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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
April 11, 2007
07-15
___________________________________
PRODUCT
Tanimura & Antle, Sysco, Cross Valley Brand Whole Head Iceberg Lettuce
in plastic wrap, in 24 and 30 count corrugated cardboard boxes and returnable
plastic containers/cartons, Recall # F-177-7
CODE
Lot number: 142598, Product numbers: 0105, 0116, 0126, 42400, 42605,
42804, 42806, 42810, 42819, 42830, 42841
RECALLING FIRM/MANUFACTURER
Tanimura & Antle, Inc., Salinas, CA., by telephone, fax and email, beginning
on November 4, 2006. Firm initiated recall is complete.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
11,755 cartons
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Old World Style Ragu Marinara 100% Natural 1 lb 10 oz (26 oz.) glass jar with
UPC 3620000400, Recall # F-178-7
CODE
Best if used by Sep 20 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ., by
letter on December 13, 2006.
Manufacturer: Unilever Foods Inc., Owensboro, KY., Firm initiated
recall is complete.
REASON
Jars labeled as Old World Style Marinara Sauce contained another product, Old
World Style Pasta Sauce, Flavored with Meat. The Sauce Flavored with Meat contains
cheese (milk allergen) which is not listed on the Old World Style Marinana
sauce label.
VOLUME OF PRODUCT IN COMMERCE
1000 jars
DISTRIBUTION
AL, AR, FL, GA, KY, MS, NC, SC, TN, VA and WV
___________________________________
PRODUCT
Dole cantaloupes, 40 pound cartons with 9, 12, or 15 cantaloupes per carton,
Recall # F-179-7
CODE
Product packed January 25, 26 and 27, 2007. Cartons have a thirteen
digit number on a white tag pasted to the carton; the tenth digit is a 2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dole Fresh Fruit Co., Westlake Village, CA, by press
release on February 16, 2007.
Manufacturer: Tropifresh De Costa Rica S.A., Guanacaste, Costa Rica. Firm
initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,104 cartons
DISTRIBUTION
NY, OH, WI, MI, PA, GA, AL, MA, MD, and Canada
___________________________________
PRODUCT
Giant Eagle Egg Free Pasta Ribbons, packaged in 12-oz. film bags, 12 bags/case,
UPC 30034 04596, Recall # F-180-7
CODE
BEST BY 011809Y2
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Italian Pasta Company, Kansas City, MO.,
by telephone and email on February 19, 2007.
Manufacturer: American Italian Pasta Company, Columbia, SC. Firm
initiated recall is complete.
REASON
Some of the Egg Free Pasta Ribbon bags contained a different product, Fine
Egg Noodles. The Find Egg Noodles contain eggs, while the label of the Egg
Free Pasta Noodles does not list eggs as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
90/12/12-oz. package cases
DISTRIBUTION
PA, OH, WV, and MD
___________________________________
PRODUCT
Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet
Proof Your Immune System * 45 tablets 500mg, sold over-the-counter, labeled
to contain a combination of herbal ingredients for use as an immune support
booster. The primary ingredients (per tablet) listed on the product's labeling
include the following: star anise extract, shikimic acid, and hypericum perforatum.
The product's labeling recommends a dosage of 3 tablets for 10 days, followed
by 1 tablet daily, UPC of: 8 57084 00079 8, Recall # F-158-7
CODE
Lot # 06202044, expiration January 2009; manufactured January 2006
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA., by letter on/about May 16, 2006. Firm
initiated recall is ongoing.
REASON
Dietary Supplement makes unapproved drug claim that it can prevent Bird Flu
and also fails to label one of its ingredients, star anise, properly.
VOLUME OF PRODUCT IN COMMERCE
2,331 bottles containing 45 tablets per bottle
DISTRIBUTION
CA, MD, SD and TX
___________________________________
PRODUCT
Diabeticine Dietary Supplement Blood Product Support, Ortho-Molecular Blend,
60 capsules, Dr. Theo’s Cellular Health, Recall # F-173-7
CODE
All lots on the market at the time of the recall
RECALLING FIRM/MANUFACTURER
Techmedica Health Inc., Grand Rapids, MI., by telephone beginning on May 9,
2006 and by letters on or about May 9, 2006 and June 23, 2006. Firm initiated
recall is complete.
REASON
The product is an unapproved new drug because the therapeutic claims on the
firm’s web site establish that the product is promoted for use in the
cure, mitigation treatment or prevention of disease (diabetes).
VOLUME OF PRODUCT IN COMMERCE
Not available
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Bulk Krinos brand Myzithra Ripened Hard Grating Cheese
packaged in 2-lb. balls, 6 per case, Product of Greece.
Imported by Les Aliments Krinos Foods Inc., NY, Quebec,
Canada,
and, Ontario, Canada, Recall # F-181-7;
b) Cut and wrapped Krinos Imported Myzithra cheese, cut and wrapped
in random weight packages weighing approximately 4.5-7-oz.
each, Recall # F-182-7
CODE
a) 6/20/2006 Sell by 6/28/2007 lot #2; 7/3/2006, Sell by 6/28/2007 lot #2;
7/4/2006, Sell by 6/29/2007 lot #2;
b) Sell by dates of 10/24/2006, 10/31/2006, 11/7/2006, 11/14/2006, 11/20/2006,
12/6/2006, 12/27/2006, 12/31/2006, 1/2/2007, 1/7/2007, 1/8/2007,
1/9/2007, 1/16/2007,
and 1/21/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Swiss-American Inc., Saint Louis, MO., by telephone
on September 19, 2006.
Manufacturer: Karalis S.A. Milk Industry of Epirus, Arta, Greece. Firm
initiated recall is complete.
REASON
The product was prepared, packed, or held under unsanitary conditions whereby
it may have become contaminated with filth based on high levels of E. coli
in the product.
VOLUME OF PRODUCT IN COMMERCE
3/6/2-lb. ball cases and 615.59 lbs. of random weight cut pieces
DISTRIBUTION
IN, LA, MO, IL, KS, MS and TN
___________________________________
PRODUCT
a) Coricidin "D", (acetaminophen 325 mg with Phenylephrine HCl 5
mg
and Chlorpheniramine Maleate 2 mg), 24 Film-Coated Tablets,
Recall # D-487-2007;
b) CVS Pharmacy brand Sinus Pain & Congestion Nighttime,
(acetaminophen 325 mg, Phenylephrine HCl 5 mg and Chlorpheniramine
Maleate 2 mg), 24 Caplets, (SKU # 405565/UPC# 50428102640)
----
Also labeled under other brand name as follows; QC-Quality
Choice
brand Multi-Symptom Allergy Relief, (SKU #QC95611/UPC# 635515956117),
Recall # D-488-2007
CODE
a) Lot numbers: (Coricidin ''D'') 6D01WN, 6E01WN, 6E02AWN, 6E02WN,
6G02WN, 6H01WN, 6H02WN, 6K01WN, 6K02WN, 6K03WN;
b) (CVS): 6NB0698 and (QC): 6NB0369
RECALLING FIRM/MANUFACTURER
Leiner Health Products LLC, Carson, CA, by letter, on February 2, 2007. Firm
initiated recall is ongoing.
REASON
Stability data does not support expiration date.
VOLUME OF PRODUCT IN COMMERCE
117,316.8 units (24 caplets per)
DISTRIBUTION
MI, RI, TN
___________________________________
PRODUCT
Differin (adapalene) Cream, 0.1%; Rx Only; NDC 0299-5915-45, Recall # D-484-2007
CODE
Lot #045193
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galderma Laboratories, Inc., Fort Worth, TX, by letter
on March 6, 2007.
Manufacturer: Galderma Production Canada, Inc., Baie-D Quebec, Canada. Firm
initiated recall is
REASON
Mispacked. Shipping containers labeled as Differin Cream actually contains
Differen Gel.
VOLUME OF PRODUCT IN COMMERCE
40,056 tubes (1669 shipping containers)
DISTRIBUTION
Nationwide and Jamaica
___________________________________
PRODUCT
Severe Cold PE Caplets (OTC), Acetaminophen 325 mg, Phenylephrine HCl 5 mg
and Diphenhydramine HCl 12.5 mg caplets. The bulk lot was subsequently packaged
under the Target label. Target UPC #: 074990747818, Recall # D-486-2007
CODE
Lot #: 6FE9056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products LLC, Carson, CA, by letter on
February 22, 2007.
Manufacturer: Amneal Pharmaceuticals, LLC., Paterson, NJ. Firm
initiated recall is ongoing.
REASON
Failed Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE
15,744 bottles (24 caplets per bottle)
DISTRIBUTION
MN
___________________________________
PRODUCT
Pharmacist Formula Women's Gentle Laxative Tablets (Bisacodyl) 5 mg, blister
packs of 30 and 90, Enteric Coated, Stimulant Laxative, Manufactured By Leiner
Health Products, ---- Also labeled under other brands as follows; Dollar General
brand Women's Laxative Tablets, Distributed by: Dolgencorp, Inc., Eckerd brand
Stimulant Laxative women's laxative, Eckerd Corporation, d/b/a Eckerd Pharmacy,
Family Dollar brand Laxative, Distribution by Family Dollar Services, Inc.,
Marc's Central Warehouse, Golub Corporation, CDMA, SAJ Distributors, Target
Corporation, and Wegmans Gentle Laxative, Distributed by Wegmans Food Markets, Select
Brand Women's Gentle Laxative, Distributed by Select Brand Distributors,
Price Chopper brand Laxative Tablets, Recall # D-489-2007
CODE
Bulk Code BA0026AA, All packaging lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leiner Health Products LLC, Carson, CA, by letter on
March 16, 2007.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall
is ongoing.
REASON
Stability data does not support expiration date.
VOLUME OF PRODUCT IN COMMERCE
408,960 tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0912-07
CODE
Units: 20LH06504 and 20LH07293
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by letter on
January 30, 2004, facsimile and telephone on August 4, 2004. Firm initiated
recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and ID
___________________________________
PRODUCT
Source Plasma, Recall # B-0980-07
CODE
Units:
0060026077, 0060026323, 0060026444, 0060026688, and 0060029038.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., by facsimile and letter on November 16, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for providing
a history of multiple high-risk behaviors, were distributed
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Spain
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0981-07
CODE
Unit: 20LH06123
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone
and letter on January 27, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0983-07;
b) Recovered Plasma, Recall # B-0984-07
CODE
a) and b) Unit: FN05164
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 16, 2003. Firm
initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from
a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0985-07
CODE
Units: LN59394, LP42505
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 27, 2003. Firm
initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to hepatitis B core
antigen (anti-HBc), but were collected from a donor who tested repeat reactive
for anti-HBc on two previous occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Source Plasma, Recall # B-0987-07
CODE
Unit: 05HINB2881
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN., by facsimile on December 21, 2006. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for a history
of receiving a tattoo and piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Human Tissue for Transplantation
Soft tissue – tendons and ligaments:
1) Item 400250, Fascia Lata (Large) Recall # B-0988-07;
2) Item 400265, 10cm x 25mm, Recall # B-0989-07;
3) Item 400266 Fascia Lata – 20cm x 25 mm, Recall # B-0990-07;
4) Item #400270 – Fascia lata (Medium), Recall # B-0991-07;
5) Item 400277 – Fascia Lata (Small), Recall # B-0992-07;
6) Item 430120 – Fascia Lata (Medium), Recall # B-0993-07;
7) Item 430160 – Fascia Lata (Small), Recall # B-0994-07;
8) Item 800251 – Fascia Lata (X-Large), Recall # B-0995-07;
9) Item 800265 – Fascia Lata 10cmx25mm, Recall # B-0996-07;
10) Item 800270 – Fascia Lata (Med.), Recall # B-0997-07;
11) Item 830140 – Fascia Lata (Lg), Recall # B-0998-07;
12) Item 830160 – Fascia Lata (Small), Recall # B-0999-07;
13) Item 450030 – Costal Cartilage, Recall # B-1000-07;
14) Item 460400– OC Fem Hemi-Condyle Medial Left, Recall # B-1001-07;
15) Item 460402 – OC Fem Hemi-Condyle Medial Right, Recall # B-1002-07;
16) Item 460403 – OC Fem Hemi-Condyle Lateral Right, Recall # B-1003-07;
17) Item 850030 – Costal Cartilage, Recall # B-1004-07;
18) Item 860400 – OC Fem Hemi – Condyle Medial Left, Recall # B-1005-07;
19) Item 850345 – Scapula, Left, Recall # B-1006-07;
20) Item 400278 Achilles Tendon with Calcaneous, Recall # B-1007-07;
21) Item 400279 – Achilles Tendon without Calcaneous, Recall # B-1008-07;
22) Item 430005 – BTB w/Quad, Hemi Small Bone Block, Recall # B-1009-07;
23) Item 430007 – Pre-shaped Hemi-BTB, Recall # B-1010-07;
24) Item 430010 – BTB w/Quad, Hemi, Recall # B-1011-07;
25) Item 430015 – BTB, hemi w/o Quad, Recall # B-1012-07;
26) Item 430030 – BTB w/Quad, whole, Recall # B-1013-07;
27) Item 430034 – BTB whole, Recall # B-1014-07;
28) Item 430036 – BTB Whole w/Quad, Recall # B-1015-07;
29) Item 430200– Achilles Tendon w/calc >= 19.5cm, Recall # B-1016-07;
30) Item 430207 – Pre-shaped Achilles Tendon, Recall # B-1017-07;
31) Item 430250 – Achilles Tendon w/calc 16-19.5cm, Recall # B-1018-07;
32) Item 430300 – Gracilis Tendon, Recall # B-1019-07;
33) Item 430335 – Anterior Tibialis Tendon, Recall # B-1020-07;
34) Item 430340 – Posterior Tibialis Tendon, Recall # B-1021-07;
35) Soft tissue – tendons and ligaments Item 430350 – Semitendinosus
Tendon >=26cm,
Recall # B-1022-07;
36) Item 430355 – Semitendinosus Tendon <26 cm, Recall # B-1023-07;
37) Item 430521 – Achilles Tendon w/o Bone Block, Recall # B-1024-07;
38) Item 800278 – Achilles Tendon w/Calcaneous, Recall # B-1025-07;
39) Item 800279 – Achilles Tendon w/o Calcaneous, Recall # B-1026-07;
40) Item 830005 – BTB w/Quad, Hemi, Small Bone Blocks, Recall # B-1027-07;
41) Item 830007 – Pre-shaped Hemi BTB, Recall # B-1028-07;
42) Item 830010 – BTB w/Quad Hemi, Recall # B-1029-07;
43) Item 830015 – BTB Hemi w/o Quad, Recall # B-1030-07;
44) Item 830034 – BTB Whole, Recall # B-1031-07;
45) Item 830036 – BTB Whole w/Quad, Recall # B-1032-07;
46) Item 830200 – Achilles Tendon w/calc >=19.5cm, Recall # B-1033-07;
47) Item 830207 – Pre-shaped Achilles Tendon, Recall # B-1034-07;
48) Item 830250 – Achilles Tendon w/calc 16-19.5cm, Recall # B-1035-07;
49) Item 830300 – Gracilis Tendon, Recall # B-1036-07;
50) Item 830335 – Anterior Tibialis Tendon, Recall # B-1037-07;
51) Item 830340 – Posterior Tibialis Tendon, Recall # B-1038-07;
52) Item 830350 – Semitendinosus Tendon >=26 cm, Recall # B-1039-07;
53) Item 830355 – Semitendinosus Tendon <26 cm, Recall # B-1040-07;
54) Item 830521 – Achiles Tendon w/o Bone, Recall # B-1041-07;
55) Item 430402 – Meniscus Lateral Left w/Hemi Plateau, Recall # B-1042-07;
56) Item 430411 – Meniscus Medial Right w/Hemi Plateau, Recall # B-1043-07;
57) Item 430412 – Meniscus Lateral Right w/Hemi Plateau, Recall # B-1044-07;
58) Item 830401 – Meniscus Medial Left w/Hemi Plateau, Recall # B-1045-07;
59) Item 830411 – Meniscus Medial Right w/Hemi Plateau, Recall # B-1046-07;
60) Item 830412 – Meniscus Lateral Right w/Hemi Plateau, Recall # B-1047-07;
61) Item 830402 – Meniscus Lateral Left w/Hemi Plateau, Recall # B-1048-07
CODE
1) 400250 006559831012P 400250 044546171010P 400250 063531941039P;
2) 40265 023499751004 400265 023499751008 400265 043522961003
400265 043522961007;
3) 400266 003526791018 400266 003536981006 400266 003536981007;
4) 400270 003520871007P 400270 003543421002A 400270 004548921011P
40270 006531901006P 400270 027538541011P 400270 031471231009A
400270 033506011026 400270 033530351001A 400270 035533551004;
5) 400277 002488811063P 400277 002488811064P 400277 003547741029A
400277 003547741030A 400277 006548391003P 400277 006548391007P
400277 006548391008P 400277 006548391009P 400277 031545411004P
400277 035527591011A;
6) 430120 083554811011P;
7) 430160 003521681022P 430160 003521681023P 430160 017534561005A
430160 082527811033P;
8) 800251 003533271004 800251 003533271011 800251 007523001011;
9) 800265 002492911021 800265 002492911025 800265 003541401004
800265 003541401011 800265 006534311012 800265 006539901047
800265 008499841008 800265 035524931051 800265 072461681011
800265 072461681012 800265 072461681020;
10) 800270 002478461028 800270 003534821014 800270 008496941008
800270 008511311007 800270 008515931013 800270
008515931020
800270 017491981015 800270 035533031022;
11) 830140 033531411027;
12) 830160 063549941001 830160 063549941002 830160 063549941009;
13) 450030 017535921024P;
14) 460400 023429271101;
15) 460402 023429271103;
16) 460403 023429271104;
17) 850030 017533261036 850030 017533261037 850030 017533261044
850030 017535871007 850030 017535871008 850030
017535871009
850030 017535871010 850030 017535871011 850030
017535871012
850030 017542601015 850030 017542601016 850030
017542601017
850030 017542601018 850030 017542601019 850030
017542601020
850030 065477521005 850030 065516271034 850030
065516271035
850030 065516271036 850030 065516271038 850030
081522681052;
18) 860400 017372331162 860400 021494451213;
19) 850345 017511011003;
20) 400278 029546041032P 400278 029546041045P 400278 033506011028;
21) 400279 035541891022 400279 035541891018;
22) 430005 002376771007P 430005 002502651015 430005 002550101046A
430005 002550101051A 430005 003552581013A 430005
004547381018P
430005 005527551008 430005 005536831050P 430005
005536831051P
430005 006527731011 430005 006527731012 430005
006527731016
430005 006527731017 430005 006530941002P 430005
006548351002P
430005 006548351003P 430005 007519891012P 430005
008502051001P
430005 008516351034A 430005 008536731021 430005
008536731024
430005 017435981002P 430005 017501401007P 430005
017501401008P
430005 017525981004P 430005 017539861030P 430005
017539861031P
430005 021541811015 430005 021541811016 430005
021549871003P
430005 021549871009P 430005 023475091019 430005
023475091020
430005 023475091022 430005 023475091023 430005
023475791003A
430005 023499751002 430005 023499751003 430005
023499751007
430005 023528461008A 430005 023528461009A 430005
028526121008P
430005 028528011008 430005 031520621009 430005
031520621014
430005 031544111001A 430005 031544111003A 430005
031545411003P
430005 032518791023P 430005 033505011001 430005
033505011002
430005 035525971020A 430005 035525971021A 430005
035525971022A
430005 035525971023A 430005 035536511002P 430005
035539661002
430005 035539661003 430005 035539661006 430005
035540041004
430005 035542091021P 430005 035542091025P 430005
035542351002
430005 035546461013P 430005 035546821003 430005
035555861002P
430005 035555861005P 430005 035556641005A 430005
038527721027
430005 038532321002 430005 038539531007 430005
043528881002
430005 043536861008 430005 043540371002 430005
043540371007
430005 043540371008 430005 043554151010A 430005
044529631038
430005 044542631007A 430005 044560591010P 430005
056516981026A
430005 056516981030A 430005 056544691017 430005
056544691018
430005 063535191002 430005 063536061012 430005
063536061013
430005 063536911004A 430005 081539521065 430005
081539521070;
23) 430007 002376771002P 430007 002376771006P 430007 002447751029
430007 002473921014 430007 002488611003P 430007
002488611008P
430007 002508501016P 430007 002508501019P 430007
002508501020P
430007 002523551024 430007 002523551028 430007
002542881002
430007 002543141002P 430007 002543141003P 430007
002543141006P
430007 002543141007P 430007 002548151002P 430007
002548151003P
430007 002548151009P 430007 002556911063P 430007
003513731002P
430007 003513731003P 430007 003513731008P 430007
003513731009P
430007 003519491019P 430007 003519491020P 430007
003520871003P
430007 003520871004P 430007 003520871012P 430007
003520871013P
430007 003521681030P 430007 003521681031P 430007
003525131027P
430007 003525131028P 430007 003525131032P 430007
003525131033P
430007 003525591002A 430007 003525591005A 430007
003528181003P
430007 003528181007P 430007 003529961006 430007
003532251002P
430007 003532251007P 430007 003537091002P 430007
003537091003P
430007 003537091006P 430007 003539211003 430007
003539211007
430007 003540811002A 430007 003540811003A 430007
003540811006A
430007 003540811007A 430007 003541241020P 430007
003541241026P
430007 003542491018 430007 003544301002A 430007
003544301009A
430007 003546121001A 430007 003547091002P 430007
003547091003P
430007 003547091006P 430007 003548001002P 430007
003548001008P
430007 003548131001A 430007 003548131003A 430007
003548161008A
430007 003548821030P 430007 003551841002P 430007
003551841003P
430007 003551841014P 430007 003551841015P 430007
003555441002A
430007 003563501006A 430007 003563501009A 430007
003563501010A
430007 005529581023 430007 005547551037P 430007
005547821008P
430007 005547821013P 430007 006531901009P 430007
006532101002P
430007 006532101008P 430007 006541111008 430007
006554521006A
430007 007505281025 430007 007505281026 430007
007515891005P
430007 007530421007P 430007 007530421008P 430007
007530641020
430007 007545731008P 430007 007545731012P 430007
007545731013P
430007 008494601003P 430007 008496561008 430007
008502051002P
430007 008502051009P 430007 008502701033 430007
008516351033A
430007 008519341002P 430007 008519341008P 430007
008519411004A
430007 008519411008A 430007 008519411009A 430007
008522761002P
430007 008522761003P 430007 008522761008P 430007
008522761009P
430007 008531521030 430007 008542651001A 430007
008542651002A
430007 017439591002P 430007 017439591003P 430007
017499261002P
430007 017501401002P 430007 017501401003P 430007
017508101008P
430007 017518711009P 430007 017527431045P 430007
017527431050P
430007 017529901038 430007 017529901045 430007
017534561002A
430007 017534561010A 430007 017535721026 430007
017535721029
430007 017535831003P 430007 017535831008P 430007
017552321010P
430007 017558061002P 430007 021492371002P 430007
021492371003P
430007 021493671020 430007 021512331009P 430007
021512331010P
430007 021512331016P 430007 021512331017P 430007
021512361007P
430007 021535371024 430007 021535371028 430007
021540881007P
430007 021540881008P 430007 021540881014P 430007
021540881015P
430007 021541811019 430007 023386951002P 430007
023386951003P
430007 023499461024A 430007 023527031002P 430007
023527031003P
430007 023527031004P 430007 023539151009 430007
023541881001A
430007 023546601018A 430007 023546601019A 430007
023546601029A
430007 023546601030A 430007 023549551002P 430007
023549551003P
430007 027538541002P 430007 027538541003P 430007
028514231016P
430007 028514231017P 430007 028514231022P 430007
028514231023P
430007 028533601001 430007 028533601004 430007
028533601005
430007 029537291023P 430007 032531101002P 430007
032531101005P
430007 032531101006P 430007 032541171038A 430007
032541171041A
430007 033524331014A 430007 035511061040P 430007
035511061044P
430007 035521131003P 430007 035522011003 430007
035525071011
430007 035525071018 430007 035527591009A 430007
035527591010A
430007 035527591016A 430007 035527591017A 430007
035528401001P
430007 035528401002P 430007 035528401005P 430007
035528401006P
430007 035529561005P 430007 035529971008 430007
035530091003P
430007 035530091007P 430007 035532681003P 430007
035532681008P
430007 035536441035P 430007 035536441036P 430007
035536441040P
430007 035536711041A 430007 035537341019 430007
035539641001P
430007 035540821018 430007 035542091022P 430007
035542941029A
430007 035546791002P 430007 035546821002 430007
035546821008
430007 035546971002P 430007 035546971003P 430007
035546971005P
430007 035546971006P 430007 035547641001P 430007
035547641002P
430007 035548331002A 430007 035548841002P 430007
035548841003P
430007 035548841008P 430007 035548841009P 430007
035553651008P
430007 035555861003P 430007 035558751001A 430007
035558751006A
430007 038539531003 430007 038539531008 430007
038554511003A
430007 038554511007A 430007 038554511008A 430007
043522961002
430007 043522961006 430007 043526371017 430007
043527581022
430007 043527691009P 430007 043527691015P 430007
043527691016P
430007 043528881003 430007 043532141006 430007
043536371003
430007 043536371009 430007 043536551036P 430007
043538281002P
430007 043538281006P 430007 043538311002P 430007
043538311003P
430007 043538311008P 430007 043538311009P 430007
043538651004
430007 043539271002 430007 043542241002P 430007
043542241008P
430007 043545181002P 430007 043545181007P 430007
043545211001P
430007 043545211002P 430007 043545211007P 430007
043548081012A
430007 043554151002A 430007 043554151009A 430007
056497921002P
430007 057516851002A 430007 057516851005A 430007
057535561005
430007 057536681002P 430007 057536681003P 430007
057536681008P
430007 057536681009P 430007 057544071006 430007
057544261001
430007 063477491028P 430007 063477491029P 430007
063477491031P
430007 063518021004P 430007 063518021010P 430007
063518021011P
430007 063528341033 430007 063528341038 430007
063529951002P
430007 063531511014P 430007 063531941015P 430007
063531941040P
430007 063531941041P 430007 063535191001 430007
063542871005
430007 063542871006 430007 063547171003A 430007
063547171008A
430007 064512981007A 430007 064512981008A 430007
064525391030
430007 064525391031 430007 064525901046 430007
064529911005A
430007 064529911006A 430007 064530861002A 430007
064530861003A
430007 064530861005A 430007 064530861006A 430007
064537241002
430007 064537241003 430007 064537241006 430007
064537241007
430007 064538431023A 430007 064538431024A 430007
064538431027A
430007 064551141034P 430007 065490011027P 430007
065490011033P
430007 065499271005P 430007 065504381002P 430007
065504381003P
430007 065504381006P 430007 065513851024 430007
065514201026
430007 065519281002A 430007 065519281005A 430007
072488491008P
430007 072488491009P 430007 076517851031 430007
076517851032
430007 076536421022P 430007 076536421023P 430007
076536421026P
430007 076542541024A 430007 076542541029A 430007
076545371052A
430007 076545461031A 430007 076546911055A 430007
078520881017P
430007 078520881018P 430007 078520881021P 430007
078520881022P
430007 079466731002P 430007 079466731003P 430007
079466731009P
430007 079466731010P 430007 082509541002A 430007
082509541008A
430007 082524101027P 430007 082524101028P 430007
082524101032P
430007 082527811038P 430007 082527811044P 430007
082546471020A
430007 083495461002P 430007 083495461008P 430007
083512961002P
430007 083512961006P 430007 083523411007 430007
083530681009A
430007 083530681010A 430007 083530681015A 430007
083530681016A
430007 083531261017A 430007 083538991009 430007
083538991010
430007 083539411007 430007 083540121037 430007
083540121038
430007 083540121041 430007 083540121042 430007
083540271040A
430007 083540271041A 430007 083541221002A 430007
083541221005A
430007 083541351002A 430007 083548051011P 430007
083548051012P
430007 083548051016P 430007 083554811009P;
24) 430010 002376771003P 430010 002447751024 430010 002447751025
430010 002447751028 430010 002473921012 430010
002473921019
430010 002473921020 430010 002475191025 430010
002475191028
430010 002475191029 430010 002488611004P 430010
002488611009P
430010 002488811061P 430010 002488811062P 430010
002534421002P
430010 002534421003P 430010 002534421007P 430010
002534421008P
430010 002542881003 430010 002542881006 430010
002542881007
430010 002545081030P 430010 002548151008P 430010
002550101047A
430010 002550101052A 430010 002552641009A 430010
002556911062P
430010 002556911068P 430010 003504491012 430010
003504491013
430010 003504491016 430010 003504491017 430010
003529961001
430010 003529961002 430010 003529961005 430010
003539211002
430010 003539211006 430010 003539391002P 430010
003539391003P
430010 003539391007P 430010 003539391008P 430010
003541241019P
430010 003541241025P 430010 003542491017 430010
003542491022
430010 003542491023 430010 003544301010A 430010
003547811014P
430010 003547811015P 430010 003548161001A 430010
003552581012A
430010 003552581019A 430010 003552581020A 430010
004535401002
4300 10 004547381019P 430010 004547381023P 430010
004547381024P
430010 004548921002P 430010 004548921003P 430010
004548921009P
430010 004548921010P 430010 005524691026 430010
005524691027
430010 005524691030 430010 005524691031 430010
005525661007P
430010 005525661008P 430010 005525661012P 430010
005525661013P
430010 005527551007 430010 005527551012 430010
005527551013
430010 005529191032 430010 005529191033 430010
005529191037
430010 005529191038 430010 005529581021 430010
005534741002
430010 005534741003 430010 005534741006 430010
005534741007
430010 005534971001A 430010 005534971002A 430010
005534971004A
430010 005534971005A 430010 005536541015 430010
005536541016
430010 005536831047P 430010 005536831048P 430010
005547551035P
430010 005547551038P 430010 005547821007P 430010
005547821012P
430010 005547861006A 430010 005547861010A 430010
006532101003P
430010 006532101009P 430010 006533251007 430010
006533251008
430010 006533251013 430010 006533251014 430010
006537751021
430010 006537751022 430010 006541111002 430010
006541111003
430010 006541111007 430010 006541681029 430010
006541681031
430010 006541681032 430010 006554521007A 430010
006562691028P
430010 007515221027 430010 007515221028 430010
007515891002P
430010 007515891006P 430010 007519891013P 430010
007530641014
430010 007530641015 430010 007530641019 430010
008479911015
430010 008479911016 430010 008479911021 430010
008479911022
430010 008496561002 430010 008496561003 430010
008496561007
430010 008502051008P 430010 008502701032 430010
008502701034
430010 008502701035 430010 008520091001A 430010
008520091002A
430010 008522581002A 430010 008522581003A 430010
008522581008A
430010 008531521029 430010 008531521032 430010
008531521033
430010 008536731020 430010 008542651003A 430010
017435981006P
430010 017529901046 430010 017533841004 430010
017534561003A
430010 017534561011A 430010 017535831002P 430010
017535831007P
430010 017537551015P 430010 017537551016P 430010
017539791022
430010 017539791023 430010 017539791027 430010
017539791028
430010 017544031002A 430010 017544031003A 430010
017544031007A
430010 017544031008A 430010 021493671019 430010
021493671026
430010 021493671027 430010 021521751002A 430010
021521751003A
430010 021530841004 430010 021535371023 430010
021535371027
430010 021549871002P 430010 021549871008P 430010
023386951005P
430010 023386951006P 430010 023475791002A 430010
023475791008A
430010 023484821013P 430010 023484821014P 430010
023491811013
430010 023491811017 430010 023491811018 430010
023499461018A
430010 023499461019A 430010 023499461023A 430010
023505241001P
430010 023505241002P 430010 023505241004P 430010
023505241005P
430010 023511431013P 430010 023511431014P 430010
023520591006A
430010 023520591007A 430010 023521281002P 430010
023526291019P
430010 023531271027 430010 023531271028 430010
023531271031
430010 023531271032 430010 023532741002A 430010
023532741003A
430010 023533371002 430010 023533371003 430010
023533371007
430010 023533371008 430010 023537911002 430010
023537911003
430010 023537911008 430010 023539031001A 430010
023539031002A
430010 023539031006A 430010 023539031007A 430010
023539151004
430010 023539151005 430010 023540171029 430010
023540171030
430010 023540171034 430010 023541881004A 430010
023541881005A
430010 023542161025 430010 023542161030 430010
023542161031
430010 023542641002 430010 023542641005 430010
023542771002
430010 023542771003 430010 023542771008 430010
023544861001P
430010 023544861002P 430010 023544861006P 430010
023548281013P
430010 027530631024 430010 027530631025 430010
027530631030
430010 027548911014P 430010 028526121002P 430010
028526121007P
430010 029528421005 430010 029537291016P 430010
029537291017P
430010 029537291022P 430010 029548121026A 430010
029548121027A
430010 029548121031A 430010 029548121032A 430010
029549761005A
430010 029549761006A 430010 029550431001P 430010
029550431002P
430010 029554381031P 430010 029554381032P 430010
029558231003A
430010 031520621010 430010 031526171026A 430010
031526171034A
430010 031526171035A 430010 031544111002A 430010
031544111004A
430010 031545411002P 430010 032541171042A 430010
033505011005
430010 033505011006 430010 033516121017 430010
033516121021
430010 033519561003P 430010 033519561004P 430010
033536311013A
430010 033536311019A 430010 033539461002A 430010
033539461006A
430010 033548781006A 430010 035505761007 430010
035505761008
430010 035505761012 430010 035505761013 430010
035511061041P
430010 035511061045P 430010 035519271002P 430010
035519271006P
430010 035521131002P 430010 035521131011P 430010
035522011002
430010 035522011008 430010 035522011009 430010
035525071010
430010 035525071017 430010 035526161003A 430010
035526161004A
430010 035529561006P 430010 035529821026 430010
035529821031
430010 035529821032 430010 035529971002 430010
035529971003
430010 035529971007 430010 035530091008P 430010
035532681002P
430010 035532681007P 430010 035532861002 430010
035532861003
430010 035532861005 430010 035532861006 430010
035533551001
430010 035533551002 430010 035535081026A 430010
035535081027A
430010 035535081032A 430010 035535081033A 430010
035535961025
430010 035535961026 430010 035535961030 430010
035535961031
430010 035536711042A 430010 035537381013 430010
035537381014
430010 035537381015 430010 035537381016 430010
035538891023
430010 035538891024 430010 035538891027 430010
035538891028
430010 035540041003 430010 035540211002A 430010
035540211005A
430010 035540211006A 430010 035540541003P 430010
035540541007P
430010 035540821013 430010 035540821014 430010
035540821017
430010 035541891019 430010 035541891020 430010
035542351001
430010 035542351005 430010 035542351006 430010
035542941030A
430010 035546461005P 430010 035546461006P 430010
035546461014P
430010 035546791003P 430010 035546791007P 430010
035546861006P
430010 035546861010P 430010 035546861011P 430010
035547641004P
430010 035547641005P 430010 035548331003A 430010
035548331008A
430010 035553651009P 430010 035556641003A 430010
035557141028A
430010 035557141029A 430010 035557141033A 430010
035557141034A
430010 035558751002A 430010 035558751007A 430010
038527721026
430010 038539531002 430010 038540981002A 430010
038540981003A
430010 038540981007A 430010 038540981008A 430010
038547671019P
430010 038547671020P 430010 038547671024P 430010
038547671025P
430010 043522571002 430010 043522571004 430010
043524061015
430010 043524061019 430010 043526371016 430010
043526371019
430010 043526371020 430010 043527581023 430010
043527581026
430010 043527581027 430010 043527711005 430010
043527711006
430010 043530301020 430010 043530301027 430010
043530301028
430010 043532141007 430010 043532141011 430010
043532141012
430010 043532751023 430010 043532751024 430010
043532751029
430010 043535171002P 430010 043535171003P 430010
043536371002
430010 043536371008 430010 043536551030P 430010
043536551035P
430010 043536861002 430010 043538651005 430010
043539091011A
430010 043539091017A 430010 043539091018A 430010
043539271003
430010 043539271009 430010 043539271010 430010
043540911008A
430010 043542241003P 430010 043542241007P 430010
043543491003A
430010 043543491007A 430010 043543731014P 430010
043543731021P
430010 043544151032P 430010 043544151038P 430010
043545001007P
430010 043548081002A 430010 043548081013A 430010
043550991035P
430010 043551481009P 430010 043554151003A 430010
044529631032
430010 044529631033 430010 044529631037 430010
044538061017
430010 044540591004 430010 044540591005 430010
044540591006
430010 044542631008A 430010 044544971001P 430010
044544971002P
430010 044544971004P 430010 044544971005P 430010
044548211009P
430010 044548211011P 430010 044562311011P 430010
056516981025A
430010 056516981029A 430010 056527401002P 430010
056527401008P
430010 056527401009P 430010 057526891002 430010
057526891003
430010 057532611005 430010 057532611006 430010
057535351018
430010 057535351019 430010 057535351024 430010
057535561004
430010 057535561008 430010 057535561009 430010
057544041027
430010 057544071002 430010 057544071003 430010
057544071005
430010 057544261003 430010 063495041042 430010
063495041043
430010 063495041046 430010 063495041047 430010
063528341032
430010 063528341037 430010 063528781009A 430010
063535191003
430010 063542871002 430010 063542871003 430010
063547171002A
430010 063547171007A 430010 064510861027 430010
064510861029
430010 064510861030 430010 064512981003A 430010
064517981002
430010 064517981003 430010 064517981007 430010
064517981008
430010 064525901037 430010 064525901038 430010
064525901047
430010 064530511002 430010 064530511003 430010
064530511007
430010 064530511008 430010 064531781002 430010
064531781003
430010 064531781006 430010 064531781007 430010
064537421003
430010 064537421004 430010 065511631002 430010
065511631003
430010 065511631006 430010 065511631007 430010
065513851023
430010 065513851027 430010 065514201021 430010
065514201025
430010 065519281006A 430010 065521201066 430010
065521201067
430010 065521201068 430010 065521201069 430010
065528231002P
430010 065528231006P 430010 065531201001P 430010
065531201004P
430010 065531201005P 430010 065535111001a 430010
065535111006A
430010 072473691002P 430010 072473691004P 430010
076513961027
430010 076513961028 430010 076513961032 430010
076513961033
430010 076514141020P 430010 076545371053A 430010
076545391008A
430010 081511761002 430010 081511761003 430010
081511761006
430010 081511761007 430010 081518671002 430010
081523421026A
430010 081523421030A 430010 081523421031A 430010
081539521066
430010 081539521071 430010 082509541003A 430010
082509541009A
430010 082523201021 430010 082523201022 430010
082523201024
430010 082523201025 430010 082527811039P 430010
082527811045P
430010 082528191011 430010 082528191012 430010
082528191014
430010 083512961003P 430010 083531261012A 430010
083531261013A
430010 083531261016A 430010 083539411008 430010
083539411010;
25) 430015 023521281003P 430015 032518791019P 430015 032518791020P
430015 032531101003P;
26) 430030 057525841014 430030 057525841018;
27) 430034 029546041033P 430034 029546041044P 430034 029555071002A;
28) 430036 003526791017 430036 003526791024 430036 003532791012
430036 003532791020 430036 003547261008P 430036
003547741028A
430036 003547741035A 430036 005519861013 430036
005519861017
430036 007544761027P 430036 007544761029P 430036
017469671008P
430036 017477331024P 430036 017477331027P 430036
017539861026P
430036 023535281073 430036 023545741022A 430036
029548891012P
430036 029548891018P 430036 033523221002A 430036
033523221008A
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430036 044539571026A 430036 044546171017P 430036
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29) 430200 002376771001P 430200 002376771005P 430200 002447751023
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006530941006P
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006559831009P
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430200 007530421006P 430200 007530421013P 430200
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008506061048A
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008519341001P
430200 008519341007P 430200 008519411003A 430200
008519411007A
430200 008520091005A 430200 008522581001A 430200
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033536311018A
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430200 035524131001P 430200 035524131003P 430200
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430200 035552651003P 430200 035553651002P 430200
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430200 035554061020A 430200 035554061022A 430200
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035557141032A
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038527721025
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038540981006A
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430200 043539091016A 430200 043539271008 430200
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430200 043540911007A 430200 043541101016 430200
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430200 044560591008P 430200 056516981024A 430200
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430200 057516851001A 430200 057516851004A 430200
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430200 063477491030P 430200 063495041041 430200
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430200 063518021003P 430200 063518021012P 430200
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430200 063529951001P 430200 063529951007P 430200
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430200 063545381018P 430200 063546551001P 430200
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430200 063546701001P 430200 063546701004P 430200
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430200 065517991003A 430200 065519281001A 430200
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430200 065526621008A 430200 065527441025a 430200
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430200 065528231001P 430200 065528231005P 430200
065533651001A
430200 065533651004A 430200 065536151001p 430200
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430200 072488491001P 430200 072488491007P 430200
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430200 076536421025P 430200 076542541023A 430200
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430200 076545391007A 430200 076545391012A 430200
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430200 076545461034A 430200 076546911057A 430200
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430200 078512141037P 430200 079466731001P 430200
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430200 081523421029A 430200 082509541001A 430200
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430200 082523201020 430200 082524101026P 430200
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430200 083548051010P 430200 083548051014P;
30) 430207 002548151001P 430207 002556911061P 430207 003519491022P
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430207 003543421001a 430207 003543421004A 430207
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430207 006531901007P 430207 006541111001 430207
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430207 021493671018 430207 029554381030P 430207
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430207 033523221007A 430207 033538971044A 430207
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430207 035530091006P 430207 035536441039P 430207
038517641006P
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31) 430250 003532791021 430250 005527551006 430250 006540001004A
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32) 430300 003532791015 430300 003532791018 430300 003536981005
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33) 430335 002376771004P 430335 002376771008P 430335 002447751026
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063536911003A
430340 063546551008P 430340 063554731014A 430340
063554731019A
430340 064512981002A 430340 064512981011A 430340
064517981005
430340 064517981010 430340 064525391029 430340
064525391033
430340 064525901041 430340 064525901051 430340
064530511005
430340 064530511010 430340 065490011030P 430340
065531201003P
430340 065531451005A 430340 065531701002P 430340
065531701004P
430340 065533651007A 430340 076517851033 430340
076542541026A
430340 076545391015A 430340 076546911061A 430340
081518671008
430340 081539521068 430340 082509541005A 430340
082509541011A
430340 082524101030P 430340 082524101034P 430340
082546471022A
430340 083495461006P 430340 083523411003 430340
083530681013A
430340 083531261018A 430340 083536691003P 430340
083536691007P
430340 083542761012P 430340 083542761015P 430340
083554811013P;
35) 430350 003532791019 430350 003537011003P 430350 003542491025
430350 003544301006A 430350 003546121003A 430350
003548161005A
430350 003548821029P 430350 004554241005P 430350
006527731015
430350 006527731020 430350 006531901005P 430350
006531901012P
430350 006532101006P 430350 006532101011P 430350
006537751019
430350 006537751024 430350 006540001005A 430350
006541111005
430350 006541111010 430350 006546741005P 430350
006548391006P
430350 006548391012P 430350 006554521004A 430350
006562691032P
430350 007515891008P 430350 007530421012P 430350
007530421017P
430350 007538931009 430350 008519411012A 430350
008520091007A
430350 008522761006P 430350 008522761013P 430350
017492391036P
430350 017500231002P 430350 017500231003P 430350
017526521005P
430350 017529901042 430350 017529901049 430350
017534561008A
430350 017534561015A 430350 017537551020P 430350
017539791025
430350 017547731003P 430350 017551911003P 430350
017552321014P
430350 021492371010P 430350 021493671031 430350
021512361004P
430350 021521751006A 430350 021535371026 430350
023475791006A
430350 023499461021A 430350 023499461026A 430350
023531271033
430350 023533371006 430350 023533371010 430350
023537911006
430350 023537911011 430350 023539031004A 430350
023539031009A
430350 023540171032 430350 023542161027 430350
023542771005
430350 023542771010 430350 023544861004P 430350
023544861009P
430350 023546601027A 430350 023546601037A 430350
023548281015P
430350 027538541007P 430350 029528421007 430350
029536491002
430350 029537291020P 430350 029546041036P 430350
029546041043P
430350 029548891016P 430350 029548891022P 430350
029549101006P
430350 029553631018A 430350 029554381029P 430350
029554381034P
430350 031520621012 430350 031520621016 430350
032518791024P
430350 033524331011A 430350 033546831026A 430350
033546831029A
430350 038511381014P 430350 038532321004 430350
038536081004P
430350 038540981005A 430350 038540981010A 430350
038546841003A
430350 038547671022P 430350 038547671027P 430350
038554511010A
430350 043524061022 430350 043527711009 430350
043528881006
430350 043530301023 430350 043530301031 430350
043532141010
430350 043532141015 430350 043536551033P 430350
043536551038P
430350 043536861005 430350 043536861010 430350
043538281005P
430350 043538281009P 430350 043538311006P 430350
043538311011P
430350 043539091021A 430350 043539271014 430350
043540371005
430350 043540371010 430350 043543731018P 430350
043543731023P
430350 043545001005P 430350 043545001011P 430350
043545181005P
430350 043545181010P 430350 043545211006P 430350
043545211011P
430350 043548081024A 430350 043550991038P 430350
043554131045A
430350 043554151006A 430350 043554151013A 430350
043554361003A
430350 044540591003 430350 044540591009 430350
063506651031
430350 063528341041 430350 063531941036P 430350
063531941044P
430350 063542871008 430350 063546701006P 430350
063547171005A
430350 063554731015A 430350 065528231004P 430350
065528231008P
430350 076513961035 430350 076514141018P 430350
076517851029
430350 076517851034 430350 076520721022P 430350
076530381009P
430350 076545391011A 430350 076545391016A 430350
076545461033A
430350 076546911062A 430350 078512141039P 430350
078520881020P
430350 079466731016P 430350 081518671004 430350
081518671009
430350 081539521069 430350 082527811037P 430350
082546471023A;
36) 430355 003541241023P 430355 003542491020 430355 004535401001
430355 004535401005 430355 006533251011 430355
006533251017
430355 007499911032P 430355 007505281029 430355
007530641017
430355 007530641022 430355 008479911020 430355
008479911026
430355 008516351037A 430355 008519341006P 430355
008519341011P
430355 017518711007P 430355 017518711012P 430355
017539791030
430355 021549871006P 430355 023491811016 430355
023491811020
430355 023531271029 430355 023541881003A 430355
027530631033
430355 043524061018 430355 043532751027 430355
043536371006
430355 043539271007 430355 043544151040P 430355
043556741005P
430355 076513961030;
37) 430521 002473921018 430521 002475191026 430521 002523551027
430521 023504681019 430521 023504681020 430521
023537911001
430521 027538541008P 430521 035525071016 430521
035529561004P
430521 035537341017 430521 035537341018 430521
035538891022
430521 035538891026 430521 043540371001 430521
043540371006
430521 043544721001A 430521 064537241005 430521
076517851025;
38) 800278 029534521038;
39) 800279 035516661001 800279 035541641053 800279 056522171030
800279 056522171033;
40) 830005 002478461032 830005 003514991005 830005 003515391022
830005 003515561008 830005 003520331002 830005
003520331003
830005 003520331006 830005 003520331007 830005
005487101011
830005 005487101012 830005 005487101015 830005
005487101016
830005 005493771003 830005 005493771007 830005
005493771008
830005 005532981027 830005 005532981028 830005
006534311011
830005 006534311015 830005 006535931004 830005
006535931005
830005 006535931010 830005 006541031005 830005
006541031006
830005 007531281019 830005 008496941010 830005
008499841003
830005 008520641024 830005 008520641025 830005
008520641026
830005 017452561025 830005 017478231007 830005
017478231008
830005 017503131009 830005 017506821007 830005
017511641010
830005 023453891038 830005 023453891043 830005
023493691037
830005 023543081007 830005 031524831023 830005
033513881022
830005 033513881027 830005 033520151038 830005
033520151043
830005 033531411025 830005 033531411026 830005
035533031029
830005 038510271009 830005 038519251006 830005
043509701023
830005 043509701024 830005 043532621016 830005
043532621017
830005 043540281003 830005 063530391013 830005
063530391018
830005 065501971001 830005 065505751002 830005
065505751005
830005 065505751006 830005 072461681009 830005
072461681018
830005 076505911038 830005 076516621077 830005
076516821019
830005 076525011018 830005 078495531005 830005
078495531006
830005 078495531008 830005 078495531009 830005
078499621004
830005 081522681047 830005 081522681048 830005
081522681054
830005 081522681055 830005 083537921029;
41) 830007 002478461033 830007 002502391003 830007 002502391004
830007 002502391007 830007 002502391008 830007
002511481020
830007 002511481024 830007 002513581007 830007
002513581012
830007 002519601012 830007 002519601013 830007
002535511029
830007 002535511030 830007 002535511032 830007
003509631002
830007 003515391018 830007 003515561009 830007
003516801007
830007 003517841002 830007 003517841007 830007
003524581019
830007 003524581024 830007 003533271002 830007
003533271009
830007 003534701029 830007 003534701039 830007
003537321033
830007 003537321035 830007 003537321036 830007
003539561023
830007 003541401002 830007 003541401003 830007
003541401010
830007 005520471017 830007 005528871002 830007
005528871006
830007 005532981032 830007 005532981033 830007
006535931009
830007 006539901039 830007 006541271017 830007
007482871021
830007 007482871022 830007 007482871027 830007
007523001014
830007 007524661046 830007 007528841007 830007
007531281020
830007 007535501026 830007 008496941011 830007
008511311002
830007 008515931023 830007 008520641027 830007
017428571033
830007 017428571034 830007 017428571037 830007
017452561028
830007 017481031011 830007 017487091028 830007
017487321013
830007 017491981014 830007 017502151031 830007
017502151035
830007 017503131010 830007 017503131015 830007
017511641007
830007 017511641011 830007 017535871017 830007
017538201025
830007 017540301001 830007 017540301002 830007
021500661030
830007 021508271032 830007 023392421044 830007
023485601015
830007 023485601022 830007 023493691031 830007
023493691032
830007 023522191002 830007 023527411008 830007
023530051016
830007 028499191011 830007 028499191012 830007
028499191016
830007 028499191017 830007 028514831018 830007
028514831019
830007 028514831023 830007 028514831024 830007
029541981010
830007 029546051010 830007 029546051014 830007
032541381024
830007 033531951041 830007 035501921040 830007
035524931055
830007 035529801005 830007 035534501021 830007
035542831003
830007 035542831007 830007 035542891032 830007
038482121007
830007 038496221022 830007 038496221023 830007
038510271008
830007 038510271015 830007 038530991002 830007
038535251001
830007 038535251002 830007 038535251006 830007
038535251007
830007 038540321002 830007 038540321009 830007
043514701013
830007 043520271023 830007 043520271024 830007
043526561002
830007 043532561008 830007 043534471001 830007
043534471004
830007 043537001017 830007 043537501002 830007
043537501009
830007 043537501010 830007 043537801030 830007
053522291031
830007 063478491002 830007 063478491005 830007
063478491006
830007 063515751025 830007 063515751031 830007
063516931002
830007 063516931005 830007 063530391012 830007
063530391017
830007 063534811019 830007 063534811023 830007
063540711024
830007 065477521001 830007 065477521008 830007
065499901022
830007 065499901025 830007 065501971002 830007
072461681010
830007 072461681019 830007 076516641035 830007
076516821016
830007 076516821018 830007 081522851002 830007
081522851006
830007 081522851007 830007 081537891005 830007
083508081005
830007 083528211007 830007 083528211008 830007
083528211013
830007 083536401022 830007 083536401023 830007
083536401024
830007 083536401025 830007 083537921030 830007
083537921034
830007 083537921035 830007 083541781095 830007
083541781096
830007 083541781099 830007 083541781100;
42) 830010 002363961002 830010 002363961006 830010 002363961007
830010 002478461026 830010 002492911019 830010
002492911020
830010 002492911023 830010 002492911024 830010
002511481019
830010 002511481023 830010 002513581006 830010
002513581011
830010 002521631003 830010 002521631007 830010
002521631008
830010 002524741002 830010 002524741003 830010
003509631008
830010 003509631009 830010 003513061002 830010
003513061007
830010 003514991001 830010 003514991002 830010
003515391017
830010 003515561003 830010 003515561004 830010
003517841003
830010 003517841006 830010 003524581018 830010
003524581023
830010 003528651002 830010 003528651006 830010
003533271001
830010 003533271008 830010 003534701028 830010
003534701038
830010 003537321032 830010 003539561022 830010
003539561028
830010 003539561029 830010 004535701018 830010
004535701019
830010 004535701022 830010 004535701023 830010
004537581007
830010 004537581008 830010 004537581010 830010
004537581011
830010 004540481020 830010 004540481023 830010
005493771002
830010 005520471011 830010 005520471012 830010
005520471016
830010 005527231027 830010 005527231031 830010
005528871003
830010 005528871007 830010 005533951005 830010
005533951006
830010 005536251023 830010 005536251024 830010
005536251028
830010 005536251029 830010 005543151020 830010
005543151021
830010 005543151023 830010 005543151024 830010
005544401023
830010 005544401026 830010 005544401027 830010
006536781031
830010 006536781032 830010 006536781034 830010
006536781035
830010 006539901040 830010 006539901045 830010
006539901046
830010 006541271018 830010 006541271023 830010
006541271024
830010 007523001007 830010 007523001008 830010
007523001013
830010 007524661040 830010 007524661041 830010
007524661045
830010 007528841008 830010 007528841013 830010
007528841014
830010 007535501021 830010 007539591020 830010
008427451048
830010 008427451049 830010 008466651014 830010
008466651015
830010 008499841002 830010 008505271006 830010
008505271007
830010 008505271012 830010 008505271013 830010
008511311003
830010 008511311009 830010 008511311010 830010
008512601037
830010 008512601038 830010 008515931015 830010
008515931016
830010 008515931022 830010 008517151002 830010
008517151004
830010 008517151005 830010 017452561026 830010
017452561029
830010 017478231015 830010 017478231016 830010
017481031005
830010 017481031006 830010 017481031010 830010
017487091027
830010 017487091033 830010 017487091034 830010
017487321012
830010 017487321019 830010 017487321020 830010
017491981013
830010 017491981019 830010 017491981020 830010
017495251039
830010 017495251040 830010 017495251045 830010
017495251046
830010 017500491012 830010 017500491016 830010
017502151030
830010 017502151034 830010 017503131014 830010
017506821002
830010 017506821003 830010 017530521018 830010
017530521019
830010 017530521023 830010 017535871005 830010
017535871006
830010 017535871016 830010 017538201024 830010
017538201029
830010 021500661023 830010 021500661024 830010
021500661029
830010 021507011026 830010 021507011027 830010
021508271031
830010 021508271035 830010 021508271036 830010
021509911011
830010 021509911012 830010 021509911014 830010
021524631008
830010 021524631009 830010 021524631014 830010
023392421038
830010 023392421039 830010 023392421043 830010
023453891039
830010 023453891044 830010 023480821013 830010
023480821014
830010 023506771002 830010 023506771003 830010
023506771008
830010 023506771009 830010 023522191003 830010
023522191005
830010 023522191006 830010 023527411007 830010
023527411013
830010 023527411014 830010 023530051015 830010
023535621082
830010 023535621086 830010 023535621087 830010
023542861037
830010 023542861038 830010 023543081003 830010
023543081008
830010 029520691009 830010 029520691010 830010
029520691015
830010 029520691016 830010 029531931004 830010
029531931005
830010 029534521039 830010 029534521040 830010
029534521045
830010 029534521046 830010 029541981011 830010
031510711002
830010 031510711007 830010 031510711008 830010
031520851002
830010 031520851003 830010 031520851008 830010
031520851009
830010 031527921028 830010 031527921029 830010
031527921033
830010 031527921034 830010 032534271004 830010
032534271005
830010 032541381020 830010 032541381021 830010
032541381025
830010 033513881021 830010 033513881026 830010
033520151039
830010 033520151044 830010 033531411032 830010
033531411033
830010 033531951040 830010 033531951044 830010
033531951045
830010 035498001001 830010 035498001002 830010
035498001004
830010 035498001005 830010 035500721042 830010
035500721043
830010 035500721045 830010 035500721046 830010
035501921032
830010 035501921033 830010 035501921041 830010
035505781026
830010 035505781027 830010 035505781030 830010
035505781031
830010 035511601001 830010 035511601002 830010
035511601004
830010 035511601005 830010 035516661002 830010
035516661003
830010 035524931054 830010 035527061003 830010
035527061004
830010 035527061008 830010 035527061009 830010
035529801002
830010 035529801003 830010 035533031024 830010
035533031025
830010 035533031028 830010 035534501020 830010
035534501024
830010 035534501025 830010 035534921001 830010
035534921002
830010 035534921005 830010 035534921006 830010
035535291025
830010 035535291026 830010 035535291029 830010
035535291030
830010 035537951001 830010 035537951002 830010
035537951004
830010 035537951005 830010 035540941001 830010
035540941005
830010 035541641051 830010 035541641055 830010
035542571003
830010 035542571004 830010 035542831002 830010
035542891031
830010 035542891035 830010 035542891036 830010
038482121002
830010 038482121003 830010 038482121006 830010
038496221018
830010 038519251005 830010 038530991006 830010
038530991007
830010 038537591017 830010 038537591018 830010
038540321003
830010 038540321010 830010 043509701019 830010
043514701007
830010 043514701008 830010 043514701014 830010
043519471010
830010 043519471011 830010 043519471014 830010
043519471015
830010 043520271027 830010 043520271028 830010
043525721007
830010 043525721011 830010 043526561003 830010
043526561008
830010 043526561009 830010 043532561002 830010
043532561003
830010 043532561007 830010 043537001010 830010
043537001011
830010 043537001018 830010 043537501003 830010
043537801031
830010 043537801036 830010 043537801037 830010
043539421002
830010 043539421003 830010 053522291024 830010
053522291025
830010 053522291030 830010 056516031005 830010
056516031006
830010 056516031010 830010 056516031011 830010
056522171031
830010 056522171032 830010 056522171034 830010
056522171035
830010 057528701006 830010 057528701007 830010
057528701011
830010 057528701012 830010 063379971010 830010
063379971011
830010 063379971014 830010 063379971015 830010
063478491003
830010 063515751024 830010 063515751030 830010
063516931001
830010 063516931004 830010 063540711019 830010
063540711020
830010 063540711023 830010 063549941006 830010
064505341002
830010 064505341003 830010 064505341007 830010
064511541030
830010 064511541031 830010 064538401001 830010
064538401004
830010 064538401005 830010 065484351002 830010
065484351003
830010 065484351007 830010 065484351008 830010
065507941015
830010 065507941016 830010 065507941019 830010
065507941020
830010 065516271042 830010 065516941020 830010
065516941021
830010 065516941023 830010 065516941024 830010
076498501028
830010 076498501029 830010 076498501033 830010
076498501034
830010 076505911037 830010 076515321022 830010
076515321023
830010 076516621070 830010 076516621071 830010
076516621076
830010 076516641029 830010 076516641030 830010
076516781019
830010 076516781020 830010 076525021006 830010
076525021007
830010 076525021011 830010 076525021012 830010
078499621013
830010 078530961022 830010 078530961023 830010
078530961027
830010 078530961028 830010 081537891006 830010
083528211012;
43) 830015 003516801006;
44) 830034 083508081008;
45) 830036 003534821013 830036 003534821017 830036 003539401015
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064505341009
830340 065484351005 830340 065505751004 830340
065516271044
830340 065516271047 830340 065522551012 830340
065522551014
830340 076498501036 830340 076516621073 830340
076516621079
830340 076516821017 830340 076525011020 830340
078499621011
830340 081537891003 830340 081537891008 830340
083508081007
830340 083508081010 830340 083537921033;
52) 830350 003509631006 830350 003513061011 830350 003521521005
830350 003533271007 830350 003533681019 830350
003538241006
830350 003538241012 830350 003539561026 830350
003539561032
830350 003541401008 830350 003541401015 830350
006528221004
830350 006536781037 830350 006541271021 830350
007523001017
830350 007528841011 830350 007539591022 830350
008466651024
830350 008479831014 830350 008496941018 830350
008499841007
830350 008505271010 830350 008511311012 830350
008515931026
830350 017452561031 830350 017478231012 830350
017487091032
830350 017487091039 830350 017487321016 830350
017491981017
830350 017491981023 830350 017500491019 830350
017506821005
830350 017530521021 830350 017538201031 830350
021500661027
830350 021507011028 830350 021507011032 830350
021508271039
830350 021509911017 830350 021524631012 830350
023488371006
830350 023488371009 830350 023493691034 830350
023493691040
830350 023523531003 830350 023523531006 830350
023535621084
830350 023535621089 830350 023542861039 830350
023543081005
830350 029520691013 830350 029520691018 830350
029534521049
830350 029541981014 830350 029546051013 830350
029546051017
830350 031527921037 830350 032534271006 830350
033531411036
830350 033531951042 830350 033531951047 830350
038510271012
830350 038530991004 830350 038535251008 830350
043503891022
830350 043509701027 830350 043514701011 830350
043514701017
830350 043520271026 830350 043525721014 830350
043526561006
830350 043526561012 830350 043532621020 830350
043534471007
830350 043537001015 830350 043537001022 830350
043537801034
830350 043537801041 830350 043539421006 830350
043540281008
830350 053522291028 830350 053522291034 830350
063499361034
830350 063515751028 830350 063515751034 830350
063534811027
830350 063549941011 830350 076505911041 830350
076515321027
830350 076516621074 830350 076516641033 830350
078499621009
830350 078499621012 830350 081522681050 830350
081522681058;
53) 830355 003513061005 830355 003533271014 830355 003534701033
830355 004540481027 830355 007482871025 830355
007482871029
830355 007539591019 830355 008496941014 830355
017481031015
830355 017506821010 830355 017535871004 830355
023506771006
830355 023522191007 830355 031524831028 830355
043519471017
830355 043540281005 830355 063540711026 830355
076498501037
830355 076515321024;
54) 830521 002502391005 830521 002521631002 830521 003529071001
830521 003529071004 830521 005493771006 830521
017538201028
830521 021524631013 830521 035477671001 830521
035477671003
830521 035524931050 830521 043525721010 830521
043537001009
830521 043537801035 830521 065477521007 830521
065484351001
830521 076516641034 830521 082478471028;
55) 430402 002473921013 430402 005519861015 430402 017529901044;
56) 430411 017529901050 430411 033523221011a 430411 056527401012P;
57) 430412 002447751033 430412 002473921021 430412 003544301014A
430412 005525661017P 430412 029546041040P 430412
057536681006P;
58) 830401 008515931017 830401 023392421040 830401 082478471029;
59) 830411 005487101019;
60) 830412 003533681021 830412 004535701020 830412 005532981036
830412 008499841005;
61) 830402 003533681015 830402 004535701016 830402 008427451046
830402 008466651020 830402 017502151028 830402
065516271039
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation (MTF), Edison, NJ, by telephone beginning
October 11, 2006 and letter dated October 12, 2006. Firm initiated recall
is ongoing.
REASON
Human tissues were processed in the same facility as other tissue which tested
positive for Chyseobacterium meningosepticum. In addition, a distributed
allograft was implanted and associated with an adverse event involving Chryseobacterium
meningosepticum.
VOLUME OF PRODUCT IN COMMERCE
4,805 allografts
DISTRIBUTION
Nationwide, Canada and Mexico
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0982-07
CODE
Unit: 1751043
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone and letter
dated February 8, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during storage,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1053-07
CODE
Unit: 20GH28987
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region,
Boise, ID, by telephone on September 9, 2004 and by letter dated September
13, 2004.
Manufacturer: American National Red Cross, Great Falls, MT. Firm
initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1054-07
CODE
Unit: 21KS45065
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone
on June 17, 2005 and by letter dated June 20, 2005. Firm initiated recall
is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1055-07
CODE
Unit: 21KL96867
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone
on March 19, 2005 and by letter dated May 5, 2005. Firm initiated recall
is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Medical Air Compressor, Model # 8413419, Recall # Z-0674-2007
CODE
Serial Numbers ARXC-001; ARXC-0002; ARXC-0009; ARXC-0011; ARXC-0012; ARXC-0013;
ARXC-0014; ARXC-0015; ARXC-0016; ARXC-0017; ARXC-0019; ARXC-0020; ARXD-0034;
ARXD-0035; ARXD-0036; ARXD-0037; ARXD-0038; ARXD-0039; ARXD-0040; ARXE-0081;
ARXE-0082; ARXE-0083; ARXE-0084; ARXE-0085; ARXE-0086; ARXE-0087; ARXE-0088;
ARXE-0089; ARXE-0090; ARXE-0091; ARXE-0092; ARXE-0093; ARXE-0094; ARXE-0095;
ARXE-0096; ARXE-0097; ARXE-0098; ARXE-0099; ARXE0100; ARXE-0101; ARXE-0102;
ARXE-0103; ARXE-0104; ARXE-0106; ARXE-0107; ARXE-0108; ARXE-0109; ARXE-0110;
ARXE-0111; ARXE-0112; ARXE-0113; ARXE-0114; ARXE-0115; ARXE-0116; ARXE-0117;
ARXE-0118; ARXE-0119; ARXE-0120; ARXE-0121; ARXE-0122; ARXE-0123; ARXE-0124;
ARXE-0125; ARXE-0126; ARXE-0127; ARXE-0128; and ARXE-0129
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA., by letter dated
January 22, 2007.
Manufacturer: Draeger Medical AG & Co., KG, Lubeck, Germany. Firm
initiated recall is ongoing.
REASON
Compressors not providing sufficient supply pressure to connected medical ventilator.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Scanlan International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use,
catalog #1001-761, Recall # Z-0701-2007
CODE
Lot: AZ115806
RECALLING FIRM/MANUFACTURER
Scanlan International, Inc., Saint Paul, MN, by letter dated February 19, 2007. Firm
initiated recall is ongoing.
REASON
Incorrectly assembled by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version
5.2 to 5.27, Recall # Z-0705-2007
CODE
There are no specific lot codes. The problem is associated only with customers
that use the ''Safe Pico'' blood sampler in conjunction with the ABL800 analyzer.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter
dated January 16, 2007.
Manufacturer Address: Radiometer Medical ApS, Bronshoj, Denmark. Firm
initiated recall is ongoing.
REASON
In some situations pre-registered patient data is not reset when leaving the
pre-registration mode in the software. This occurs when a Safe Pico blood sampler
associated with a specific patient is pre-registered in the analyzer by scanning
a barcode.
VOLUME OF PRODUCT IN COMMERCE
1345 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CELL-DYN 3200 Diluent/Sheath Reagent, List Number 03H79-01, Recall # Z-0706-2007
CODE
Lot Numbers: 1446512, 1559712, 1559812, 1675212, 1675312, 1675412, 1794312,
1794612, 1794712, 1794912, 1795012, 1795212, 1795312, 1795412, 1810712, 1810812,
1810912, 1811012
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA., by letters on September 29, 2004. Firm
initiated recall is complete.
REASON
Elevated platelet background count results-some products may show a higher
than expected platelet background count when used on the CELL-DYN 3200 System
and report patient results that are unacceptable-out-of-range.
VOLUME OF PRODUCT IN COMMERCE
27,411 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CELL-DYN Sapphire and CELL-DYN 4000 Diluent/Sheath Systems, List Number 01H73-01,
Recall # Z-0708-2007
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA., by letters on April 17, 2006. Firm
initiated recall is complete.
REASON
High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN
Sapphire System; with patient results that are unacceptable-out-of-range.
VOLUME OF PRODUCT IN COMMERCE
56,075 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ThermaSure Medical Device Drying Cabinet, series 130
Catalog #s 090035-00, 090035-03, 090036-00, 090036-02,
Recall # Z-0711-2007
b) ThermaSure Medical Device Drying Cabinet, series 300,
Catalog #s: 090033-02, 090033-04, 090034-02, 090034-04,
Recall # Z-0712-2007;
c) ThermaSure Medical Device Drying Cabinet, series 1000,
Catalog #s: 090010-02, 090010-04, 090011-00, 090011-02,
Recall # Z-0713-2007
CODE
Serial Numbers: 350305, 350306, 350307, 350308, 360309, 350310,
350311, 360312, 350313, 350314, 350401, 350402, 350403,
350404,
350405, 350406, 350407, 350408, 350409, 350410, 350411,
350412,
350413, 350414, 350415, 350416, 350417, 350418, 350419,
350420,
350421, 350422, 350423, 350424, 350425, 350426, 350427,
350501,
360502, 350503, 350504, 350505, 350506, 350507, 350508,
350509,
350510, 350511, 350512, 350513, 350514, 350515, 350516,
350517,
350518, 360519, 350520, 350521, 350522, 350523, 350524,
350525,
350526, 350527, 350528, 350529, 350530, 360531, 350532,
350533,
350534, 350601, 350602, 350603, 350604, 350605, 350606,
350607,
350608, 350609, 350610, 360611, 360612, 350613, 350614,
350615,
350616, 350617, 350618, 350619, 350620, 350621, 350621A,
350622,
350623, 350624, 350625, 350626, 350627, 350628, 350629;
b) Serial Numbers: 330304, 330305, 330306, 330307, 330308, 330309,
330310, 330311, 330312, 330313, 330401, 330402, 330403,
340404,
330405, 340406, 330407, 330408, 330409, 330410, 330411,
340412,
330413, 330414, 330415, 330416, 340417, 340501, 330502,
330503,
330504, 330505, 340506, 330507, 330508, 330509, 330510,
330511,
330512, 330601, 330602, 330603, 330604, 330605, 330606,
330607,
330608, 330609, 330610, 330611;
c) Serial Numbers: 100401, 100402, 100403, 100404, 100501, 100601,
100602, 100603
RECALLING FIRM/MANUFACTURER
Cenorin, Kent, WA, by letter dated December 20, 2006. Firm initiated
recall is ongoing.
REASON
Potential for user to receive an electrical shock.
VOLUME OF PRODUCT IN COMMERCE
159 dryers
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number
AR-1625, Recall # Z-0714-2007
CODE
Lot: D632517
RECALLING FIRM/MANUFACTURER
Integra Biotechnical LLC, Vista, CA, by email and/or fax starting on February
1, 2007. Firm initiated recall is ongoing.
REASON
During routine new product testing, it was discovered that the product may
not be sterile, although sterilized in accordance with validated parameters.
VOLUME OF PRODUCT IN COMMERCE
1,769 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Contact lens solution. The product is distributed under the following trade
names: Bausch & Lomb ReNu® Multi-Purpose Solution, Equate Multi-Purpose
Solution and Target Brand Multi-Purpose Solution. The product is distributed
in up to three sizes: 4 fl. oz., 12 fl. oz. and 16 fl. oz, Recall # Z-0715-2007
CODE
Lot numbers appearing on the bottles distributed in the U.S.: GCT6030, GC6037,
GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration
date ''2008-03'' on the bottle. Lot numbers appearing on bottles distributed
only outside of the U.S.: GC6038, GC6048 and GC6052.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by press release
on March 5, 2006 and a customized Recall Notification Package on March 6, 2007.
Manufacturer: Bausch & Lomb Inc., Greenville, SC. Firm
initiated recall is ongoing.
REASON
A higher than expected amount of trace iron in some bottles of finished product
that over time affects the product's stability and color.
VOLUME OF PRODUCT IN COMMERCE
1.5 million units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless)
interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall
# Z-0716-2007
CODE
Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT,
and 2706AU0641E-BT
RECALLING FIRM/MANUFACTURER
Pulse Biomedical, Inc., Norristown, PA, by telephone and letter dated March
5, 2007. Firm initiated recall is ongoing.
REASON
No 510 (k) marketing clearance for the product.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY, NJ, Chile, Greece, and the Netherlands
___________________________________
PRODUCT
BD 30ml Syringe Luer-Lok tip Sterile, Made in USA, Reorder number 309650, Recall
# Z-0719-2007
CODE
Lot numbers 6188613, 6188614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ.,
by letters on February 1, 2007.
Manufacturer: Becton Dickinson & Co., Columbus, NB. Firm initiated
recall is ongoing.
REASON
The unit label on a limited number of syringes is incorrect, citing a 20 ml
size. All other levels of labeling are correct, identifying the product as
30 ml size.
VOLUME OF PRODUCT IN COMMERCE
332,400 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Z-0720-2007
a) Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic
urethra lengths of 3.0-5.0 cm only. Model TA1121D, Recall
# Z-0720-2007;
b) Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic
urethra lengths of 2.5-3.5 cm only. Model TA1321D, Recall # Z-0721-2007
CODE
a) Individual Catheter lot numbers: M002671,M002672, M002589 and M002736.
Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205,
KP0011206;
b) Individual catheter lot number KG001346.
Kit box lot number KGP111105
RECALLING FIRM/MANUFACTURER
Urologix, Inc., Minneapolis, MN, by letter dated March 16, 2007. Firm
initiated recall is ongoing.
REASON
The catheter in the kit matches the description on the kit and pouch label;
however, an incorrect label was placed onto the catheter during manufacturing.
VOLUME OF PRODUCT IN COMMERCE
117 kits
DISTRIBUTION
Nationwide and the Netherlands
___________________________________
PRODUCT
Clinical Chemistry Phosphorus in vitro diagnostic, List Number: 7D71-30 and
7D71-20, Recall # Z-0722-2007
CODE
42020HW00 and 44037HW00
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories Inc., South Pasadena, CA., by
letter dated January 30, 2007.
Manufacturer: Microgenics Corp., Fremont, CA. Firm initiated recall
is ongoing.
REASON
Patient results are falsely decreased by up to 15% at these levels: 1) Serum
Plasma phosphorus greater than 8.0 mg/dL (2.60 mmol/L) 2) Urine phosphorus
greater than 80.0 mg/dL (25.80 mmol/L).
VOLUME OF PRODUCT IN COMMERCE
1,665 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Hamilton brand Disposable Precision Tips, Part Number 235300 (box containing
504 tips) and 235400 (case containing 20 boxes), Recall # Z-0723-2007
CODE
Lot: 33906 P5 and Lot: 63906 P5
RECALLING FIRM/MANUFACTURER
Hamilton Co., Reno, NV., by letter and email on January 30, 2007. Firm
initiated recall is ongoing.
REASON
Some of the packaged tips have increased force during aspiration, which can
lead to pipetting errors such as LLD error messages, and also has risk of causing
a missed pipetting.
VOLUME OF PRODUCT IN COMMERCE
37 cases
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Smith & Nephew Suture Passer 12 inch, Part number: 7209166,
Recall # Z-0724-2007;
b) Smith & Nephew Suture Passer 12 inch, Part number: 7209166D,
(refurbished), Recall # Z-0725-2007;
c) Smith & Nephew Suture Passer 2 inch, Part number: 7209167,
Recall # Z-0726-2007
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Div., Andover, MA.,
by letter on March 1, 2007.
Manufacturer: Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA. Firm
initiated recall is ongoing.
REASON
Product is labeled as reusable but there is a potential that the Cannulated
handle of the product cannot be cleaned adequately following use.
VOLUME OF PRODUCT IN COMMERCE
12,292 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm
VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01
(PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007
CODE
Serial numbers affected: 691099, 691108, 691117, 691700, 691704, 691713, 691719,
691724, 691729, 691731, 691734, 691737, 691739, 691744, 691748, 691756, 691761,
691764, 691769, 691772, 691776, 691780, 691785, 691788, 691793, 691794, 691798
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone on February 1, 2007. Firm
initiated recall is ongoing..
REASON
The year of manufacture had been incorrectly entered as 1980 into the pumps
software during the manufacture process. As a result the pump may go into an
immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs
service soon' alarm message indicating that the pump requires servicing.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles
and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests)
and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Recall # Z-0728-2007
CODE
Lot numbers 42462M100 and 42462M101
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter dated February 19, 2007. Firm
initiated recall is ongoing.
REASON
A small number of reagent kits were incorrectly configured. The affected kits
contain either two bottles of conjugate or two bottles of assay diluent instead
of one bottle of each.
VOLUME OF PRODUCT IN COMMERCE
1,944 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) 12% Sweet Feed with Corn, 50 lb poly bags, labeled in part ***
cautionary statement ***NOT INTENDED FOR HORSE USE***,
Recall # V-026-2007;
b) 16% Sheep Feed Textured, 50 lb poly bags, Recall # V-027-2007;
c) Big Buck Wildlife Food with Sweet Cane Molasses, 50 lb poly bags,
Recall # V-028-2007;
d) Feed Mixes, farm specific custom blends, bulk and bagged,
Recall # V-029-2007
CODE
a) 507-80002;
b) and c) 507-80008;
d) Lot information is not found on custom bagged feed,
which is packaged in 50 pound plain polybags. Various product
numbers related to specific customer order are found on
invoices
provided to purchasers at time of sale.
RECALLING FIRM/MANUFACTURER
Southern States Frederick Cooperative, Inc., Frederick, MD, by telephone on
February 22, 2007 and by press release on February 23, 2007. Firm initiated
recall is ongoing.
REASON
A liquid supplement was added to feed products processed by a feed mill and
the ingredient was not declared on labels of bulk and bagged feed. The supplement
is not intended for use in some animals.
VOLUME OF PRODUCT IN COMMERCE
101 tons
DISTRIBUTION
MD
END OF ENFORCEMENT REPORT FOR APRIL 11, 2007
###