, Jakarta, Indonesia. Firm initiated recall is ongoing.
REASON
Product contains elevated levels of histamine.
VOLUME OF PRODUCT IN COMMERCE
399 cases
DISTRIBUTION
CA, CT, DE, LA, KS, MA, MO, NC, NM, NY, PA, and VA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

___________________________________
PRODUCT
a) Levothyroxine Sodium Tablets USP, 25 mcg (0.025 mg), 100 and 1000 tablet bottles,
Rx only, Recall # D-449-2007;
b) Levothyroxine Sodium Tablets, USP, 50 mcg (0.050mg), 100 and 1000 tablet bottles,
Rx only, Recall # D-450-2007;
c) Levothyroxine Sodium Tablets, USP, 75 mcg (0.075mg), 100 and 1000 tablet bottles,
Rx only, Recall # D-451-2007;
d) Levothyroxine Sodium Tablets, USP, 88 mcg (0.088mg), 100 tablet bottles,
Rx only, Recall # D-452-2007;
e) Levothyroxine Sodium Tablets, USP, 100 mcg (0.1mg), 100 and 1000 tablet bottles,
Rx only, Recall # D-453-2007;
f) Levothyroxine Sodium Tablets, USP, 112 mcg (0.112mg), 100 tablet bottles,
Rx only, Recall # D-454-2007;
g) Levothyroxine Sodium Tablets, USP, 125 mcg (0.125mg), 100 tablet bottles,
Rx only, Recall # D-455-2007;
h) Levothyroxine Sodium Tablets, USP, 137 mcg (0.137mg), 100 tablet bottles,
Rx only, Recall # D-456-2007;
i) Levothyroxine Sodium Tablets, USP, 150 mcg (0.150mg), 100 and 1000 tablet bottles,
Rx only, Recall # D-457-2007;
j) Levothyroxine Sodium Tablets, USP, 175 mcg (0.175mg), 100 tablet bottles,
Rx only, Recall # D-458-2007;
k) Levothyroxine Sodium Tablets, USP, 200 mcg (0.200mg), 100 tablet bottles,
Rx only, Recall # D-459-2007;
l) Levothyroxine Sodium Tablets, USP, 300 mcg (0.300mg), 100 tablet bottles,
Rx only, Recall # D-460-2007
CODE
a) C05T2671A 05T2670 Exp Feb. 07, C06T0311A2 06T0020 Exp Jul 07,
C06T0311A3 06T0030 Exp Jul 07, C06T0321A3 06T0090 Exp Jul 07,
C06T0341A2 06T2630 Exp Aug 07, C06T1051A6 06T6370 Exp Sep 07,
C06T0881A1 06T4820 Exp Sep 07, C06T0341A1 06T2620 Exp Aug 07,
C06T0341A4 06T2650 Exp Aug 07, C06T0341A5 06T2660 Exp Aug 07,
C06T0341A6 06T2670 Exp Aug 07, C06T0361A1 06T2720 Exp Aug 07,
C06T0361A2 06T2730 Exp Aug 07, C06T0361A3 06T2740 Exp Aug 07,
C06T035IA4 06T2680 Aug 07, C06T0351A2 06T2700 Exp Aug 07,
C06T0351A1 06T2690 Exp Aug 07, C06T0871A1 06T4270 Exp Sept 07,
C06T0871A2 06T4280 Exp Sep07, C06T0871A5 06T4800 Exp Sep 07,
C06T0871A6 06T481O Exp Sep 07, C06Tl041A1 06T6280 Exp Sep 07,
C06Tl041A2 06T6300 Exp Sep 07, C06Tl041A3 06T6310 Exp Sep 07,
C06T1061A3 06T6400 Exp Sep 07, C06T1051A1 06T6320 Exp Sep 07,
C06Tl051A2 06T6330 Exp Sep 07, C06T1051A3 06T6340 Exp Sep 07,
C06T0881A2 06T6230 Exp Sep 07, C06T0881A4 06T6250 Exp Sep 07,
C06T0881A5 06T6260 Exp Sep 07, C06T0881A6 06T6270 Exp Sep 07,
C06T1071A4 06T6450 Exp Oct 07, C06Tl071A6 06T6470 Exp Oct 07,
C06Tl081A3 06T6500 Exp Oct 07, C06T0351A3 06T271O Exp Aug 07,
C06T0871A3 06T4290 Exp Sep 07, C06T0871A4 06T4300 Exp Sep 07,
C06T0881A3 06T6240 Exp Sep 07, C04T1641A 04T12200 Exp Dec 06,
C04T1641A 04T12210 Exp Dec 06, C04T1661A 04T12300 Exp Dec 06;
b) C06T0211A1 05T2140 Exp Jul 07, C06T0221A2 06T2030 Exp Jul 07,
C06T0231A1 06T2040 Exp Jul 07, 06T4831A 06T4830 Exp Sep 07,
C06Tl111A1 06T651O Exp Oct 07, C06T0471A1 06T2770 Exp Aug 07,
06T2811A 06T2810 Exp Aug 07, C06T0461A2 06T2760 Exp Aug 07,
06T4351A 06T4350 Exp Sep 07, C06T0481A1 06T2790 Exp Aug 07,
C06T0211A2 06T2150 Exp Jul 07, C06T0241A2 06T2180 Exp Jul 07,
C06T0241A1 06T2170 Exp Jul 07, C06T0231A2 06T2160 Exp Jul 07,
C06T0121A1 06T2210 Exp Jul 07, C06T0121A2 06T2220 Exp Jul 07,
C06T0131A1 06T219O Exp Jul 07, 06T2231A 06T2230 Exp Jul 07,
C06T0461A1 06T2750 Aug 07, C06T0471A2 06T2780 Exp Aug 07,
C06T0481A2 06T2800 Exp Aug 07, C06T0491A1 06T2820 Exp Aug 07,
06T4311A 06T431O Exp Sep 07, C06T0791A1 06T4320 Exp Sep 07,
C06T0791A2 06T4340 Exp Sep 07, 05T3441A Exp Apr 07,
C05T0071A4 Exp May 07, 05T9061A Exp Jul 07;
c) C04T2511A 04T16040 Exp Feb 07, C05T1011A1 05T11320 Exp Feb 07,
C05T1011A2 05T11340 Exp Feb 07, C05T1011A3 05T11350 Exp Feb 07,
C05T1011A4 05T11360 Exp Feb 07, C05T1011A5 05T11370 Exp Feb 07,
C05T1031A4 05T11470 Exp Feb 07, C05T1031A4 05T11480 Exp Feb 07,
C05T1041A3 05T11520 Exp Feb 07, C05T1051A1 05T11560 Exp Feb 07,
C05T0571A5 05T10870 Exp Dec 06, C05T0571A1 05T9080 Exp Dec 06,
05T7491A 05T7491 Exp May 07, C05T1021A2 05T11390 Exp Feb 07,
C05T1021A4 05T11410 Exp Feb 07, C05T1381A2 05T13890 Exp Mar 07,
C05T1381A5 05T13920 Exp Mar 07, C05T1391A1 05T13940 Exp Mar 07,
C05T1391A4 05T13970 Exp Mar 07, C05T11381A6 05T13930 Exp Mar 07,
C05T1381A1 05T11710 Exp Mar 07, C05T1021A3 05T11400 Exp Mar 07,
C05T1041A1 05T11500 Exp Feb 07, C05T1041A2 05T11510 Exp Mar 07,
C05T1041A4 05T11530 Exp Mar 07, C05T1041A5 05T11540 Exp Mar 07,
C05T1041A6 05T11550 Exp Mar 07, C05T1051A2 05T11570 Exp Mar 07,
C05T10571A2 05T9090 Exp Mar 07, C05T10571A3 05T9760 Exp Dec 06,
C05T0571A4 05T10860 Exp Dec 06, 05T5801A 05T5800 Exp May 07,
C05T0231A2 05T6940 Exp May 07, 05T5661A Exp Apr 07, 05T7491A Exp May 07;
d) C05T0841A1 05T7080 Exp Mav 07;
e) C04T2291A Exp Jan 07;
f) C04T2251A Exp. Feb 07;
g) C05T0431A Exp Feb 07;
h) C05T2261A2, C05T2261A3;
i) C05T1411A3 05T14130 Exp Mar 07, C05T0941A Exp Apr 07;
j) 05T3211A 05T3210 Exp Mar 07, C05T0681A1 Exp May 07;
k) C05T0131A1 05T7320 Exp Mar 07, C05T0801A1 05T11200 Exp Jul 07;
l) 05T9391A Exp Jul 07, 04T11911A Exp Nov 06
RECALLING FIRM/MANUFACTURER
Recalling Firm: ALARA Pharmaceutical Corp, Caguas, PR, by letter on November 20, 2006.
Manufacturer: Mova Pharmaceutical Corp, Caguas, PR. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and PR

___________________________________
PRODUCT
a) Thyro-Tab 0.025 mg, packaged in 150,000-tablet bulk drums intended
for repackaging, Recall # D-461-2007;
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, packaged in
100- and 1,000-count bottles, Rx only, NDC 0456-1320-01 (100-ct.) and
NDC 0456-1320-00 (1,000-ct.), Recall # D-462-2007
CODE
a) Lot #HA08306, Exp. April 2007;
b) Lot 050604 (100 ct.) and Lot 050605 (1,000-ct.), Exp. April 2007
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA, by letter and via e-mail dated December 19, 2006 and December 22, 2006. Firm initiated recall is ongoing.
REASON
Subpotent (6-month stability)
VOLUME OF PRODUCT IN COMMERCE
1,922,958 bulk tablets; 13,286/100-tablet bottles and 544/1,000-tablet bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Tizanidine HCl Tablets, 2 mg, packaged in 150 tablet plastic bottles, Rx only, Recall # D-463-2007
CODE
Lot 9694 Exp September 2007
RECALLING FIRM/MANUFACTURER
Alphapharm Pty, Ltd. Carole Park, Australia, by faxed letter dated November 17, 2006. Firm initiated recall is ongoing.
REASON
Failed Dissolution Test Requirements
VOLUME OF PRODUCT IN COMMERCE
48 bottles/150 count
DISTRIBUTION
CO and TN

___________________________________
PRODUCT
Dacarbazine for Injection USP, 200 mg, prepared as the citrate salt, 1 vial - sterile, Rx only, Cytotoxic Agent, For Intravenous Use Only, NDC 61703-327-22, Recall # D-464-2007
CODE
Lot # S012223, Expiration 03/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mayne Pharma (USA) Inc., Paramus, NJ, by letter on January 19, 2007.
Manufacturer: Mayne Pharma Group, Victoria, Australia. Firm initiated recall is ongoing
REASON
Discoloration due to impurity (3 and 6 month stability time points)
VOLUME OF PRODUCT IN COMMERCE
3,391 vials
DISTRIBUTION
MI, SC, NY, PA, FL, NJ, AL, OH, CA, CT and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0634-07;
b) Fresh Frozen Plasma (Apheresis), Recall # B-0635-07;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0636-07;
d) Fresh Frozen Plasma, Recall # B-0637-07
CODE
a) Unit: 5253220;
b) Units: 5253220, 4482296;
c) and d) Unit: 5202821
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, OK, by fax on October 30, 2005 or November 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OK, FL, and LA

___________________________________
PRODUCT
Platelets, Pooled Leukocytes Reduced, Recall # B-0730-07
CODE
Units: 033FY02069, 033GJ91810, 033GL66664, 033GL66669 and 033GV89310
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 28, 2006 and by letter on November 30, 2006. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CT

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0756-07;
b) Red Blood Cells, Recall # B-0757-07;
c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0758-07;
d) Whole Blood, Recall # B-0759-07;
e) Cryoprecipitated AHF, Recall # B-0760-07;
f) Platelets, Leukocytes Reduced, Recall # B-0761-07;
g) Fresh Frozen Plasma, Recall # B-0762-07;
h) Plasma, Frozen, Recall # B-0763-07;
i) Plasma, Cryoprecipitate Reduced, Recall # B-0764-07
CODE
a) Units: 022FQ39509, 022FQ39511, 022FQ39512, 022FQ39521, 022FQ39523, 022FX29477,
022FX29479, 022FX29486, 022FX29488, 022FX29491, 022FX29492, 022FX29494, 022FX29498,
022FX29502, 022FX29642, 022FX29643, 022FX29648, 022FX29654, 022FX29662, 022FX29791,
022FX29823, 022FX29828, 022GE94306, 022GE94307, 022GE94308, 022GE94312, 022GE94313,
022GE94318, 022GE94320, 022GE94322, 022GE94431, 022GQ15902, 022GQ15903, 022GQ15909,
022GQ16061, 022GQ16067, 022GQ16070, 022GQ16072, 022GQ16075, 022GQ16077, 022GQ16197,
022GQ16198, 022GQ16203, 022GQ16204, 022KC88954, 022KC88956, 022KC88981, 022KC88984,
022KE32587, 022KE32603, 022KN70992, 022KN70994, 022KN70998, 022LZ11657, 022LZ11658,
022LZ11705, 022LZ11712, 022LZ11719, 022LZ11731, 022LZ11732, 022FM03535, 022FM03539,
022FM03543, 022FM03544, 022FM03547, 022FM03549, 022FQ39741, 022FQ39744, 022FQ39747,
022FQ39748, 022FQ40042, 022FQ40043, 022FQ40045, 022FQ40046, 022FQ40047, 022FQ40049,
022FQ40050, 022FQ40053, 022FQ40237, 022FQ40241, 022FQ40262, 022FQ40269, 022FQ40271,
022FQ40275, 022FQ40277, 022FS46066, 022FX29589, 022FX29592, 022FX29593, 022FX29601,
022GE94405, 022GE94407, 022GE94408, 022GE94411, 022GE94412, 022GG04735, 022GG04739,
022GG04752, 022GG05229, 022GG05231, 022GG05233, 022GG05235, 022GL35092, 022GL35096,
022GL35099, 022KE33679, 022KE33682, 022KE33688, 022KE33690, 022KE33700, 022KE33704,
022KE33708, 022KE34322, 022KK81693, 022KK81696, 022KK81698, 022KK81702, 022KK81707,
022KK81729, 022KK81737, 022KK81742, 022KK81974, 022KK81978, 022KN71049, 022KN71091,
022KN71100, 022KX82833, 022KX83055, 022KX83057, 022KX83058, 022KX83072, 022KX83078,
022KX83091, 022LP16718, 022LP16723, 022LP16726, 022LP16728, 022LP16729, 022LP16734,
022LP16735, 022LP16736;
b) Units: 022FR00429, 022FX29475, 022KN70990, 022KN70991, 022LP14682;
c) Units: 022GG04749, 022KE34336;
d) Units: 022FR00428, 022FR00430, 022GQ16186, 022GQ16189, 022LL22957,
022LL22961, 022LL22963, 022LL22964, 022LL22966, 022LL22967, 022LL22969, 022LL22970,
022LL22975;
e) Units: 022FC38307, 022FC38312, 022FC38314, 022FC38315, 022FM01476, 022FM01881,
022FM01889, 022FM01908, 022FM01909, 022FQ39521,022FQ39523, 022FX28471, 022FX28472,
022FX28481, 022FX28482, 022FX28486, 022FX29488, 022GM04902, 022GM04910, 022GM04912,
022GQ15264, 022GS23715, 022GS23721, 022GS23722,022KE32603, 022KL30670, 022KL30708,
022KL30715, 022KL30722, 022KL30739, 022KN69595, 022KN69598, 022KN69600, 022KN69604,
022KN70050, 022KN70051, 022KV87386, 022KV87388, 022KV87392, 022KW74309, 022KW74312,
022KW74315, 022KW74326, 022KW74329, 022LP14689, 022LP14693, 022LP14884, 022LP14887,
022LW87979, 022LW87980, 022LW87988, 022LZ11229, 022LZ11658;
f) Units: 022GL35419, 022GL35422, 022GL35424, 022GL35426, 022KE34322, 022KE34336,
022KE34338, 022KE34339;
g) Units (123 units) 022FM01477, 022FM01500, 022FM01503, 022FM01505, 022FM02910,
022FM02914, 022FM03535, 022FM03539, 022FM03544, 022FM03547, 022FM03549, 022FQ37539,
022FQ37543, 022FQ39737, 022FQ39741, 022FQ39742, 022FQ39744, 022FQ39747, 022FQ39748,
022FQ40043, 022FQ40045, 022FQ40046, 022FQ40047, 022FQ40049, 022FQ40050, 022FQ40053,
022FQ40237, 022FQ40241, 022FQ40275, 022FQ40277, 022FS46066, 022FX28427, 022FX28433,
022FX28469, 022FX29185, 022FX29589, 022FX29592, 022FX29823, 022FZ24827, 022FZ24831,
022GE93467, 022GE93470, 022GE93471, 022GE94405, 022GE94407, 022GE94408, 022GE94409,
022GE94411, 022GG04735, 022GG04749, 022GG04752, 022GG05231, 022GG05233, 022GG05235,
022GL35092, 022GL35096, 022GL35099, 022GS22281, 022GS22288, 022KE33459, 022KE33462,
022KE33469, 022KE33471, 022KE33474, 022KE33688, 022KE33690, 022KE33704, 022KE33708,
022KK79489, 022KK79495, 022KK79499, 022KK79511, 022KK79515, 022KK79520, 022KK79522,
022KK79526, 022KK79905, 022KK81693, 022KK81696, 022KK81729, 022KK81737, 022KK81742,
022KK81973, 022KK81976, 022KN69672, 022KN69679, 022KN70019, 022KN70029, 022KN70047,
022KN70048, 022KN71047, 022KN71049, 022KN71052, 022KN71058, 022KN71091, 022KV87019,
022KV87077, 022KV87091, 022KX83055, 022KX83057, 022KX83058, 022KX83072, 022KX83078,
022KX83091, 022LP14694, 022LP14753, 022LP14764, 022LP14772, 022LP14875, 022LP16718,
022LP16723, 022LP16726, 022LP16728, 022LP16729, 022LP16734, 022LP16735, 022LP16736,
022LW87999, 022LZ10913, 022LZ11340, 022LZ11341, 022LZ11508, 022LZ11514;
h) Units: 022FQ39331, 022FQ40267, 022FQ40269, 022FX29662, 022FZ24825, 022FZ24829,
022GM06103, 022KE31972, 022KE31976, 022KK79879, 022KK79885, 022KK81698, 022KK81702,
022KK81707, 022KN68979, 022KV87063, 022KV87067, 022KV87078, 022KV87086, 022KW74283,
022KW74302, 022LP14679, 022LP14745, 022LP14787, 022LP14852, 022LP14853, 022LP14856,
022LP14857, 022LZ10904;
i) Units: 022FM01476, 022FM01886, 022FX29189, 022GM04902, 022KE32587, 022KW74309,
022KW74312
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated August 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
379 units
DISTRIBUTION
Pa, NJ, DL, MI, MD, D.C., VA, and CA

___________________________________
PRODUCT
Platelets, Recall # B-0765-07
CODE
Units: Y54955, Y53849
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 19, 2005. Firm initiated recall is complete.
REASON
Platelets, manufactured with an incorrect second spin setting, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0766-07;
b) Platelets, Recall # B-0767-07
CODE
a) and b) Unit: Y49726
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on December 28, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0774-07
CODE
Unit: 2506931
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone and facsimile on March 29, 2005.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable hemoglobin value, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0831-07;
b) Recovered Plasma, Recall # B-0832-07
CODE
a) and b) Unit: 4148197
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on November 28, 2006 and by facsimile on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and Austria

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0836-07;
b) Fresh Frozen Plasma, Recall # B-0837-07;
c) Cryoprecipitated, AHF, Recall # B-0838-07
CODE
a), b), and c) Unit: KS07332
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, Va., by letter dated April 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
VA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0638-07
CODE
Unit: 5202821
RECALLING FIRM/MANUFACTURER
Sylvan N. Goldman Center, Oklahoma Blood Institute, OK, by fax on October 30, 2005 or November 28, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK, FL, and LA

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0768-07;
b) Recovered Plasma, Recall # B-0769-07
CODE
a) and b) Unit: 5422863
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland,

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0770-07;
b) Fresh Frozen Plasma, Recall # B-0771-07
CODE
a) and b) Unit: 8304864
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc. New York, NY, by telephone on September 27, 2004 and by letter dated September 27, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Platelets that was possibly contaminated with gram positive rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0773-07
CODE
Units: 5001707, 5001709, 5001694
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Scarborough, ME, by telephone on November 29, 2006 and by letter dated November 29, 3006. Firm initiated recall is complete.
REASON
Blood products, which were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
ME

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0833-07
CODE
Unit: 9723797
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on December 17, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0834-07;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0835-07
CODE
a) and b) Unit: 040FP26080
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America, Peoria, IL, by telephone on October 15, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
a) Sara Active Sling, patient lift - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240,
Recall # Z-0424-2007;
b) Sara Active Sling, patient lift - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241,
Recall # Z-0425-2007;
c) Sara Active Sling, patient lift - Standard; item KK53210.0 - model KA1210 (with safety),
Recall # Z-0426-2007
CODE
a) Item KKX053850.0 - models KA1230 (with safety) and KA1240, with production dates of
September 2006 through December 2006. The tag on the sling will state the item number
and have the year '06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or
'12' hole-punched in the third line 'M';
b) Item KKX00120.0 - models KA1231 (with safety) and KA1241, with production dates of
September 2006 through December 2006. The tag on the sling will state the item number
and have the year '06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or
'12' hole-punched in the third line 'M';
c) Item KK53210.0 - model KA1210 (with safety), with production dates of September 2006
through December 2006. The tag on the sling will state the item number and have the year
'06' hole-punched in the top line 'Y', and either the month '09', '10', '11' or '12' hole-punched
in the third line 'M'
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL, by letters dated January 9, 2007.
Manufacturer: Medibo N.V., Achel, Belgium. Firm initiated recall is ongoing.
REASON
There is the potential for the slings to come apart, potentially allowing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
95 slings
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
O²Optix™ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package), Recall # Z-0427-2007
CODE
All Lots starting with 6644001 through 6721262, with expiration dating of 2011/09 through 2011/11, and Lot numbers: 6626127, 6636101, 637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, 6642132 and 6643080, all with expiration dating of 2011/08
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on January 12, 2007. Firm initiated recall is ongoing.
REASON
Reduced lon Permeability
VOLUME OF PRODUCT IN COMMERCE
11.4 million lenses
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; the individually packaged, sterilized catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit, Recall # Z-0428-2007
CODE
Lot number 04116, use by 2008-01, and lot number 05178, use by 2008-09 These two lots of catheters were sold individually and as sterile components of catalog number (REF) 50000, kit lot numbers KC05107, KC05186, KC06002, KC06025, KC06071, KC06060, KC06087, KC06116
RECALLING FIRM/MANUFACTURER
Taut, Inc., Geneva, IL, by letters dated January 19, 2007. Firm initiated recall is ongoing.
REASON
Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
VOLUME OF PRODUCT IN COMMERCE
5,769 catheters
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
IMx Sirolimus Reagent Pack, in vitro diagnostic; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM, Recall # Z-0501-2007
CODE
Lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter dated August 11, 1006.
Manufacturer: Axis-Shield Diagnostics, Ltd., The Technology Park, Dundee, Scotland, UK. Firm initiated recall is complete.
REASON
The sirolimus values may shift higher after storage at 2-8°C or after one freeze/thaw cycle of specimens.
VOLUME OF PRODUCT IN COMMERCE
1,143 kits – U.S., 1,657 kits - Internationally
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Quantum TTC Biliary Balloon Dilation Catheter, Order number QBD-10X3, Recall # Z-0520-2007
CODE
Lot number W2287708
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letters on/about January 31, 2007. Firm initiated recall is ongoing.
REASON
The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19" diameter lighthead;
Models IN19, IN19EL, IN19LH and IN19S, Recall # Z-0524-2007;
b) Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads,
3 bulbs in each of 2 - 19" diameter lightheads, Made in Japan; Models IN1919 and IN1919EL
and IN1919EL/PT, Recall # Z-0525-2007;
c) Skytron Infinity Series surgical light, 4 bulbs in 1 - 22" diameter lighthead, Made in Japan;
Models IF54, IF54EL, IF54LH and IF54S, Recall # Z-0526-2007;
d) Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22" diameter
lightheads, Made in Japan; Models IF5454 and IF5454EL, Recall # Z-0527-2007;
e) Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22" diameter
lightheads, Made in Japan; Models IF545454 and IF545454EL, Recall # Z-0528-2007;
f) Skytron Infinity Series surgical light, 5 bulbs in 1 - 22" diameter lighthead, Made in Japan;
Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL),
Recall # Z-0529-2007;
g) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22" diameter
lightheads, Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL,
Recall # Z-0530-2007;
h) Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22" lighthead
and 8 bulbs in 1 - 30" diameter lighthead. Made in Japan; Model IF3022B. (note only the
22' lighthead is affected.), Recall # Z-0531-2007;
i) Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22"
diameter lightheads, Made in Japan; Models IF222222-B, IF222222EL and IN222222EL,
Recall # Z-0532-2007;
j) Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30" diameter lighthead
and 5 bulbs in 1 - 22" diameter lighthead, Made in Japan; Models IN3022EL and IF3022EL.
(note only the 22' lighthead is affected), Recall # Z-0533-2007;
k) Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30" diameter
lighthead and 5 bulbs in each of 2 - 22" diameter lightheads, Model IN302222EL,
IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22' lightheads are affected),
Recall # Z-0534-2007
CODE
a) Each lighthead bears a unique serial number. For units with model numbers beginning with IN 19,
all seven digit serial numbers with the following numbers in the third and fourth positions of the
numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight serial numbers with a 0
in the fifth position (example: xxxx0xxx);
b) Code Information: Each lighthead bears a unique serial number. For units with model numbers
beginning with IN 19, all seven digit serial numbers with the following numbers in the third and
fourth positions of the numerical series: 95, 96, 97, 98 or 99 (example: xx95xxx) plus all eight
serial numbers with a 0 in the fifth position (example: xxxx0xxx);
c) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54,
all serial numbers with the following numbers in the third and fourth positions of the numerical
series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
d) Each lighthead bears a unique serial number. For units with model numbers beginning in IF54,
all serial numbers with the following numbers in the third and fourth positions of the numerical
series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
e) Code Information: Each lighthead bears a unique serial number. For units with model numbers
beginning in IF54, all serial numbers with the following numbers in the third and fourth positions
of the numerical series: 95, 96, 97, 98, 99, 00 or 01 (example: xx98xxx);
f) Each lighthead bears a unique serial number. For units with model numbers beginning with IF22,
all serial numbers with the following numbers in the third and fourth position of the numerical
series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB). For units with model
numbers beginning with IN22 , all serial numbers with the following numbers in the third and
fourth positions of the numerical series: 92, 93 or 94 (example: xx93xxxx);
g) Each lighthead bears a unique serial number. For units with model numbers beginning
with IF22, all serial numbers with the following numbers in the third and fourth position
of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB).
For units with model numbers beginning with IN22 , all serial numbers with the following
numbers in the third and fourth positions of the numerical series: 92, 93 or 94
(example: xx93xxxx);
h) Each lighthead bears a unique serial number. For units with model numbers containing
IF and 22, all serial numbers with the following numbers in the third and fourth position
of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB);
i) Code Information: Each lighthead bears a unique serial number. For units with model
numbers beginning with IF22, all serial numbers with the following numbers in the third
and fourth position of the numerical series: 95, 96, 97, 98, 99 or 00
(examples: xx97xxxx or xx00xxxB). For units with model numbers beginning with IN22,
all serial numbers with the following numbers in the third and fourth positions of the
numerical series: 92, 93 or 94 (example: xx93xxxx);
j) Each lighthead bears a unique serial number. For units with model numbers containing
IF and 22, all serial numbers with the following numbers in the third and fourth position
of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB).
For units with model numbers containing IN and 22 , all serial numbers with the following
numbers in the third and fourth positions of the numerical series: 92, 93 or 94
(example: xx93xxxx);
k) Each lighthead bears a unique serial number. For units with model numbers containing
IF and 22, all serial numbers with the following numbers in the third and fourth position
of the numerical series: 95, 96, 97, 98, 99 or 00 (examples: xx97xxxx or xx00xxxB).
For units with model numbers containing IN and 22 , all serial numbers with the following
numbers in the third and fourth positions of the numerical series: 92, 93 or 94
(example: xx93xxxx)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, by letters on November 23, 1999, November 1, 2002 and again on January 8, 2007.
Manufacturer: Dai-Ichi Shomei Co., Ltd. Tokyo, Japan. Firm initiated recall is ongoing.
REASON
If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
VOLUME OF PRODUCT IN COMMERCE
Approximately 5,000 units
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
a) Symbia S Series SPECT (Single-Photon Emission Computed Tomography)
System with a Pinhole Collimator; part number 08717741, Recall # Z-0548-2007;
b) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography
and Computed Tomography) System with a Pinhole Collimator, Recall # Z-0549-2007
CODE
a) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01006, 01008, 01009, 01019, 01021, 01022, 01024, 01032,
01033, 01034, 01038, 01044, 01045, 01049, 01051, 01052;
b) All systems with pinhole collimators and e.soft software versions 5.5 or earlier:
Serial numbers 01015, 01032, 01037, 01045, 01061, 01065, 01068, 01072, 01074,
01076, 01077
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated January 30, 2007. Firm initiated recall is ongoing.
REASON
Symbia systems, running on e.soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Cmax Surgical Table, Model No. 2182625, Recall # Z-0554-2007
CODE
Serial Numbers: C429106030 through C436306020
RECALLING FIRM/MANUFACTURER
Steris Corporation, Montgomery, AL, by letter on February 6, 2007. Firm initiated recall is ongoing.
REASON
A variation in suppliers welding processes, at the inner section of the hydraulic lift column, of the surgical table, may result in the table top becoming unstable, which could result in injury to patients or staff.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems, Recall # Z-0380-2007
CODE
NicoletOne Version 5.20 software released and installed after August 07, 2006.
RECALLING FIRM/MANUFACTURER
Nicolet Biomedical, Div of Viasys Healthcare, Madison, WI, by Advisory Notice, dated August 25, 2006. Firm initiated recall is ongoing.
REASON
A software anomaly exists in the 5.20.1038 NicoletOne LTM, Sleep, nEEG, vEEG and ICU Monitor systems using the M, and/or C series amplifiers. If this anomaly occurs, the system will display the data for channel one in all channels on NicoletOne LTM, Sleep, nEEG, vEEG or ICU Monitor systems.
VOLUME OF PRODUCT IN COMMERCE
75 systems
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc, Recall # Z-0423-2007
CODE
Batch numbers shipped to US: 82/0415, 82/04474, 82/05062, 82A/05454, 82/04172, 82/04264, 82/04274, 82/04472, 82/04511, 82/05052, 82A/0526, 82A/05404, 82A/0619, 82/04182, 82/04204, 82/04252, 82A/05452, 82A/06014, 82A/0620, 82/04194, 82/04242, 82/04492 & 82A/06024
RECALLING FIRM/MANUFACTURER
Teknimed SA, L, France, by letter dated August 31, 2006 and October 1, 2006. Firm initiated recall is ongoing.
REASON
The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.
VOLUME OF PRODUCT IN COMMERCE
3,366 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Anaerotest for microbiology, in vitro diagnostic. Specification: Performance Test Anerobic:
white within 4-6 hours; aerobic: blue with 20 minutes Item # 1.19034.0002 17.08.06 1 unit
UPC 4 022536 667928, Recall # Z-0498-2007;
b) Anaerotest, in vitro diagnostic; Microbiology, 50 test strips Item # 1.15112.001. Store dry and
tightly closed. Store at + 15 C to +25C, Recall # Z-0499-2007
CODE
a) and b) Lot # OC553145
RECALLING FIRM/MANUFACTURER
Recalling Firm: EMD Chemicals Inc, Gibbstown, NJ, by letter on August 17, 2006.
Manufacturer: Merck KGaA, Darmstadt, Germany. Firm Initiated recall is complete.
REASON
Lot # OC553145 of Anaerotest failed to remain in specification. QC indicator shows an anaerobic environment even if oxygen is present.
VOLUME OF PRODUCT IN COMMERCE
8 rolls item #1.19034.002; 800 packages of 50 strips of item #1.15112.001
DISTRIBUTION
Nationwide including PR

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES -- CLASS II

___________________________________
PRODUCT
Broiler Grower, 200-118-101, medicated, bulk poultry feed, Recall # V-019-2007
CODE
None, bulk product
RECALLING FIRM/MANUFACTURER
Golden Rod Feed Mill Inc., Cullman, AL., by visit on October 2, 2006. Firm initiated recall is complete.
REASON
Feed contained excessive amounts of sodium.
VOLUME OF PRODUCT IN COMMERCE
52,550 lbs.
DISTRIBUTION
AL

___________________________________
PRODUCT
Dairy cattle feed blends containing ProLak and/or ProAmino II protein concentrate, Recall # V-020-2007
CODE
All finished product manufactured from April, 3, 2006 to April 30, 2006
RECALLING FIRM/MANUFACTURER
Eatonton Co-Op Feed Company, Eatonton, GA, by letter on/about December 12, 2006. Firm initiated recall is complete.
REASON
Finished feed product was manufactured from raw feed material that may have been contaminated with ruminant derived protein.
VOLUME OF PRODUCT IN COMMERCE
25 tons
DISTRIBUTION
GA

___________________________________
PRODUCT
Sweet Dairy Whey (Edible Grade) Product Code: 7012 A Derivative of Milk Plant 49-66, UTAH PROTEINS 6350 North 2150 West, Smithfield, UT 84335, Net Wt: 50 lb bags, Made in USA., held in paper bags lined with polyethylene liner, stored under ambient conditions, Recall # V-021-2007
CODE
Lot SM06300, SM06306, SM06307, SM06296.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Protient, Inc., Saint Paul, MN, by telephone and letter on November 18, 2006 and follow-up letter on November 21, 2006.
Manufacturer: Utah Proteins LLC, Smithfield, UT. Firm initiated recall is ongoing.
REASON
Sweet Dairy Whey Powder ingredient may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
90,000 lbs
DISTRIBUTION
CA, UT, NE

END OF ENFORCEMENT REPORT FOR FEBRUARY 28, 2007

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