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U.S. Department of Health and Human Services

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Enforcement Report for August 20, 2008

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. 

August 20, 2008

08-33

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Sau-Sea Brand Smoked Salmon Spread 7.5 oz plastic tub, Maine Made. Keep Refrigerated. UPC: 0 41638 08965 4; Recall # F-517-8
CODE
Sell By Dates: 072308, 082708, 092408, 112508, 031309
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sau-Sea Foods, Inc., Water Mill, NY, by press release on July 18, 2008.
Manufacturer: Lukas Foods, Inc., Biddeford, ME. Firm initiated recall is ongoing.
REASON
Product label fails to declare eggs.
VOLUME OF PRODUCT IN COMMERCE
3,954 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT
a) Stop Shop Garlic Bread, 9 oz and 16 0z UPC: 20540880000 and
20540900000 Giant Garlic Bread 16 oz UPC: 21476670000; Recall # F-519-8;
b) Stop & Shop Garlic Spread Tubs Size: 16 oz. UPC: 20549280000
Giant Garlic Spread Tubs, 16 oz UPC: 20173310000; Recall # F-520-8
CODE
Product sold prior to June 27, 2008
RECALLING FIRM/MANUFACTURER
The Stop & Shop Supermarket Company LLC, Quincy, MA, by e-mail and press release on June 27, 2008. Firm initiated recall is complete.
REASON
Products contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
10,685 units
DISTRIBUTION
MA, CT, RI, ME, NH, NY, NJ, VA, MD, DE, D.C.
___________________________________
PRODUCT
a) Wegmans Green Apple Sorbet -- Naturally Flavored -- One Pint 473mL),
UPC: 0 77890 79322 0 -- Plant Code: 36-3553; Recall # F-521-8;
b) Wegmans Lemon Sorbet -- Naturally Flavored -- One Pint 473mL),
UPC: 0 77890 79310 7 -- Plant Code: 36-3553; Recall # F-522-8;
c) Wegmans Pink Grapefruit Sorbet -- Naturally Flavored -- One Pint (473mL),
UPC 0 77890 79337 4 -- Plant Code: 36-3553; Recall # F-523-8;
d) Wegmans Raspberry Sorbet – Naturally Flavored -- One Pint (473mL),
UPC: 0 77890 79331 2 -- Plant Code: 36-3553, Recall # F-524-8
CODE
a) BEST USED BY" date codes: OCT 2008; MAR 15, 09 (found on the
bottom of the container);
b) "BEST USED BY" date code: FEB 11, 09 (found on the bottom of
the container);
c) "BEST USED BY" date code: FEB 11, 09 (found on the bottom of
the container);
d) "BEST USED BY" date codes: SEP 2008; NOV 2, 08; FEB 11, 09
(found on the bottom of the container)
RECALLING FIRM/MANUFACTURER
Perry’s Ice Cream Co., Inc., Akron, NY, by telephone on July 30, 2008 and by e-mail and press release on July 31, 2008. Firm initiated recall is ongoing.
REASON
The affected codes of Wegmans sorbets may contain undeclared milk due to a manufacturing error.
VOLUME OF PRODUCT IN COMMERCE
6,815 sleeves (8 pints per sleeve)
DISTRIBUTION
NY, PA, NJ, VA, MD

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Collard greens shipped in cardboard boxes labeled Rocco’s, Collard 2 Doz. Boxes contain 24 bunched collards wrapped by a twist tie; Recall # F-518-8
CODE
No codes on product
RECALLING FIRM/MANUFACTURER
David Petrocco Farms, Inc., Brighton, CO, by telephone on July 12 and 13, 2008. Firm initiated recall is complete.
REASON
Nightshade, a toxic plant, was co-harvested with the collard greens.
VOLUME OF PRODUCT IN COMMERCE
18,992 boxes containing 24 bunched greens
DISTRIBUTION
CO, KS, TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I
___________________________________
PRODUCT
Unprocessed Skin from donor #APS-9920-06, Recall # B-1731-08
CODE
AS9920000106
RECALLING FIRM/MANUFACTURER
Lifelink Foundation Tissue Bank, Tampa, FL, by letter and telephone on November 27, 2007. Firm initiated recall is complete.
REASON
Donor samples were retested for Hepatitis B surface antigen and Anti-HBcore due to the discovery that the original test kits used were diagnostic kits instead of FDA licensed or cleared donor screening kits. A sample from one donor re-tested repeatedly reactive, neutralization confirmed for hepatitis B surface antigen, core total antibody negative. Samples from all remaining donors retested negative for Hepatitis B surface antigen and Hepatitis B core total antibody negative.
VOLUME OF PRODUCT IN COMMERCE
1 piece
DISTRIBUTION
NJ, VA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta) Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta); Recall # B-1740-08
CODE
Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta) v6.1, v6.2, v6.3 and v6.3.1 (Beta)
RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson AZ, by e-mail on June 24, 2008. Firm initiated recall is ongoing.
REASON
Software, with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
276 Nationwide and 14 Internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Source Plasma, Recall # B-1759-08
CODE
Units: 05JCTB9101, 05JCTB8805, 05JCTB6239, 05JCTB4117, 05JCTB3888, 05JCTB3377, 05JCTB3196, 05JCTB2949, 05JCTB2621, 05JCTB2291, 05JCTB1964, 05JCTB1804, 05JCTC2311, 05JCTC2113, 05JCTC1200, 05JCTC0625, 05JCTC0147, 05JCTB9786, 05JCTB0991, 05JCTB0365, 05JCTB0112, 35528159, 35524281, 35439684, 35431985, 35408031, 35400769, 35383642, 35381815, 35378969, 35376668, 35367079
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by letter on February 7, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1761-08
CODE
Unit: 72F925740
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on March 20, 2008. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma volume to support the platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1762-08
CODE
Unit: 72E906205
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on March 6, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1763-08
CODE
Unit: 72E626810
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on January 16, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1765-08
CODE
Unit numbers 027LN28495 (parts 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on May 13, 2008 and by letter dated May 15, 2008.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WV, PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1766-08
CODE
Unit: 0665157
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Jackson, MS, by fax on April 19, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1767-08
CODE
Unit: 163902686
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on March 6, 2007. 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
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1774-08
CODE
Unit: 2626781
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc., Baton Rouge, LA, by fax on February 4, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1776-08
CODE
Unit: 225466529
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by letter dated April 28, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1779-08
CODE
Unit: 4037142
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on July 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma, Recall # B-1793-08
CODE
Units: 380065622; 380061296; 380059356; 380057703; 380044923; 380044892
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Monroe, LA, by facsimile on June 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Chembio/Inverness Medical Clearview HIV Rapid Test Control Pack, Catalogue # 92112, quality control reagents for use with the Clearview HIV 1/2 STAT-PAK Assay only. Contents of 92112 pack: a product insert, three (3) vials (one HIV 1 Reactive Control, one HIV 2 Reactive Control, one Nonreactive Control). PMA # BP050010. --- Clearview HIV Reactive/Nonreactive Controls are human, plasma-based reagents. The Controls are specifically formulated and manufactured to ensure performance of the test, and are used to verify the user's ability to properly perform the test and interpret the results. The Clearview HIV 1 and HIV 2 Reactive Controls will produce a REACTIVE Test Result and have been manufactured to produce a faint Test "T" line. The Clearview Nonreactive Control will produce a NONREACTIVE Test Result. Use of Control Reagents manufactured by another source may not produce the required results, and therefore, will not meet the requirements for an adequate quality assurance program for the Clearview HIV 1/2 STAT-PAK Assay, Recall # B-1833-08
CODE
Lots 7A322 and 6MD101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chembio Diagnostic System Inc., Medford, NY, by letters on April 07, 2008.
Manufacturer: ZeptoMetrix Corporation, Buffalo, NY. Firm initiated recall is complete.
REASON
HIV Reactive/Nonreactive Controls, linked to customer complaints of false negative or too weak results associated with the lots of product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,718 packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1837-08
CODE
Unit: X22865
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on November 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1838-08
CODE
Unit: X23613
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who warranted deferral due to travel to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1839-08
CODE
Units: 9223553, 9223559
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone and letter on January 23, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1840-08
CODE
Unit: 72F017621
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on April 10, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1848-08
CODE
Unit: 166468579
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba, United Blood Services, Meridian, MS, by telephone on February 11, 2008.
Manufacturer: Blood Systems Inc/dba, United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS, AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1849-08
CODE
Unit: X26698
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga TN, by telephone on 1/09/2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1850-08
CODE
Units: 161673665 Part A; 161673665 Part B
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on January 15, 2008. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS, AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1851-08
CODE
Units: 0701347A, 0701347B, 0701347C
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Jackson, MS, by telephone and facsimile on November 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1852-08
CODE
Unit: 0688220
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Jackson, MS, by facsimile on September 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
a) Unprocessed HV (Heart), Recall # B-1729-08;
b) Unprocessed Skin, Recall # B-1730-08
CODE
a) 046017125 046024125 046030125 046035134 046036090 046073147
046091125 046110136 046108105 046106125 046138090 046169125 046202147
046209146 046214125 046251125 046279124 046298125 046310125 046325125
046427124 046428134 046422125 056442125 056448098 056463163 056479125
056494125 056582125 056660125 056679162 056688152 056700125 056728162
056744152 056765125 056801136 056837125 056912125 056933125 066950134
066971152 067024136 067035135 067059152 067064173 067102125 067155125
067196172 067238128 067227125 067253157 067254125 067342176 067426181
067424180 067442162 077581125 077584163 077619162 077655105 077656162
077696187 077715162 077787175 077772188 036007093 046078107 046115093
046132107 046183128 046247152 046319093 046404093 046434158 056507128
056530152 056536093 056555158 056571152 056607093 056692152 056725158
056813152 056888093 067007158 067072152 067124107 067132180 067169180
067180158 067233179 067396128 067420093 077636180 077711182 067446152;
b) APS767003 APS767904 APS781404 APS799404 APS805004 APS813404
APS814704 APS814904 APS816604 APS822304 APS823904 APS828004
APS828704 APS834504 APS847804 APS851204 APS862904 APS869905
APS875505 APS880805 APS894505 APS903605 APS918905 APS949905
APS953205 APS954305 APS957105 APS958505 APS967005 APS969306
APS977906 APS985106 APS992006 APS992106 APS996206 APS998606
APSA06406 APSA15406 APSA16106 APSA19906 APSA21406 APSA23306
APSA26106 APSA28106 APSA28206 APSA32106 APSA34906 APSA45606
APSA54006 APSA56106 APSA67306 APSA69406 APSA69606 APSA76006
APSA81006 APSA95507 APSB04407 APSB12207 APSB36807 APSB37307
APSB45807 APSB55307 APSB55907 APSB56607 ASO877205 ASO917405
ASO996006 ASOA27106 ASOA72806 ASOA85906 ASOA92707 ASOB23607
RECALLING FIRM/MANUFACTURER
Lifelink Foundation Tissue Bank, Tampa, FL, by letter and telephone on November 27, 2007. Firm initiated recall is complete.
REASON
Donor samples were retested for Hepatitis B surface antigen and Anti-HBcore due to the discovery that the original test kits used were diagnostic kits instead of FDA licensed or cleared donor screening kits. A sample from one donor re-tested repeatedly reactive, neutralization confirmed for hepatitis B surface antigen, core total antibody negative. Samples from all remaining donors retested negative for Hepatitis B surface antigen and Hepatitis B core total antibody negative.
VOLUME OF PRODUCT IN COMMERCE
169 pieces
DISTRIBUTION
NJ, VA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1780-08
CODE
Unit: 4037142
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by fax on July 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1805-08
CODE
Unit: 2643556
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc., Baton Rouge, LA, by telephone on April 10, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Solid Waste Chute (DiTi Slide) for use with the Abbott m2000sp (List 9K14-01 and 9K14-02) Automated Sample Preparation System. The solid waste chutes are sold as a component of the instruments as well as replacement components; Recall # B -1832-08
CODE
List 04J72-29, which is sold as a replacement part or as a component of list 9K14-01 and 9K14-02 ABbott m2000sp instruments.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Molecular, Des Plaines, IL, by letters dated June 30, 2008.
Manufacturer: Tecan Schweiz Ag, Mannedorf Zuerich, Switzerland. Firm initiated recall is complete.
REASON
The solid waste chute (DiTi Slide 04J72-29) for use with the Abbott m2000sp Automated Sample Preparation System, may have sharp edges that may injure the instrument user.
VOLUME OF PRODUCT IN COMMERCE
437 chutes
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. US - Material Number (UPN) M001553030, Catalog Number 55-303;
OUS - Material Number (UPN) M001553000, Catalog Number 55-300; Recall # Z-2141-2008
CODE
US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203;
OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Maple Grove, MN, by letter, dated June 6, 2008.
Manufacturer: Boston Scientific Cupertino, Corporation, Cupertino, CA. Firm initiated recall is ongoing.
REASON
Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the stent, this recall does not affect stents that have already been implanted. Patients who have already received a NexStent Carotid Stent are at no additional risk with respect to this product issue.
VOLUME OF PRODUCT IN COMMERCE
1,946 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical
chemistry analyzer; Catalog number 04998618001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Z-0866-2008;
b) Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical
chemistry analyzer; Catalog number 04998669001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Z-0867-2008;
c) Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay
analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative
and quantitative in vitro determinations using a wide variety of tests; Recall # Z-0868-
2008;
d) Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical
chemistry analyzer; Catalog number 03284522001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Recall # Z-0869-
2008;
e) Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay
analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in
vitro determinations using a wide variety of tests; Recall # Z-0870-2008
CODE
All units with software version 08-02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 21, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
REASON
Possible mismatch between patient and result.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks, Recall # Z-1442-2008
CODE
All serial numbers between H080002 to H080006, H080008 to H080014, H080016 to H080022, H080024 to H080050, H080052 to H080057, H080059 to H080066, H080068 to H080070, H080072 to H080075, H080077, H080078, H080080 to H080089, H080091, H080092, H080094 to H080105, H080107 to H080117, H080119 to H080134, H080136, H080137, H080139 to H080145, H080147 to H080158, H080160 to H080163, H080166, H080168 to H080200, H080202 to H080222, H080224 to H080228, H080230 to H080232, H080235, H080236, H080239, H080240, H080244, H080246 to H080248, H080251, H080254, H080256 to H080258, H080260 to H080263, H080265 to H080268, H080271 to H080282, H080286 to H080288, H080290 to H080292, H080294, H080296, H080301, H080303, H080304, H080306, H080307, H080309, H080311, H080312, H080314, H080318, H080320, H080321, H080324, H080325, H080328, H080329, H080335, H080348, H080351, H082000 to H082002, H082007, H082009 to H082012, H082020 to H082023, H082026, H082034, H082036, H082038, H082043, H082044, H082048, H082070, H082073, H082088, H082204
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters starting January 3, 2008. Firm initiated recall is ongoing.
REASON
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
VOLUME OF PRODUCT IN COMMERCE
291 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Philips Medical Systems iSite PACS (Picture Archiving and Communications
Systems) version 3.6.28.0 - Radiology Image management system;
Recall # Z-1443-2008;
b) Philips Medical Systems iSite PACS (Picture Archiving and Communications
Systems) version 4.1.17.0 - Radiology Image management system;
Recall # Z-1444-2008
CODE
a) Version number 3.6.28.0;
b) Version 4.1.17.0
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on February 20, 2008. Firm initiated recall is ongoing.
REASON
When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a discrepancy exists in the measurement provided by the tool.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for
fixation of bone fractures or for bone reconstruction. Catalog number: 111426S;
Recall # Z-1445-2008;
b) QWIX Screw 4.3mm diam, length 28 mm; The stabilization screw is indicated for
fixation of bone fractures or for bone reconstruction. Catalog Number 222428S;
Recall # Z-1446-2008
CODE
a) Lot E54Q;
b) Lot E54R
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters on February 27, 2008.
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.
REASON
Certain QWIX Fixation Screws (Part numbers 111426s and 111428s) have been etched and labeled with an incorrect length.
VOLUME OF PRODUCT IN COMMERCE
a) 42; b) 20
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal
battery, external battery or AC power. Applications include long term acute care or
short term / recovery room; Recall # Z-1463-2008;
b) Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room. Recall # Z-1464-2008;
c) Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room; Recall # Z-1465-2008;
d) Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is
suitable for use in institutional, home or transport settings. Fully self-contained
ventilator in a compact and lightweight design. It can operate from an internal battery,
external battery or AC power. Applications include long term acute care or short term /
recovery room; Recall # Z-1466-2008;
e) Replacement Kit, Power PCBA with DC power cord. REF 11590; Recall # Z-1467-
2008;
f) Replacement Kit, Power PCBA without Memory Board. REF 14157;
Recall # Z-1468-2008;
g) Replacement Kit, Power PCBA with Memory PCBA. REF 14425; Recall # Z-1469-
2008;
h) Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US;
Recall # Z-1470-2008
CODE
a) Serial numbers: A01014, A01016, A01020, A01021, A01023, A01024, A01025, A01026, A01027, A01028, A01029, A01030, A01033, A01038, A01039, A01040, A01043, A01045, A01048, A01049, A01050, A01051, A01052, A01053, A01054, A01055, A01056, A01059, A01062, A01063, A01064, A01067, A01068, A01069, A01070, A01073, A01075, A01076, A01077, A01079, A01082, A01083, A01086, A01087, A01088, A01089, A01090, A01096, A01106, A01109, A01112, A01117, A01118, A01119, A01121, A01123, A01125, A01126, A01127, A01128, A01131, A01132, A01134, A01135, A01140, A01142, A01150, A01162, A01171, A01172, A01175, A01177, A01178, A01179, A01181, A01183, A01184, A01188, A01190, A01192, A01193, A01197, A01199, A01201, A01204, A01205, A01206, A01210, A01212, A01213, A01219, A01220, A01221, A01223, A01224, A01228, A01230, A01238, A01239, A01240, A01241, A01243, A01244, A01245, A01246, A01247, A01248, A01251, A01253, A01255, A01256, A01257, A01263, A01264, A01266, A01268, A01270, A01272, A01274, A01282, A01285, A01286, A01292, A01296, A01297, A01298, A01299, A01301, A01302, A01303, A01304, A01305, A01307, A01310, A01312, A01314, A01315, A01316, A01318, A01319, A01321, A01323, A01324, A01327, A01328, A01331, A01335, A01337, A01338, A01344, A01346, A01347, A01349, A01350, A01352, A01353, A01354, A01355, A01356, A01357, A01358, A01359, A01360, A01361, A01363, A01364, A01366, A01367, A01368, A01370, A01375, A01376, A01379, A01383, A01387, A01389, A01391, A01392, A01393, A01394, A01395, A01397, A01399, A01401, A01403, A01405, A01406, A01409, A01410, A01415, A01416, A01418, A01420, A01422, A01423, A01427, A01428, A01429, A01430, A01431, A01432, A01433, A01434, A01435, A01437, A01438, A01440, A01441, A01443, A01444, A01445, A01446, A01447, A01448, A01449, A01450, A01453, A01454, A01455, A01456, A01459, A01460, A01461, A01462, A01463, A01464, A01465, A01466, A01468, A01473, A01476, A01479, A01480, A01482, A01484, A01486, A01487, A01488, A01489, A01490, A01493, A01494, A01495, A01496, A01497, A01499, A01500, A01503, A01505, A01508, A01509, A01512, A01515, A01516, A01518, A01519, A01521, A01523, A01526, A01532, A01534, A01538, A01539, A01540, A01541, A01542, A01544, A01545, A01551, A01553, A01556, A01559, A01561, A01572, A01574, A01576, A01577, A01578, A01583, A01587, A01588, A01593, A01594, A01596, A01597, A01599, A01600, A01601, A01603, A01604, A01607, A01608, A01618, A01620, A01631, A01633, A01634, A01635, A01636, A01637, A01638, A01639, A01640, A01641, A01642, A01645, A01646, A01649, A01651, A01652, A01654, A01659, A01662, A01665, A01666, A01668, A01675, A01676, A01681, A01683, A01684, A01685, A01686, A01687, A01688, A01690, A01691, A01694, A01697, A01698, A01699, A01700, A01701, A01709, A01712, A01714, A01715, A01717, A01719, A01721, A01723, A01724, A01725, A01729, A01734, A01735, A01736, A01741, A01745, A01747, A01748, A01749, A01751, A01752, A01753, A01754, A01756, A01758, A01760, A01762, A01763, A01766, A01767, A01768, A01769, A01770, A01771, A01772, A01773, A01774, A01776, A01778, A01783, A01791, A01792, A01793, A01795, A01800, A01802, A01803, A01804, A01807, A01810, A01811, A01813, A01814, A01815, A01816, A01817, A01823, A01827, A01835, A01836, A01838, A01844, A01846, A01847, A01850, A01851, A01852, A01857, A01860, A01862, A01863, A01865, A01873, A01876, A01878, A01880, A01881, A01886, A01887, A01888, A01890, A01891, A01892, A01893, A01894, A01897, A01898, A01899, A01901, A01902, A01903, A01904, A01905, A01907, A01908, A01909, A01911, A01913, A01914, A01917, A01920, A01925, A01926, A01927, A01929, A01931, A01932, A01935, A01940, A01944, A01947, A01950, A01951, A01954, A01957, A01959, A01960, A01963, A01964, A01965, A01966, A01971, A01973, A01974, A01978, A01979, A01981, A01982, A01986, A01987, A01988, A01991, A01993, A01996, A01997, A02009, A02014, A02015, A02017, A02019, A02020, A02022, A02023, A02024, A02025, A02027, A02028, A02029, A02030, A02031, A02032, A02035, A02036, A02037, A02038, A02040, A02048, A02050, A02052, A02054, A02055, A02056, A02063, A02065, A02069, A02071, A02072, A02073, A02075, A02078, A02080, A02086, A02092, A02095, A02096, A02097, A02103, A02105, A02107, A02108, A02114, A02117, A02120, A02121, A02123, A02124, A02126, A02128, A02129, A02133, A02135, A02138, A02139, A02140, A02143, A02144, A02145, A02147, A02148, A02149, A02150, A02152, A02154, A02155, A02156, A02157, A02158, A02159, A02163, A02167, A02170, A02177, A02182, A02188, A02189, A02190, A02191, A02192, A02193, A02194, A02197, A02198, A02199, A02200, A02206, A02210, A02213, A02215, A02216, A02217, A02218, A02219, A02220, A02221, A02225, A02227, A02228, A02230, A02231, A02232, A02233, A02234, A02235, A02239, A02242, A02249, A02250, A02253, A02257, A02259, A02262, A02267, A02268, A02274, A02276, A02279, A02281, A02289, A02290, A02291, A02295, A02303, A02304, A02321, A02322, A02343, A02344, A02345, A02347, A02349, A02351, A02352, A02353, A02355, A02356, A02357, A02358, A02360, A02361, A02363, A02366, A02369, A02370, A02403, A02404, A02405, A02406, A02407, A02408, A02409, A02410, A02411, A02412, A02413, A02414, A02416, A02417, A02418, A02419, A02420, A02422, A02424, A02425, A02426, A02430, A02432, A02433, A02434, A02437, A02440, A02451, A02457, A02459, A02463, A02465, A02466, A02468, A02473, A02474, A02476, A02477, A02484, A02488, A02489, A02490, A02496, A02499, A02503, A02506, A02508, A02509, A02510, A02512, A02513, A02515, A02516, A02518, A02519, A02523, A02524, A02525, A02526, A02527, A02528, A02529, A02531, A02538, A02539, A02541, A02542, A02544, A02546, A02547, A02548, A02550, A02557, A02558, A02559, A02562, A02565, A02566, A02568, A02578, A02580, A02581, A02582, A02583, A02584, A02587, A02590, A02592, A02595, A02606, A02609, A02611, A02612, A02613, A02621, A02628, A02630, A02633, A02634, A02635, A02636, A02637, A02638, A02641, A02642, A02644, A02645, A02647, A02650, A02653, A02654, A02657, A02658, A02660, A02665, A02666, A02667, A02670, A02672, A02686, A02688, A02689, A02692, A02714, A02715, A02718, A02722, A02723, A02727, A02729, A02732, A02736, A02739, A02747, A02748, A02749, A02752, A02753, A02756, A02757, A02758, A02761, A02762, A02764, A02765, A02766, A02768, A02769, A02770, A02772, A02774, A02775, A02778, A02779, A02780, A02781, A02782, A02783, A02784, A02786, A02787, A02788, A02789, A02790, A02793, A02798, A02799, A02802, A02803, A02805, A02806, A02808, A02814, A02816, A02821, A02822, A02823, A02825, A02826, A02827, A02831, A02834, A02835, A02838, A02841, A02842, A02847, A02850, A02852, A02853, A02855, A02857, A02859, A02861, A02864, A02865, A02867, A02868, A02869, A02871, A02875, A02879, A02881, A02883, A02884, A02885, A02886, A02888, A02891, A02895, A02903, A02904, A02907, A02909, A02910, A02911, A02913, A02914, A02915, A02916, A02918, A02919, A02920, A02921, A02922, A02923, A02924, A02925, A02926, A02927, A02930, A02932, A02935, A02937, A02943, A02944, A02951, A02954, A02961, A02965, A02966, A02972, A02973, A02976, A02977, A02978, A02979, A02980, A02981, A02982, A02983, A02984, A02987, A02988, A02990, A02991, A02992, A02993, A02998, A03000, A03003, A03004, A03005, A03007, A03008, A03009, A03011, A03012, A03014, A03015, A03017, A03018, A03021, A03026, A03027, A03031, A03034, A03040, A03042, A03044, A03045, A03046, A03047, A03052, A03054, A03058, A03059, A03060, A03063, A03064, A03065, A03066, A03067, A03072, A03076, A03082, A03083, A03085, A03087, A03090, A03091, A03092, A03097, A03098, A03101, A03103, A03107, A03108, A03110, A03116, A03122, A03123, A03127, A03128, A03137, A03139, A03140, A03142, A03147, A03150, A03156, A03158, A03161, A03162, A03163, A03167, A03168, A03169, A03170, A03172, A03174, A03175, A03176, A03177, A03178, A03179, A03180, A03183, A03184, A03186, A03192, A03199, A03214, A03215, A03216, A03217, A03218, A03219, A03220, A03221, A03227, A03228, A03229, A03230, A03231, A03232, A03233, A03234, A03235, A03236, A03237, A03238, A03239, A03245, A03246, A03247, A03248, A03253, A03254, A03255, A03256, A03257, A03258, A03259, A03260, A03261, A03262, A03263, A03264, A03265, A03266, A03267, A03268, A03269, A03271, A03272, A03275, A03278, A03281, A03285, A03286, A03289, A03290, A03291, A03292, A03294, A03296, A03298, A03299, A03300, A03301, A03303, A03304, A03305, A03308, A03310, A03311, A03312, A03313, A03315, A03323, A03327, A03328, A03330, A03332, A03339, A03343, A03355, A03357, A03358, A03360, A03362, A03365, A03366, A03367, A03372, A03375, A03377, A03381, A03386, A03388, A03389, A03391, A03392, A03393, A03394, A03395, A03398, A03399, A03400, A03402, A03403, A03404, A03405, A03406, A03407, A03408, A03409, A03429, A03434, A03442, A03444, A03447, A03450, A03454, A03456, A03457, A03459, A03460, A03465, A03466, A03467, A03468, A03470, A03472, A03485, A03490, A03496, A03498, A03508, A03511, A03514, A03519, A03520, A03522, A03525, A03526, A03531, A03533, A03534, A03535, A03539, A03540, A03541, A03542, A03543, A03544, A03545, A03546, A03547, A03549, A03550, A03551, A03553, A03555, A03556, A03557, A03558, A03559, A03560, A03561, A03562, A03563, A03564, A03565, A03566, A03567, A03568, A03569, A03570, A03572, A03573, A03574, A03575, A03576, A03577, A03578, A03579, A03580, A03581, A03582, A03584, A03585, A03586, A03587, A03590, A03593, A03595, A03599, A03600, A03601, A03606, A03607, A03608, A03610, A03611, A03614, A03617, A03619, A03622, A03623, A03626, A03633, A03637, A03638, A03640, A03649, A03650, A03652, A03653, A03655, A03659, A03660, A03661, A03665, A03666, A03667, A03671, A03673, A03674, A03676, A03677, A03678, A03680, A03681, A03682, A03684, A03685, A03686, A03687, A03688, A03691, A03692, A03693, A03697, A03698, A03701, A03704, A03705, A03707, A03709, A03710, A03711, A03712, A03715, A03718, A03719, A03720, A03721, A03722, A03724, A03725, A03726, A03729, A03731, A03732, A03733, A03735, A03736, A03737, A03739, A03742, A03743, A03745, A03747, A03749, A03750, A03753, A03755, A03756, A03764, A03765, A03766, A03767, A03768, A03770, A03772, A03775, A03777, A03778, A03780, A03781, A03783, A03784, A03785, A03788, A03792, A03796, A03797, A03798, A03799, A03800, A03801, A03802, A03804, A03807, A03808, A03809, A03810, A03814, A03815, A03817, A03818, A03821, A03823, A03828, A03829, A03831, A03833, A03836, A03837, A03838, A03839, A03840, A03841, A03842, A03843, A03844, A03845, A03847, A03848, A03849, A03850, A03851, A03853, A03855, A03859, A03864, A03868, A03871, A03879, A03883, A03893, A03897, A03898, A03899, A03900, A03904, A03906, A03908, A03909, A03914, A03915, A03918, A03919, A03921, A03922, A03923, A03925, A03926, A03927, A03928, A03929, A03930, A03937, A03939, A03941, A03945, A03946, A03954, A03957, A03967, A03974, A03976, A03982, A03983, A03991, A03993, A03994, A03996, A03997, A03998, A04000, A04006, A04010, A04013, A04014, A04015, A04016, A04017, A04018, A04019, A04021, A04022, A04023, A04025, A04026, A04029, A04035, A04036, A04038, A04045, A04047, A04048, A04051, A04060, A04061, A04065, A04066, A04067, A04068, A04069, A04072, A04074, A04077, A04078, A04079, A04080, A04087, A04090, A04091, A04092, A04094, A04096, A04099, A04100, A04101, A04102, A04108, A04109, A04110, A04111, A04112, A04113, A04115, A04116, A04117, A04118, A04119, A04120, A04121, A04124, A04126, A04127, A04128, A04129, A04131, A04132, A04134, A04136, A04138, A04144, A04145, A04148, A04149, A04150, A04153, A04159, A04160, A04166, A04171, A04173, A04175, A04180, A04181, A04182, A04185, A04187, A04189, A04190, A04192, A04196, A04199, A04200, A04202, A04205, A04207, A04209, A04210, A04211, A04212, A04217, A04218, A04221, A04223, A04225, A04226, A04228, A04229, A04232, A04234, A04236, A04241, A04242, A04243, A04244, A04245, A04246, A04247, A04248, A04249, A04250, A04253, A04254, A04255, A04258, A04260, A04264, A04265, A04267, A04268, A04270, A04271, A04274, A04276, A04277, A04278, A04280, A04281, A04283, A04284, A04285, A04286, A04287, A04288, A04292, A04293, A04294, A04295, A04297, A04298, A04299, A04301, A04302, A04303, A04304, A04306, A04308, A04309, A04311, A04312, A04314, A04315, A04316, A04317, A04319, A04321, A04322, A04324, A04325, A04326, 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A07647, A07648, A07649, A07650, A07651, A07652, A07653, A07654, A07656, A07657, A07659, A07661, A07663, A07664, A07665, A07666, A07667, A07668, A07669, A07670, A07671, A07672, A07673, A07674, A07676, A07677, A07684, A07689, A07690, A07691, A07692, A07693, A07694, A07695, A07696, A07697, A07698, A07706, A07711, A07718, A07719, A07720, A07721, A07722, A07723, A07724, A07725, A07726, A07727, A07728, A07729, A07730, A07731, A07732, A07733, A07734, A07735, A07736, A07737, A07739, A07742, A07745, A07751, A07752, A07755, A07756, A07759, A07761, A07768, A07769, A07770, A07771, A07773, A07774, A07775, A07776, A07777, A07778, A07779, A07780, A07781, A07782, A07783, A07784, A07785, A07786, A07787, A07788, A07789, A07790, A07791, A07792, A07793, A07794, A07795, A07796, A07797, A07798, A07799, A07800, A07801, A07802, A07804, A07805, A07806, A07807, A07808, A07809, A07810, A07813, A07818, A07820, A07821, A07825, A07828, A07831, A07833, A07838, A07839, A07841, A07842, A07853, A07855, A07857, A07863, A07864, A07865, A07866, A07867, A07868, A07869, A07870, A07871, A07872, A07873, A07874, A07875, A07876, A07877, A07878, A07879, A07880, A07881, A07882, A07883, A07884, A07885, A07886, A07887, A07888, A07889, A07890, A07891, A07892, A07893, A07894, A07895, A07896, A07897, A07898, A07899, A07900, A07901, A07902, A07903, A07904, A07905, A07906, A07907, A07908, A07909, A07910, A07911, A07912, A07913, A07914, A07915, A07916, A07917, A07918, A07919, A07920, A07921, A07922, A07923, A07924, A07925, A07926, A07927, A07928, A07929, A07930, A07931, A07932, A07935, A07936, A07937, A07941, A07944, A07948, A07950, A07951, A07953, A07954, A07955, A07956, A07957, A07958, A07959, A07961, A07962, A07963, A07964, A07965, A07967, A07969, A07977, A07978, A07979, A07980, A07981, A07982, A07983, A07984, A07985, A07986, A07987, A07988, A07989, A07990, A07991, A07992, A07993, A07994, A07995, A07996, A07997, A07998, A07999, A08000, A08001, A08002, A08004, A08005, A08006, A08007, A08008, A08009, A08010, A08011, A08012, A08013, A08014, A08015, A08016, A08017, A08018, A08019, A08020, A08021, A08031, A08037, A08041, A08048, A08063, A08070, A08071, A08073, A08076, A08077, A08079, A08080, A08082, A08083, A08084, A08085, A08086, A08087, A08088, A08089, A08090, A08091, A08092, A08093, A08094, A08095, A08096, A08097, A08098, A08099, A08100, A08101, A08102, A08103, A08104, A08106, A08107, A08108, A08109, A08110, A08112, A08114, A08115, A08116, A08117, A08119, A08122, A08123, A08124, A08125, A08126, A08127, A08128, A08129, A08130, A08131, A08132, A08133, A08134, A08135, A08145, A08153, A08154, A08158, A08161, A08162, A08166, A08168, A08170, A08178, A08181, A08184, A08185, A08186, A08187, A08188, A08189, A08190, A08191, A08192, A08193, A08194, A08195, A08196, A08197, A08198, A08199, A08200, A08201, A08202, A08203, A08204, A08205, A08206, A08207, A08208, A08209, A08210, A08211, A08212, A08213, A08214, A08215, A08216, A08217, A08218, A08219, A08220, A08221, A08222, A08223, A08224, A08225, A08226, A08227, A08228, A08229, A08230, A08231, A08234, A08235, A08236, A08238, A08243, A08247, A08249, A08262, A08264, A08267, A08269, A08273, A08277, A08279, A08281, A08282, A08283, A08284, A08286, A08288, A08289, A08290, A08291, A08292, A08293, A08294, A08295, A08296, A08297, A08298, A08299, A08300, A08301, A08302, A08303, A08304, A08305, A08310, A08311, A08312, A08313, A08314, A08315, A08316, A08320, A08321, A08322, A08323, A08324, A08325, A08328, A08330, A08331, A08332, A08333, A08335, A08336, A08340, A08342, A08350, A08351, A08352, A08353, A08354, A08355, A08356, A08357, A08358, A08359, A08360, A08361, A08362, A08363, A08364, A08365, A08366, A08367, A08368, A08369, A08370, A08371, A08372, A08373, A08375, A08377, A08378, A08379, A08380, A08381, A08382, A08383, A08384, A08385, A08387, A08388, A08389, A08390, A08391, A08392, A08393, A08394, A08395, A08396, A08397, A08398, A08399, A08400, A08401, A08403, A08404, A08405, A08406, A08407, A08408, A08409, A08410, A08411, A08412, A08413, A08414, A08415, A08416, A08417, A08418, A08419, A08420, A08421, A08422, A08423, A08424, A08425, A08426, A08427, A08428, A08429, A08430, A08432, A08433, A08434, A08435, A08437, A08438, A08439, A08440, A08441, A08442, A08443, A08444, A08445, A08446, A08448, A08449, A08450, A08451, A08452, A08453, A08454, A08455, A08456, A08457, A08458, A08459, A08460, A08461, A08462, A08463, A08464, A08465, A08466, A08467, A08468, A08469, A08470, A08471, A08472, A08473, A08474, A08475, A08476, A08477, A08478, A08479, A08480, A08481, A08482, A08483, A08484, A08485, A08486, A08487, A08488, A08489, A08490, A08491, A08492, A08493, A08494, A08495, A08496, A08497, A08498, A08499, A08500, A08501, A08502, A08503, A08504, A08505, A08507, A08508, A08509, A08511, A08512, A08513, A08515, A08516, A08517, A08520, A08521, A08522, A08524, A08525, A08526, A08527, A08528, A08529, A08530, A08531, A08532, A08535, A08536, A08537, A08538, A08539, A08540, A08541, A08542, A08543, A08544, A08545, A08546, A08547, A08550, A08551, A08553, A08554, A08555, A08556, A08557, A08558, A08559, A08560, A08561, A08562, A08563, A08564, A08565, A08566, A08567, A08569, A08570, A08571, A08572, A08573, A08574, A08575, A08577, A08578, A08579, A08580, A08581, A08583, A08584, A08585, A08586, A08587, A08588, A08589, A08590, A08591, A08592, A08594, A08595, A08596, A08597, A08598, A08599, A08600, A08601, A08602, A08603, A08604, A08605, A08606, A08607, A08608, A08610, A08611, A08612, A08614, A08615, A08616, A08617, A08618, A08619, A08620, A08621, A08622, A08623, A08624, A08625, A08627, A08631, A08633, A08637, A08638, A08639, A08642, A08644, A08645, A08646, A08647, A08648, A08649, A08650, A08652, A08654, A08657, A08658, A08659, A08662, A08663, A08664, A08665, A08667, A08669, A08670, A08671, A08672, A08673, A08674, A08675, A08676, A08677, A08678, A08679, A08680, A08681, A08682, A08683, A08684, A08685, A08686, A08687, A08688, A08689, A08690, A08691, A08692, A08693, A08694, A08695, A08696, A08697, A08698, A08699, A08700, A08701, A08702, A08703, A08704, A08706, A08708, A08709, A08710, A08711, A08712, A08713, A08714, A08715, A08717, A08718, A08719, A08720, A08721, A08722, A08724, A08725, A08726, A08727, A08728, A08729, A08730, A08733, A08734, A08735, A08736, A08737, A08738, A08739, A08741, A08742, A08743, A08744, A08745, A08746, A08747, A08748, A08749, A08750, A08751, A08752, A08753, A08754, A08755, A08756, A08757, A08758, A08759, A08760, A08761, A08762, A08763, A08764, A08765, A08766, A08767, A08768, A08769, A08770, A08771, A08772, A08773, A08774, A08775, A08776, A08777, A08778, A08779, A08780, A08781, A08782, A08783, A08784, A08785, A08786, A08787, A08788, A08789, A08790, A08791, A08792, A08793, A08794, A08795, A08796, A08797, A08798, A08799, A08800, A08801, A08802, A08803, A08804, A08805, A08806, A08808, A08809, A08810, A08811, A08812, A08813, A08814, A08815, A08816, A08817, A08818, A08819, A08820, A08821, A08822, A08823, A08824, A08825, A08826, A08827, A08828, A08829, A08830, A08831, A08832, A08833, A08834, A08835, A08836, A08837, A08838, A08839, A08840, A08841, A08842, A08843, A08844, A08845, A08846, A08847, A08848, A08849, A08850, A08851, A08852, A08853, A08854, A08855, A08856, A08857, A08858, A08859, A08860, A08861, A08862, A08863, A08864, A08865, A08866, A08868, A08869, A08870, A08871, A08873, A08874, A08875, A08876, A08877, A08878, A08879, A08880, A08881, A08882, A08883, A08884, A08885, A08886, A08887, A08888, A08889, A08890, A08891, A08892, A08893, A08894, A08895, A08896, A08897, A08898, A08899, A08900, A08901, A08902, A08903, A08904, A08905, A08906, A08907, A08909, A08910, A08911, A08912, A08913, A08914, A08916, A08917, A08918, A08919, A08920, A08921, A08922, A08923, A08924, A08925, A08926, A08927, A08928, A08929, A08930, A08931, A08932, A08933, A08934, A08935, A08936, A08937, A08938, A08939, A08940, A08941, A08942, A08943, A08945, A08946, A08947, A08950, A08951, A08952, A08953, A08954, A08955, A08956, A08957, A08959, A08960, A08961, A08962, A08963, A08964, A08965, A08966, A08967, A08969, A08970, A08971, A08972, A08973, A08974, A08975, A08976, A08977, A08978, A08979, A08980, A08981, A08982, A08983, A08984, A08985, A08986, A08987, A08988, A08989, A08990, A08991, A08992, A08993, A08994, A08995, A08996, A08997, A08998, A08999, A09001, A09002, A09003, A09004, A09005, A09006, A09007, A09008, A09009, A09010, A09011, A09012, A09013, A09014, A09015, A09016, A09017, A09018, A09019, A09021, A09022, A09023, A09024, A09025, A09026, A09028, A09029, A09030, A09031, A09032, A09033, A09034, A09035, A09036, A09037, A09038, A09039, A09040, A09041, A09042, A09043, A09045, A09047, A09048, A09049, A09050, A09051, A09052, A09053, A09054, A09055, A09056, A09057, A09058, A09059, A09060, A09061, A09062, A09063, A09064, A09065, A09066, A09067, A09068, A09069, A09070, A09071, A09072, A09073, A09074, A09075, A09077, A09078, A09079, A09080, A09081, A09082, A09083, A09084, A09085, A09086, A09088, A09089, A09090, A09091, A09092, A09093, A09094, A09095, A09096, A09097, A09098, A09099, A09100, A09101, A09102, A09103, A09104, A09106, A09107, A09108, A09109, A09110, A09111, A09112, A09113, A09114, A09116, A09117, A09119, A09121, A09122, A09123, A09124, A09125, A09126, A09127, A09128, A09129, A09130, A09131, A09132, A09133, A09134, A09135, A09136, A09137, A09138, A09139, A09140, A09142, A09143, A09145, A09146, A09147, A09148, A09149, A09150, A09151, A09152, A09153, A09154, A09155, A09156, A09157, A09158, A09159, A09160, A09161, A09163, A09164, A09165, A09166, A09167, A09168, A09169, A09170, A09171, A09172, A09173, A09174, A09175, A09176, A09177, A09178, A09179, A09180, A09181, A09182, A09183, A09184, A09185, A09186, A09187, A09190, A09191, A09192, A09193, A09194, A09195, A09197, A09198, A09199, A09200, A09202, A09203, A09204, A09205, A09206, A09207, A09208, A09209, A09210, A09211, A09212, A09213, A09214, A09215, A09216, A09218, A09219, A09221, A09222, A09223, A09224, A09225, A09227, A09228, A09229, A09230, A09231, A09232, A09233, A09234, A09235, A09236, A09237, A09238, A09239, A09240, A09241, A09242, A09244, A09246, A09247, A09248, A09249, A09250, A09251, A09253, A09254, A09255, A09256, A09257, A09259, A09260, A09261, A09262, A09263, A09264, A09265, A09265, A09266, A09267, A09268, A09269, A09270, A09271, A09272, A09273, A09274, A09275, A09276, A09278, A09279, A09280, A09281, A09282, A09283, A09284, A09285, A09286, A09287, A09288, A09290, A09291, A09292, A09293, A09294, A09295, A09296, A09297, A09299, A09300, A09302, A09303, A09304, A09305, A09306, A09307, A09308, A09309, A09310, A09311, A09312, A09313, A09314, A09315, A09316, A09317, A09318, A09319, A09320, A09321, A09322, A09323, A09324, A09325, A09326, A09327, A09328, A09329, A09330, A09331, A09332, A09333, A09334, A09335, A09336, A09338, A09340, A09341, A09342, A09344, A09345, A09346, A09347, A09348, A09349, A09350, A09351, A09352, A09353, A09354, A09355, A09356, A09357, A09358, A09359, A09360, A09361, A09362, A09363, A09364, A09365, A09366, A09367, A09368, A09369, A09370, A09371, A09372, A09373, A09374, A09375, A09376, A09377, A09379, A09380, A09381, A09382, A09383, A09384, A09385, A09386, A09387, A09388, A09389, A09390, A09391, A09392, A09393, A09394, A09395, A09396, A09397, A09398, A09399, A09400, A09401, A09402, A09403, A09404, A09405, A09406, A09407, A09408, A09409, A09410, A09411, A09412, A09413, A09414, A09415, A09416, A09418, A09419, A09420, A09421, A09422, A09423, A09424, A09425, A09426, A09427, A09428, A09429, A09430, A09431, A09432, A09433, A09434, A09435, A09436, A09437, A09438, A09439, A09440, A09441, A09442, A09443, A09444, A09445, A09446, A09447, A09448, A09449, A09450, A09451, A09452, A09453, A09454, A09455, A09457, A09458, A09459, A09460, A09461, A09462, A09463, A09464, A09465, A09466, A09467, A09468, A09469, A09470, A09471, A09472, A09473, A09474, A09475, A09476, A09477, A09478, A09479, A09480, A09481, A09482, A09483, A09484, A09485, A09486, A09487, A09488, A09489, A09490, A09491, A09492, A09493, A09494, A09495, A09496, A09497, A09499, A09500, A09501, A09502, A09503, A09504, A09505, A09506, A09507, A09508, A09510, A09511, A09513, A09514, A09515, A09516, A09517, A09518, A09519, A09520, A09521, A09522, A09523, A09524, A09525, A09526, A09527, A09528, A09529, A09530, A09531, A09532, A09533, A09534, A09535, A09536, A09537, A09538, A09539, A09540, A09541, A09542, A09543, A09544, A09545, A09546, A09547, A09548, A09550, A09551, A09552, A09553, A09554, A09555, A09557, A09558, A09559, A09560, A09561, A09562, A09567, A09580, A09588, A09640, A09645, A09647, A09648, A09862, A09866, A10461;

b) Serial numbers: C01001, C01002, C01003, C01022, C01026, C01027, C01029, C01030, C01031, C01032, C01033, C01034, C01039, C01045, C01054, C01055, C01060, C01061, C01062, C01064, C01066, C01067, C01068, C01069, C01070, C01072, C01074, C01076, C01077, C01078, C01079, C01080, C01081, C01082, C01084, C01085, C01086, C01087, C01089, C01090, C01092, C01093, C01094, C01095, C01096, C01097, C01098, C01099, C01100, C01101, C01102, C01103, C01104, C01105, C01106, C01107, C01108, C01110, C01111, C01113, C01114, C01115, C01116, C01117, C01118, C01119, C01122, C01123, C01124, C01126, C01130, C01131, C01132, C01133, C01134, C01138, C01139, C01140, C01141, C01142, C01144, C01147, C01148, C01149, C01151, C01153, C01154, C01163, C01166, C01167, C01173, C01177, C01179, C01180, C01182, C01183, C01185, C01186, C01187, C01188, C01189, C01192, C01193, C01194, C01195, C01196, C01198, C01199, C01200, C01201, C01203, C01204, C01205, C01206, C01207, C01208, C01209, C01210, C01211, C01212, C01213, C01214, C01228, C01231, C01232, C01237, C01240, C01250, C01251, C01252, C01255, C01256, C01257, C01259, C01261, C01262, C01264, C01265, C01267, C01268, C01269, C01270, C01271, C01273, C01274, C01283, C01284, C01286, C01292, C01302, C01303, C01304, C01305, C01307, C01309, C01310, C01311, C01312, C01313, C01314, C01315, C01319, C01320, C01321, C01322, C01323, C01326, C01327, C01328, C01329, C01333, C01339, C01340, C01343, C01344, C01345, C01346, C01348, C01350, C01351, C01353, C01354, C01355, C01356, C01357, C01358, C01359, C01363, C01364, C01374, C01385, C01386, C01388, C01389, C01390, C01391, C01392, C01393, C01394, C01395, C01398, C01401, C01402, C01403, C01405, C01406, C01407, C01408, C01413, C01420, C01429, C01430, C01431, C01432, C01433, C01435, C01437, C01438, C01439, C01441, C01443, C01444, C01445, C01446, C01448, C01452, C01453, C01454, C01461, C01475, C01476, C01477, C01478, C01479, C01480, C01481, C01482, C01483, C01484, C01485, C01486, C01488, C01489, C01492, C01494, C01496, C01497, C01499, C01505, C01506, C01514, C01519, C01520, C01521, C01522, C01523, C01524, C01525, C01526, C01527, C01529, C01530, C01531, C01532, C01533, C01534, C01536, C01537, C01539, C01540, C01541, C01553, C01557, C01559, C01560, C01561, C01562, C01563, C01564, C01565, C01567, C01570, C01571, C01572, C01573, C01574, C01576, C01577, C01578, C01579, C01580, C01581, C01582, C01583, C01585, C01586, C01589, C01591, C01592, C01594, C01595, C01596, C01597, C01598, C01600, C01601, C01603, C01604, C01611, C01612, C01613, C01615, C01616, C01624, C01625, C01632, C01635, C01638, C01639, C01640, C01641, C01642, C01644, C01645, C01646, C01647, C01648, C01650, C01651, C01652, C01654, C01656, C01657, C01658, C01659, C01660, C01662, C01670, C01681, C01694, C01695, C01697, C01699, C01700, C01701, C01703, C01705, C01707, C01708, C01710, C01711, C01712, C01713, C01714, C01716, C01717, C01725, C01743, C01744, C01746, C01747, C01749, C01750, C01752, C01753, C01754, C01757, C01762, C01764, C01768, C01769, C01770, C01771, C01772, C01777, C01778, C01779, C01780, C01781, C01783, C01784, C01785, C01786, C01789, C01790, C01791, C01792, C01794, C01795, C01796, C01797, C01824, C01829, C01831, C01832, C01834, C01836, C01837, C01838, C01840, C01841, C01842, C01843, C01844, C01845, C01845, C01848, C01849, C01850, C01852, C01853, C01854, C01855, C01858, C01861, C01862, C01863, C01864, C01865, C01866, C01867, C01868, C01869, C01871, C01873, C01874, C01875, C01876, C01877, C01878, C01880, C01881, C01883, C01884, C01885, C01895, C01896, C01901, C01903, C01904, C01907, C01908, C01909, C01910, C01913, C01914, C01916, C01917, C01919, C01920, C01921, C01922, C01923, C01929, C01930, C01933, C01935, C01939, C01941, C01942, C01943, C01945, C01946, C01948, C01949, C01950, C01966, C01980, C01981, C01982, C01983, C01984, C01985, C01986, C01987, C01988, C01989, C01991, C01993, C01994, C01995, C01996, C01998, C01999, C02000, C02001, C02005, C02006, C02007, C02010, C02021, C02023, C02025, C02026, C02027, C02028, C02029, C02030, C02031, C02032, C02033, C02036, C02037, C02038, C02039, C02041, C02042, C02043, C02044, C02047, C02048, C02049, C02050, C02071, C02072, C02073, C02074, C02076, C02077, C02078, C02080, C02083, C02084, C02085, C02087, C02089, C02090, C02091, C02092, C02094, C02095, C02097, C02102, C02103, C02104, C02105, C02108, C02110, C02111, C02114, C02115, C02123, C02125, C02127, C02128, C02130, C02132, C02133, C02134, C02135, C02136, C02137, C02139, C02140, C02141, C02143, C02144, C02145, C02146, C02147, C02148, C02149, C02150, C02151, C02152, C02156, C02158, C02159, C02160, C02163, C02164, C02186, C02203, C02204, C02207, C02208, C02209, C02210, C02211, C02212, C02214, C02215, C02216, C02217, C02219, C02220, C02221, C02222, C02223, C02224, C02225, C02226, C02227, C02228, C02234, C02238, C02239, C02240, C02241, C02242, C02245, C02246, C02248, C02249, C02250, C02251, C02252, C02253, C02254, C02255, C02260, C02261, C02262, C02263, C02265, C02266, C02268, C02269, C02270, C02275, C02276, C02277, C02280, C02284, C02285, C02286, C02287, C02288, C02289, C02290, C02291, C02292, C02293, C02295, C02297, C02302, C02303, C02304, C02305, C02306, C02307, C02308, C02309, C02311, C02313, C02314, C02315, C02316, C02317, C02319, C02320, C02324, C02326, C02327, C02328, C02358, C02359, C02360, C02363, C02367, C02371, C02375, C02376, C02379, C02381, C02382, C02384, C02385, C02386, C02388, C02389, C02390, C02391, C02392, C02393, C02394, C02396, C02397, C02398, C02399, C02400, C02401, C02402, C02403, C02404, C02405, C02406, C02408, C02409, C02410, C02411, C02412, C02413, C02414, C02415, C02416, C02417, C02418, C02420, C02421, C02430, C02434, C02444, C02445, C02446, C02448, C02450, C02451, C02452, C02454, C02455, C02460, C02461, C02462, C02463, C02466, C02468, C02470, C02472, C02480, C02482, C02483, C02486, C02487, C02488, C02490, C02492, C02493, C02495, C02496, C02498, C02499, C02500, C02501, C02502, C02503, C02506, C02507, C02508, C02509, C02511, C02515, C02516, C02519, C02528, C02530, C02531, C02536, C02537, C02544, C02546, C02547, C02548, C02549, C02550, C02552, C02554, C02556, C02558, C02560, C02561, C02562, C02567, C02568, C02569, C02570, C02571, C02572, C02573, C02574, C02575, C02576, C02578, C02580, C02581, C02582, C02583, C02584, C02585, C02586, C02587, C02588, C02589, C02590, C02597, C02600, C02616, C02617, C02620, C02621, C02624, C02626, C02633, C02634, C02638, C02640, C02642, C02643, C02645, C02647, C02648, C02650, C02651, C02653, C02655, C02656, C02657, C02658, C02659, C02660, C02662, C02664, C02665, C02666, C02667, C02669, C02671, C02672, C02673, C02674, C02677, C02678, C02680, C02681, C02682, C02683, C02685, C02686, C02687, C02688, C02689, C02690, C02691, C02692, C02693, C02696, C02697, C02698, C02699, C02700, C02703, C02704, C02705, C02706, C02711, C02712, C02713, C02715, C02716, C02719, C02720, C02721, C02722, C02723, C02724, C02726, C02727, C02728, C02729, C02730, C02731, C02732, C02733, C02735, C02736, C02737, C02738, C02739, C02740, C02742, C02743, C02744, C02746, C02747, C02749, C02750, C02751, C02752, C02753, C02754, C02755, C02756, C02757, C02758, C02759, C02760, C02761, C02767, C02768, C02769, C02770, C02771, C02772, C02773, C02774, C02776, C02779, C02780, C02810, C02812, C02813, C02814, C02815, C02816, C02817, C02818, C02819, C02821, C02822, C02823, C02824, C02825, C02826, C02827, C02828, C02829, C02830, C02831, C02832, C02833, C02835, C02836, C02838, C02839, C02840, C02841, C02845, C02846, C02848, C02849, C02851, C02852, C02853, C02854, C02855, C02856, C02858, C02859, C02860, C02861, C02862, C02863, C02864, C02865, C02866, C02867, C02868, C02869, C02870, C02873, C02874, C02876, C02877, C02878, C02879, C02880, C02881, C02882, C02883, C02884, C02885, C02886, C02887, C02888, C02889, C02890, C02891, C02893, C02894, C02895, C02896, C02898, C02899, C02900, C02901, C02904, C02905, C02906, C02907, C02908, C02910, C02911, C02912, C02913, C02915, C02916, C02918, C02919, C02920, C02921, C02922, C02923, C02924, C02925, C02926, C02927, C02928, C02929, C02931, C02932, C02933, C02934, C02935, C02936, C02938, C02939, C02940, C02941, C02942, C02944, C02947, C02948, C02949, C02950, C02951, C02953, C02954, C02957, C02958, C02959, C02960, C02961, C02962, C02963, C02964, C02965, C02967, C02968, C02969, C02970, C02971, C02972, C02973, C02974, C02975, C02976, C02977, C02978, C02981, C02982, C02983, C02984, C02987, C02988, C02989, C02990, C02991, C02992, C02993, C02994, C02995, C02996, C02997, C02998, C02999, C03000, C03001, C03003, C03005, C03006, C03007, C03008, C03009, C03010, C03011, C03013, C03014, C03015, C03016, C03018, C03021, C03023, C03026, C03027, C03028, C03030, C03031, C03033, C03034, C03035, C03036, C03037, C03039, C03041, C03042, C03043, C03044, C03045, C03046, C03047, C03048, C03049, C03050, C03051, C03053, C03056, C03057, C03059, C03060, C03061, C03063, C03064, C03067, C03068, C03070, C03071, C03072, C03073, C03075, C03076, C03077, C03078, C03079, C03080, C03084, C03085, C03087, C03088, C03089, C03093, C03094, C03095, C03097, C03098, C03099, C03100, C03102, C03103, C03107, C03109, C03110, C03111, C03114, C03115, C03118, C03119, C03120, C03121, C03124, C03125, C03127, C03128, C03131, C03133, C03134, C03135, C03136, C03139, C03140, C03141, C03147, C03149, C03151, C03152, C03153, C03154, C03156, C03157, C03158, C03159, C03160, C03161, C03162, C03163, C03164, C03165, C03166, C03167, C03180, C03184, C03185, C03189, C03193, C03198, C03200, C03201, C03204, C03205, C03206, C03207, C03209, C03210, C03212, C03215, C03218, C03222, C03223, C03224, C03226, C03228, C03229, C03231, C03232, C03233, C03234, C03235, C03236, C03237, C03239, C03240, C03241, C03242, C03243, C03244, C03245, C03246, C03247, C03248, C03249, C03250, C03251, C03254, C03255, C03257, C03259, C03260, C03261, C03262, C03264, C03265, C03266, C03268, C03269, C03271, C03272, C03275, C03276, C03278, C03279, C03280, C03281, C03282, C03283, C03284, C03285, C03286, C03287, C03289, C03290, C03291, C03292, C03294, C03296, C03297, C03298, C03299, C03300, C03302, C03303, C03304, C03306, C03307, C03308, C03310, C03312, C03313, C03316, C03318, C03319, C03320, C03322, C03324, C03325, C03326, C03328, C03330, C03331, C03332, C03335, C03336, C03338, C03346, C03349, C03352, C03354, C03362, C03364, C03368, C03369, C03370, C03374, C03375, C03377, C03379, C03380, C03381, C03382, C03383, C03384, C03386, C03387, C03388, C03389, C03390, C03391, C03392, C03393, C03394, C03395, C03397, C03398, C03399, C03400, C03401, C03402, C03403, C03404, C03405, C03408, C03412, C03413, C03414, C03416, C03418, C03419, C03420, C03421, C03422, C03424, C03426, C03427, C03428, C03429, C03430, C03431, C03432, C03433, C03434, C03436, C03438, C03439, C03440, C03441, C03443, C03446, C03449, C03451, C03454, C03457, C03458, C03460, C03461, C03462, C03463, C03465, C03467, C03469, C03472, C03473, C03474, C03475, C03476, C03477, C03478, C03479, C03480, C03481, C03482, C03486, C03487, C03488, C03489, C03491, C03493, C03494, C03495, C03496, C03497, C03498, C03499, C03501, C03503, C03504, C03505, C03506, C03508, C03509, C03510, C03513, C03514, C03516, C03517, C03518, C03521, C03523, C03524, C03525, C03526, C03527, C03529, C03531, C03532, C03533, C03534, C03536, C03537, C03538, C03540, C03544, C03546, C03549, C03550, C03551, C03554, C03557, C03558, C03559, C03560, C03561, C03562, C03563, C03564, C03566, C03568, C03569, C03573, C03574, C03575, C03576, C03578, C03580, C03583, C03584, C03589, C03592, C03593, C03594, C03595, C03596, C03598, C03599, C03601, C03602, C03603, C03604, C03606, C03608, C03609, C03614, C03617, C03620, C03621, C03622, C03624, C03629, C03631, C03633, C03634, C03636, C03637, C03639, C03641, C03642, C03644, C03645, C03647, C03648, C03649, C03652, C03656, C03661, C03662, C03666, C03668, C03669, C03670, C03671, C03673, C03680, C03682, C03683, C03684, C03685, C03687, C03688, C03689, C03690, C03691, C03692, C03694, C03695, C03696, C03697, C03699, C03701, C03702, C03703, C03705, C03706, C03710, C03713, C03714, C03716, C03717, C03718, C03719, C03720, C03722, C03724, C03725, C03726, C03730, C03731, C03732, C03734, C03736, C03737, C03738, C03739, C03741, C03742, C03744, C03745, C03746, C03748, C03749, C03750, C03751, C03752, C03753, C03754, C03756, C03757, C03758, C03760, C03761, C03763, C03765, C03766, C03768, C03770, C03771, C03772, C03773, C03774, C03775, C03776, C03777, C03778, C03779, C03780, C03781, C03782, C03783, C03784, C03787, C03788, C03789, C03790, C03791, C03792, C03793, C03794, C03796, C03797, C03798, C03799, C03801, C03803, C03804, C03805, C03808, C03809, C03811, C03813, C03814, C03815, C03817, C03818, C03819, C03820, C03821, C03822, C03823, C03824, C03825, C03827, C03828, C03829, C03830, C03831, C03832, C03833, C03834, C03836, C03837, C03838, C03839, C03840, C03842, C03843, C03844, C03845, C03850, C03851, C03852, C03857, C03858, C03859, C03861, C03862, C03863, C03864, C03866, C03868, C03872, C03873, C03874, C03875, C03877, C03879, C03880, C03881, C03883, C03887, C03888, C03889, C03890, C03891, C03892, C03893, C03894, 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C09405, C09407, C09408, C09409, C09410, C09411, C09412, C09414, C09415, C09416, C09417, C09418, C09419, C09420, C09421, C09422, C09423, C09424, C09425, C09426, C09427, C09428, C09429, C09430, C09431, C09433, C09434, C09435, C09436, C09437, C09438, C09439, C09440, C09441, C09442, C09443, C09444, C09445, C09446, C09447, C09448, C09449, C09450, C09451, C09452, C09453, C09454, C09455, C09456, C09457, C09458, C09459, C09460, C09461, C09462, C09464, C09465, C09466, C09467, C09468, C09469, C09470, C09471, C09472, C09473, C09474, C09475, C09476, C09477, C09478, C09479, C09480, C09481, C09482, C09483, C09484, C09485, C09486, C09488, C09489, C09490, C09491, C09492, C09493, C09494, C09495, C09496, C09497, C09498, C09499, C09500, C09501, C09502, C09503, C09504, C09505, C09506, C09507, C09508, C09510, C09511, C09512, C09513, C09514, C09515, C09516, C09518, C09519, C09521, C09522, C09523, C09525, C09526, C09527, C09528, C09529, C09530, C09532, C09533, C09534, C09535, C09536, C09537, C09538, C09539, 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C09682, C09684, C09685, C09686, C09687, C09688, C09689, C09690, C09691, C09692, C09693, C09694, C09695, C09697, C09698, C09699, C09702, C09703, C09704, C09705, C09706, C09707, C09708, C09709, C09710, C09711, C09712, C09713, C09714, C09715, C09716, C09717, C09718, C09719, C09720, C09721, C09724, C09725, C09726, C09727, C09728, C09729, C09731, C09732, C09733, C09734, C09735, C09736, C09737, C09738, C09739, C09740, C09741, C09742, C09743, C09744, C09745, C09746, C09747, C09748, C09749, C09750, C09751, C09752, C09754, C09755, C09756, C09758, C09759, C09760, C09763, C09765, C09766, C09767, C09768, C09769, C09770, C09771, C09772, C09773, C09774, C09775, C09776, C09777, C09778, C09779, C09780, C09781, C09782, C09783, C09784, C09785, C09786, C09788, C09789, C09790, C09791, C09792, C09793, C09794, C09795, C09796, C09797, C09798, C09799, C09800, C09801, C09802, C09804, C09805, C09807, C09808, C09809, C09810, C09811, C09812, C09813, C09814, C09815, C09816, C09819, C09821, C09822, C09823, C09824, C09825, C09827, C09828, C09830, C09831, C09832, C09833, C09834, C09835, C09836, C09837, C09839, C09841, C09842, C09843, C09844, C09845, C09846, C09847, C09848, C09849, C09850, C09851, C09852, C09853, C09854, C09856, C09857, C09858, C09859, C09860, C09861, C09862, C09863, C09864, C09866, C09867, C09869, C09870, C09871, C09872, C09873, C09874, C09875, C09876, C09877, C09878, C09879, C09880, C09881, C09882, C09883, C09884, C09885, C09886, C09887, C09888, C09889, C09890, C09891, C09892, C09893, C09894, C09895, C09896, C09897, C09898, C09899, C09900, C09901, C09902, C09903, C09904, C09905, C09906, C09907, C09908, C09909, C09910, C09911, C09913, C09914, C09915, C09916, C09917, C09918, C09919, C09920, C09921, C09922, C09923, C09924, C09925, C09927, C09928, C09929, C09930, C09931, C09933, C09934, C09935, C09937, C09938, C09939, C09941, C09943, C09944, C09945, C09946, C09947, C09948, C09949, C09950, C09951, C09952, C09953, C09954, C09955, C09956, C09957, C09958, C09959, C09960, C09961, C09962, C09963, C09964, C09965, C09966, C09967, C09968, C09969, C09970, C09971, C09972, C09974, C09975, C09976, C09977, C09978, C09979, C09980, C09982, C09983, C09984, C09985, C09986, C09987, C09988, C09989, C09990, C09991, C09992, C09993, C09994, C09995, C09997, C09998, C09999, C10000, C10001, C10002, C10003, C10004, C10005, C10006, C10007, C10008, C10009, C10010, C10011, C10012, C10013, C10015, C10016, C10017, C10018, C10019, C10020, C10021, C10022, C10023, C10024, C10025, C10026, C10027, C10028, C10029, C10030, C10031, C10032, C10033, C10034, C10035, C10036, C10037, C10038, C10039, C10040, C10041, C10042, C10043, C10044, C10045, C10046, C10047, C10048, C10049, C10050, C10052, C10053, C10054, C10055, C10056, C10057, C10058, C10059, C10060, C10061, C10062, C10063, C10064, C10065, C10066, C10067, C10068, C10069, C10070, C10071, C10072, C10073, C10074, C10075, C10076, C10077, C10078, C10079, C10080, C10081, C10082, C10083, C10084, C10085, C10086, C10087, C10088, C10089, C10090, C10091, C10092, C10093, C10094, C10095, C10096, C10097, C10098, C10099, C10100, C10101, C10102, C10103, C10104, C10105, C10106, C10107, C10108, C10109, C10110, C10111, C10112, C10113, C10114, C10115, C10116, C10117, C10118, C10119, C10120, C10121, C10122, C10123, C10124, C10125, C10126, C10127, C10128, C10129, C10130, C10131, C10132, C10133, C10134, C10135, C10136, C10137, C10138, C10139, C10140, C10141, C10142, C10143, C10144, C10145, C10146, C10147, C10149, C10150, C10151, C10152, C10153, C10154, C10155, C10156, C10157, C10158, C10159, C10160, C10161, C10162, C10163, C10164, C10165, C10166, C10167, C10168, C10169, C10170, C10171, C10172, C10173, C10174, C10175, C10176, C10177, C10178, C10179, C10180, C10181, C10182, C10183, C10184, C10185, C10186, C10187, C10188, C10189, C10190, C10191, C10192, C10193, C10194, C10195, C10196, C10197, C10198, C10199, C10200, C10201, C10202, C10203, C10204, C10205, C10206, C10207, C10208, C10209, C10210, C10211, C10212, C10213, C10214, C10215, C10216, C10217, C10218, C10219, C10220, C10221, C10222, C10223, C10224, C10225, C10226, C10227, C10228, C10229, C10230, C10231, C10232, C10233, C10234, C10235, C10236, C10237, C10238, C10239, C10240, C10241, C10242, C10243, C10244, C10245, C10246, C10247, C10248, C10249, C10250, C10251, C10252, C10253, C10254, C10255, C10256, C10257, C10258, C10259, C10260, C10261, C10262, C10263, C10264, C10265, C10266, C10267, C10268, C10269, C10270, C10271, C10272, C10273, C10274, C10275, C10276, C10277, C10278, C10279, C10280, C10281, C10282, C10283, C10284, C10285, C10286, C10287, C10288, C10289, C10290, C10291, C10292, C10293, C10294, C10295, C10296, C10297, C10298, C10299, C10300, C10301, C10302, C10303, C10304, C10305, C10306, C10307, C10308, C10309, C10310, C10311, C10312, C10313, C10314, C10315, C10316, C10317, C10318, C10319, C10320, C10321, C10322, C10323, C10324, C10325, C10326, C10327, C10328, C10329, C10330, C10331, C10332, C10333, C10334, C10335, C10336, C10337, C10338, C10339, C10340, C10341, C10342, C10343, C10344, C10345, C10346, C10348, C10349, C10350, C10351, C10352, C10353, C10354, C10355, C10356, C10357, C10358, C10359, C10360, C10361, C10362, C10363, C10364, C10365, C10366, C10367, C10368, C10369, C10371, C10373, C10374, C10375, C10376, C10377, C10378, C10379, C10380, C10381, C10382, C10383, C10385, C10386, C10387, C10388, C10389, C10390, C10391, C10392, C10393, C10394, C10395, C10396, C10397, C10398, C10399, C10400, C10401, C10402, C10403, C10404, C10405, C10406, C10407, C10408, C10409, C10410, C10411, C10412, C10413, C10414, C10415, C10416, C10417, C10418, C10419, C10420, C10421, C10422, C10423, C10424, C10425, C10426, C10427, C10428, C10430, C10431, C10432, C10433, C10434, C10435, C10436, C10437, C10438, C10439, C10440, C10441, C10442, C10443, C10444, C10445, C10446, C10447, C10448, C10449, C10450, C10451, C10452, C10453, C10454, C10455, C10456, C10457, C10458, C10459, C10460, C10461, C10462, C10463, C10464, C10465, C10466, C10467, C10468, C10469, C10470, C10471, C10472, C10473, C10475, C10476, C10477, C10478, C10479, C10480, C10481, C10482, C10483, C10484, C10485, C10486, C10487, C10488, C10489, C10490, C10491, C10492, C10493, C10494, C10495, C10496, C10497, C10498, C10499, C10500, C10501, C10502, C10503, C10504, C10505, C10506, C10507, C10508, C10509, C10510, C10511, C10512, C10513, C10514, C10515, C10516, C10517, C10518, C10519, C10520, C10521, C10522, C10523, C10524, C10525, C10526, C10527, C10528, C10529, C10530, C10531, C10532, C10533, C10534, C10535, C10536, C10537, C10538, C10539, C10540, C10541, C10542, C10543, C10544, C10545, C10546, C10547, C10548, C10549, C10550, C10551, C10552, C10553, C10554, C10555, C10556, C10557, C10558, C10560, C10561, C10562, C10563, C10564, C10565, C10566, C10567, C10568, C10569, C10570, C10571, C10572, C10573, C10575, C10577, C10578, C10580, C10581, C10582, C10583, C10584, C10585, C10586, C10587, C10588, C10589, C10590, C10591, C10592, C10593, C10594, C10595, C10596, C10597, C10598, C10599, C10600, C10601, C10602, C10603, C10604, C10605, C10606, C10607, C10608, C10609, C10610, C10611, C10612, C10613, C10614, C10615, C10616, C10617, C10618, C10619, C10620, C10621, C10622, C10623, C10624, C10625, C10626, C10627, C10628, C10629, C10630, C10631, C10632, C10633, C10634, C10635, C10636, C10637, C10638, C10639, C10640, C10641, C10642, C10643, C10644, C10645, C10646, C10647, C10648, C10649, C10650, C10651, C10653, C10654, C10655, C10656, C10657, C10658, C10659, C10660, C10661, C10662, C10663, C10664, C10665, C10666, C10667, C10668, C10669, C10670, C10671, C10672, C10673, C10674, C10675, C10676, C10677, C10678, C10679, C10681, C10682, C10683, C10684, C10685, C10686, C10687, C10688, C10689, C10690, C10691, C10692, C10693, C10694, C10695, C10696, C10697, C10698, C10699, C10700, C10701, C10702, C10703, C10704, C10705, C10706, C10707, C10708, C10709, C10710, C10711, C10713, C10714, C10715, C10716, C10717, C10718, C10719, C10720, C10721, C10722, C10723, C10724, C10725, C10726, C10727, C10728, C10729, C10730, C10731, C10732, C10733, C10734, C10735, C10736, C10737, C10738, C10739, C10740, C10741, C10742, C10743, C10744, C10745, C10746, C10747, C10748, C10749, C10750, C10751, C10752, C10753, C10754, C10755, C10756, C10757, C10758, C10759, C10760, C10761, C10762, C10763, C10764, C10765, C10766, C10767, C10768, C10769, C10770, C10771, C10772, C10773, C10774, C10775, C10776, C10777, C10778, C10779, C10780, C10781, C10782, C10784, C10785, C10786, C10787, C10788, C10789, C10790, C10791, C10792, C10794, C10796, C10797, C10798, C10799, C10800, C10801, C10802, C10803, C10804, C10805, C10806, C10807, C10808, C10809, C10810, C10811, C10812, C10813, C10814, C10815, C10816, C10817, C10818, C10819, C10820, C10821, C10822, C10823, C10824, C10825, C10826, C10827, C10828, C10829, C10830, C10831, C10832, C10833, C10834, C10835, C10836, C10837, C10838, C10839, C10840, C10841, C10842, C10843, C10844, C10845, C10846, C10847, C10848, C10849, C10850, C10851, C10852, C10853, C10854, C10855, C10856, C10857, C10858, C10859, C10860, C10861, C10862, C10863, C10864, C10865, C10866, C10867, C10868, C10869, C10870, C10871, C10872, C10873, C10874, C10875, C10876, C10877, C10878, C10879, C10880, C10881, C10882, C10883, C10884, C10885, C10886, C10887, C10888, C10889, C10890, C10892, C10893, C10894, C10897, C10898, C10899, C10900, C10901, C10902, C10903, C10904, C10905, C10906, C10907, C10908, C10909, C10910, C10911, C10912, C10913, C10914, C10915, C10916, C10917, C10918, C10919, C10920, C10921, C10922, C10923, C10924, C10925, C10926, C10927, C10928, C10929, C10930, C10931, C10933, C10934, C10935, C10936, C10937, C10938, C10939, C10940, C10941, C10942, C10943, C10944, C10945, C10946, C10947, C10948, C10949, C10950, C10951, C10953, C10954, C10955, C10956, C10957, C10958, C10959, C10960, C10961, C10962, C10963, C10964, C10965, C10966, C10967, C10968, C10969, C10970, C10971, C10972, C10973, C10974, C10975, C10976, C10977, C10978, C10979, C10980, C10981, C10982, C10984, C10985, C10986, C10987, C10988, C10989, C10990, C10991, C10992, C10993, C10994, C10995, C10996, C10997, C10998, C10999, C11000, C11001, C11002, C11003, C11004, C11005, C11006, C11007, C11008, C11009, C11010, C11011, C11012, C11013, C11014, C11015, C11016, C11017, C11018, C11019, C11020, C11021, C11022, C11023, C11024, C11025, C11026, C11027, C11028, C11029, C11030, C11031, C11032, C11033, C11035, C11036, C11037, C11038, C11039, C11040, C11041, C11042, C11043, C11044, C11045, C11046, C11047, C11048, C11049, C11050, C11051, C11052, C11053, C11054, C11055, C11056, C11057, C11058, C11059, C11060, C11061, C11062, C11063, C11064, C11065, C11066, C11067, C11068, C11069, C11070, C11071, C11072, C11073, C11074, C11075, C11076, C11077, C11078, C11079, C11080, C11081, C11082, C11083, C11084, C11085, C11086, C11087, C11088, C11089, C11090, C11091, C11092, C11093, C11095, C11096, C11097, C11098, C11099, C11100, C11101, C11102, C11103, C11104, C11105, C11106, C11107, C11108, C11109, C11110, C11111, C11112, C11113, C11114, C11115, C11116, C11117, C11118, C11119, C11120, C11121, C11122, C11124, C11125, C11126, C11127, C11128, C11129, C11130, C11131, C11132, C11133, C11134, C11135, C11137, C11138, C11139, C11140, C11141, C11142, C11143, C11144, C11145, C11146, C11147, C11148, C11149, C11150, C11151, C11152, C11153, C11154, C11155, C11156, C11157, C11158, C11159, C11160, C11161, C11162, C11163, C11164, C11165, C11166, C11167, C11168, C11169, C11170, C11171, C11172, C11174, C11175, C11176, C11177, C11178, C11179, C11180, C11181, C11182, C11184, C11185, C11186, C11188, C11189, C11190, C11191, C11192, C11193, C11194, C11195, C11196, C11197, C11198, C11199, C11200, C11201, C11202, C11204, C11205, C11206, C11207, C11208, C11209, C11211, C11212, C11213, C11214, C11215, C11216, C11217, C11218, C11219, C11220, C11221, C11222, C11223, C11224, C11225, C11226, C11227, C11228, C11229, C11230, C11231, C11232, C11233, C11234, C11235, C11236, C11237, C11238, C11240, C11241, C11242, C11243, C11244, C11245, C11246, C11247, C11248, C11249, C11250, C11251, C11252, C11253, C11254, C11255, C11256, C11257, C11258, C11259, C11260, C11261, C11263, C11264, C11265, C11266, C11267, C11268, C11269, C11270, C11271, C11272, C11276, C11277, C11278, C11279, C11280, C11281, C11282, C11283, C11284, C11285, C11286, C11287, C11288, C11289, C11290, C11291, C11352, C11353, C11354, C11355, C11356, C11357, C11358, C11359, C11360, C11361, C11362, C11363, C11364, C11365, C11366, C11367, C11368, C11369, C11370, C11371, C11372, C11373, C11374, C11375, C11376, C11377, C11378, C11379, C11380, C11382, C11383, C11384, C11385, C11386, C11387, C11388, C11389, C11390, C11391, C11392, C11393, C11394, C11395, C11396, C11397, C11398, C11400, C11401, C11402, C11403, C11404, C11406, C11407, C11408, C11409, C11410, C11411, C11412, C11432, C11579, C11626, C11743, C11744, C11747, C11842, C12012, C14890, C15138, C15422, C15424, C15505, C15506

c) Serial numbers: B01012, B01052, B01053, B01056, B01060, B01062, B01064, B01066, B01068, B01074, B01075, B01076, B01077, B01079, B01080, B01082, B01083, B01084, B01085, B01086, B01087, B01089, B01091, B01092, B01093, B01094, B01095, B01096, B01099, B01100, B01101, B01102, B01103, B01104, B01105, B01106, B01107, B01108, B01109, B01112, B01114, B01115, B01118, B01121, B01123, B01125, B01129, B01130, B01131, B01132, B01134, B01137, B01140, B01144, B01147, B01148, B01149, B01151, B01152, B01156, B01159, B01161, B01162, B01163, B01165, B01167, B01169, B01171, B01172, B01174, B01175, B01176, B01177, B01180, B01184, B01185, B01186, B01187, B01188, B01189, B01190, B01191, B01193, B01195, B01198, B01200, B01201, B01202, B01203, B01205, B01206, B01207, B01210, B01216, B01223, B01230, B01232, B01236, B01238, B01239, B01240, B01243, B01244, B01251, B01252, B01256, B01259, B01260, B01262, B01263, B01265, B01266, B01267, B01268, B01269, B01270, B01271, B01272, B01273, B01276, B01277, B01278, B01280, B01283, B01284, B01285, B01287, B01288, B01289, B01290, B01292, B01294, B01295, B01296, B01297, B01298, B01299, B01301, B01302, B01303, B01304, B01305, B01307, B01309, B01312, B01314, B01316, B01317, B01318, B01320, B01321, B01322, B01324, B01327, B01329, B01330, B01331, B01334, B01335, B01336, B01339, B01341, B01342, B01343, B01344, B01345, B01346, B01347, B01348, B01349, B01350, B01354, B01357, B01358, B01359, B01364, B01365, B01367, B01368, B01369, B01370, B01375, B01376, B01377, B01383, B01388, B01389, B01390, B01391, B01393, B01394, B01395, B01396, B01397, B01399, B01401, B01403, B01404, B01406, B01409, B01410, B01414, B01416, B01417, B01418, B01422, B01423, B01425, B01426, B01428, B01430, B01431, B01432, B01433, B01434, B01436, B01437, B01438, B01442, B01443, B01444, B01445, B01449, B01450, B01454, B01455, B01457, B01458, B01459, B01461, B01463, B01464, B01465, B01466, B01467, B01468, B01469, B01470, B01474, B01475, B01476, B01477, B01478, B01480, B01481, B01485, B01487, B01488, B01491, B01492, B01493, B01494, B01495, B01496, B01500, B01501, B01505, B01507, B01508, B01512, B01514, B01515, B01518, B01520, B01523, B01525, B01526, B01527, B01528, B01529, B01531, B01533, B01534, B01536, B01537, B01539, B01540, B01542, B01544, B01545, B01546, B01550, B01552, B01553, B01554, B01555, B01556, B01558, B01563, B01564, B01567, B01569, B01570, B01572, B01573, B01574, B01575, B01579, B01585, B01586, B01587, B01588, B01589, B01590, B01591, B01592, B01594, B01598, B01599, B01600, B01601, B01604, B01607, B01610, B01611, B01612, B01613, B01616, B01617, B01619, B01620, B01621, B01623, B01625, B01625, B01629, B01633, B01636, B01637, B01638, B01639, B01641, B01643, B01646, B01649, B01651, B01652, B01655, B01656, B01659, B01661, B01663, B01664, B01666, B01667, B01668, B01669, B01671, B01672, B01673, B01674, B01675, B01676, B01679, B01680, B01682, B01686, B01687, B01689, B01691, B01692, B01693, B01694, B01699, B01700, B01702, B01703, B01704, B01705, B01706, B01707, B01708, B01709, B01711, B01712, B01715, B01716, B01718, B01721, B01722, B01723, B01724, B01728, B01730, B01731, B01732, B01733, B01742, B01744, B01745, B01747, B01748, B01749, B01750, B01751, B01753, B01754, B01755, B01758, B01760, B01762, B01763, B01767, B01769, B01770, B01774, B01777, B01779, B01781, B01783, B01784, B01785, B01786, B01787, B01788, B01789, B01790, B01791, B01793, B01794, B01796, B01797, B01798, B01799, B01800, B01801, B01803, B01805, B01806, B01807, B01808, B01810, B01811, B01812, B01814, B01815, B01829, B01831, B01832, B01833, B01836, B01837, B01838, B01840, B01841, B01843, B01844, B01845, B01846, B01847, B01848, B01849, B01850, B01851, B01852, B01855, B01873, B01875, B01876, B01877, B01878, B01879, B01880, B01883, B01885, B01886, B01888, B01889, B01890, B01892, B01893, B01894, B01895, B01896, B01898, B01899, B01900, B01903, B01905, B01906, B01907, B01908, B01909, B01911, B01914, B01916, B01917, B01918, B01919, B01921, B01924, B01925, B01926, B01928, B01930, B01933, B01934, B01936, B01938, B01940, B01941, B01943, B01945, B01946, B01949, B01950, B01955, B01958, B01959, B01960, B01961, B01962, B01964, B01965, B01966, B01967, B01968, B01971, B01972, B01973, B01975, B01976, B01977, B01979, B01982, B01983, B01984, B01986, B01988, B01989, B01990, B01991, B01992, B01993, B01994, B01995, B01998, B02000, B02002, B02003, B02005, B02007, B02008, B02009, B02011, B02012, B02013, B02014, B02016, B02017, B02018, B02019, B02020, B02021, B02022, B02023, B02024, B02025, B02027, B02029, B02030, B02031, B02032, B02034, B02036, B02039, B02040, B02044, B02045, B02046, B02047, B02049, B02050, B02051, B02052, B02054, B02056, B02057, B02061, B02062, B02063, B02064, B02067, B02068, B02071, B02074, B02075, B02076, B02077, B02078, B02079, B02081, B02082, B02084, B02085, B02086, B02090, B02091, B02092, B02097, B02098, B02099, B02101, B02102, B02103, B02106, B02110, B02111, B02112, B02113, B02115, B02116, B02117, B02118, B02119, B02120, B02121, B02122, B02123, B02124, B02125, B02126, B02127, B02128, B02129, B02130, B02131, B02132, B02133, B02134, B02135, B02136, B02137, B02142, B02145, B02148, B02149, B02150, B02151, B02152, B02153, B02156, B02157, B02159, B02160, B02162, B02163, B02164, B02165, B02166, B02167, B02168, B02169, B02170, B02171, B02172, B02173, B02174, B02175, B02176, B02177, B02178, B02179, B02180, B02182, B02183, B02184, B02185, B02186, B02188, B02189, B02191, B02193, B02195, B02197, B02198, B02199, B02200, B02201, B02202, B02203, B02205, B02206, B02209, B02210, B02211, B02213, B02214, B02216, B02217, B02222, B02223, B02227, B02228, B02229, B02230, B02231, B02235, B02238, B02241, B02242, B02243, B02244, B02245, B02246, B02248, B02249, B02250, B02253, B02260, B02262, B02263, B02266, B02267, B02268, B02269, B02270, B02271, B02274, B02275, B02276, B02277, B02278, B02279, B02280, B02281, B02282, B02283, B02284, B02286, B02287, B02288, B02292, B02293, B02294, B02296, B02297, B02298, B02300, B02301, B02303, B02305, B02307, B02308, B02313, B02315, B02316, B02317, B02319, B02320, B02321, B02323, B02324, B02327, B02328, B02330, B02333, B02334, B02335, B02336, B02337, B02339, B02342, B02344, B02346, B02348, B02349, B02350, B02351, B02352, B02353, B02354, B02355, B02356, B02357, B02358, B02359, B02360, B02361, B02363, B02365, B02366, B02367, B02369, B02370, B02371, B02374, B02376, B02378, B02379, B02380, B02382, B02388, B02392, B02393, B02394, B02395, B02396, B02397, B02398, B02399, B02402, B02405, B02406, B02409, B02410, B02411, B02412, B02414, B02416, B02420, B02421, B02423, B02425, B02427, B02428, B02429, B02431, B02436, B02438, B02439, B02444, B02445, B02446, B02449, B02450, B02451, B02453, B02455, B02456, B02457, B02458, B02459, B02460, B02461, B02462, B02465, B02466, B02467, B02469, B02470, B02471, B02472, B02473, B02474, B02475, B02476, B02477, B02478, B02479, B02480, B02481, B02482, B02483, B02485, B02486, B02490, B02491, B02492, B02493, B02496, B02497, B02498, B02499, B02500, B02501, B02502, B02503, B02505, B02506, B02507, B02508, B02509, B02510, B02512, B02513, B02514, B02515, B02517, B02518, B02519, B02520, B02521, B02522, B02525, B02526, B02527, B02528, B02530, B02531, B02532, B02533, B02534, B02535, B02536, B02537, B02538, B02539, B02541, B02542, B02543, B02544, B02545, B02546, B02548, B02550, B02551, B02552, B02553, B02554, B02559, B02560, B02561, B02562, B02563, B02564, B02565, B02567, B02568, B02569, B02571, B02580, B02581, B02582, B02583, B02586, B02587, B02589, B02593, B02595, B02597, B02598, B02599, B02600, B02601, B02602, B02603, B02605, B02606, B02607, B02608, B02609, B02611, B02612, B02613, B02614, B02616, B02617, B02619, B02620, B02621, B02622, B02623, B02625, B02628, B02629, B02630, B02631, B02632, B02633, B02634, B02635, B02636, B02637, B02639, B02640, B02641, B02642, B02644, B02645, B02646, B02648, B02649, B02651, B02652, B02654, B02655, B02656, B02657, B02658, B02659, B02660, B02661, B02662, B02663, B02664, B02665, B02666, B02668, B02669, B02671, B02672, B02673, B02675, B02676, B02678, B02680, B02682, B02685, B02686, B02687, B02689, B02690, B02691, B02694, B02695, B02696, B02699, B02704, B02705, B02706, B02707, B02709, B02713, B02715, B02716, B02717, B02718, B02720, B02721, B02722, B02723, B02725, B02726, B02727, B02728, B02732, B02733, B02735, B02738, B02742, B02746, B02748, B02749, B02750, B02752, B02753, B02756, B02758, B02759, B02760, B02761, B02762, B02764, B02768, B02772, B02775, B02776, B02777, B02778, B02780, B02781, B02782, B02783, B02784, B02786, B02787, B02788, B02789, B02790, B02791, B02792, B02793, B02795, B02797, B02798, B02799, B02801, B02802, B02803, B02805, B02807, B02808, B02809, B02810, B02811, B02814, B02815, B02816, B02818, B02820, B02821, B02822, B02823, B02824, B02825, B02826, B02827, B02829, B02831, B02832, B02833, B02837, B02839, B02840, B02841, B02843, B02844, B02847, B02850, B02851, B02852, B02853, B02856, B02857, B02858, B02859, B02861, B02862, B02863, B02866, B03000, B03001, B03003, B03004, B03005, B03006, B03007, B03010, B03012, B03013, B03014, B03015, B03016, B03017, B03018, B03021, B03023, B03024, B03030, B03031, B03035, B03037, B03038, B03039, B03040, B03041, B03042, B03043, B03044, B03045, B03046, B03048, B03052, B03053, B03055, B03058, B03063, B03064, B03065, B03066, B03067, B03068, B03070, B03071, B03072, B03073, B03077, B03078, B03079, B03081, B03083, B03086, B03088, B03090, B03091, B03092, B03093, B03094, B03097, B03098, B03099, B03101, B03103, B03104, B03105, B03106, B03108, B03109, B03111, B03112, B03114, B03115, B03116, B03118, B03119, B03121, B03123, B03124, B03127, B03129, B03130, B03131, B03133, B03134, B03135, B03137, B03138, B03141, B03142, B03143, B03144, B03145, B03146, B03147, B03149, B03150, B03151, B03152, B03157, B03159, B03160, B03163, B03164, B03165, B03166, B03167, B03168, B03169, B03170, B03171, B03172, B03173, B03174, B03175, B03503, B03508, B03521, B03525, B03526, B03529, B03530, B03536, B03537, B03538, B03540, B03541, B03542, B03543, B03544, B03545, B03546, B03548, B03549, B03550, B03551, B03552, B03553, B03554, B03555, B03556, B03557, B03558, B03559, B03560, B03561, B03562, B03564, B03566, B03568, B03572, B03574, B03575, B03577, B03578, B03579, B03580, B03581, B03582, B03583, B03584, B03585, B03586, B03587, B03588, B03589, B03590, B03591, B03593, B03594, B03595, B03596, B03599, B03600, B03601, B03602, B03603, B03604, B03605, B03606, B03607, B03608, B03609, B03611, B03612, B03613, B03614, B03615, B03616, B03618, B03619, B03620, B03621, B03622, B03623, B03625, B03626, B03627, B03628, B03629, B03630, B03631, B03632, B03633, B03634, B03635, B03636, B03637, B03638, B03639, B03640, B03641, B03643, B03644, B03645, B03646, B03647, B03648, B03649, B03651, B03653, B03654, B03655, B03656, B03658, B03659, B03660, B03661, B03663, B03664, B03666, B03667, B03668, B03669, B03670, B03671, B03673, B03674, B03675, B03676, B03677, B03678, B03679, B03680, B03681, B03684, B03685, B03686, B03687, B03688, B03689, B03690, B03692, B03693, B03695, B03696, B03697, B03698, B03699, B03700, B03701, B03703, B03704, B03705, B03706, B03707, B03709, B03710, B03711, B03712, B03713, B03714, B03718, B03719, B03720, B03721, B03722, B03723, B03724, B03725, B03727, B03729, B03730, B03731, B03732, B03733, B03734, B03735, B03736, B03738, B03739, B03741, B03743, B03745, B03746, B03747, B03748, B03749, B03750, B03751, B03752, B03753, B03754, B03755, B03756, B03758, B03759, B03760, B03761, B03762, B03763, B03764, B03765, B03766, B03767, B03768, B03769, B03770, B03771, B03772, B03773, B03774, B03775, B03776, B03777, B03778, B03779, B03780, B03781, B03782, B03783, B03784, B03785, B03786, B03788, B03789, B03790, B03791, B03792, B03793, B03794, B03795, B03797, B03798, B03799, B03800, B03801, B03802, B03803, B03804, B03805, B03806, B03807, B03808, B03810, B03811, B03812, B03813, B03814, B03815, B03816, B03817, B03819, B03820, B03821, B03822, B03823, B03825, B03826, B03827, B03828, B03829, B03831, B03832, B03833, B03834, B03835, B03836, B03837, B03838, B03839, B03840, B03841, B03842, B03843, B03844, B03845, B03846, B03847, B03848, B03849, B03850, B03852, B03853, B03854, B03855, B03856, B03857, B03858, B03859, B03860, B03862, B03863, B03864, B03865, B03867, B03869, B03870, B03871, B03872, B03873, B03874, B03875, B03876, B03877, B03878, B03879, B03880, B03882, B03883, B03884, B03886, B03887, B03888, B03889, B03890, B03891, B03892, B03893, B03894, B03895, B03896, B03897, B03898, B03899, B03900, B03901, B03902, B03903, B03904, B03905, B03906, B03907, B03908, B03909, B03910, B03911, B03912, B03913, B03914, B03915, B03916, B03917, B03918, B03919, B03921, B03922, B03923, B03924, B03925, B03926, B03927, B03928, B03929, B03930, B03931, B03933, B03934, B03935, B03936, B03937, B03938, B03939, B03940, B03941, B03942, B03943, B03944, B03945, B03946, B03947, B03949, B03950, B03952, B03953, B03954, B03956, B03957, B03958, B03959, B03960, B03961, B03962, B03963, B03964, B03965, B03966, B03967, B03969, B03970, B03971, B03972, B03973, B03974, B03975, B03976, B03977, B03978, B03979, B03980, B03981, B03982, B03984, B03985, B03986, B03987, B03988, B03989, B03990, B03991, B03992, B03993, B03995, B03996, B03997, B04014, B04015, B04016, B04017, B04018, B04019, B04020, B04021, B04022, B04023, B04024, B04025, B04026, B04027, B04028, B04029, B04030, B04031, B04032, B04033, B04034, B04035, B04036, B04037, B04038, B04039, B04040, B04041, B04042, B04043, B04044, B04045, B04046, B04047, B04048, B04049, B04050, B04051, B04052, B04053, B04054, B04055, B04056, B04057, B04058, B04059, B04060, B04061, B04062, B04063, B04064, B04065, B04066, B04067, B04068, B04069, B04070, B04071, B04072, B04073, B04074, B04075, B04076, B04077, B04078, B04079, B04080, B04081, B04082, B04083, B04084, B04085, B04086, B04087, B04088, B04089, B04090, B04091, B04092, B04093, B04094, B04095, B04096, B04097, B04098, B04099, B04101, B04102, B04103, B04104, B04105, B04106, B04107, B04108, B04109, B04110, B04111, B04112, B04113, B04114, B04115, B04116, B04117, B04118, B04119, B04120, B04121, B04122, B04123, B04124, B04125, B04126, B04127, B04128, B04129, B04130, B04131, B04132, B04133, B04134, B04135, B04136, B04137, B04138, B04139, B04140, B04141, B04142, B04143, B04144, B04145, B04146, B04147, B04148, B04150, B04151, B04152, B04153, B04154, B04155, B04156, B04157, B04158, B04159, B04160, B04161, B04162, B04163, B04164, B04165, B04166, B04167, B04168, B04169, B04170, B04171, B04172, B04173, B04175, B04176, B04177, B04178, B04179, B04180, B04181, B04182, B04183, B04184, B04185, B04186, B04187, B04188, B04189, B04190, B04191, B04192, B04193, B04194, B04195, B04196, B04197, B04198, B04199, B04200, B04201, B04202, B04203, B04204, B04205, B04206, B04207, B04208, B04209, B04210, B04211, B04212, B04213, B04214, B04215, B04216, B04217, B04218, B04219, B04220, B04221, B04222, B04223, B04224, B04225, B04227, B04228, B04230, B04231, B04232, B04233, B04234, B04235, B04236, B04237, B04238, B04239, B04240, B04241, B04242, B04243, B04244, B04245, B04246, B04247, B04248, B04249, B04250, B04251, B04252, B04253, B04254, B04255, B04256, B04257, B04258, B04259, B04260, B04261, B04262, B04263, B04264, B04265, B04266, B04267, B04268, B04269, B04270, B04271, B04272, B04273, B04274, B04275, B04276, B04277, B04278, B04279, B04280, B04281, B04282, B04283, B04284, B04285, B04286, B04287, B04288, B04289, B04290, B04291, B04292, B04293, B04294, B04295, B04296, B04297, B04298, B04299, B04301, B04302, B04303, B04304, B04305, B04306, B04307, B04308, B04309, B04310, B04317;

d) Serial numbers: D01002, D01004, D01005, D01006, D01007, D01011, D01013, D01014, D01015, D01016, D01017, D01018, D01019, D01024, D01025, D01026, D01027, D01031, D01033, D01034, D01035, D01037, D01038, D01040, D01043, D01044, D01045, D01046, D01048, D01049, D01051, D01053, D01055, D01056, D01060, D01066, D01067, D01068, D01069, D01070, D01071, D01072, D01074, D01075, D01076, D01078, D01079, D01080, D01083, D01084, D01086, D01087, D01091, D01092, D01094, D01096, D01097, D01098, D01099, D01100, D01103, D01104, D01106, D01107, D01108, D01111, D01113, D01114, D01118, D01121, D01122, D01124, D01125, D01126, D01127, D01130, D01131, D01133, D01136, D01137, D01138, D01139, D01140, D01142, D01144, D01145, D01147, D01149, D01152, D01153, D01154, D01157, D01162, D01165, D01166, D01168, D01169, D01170, D01172, D01173, D01174, D01175, D01176, D01177, D01179, D01181, D01183, D01185, D01186, D01187, D01189, D01190, D01191, D01192, D01193, D01194, D01195, D01196, D01197, D01198, D01199, D01300, D01301, D01302, D01303, D01304, D01306, D01307, D01308, D01309, D01310, D01311, D01312, D01313, D01316, D01317, D01318, D01319, D01320, D01321, D01324, D01325, D01326, D01329, D01330, D01332, D01335, D01336, D01400, D01401, D01402, D01403, D01404, D01405, D01406, D01407, D01408, D01409, D01410, D01411, D01412, D01413, D01414, D01415, D01417, D01418, D01419, D01420, D01421, D01423, D01424, D01425, D01426, D01427, D01428, D01430, D01432, D01434, D01435, D01436, D01437, D01438, D01439, D01440, D01441, D01442, D01443, D01444, D01445, D01446, D01447, D01448, D01449, D01450, D01451, D01452, D01453, D01454, D01455, D01456, D01457, D01458, D01460, D01461, D01462, D01464, D01465, D01466, D01467, D01468, D01470, D01471, D01472, D01473, D01474, D01475, D01476, D01477, D01478, D01479, D01480, D01481, D01482, D01483, D01484, D01485, D01486, D01487, D01488, D01489, D01490, D01491, D01492, D01493, D01494, D01495, D01496, D01497, D01499, D01500, D01501, D01502, D01505, D01506, D01507, D01508, D01509, D01510, D01511, D01512, D01513, D01514, D01515, D01516, D01517, D01518, D01519, D01520, D01521, D01522, D01523, D01524, D01525, D01526, D01527, D01528, D01529, D01530, D01531, D01532, D01533, D01534, D01535, D01536, D01537, D01538, D01539, D01540, D01541, D01542, D01543, D01544, D01545, D01546, D01547, D01548, D01549, D01550, D01551, D01552, D01553, D01554, D01555, D01556, D01557, D01558, D01559, D01560, D01561, D01562, D01563, D01564, D01565, D01566, D01567, D01568, D01569, D01570, D01571, D01572, D01573, D01574, D01575, D01576, D01577, D01578, D01579, D01580, D01581, D01582, D01583, D01584, D01585, D01586, D01587, D01588, D01589, D01590, D01591, D01592, D01593, D01594, D01595, D01596, D01597, D01598, D01599;

e) Lot number: PWRRK0324502, PWRRK0327403, PWRRK0334402, PWRRK0336401, PWRRK0402801, PWRRK0405015, PWRRK0406201, PWRRK0408407, PWRRK0419801, PWRRK0427307, PWRRK0429501, PWRRK0430301, PWRRK0434102, PWRRK0435701, PWRRK0501302, PWRRK0505404, PWRRK0515203, PWRRK0516001, PWRRK0526901, PWRRK0527803,

f) Lot number: RKPWR0323911, RKPWR0325801, RKPWR0326802, RKPWR0328802, RKPWR0329504, RKPWR0330701, RKPWR0331801, RKPWR0334504, RKPWR0416008, RKPWR0420104, RKPWR0423903, RKPWR0430201, RKPWR0430803, RKPWR0434902, RKPWR0435702, RKPWR0502401, RKPWR0503901, RKPWR0504602, RKPWR0505403, RKPWR0506601, RKPWR0507701, RKPWR0508211, RKPWR0509501, RKPWR0510302, RKPWR0510803, RKPWR0511501, RKPWR0511904, RKPWR0514312, RKPWR0515202, RKPWR0516002, RKPWR0516602, RKPWR0519302, RKPWR0525802

g) Lot number: PWRMK0325902, PWRMK0407201, PWRMK0420105, PWRMK0436501, PWRMK0501101, PWRMK0504603, PWRMK0505402, PWRMK0506602, PWRMK0510303, PWRMK0510804, PWRMK0512201, PWRMK0512303, PWRMK0514313, PWRMK0515201, PWRMK0515701, PWRMK0517802, PWRMK0518701, PWRMK0526503;

h) Lot number: UK0335101, UK0400602, UK0404202, UK0408406, UK0410704, UK0412510, UK0424602, UK0427801, UK0430110, UK0433602, UK0504203, UK0508201
RECALLING FIRM/MANUFACTURER
Cardinal Health 203, Inc., Minneapolis, MN, by letter dated February 22, 2008 and March 4, 2008. Firm initiated recall is ongoing.
REASON
The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.
VOLUME OF PRODUCT IN COMMERCE
14,034 ventilators and 6,549 circuit boards
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO. Used to facilitate the delivery of defined radiotherapy treatment plans; Recall # Z-1515-2008
CODE
MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens
RECALLING FIRM/MANUFACTURER
Impac Medical Systems, Inc., Sunnyvale, CA, by letter or telephone on or about February 14, 2008. Firm initiated recall is ongoing.
REASON
Software issue may result in change to intended treatment field, Potentially resulting in mistreatment.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
FACSDiva Software Versions 4.0.1 to 5.0.2, Flow Cytometry Acquisition & Analysis software. Catalog number 641609 Flexible data acquisition and analysis package specifically designed for digital-based flow cytometers; Recall # Z-1525-2008
CODE
Software versions 4.0.1 to 5.0.2.
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on April 20, 2007. Firm initiated recall is ongoing.
REASON
When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
VOLUME OF PRODUCT IN COMMERCE
1,074 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe; Recall # Z-1526-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by letter on July 2, 2007.
Manufacturer: Acutronic Medical Systems Ag, Hirzel, Switzerland. Firm initiated recall is ongoing.
REASON
Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engström Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
VOLUME OF PRODUCT IN COMMERCE
394 (197 boxes and 2 Flow sensors/box)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials
individually sold or packed as a component in the Difco(tm) "Shigella Grouping
Antiserum Set", Cat. 241108, Lot 6073806). Vials are labeled in part ***S. flexneri
Serotypes 1-6***Used for the identification of Shigella species by the slide
agglutination test; Recall # Z-1527-2008;
b) Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722,
10 mL vials and labeled in part *** Used for the identification of Shigella species
by the slide agglutination test, Recall # Z-1528-2008
CODE
a) Lot 5059542 Exp March 30, 2008 Lot 6023471 Exp March 30, 2008
Lot 7072998 Exp March 30, 2008 Lot 7116967 Exp April 12, 2010;
b) Lot 6009070 Exp November 03, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter and e-mail on November 30, 2007 through December 6, 2007.
Manufacturer: BD Diagnostic Systems, Lee Laboratories, Grayson, GA. Firm initiated recall is ongoing.
REASON
In vitro diagnostic test reagent for identification of Shigella bacteria in patient samples may cause false negative results.
VOLUME OF PRODUCT IN COMMERCE
643 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BCI ®3180 Oximeter - Patient monitoring medical device, For continuous patient monitoring of blood oxygen levels, pulse rate and pulse strength measurements. It is only used in hospital or clinical settings or emergency response environments, Recall # Z-1619-2008
CODE
Serial Number AG06100001 AG06100063 AG06100069 AG06100097 AG06100098 AG06100099 AG06120001 AG06120002 AG06120003 AG06120004 AG06120008 AG06120009 AG06120012 AG06120013 AG06120018 AG06120020 AG06120022 AG06120026 AG06120030 AG06120031 AG06120034 AG06120035 AG06120036 AG06120038 AG06120039 AG06120040 AG06120041 AG06120042 AG06120043 AG06120044 AG06120045 AG06120046 AG06120047 AG06120049 AG06120050 AG06120051 AG06120054 AG06120055 AG06120056 AG06120057 AG06120058 AG06120059 AG06120060 AG06120061 AG06120063 AG06120066 AG06120067 AG06120068 AG06120069 AG06120070 AG06120071 AG06120073 AG06120074 AG05050047 AG05070028 AG05070030 AG05070031 AG05070033 AG05070036 AG05120044 AG05120051 AG06120052 AG06120062 AG07010000 AG07010001 AG07010002 AG07010003 AG07010004 AG07010005 AG07010006 AG07010007 AG07010008 AG07010009 AG07010010 AG07010011 AG07010012 AG07010013 AG07010014 AG07010015 AG07010016 AG07010017 AG07010018 AG07010019 AG07010020 AG07010021 AG07010023 AG07010024 AG07010026 AG07010027 AG07010028 AG07010031 AG07010032 AG07010033 AG07010034 AG07010035 AG07010036 AG07010037 AG07010038 AG07010039 AG07010040 AG07010042 AG07010043 AG07010045 AG07010046 AG07010047 AG07010048 AG07010049 AG07010050 AG07010051 AG07010052 AG07010053 AG07010054 AG07010055 AG07010056 AG07010058 AG07010059 AG07010067 AG07010070 AG07010074 AG07010080 AG07010085 AG05050000 AG05050001 AG05050002 AG05050003 AG05050004 AG05050006 AG05050007 AG05050010 AG05050012 AG05050013 AG05050014 AG05050015 AG05050016 AG05050017 AG05050018 AG05050020 AG05050021 AG05050022 AG05050023 AG05050024 AG05050025 AG05050027 AG05050028 AG05050030 AG05050031 AG05050032 AG05070019 AG05070021 AG05070024 AG05070025 AG05070026 AG05070027 AG05070029 AG06050054 AG06050055 AG06050056 AG06050057 AG06050058 AG06050060 AG06050062 AG06050063 AG06050064 AG06050067 AG06050068 AG06050069 AG06050070 AG06050072 AG06050073 AG06050074 AG06050075 AG06050076 AG06050077 AG06050079 AG06050080 AG06050081 AG06050082 AG06050083 AG06050084 AG06050085 AG06050086 AG06050087 AG06050088 AG06050089 AG06050091 AG06050092 AG06050094 AG06050099 AG06080001 AG06080002 AG06080003 AG06080004 AG06080005 AG06080006 AG06080007 AG06080008 AG06080009 AG06080010 AG06080011 AG06080012 AG06080014 AG06080015 AG06080016 AG06080017 AG06080018 AG06080019 AG06080020 AG06080021 AG06080022 AG06080025 AG06080026 AG06080028 AG06080031 AG06080032 AG06080033 AG06080037 AG06080056 AG06080057 AG06080060 AG06080061 AG06080062 AG06080063 AG06080064 AG06080066 AG06080067 AG06080069 AG06080070 AG06080071 AG06080072 AG06080075 AG06080076 AG06080079 AG05070099 AG05100010 AG05100013 AG05100018 AG05100020 AG05100023 AG05100024 AG05100025 AG05100028 AG05100031 AG05100038 AG06080029 AG06080036 AG06080038 AG06100009 AG06100054 AG05050026 AG05050029 AG05050033 AG05050034 AG05050037 AG05050040 AG05100007 AG05100008 AG05100053 AG05100056 AG05100072 AG05100073 AG06100071 AG06100073 AG06100074 AG06100075 AG06100076 AG06100077 AG06050004 AG06050053 AG06100030 AG05050063 AG05050065 AG05050066 AG05050067 AG05050071 AG05050072 AG05050074 AG05050076 AG05050077 AG05050080 AG05050081 AG05050083 AG05050087 AG05050088 AG05070014 AG05070049 AG05070050 AG05070051 AG05100026 AG05100048 AG07010076 AG07010110 AG07010112 AG07010117 AG07010124 AG07010126 AG07010128 AG07010129 AG07010073 AG07010094 AG07010099 AG07010107 AG07010119 AG05070059 AG05070060 AG05070061 AG05070066 AG05070067 AG05070068 AG05070070 AG05070072 AG05070073 AG05070075 AG05070076 AG05070077 AG06050042 AG06050059 AG06050065 AG06050071 AG06080023 AG06080030 AG06080034 AG06080040 AG06080042 AG06080043
Replacement Board AG05100006 AG05100097 AG07010030 AG06120064 AG07010022 AG07010025 AG07010029 AG07010044 AG07010057 AG06080051 AG06080052 AG06080055 AG06080058 AG06080059 AG06100018 AG06100019 AG06100020 AG06100021 AG06100022 AG06100028 AG06100061 AG06100066 AG06100068 AG06100070 AG06100095 AG06120000 AG06120005 AG06120006 AG06120007 AG06120010 AG06120011 AG06120014 AG06120015 AG06120016 AG06120017 AG06120019 AG06120021 AG06120023 AG06120024 AG06120025 AG06120027 AG06120028 AG06120029 AG06120032 AG06120033 AG06120037 AG06120048 AG07010060 AG07010061 AG07010062 AG07010063 AG07010064 AG07010077 AG07010083 AG07010133 AG05120092 AG06080097 AG06100000 AG07010072 AG05070052 AG05070053 AG05050019 AG05050038 AG05050039 AG05050041 AG05050042 AG05050055 AG05050056 AG05050058 AG05050060 AG05070008 AG06050005 AG06050006 AG06050007 AG06050011 AG06050012 AG06050013 AG06050014 AG06050015 AG06050017 AG06050019 AG06050020 AG06050022 AG06050025 AG06050026 AG06050028 AG06050030 AG06050033 AG06050035 AG07010084 AG07010086 AG07010087 AG07010088 AG07010090 AG07010091 AG07010092 AG07010093 AG07010095 AG07010096 AG07010097 AG07010101 AG07010113 AG07010114 AG07010115 AG07010116 AG05050090 AG05050092 AG05050095 AG05050097 AG05070016 AG05070020 AG05070022 AG05070023 AG05070032 AG05070035 AG06100002 AG06100003 AG06100004 AG06100017 AG06100023 AG06100024 AG06100026 AG06100027 AG06100029 AG06100032 AG06100034 AG06100036 AG06100040 AG06100041 AG06100042 AG06100044 AG06100045 AG06100046 AG06100047 AG06100048 AG06100049 AG06100052 AG06100057 AG06100064 AG06100065 AG07010065 AG07010068 AG07010075 AG07010079 AG07010082 AG07010103 AG07010104 AG07010105 AG07010106 AG07010118 AG05050044 AG05050049 AG05050057 AG05050061 AG05050062 AG06080024 AG06080045 AG06080046 AG06080047 AG06080048 AG06080050 AG06080053 AG06080054 AG06080068 AG06080077 AG06080078 AG06080080 AG06080081 AG06080082 AG06080083 AG06080084 AG06080085 AG06080086 AG06080087 AG06080088 AG06080089 AG06080090 AG06080091 AG06080092 AG06080093 AG06080094 AG06080095 AG06080096 AG06080098 AG06080099 AG05100014 AG05100027 AG05100054 AG05100057 AG05100058 AG05100059 AG05100060 AG05100061 AG05100062 AG05100063 AG05100064 AG05100066 AG05100068 AG05100069 AG05100070 AG05100071 AG05100079 AG05100080 AG05100081 AG05100082 AG05100087 AG05100089 AG05100090 AG05100092 AG05100093 AG05100094 AG05100095 AG05100098 AG05100099 AG05120002 AG05120005 AG05120006 AG05120008 AG05120009 AG05120010 AG05120011 AG05120012 AG05120013 AG05120014 AG05120015 AG05120016 AG06080013 AG05120023 AG06050002 AG05050045 AG05050046 AG05050048 AG05050050 AG05050052 AG05050053 AG05050054 AG05050059 AG06100060 AG06100078 AG06100079 AG06100080 AG06100081 AG06100082 AG06100083 AG06100084 AG06100085 AG06100086 AG06100087 AG06100088 AG06100089 AG06100090 AG06100091 AG06100092 AG06100093 AG06100094 AG06100096 AG07010066 AG07010102 AG07010121 AG07010122 AG07010125 AG07010127 AG07010130 AG07010132 AG07010134 AG07010135 AG07010136 AG07010137 AG07010138 AG07010139 AG07010140 AG07010141 AG07010142 AG07010143 AG07010147 AG07010149 AG07010150 AG07010151 AG07010153 AG06100031 AG06080000 AG06080039 AG06080044 AG06080065 AG06080073 AG06080074 AG06100008 AG06100010 AG06100011 AG06100012 AG06100013 AG06100014 AG06100015 AG06100016 AG06100033 AG06100035 AG06100037 AG06100038 AG06100039 AG06100043 AG05120022 AG05120038 AG05120042 AG05120043 AG05120048 AG05120049 AG05120056 AG05120064 AG05120066 AG05120069 AG05120073 AG05120082 AG05070054 AG05070055 AG05070056 AG05070058 AG05070081 AG05100022 AG05120040 AG05120041 AG05120045 AG05120059 AG05120060 AG05120063 AG05120065 AG05120067 AG05120070 AG05120071 AG05120072 AG05120074 AG05120075 AG05120076 AG05120077 AG05120078 AG05120079 AG05120080 AG05120083 AG05120084
Replacement Board AG05070045 AG05070046 AG05070047 AG05070048 AG06080049 AG06100005 AG06100006 AG06100007 AG07010148 AG05050068 AG05070043 AG05100021 AG06050040 AG06100053 AG06100059 AG05070044 AG05100011 AG07010100 AG05100083 AG05100086 AG05100088 AG05050070 AG05050085 AG05070002 AG05070003 AG05070004 AG05070005 AG05070006 AG05070007 AG05070009 AG05070011 AG06050078 AG06050090 AG06050093 AG06050095 AG05120058 AG06100051 AG05050043 AG05050073 AG05050075 AG05050078 AG05050079 AG05050082 AG05050084 AG05050086 AG05050089 AG05050091 AG05050093 AG05050094 AG05050098 AG05050099 AG05070000 AG05070001 AG05070010 AG05070012 AG05070013 AG05070015 AG05070017 AG05070018 AG05070057 AG05070062 AG05070063 AG05070064 AG05070065 AG05070069 AG05070071 AG05070074 AG05070078 AG05070079 AG05070080 AG05070083 AG05070084 AG05070085 AG05070086 AG05070087 AG05070088 AG05070089 AG05070091 AG05070092 AG05070093 AG05070094 AG05070096 AG06050021 AG06050023 AG06050024 AG06050027 AG06050031 AG06050032 AG06050034 AG06050041 AG06050043 AG06050044 AG06050045 AG06050046 AG06050047 AG06050048 AG06050049 AG06050050 AG06050051 AG06050052 AG06050061 AG06050066 AG07060047 AG05050005 AG05050011 AG05050035 AG05050064 AG05050069 AG06050037 AG07010108 AG07010111 AG05100032 AG07060049 AG05120031 AG05120095 AG06050036 AG06050096 AG06080027 AG06100025 AG06100062 AG06100067 AG05100096 AG05120037 AG05120087 AG05100033 AG05100039 AG05100045 AG05100046 AG05100047 AG05120032 AG05120034 AG06100058 AG06100072 AG05100030 AG05100041 AG05100043 AG05100044 AG05120085 AG05100035 AG05100040 AG05120030 AG06100055 AG05120088 AG05120090 AG06050001 AG06050003 AG06050008 AG06050009 AG06050010 AG05100009 AG05120026 AG05120035 AG05050036 AG05100034 AG05100036 AG05120021 AG05120039 AG05120093 AG06100050 AG05120091 AG06050016 AG06050018 AG05120052 AG05120054 AG05070082 AG05070090 AG05070095 AG05070097 AG05070098 AG05100037 AG05100042 AG05120096 AG06050000 AG05070037 AG05100049 AG05100065 AG05100084 AG05120007 AG05120025 AG05120028 AG05120029 AG05120036 AG05120081 AG05120086 AG05120089 AG07010041 AG07010078 AG07010109 AG05050051 AG05070038 AG05070039 AG05070040 AG05070041 AG05070042 AG05100091 AG05120027 AG05050009 AG05120068 AG05120098 AG05120099 AG05100016 AG07010069 AG07010071 AG07010081 AG07010098
Replacement Board AG06100056 AG06050029 AG05120033 AG05100015 AG05100017 AG05120046 AG05120050 AG05120053 AG05120055 AG06120053 AG06120065 AG06120072 AG07010089 AG07010123 AG07010131 AG07010152 AG07010154 AG05100012 AG05100029 AG05100050 AG05100051 AG05100052 AG05100055 AG05100067 AG05100074 AG05120057 AG05050096 AG05070034 AG05100005 AG05100085
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter dated March 11, 2008 and e-mail between March 7 and March 13, 2008. Firm initiated recall is ongoing.
REASON
The Smith Medical PM, Inc. BCI ®3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse polarity voltages that may lead to their pre-mature failure. As a result, the identified monitors may exhibit failure modes such as the monitor may shut down and not produce alarms or signals to indicate the event has occurred; or the monitor may exhibit erratic readings along with a "small pulse" or "lost pulse" alarm.
VOLUME OF PRODUCT IN COMMERCE
900 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CADD-MS ®3 Ambulatory Infusion Pump, Model 7400. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by homecare patients but can also used in health care facilities, Recall # Z-1621-2008
CODE
USA 440038 440096 440114 440122 440126 440128 440206 440235 440242 440247 440269 440313 440397 440418 440447 440455 440458 440484 440487 440501 440504 440560 440582 440584 440596 440614 440641 440848 440877 442365 442366 442367 442368 442369 442370 442371 442372 442373 442374 442375 442376 442377 442378 442364 442379 442380 442381 442382 442383 442384 442461 442462 442463 442464 442465 442466 442467 442468 442387 442388 442389 442390 442391 442392 442393 442394 442395 442396 442397 442398 442399 442400 442401 442402 442403 442404 442405 442406 442407 442408 442409 442410 442411 442412 442413 442414 442415 442416 442417 442418 442419 442420 442421 442422 442423 442424 442425 442426 442427 442428 442429 442430 442431 442432 442433 442434 442435 442436 442437 442438 442439 442440 442441 442442 442443 442444 442445 442446 442498 442448 441866 441867 441868 441869 441870 441871 441872 441873 441874 441875 441876 441877 441878 441879 441880 441881 441882 441883 441884 441885 441886 441887 441888 441889 441890 441891 441892 441893 441894 441895 441896 441897 441898 441899 441900 441901 441902 441903 441904 441905 441906 441907 441908 441909 441910 441911 441912 441913 441914 441915 441916 441917 441918 441919 441920 441921 441922 441923 441924 441925 441926 441927 441928 441929 441930 441931 441932 441933 441934 441935 441936 441937 441938 441939 441940 441941 441942 441943 441944 441945 441946 441947 441948 441949 441950 441951 441952 441953 441954 441955 441956 441957 441958 441959 441960 441961 441962 441963 441964 441965 441966 441967 441968 441969 441970 441971 441972 441973 441974 441975 441976 441977 441978 441979 441980 441981 441982 441983 441984 441985 441986 441987 441988 441989 441990 441991 441992 441993 441994 441995 441996 441997 441998 441999 442000 442001 442002 442003 442004 442005 442006 442007 442008 442009 442010 442011 442012 442013 442014 442015 442016 442017 442018 442019 442020 442021 442022 442023 442024 442025 442026 442027 442028 442029 442030 442031 442032 442033 442034 442035 442036 442037 442038 442039 442040 442041 442042 442043 442044 442045 442046 442047 442048 442049 442050 442051 442052 442053 442054 442055 442056 442057 442058 442059 442060 442061 442062 442063 442064 442065 442066 442067 442068 442069 442070 442071 442072 442073 442074 442075 442076 442077 442078 442079 442080 442081 442082 442083 442084 442085 442086 442087 442088 442089 442090 442091 442092 442093 442094 442095 442096 442097 442098 442099 442100 442101 442102 442103 442104 442105 442106 442107 442108 442109 442110 442111 442112 442113 442114 442115 442116 442117 442118 442119 442120 442121 442122 442123 442124 442125 442126 442127 442128 442129 442130 442131 442132 442133 442134 442135 442136 442137 442138 442139 442140 442141 442142 442143 442144 442145 442146 442147 442148 442149 442150 442151 442152 442153 442154 442155 442156 442157 442158 442159 442160 442161 442162 442163 442164 442165 442166 442167 442168 442169 442170 442171 442172 442173 442174 442175 442176 442177 442178 442179 442180 442181 442182 442183 442184 442185 442186 442187 442188 442189 442190 442191 442192 442193 442194 442195 442196 442197 442198 442199 442200 442201 442202 442203 442204 442205 442206 442207 442208 442209 442210 442211 442212 442213 442214 442215 442216 442217 442218 442219 442220 442221 442222 442223 442224 442225 442226 442227 442228 442229 442230 442231 442232 442233 442234 442235 442236 442237 442238 442239 442240 442241 442242 442243 442244 442245 442246 442247 442248 442249 442250 442251 442252 442253 442254 442255 442256 442257 442258 442259 442260 442261 442262 442263 442264 442265 442266 442267 442268 442270 442271 442272 442273 442274 442275 442276 442277 442278 442279 442280 442281 442282 442283 442284 442285 442286 442287 442288 442289 442290 442291 442292 442293 442294 442295 442296 442297 442298 442299 442300 442301 442302 442303 442304 442305 442306 442307 442308 442309 442310 442311 442312 442313 442314 442315 442316 442317 442318 442319 442320 442321 442322 442323 442324 442325 442326 442327 442328 442329 442330 442331 442332 442333 442334 442335 442336 442337 442338 442339 442340 442341 442342 442343 442344 442345 442346 442347 442348 442349 442350 442351 442352 442353 442354 442355 442356 442357 442358 442359 442360 442361 442362 442363 442385 441860 441861 441862 441863 441864 441865 442386 442447 OUSA 441857 441858 441859 442269 442492 442493 442494 442495 442496 442497 442482 442483 442484 442485 442486 442487 442488 442489 442490 and 442491
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by letter dated March 7, 2008. Firm initiated recall is ongoing.
REASON
Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS ®3 Ambulatory Infusion Pump. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.
VOLUME OF PRODUCT IN COMMERCE
646 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Deltec Cozmo® Insulin Pump, Model 1700, This is a syringe infusion pump intended for Continuous Subcutaneous Insulin Infusion for the control of diabetes; Recall # Z-1622-2008
CODE
USA: A08931 A37582 A13919 A39717 A43779 A45238 A31455 A38022 A21231 A14506 A40945 A19565 A26902 A31456 A19183 A11164 A43688 A54693 A22987 A34082 A35045 A31734 A16731 A17680 A20964 A12734 A24282 A26705 A35021 A23011 A34093 A39305 A21668 A30450 A16812 A23847 A39749 A22562 A18159 A38668 A23865 A19831 A14238 A42892 A15124 A27546 A29491 A18301 A24937 A16705 A11642 A41116 A23918 A40202 A26898 A18536 A21528 A24912 A23885 A45265 A19655 A22949 A20090 A14889 A31446 A46481 A23843 A48103 A44743 A24915 A22512 A32363 A21651 A30518 A18807 A20095 A13355 A35483 A24920 A29444 A35971 A12348 A34381 A36301 A30298 A30294 A45962 A23118 A16306 A29579 A40122 A44079 A23057 A14766 A59064 A47805 A42830 A23713 A38977 A18625 A27345 A13259 A32088 A21117 A44520 A35605 A30301 A47556 A39474 A14930 A25210 A35185 A38857 A34922 A27575 A21109 A32117 A13116 A33028 A43376 A17517 A21397 A40084 A23249 A17541 A46130 A21168 A22859 A25431 A40360 A24036 A31866 A34386 A39033 A23372 A45821 A28832 A39169 A42688 A27708 A25557 A14218 A25441 A24062 A35773 A36049 A25957 A36902 A39166 A28844 A25588 A18307 A40670 A26240 A16055 A30771 A43865 A27355 A57681 A35005 A41347 A23612 A25584 A17427 A31296 A22226 A14179 A39931 A41047 A14168 A39952 A25586 A25401
Int. OUSA: A62390 - A62410, A64852 A64848 A64849 A64850 A64851 A13373 A43584 A31922 A43203 A20328 A22944 A23913 A25531 A27179 A34570 A39759 A10598 A14839 A24356 A37652 A43403 A23308 A31973 A13059 A15689 A20902 A46920 A29579 A40046 A40126 A42227 A17473 A33716 A23607 A27747 A64876 A64877 A64878 A64879 A64880 A64881 A64882 A64883 A64884 A64885 A64843 A64844 A64845 A64846 A64847 A64886 A64887 A64888 A64889 A64890 A64891 A64892 A64893 A64894 A64895 A64896 A64897 A64898 A64899 A64900 A64901 A64902 A64903 A64904 A64905 A64853 A64854 A64855 A64856 A64857 A64858 A64859 A64860 A64861 A64862 A64863 A64864 A64865 A64866 A64867 A64868 A64869 A64870 A64871 A64872 A64873 A64874 A64875 A23694 A62389 A62411 A62412 A62413 A62414 A62415 A62416 A62417 A62418 A62419 A62420 A62421 A62422 A62423 A62424 A62425 A62426 A62427 A62428 A62429 A62430 A62431 A62432 A62433 A62434 A62435 A62436 A62437 A62438 A62439 A62440 A62441 A62442 A64283 A64284 A64285 A64286 A64287 A37787 A64314 A64315 A64316 A64317 A64318 A64319 A64320 A64321 A64322 A64323 A64294 A64295 A64296 A64297 A64298 A64299 A64300 A64301 A64302 A64303 A64304 A64305 A64306 A64307 A64308 A64309 A64310 A64311 A64312 A64313 A64288 A64289 A64290 A64291 A64292 A64293 A28988 A44353 A29785 A42587 A27355 A22226 OUSA GERMANY A15333 A22296 A26590 A39620 A36148 A12916 A15802 A37829 A15783 A31614 A26588 A52036 A25358 A56553 A43596 A35741 A26279 A56671 A39281 A56678 A26437 A26508 A20796 A54523 A11423 A21748 A26404 A40423 A31601 A53074 A54437 A11768 A26460 A24169 A28369 A17974 A23650 A24394 A22742 A20848 A40466 A39649 A46748 AUSTRALIA A58721 A36572 A16409 A47779 A34280 A48715 A48800 A35900 A36880 A27391 A22826 A41379 A39273 A40077 A44953 A19952 A44360 A27706 A26090 A43476 A48470 A46076 A34462 A57692
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by letter dated March 10, 2008. Firm initiated recall is ongoing.
REASON
Smith Medical discovered an issue with a motor component in specific serial numbers of the Deltec Cozmo ®Insulin Pump, Model Numbers 1700 and 1800. This issue affects how the motor operates and may cause an over-delivery of insulin which could result in injury to the user.
VOLUME OF PRODUCT IN COMMERCE
1,502 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791; Recall # Z-1635-2008
CODE
Lot Numbers: W0801021, W801104, W0711154
RECALLING FIRM/MANUFACTURER
Integra Pain Management, Salt Lake City, UT, by letter on March 18, 2008. Firm initiated recall is ongoing.
REASON
Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.
VOLUME OF PRODUCT IN COMMERCE
500 kits
DISTRIBUTION
CO
___________________________________
PRODUCT
1) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case;
Recall # Z-1830-2008;
2) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case;
Recall # Z-1831-2008;
3) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9020, Size (Fr) 20, # Eyelets 4, 10 per case;
Recall # Z-1832-2008;
4) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9024, Size (Fr) 24, # Eyelets 5, 10 per case;
Recall # Z-1833-2008;
5) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case;
Recall # Z-1834-2008;
6) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9032, Size (Fr) 32, # Eyelets 6, 10 per case;
Recall # Z-1835-2008;
7) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case;
Recall # Z-1836-2008;
8) HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case;
Recall # Z-1837-2008;
9) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9116, Size (Fr) 16, # Eyelets 4, 10 per case;
Recall # Z-1838-2008;
10) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case;
Recall # Z-1839-2008;
11) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered
Connector Tip, Atrium Code # 9124, Size (Fr) 24, # Eyelets 4, 10 per case;
Recall # Z-1840-2008;
12) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9128, Size (Fr) 28, # Eyelets 5,
10 per case; Recall # Z-1841-2008;
13) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9132, Size (Fr) 32, # Eyelets 5,
10 per case; Recall # Z-1842-2008;
14) HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with
Tapered Connector Tip, Atrium Code # 9136, Size (Fr) 36, # Eyelets 5,
10 per case; Recall # Z-1843-2008;
15) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9408,
Size (Fr) 8, # Eyelets 2, 10 per case; Recall # Z-1844-2008;
16) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420,
Size (Fr) 20, # Eyelets 2, 10 per case; Recall # Z-1845-2008;
17) ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9428,
Size (Fr) 28, # Eyelets 2, 10 per case; Recall # Z-1846-2008;
18) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14120, Size (Fr) 20, # Eyelets 5, 10 per case; Recall # Z-1847-2008;
19) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14124, Size (Fr) 24, # Eyelets 6, 10 per case; Recall # Z-1848-2008;
20) HydraGlide Heparin Coated Silicone Thoracic Catheters - Straight, Atrium
Code # 14132, Size (Fr) 32, # Eyelets 6; Recall # Z-1849-2008;
21) HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal,
Eyes on Top & Bottom, Atrium Code # 14509, Size 9mm, # Eyelets 9,
10 per case; Recall # Z-1850-2008;
22) HydraGlide Heparin Coated Silicone Thoracic Catheters - Mediastinal,
Eyes on Top, Atrium Code # 14709, Size 9mm, # Eyelets 6, 10 per case;
Recall # Z-1851-2008;
23) HydraGlide XL Heparin Coated Silicone Thoracic Catheters, Increased
number of eyelets, Increased Length by 6", Atrium Code # 14720, Size 20,
# Eyelets 15, 10 per case; Recall # Z-1852-2008;
24) HydraGlide XL Heparin Coated Silicone Thoracic Catheters, with
oversulfated chondroitin sulfate; Recall # Z-1853-2008
CODE
1) Lot # 10311107;
2) Lot #s 10304311, 10321933, 10336423;
3) Lot #s 10321934,10336528,10337106;
4) Lot #s 10311122, 10321935,10342004, 10348451;
5) Lot #s 10289970, 10311123, 10311257, 10327131;
6) Lot #s 10300922, 10307009, 10311228, 10318705, 10321932,
10336320, 10336530;
7) Lot #s 10311124, 10318749, 10336424, 10348452;
8) Lot #s 10341904, 10348104;
9) Lot # 10311108;
10) Lot #s 10300921, 10326510, 10358305;
11) Lot #s 10321936, 10348204;
12) Lot #s 10300923, 10311229, 10318744, 10336321, 10348453;
13) Lot #s 10289971, 10311230, 10318745, 10334208, 10336425, 10348454;
14) Lot #s 10304312, 10318704, 10336531;
15) Lot # 10311106;
16) Lot # 10307010;
17) Lot # 10358504;
18) Lot # 10327128;
19) Lot #s 10304308, 10311258, 10327153;
20) Lot #s 10304309, 10318735, 10344304;
21) Lot 10311260;
22) Lot # 10327130;
23) Lot #s 10307011, 10311261, 10318740, 10327154, 10336322, 10336532;
24) Lot #s 10304307, 10307012, 10311125, 10311233, 10318739, 10327129,
10336323, 10336426
RECALLING FIRM/MANUFACTURER
Atrium Medical Corporation, Hudson, NH, by a press release on May 12, 2008 and by facsimile on May 12, 2008. Firm initiated recall is ongoing.
REASON
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate.
VOLUME OF PRODUCT IN COMMERCE
1,842 cases (10 Individual/case)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200µl, Heparinized: 6 IU Na & 9 IU Li/100 µl, Part #MC0024; Recall # Z-2152-2008
CODE
Lot #1112254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Opti Medical Systems Inc, Roswell, GA, by letter dated May 8, 2008 and by email on/about May 5th thru 7, 2008.
Manufacturer: Vitrex Medical ApS, Herlev, Denmark. Firm initiated recall is ongoing.
REASON
This lot of Heparinized Capillary Tubes contain contaminated lithium heparin.
VOLUME OF PRODUCT IN COMMERCE
31,750 tubes
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
a) 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2,
Part Number: 1001934-06, Designed to provide a pathway trough
which therapeutic and diagnostic devices are introduced;
Recall # Z-1633-2008;
b) 6F Viking Guiding Catheter, Percutaneous catheter Shape BP-L,
Part Number: 1001970-06, Intended to provide a pathway through
which therapeutic and diagnostic devices are introduced;
Recall # Z-1634-2008
CODE
a) and b) : Lot # 8011791
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA, by letter dated and hand delivered starting March 18, 2008. Firm initiated recall is ongoing.
REASON
The part number on the product label packaging may not match the product.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I
___________________________________
PRODUCT
a) Lake Country Animal Nutrition Honor Showlamb Grower DX Pellet, Medicated,
For Growing and Finishing Sheep, containing 0.0016% (7.5 mg/lb) decoquinate,
packaged in 50-lb. bags, Item #1311317; Recall # V-216-2008;
b) Lake Country Animal Nutrition Honor Showlamb Starter DX Pellet, Medicated,
For Pre-Weaned and Weaned Lambs, containing 0.0030% (13.6 mg/lb) decoquinate,
packaged in 50-lb. bags, Item #1311319; Recall # V-217-2008;
c) Lake Country Animal Nutrition Honor Showlamb Grower B30 Pellet,
Medicated, For Growing and Finishing Sheep, containing 30 g/ton lasalocid
(as lasalocid sodium), bulk and in 50-lb. bags, Item #1311326;
Recall # V-218-2008;
d) Land O Lakes Lamb Grower-Finisher B30, Medicated, Complete Feed
for Growing Finishing Lambs, containing 30 g/ton lasalocid
(as lasalocid sodium), bulk and in 50-lb. bags, Item #1851800;
Recall # V-219-2008
CODE
a) 8FEB23FRE1 thru 8MAY30FRE1;
b) 8JAN2FRE1 thru 8MAY29FRE1;
c) Bulk - May 6, 2008; bagged - 8APR24FRE1;
d) Bulk - March 20, 2008; bagged - 8JAN24FRE1 thru 8APR02FRE1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purina Mills LLC, Saint Louis, MO, by telephone on June 2, 2008, by letters and press release on June 6, and June 11, 2008 and by telephone and letter on June 27, 2008.
Manufacturer: Land O'Lakes Purina Feed LLC, Fremont, NB. Firm initiated recall is ongoing.
REASON
The product contains higher than acceptable levels of copper.
VOLUME OF PRODUCT IN COMMERCE
24,040 lbs. bulk and 8,413/50-lb. bags
DISTRIBUTION
IA, KS, NE, MN, and CO

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
___________________________________
PRODUCT
a) Land O Lakes Special Lamb Creep B90 Medicated, containing 90 g/ton
Lasalocid (as Lasalocid Sodium), packaged in 50-lb. bags, Item #1852700;
Recall # V-220-2008;
b) Land O Lakes Sheep Balancer, For All Classes of Sheep, packaged in
50-lb. bags, Item #1860210; Recall # V-221-2008;
c) Land O Lakes Sheep Balancer B136 Medicated, For All Classes of Sheep,
containing 136 g/ton Lasalocid (as lasalocid sodium), packaged in 50-lb.
bags and in bulk, Item 1860220; Recall # V-222-2008
CODE
a) 8FEB1FRE1 thru 8APR10FRE1;
b) 8APR15FRE1;
c) Bulk - shipped 4/16/08 and 5/1/08; bagged - 8MAR20FRE1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purina Mills LLC, Saint Louis, MO, by telephone on June 2, 2008, by letters and press release on June 6, and June 11, 2008 and by telephone and letter on June 27, 2008.
Manufacturer: Land O'Lakes Purina Feed LLC, Fremont, NB. Firm initiated recall is ongoing.
REASON
The product contains higher than acceptable levels of copper.
VOLUME OF PRODUCT IN COMMERCE
24,040 lbs. bulk and 8,413/50-lb. bags
DISTRIBUTION
IA, KS, NE, MN, and CO

END OF ENFORCEMENT REPORT FOR AUGUST 20, 2008

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