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U.S. Department of Health and Human Services

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Enforcement Report for April 26, 2006

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

April 26, 2006
06-17

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Tizanidine Hydrochloride Tablets, 4 mg, Rx only, NDC 0093-5160-51,
Recall # D-229-6;
b) Tizanidine Hydrochloride Tablets, 2 mg, Rx only, Recall # D-230-6
CODE
a) Lot # 22765D exp 3/06, 22766D exp 3/06, 22767D exp 3/06, 22609 exp 3/06,
22610 exp 3/06, 22762 exp 4/06, 22763 exp 4/06, 22764 exp 7/06,
23241 exp 7/06, 23242 exp 7/06, 23348 exp 8/06, 23349 exp 8/06,
23739 exp 9/06, 23740 exp 9/06, 23854 exp 11/06, 23963 exp 12/06,
23964 exp 1/07, 24077 exp 2/07, 24369 exp 2/07, 24454 exp 2/07,
24626 exp 4/07, and 24627 exp 4/07;
b) Lot # 22791D exp 4/06, 22792D exp 4/06, 22793D exp 4/06, 22805 exp 4/06,
23745 exp 9/06, 23965 exp 10/06, 23966 exp 1/07, and 24375 exp 3/07
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals, Sellersville, PA, by letters on/about March 20, 2006, firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
515,842 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and
pramoxine HCl 1%) Net Wt. 1 oz tube, Rx only, NDC 0496-0800-04,
Recall # D-231-6;
b) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and
pramoxine HCl 1%) Professional sample, Net Wt. 3 gram tube,
Rx only, NDC 0496-0800-33, Recall # D-232-6;
c) L.M.X.5 (lidocaine 5%) Anorectal Cream, Net Wt. 15 gram tube,
OTC, NDC 0496-0883-15, Recall # D-233-6;
d) Analpram HC Cream 1% (hydrocortisone acetate 1% and
pramoxine HCl 1%) Net Wt. 1 oz tube, Rx only, NDC 0496-0778-04,
Recall # D-234-6
CODE
a) Lots 04122A (exp. 07/06), 04123A (exp. 07/06), 04124A (exp. 07/06),
04138A (exp. 08/06), 04139A (exp. 08/06), 05042A (exp. 02/07),
05044A (exp. 02/07), 05058A (exp. 03/07), 05059A (exp. 03/07),
05060A (exp. 03/07), 05068A (exp. 03/07), 05079A (exp. 04/07),
05080A (exp. 04/07), 05081A (exp. 04/07), 05091A (exp. 04/07),
05092A (exp. 04/07), 05093A (exp. 04/07), 05094A (exp. 06/07),
05095A (exp. 06/07), 05096A (exp. 08/07), 05173A (exp. 08/07)
and 05231A (exp. 08/07);
b) Lots 05145A (exp. 05/07), 05079B (exp. 04/07), 05080B (exp. 04/07),
and 05081B (exp. 04/07);
c) Lots 04021A (exp. 04/06) and 05085A (exp. 04/08);
d) Lots 04135A (exp. 08/07), 04136A (exp. 08/07), 04186A (exp. 11/07),
04189A (exp. 11/07), 04190A (exp. 11/07), 04191A (exp. 11/07),
04201A (exp. 12/07) and 04202A (exp. 12/07)
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, MI, by letter dated March 24, 2006, firm initiated recall is ongoing.
REASON
Reports of adverse events: The firm redesigned the applicator and, since the design change, patients have reported being injured by the applicator upon use.
VOLUME OF PRODUCT IN COMMERCE
414,259 tubes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nugest 900 Topical Cream, Progesterone USP, packaged in 2-oz. jars, Recall # D-236-6
CODE
Lot number: 51311
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutraceutics, Saint Louis, MO, by letters dated March 23, 2006.
Manufacturer: GDMI, Inc., Garland, TX, firm initiated recall is ongoing.
REASON
Unapproved New Drug; over the counter cream contains Progesterone, USP.
VOLUME OF PRODUCT IN COMMERCE
3,379 jars
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Methylphenidate Hydrochloride Extended-Release Tablets, USP, 20 mg, CII, Rx only, 100 Tablets, NDC 0591-3111-01, Recall # D-235-6
CODE
Lot L5L1270, Exp. Date 12/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA, by letters dated, March 27, 2006.
Manufacturer: Watson Laboratories, Inc., Carmel, NY, firm initiated recall is ongoing.
REASON
Failed Dissolution Specification; 3-month stability.
VOLUME OF PRODUCT IN COMMERCE
4,993 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-0616-6
CODE
Unit number: 0370521116
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Medford, OR, by facsimile on February 19, 2004 and March 9, 2004, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor that subsequently was determined to have an unreported body piercing, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0681-6
CODE
Unit numbers: 4232511, 4232493 (part of split product)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by fax on April 5, 2005, firm initiated recall is complete.
REASON
Blood products, collected using equipment that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0860-6
CODE
Unit number: 012GF17754
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on August 30, 2004, and by letter dated September 7, 2004, firm initiated recall is complete.
REASON
Red Cells, prior to completion of validation studies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0921-6
CODE
Unit number: 36FG26262
RECALLING FIRM/MANUFACTURER
The American National Red Cross, South Carolina Region, Columbia, SC, by telephone on June 23, 2005, and by letter dated June 27, 2005, firm initiated recall is complete.
REASON
Blood product, collected from a donor previously diagnosed with lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0922-6;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0923-6;
c) Red Blood Cells, Recall # B-0924-6
CODE
a) Unit numbers: B212072 (split product), B21179;
b) Unit number: B21179;
c) Unit number: Z110691
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated September 5, 2003, firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
_____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0925-6
CODE
Unit number: 71Q93466-3
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center, Dunwoody, GA, by fax on November 16, 2005, firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted red blood cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0931-6;
b) Recovered Plasma, Recall # B-0932-6
CODE
a) and b) Unit number: 12KP84231
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone and letter on April 29, 2004, firm initiated recall is complete.
REASON
Blood products, which tested negative for anti-HCV, but were collected from an ineligible donor who previously tested repeat reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0965-6
CODE
Unit number: 36Y75006
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region, Columbia, SC, by telephone on August 7, 2003 and by letter on August 8, 2003, firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Lupron, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0967-6
CODE
Unit number: 04R34997
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by facsimile and by letter on January 8, 2006, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NH

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0968-6
CODE
Unit number: 04LQ29358
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by facsimile and by letter on January 17, 2006, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NH

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0969-6
CODE
Unit number: 06GF83952
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone on July 3, 2002, and by letter dated August 13, 2002, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0970-6
CODE
Unit number: 102908081
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by telephone on May 24, 2004, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0971-6
CODE
Unit number: 06GV14741
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Pomona, CA, by telephone on August 26, 2003, and by letter dated September 4, 2003, firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0976-6;
b) Plasma Frozen, Recall # B-0977-6
CODE
a) and b) Unit number: 100485227
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by telephone on August 1, 2004, firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0978-6;
b) Platelets, Recall # B-0979-6
CODE
a) and b) Unit number: 4356015
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by telephone and by facsimile on January 28, 2005, 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
2 units
DISTRIBUTION
FL
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0862-6
CODE
Unit number: 12KG72874
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone and facsimile transmission dated June 11, 2005, and by letter on June 14, 2005, firm initiated recall is complete.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0875-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0876-6
CODE
a) Unit numbers: G44413, G44415, G44417, G44418, G44420, G44422, G44424,
G44425, G44426, G44427, G44429, G44431, G44432, G44434, G44439,
G44440, G44442, G44443;
b) G44411, G44412, G44414, G44416, G44419, G44421, G44423, G44428,
G44430, G44433, G44435, G44441, G44445
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax and letter on September 12, 2005, firm initiated recall is complete.
REASON
Blood products, collected from donors whose hematocrits were not recorded concurrently during screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
IL and LA

______________________________
PRODUCT
Reagent Red Blood Cells (Referencells A1 and B), Package Size: 2 x 10mL, Recall # B-0944-6
CODE
Lot number: 27461, Expiration Date: September 2, 2005
RECALLING FIRM/MANUFACTURER
Immucor, Inc, Norcross, GA, by letter dated August 4, 2005, firm initiated recall is complete.
REASON
Reagent Red Blood Cells, containing incorrect package inserts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6,588 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Red Blood Cells, Recall # B-0946-6
CODE
Unit numbers: 0208286; 0208288; 0208290; 0208360; 0208542; 0208552; 0209034; 0208868
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by letter dated January 4, 2005, firm initiated recall is complete.
REASON
Red cells, collected in bags that had exceed their expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
GA and SC

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092, Recall # Z-0716-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Blackstone Medical, Inc., Springfield, MA, by email on December 23, 2005 and by letter on December 28, 2005, firm initiated recall is ongoing.
REASON
Pedicle Screw may disengage in post operative period requiring intervention.
VOLUME OF PRODUCT IN COMMERCE
24 sets
DISTRIBUTION
AL, CA, CO, IL, NH, NM, TX, BMI, Diessen, Germany

______________________________
PRODUCT
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy, Recall # Z-0765-06
CODE
Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated March 28, 2006 and by press release on March 31, 2006.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK, firm initiated recall is ongoing.
REASON
Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.
VOLUME OF PRODUCT IN COMMERCE
2000 units
DISTRIBUTION
Nationwide and Canada
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

*****CORRECTION*****

In the April 12, 2006 Enforcement Report the serial numbers listed for recall # Z-0710-06 (Lifepak 12) are the serial numbers for recall Z-0711-06 (Lifepak 20). See correct Codes below:

______________________________
PRODUCT
a) Lifepak 12 defibrillator/monitor, Recall # Z-0710-06;
b) Lifepak 20 defibrillator/monitor, Recall # Z-0711-06
CODE
a) Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 34087619, 34087620, 34087605, 34087610, 34087612, 34087035, 34087892, 34087602, 34087615, 34087616, 34087617, 34087618, 34086700, 34086709, 34086715, 34087613, 34086714, 34087609, 34087607, 34087614, 34087608, 34086718, 34086706, 34086719, 34086711, 34086713, 34086705, 34086717, 34086702, 34087606, 34086703, 34087033, 34086708, 34086712, 34087603, 34086707, 34087604, 34086716, 34087601, 34087034, 34091720, 33949930, 34091120, 34039430, 34039429, 34015786, 34011974, 33982989, 33899585, 33995356, 33995351, 33995350, 33995346, 33995360, 33995355, 33995369, 33995349, 33995348, 33995352, 33995347, 33995359, 33995353, 33995345, 33995358, 33995354, 12737672, 33913878, 34094631, 34049603, 34049601, 34049604, 34049611, 34049606, 34049607, 34049609, 34049612, 34049608, 34049610, 34049605, 34049602, 30859396, 33978921, 33978922, 33978923, 33978924, 34039468, 34039433, 34039470, 34083705, 34096379, 33915357, 33988150, 33992032, 33931367, 33931365, 33931364, 33931363, 33931362, 33931366, 34052702, 34052703, 33795379, 34095303, 34095298, 34095299, 34095304, 34095300, 34096375, 34095314, 34095313, 34095312, 34095307, 34095306, 34095305, 33862271, 34019587, 34020177, 34019586, 34019585, 34090338, 34090337, 34049130, 34043663, 34086675, 34086676, 34086671, 34086672, 34086674, 34086673, 33832318, 33888386, 33888372, 33888377, 33888376, 33888378, 33888379, 33888383, 33888385, 33888384, 33888373, 34044798, 34064654, 34019555, 34019554, 33802295, 33990042, 33982418, 33982417, 34074060, 34074061, 34095296, 34039463, 33950592, 33983052, 34099021, 34095323, 34082638, 34078647, 34078648, 34078646, 34082590, 34082591, 34048199, 34048200, 34049140, 34049141, 34048196, 34048198, 34045124, 34048194, 34010325, 33899587, 34096386, 34074089, 33974887, 33974888, 34078076, 34100491, 34100492, 34099179, 34099180, 34099178, 34099177, 34099176, 34090571, 34067899, 33995913, 33995914, 33974374, 33974373, 34013030, 34083205, 34019584, 10732394, 10732404, 34079488, 34084291, 34084290, 34004900, 34019558, 34019561, 33913867, 33913879, 33913888, 33995281, 33995280, 34090554, 34090556, 34090555, 34052280, 33991462, 34065273, 34048197, 34048195, 34034132, 34004904, 34082921, 34060126, 34060127, 34060128, 34086704, 34086701, 34086710, 33992506, 34074081, 34074073, 33855207, 33995302, 33995301, 34054626, 34054625, 33904163, 12776983, 33997196, 33987972, 33987973, 33928602, 34010320, 33974366, 34095302, 33938189, 34040207, 34039481, 34060174, 34060158, 34060161, 34060160, 34064667, 34003616, 34039469, 34060746, 34034134, 34106173, 33995035, 34074053, 34010323, 34090366, 34087611, 34090303, 34090302, 34091128, 34091129, 34095293, 33897593, 34078783, 34078784, 34078785, 34074072, 33992007, 33992020, 33993956, 33992022, 33992002, 33992021, 33992024, 33992025, 33992026, 33992004, 33992009, 33992015, 33992001, 33990248, 33992006, 33992005, 33992008, 33992014, 33992018, 33992017, 33990243, 33990246, 33990247, 33992011, 33992012, 33992013, 33992019, 33992010, 34019904, 33899702, 33960797, 33960796, 33960799, 33960798, 33960795, 33995049, 34061036, 34090589, 33931359, 33931358, 33931355, 33931356, 33931357, 34079490, 34079489, 34079833, 34079492, 34079491, 34079487, 34079486, 34079485, 33936114, 34068040, 34068041, 34078675, 33925842, 33925844, 33925846, 33925841, 33925843, 33925845, 33935283, 33935282, 33935281, 33935280, 33928109, 34090546, 34039464, 34082588, 33911101, 33911100, 33965863, 34074054, 34070493, 33997671, 33997672, 34078070, 34064659, 33996557, 33996553, 33996551, 33996550, 33996556, 33996549, 33996849, 33996558, 33996554, 33996552, 33993444, 34095321, 34095327, 34095331, 34095330, 34095326, 34095329, 34095320, 34095324, 34095328, 34095322, 33983339, 33976090, 33983346, 33983345, 33983338, 33983337, 33983336, 33983335, 32525390, 33995263, 34020191, 34019826, 34019557, 34019827, 34019556, 13583628, 34005592, 34005591, 34005587, 34005588, 34005589, 34005590, 33969580, 33969582, 33969581, 33969583, 33969584, 33995222, 34045762, 34099186, 34099185, 33991446, 33903858, 33997197, 34084471, 34075613, 34075614. International Serial Numbers: 34098600, 34098601, 34090290, 34049509, 34049514, 34049515, 34083701, 34083702, 34044802, 33982442, 33982438, 33982439, 33934527, 33903205, 33903206, 33903208, 33903204, 33903198, 33903203, 33903207, 33903201, 33903210, 33903202, 33903199, 33903200, 33934528, 33934531, 33934529, 33934526, 33934530, 33928168, 33903217, 33928174, 33928165, 33982454, 33982437, 33982443, 33982440, 33903216, 33903215, 33982453, 33982452, 33982451, 33982450, 33982441, 33982448, 33982447, 33982446, 33982445, 33982444, 33982449, 33903209, 33928169, 33928160, 33928161, 33928162, 33928164, 33928170, 33928171, 33928172, 33928173, 33928175, 33928176, 33928177, 33928167, 33903211, 33903212, 33903213, 33903214, 33928159, 33950039, 33950038, 33950048, 33952773, 33952774, 33952775, 33952771, 34105152, 33950032, 33876945, 33876930, 33821315, 33876931, 34078216, 33876941, 33876943, 33876942, 33876938, 33876944, 33876952, 33876928, 33876946, 33876951, 33876950, 33876948, 33876940, 33876933, 33876935, 33876936, 33876937, 33950037, 33929937, 33950034, 33950043, 33950042, 33950041, 33950040, 33950053, 33950052, 33950051, 33950049, 33950045, 33950046, 33950047, 33950035, 33950050, 33950054, 33876949, 33876947, 33876939, 33876934, 33876932, 34079098, 33876929, 33950044, 33950033, 33950031, 33950030, 33950036, 34078082, 34078078, 34078081, 34078080, 34079097, 34083393, 34078079, 33985301, 33985300, 33985299, 33985307, 33986568, 33952772, 34079096, 34078215, 34078217, 34078225, 33982471, 33985298, 33985303, 33985304, 33986537, 33985302, 34009595, 34009594, 34009593, 34083729, 34083732, 34077752, 34106204, 34091376, 13669402, 33928605, 33985022, 33983183, 33979582, 33979583, 33974289, 33974293, 33952829, 33952830, 33798619, 33913915, 33798616, 33913909, 33918168, 33918735, 33918736, 33872713, 33918165, 33918166, 33918167, 33918181, 33795390, 33798614, 33896029, 33887441, 33798612, 33795399, 33795397, 33932561, 34094348, 34094349, 34091746, 33986283, 34039425, 33986294, 33983009, 33795389, 33983184, 33983178, 33983010, 33961531, 34074827, 34087714, 33974286, 34049521, 34049526, 34049527, 34049528, 34049529, 34049530, 34053704, 34049523, 33913897, 33913904, 34008743, 34008737, 34003664, 34003634, 34020680, 34020681, 34020164, 34020510, 34034118, 34034725, 33983556, 33974288, 33974287, 33979581, 33974290, 33974291, 34049522, 33983555, 33983554, 33979580, 33974229, 33974292, 33986320, 33913913, 34049520, 33986261, 33974295, 34053733, 34049525, 34053699, 34049524, 33913899, 33913900, 33913901, 33913902, 33985306, 33913905, 34069183, 33985305, 33913898, 33913903, 33913906, 33986313, 33986285, 34003817, 34049519, 34003650, 34003796, 34004911, 34008686, 34008744, 34008742, 34008740, 34008739, 34008738, 34008687, 34008745, 34008741, 34003658, 34020516, 34084458, 34084468, 34074427, 34084092, 34087711, 34087496, 33937399, 33937400, 33937398, 34090742, 33937401, 33937404, 34074835, 33937402, 34083715, 33937403, 33937397, 34090743, 33937405, 33910410, 33910411, 34090741, 34083714, 34044811, 34044812, 34039416, 34074102, 33979590, 34074107, 33983550, 34039419, 34073371, 34039413, 33958404, 33958774, 34074106, 33855054, 33921591, 33921592, 33880013, 33880012, 33880011, 33895654, 33900603, 33899646, 33895655, 33961098, 33961097, 33978886, 34074101, 34106223, 33973952, 33978885, 33979004, 33978888, 33978887, 33983551, 34039415, 34039409, 34039408, 33979564, 33979567, 34079036, 33895653, 33895652, 33895651, 33895650, 33895649, 33893664, 33892562, 33945926, 34074108, 34064246, 34039418, 33895656, 34064247, 34074105, 33968953, 34074099, 34074595, 34074596, 34074104, 34074098, 33949217, 33968972, 33969016, 34074103, 34008392, 34039421, 34012451, 34039422, 34040777, 34040525, 33969015, 34039406, 33968973, 34039405, 33968970, 33968962, 33968966, 33968964, 33969014, 34039407, 33968968, 34034122, 34034124, 34034127, 34034129, 34073370, 33983559, 34073365, 34073366, 34073376, 34065724, 34073364, 33905086, 33905087, 33905088, 33905089, 34003929, 34073369, 34073372, 34073373, 34073374, 34073375, 33968961, 33968963, 33983561, 34079035, 34043644, 34079040, 34079039, 34079037, 34073368, 34073367, 34073363, 34079038, 33928097, 34039410, 34043602, 33983560, 34039411, 34039412, 34043601, 34039414, 33928392, 33968957, 33968956, 33968955, 33968954, 34004876, 34043599, 34044807, 34004928, 34004927, 33968971, 34039417, 34003928, 34004922, 34004924, 34039423, 33968959, 34106425, 34106224, 34106225, 34086724, 34091392, 34086725;
b) Domestic Serial Numbers: 33884879, 33884872, 33884912, 33884871, 33884867, 33884866, 33829105, 33829090, 33950589, 33911492, 33946302, 33884898, 33951494, 33980272, 33986554, 33818744, 33818718, 33924702, 33881437, 33905482, 33894423, 33951266, 33905466, 33955767, 33900980, 33980275, 33980280, 33980287, 33980281, 33819680, 33829407, 33971829, 33986933, 33967385, 34011822, 34011819, 33894426, 33894572, 33900981, 33936889, 33884924, 33826068, 33981789, 33981799, 33981792, 33981805, 33981794, 33981796, 33981793, 33981795, 33981797, 33959538, 33938363, 34011821, 33894425, 33959550, 33938924, 33938921, 33922299, 33930122, 33933904, 33826017, 33955760, 33897337, 33955747, 33951295, 33951456, 33976455, 33951447, 33951275, 33979473, 33979470, 33979471, 33979472, 33979474, 33979469, 33976420, 33976429, 33976413, 33976414, 33976415, 33976416, 33976411, 33976418, 33976410, 33976424, 33976426, 33976427, 33976417, 33976412, 33976430, 33976406, 33976407, 33976408, 33976428, 33976431, 33976419, 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33884911, 33990265, 34015699, 31368552, 33986913, 33911532, 33911535, 33936914, 33971950, 33894290, 33911625, 33986559, 33986549, 33986551, 33986323, 33911595, 33915885, 33933909, 33826019, 33826001, 33825999, 33826000, 33823372, 33823373, 33823375, 33823342, 33823340, 33823348, 33823367, 33823366, 33823358, 33823356, 33829111, 33823382, 33823386, 33823381, 33823378, 33823384, 33951602, 33951449, 33986558, 33986556, 33986553, 33986325, 33986339, 33818733, 33951572, 33951568, 33951439, 33951556, 33980297, 33897327, 33980274, 33915956, 33826048, 33951476, 31388033, 33905592, 33905589, 33990271, 34011832, 33933911, 33905582, 33894597, 33955840, 33915926, 33915939, 33933931, 33884958, 33997573, 33997566, 33946303, 33930103, 33924697, 33924699, 33924696, 33924695, 33924703, 33924705, 33924706, 33924692, 33930102, 33930105, 33897353, 33924701, 33818749, 33946314, 33930107, 33924684, 33924682, 33955755, 33986911, 34011824, 34017741, 33980296, 33986546, 33986334, 33986343, 33986335, 33986337, 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33980267, 30587187, 33915937, 33915935, 33915949, 30540981, 30880107, 30523113, 30416301, 30493029, 33915900, 33915913, 33950577, 33826055, 33826054, 33826052, 33819668, 33818760, 33951289, 31005264, 31003144, 33905623, 33884876, 33976423, 33818738, 33884937, 33980282, 33911598, 33951511, 33951491, 33884950, 33829119, 33951092, 33976451, 33884930, 33905583, 33905579, 34015708, 33894424, 33894417, 33976433, 33823360, 30569230, 33947933, 33971920, 33971925, 33971924, 33971949, 33971940, 33971937, 33971917, 33971884, 30559186, 33947916, 33947943, 33947923, 33947908, 33947907, 33947905, 33947903, 33947902, 33947901, 33947898, 33947262, 33947913, 33967346, 33967344, 33967343, 33936894, 33823364, 33980303, 33986557, 33980286, 33971946, 33971904, 33951522, 33951515, 33884959, 33826018, 33826007, 33915950, 33971954, 33884925, 33884965, 33884957, 33889423, 33889419, 33826081, 33829129, 33959564, 33959563, 33959565, 33955797, 33936910, 33894414, 33951546, 33986552, 33986929, 33946308, 33947254, 33967373, 33967366, 33967364, 33967357, 33967353, 33967392, 33915938, 33915918, 33915920, 33911441, 33911442, 33905584, 33905429, 33905439, 33905437, 33905426, 33904939, 33905431, 33905450, 33905612, 33905448, 33911443, 33905607, 33905604, 33905602, 33905601, 33911508, 33911472, 33911451, 33911466, 33905490, 33905489, 33905481, 33905479, 33905469, 33905465, 33905464, 33905594, 33905593, 33905588, 33905597, 33905498, 33901775, 33901789, 33911567, 33911576, 30553853, 33911527, 33911515, 33911513, 33911521, 33911522, 33911523, 33911524, 33911529, 33911531, 33911534, 33911537, 33911525, 33826035, 33829098, 33829107, 33829112, 33829104, 33829103, 33829096, 33951567, 30568542, 33946304, 33947263, 33898454, 33986876, 33946298, 33971837, 33955842, 32878915, 33955807, 33981800, 33981802, 33981803, 33938362, 33951412, 33889429, 33979557, 33932721, 33924698, 33924693, 33924694, 33932704, 33932720, 33932703, 33932702, 33932701, 33932699, 33932698, 33932717, 33932713, 33932705, 33932682, 33932692, 33932685, 33932680, 33932690, 33932676, 33932686, 33932677, 33932675, 33932684, 33932683, 33932697, 33932696, 33932695, 33932694, 33932693, 33929484, 33929498, 33929497, 33929496, 33929495, 33929494, 33929493, 33929492, 33929490, 33929489, 33929487, 33929501, 33929483, 33929481, 33929480, 33924690, 33924689, 33924688, 33924687, 33924686, 33929488, 33929514, 33929531, 33929530, 33929527, 33929526, 33929525, 33929524, 33929522, 33929521, 33929519, 33929499, 33929516, 33929500, 33929513, 33929512, 33929511, 33929510, 33929509, 33929507, 33929505, 33929504, 33929503, 33929517, 33924685, 33894552, 33924681, 33924664, 33924663, 33932738, 33932743, 33932739, 33932737, 33932733, 33932731, 33932729, 33932728, 33932727, 33932726, 33932725, 33932724, 33932740, 33898445, 33929532, 33929533, 33898428, 33898440, 33898447, 33898448, 33930017, 33930030, 33930028, 33930027, 33930026, 33930025, 33930024, 33930021, 33930020, 33930032, 33930018, 33930033, 33930015, 33930014, 33930011, 33930010, 33929540, 33929539, 33929538, 33929536, 33929535, 33930019, 33930031, 33930101, 33930042, 33930041, 33930040, 33930039, 33930038, 33930036, 33930034, 33894420, 33894573, 33894577, 33823351, 33881444, 33826061, 33826059, 33826057, 33819678, 33819663, 33818713, 33818717, 33818724, 33818728, 33818730, 33818734, 33911444, 33955786, 33981788, 33938927, 33950571, 33911630, 33904879, 33951416, 33951281, 33951274, 33911629, 33917451, 33997568, 33915923, 33915924, 33922355, 33915963, 33955849, 33921044, 33955749, 33992550, 33992554, 33959560, 33959561, 33959568, 33959562, 34052683, 34052645, 34052646, 34052647, 34052649, 34052652, 34052656, 34052657, 34052665, 34052671, 34052672, 34052675, 34052676, 34060188, 34054500, 34060186, 34060185, 34054534, 34054532, 34052677, 34054510, 34052679, 34054494, 34054492, 34052695, 34052692, 34052684, 34052641, 34054512, 33992561, 34052643, 33992567, 33992566, 33992565, 33992564, 33992571, 33992562, 33992572, 33992560, 33992559, 33992558, 33992557, 33992556, 33992555, 33992563, 33992553, 34060189, 34052639, 34052638, 34052637, 34052635, 33992568, 34022199, 34052642, 34022197, 34022196, 34022194, 34022193, 34022191, 34022190, 34022200, 34060187, 33992552, 33955782, 33951459, 33955779, 33955780, 33955781, 34060216, 34060193, 34060190, 33955785, 33986865, 33992549, 33992547, 33992545, 33992542, 33955784, 33955789, 33992540, 34060200, 34060196, 34060195, 34060194, 33955787, 34060209, 33955796, 33955790, 33955791, 33955793, 33981809, 34060201, 33955795, 34060205, 34060824, 34060819, 34060215, 34060214, 34060210, 33955788, 33981808, 33959573, 33959574, 33955805, 33959602, 33959603, 33955804, 33955801, 34060820, 33955830, 33959572, 33959609, 33955800, 33955798, 33938928, 33955853, 33955847, 33955846, 33894287, 33938359, 33938357, 33938356, 33955770, 33955756, 33955778, 33951441, 33894574, 33904918, 33904915, 33904877, 33905454, 33900863, 33901123, 33901772, 33901776, 33901783, 33901784, 33901788, 33901786, 33901760, 33901740, 33900860, 33898456, 33898453, 33946288, 33946285, 34052666, 33950581, 33819651, 33894593, 33894584, 33897332, 33951507, 33897352, 33897354, 33951443, 33951286, 33951290, 33980265, 33980307, 33981766, 33981767, 33981769, 33823355, 33997576, 33947868, 33930112, 33936855, 33936883, 33936881, 33936880, 33936856, 33936853, 33936851, 33933930, 33936898, 33936884, 33936885, 33936897, 33936895, 33936891, 33936888, 33936903, 33930118, 33933896, 33933924, 33933901, 33936904, 33986912, 34011818, 33986341, 33976461, 33959569, 33947937, 33951124, 33967369, 33967368, 33967361, 33967358, 33967354, 33967380, 33971927, 33971922, 33971944, 33971942, 33967389, 33967386, 33901118, 33901101, 33901097, 33955845, 33894412, 33911590, 33894590, 33898503, 33894578, 33894589, 33980277, 33951584, 33823377, 33936861, 33936859, 33936886, 33936892, 33936907, 33884885, 33884889, 33829091, 33829095, 33818755, 33955799, 33955835, 33946300, 33946321, 33947896, 33947921, 33936909, 33936912, 33829088, 33922371, 33971945, 33976465, 33976460, 33976457, 33976452, 33976459, 33976448, 33976450, 33976445, 31305464, 30553849, 33955844, 33955837, 33955836, 33955817, 33955851, 33959542, 33922296, 33955773, 30553852, 34015706, 33894401, 31421058, 33947912, 33980289, 33933900;
International Serial Numbers: 33947246, 33947247, 33890408, 33892605, 33790557, 33819595, 33819594, 33894427, 33826015, 33823319, 33823313, 33946278, 33933874, 33946270, 33933948, 33933865, 33933882, 33950568, 33933892, 33933893, 33933895, 33933887, 33933912, 33933913, 33933898, 33933889, 33930119, 33933884, 33826079, 33819604, 33905620, 33823314, 33946287, 33889422, 33892602, 33884927, 33884920, 33884935, 33894575, 33894408, 33894407, 33894595, 33894576, 33905610, 33905613, 33911432, 33905605, 33950445, 33915942, 33915932, 33922354, 33915948, 33915934, 33819610, 33823315, 33946291, 33946292, 33946294, 33946295, 33976467, 33946290, 33881436, 33986796, 33986798, 33986801, 33959551, 33959548, 33976462, 33959557, 33979559, 33986803, 33976405, 33976466, 33980269, 33955843, 33986812, 33986813, 33955783, 33980292, 33976473, 33976469, 33986875, 33976438, 33976439, 33986805, 33946309, 33976442, 33986806, 33976444, 33976484, 33980284, 33976449, 33986810, 33890389, 33890402, 33890398, 33890397, 33890396, 33889497, 33890390, 33889504, 33890395, 33881434, 33890417, 33890403, 33890404, 33890409, 33890407, 33890406, 33889418, 33889432, 33889431, 33889426, 33889420, 33889472, 33889417, 33889415, 33889414, 33885001, 33884998, 33884994, 33884989, 33889421, 33889481, 33889475, 34003588, 34003564, 33992548, 33986914, 34011707, 34011704, 34003590, 34003621, 34003619, 34003611, 34003605, 34003594, 34011697, 33892597, 33892606, 33892604, 33892600, 33892598, 33892609, 33892596, 33892592, 33892591, 33892589, 33986347, 33981801, 33892607, 33892608, 33892614, 33892613, 33892612, 33892610, 33884955, 33959604, 33881413, 33881411, 33881410, 33881408, 33881399, 33884986, 33881409, 33881438, 33881418, 33881421, 33881396, 33881383, 33881441, 33884914, 33884921, 33884919, 33884918, 33881439, 33884915, 33884932, 33884913, 33884907, 33884906, 33884905, 33884916, 33884954, 33884951, 33884949, 33884947, 33884943, 33884941, 33884939, 33884933, 33884869, 33884880, 33884956, 33884900, 33884895, 33884877, 33884893, 33884891, 33884883, 33819599, 33829408, 33819612, 33829394, 33829397, 33819585, 33819587, 33794788, 33814241, 33794789, 33894570, 33930104, 33932691, 33894422, 33930111, 33897330, 33897347, 33905504, 33897351, 33894550, 33897348, 33897345, 33897339, 33897338, 33897334, 33897349, 33826095, 33826096, 33823347, 33819584, 33826091, 33829094, 33826038, 33826044, 33826045, 33826047, 33826075, 33826051, 33905606, 33905624, 33911440, 33911519, 33911517, 33911514, 33826032, 33819583, 33818771, 33818767, 33819659, 33819647, 33819653, 33819658, 33819657, 33819630, 33819616, 33819619, 33819621, 33819623, 33819625, 33819626, 33819633, 33819637, 33829113, 33829108, 33829101, 33826024, 33826030, 33819615, 33823312, 33823316, 33823318, 33823320, 33823321, 33823327, 33933940, 33946279, 33933935, 33933936, 33922361, 33898444, 33922360, 33936913, 33936908, 33894549, 33933943, 33946284, 33898433, 33933957, 33932732, 33898443, 33936905, 33924677, 33933879, 33924668, 33929478, 33922379, 33922374, 33933875, 33924670, 33922373, 33922380, 33922381, 33924667, 33933871, 33933934, 33933951, 33946275, 33932735, 33922365, 33922366, 33933933, 33933862, 33933880, 33951127, 33950578, 33951103, 33950576, 33951122, 33955777, 33950456, 33947932, 33950447, 33950452, 33950453, 33950579, 33950455, 33950457, 33950570, 33950572, 33950573, 33950575, 33950454, 33922297, 33951271, 33947892, 33955850, 33959541, 33959543, 33915946, 33915959, 33951402, 33951401, 33971930, 33971931, 33971929, 33933908, 33971915, 33971912, 33936858, 33971958, 33971957, 33971952, 33971951, 33936900, 33930126, 33947881, 33947882, 33947885, 33947887, 33947888, 33936882, 33947878, 33951591, 33951587, 33971960, 33947889, 33947870, 33936901, 33947869, 33947879, 33947871, 33947872, 33947873, 33947874, 33936890, 33986326, 33955834, 33955811, 33976481, 33955810, 33976482, 33976480, 33955808, 33976483, 33889425, 33889434, 33881406, 33881393, 33881362, 33881372, 33881369, 33881366, 33881363, 33881375, 33881361, 33881360, 33881359, 33881358, 33881357, 33881356, 33881355, 33881364, 33881374, 33881380, 33881379, 33881376, 33884909, 33881450, 33881445, 33884886, 33884884, 33884894, 33819598, 33819606, 33819608, 33829152, 33829149, 33829154, 33829153, 33829150, 33829148, 33819592, 33829146, 33829144, 33819596, 33932689, 33894390, 33894389, 33892593, 33894571, 33894386, 33932679, 33881331, 33894388, 33881354, 33881353, 33881352, 33881351, 33881350, 33881333, 33881330, 33881329, 33881327, 33830738, 33881349, 33894385, 33894384, 33894383, 33894381, 33894291, 33904919, 33826060, 33826072, 33818791, 33818742, 33818787, 33819655, 33819643, 33819667, 33819635, 33823336, 33823324, 33823331, 33823317, 33946282, 33933937, 33898446, 33898432, 33933944, 33894554, 33898435, 33898436, 33933942, 33933869, 33932741, 33933870, 33933868, 33933876, 33933872, 33933858, 33932744, 33946269, 33933863, 33933861, 33950583, 33950446, 33950449, 33950574, 33947930, 33921056, 33921048, 33921054, 33933886, 33947883, 33947886, 33936902, 33947875, 33894596, 33980270, 33980299, 33986794, 33976425, 33955823, 33959553, 33959545, 33959544, 33979505, 33991489, 33991484, 33991483, 33991478, 33991494, 33991477, 33991499, 33890401, 33890400, 33890399, 33890405, 33889503, 33889502, 33889501, 33889500, 33889499, 33890424, 33890413, 33890422, 33890421, 33890420, 33890418, 33890416, 33890414, 33890412, 33890411, 33890410, 33889496, 33890415, 33889428, 33889498, 33889486, 33889495, 33889494, 33889493, 33889492, 33889491, 33889490, 33889489, 33889487, 33889484, 33889483, 33889480, 33889479, 33889477, 33892588, 33889488, 34003578, 34003565, 33997578, 33997575, 34003593, 33890423, 34011834, 34022211, 34015723, 34011708, 34011705, 34011703, 34011696, 34003592, 34011829, 34011813, 33892603, 33892601, 33892595, 33892594, 33892590, 33892599, 33981790, 33959608, 33959607, 33959600, 33959566, 33892611, 33881407, 33881416, 33881415, 33881414, 33881412, 33881395, 33881419, 33881405, 33881400, 33881398, 33881397, 33881428, 34022212, 33881435, 33946286, 33881433, 33881432, 33881431, 33881417, 33881429, 33881427, 33881426, 33881425, 33881424, 33881423, 33881420, 33881430, 33881370, 33881368, 33881365, 33881392, 33881391, 33881390, 33881389, 33881388, 33881387, 33881386, 33881373, 33881384, 33881382, 33881381, 33881378, 33881377, 33881385, 33884917, 33884910, 33884908, 33884942, 34022198, 33884948, 33884946, 33884931, 33884938, 33884936, 33884934, 33884902, 33884944, 33884904, 33884874, 33884870, 33881455, 33881454, 33881453, 33884878, 33881451, 33881449, 33881448, 33881447, 33881446, 33881443, 33881442, 33881452, 33884892, 33881440, 33884901, 33884899, 33884897, 33884896, 33884903, 33884890, 33884888, 33884887, 33884881, 33829395, 33819600, 33819601, 33819607, 33819597, 33819613, 33829409, 33829406, 33829405, 33829404, 33829403, 33829401, 33819609, 33829399, 33829398, 33829396, 33829128, 33829402, 33829142, 33819588, 33829132, 33829131, 33829130, 33819586, 33829143, 33829410, 33814240, 33814239, 33829393, 33829392, 33819589, 33819590, 33829147, 33819591, 33819593, 33819614, 33930108, 33930115, 33932678, 33894551, 33830737, 33830736, 33829411, 33924700, 33826093, 33826077, 33826078, 33826080, 33826082, 33826083, 33823374, 33826085, 33826086, 33826089, 33826033, 33826092, 33826073, 33826094, 33829140, 33823361, 33819605, 33819603, 33819602, 33823380, 33819676, 33826039, 33829093, 33826043, 33829089, 33826049, 33826050, 33823383, 33826074, 33826058, 33826062, 33826063, 33826064, 33826065, 33826066, 33826067, 33826070, 33826071, 33817019, 33818757, 33818756, 33818748, 33818745, 33818740, 33818737, 33818725, 33818761, 33818763, 33818790, 33818789, 33818788, 33818786, 33818785, 33818784, 33818782, 33818759, 33818780, 33818775, 33818773, 33818772, 33818770, 33818769, 33818768, 33818766, 33818764, 33818781, 33819646, 33819648, 33819649, 33819650, 33829125, 33819652, 33819654, 33819656, 33826034, 33819660, 33819661, 33829124, 33819664, 33829123, 33819666, 33829122, 33829121, 33819670, 33819671, 33819617, 33819618, 33819620, 33819622, 33819624, 33819627, 33819645, 33819629, 33819631, 33819632, 33829127, 33829126, 33819638, 33819641, 33819674, 33819628, 33829120, 33829115, 33829114, 33826002, 33829110, 33826006, 33829106, 33826011, 33823334, 33826014, 33823333, 33826016, 33829102, 33826020, 33826025, 33826026, 33829097, 33826028, 33826031, 33826012, 33819675, 33819677, 33819679, 33829118, 33829117, 33823335, 33819673, 33823322, 33823325, 33823326, 33823328, 33823329, 33823330, 33823332, 33922359, 33946280, 33946283, 33933954, 33933952, 33933953, 33900686, 33933939, 33933955, 33933938, 33894553, 33933946, 33898429, 33898431, 33898449, 33933956, 33898441, 33898442, 33933941, 33924678, 33929476, 33924669, 33929477, 33922368, 33922367, 33933867, 33922370, 33922376, 33946267, 33933947, 33922382, 33922378, 33929479, 33933860, 33946273, 33922363, 33946276, 33933949, 33933950, 33922364, 33933864, 33933866, 33951115, 33950582, 33950585, 33950586, 33951064, 33951074, 33951116, 33951117, 33951119, 33951120, 33951123, 33951125, 33951084, 33951132, 33924676, 33951126, 33922375, 33924662, 33924665, 33924666, 33924671, 33924672, 33924674, 33922295, 33924680, 33924683, 33924691, 33930141, 33930100, 33930099, 33924673, 33915933, 33932722, 33947926, 33915943, 33915957, 33915960, 33933902, 33933891, 33933897, 33933903, 33930120, 33930123, 33933883, 33933885, 33947895, 33947891, 33947906, 33947911, 33947914, 33947918, 33947928, 33938358, 33938361, 33947880, 33947876, 33894387, 33979498, 33979556, 33979520, 33976422, 33933881, 33946310, 33889471, 33881371, 33884922, 33894568, 33894588, 33894581, 33894579, 33884928, 33826076, 33915902
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters dated March 2006, firm initiated recall is ongoing.
REASON
Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
VOLUME OF PRODUCT IN COMMERCE
942 Lifepak 12 devices; 2678 Lifepak 20 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
******RECALL EXTENSION******
PRODUCT
a) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left,
45 degrees, non-sterile; Part number 00-7712-035-01, Recall # Z-0671-06;
b) Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right,
45 degrees, non-sterile; Part number 00-7712-035-02, Recall # Z-0672-06;
c) Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number
83-7712-035-01. Recall Z-0671-06 extended to include this product,
Recall # Z-0770-06;
d) Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number
83-7712-035-02. Recall Z-0671-06 extended to include this product,
Recall # Z-0771-06
CODE
a) Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739,
60330363 and 60342788;
b) Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480,
60307612, 60333170 and 60336853;
c) Lots 08686700 and 08686500;
d) Lots 08686600 and 08686800
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated February 8, 2006 and by letter dated February 27, 2006 when the recall was extended to the two additional products. Firm initiated recall is ongoing.
REASON
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
VOLUME OF PRODUCT IN COMMERCE
527 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; product codes SYS1000L3, SYS1000L3P, SYS1000L3T, SYS1000L3D, SYS1000L32C2, SYS1000L3TD, SYS1000LC2, Recall # Z-0766-06
CODE
All serial numbers within the range of 1001 through 22000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Mc Gaw Park, IL, by letters dated February 24, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is ongoing.
REASON
The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.
VOLUME OF PRODUCT IN COMMERCE
14,977 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) STS-400 Levell® Skin Temperature Sensor with 400 Series Thermistor,
Recall # Z-0767-06;
b) TTS-400J Levell® Tympanic Temperature Sensor with 400 Series Thermistor,
Recall # Z-0768-06
CODE
a) Lot number: 3141;
b) Lot number: 3080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc., Rockland, MA, by letter dated March 8, 2005.
Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, Mexico, firm initiated recall is ongoing.
REASON
Product temperature readings may be 2ºC higher than the actual temperature.
VOLUME OF PRODUCT IN COMMERCE
20,400 devices
DISTRIBUTION
Nationwide, Canada, France, Japan, Netherlands

______________________________
PRODUCT
Storz Documentation Cart with Articulating Arm, Model Number 9601F, Recall # Z-0769-06
CODE
Serial numbers: 82861-8 84504-21 84505-10 84505-30 84987-15 82859-4 82859-5 82859-6 82859-7 82858-8 82858-9 82858-10 81553-1 85358-35 80486C-9 84505-14 82861-1 82861-2 82861-3 82861-4 82861-5 80486C-17 81553-14 81553-20 84987-17 84987-18 84987-19 84987-20 84987-21 84987-22 84987-23 84987-24 84987-34 84987-35 84504-20 84504-24 85358-9 80485-1 80485-2 81552-11 81552-10 81553-19 85358-37 80486C-1 80486C-2 84505-12 82858-4 82858-5 82858-6 82858-7 84987-6 84987-7 84987-8 84987-9 84987-10 84987-11 84504-17 84504-18 84504-19 84505-19 84505-20 84505-21 84505-16 84505-17 84505-18 85358-41 84504-28 82859-3 82859-2 80486C-3 80486C-4 80486C-5 80486C-6 84504-9 84504-10 82861-10 82861-9 81553-6 81553-7 81552-37 81552-19 81552-18 84505-27 84505-28 85358-40 82861-7 82861-6 82860-1 84987-1 84987-2 84505-7 81553-18 84987-3 84987-16 84504-26 85358-15 85358-16 85358-17 85358-18 85358-19 85358-20 85358-38 85358-39 85358-1 85358-2 85358-3 85358-4 85358-5 85358-6 80486C-8 85358-21 84505-24 84505-9 81552-14 81552-15 81552-16 80486C-14 81552-17 82860-2 82860-3 82860-4 82860-5 85358-33 85358-34 85358-48 85358-49 85358-50 84505-1 84505-2 84505-3 84505-4 85358-45 85358-46 85358-47 81552-22 81552-23 81552-24 81552-25 81552-26 81552-27 81552-28 81552-29 81552-30 81552-31 81552-32 81552-33 81552-34 81552-35 81553-8 81553-9 81552-4 81552-3 80485-7 82859-1 81553-3 81553-2 80486C-7 81553-10 81552-5 80486C-16 81552-6 80484B-16 80484B-17 80484B-18 80484B-19 80485-3 80485-4 82860-9 82858-1 80484B-6 80484B-7 80484B-8 80484B-9 80484B-10 80484B-11 80484B-12 80484B-13 80484B-14 80484B-15 84957A-1 84957A-3 84957A-5 84957A-4 84957A-7 84957A-2 84957A-6 84504-25 85358-8 85358-9 80486C-11 80486C-12 81553-13 82860-6 82860-7 82860-8 80485-8 80485-9 80485-10 84505-8 80484B-20 81553-4 81553-5 82858-3 85358-26 85358-27 85358-28 85358-29 85358-30 85358-31 85358-32 84987-5 84987-4 81553-15 81553-16 84505-15 85358-10 85358-11 85358-12 85358-13 84504-16 84505-22 84505-23 85358-42 85358-43 85358-44 84504-29 81552-13 80485-5 80485-6 84504-11 84504-12 84504-13 84504-14 84504-15 80486C-19 80486C-20 84505-13 84987-12 84987-28 84987-29 84987-30 84987-31 84987-32 84987-33 84987-3 86058-1 86058-2 86058-3 86058-4 86058-5 86058-6 86058-7 86058-8 84987-25 84987-26 84987-27 84987-13 84987-14 86058-11 86058-10 86058-9 86058-12 86058-13 86058-14 86058-15 86747-1 86747-2 86747-3 86747-4 86747-5 86747-6 86747-7 86747-8 86747-9 86747-10 86058-18 86058-17 86747-12 86747-13 86747-14 86747-15 86747-16 86747-11 86747-17 86747-18 86747-29 86747-30 86747-28 86747-21 86747-22 86747-23 86747-24 86747-20 86747-27 86747-31 86747-32 86747-33 86747-34 86747-35 86747-39 86747-38 86747-37 86747-36 86747-49 86747-50 86747-48 86747-46 86747-47 86747-43 86747-44 86747-45 86747-42 86058-2 86058-3 84987-36 84987-37 86058-1 82859-9 82859-10 84504-1 84504-3 84504-4 84504-5 84504-6 84504-7 84504-8 84504-2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Karl Storz Endoscopy America Inc, Culver City, CA, by letter on March 10, 2006.
Manufacturer: Omni Corp., Livonia, MI, firm initiated recall is ongoing.
REASON
The articulating arm on the cart, which holds the monitor, may fall off from the cart during manipulation. When it falls, it could hit the ground or fall on the people/objects that are in close proximity.
VOLUME OF PRODUCT IN COMMERCE
333 units
DISTRIBUTION
Nationwide

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PRODUCT
a) LigaSure Atlas Laparoscopic Vessel Sealer/Divider, Catalog Number LS1100,
Recall # Z-0772-06;
b) LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider,
Catalog Number LS1120, Recall # Z-0773-06
CODE
a) Lot Numbers: Any lot number beginning with U, N2, N3, N4,
or N5A through N5L247K;
b) Lot numbers: Any lot number beginning with N2, N3, N4,
or N5A through N5L235K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Valleylab, Boulder, CO, by letter on January 27, 2006.
Manufacturer: United States Surgical Corporation, North Haven, CT, firm initiated recall is ongoing.
REASON
Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
VOLUME OF PRODUCT IN COMMERCE
247,000 domestic, 252000 internationally
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) MagNA Pure LC System. An automated, general purpose instrument for
isolation and purification of nucleic acids and assembly of PCR reactions.
Catalog numbers 12236931001 and 03670325001, Recall # Z-0774-06;
b) MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001,
Recall # Z-0775-06;
c) MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number
03264793001, Recall # Z-0776-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 4, 2006.
Manufacturer: Precision Systems, Chiba, Japan, firm initiated recall is ongoing.
REASON
The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument.
VOLUME OF PRODUCT IN COMMERCE
251 instruments
DISTRIBUTION
Nationwide

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PRODUCT
Proxima Sterile, Disposable Set Up Pack III, Reorder DYNJP1047; a sterilized convenience kit for surgical procedures comprised of 2 Aurora Gowns, 1 Mayo stand cover, 10 O.R. towels and 1 table cover; 5 kits per case, Recall # Z-0777-06
CODE
Lot number: 5149116
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc. Waukegan, IL, by visit on March 30, 2006.
Manufacturer: Master & Frank Enterprise Co. Ltd, Kuantung, China, firm initiated recall is complete.
REASON
The product may not be sterile. The pouches were damaged during sterilization.
VOLUME OF PRODUCT IN COMMERCE
21 cases
DISTRIBUTION
TX

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PRODUCT
a) Rocker Switch Electrosurgical Pencil with E-Z Clean Tip, Catalog Number 0030H,
Recall # Z-0778-06;
b) Button Switch Electrosurgical Pencil with E-Z Clean Tip and Holster, Catalog
Number 0035H, Recall # Z-0779-06;
c) Rocker Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster,
Catalog Number 0036H, Recall # Z-0780-06;
d) Button Switch Electrosurgical Pencil with Modified E-Z Clean Tip and Holster,
Catalog Number 0037H, Recall # Z-0781-06;
e) Rocker Switch Electrosurgical Pencil with Stainless Steel Tip and Holster,
Catalog Number 0038H, Recall # Z-0782-06;
f) Button Switch Electrosurgical Pencil with Stainless Steel Tip and Holster,
Catalog Number 0039H, Recall # Z-0783-06;
g) Rocker Switch Electrosurgical Pencil with Holster, Catalog Number 3030HT,
Recall # Z-0784-06;
h) Button Switch Electrosurgical Pencil with Holster, Catalog Number 3035HT,
Recall # Z-0785-06
CODE
a) Lot numbers: 51269, 51270, 51271, 51272, 51273, 60101, 60102;
b) Lot Numbers: 51413, 51414, 52024, 52025, 52026, 60005, 60113,
60114, 60115, 60302, 60358, 60365;
c) Lot number: 51739;
d) Lot numbers: 51762, 60119, 60383, 60384;
e) Lot numbers: 51030, 51951, 51952;
f) Lot numbers: 60121, 60456;
g) Lot number: 51624;
h) Lot number 51625
RECALLING FIRM/MANUFACTURER
Megadyne Medical Products, Inc, Draper, UT, by letter on April 6, 2006, firm initiated recall is ongoing.
REASON
Surgical device packaging may be damaged and may compromise sterility.
VOLUME OF PRODUCT IN COMMERCE
143,198 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
ILab Utrasound Imaging System, software controlled Imaging Catheter, Model Numbers M0004EPiL120CART0, H749iLab120CART0, H749iLab120CARTD0, H749iLab120CARTR0, H749iLab120INS0, Recall # Z-0789-06
CODE
Serial number 4037; serial numbers 4041, 4020, 4056, 4018, 4037; serial number 4064; serial number 4022; serial numbers 4016, 4015, 4008, 4043
RECALLING FIRM/MANUFACTURER
Boston Scientific Target, Fremont, CA, by letters on March 6, and March 21, 2006, firm initiated recall is ongoing.
REASON
Using the product for procedures that exceed manual record mode may result in inadvertent needle stick to myocardium or blood vessel. (with ICE intracardiac imaging catheters only).
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Oxoid Infectious Mononucleosis Test, Catalog # DR0680M, Recall # Z-0786-06
CODE
Lot number: 382735, Exp. 2006/06/30
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc. Lenexa, KS, by letter dated February 14, 2006, firm initiated recall is complete.
REASON
Some units exhibit weak false-positive reactions with some negative patient serum.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide

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PRODUCT
Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: "b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well", Recall # Z-0787-06
CODE
AN1 (100 dose) Lot #022206 - 16404-100, Exp. Date: August 22, 2006, and AN5 (20 dose) Lot #022206 - 16404-20, Exp. Date: August 22, 2006
RECALLING FIRM/MANUFACTURER
BEC Laboratories, Inc., Toledo, OH, by fax on March 29, 2006, firm initiated recall is ongoing.
REASON
Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 vials of 100 dose and 3 vials of 20 dose
DISTRIBUTION
CA, CO, GA, IL, NE, OH, PR and TX

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PRODUCT
Mamoray™ HDR-C PLUS Mammography film, Recall # Z-0788-06
CODE
Product Code: EMLOV, Batch 37300052
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on/about February 16, 2006.
Manufacturer: AGFA Corp., Goose Creek, SC, firm initiated recall is ongoing.
REASON
The film was incorrectly notched.
VOLUME OF PRODUCT IN COMMERCE
16,523 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR APRIL 26, 2006

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