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U.S. Department of Health and Human Services

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Enforcement Report for July 30, 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.

July 30, 2008
08-30

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
a) Fraxel Green Tea Infusion Mask maintenance, by Fraxel Skin Ecology System,
     in cardboard box, 3 masks per box Part number 09-03730, Recall # F-503-8;
b) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System,
    in cardboard box, 3 masks per box Part number 09-03772, Recall # F-504-8;
c) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System,
    in cardboard box, 10 masks per box Part number 09-03721, Recall # F-505-8
CODE
All product shipped before 04/09/2008, with an expiration date of September 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reliant Technologies Inc., Mountain View, CA, by telephone and letter beginning May 22, 2008.
Manufacturer: Dicon Technologies Llc, Allendale, NJ. Firm initiated recall is ongoing.
REASON
a) Products may be contaminated with Penicillium spp., and Mucor spp;
b) and c) Products may be contaminated with Penicillium spp., Candida sp., and Cladosporium spp.
VOLUME OF PRODUCT IN COMMERCE
17,428 masks
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Sushi Man brand California Combo, fully cooked, ready to eat, sushi tray,
    Net Wt. 7.5 oz., Recall # F-506-8;
b) Sushi Man brand Mini Marina Tray, fully cooked, ready to eat, sushi tray
    with 21 pieces, Net Wt. 20 oz., Recall # F-507-8
c) Sushi Man brand Marina Special Tray, fully cooked, ready to eat, sushi tray,
    Net Wt. 5.8 oz., Recall # F-508-8
CODE
Best by 4-13/07, 4-14/07, 4-15/07 and 4-16/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Japanese Food Express, Houston, TX, by telephone and letter on April 10, 2007.
Manufacturer: Japanese Food Express, Wyandotte, MI. Firm initiated recall is complete.
REASON
The product was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
VOLUME OF PRODUCT IN COMMERCE
3,440 trays
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Paroxetine Tablets, USP. 20mg, NDC: 54458-989-10, Recall # D-237-2008
CODE
T4362A
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Laboratories, Inc., St Petersburg, FL, by letter, telephone, and e-mail on January 22, 2008.   
Manufacturer: Cadila Healthcare Limited, Ahmedabad, Gujarat, India. Firm initiated recall is ongoing.
REASON
Mispacked; patient compliance pack container called (Shell Pak) labeled to contain 20mg unit of use blister cards actually contain 10mg unit of use blister cards.
VOLUME OF PRODUCT IN COMMERCE
3,798 dispensing cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Chlordiazepoxide and Clidinium Bromide Capsules, 5mg/2.5mg, 100, 500 and 1000 capsule bottles,
    Rx only, NDC 52152-018-02, 52152-018-04, 52152-18-05; Recall # D-242-2008;
b) Amantadine Hydrochloride Capsules, USP, 100 mg, 100 and 500 count bottles, Rx only,
    NDC 52152-309-02, 52152-309-04, Recall # D-243-2008;
c) Glyburide (micronized) Tablets, USP; 1.5 mg, 100 count bottle, NDC 52152-133-02,
    Recall # D-249-2008;
d) Glyburide (Micronized) Tablets, USP, 3 mg, 100, 500, and 1000 count bottles, NDC 52152-34-02,
    NDC 52152-134-04 - NDC 52152-134-05, Recall # D-250-2008;
e) Glyburide (Micronized) Tablets, USP 6 mg, 100, 500 and 1000 count bottles, NDC 52152-135-02,
    NDC 52152-135-04, NDC 52152-135-05, Recall # D-251-2008;
f) Multi-Vita-Bets with Fluoride Chewable Tablets, 0.25mg, 100 and 1000 count bottles,
    NDC 52152-150-02, Recall # D-252-2008;
g) Hydrocodone Bitartrate and Homatropine Methylbromide Tablets 5mg/1.5mg CIII,
    100 count bottles, NDC 52152-140-02, Recall # D-256-2008;
CODE
a) Lot numbers: 5369A2 May 08, 5370A2 May 08, 5370A3 May 08, 5553A2 Jun 08, 5553A3 Jun 08,
    5554A2 Jun 08, 60315A2 Apr 08, 60315A3 Apr 08, 60316A1 Apr 08, 60316A2 Apr 08, 60346A1 Apr 08,
    60346A2 Apr 08, 60347A1 Apr 08, 60347A2 Apr 08, 60347A3 Apr 08, 60468A2 May 08, 60468A3 May 08,
    60533A1 Jun 08, 60534A1 Jun 08, 60587A1 Jun 08, 60587A2 Jun 08, 60587A3 Jun 08, 60691A1 Aug 08,
    60691A2 Aug 08, 60861A1 Oct 08, 60861A2 Oct 08, 60861A3 Oct 08, 60862A1 Oct 08, 60862A2 Oct 08,
    61020A1 Nov 08, 61020A2 Nov 08, 61021A1 Nov 08, 61105A1 Dec 08, 61106A1 Dec 08, 70049A1 Jan 09,
    70049A2 Jan 09, 70049A3 Jan 09, 70050A1 Jan 09, 70050A2 Jan 09, 70182A1 Mar 09, 70182A2 Mar 09,
    70182A3 Mar 09, 70241A1 Apr 09, 70241A2 Apr 09, 70378A1 May 09, 70378A2 May 09, 70422A1
    May 09, 70422A2 May 09, 70564A1 Jul 09, 70564A2 Jul 09, 70565A1 Jul 09, 70565A2 Jul 09, 70637A1
    Aug 09, 70638A1 Aug 09, 70638A2 Aug 09;
b) Lot numbers: 60324A1 Apr 08, 60325A1 Apr 08, 60325A2 Apr 08, 60325A3 Apr 08, 60798A1 Sep 08,
    60799A1 Sep 08, 61107A1 Dec 08, 61107A2 Dec 08, 61108A1 Dec 08, 70483A1 Jun 09, 70500A1 Jun 09,
    70689A1 Aug 09, 70689A2 Aug 09, 70690A1 Oct 09, 70879A1 Oct 09, 80007A1 Jan 10, 80007A2 Jan 10,
    80008A1 Jan 10;
c) Lot number: 70200A1 Mar 09;
d) Lot numbers: 60718A1 Aug 08, 60718A2 Aug 08, 61094A1 Dec 08, 61094A2 Dec 08,
    70197A1 Mar 09, 70197A2 Mar 09, 70198A1 Mar 09, 70375A1 Apr 09, 70375A2 Apr 09,
    70376A1 Apr 09, 70816A1 Oct 09;
e) Lot numbers: 60719A1 Aug 08, 60719A2 Aug 08, 60719A3 Aug 08, 70167A1 Feb 09,
    70167A2 Feb 09, 70167A3 Feb 09, 70377A1 Apr 09, 70377A2 Apr 09, 70377A3 Apr 09,
    70810A1 Oct 09, 70810A2 Oct 09, 70810A3 Oct 09;
f) 60337A1 Apr-08, 60337A2 Apr-08, 60408A1 Jun-08, 60408A2 Jun-08, 60690A1 Aug-08,
    60690A2 Aug-08, 60690A3 Aug-08, 60880A1 Oct-08, 60880A2 Oct-08, 61120A1 Dec-08,
    61120A2 Dec-08, 70093A1 Jan-09, 70093A2 Jan-09, 70334A1 Apr-09, 70334A2 Apr-09,
    70579A1 Jul-09, 70579A2 Jul-09, 70758A1 Sep-09, 70948A1 Nov-09;
g) Lot numbers: 60437A1 May 08, 60438A1 May 08, 60636A1 Jul 08, 60637A1 Jul 08,
    60785A1 Sep 08, 60786A1 Sep 08, 60911A1 Oct 08, 60912A1 Oct 08, 61058A1 Nov 08,
    61059A1 Nov 08, 70098A2 Feb 09, 70113A1 Feb 09, 70113A2 Feb 09, 70201A1 Mar 09,
    70202A1 Mar 09, 70341A1 Apr 09, 70432A1 Apr 09;
RECALLING FIRM/MANUFACTURER
Actavis, Totowa, NJ, by letters on May 7, 2008. Firm initiated recall is ongoing.
REASON
a), b),  Subpotent; 18 month stability
c), d), e)   Exceeded Impurity Specification;
f) Superpotent, thiamine;
g) Subpotent; homatropine methylbromide;
VOLUME OF PRODUCT IN COMMERCE
Chloridazepoxide: 548.200; Amantadine: 117469; Amidrine: 64950; Glyburide: 42024; Multi Vita Bets: 2,091193; Hydrocodone Bitartrate: 157237
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
a) Carisoprodol and Aspirin Tablets, USP 200 mg/325 mg, 100 count bottles, NDC 52152-137-02;
    0037-2103-01; Soma Compound Tablets, USP, NDC 0037-2103-01, Recall # D-244-2008;
b) Amidrine Capsules CAIV, USP, (Isometheptene Mucate, Dichloralphenazone and Acetaminophen),
    65mg/100mg/325mg, in 100, 250 and 1000 count bottles, Rx only, NDC 52152-039-02; 52152-039-03,
    Recall # D-245-2008
c) Mirtazapine Orally Disintegrating Tablets, 15 mg, 6x5 (30) unit-dose blister pack, Rx only,
    NDC 52152-254-18, Recall # D-246-2008;
d) Mirtazapine Orally Disintegrating Tablets, 30 mg, 6x5 (30) unit-dose blister packs, Rx only,
    NDC 52125-255-18, Recall # D-247-2008;
e) Mirtazapine Orally Disintegrating Tablets, 45 mg, 6x5 (30) unit-dose blister packs, NDC # 52152-256-18,
    Recall # D-248-2008;
f) Multi Vita Bets with Fluoride Chewable Tablets, 0.5 mg, 100 and 1000 count bottles,
    NDC 52152-031-02, NDC 52152-031-05, NDC 0904-5274-60, Recall # D-253-2008;
g) Multi Vita Bets with Fluoride Chewable Tablets, 1.0mg, 100 and 1000 count bottles,
    NDC 52152-001-02, NDC 52152-001-05; Recall # D-254-2008;
h) Phentermine Hydrochloride Capsules, USP 30 mg CIV, 100 and 1000 count bottles,
    NDC 52152-160-02; 52152-160-05, Recall # D-255-2008;
i) Phentermine Hydrochloride Capsules CIV, USP, 15 mg, NDC 52152-170-02 - 100 count;
    NDC 52152-170-05- 1000 count bottles, Recall # D-257-2008;
j) Phentermine Hydrochloride Capsules CIV, USP, 37.5 mg, Rx only, NDC 52152-167-02 –
    100 count; 522152-167-05 - 1000 count bottles, Recall # D-258-2008;
k) Phentermine Hydrochloride Tablets, USP, 37.5 mg Rx only, CIV, NDC 52152-159-02 –
    100 count bottles; NDC 52152-159-05 – 1000 count bottles, Recall # D-259-2008;
l) Phentermine Hydrochloride Capsules, USP, 30 mg, (Seed Formulation) Rx only, CIV,
    NDC 52152-173-02 - 100 count; NDC 52152-173-05 - 1000 count bottles,
    Recall # D-260-2008
CODE
a) Lot numbers: 60725A1 Oct 08, 61060A1 Nov 08, 70255A1 Apr 09, 70594A1 Jul 09, 70668A1 Aug 09;
b) Lot numbers: 60295A1 Apr 08, 60336A1 Apr 08, 60390A1 Apr 08, 60391A1 Apr 08, 60391A2 Apr 08,
    60425A1 May 08, 60426A1 May 08, 60480A1 May 08, 60486A1 May 08, 60519A1 Jun 08, 60521A1
    Jun 08, 60613A1 Jul 08, 60613A2 Jul 08, 60663A1 Jul 08, 60664A1 Jul 08, 60702A1 Aug 08, 60703A1
    Aug 08, 60764A1 Aug 08;
c) Lot numbers: 60794A1 Sep 08, 60988A1 Nov 08, 70279A1 Mar 09, 70420A1 May 09,
    70420A2 May 09, 70893A1 Oct 09, 70933A1 Nov 09, 70581A1 Jul 09;
d) Lot numbers: 60795A1 Sep 08, 60989A1 Nov 08, 70280A1 Mar 09, 70421A1 May 09,
     70894A1 Oct 09, 70934A1 Nov 09, 70999A1 Dec 09, 70580A1 Jul 09;
e) Lot numbers: 60796A1 Sep 08, 70281A1 Mar 09, 70419A1 May 09, 70895A1 Oct 09, 70935A1 Nov 09,
    70998A1 Nov 09;
f) Lot numbers: 60396A1 Apr 08, 60396A2 Apr 08, 60412A1 May 08, 60412A2 May 08,
    60495A1 May 08, 60539A1 Jun 08, 60539A2 Jun 08, 60642A1 Jul 08, 60730A1 Sep 08,
    60730A2 Sep 08, 60845A1 Sep 08, 60971A1 Nov 08, 60971A2 Nov 08, 61028A1 Nov 08,
    61028A2 Nov 08, 61028A3 Nov 08, 61093A1 Dec 08, 61093A2 Dec 08, 70045A1 Jan 09,
    70094A1 Jan 09, 70094A2 Jan 09, 70239A1 Mar 09, 70270A1 Apr 09, 70270A2 Apr 09,
    70448A1 May 09, 70528A1 Jun 09, 70528A2 Jun 09, 70633A1 Jul 09, 70719A1 Aug 09,
    70754A1 Sep 09, 70754A2 Sep 09, 70886A1 Nov 09, 70886A2 Nov 09, 71030A1 Dec 09,
    71030A2 Dec 09, 71030A3 Dec 09, 80173A1 Feb 10, 80173A2 Feb 10;
g) Lot numbers: 60345A1 Apr 08, 60345A2 Apr 08, 60345A3 Apr 08, 60415A1 May 08,
    60415A2 May 08, 60415A3 May 08, 60516A1 Jun 08, 60615A1 Jul 08, 60615A2 Jul 08,
    60714A1 Aug 08, 60714A2 Aug 08, 60714A3 Aug 08, 60914A1 Oct 08, 60914A2 Oct 08,
    60914A3 Oct 08, 61121A1 Dec 08, 61121A2 Dec 08, 61121A3 Dec 08, 70150A1 Feb 09,
    70150A2 Feb 09, 70380A1 May 09, 70380A2 May 09, 70525A1 Jul 09, 70525A2 Jul 09,
    70525A3 Jul 09, 70674A1 Aug 09, 70674A2 Aug 09, 70874A1 Oct 09, 70874A2 Oct 09,
    70874A3 Oct 09, 70972A1 Nov 09 70972A2 Nov 09, 70972A3 Nov 09, 80166A1 Feb 10,
    80166A2 Feb 10, 80166A3 Feb 10;
h) Lot numbers: 60427A1 May 08, 60427A2 May 08, 60572A1 Jun 08, 60572A2 Jun 08,
    60710A1 Aug 08, 60710A2 Aug 08, 60711A1 Aug 08, 60711A2 Aug 08, 60940A1 Oct 08,
    60941A1 Oct 08, 70151A1 Feb 09, 70151A2 Feb 09, 70152A1 Feb 09, 70152A2 Feb 09,
    70271A1 Mar 09, 70271A2 Mar 09, 70272A1 Mar 09, 70511A1 Jun 09, 70512A1 Jun 09,
    70801A1 Sep 09, 70802A1 Sep 09, 71018A1 Dec 09, 71019A1 Dec 09;
i) Lot numbers: 60428A1 May-08, 60565A1 Jun-08, 60582A1 Jun-08, 60582A2 Jun-08,
    60810A1 Sep-08 60811A1 Sep-08 60851A1 Sep-08 60852A1 Oct-08 60852A2 Oct-08,
    60852A3 Oct-08 70364A1 Apr-09 70462A1 Jun-09 70463A1 Jun-09 70654A1 Aug-09,
    70655A1 Aug-09 70655A2 Aug-09 70900A1 Nov-09 70901A1 Nov-09 70901A2 Nov-09;
j) Lot numbers: 60340A1 Apr-08, 60340A2 Apr-08, 60481A1 Jun-08, 60481A2 Jun-08,
    60526A1 Jun-08, 60835A1 Sep-08, 60835A2 Sep-08, 60836A1 Sep-08, 70095A1 Jan-09,
    70096A1 Jan-09, 70096A2 Jan-09, 70464A1 Jun-09, 70465A1 Jun-09, 70710A1 Aug-09,
    70711A1 Aug-09, 70995A1 Dec-09, 70996A1 Dec-09, 70996A2 Dec-09;
k) and l) All lots within expiry
RECALLING FIRM/MANUFACTURER
Actavis, Totowa, NJ, by letters on May 7, 2008. Firm initiated recall is ongoing.
REASON
a)  Subpotent; carisoprodol;
b) Subpotent; acetaminophen and dichloralphenazone;
c), d), e)  Exceeded Impurity Specification;
f), g) Superpotent, thiamine;
h) Superpotent: phentermine HCI
i), j) k) and l) cGMP Deviations; lack of stability data to support expiry
VOLUME OF PRODUCT IN COMMERCE
Carisprodol/Aspirin: 7065; Amidrine: 64950; Mirtazapine: 89201; Phentermine HCL: 139854
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Pentazocine and Naloxone Hydrochlorides Tablets, USP; 50 mg (base) 0.5 mg (base), 100 tablet bottles, Rx only, NDC 52152-211-04; NDC 0024-1951-04, Recall # D-262-2008
CODE
Lot #’s: 60305A1 Apr-08; 60306A1 Apr-08; 60308A1 Apr-08; 60397A1 May-08; 60398A1 May-08; 60522A1 Jun-08; 60523A1 Jun-08; 60640A1 Jul-08; 60641A1 Jul-08; 60704A1 Aug-08; 60704A2 Aug-08; 60705A1 Aug-08; 60854A1 Oct-08; 60855A1 Oct-08; 60856A1 Oct-08; 60856A2 Oct-08; 60966A1 Nov-08; 60967A1 Nov-08; 61074A1 Dec-08; 61075A1 Dec-08; 70053A2 Jan-10; 70053A3 Jan-10; 70054A1 Jan-10; 70188A1 Mar-10; 70189A1 Mar-10; 70273A1 Mar-10; 70274A1 Mar-10; 70275A1 Mar-10; 70286A1 Mar-10; 70286A2 Mar-10; 70327A1 Apr-10; 70328A1 Apr-10; 70619A1 Jul-10; 70620A1 Jul-10; 70621A1 Jul-10; 70622A1 Jul-10; 70777A1 Sep-10; 70778A1 Sep-10; 70908A1 Nov-10; 70909A1 Nov-10; 70909A2 Nov-10; 70910A1 Nov-10; 70911A1 Nov-10; 80015A1 Jan-11; 80016A1 Jan-11
RECALLING FIRM/MANUFACTURER
Actavis, Totowa, NJ, by letters on April 30, 2008. Firm initiated recall is ongoing.
REASON
Superpotent; Naloxone (9 month stability)
VOLUME OF PRODUCT IN COMMERCE
224,247 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) AVANDIA® (rosiglitazone maleate), 4mg, Bottles of 90 Tiltab Tablets, NDC 0029-3159-00,
    Recall # D-263-2008;
b) AVANDIA® (rosiglitazone maleate), 8mg, Bottles of 30 Tablets, NDC 0029-3160-13,
    Recall # D-264-2008;
c) AVANDAMET® (rosiglitazone maleate/metformin hydrochloride), 2 mg/1000mg bottles of 60 Tablets,
    NDC 0007-3163-18, Recall # D-265-2008;
d) AVANDARYL® (rosiglitazone maleate and glimepiride), 4mg/1 mg, bottles of 30 Tablets,
    NDC 0007-3151-13, Recall # D-266-2008;
e) AVANDARYL® (rosiglitazone maleate and glimepiride) Tablets, 8mg/4mg, bottles of 30 Tablets,
    NDC 0007-3149-13, Recall # D-267-2008
CODE
a) Lot number: 7C019;
b) Lot number: 7ZP1876;
c) Lot numbers: 417A63 and 437A63;
d) Lot number 7ZP4162;
e) Lot number: 7ZP1220
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC, by letters on/about April 16, 2008. Firm initiated recall is ongoing.
REASON
Incorrect package insert; the lots do not have the most current version of the prescribing information.
VOLUME OF PRODUCT IN COMMERCE
56,483 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Source Plasma, Recall # B-0812-08
CODE
Unit: DQ018377
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Johnson City, TN, by facsimile on November 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of multiple high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0987-08
CODE
Units: 5765417; 5750485; 5717274; 5830067; 5784918
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone and facsimile on November 3, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
LA, AR, NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1579-08
CODE
Unit: X82597
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated October 8, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-1596-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1597-08
CODE
a) and b) Units: 4403042
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by electronic mail on September 18, 2007 and letter dated September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for HIV Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, Switzerland
___________________________________
PRODUCT 
Source Plasma, Recall # B-1616-08
CODE
Units: DQ039781, DQ039474, DQ039152, DQ038712, DQ038259, DQ037938
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1635-08
CODE
Units: 72C037452 Part 1, 72C037452 Part 2
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on July 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1650-08
CODE
Unit: 113064649
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone on April 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1654-08
CODE
Unit: 318651854
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc/dba United Blood Services, Tupelo, MS, by telephone on December 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process, for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
Source Plasma, Recall # B-1665-08
CODE
Units: 05GWIF4838, 05GWIF4100, 05GWIF3141, 05GWIF2500, 05GWIE9942, 05GWIE9263, 05GWIE7624, 05GWIE7152, 05GWIE6094, 05GWIE4754, 05GWIE4087, 05GWIE3110, 05GWIE2601, 05GWIE1550, 05GWIE0828, 05GWID8567, 05GWID7818, 05GWID6736, 05GWID6086, 05GWID5042, 05GWID4615, 05GWID3577, 05GWID2592, 05GWID1848, 05GWID0880, 05GWID0279, 05GWIC9136, 05GWIC8329, 05GWIC7341, 05GWIC6593, 05GWIC5611, 05GWIC4834, 05GWIC3850, 05GWIC3245, 05GWIC2240, 05GWIC1443, 05GWIC0458, 05GWIB9718, 05GWIB8677, 05GWIB8120, 05GWIB6978, 05GWIB6077, 05GWIB5308, 05GWIB4467, 05GWIB3706, 05GWIB2768, 05GWIB1974
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on May 15, 2006.
Manufacturer: BioLife Plasma Services, LP, Green Bay, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received two tattoos within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
NC, CA and Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1666-08
CODE
Units: 06FNDC1693, 06FNDC3648, 06FNDC4527, 06FNDC5886, 06FNDC6855, 06FNDC8258, 06FNDD2008, 06FNDD2910, 06FNDD4291, 06FNDD5129, 06FNDD8741, 06FNDE0173, 06FNDE0981, 06FNDD6679, 06FNDD7400, 06FNDE2735, 06FNDE8424, 06FNDF1186, 06FNDF2378, 06FNDG1054, 06FNDG1884, 06FNDG2870, 06FNDG3767, 06FNDH0815, 06FNDH1630, 06FNDJH8927, 06FNDH9555, 06FNDI3197, 06FNDI4014, 06FNDI6284, 06FNDI7576, 06FNDI8453, 06FNDJ1930, 06FNDJ2980, 06FNDJ8490, 06FNDJ9521, 06FNDE3705, 06FNDE4385, 06FNDE9277, 06FNDF0407, 06FNDF3366, 06FNDF4424, 06FNDF5590, 06FNDF6298, 06FNDF9040, 06FNDG4962, 06FNDG5684, 06FNDG6880, 06FNDG7635, 06FNDH3558, 06FNDH6710, 06FNDH7718, 06FNDI1112, 06FNDI1980, 06FNDI5420, 06FNDI9800, 06FNDJ0657, 06FNDJ4414, 06FNDJ5170, 06FNDE5558, 06FNDE6223, 06FNDE7544, 06FNDG8756, 06FNDG9514, 06FNDJ6710, 06FNDJ7580
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by fax on January 16, 2007.
Manufacturer: BioLife Plasma Services, LP, Fargo, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
Austria and NC
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1667-08
CODE
Unit: 72E931890 (Part 1& 2)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on January 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1669-08
CODE
Units: KP107018; KZ023283
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc, Memphis, TN, by letter on May 3, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was over due for a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC, Austria
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1670-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1671-08
CODE
a) Units: 8216227, 8215533;
b) Unit: 8214937
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated December 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL, MO, WI
___________________________________
PRODUCT 
Source Plasma, Recall # B-1672-08
CODE
Units: 06MWIA3086, 06MWIA2374, 06MWIA1092, 06MWIA0480, 05MWIJ5274, 05MWIJ5862
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on November 30, 2006.
Manufacturer: BioLife Plasma Services, LP, Menasha, WI. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning receipt of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1673-08
CODE
Unit: 06SWID8145
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on October 17, 2006.
Manufacturer: BioLife Plasma Services LP, Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning a history of incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1674-08;
b) Fresh Frozen Plasma, Recall # B-1675-08;
c) Platelets Leukocytes Reduced, Recall # B-1676-08
CODE
a), b) and c) Units: 22GY20622
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on April 3, 2008 or by facsimile on April 11, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1678-08
CODE
Unit: 30GV38486
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by facsimile and telephone or by electronic notification on April 29, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-1679-08;
b) Platelets, Recall # B-1680-08;
c) Fresh Frozen Plasma, Recall # B-1681-08
CODE
a) Units: LV84230, LV84237, LV84226, LV84229, LV84224;
b) Units: LV84237, LV84229;
c) Units: LV84224, LV84237, LV84226, LV84229
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Source Plasma, Recall # B-1682-08
CODE
Units: 06LWIB6379, 06LWIB7832
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on June 28, 2006.
Manufacturer: BioLife Plasma Services, LP, Onalaska, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received the MMR vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1683-08
CODE
Units: 06LWIE4159, 06LWIE2787, 06LWIE2299, 06LWIE5482, 06LWIE4675
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on December 4, 2006.
Manufacturer: BioLife Plasma Services, LP, Onalaska, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received the MMR vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-1684-08;
b) Fresh Frozen Plasma, Recall # B-1685-08
CODE
a) Units: E36144, E24239;
b) Unit: E26025
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saint Joseph, MI, by facsimile or electronic notification on May 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI and Switzerland
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1690-08
CODE
Unit: 9074642 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on March 26, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1691-08
CODE
Unit: DQ039673
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1692-08
CODE
Unit: DQ039440
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1693-08
CODE
Unit: DQ038534, DQ038363
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by facsimile on August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-1695-08
CODE
Unit: 18GP19731
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by e-mail on October 18, 2007, by telephone and letter on October 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-1697-08
CODE
Units: 18FN17013 and 18GN56821
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by e-mail and telephone on December 3, 2007, and by letter on December 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-1700-08;
b) Platelets, Recall # B-1701-08;
c) Recovered Plasma, Recall # B-1702-08
CODE
a) and c) Units: W00040 and T29965;
b) Units: W00495, W00040 and T29965
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on February 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
FL, MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1714-08
CODE
Unit: 72C018806
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc, East Alabama Region, Opelika, AL, by fax on January 23, 2008. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to several malarial endemic areas, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1715-08
CODE
Unit: 72E926357
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc, Birmingham Region, Birmingham, AL, by fax on February 12, 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 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1722-08;
b) Platelets Leukocytes Reduced, Recall # B-1723-08
CODE
a) and b) Units: 13KF07878
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on November 19, 2007 and by letter dated November 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1736-08
CODE
Units: 159505163, 159505142
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lubbock Center, Lubbock, TX, by letter on April 27, 2006. Firm initiated recall is complete.
REASON
Blood products, manufactured from overweight whole blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Source Plasma, Recall # B-1737-08
CODE
Units: 05SWAI7921, 05SWIA8737, 05SWIB0136, 05SWIB1318, 05SWIB4111, 05SWIB7817, 05SWIB8492, 05SWIB9287, 05SWIB9805, 05SWIC1120, 05SWIC1612, 05SWIC6333, 05SWIC6958, 05SWIC7966, 05SWIC9223, 05SWIE5763, 05SWIE6239, 05SWIH1492, 05SWIH2224, 05SWIA2807, 05SWIA3586, 05SWIA4393, 05SWIA5191, 05SWIA5862, 05SWIA6552 05SWIA1485, 05SWIA3042, 05SWIA3529, 05SWIA5655, 05SWIA6403, 05SWIA9255, 05SWIB1704, 05SWIB2664, 05SWIB5049, 05SWIB5605, 05SWIB7191, 05SWIC9687, 05SWID0552, 05SWID1304, 05SWID2537, 05SWID4340, 05SWID4847, 05SWID5714, 05SWID6331, 05SWID6907, 05SWID7507, 05SWID8421, 05SWID8962, 05SWIE0402, 05SWIE2044, 05SWIE3216, 05SWIE3772, 05SWIC2480, 05SWIC3990, 05SWIC4557
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on April 4, 2007.
Manufacturer: BioLife Plasma Services LLC, Sheboygan, WI. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of multiple high risk behaviors/contacts, IV drug use and incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Austria and CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1738-08
CODE
Unit: 2349079
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on October 8, 2007. 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
TN

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-1044-08
CODE
Units: 04JCTA0227; 20269869
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by letter on January 12, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not tested for HIV-1 and HCV, Nucleic Acid Testing (NAT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets, Recall # B-1633-08
CODE
Units: W00871, W00873, W00875, W00923, W00924, W00925
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on February 25, 2008 and February 28, 2008. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1651-08
CODE
Unit: 17FR31820
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by telephone on January 6, 2005 and by letter on January 7, 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
MA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1655-08
CODE
Unit: 318651854
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc/dba United Blood Services, Tupelo, MS, by email on December 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process, for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1656-08
CODE
Unit: 150186430
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on January 20, 2006.
Manufacturer: Blood Systems, Inc., Midland, TX. Firm initiated recall is complete.
REASON
Blood product, which reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1668-08
CODE
Unit: 208468655
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Lafayette, LA, by telephone on February 28, 2007. Firm initiated recall is complete.
REASON
Blood product, possibly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1677-08
CODE
Unit: 30GV38486
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by facsimile and telephone or by electronic notification on April 29, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1686-08;
b) Platelets, Recall # B-1687-08
CODE
a) and b) Unit: 2876329
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on September 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma, Recall # B-1694-08
CODE
Units: 380010971, 380000487, 380004378, 380004018, 380014280, 380006137, 380016345, 380001686, 380009835, 380015714, 380005080, 380006549, 380007098, 380007910
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Monroe, LA, by facsimile on July 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1696-08
CODE
Unit: 18GP19731
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by e-mail on October 18, 2007, by telephone and letter on October 26, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1698-08
CODE
Units: 18FN17013 and 18GN56821
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by e-mail and telephone on December 3, 2007, and by letter on December 17, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Cryoprecipitated AHF, Recall # B-1739-08
CODE
Unit: 2909314
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on August 20, 2007 and  letter on August 21, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured from Whole Blood unit that may have had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________
PRODUCT 
a) Levitronix CentriMag Primary System, Article Number: 201-30100;
    extracorporeal blood circulation system, Recall # Z-1901-2008;
b) Levitronix CentriMag Back-Up Console Article Number: 201-30200;
    extracorporeal blood circulation system, Recall # Z-1902-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Levitronix, Llc, Waltham, MA, by letters on March 12 through March 19, 2008. On July 24, 2008 the firm issued a revised Recall Letter to advise users not to use ValleyLab Force FX-C or SSE2L Electrosurgery device with the firm’s CentriMag Blood Pumping System and include the significant risk to health. The firm revised their letter and Black Box Warning and reissued the letters to the hospital, surgeons, etc on July 24, 2008.
Manufacturer: Levitronix, GmbH, Zurich, Switzerland. Firm initiated recall is ongoing.
REASON
Stops pumping: Interruption of CentriMag System support may occur when using a ValleyLab Force FX-C Electrocautery Unit.
VOLUME OF PRODUCT IN COMMERCE
630 primary units/237 units back up
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
a) Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing,
    sterile; Part 183448, Recall # Z-1375-2008;
b) Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing,
    sterile; Part 183464, Recall # Z-1376-2008
CODE
a) Lot 743430;
b) Lot 743470
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated February 12, 2008. Firm initiated recall is complete.
REASON
Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator;
    Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator
    designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician,
    Recall # Z-1473-2008;
b) Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator;
    Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed
    to provide oxygen to patient who has been prescribed oxygen therapy by a physician,
    Recall # Z-1474-2008
CODE
All units produced since July 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc, Mundelein IL, by a letter on March 4, 2008. 
Manufacturer: EMG Technology Co., Ltd, Taya Hsiang, Taichung Hsien, Taiwan. Firm initiated recall is ongoing.
REASON
Overheating of Components: There is the potential for an electrical component in the oxygen concentrator to overheat, causing damage to the unit and making it nonfunctional.
VOLUME OF PRODUCT IN COMMERCE
6,453 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that determines amount of human thyroid stimulating hormone in human serum and plasma, Recall # Z-1566-2008
CODE
Lot 50082Q100 Exp Date 02/23/2008, Lot 52369Q100 Exp Date 04/20/2008, Lot # 53620Q100 Exp Date 06/26/2008 and Lot # 57518Q100 Exp Date 09/07/2008
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters dated February 22, 2008. Firm initiated recall is ongoing.
REASON
High Control value out of range after calibration. An increased Frequency of High Control Values Beyond the Upper Limit of the Range Specified by the Package Insert.
VOLUME OF PRODUCT IN COMMERCE
882 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catalog Number 5512-T-101, Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1572-2008;
b) Triathlon TS Femoral Trial; Size 1 Right Non-Sterile Catalog Number: 5512-T-102; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1573-2008;
c) Triathlon TS Femoral Trial; Size 2 Left Non-Sterile Catalog Number 5512-T-201; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1574-2008;
d) Triathlon TS Femoral Trial; Size 2 Right Non-Sterile Catalog Number: 5512-T-202; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1575-2008;
e) Triathlon TS Femoral Trial; Size 3 Left Non-Sterile Catalog Number: 5512-T-301; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1576-2008;
f) Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number : 5512-T-302; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1577-2008;
g) Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog Number: 5512-T-401; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1578-2008;;
h) Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1579-2008;
i) Triathlon TS Femoral Trial; Size 5 Left Non-Sterile Catalog Number: 5512-T-501; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1580-2008;
j) Triathlon TS Femoral Trial; Size 5 Right Non-Sterile Catalog Number: 5512-T-502; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1581-2008;
k) Triathlon TS Femoral Trial; Size 6 Left Non-Sterile Catalog Number: 5512-T-601; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1582-2008;
l) Triathlon TS Femoral Trial; Size 6 Right Non-Sterile Catalog Number: 5512-T-602; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1583-2008;
m) Triathlon TS Femoral Trial; Size 7 Left Non-Sterile Catalog Number: 5512-T-701; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1584-2008;
n) Triathlon TS Femoral Trial; Size 7 Right Non-Sterile Catalog Number: 5512-T-702; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1585-2008;
o) Triathlon TS Femoral Trial; Size 8 Left Non-Sterile Catalog Number: 5512-T-801; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1586-2008;
p) Triathlon TS Femoral Trial; Size 8 Right Non-Sterile Catalog Number: 5512-T-802; Orthopedic Manual
    Surgical Instrument indicated for use in revision Total Knee Arthroplasty, Recall # Z-1587-2008
CODE
a) Lot Code: WFLD;
b) Lot Code: WFLI;
c) Lot Code: WFLV;
d) Lot Codes: TYHMPD, WFCP;
e) Lot Codes: N4TMPD, PDAMPD, WEWC;
f) Lot Code: WFIC;
g) Lot Codes: N4WMPD, PDVMPD, WFCY;
h) Lot Codes:N4XMPD,WFDC;
i) Lot Code: WFCC;
j) Lot codes:N50MPD, WFKF;
k) Lot code: WFFB;
l)  Lot Code: WFIZ;
m) Lot Code: WFIP, 1TXMRD;
n) Lot Codes: V04MPD, WEVN;
o)Lot Code: WFJY;
p) Lot code: WFIT
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on March 5, 2008. Firm initiated recall is ongoing.
REASON
Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.
VOLUME OF PRODUCT IN COMMERCE
106 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Medtronic Affinity NT Hollow Fiber Oxygenator with Carmeda
    BioActive Surface, CB511, with Plasma Resistant Fiber. Single Use gas
    exchange device for Cardiopulmonary Bypass. Catalog Number: 71166,
    Recall # Z-1919-2008;
b) Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary
    Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15,
    CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12,
    CB1Z69R12, CB1Z85R16, CB2503R1, CB2K59R8, CB2K59R8,
    CB2S52R4, CB2U05R1, CB2W86R2, CB3E29R5, CB3L87R4,
    CB3U53R7, CB3X44R4, CB4741R15, CB4E05R6, CB4F32R3,
    CB4F32R3, CB4F32R3, CB4G10R5, CB4Q81R, CB4S04R2, CB4T12R2,
    CB4W67R3, CB5N65R2, HY1709R34, HY3B29R13, HY4X31R7,
    HY5C74R15, HY5H32R5, HY5L38R1, HY5L72R1, HY5R03R, and
    TL2L66R5, Recall # Z-1920-2008;
c) Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for
    Cardiopulmonary Bypass. Catalog Number: CB4014, Recall # Z-1921-2008;
d) Medtronic Affinity NT Hollow Fiber Oxygenator with Plasma Resistant
    fiber with Carmeda BioActive Surface, Catalog Number: CB511,
    CB5201R14, and CB5227R4, Recall # Z-1922-2008;
e) Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary
    bypass. Catalog Number: CB67532, Recall # Z-1923-2008;
f) Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive
    Surface, for Vascular Cardiopulmonary Bypass. Catalog Number: CB68122,
    Recall # Z-1924-2008;
g) Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass.
    Catalog Numbers: CB71424, CB77008, and CB77010,  Recall # Z-1925-2008;
h) Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall
    wire-wound PVC bodies with angled, beveled tips. Catalog Number: CB78722,
    Recall # Z-1926-2008;
i) Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass.
   Catalog Numbers: CB81120 and CB87022, Recall # Z-1927-2008;
j) Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary
    Bypass. Catalog Numbers: CB96345-023, CB96345-023, and CB96345-029,
    Recall # Z-1928-2008;
k) Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set,
    Catalog Number: CB96535-015, Recall # Z-1929-2008;
l) Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary
    Bypass. This product is only available OUS. Catalog number: M470450E,
    Recall # Z-1930-2008
CODE
a) Lot numbers: 9821992, 9826735;
b) Lot numbers: 9871463, 9904942, 9818263, 9887322, 9872639, 9568381,
    9805685, 9819156, 9816273, 9879856, 9816253, 9819175, 9882568,
    9834608, 9812228, 9819173, 9839338, 9894969, 9837298, 9823284,
    9892093, 9819157, 9819650, 9867648, 9885608, 9866753, 9841997,
    9861563, 9837302, 9904072, 9818265, 9895128, 9864540, 9838652,
    9879895, 9859513, 9882604, 9861103, 9859465;
c) Lot numbers: CB4014 / 9827678;
d) Lot numbers: 9816345, 9828465, 9879857;
e) Lot number: 9816217;
f) Lot number: 9816218;
g) Lot numbers: 9816219, 9816221, 9816222;
h) Lot number: 9807485;
i) Lot numbers: 9890943, 9816224;
j) Lot numbers: 9890956, CB96345-023 / 9890955, CB96345-029 / 9866550;
k) Lot number: 9890940;
l) Lot number: 200968580
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic International Trade Inc, Brooklyn Park, MN, by press release and letter on May 7, 2008.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V, Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Products were manufactured with heparin that were contaminated with oversulfated chondroitin sulfate (OSCS).
VOLUME OF PRODUCT IN COMMERCE
844 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5, 4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83R, 5R69R1, 5U35R, 9059R20, 9243R19, CB0A12R15, CB2T58R4, CB3L15R5, CB4D99R4, CB4E05R6, CB4J24R2, CB4J67R1, CB4K47R1, CB4K64R5, CB5B53R, CB5C01R2, CB5C82R9, CB5P29R4, CB5Q88R, CB5S97R2, DP38T, HY0W55R17, HY0Y86R17, HY1709R34, HY1C73R16, HY2F13R22, HY2F13R23, HY2J04R2, HY2K12R5, HY2K16R5, HY2K51R14, HY2K60R3, HY2Q31R1, HY2Q32R2, HY2T49R3, HY2U43R5, HY2U98R5, HY2W85R9, HY3B29R13, HY3C53R1, HY3E77R13, HY3H52R13, HY3L42R12, HY3L78R1, HY3M41R4, HY3M43R1, HY3M45R1, HY3Q11R14, HY3T77R2, HY3U59R4, HY4A96R3, HY4B44R, HY4B50R, HY4E05R8, HY4E66R5, HY4V82R2, HY4X31R7, HY4Y15R11, HY4Z59R7, HY4Z62R5, HY5C74R15, HY5D07R, HY5D70R1, HY5L38R1, HY5N41R2, HY5N42R3, HY5P52R, HY5Q00R, HY5S13R, HY5S33R2, JP1Z53R11, M310113Q, M310319A, M310523D, M310525C, M310531G, M310538A, M310543F, M310824V, M310852C, M310854A, M311028K, M311224A, M311818C, M320234E, M320410V, M320608K, M321014K, M321505L, M322318C, M330112G, M330344D, M330607H, M332108C, M332607G, M333405W, M333809B, M334007C, M334007C, M334008D, M334209A, M335615B, M336202V, M337412A, M337414A, M337415A, M337417A, M337418B, M338001P, M340305C, M340615E, M343105G, M380324D, M390206E, M390322C, M390508D, M390824C, M391817L, M391817M, M391908B, M392814A, M392815A, M395216B, M395217B, M395319B, M396010D, M397013G, M397912B, M398309C, M399510A, M399511A, M410811K, M430737A, M443307B, M443822B, M443823B, M447005R, M460524D, M460530B, M460531B, M460532B, M462007B, M470233C, M470237C, M470945S, M470945T, M490750B, M495512K, M580211B, M580416B, M580418E, M720407F, M720409F, M720714C, M720718D, M720720B, M930401B, M930402B, M960116A, M960119A, M973502E, M973901C, M999308D, P391401B, TL0A42R21, TL0W56R7, TL1E95R12, TL1J50R3, TL2C82R4, TL2H89R7, TL2J77R, TL2K45R6, TL2L66R5 TL2L67R, TL2M25R6, TL2P63R1, TL2P93R5, TL2P94R9, TL2R00R3, TL2R66R, TL2S03R4, TL2S21R1, TL2S24R3, TL2S80R24, TL2S80R30, TL2S80R30, TL2T46R7, TL2U42R13, TL2U59R, TL2W21R, TL2W22R5, TL2W90R11, TL2Z00R4, TL2Z34R, TL2Z35R, TL3A08R16, TL3B47R8, TL3C66R4, TL3C69R16, TL3E97R5, TL3E98R7, TL3E99R2, TL3F17R2, TL3F33R1, TL3G03R2, TL3G89R1, TL3H76R12, TL3H85R1, TL3H86R6, TL3K26R8, TL3L73R5, TL3M00R7, TL3M35R14, TL3M92R1, TL3N21R3, TL3N58R1, TL3P08R4, TL3P79R8, TL3R32R4, TL3R79R4, TL3R82R6, TL3R95R3, TL3S25R, TL3S39R3, TL3S63R, TL3T02R2, TL3T11R11, TL3V10R11, TL3V42R6, TL3X14R3, TL3X14R4, TL3X86R5, TL3Y45R1, TL3Y70R1, TL3Y77R, TL3Z02R4, TL3Z07R, TL3Z67R4, TL4A55R19, TL4A76R, TL4A98R1, TL4B15R2, TL4B16R5, TL4C84R, TL4D71R1, TL4E06R1, TL4E30R11, TL4F57R2, TL4F60R, TL4F71R1, TL4F88R6, TL4F97R7, TL4H65R, TL4H98R1, TL4J16R, TL4J32R10, TL4J96R7, TL4K33R3, TL4K78R, TL4K84R8, TL4K88R, TL4K93R, TL4K95R3, TL4L34R4, TL4M16R2, TL4M22R10, TL4M94R5, TL4N20R10, TL4N27R3, TL4N84R, TL4P48R2, TL4P64R4, TL4Q43R3, TL4Q43R4, TL4R10R2, TL4R21R, TL4S97R8, TL4T06R3, TL4U93R7, TL4V76R1, TL4V77R, TL4W07R4, TL4W22R, TL4W94R1, TL4X63R1, TL4X99R8, TL4Y20R2, TL4Z28R2, TL5054R11, TL5263R2, TL5398R19, TL5398R20, TL5A39R3, TL5B82R1, TL5B83R1, TL5C29R2, TL5C35R6, TL5C63R2, TL5C64R3, TL5C97R6, TL5D45R4, TL5D65R, TL5D66R3, TL5E04R, TL5E11R1, TL5F48R, TL5F62R5, TL5F64R4, TL5F96R, TL5G03R2, TL5G04R2, TL5G26R1, TL5G27R, TL5G27R1, TL5G41R2, TL5H55R1, TL5J24R6, TL5J74R2, TL5L27R1, TL5N42R2, TL5N43R3, TL5N53R1, TL5N59R, TL5N60R, TL5N62R4, TL5N79R, TL5N94R, TL5P14R, TL5P59R2, TL5P73R2, TL5P76R2, TL5Q40R1, TL5Q76R3, TL5Q85R2, TL5Q89R1, TL5R08R, TL5R15R2, TL5R18R1, TL5R52R, TL5R57R1, TL5R91R5, TL5S53R, TL5T73R, TL5U33R, TS1259R14, TS1259R15, TS1366R3, TS1366R4, TS1366R5, TS1404R1, TS1414R3, TS1420R, TS1423R3, TS1434R, TS1434R1, TS1434R2, TS1441R1, TS1442R1, TS1464R1, TS1470R, TS1476R, TS1477R3, TS1480R3, TS1480R5, TS1487R, TS1487R1, TS1487R2, TS1489R, TS1491R, TS8008R26, TS8024R18, TS8040R28, TS8040R29, TS8041R20, TS8041R21, TS8093R12, TS8148R15, TS8148R16, TS8151R9, TS8163R10, TS8163R11, TS8163R12, TS8178R8, TS8182R15, TS8183R10, TS8183R9, TS8184R15, TS8184R16, TS8212R5, TS8212R6, TS8258R2, TS8258R3, TS8267R3, TS8287R3, TS8287R4, TS8296R9, TS8309R4, TS8309R5, TS8311R1, TS8323R6, TS8328R8, TS8328R9, TS8329R6, TS8339R3, TS8340R6, TS8345R1, TS8345R2, TS8348R5, TS8348R6, TS8349R7, TS8350R4, TS8350R6, TS8357R2, TS8357R4, TS8363R3, TS8363R5, TS8376R3, TS8376R4, TS8380R4, TS8380R5, TS8380R6, TS8381R6, TS8382R5, TS8382R6, TS8387R5, TS8388R3, TS8388R4, TS8390R3, TS8390R4, TS8390R5, TS9412R4, TS9416R1, TS9416R2, TS9420R4, TS9422R35, TS9423R2, TS9423R3, TS9425R38, TS9749R27, TS9781R11, TS9781R12, TS9800R30, TS9806R11, TS9807R23, TS9818R23, TS9818R24, TS9824R16, TS9917R27, TS9950R21, TS9959R12, TS9959R13, XP41BT, and XP41T, Recall # Z-2005-2008
CODE
MODEL # / LOT #: 95215/ 9834158, 9836054, 9840678, 9841550, 9841559, 9845071, 9847467, 9850444, 9855692, 9856192, 9862423, 9864967, 9866563, 9868270, 9871572, 9874613, 9875139, 9882831, 9884748, 9889245, 9891467, 9892254, 9918684;
95216/ 9842281, 9846078, 9849122, 9851739, 9858463, 9864836, 9870318, 9870329, 9881577, 9885872, 9890513, 9892011, 9895530, 9896568, 9904481, 9905578, 9905755, 9907437, 9911601, 9912191;
95217/ 9837473 9837609, 9837669, 9838938, 9839026, 9842333, 9842382, 9842493, 9844162, 9845850, 9846383, 9847644, 9848942, 9849195, 9849848, 9850346, 9851508, 9852863, 9853060, 9854098, 9856703, 9856833, 9857062, 9858085, 9858293, 9860038, 9861271, 9861502, 9862976, 9863247, 9864837, 9865234, 9865893, 9866024, 9866164, 9868050, 9868760, 9870331, 9870409, 9870650, 9871483, 9872441, 9874427, 9875822, 9877281, 9877367, 9877440, 9877762, 9879316, 9880467, 9880641, 9881610, 9881925, 9881981, 9882840, 9883447, 9883450, 9884377, 9884881, 9886033, 9888892, 9888949, 9888952, 9889923, 9890206, 9891481, 9891930, 9892779, 9894202, 9894438, 9895542, 9895563, 9895750, 9897223, 9897279, 9897429, 9897698, 9898810, 9898944, 9898999, 9900403, 9900493, 9900526, 9900613, 9900980, 9901023, 9901088, 9901471, 9901630, 9901950, 9902927, 9903604, 9904240, 9904417, 9905391, 9905487, 9907004, 9907578, 9907584, 9908483, 9910191, 9910776, 9911401, 9911717, 9912960, 9913072, 9913268, 9920082; 95249/9844242, 9866206, 9875679, 9879355, 9884526, 9899196, 9900455, 9901014, 9901467, 9904646, 9910460, 9918448; 95250/9838923, 9839181, 9845804, 9860022, 9864835, 9868938, 9875809, 9877559, 9880811, 9880821, 9881576, 9889922, 9894165, 9901002, 9903602, 9905673, 9907549, 9907592, 9908172, 9908874, 9913036, 9919854; 95252/9845799, 9907597; 0H46R28/9801904, 9849211, 9874833, 9904051, 9904052; 0M81R41/9856457; 0R35R13/9856482, 9915510; 0Y95R22/9801921; 1702R51/9871082;1A11R16/9864529, 9898363, 9900836; 1A19R26/9871079; 1B22R5/9852609, 9852610, 9876095; 1F66R12/9852612, 9906222; 1G47R4/9859472; 1K86R3/9812743, 9845548; 1K93R5/9823298, 9898343; 1L71R20/9904065;  1M05R12/9882585; 1P07R6/9849635, 9906224, 9909834;  1X24R/9828429, 9882586; 2892R18/9823305;  2D64R12/9849668, 9849669, 9898367; 2E55R9/9842027, 9895126, 9895127; 2N90R8/9898372; 2V85R4/9898358;  
3B89R12/9859504;  3C98R7/9849639;  3C98R7/9849640;  3P11R4/9818271, 9894029;  3R39R2/9848260, 9876345, 9911074;  3R42R14/9900843, 9900844;  4B46R16/9849670;  4E58R16/9856481;  4F13R2/9856483;  4J01R7/9891239;  4Q39R1/9864519, 9906234;  4R68R5/9836720;  4R68R6/9906246;  4W65R/9842003;  4X44R7/9866759, 5633R30/9842026, 5C89R2/9845566, 5D83R/9866760, 5R69R1/9875367, 5R69R1/9895326, 5U35R/9929024, 9059R20/9842010, 9059R20/9900837, 9243R19/9845568, 9243R19/9895319, 9243R19/9909937, CB0A12R15/9818152, CB2T58R4/9869742, CB3L15R5/9853896, CB3L15R5/9904049, CB4D99R4/9915505, CB4E05R6/9828459, CB4E05R6/9874930, CB4J24R2/9906207, CB4J67R1/9895280, CB4K47R1/9909756, CB4K64R5/9856461, CB5B53R/9882599, CB5B53R/9915507, CB5C01R2/9864545, CB5C82R9/9864546, CB5C82R9/9864653, CB5P29R4/9871450, CB5P29R4/9914212, CB5Q88R/9861123, CB5S97R2/9921078, DP38T/9874904, DP38T/9904640, HY0W55R17/9808971, HY0W55R17/9910794, HY0Y86R17/9895142, HY0Y86R17/9895324, HY1709R34/9914044, HY1C73R16/9856469, HY2F13R22/9836729, HY2F13R23/9916965, HY2J04R2/9856414, HY2K12R5/9900680, HY2K16R5/9861559, HY2K16R5/9897791, HY2K51R14/9853921, HY2K51R14/9871066, HY2K51R14/9897797, HY2K60R3/9828457, HY2Q31R1/9856468, HY2Q32R2/9909790, HY2T49R3/9898330, HY2U43R5/9895125, HY2U98R5/9909926, HY2W85R9/9849675, HY2W85R9/9849676, HY2W85R9/9849677, HY3B29R13/9895322, HY3C53R1/9871041, HY3E77R13/9849120, HY3H52R13/9895169, HY3L42R12/9866761, HY3L42R12/9886081, HY3L78R1/9923377, HY3M41R4/9849658, HY3M43R1/9828413, HY3M45R1/9864484, HY3Q11R14/9895138, HY3Q11R14/9895139, HY3T77R2/9896464, HY3T77R2/9898435, HY3U59R4/9865471, HY3U59R4/9923417, HY4A96R3/9828227, HY4B44R/9874912, HY4B50R/9864521, HY4E05R8/9909957, HY4E66R5/9855421, HY4V82R2/9882601, HY4X31R7/9914047, HY4Y15R11/9897011, HY4Y15R11/9907958, HY4Z59R7/9902612, HY4Z62R5/9882303, HY5C74R15/9871083, HY5D07R/9864530, HY5D70R1/9853933, HY5D70R1/9909930, HY5L38R1/9904073, HY5L38R1/9918472, HY5N41R2/9869677, HY5N42R3/9900846, HY5P52R/9877621, HY5P52R/9902248, HY5Q00R/9857173, HY5S13R/9911027, HY5S33R2/9922456, JP1Z53R11/9860355, M310113Q/200986523, M310113Q/201017351, M310319A/201004514, M310523D/200960594, M310523D/200983800, M310523D/201014186, M310525C/200776830, M310525C/200914593, M310525C/200999719, M310531G/200951787, M310538A/200767906, M310538A/200998230, M310543F/200933365, M310543F/200968691, M310543F/200996499, M310824V/200986605, M310824V/201017488, M310852C/200946515, M310854A/200946514, M311028K/200937915, M311028K/200971865, M311028K/201025580, M311224A/200970165, M311224A/200996653, M311818C/200979740, M320234E/200951680, M320410V/201011466, M320608K/200991864, M320608K/201021498, M321014K/200995749, M321505L/200973472, M322318C/200945750, M322318C/200973463, M330112G/200983044, M330344D/200973338, M330607H/200978376, M332108C/201004516, M332108C/201029676, M332607G/200996493, M333405W/200986410, M333809B/200972405, M334007C/200926570, M334007C/200974974, M334007C/201033042, M334008D/200962670, M334008D/200978372, M334209A/200974961, M334209A/200984671, M334209A/201016613, M335615B/200995752, M336202V/200978364, M336202V/201011474, M337412A/200962585, M337412A/201017359, M337414A/200962660, M337414A/201020119, M337414A/201029347, M337415A/200950040, M337415A/200977462, M337417A/200984626, M337418B/200984630, M337418B/201016607, M338001P/200981099, M338001P/201024768, M340305C/200936579, M340615E/200972408, M343105G/200979741, M380324D/200978556, M380324D/201012978, M390206E/200948497, M390206E/200973465, M390322C/200957117, M390508D/200971872, M390824C/200933406, M390824C/201017510, M391817L/200948854, M391817M/200974967, M391908B/200945741, M391908B/200990138, M392814A/200977455, M392814A/201001630, M392814A/201034510, M392815A/200950055, M395216B/200962721, M395216B/200985176, M395217B/200933306, M395217B/200971868, M395319B/200973265, M396010D/200970167, M397013G/200950190, M397013G/201001823, M397912B/200935634, M397912B/201049318, M398309C/200984061, M398309C/201014558, M399510A/200975056, M399511A/200964869, M399511A/201017354, M410811K/200935071, M410811L/200977489, M430737A/200973327, M430737A/201054543, M443307B/201039509, M443822B/200976415, M443822B/201054699, M443823B/200976416, M443823B/201054695, M447005R/200978551, M460524D/200949744, M460530B/200949742, M460530B/200966981, M460531B/200999992, M460532B/200926957, M460532B/200966932, M460532B/200999981, M462007B/200991873, M462007B/201021499, M470233C/200974975, M470233C/201029764, M470237C/200975131, M470945S/200933318, M470945S/200971849, M470945T/201001926, M490750B/200938518, M495512K/200987075, M495512K/201004645, M580211B/200957101, M580211B/201036281, M580416B/200945726, M580416B/201024718, M580418E/200983048, M720407F/200968561, M720409F/200938479, M720409F/200974976, M720714C/200938466, M720714C/200973329, M720714C/201001639, M720718D/200968698, M720718D/200973667, M720720B/200964933, M930401B/200922137, M930402B/200922135, M960116A/200979559, M960119A/200979558, M973502E/200984001, M973502E/201013844, M973901C/200813720, M999308D/200948517, M999308D/200974969, P391401B/200953133, P391401B/201054693, TL0A42R21/9882593, TL0W56R7/9868069, TL1E95R12/9909898, TL1J50R3/9658714, TL2C82R4/9923403, TL2H89R7/9898365, TL2J77R/9841963, TL2K45R6/9845562, TL2K45R6/9900831, TL2L66R5/9895285, TL2L66R5/9909791, TL2L67R/9898332, TL2M25R6/9854038, TL2P63R1/9856415, TL2P93R5/9904074, TL2P94R9/9906240, TL2R00R3/9856416, TL2R00R3/9909792, TL2R66R/9874913, TL2S03R4/9906233, TL2S03R4/9909890, TL2S21R1/9836684, TL2S24R3/9874935, TL2S80R24/9853927, TL2S80R30/9868071, TL2S80R30/9885490, TL2S80R30/9897798, TL2T46R7/9915448, TL2U42R13/9849687, TL2U42R13/9898371, TL2U59R/9895286, TL2W21R/9849620, TL2W22R5/9923378, TL2W90R11/9879897, TL2Z00R4/9895111, TL2Z34R/9909795, TL2Z35R/9915484, TL3A08R16/9891237, TL3B47R8/9841965, TL3C66R4/9864486, TL3C66R4/9864487, TL3C69R16/9828450, TL3E97R5/9845541, TL3E98R7/9921079, TL3E99R2/9885607, TL3F17R2/9898451, TL3F33R1/9919253, TL3G03R2/9871067, TL3G89R1/9593332, TL3G89R1/9898334, TL3H76R12/9846723, TL3H85R1/9891217, TL3H86R6/9911088, TL3K26R8/9809022, TL3L73R5/9895287, TL3L73R5/9923379, TL3M00R7/9879882, TL3M35R14/9863156, TL3M35R14/9868110, TL3M92R1/9911060, TL3N21R3/9864488, TL3N58R1/9926687, TL3P08R4/9849753, TL3P08R4/9923415, TL3P79R8/9875092, TL3P79R8/9910788, TL3R32R4/9808976, TL3R32R4/9871042, TL3R79R4/9887326, TL3R82R6/9856417, TL3R82R6/9856418, TL3R95R3/9915500, TL3S25R/9887067, TL3S39R3/9925910, TL3S63R/9898336, TL3T02R2/9812851, TL3T11R11/9900024, TL3T11R11/9900024, TL3V10R11/9874853, TL3V42R6/9904031, TL3V42R6/9914075, TL3V42R6/9919254, TL3X14R3/9856420, TL3X14R4/9909961, TL3X86R5/9906215, TL3Y45R1/9881136, TL3Y45R1/9891218, TL3Y70R1/9924750, TL3Y77R/9864490, TL3Y77R/9898337, TL3Y77R/9900811, TL3Z02R4/9887333, TL3Z07R/9852606, TL3Z07R/9895270, TL3Z67R4/9845542, TL4A55R19/9874941, TL4A76R/9866737, TL4A98R1/9856421, TL4A98R1/9856422, TL4A98R1/9909804, TL4B15R2/9818238, TL4B16R5/9859493, TL4C84R/9859466, TL4D71R1/9895289, TL4E06R1/9904071, TL4E30R11/9879885, TL4F57R2/9919260, TL4F60R/9834322, TL4F71R1/9859497, TL4F71R1/9891235, TL4F88R6/9871078, TL4F97R7/9864517, TL4H65R/9885464, TL4H65R/9909805, TL4H98R1/9909892, TL4J16R/9909806, TL4J32R10/9845571, TL4J32R10/9906244, TL4J32R10/9909956, TL4J96R7/9895309, TL4J96R7/9906235, TL4J96R7/9909902, TL4K33R3/9864974, TL4K33R3/9883915, TL4K33R3/9895124, TL4K33R3/9929052, TL4K78R/9914187, TL4K84R8/9911087, TL4K88R/9856456, TL4K93R/9895307, TL4K93R/9909889, TL4K95R3/9874933, TL4L34R4/9930801, TL4M16R2/9841994, TL4M16R2/9841995, TL4M16R2/9911076, TL4M22R10/9859501, TL4M94R5/9854039, TL4N20R10/9896593, TL4N27R3/9871071, TL4N84R/9849655, TL4N84R/9909908, TL4P48R2/9895320, TL4P64R4/9849671, TL4P64R4/9907954, TL4Q43R3/9852368, TL4Q43R4/9898373, TL4R10R2/9845570, TL4R10R2/9879894, TL4R21R/9914198, TL4R21R/9931609, TL4S97R8/9859509, TL4T06R3/9871074, TL4U93R7/9911026, TL4V76R1/9923408, TL4V77R/9903794, TL4W07R4/9913292, TL4W22R/9871068, TL4W22R/9895313, TL4W94R1/9900834, TL4X63R1/9882598, TL4X99R8/9852634, TL4Y20R2/9895131, TL4Z28R2/9885485, TL4Z28R2/9887337, TL4Z28R2/9909940, TL5054R11/9856424, TL5263R2/9909906, TL5398R19/9843924, TL5398R20/9895328, TL5A39R3/9864541, TL5B82R1/9849665, TL5B82R1/9859499, TL5B82R1/9879887, TL5B83R1/9859500, TL5B83R1/9879888, TL5C29R2/9866092, TL5C29R2/9916514, TL5C35R6/9900842, TL5C63R2/9841958, TL5C63R2/9859389, TL5C63R2/9862430, TL5C63R2/9915511, TL5C64R3/9904062, TL5C97R6/9895137, TL5D45R4/9871075, TL5D65R/9890576, TL5D66R3/9834377, TL5D66R3/9859510, TL5D66R3/9859511, TL5D66R3/9927936, TL5E04R/9911079, TL5E04R/9929680, TL5E11R1/9921081, TL5F48R/9836721, TL5F48R/9900839, TL5F62R5/9896938, TL5F64R4/9896939, TL5F96R/9896940, TL5G03R2/9896941, TL5G04R2/9896942, TL5G26R1/9931614, TL5G27R/9893749, TL5G27R1/9910921, TL5G41R2/9879902, TL5H55R1/9858542, TL5H55R1/9885489, TL5J24R6/9868594, TL5J24R6/9870786, TL5J74R2/9891246, TL5J74R2/9904064, TL5L27R1/9828462, TL5N42R2/9869678, TL5N43R3/9865432, TL5N43R3/9914137, TL5N53R1/9921857, TL5N59R/9869738, TL5N60R/9869785, TL5N60R/9926703, TL5N62R4/9864809, TL5N62R4/9887341, TL5N62R4/9894785, TL5N79R/9911085, TL5N94R/9874148, TL5P14R/9883936, TL5P59R2/9896929; TL5P73R2/9925064; TL5P76R2/9932315, TL5Q40R1/9879468; TL5Q76R3/9930859, 9932577; TL5Q85R2/9913293, TL5Q89R1/9892383, 9926708; TL5R08R/9875101; TL5R15R2/9878911; TL5R18R1/9923206; TL5R52R/9894022; TL5R57R1/9918893; TL5R91R5/9918898, 9931616; TL5S53R/9892387, 9910061, 9918921; TL5U33R/9932314; TS1259R14/0000678918, 0000680574, 0000698748; TS1259R15/0000717577; TS1366R3/0000666582, 0000666584; TS1366R4/0000674278, 0000674279, 0000676748, 0000690365, 0000690367, 000711275, 0000711278, 0000711281, 0000714758, 0000714759; TS1366R5/0000679864, 0000679865, 0000679877, 0000679878, 0000680617, 0000683344, 0000683365, 0000685091, 0000685092, 0000687732, 0000687733, 0000693076, 0000693081, 0000694811, 0000697858, 0000697859, 0000699550, 0000699552, 0000703198, 0000704023, 0000705433, 0000705434, 0000709159, 0000709160, 0000717459, 0000717579, 0000721710, 0000721714, 0000724038, 0000724040, 0000727453; TS1404R1/0000702270, 0000706954, 0000713786, 0000714751, 0000717143, 0000717431, 0000720102, 0000721485; TS1405R1/0000725135, 0000727254; TS1406R1/0000708248; TS1414R3/0000694899; TS1420R/0000671368, 0000676756, 0000679997, 0000680698, 0000686918, 0000689296, 0000689303, 0000690357, 0000700945, 0000704416, 0000704575, 0000707196, 0000708343, 0000712408, 0000716405, 0000720477, 0000724108, 0000727448; TS1423R3/0000672120, 0000674975, 0000676009, 0000683458, 0000692018, 0000697723, 0000697734, 0000700801, 0000704367, 0000707214, 0000720398, 0000727391; TS1434R/0000687709, 0000692805, 0000699993, 0000712504, 0000725183; TS1434R1/0000717260, 0000717582, 0000718578, 0000721812; TS1434R2/0000678999, 0000681548, 0000687716, 0000712336, 0000714756, 0000723102, 0000723732, 0000725187, 0000727458, TS1436R2/0000677992; TS1436R2/0000698843, 0000720585; TS1441R1/0000679020, 0000693083, 0000701007, 0000714931, 0000725137; TS1442R1/0000703329, 0000704007; TS1464R1/0000674905, 0000700813; TS1470R/0000664062, 0000676148, 0000676810, 0000678000, 0000689134, /0000692914, 0000692981, 0000694076, 0000710419, 0000691107; TS1476R/0000705312, 0000711280, 0000721321; TS1477R3/0000664920;  TS1480R3/0000682643; TS1480R5/0000682651, 0000685096, 0000689355, 0000698716, 0000704319, 0000710146, 0000716164; TS1487R/0000663088, 0000666583, 0000666630, 0000678776, 0000678783, 0000678801; TS1487R1/0000687729, 0000687731, 0000690238, 0000691281, 0000692990, 0000697608, 0000717379; TS1487R2/0000699592, 0000706950, 0000708267, 0000712299, 0000713681, 0000721526; TS1489R/0000718453; TS1491R/0000685752, 0000685754; TS8008R26/0000675071, 0000708169, 0000714871; TS8024R18/0000705493; TS8040R28/0000666588, 0000674368, 0000676750; TS8040R29/0000672038, 0000679875, 0000683433, 0000685093, 0000690113, 0000690366, 0000693079, 0000694813, 0000697860, 0000699551, 0000703230, 0000705431, 0000709006, 0000711274, 0000714757, 0000717461, 0000721712, 0000724041; TS8041R20/0000678901, 0000680561; TS8041R21/0000689220; TS8093R12/0000713994; TS8148R15/0000687704; TS8148R16/0000689307, 0000695319, 0000711323, 0000712300, 0000713895, 0000718475, 0000722562; TS8151R9/0000673946, 0000677841, 0000685846, 0000690190, 0000692240, 0000696181, 0000705370, 0000711440, /0000718570, 0000722592; TS8163R10/0000665624, 0000666650; TS8163R11/0000672251, 0000672834, 0000676653, 0000679964, 0000682493, 0000685839; TS8163R12/0000689004, 0000689978, 0000690490, 0000692238, 0000696205, 0000697740, 0000702224, 0000707102, 0000708272, 0000709201, 0000711251, 0000717014, 0000717015, 0000722920, 0000724873; TS8178R8/0000676646, 0000684077, /0000686010, 0000689240; TS8182R15/0000685793, 0000686030, 0000704422; TS8183R10/0000676650, 0000681387, 0000686020, 0000693138, 0000697660, 0000703123, 0000707104, 0000709012, 0000712314, 0000718376, 0000722940, 0000725096, 0000726183; TS8183R9/0000672138, 0000673930; TS8184R15/0000672061, TS8184R15/0000673924; TS8184R16/0000684081, 0000684083, 0000685763, 0000687711, 0000690156, 0000692966, 0000696108, 0000700721, 0000707030, 0000708997, 0000712312, 0000718372, 0000724871; TS8212R5/0000667107, 0000672190, 0000673921, 0000675074, 0000677755, 0000679826, 0000680582, 0000683308, 0000684936; TS8212R6/0000687727, 0000689379, 0000691242, 0000692012, 0000693784, 0000699591, 0000700636, 0000704357, 0000705311, 0000707975, 0000711462, 0000714659, 0000717141, 0000720220, 0000722455, 0000726154, 0000727385; TS8258R2/0000686006; TS8258R3/0000675072, 0000696184, 0000702234; TS8267R3/0000690451; TS8267R4/0000711409; TS8287R3/0000665661, 0000673927; TS8287R4/0000686951, 0000692017, 0000703002, 0000713560, 0000720183; TS8296R9/0000689212, 0000694040, 0000700867, 0000712412, 0000713824; TS8309R4/0000667327, TS8309R5/0000676110, 0000684159, 0000691354, 0000699633, 0000709010, 0000715985, 0000721464; TS8311R1/0000685019, 0000721524, 0000722574; TS8323R6/0000686933, 0000708172; TS8328R8/0000675082, 0000676691, 0000677937, 0000681483, 0000681485, 0000684167, 0000685857, 0000686930, 0000704402, 0000708271; TS8328R9/0000716362, 0000718476;  TS8329R6/0000675972, 0000678643, 0000682496, 0000690153, 0000694609, 0000698829, 0000713937, 0000720242, 0000727366; TS8339R3/0000685016, 0000709246, 0000714930, 0000720450;  TS8340R6/0000678804, 0000691166, 0000718471, 0000726245,  TS8345R1/0000665622; TS8345R2/0000682432, 0000697658, 0000713763; TS8348R5/0000672917; TS8348R6/0000679862, 0000692188, 0000693951, 0000700637, 0000702900, 0000708230, 0000711369, 0000714782, 0000720328, 0000726226, 0000727365;  TS8349R7/0000685097, 0000713789; TS8350R4/0000666627, 0000674282; TS8350R6/0000678857, 0000685025, 0000707078, 0000711382, 0000718473, 0000725003; TS8357R2/0000674242; TS8357R4/0000677770, 0000679825, 0000693921, 0000714008, 0000723733, 0000724050; TS8363R3/0000685840, 0000716000; TS8363R5/0000689009, 0000694043, 0000722560, 0000723918; TS8365R5/0000681505, 0000689964, 0000712247, 0000713977; TS8376R3/0000685786, 0000685788, 0000690097; TS8376R4/0000695350, 0000695356, 0000698742, 0000708404, 0000708405, 0000716494, 0000716498, 0000721487, 0000724870; TS8380R4/0000672239, 0000675975, 0000680565, 0000684934, 0000685790; TS8380R5/0000687712, 0000688054, 0000688084, 0000693074, 0000694815, 0000696107, 0000700717, 0000703228; TS8380R6/0000704550, 0000708944, 0000712517, 0000718406, 0000721782, 0000683469, 0000683470, 0000687082, 0000691322, 0000692011, 0000701974, 0000720415, 0000723734, 000725138; TS8382R5/0000674951, 0000685844;  TS8382R6/0000691102, 0000699992, 0000704356, 0000710029, 0000716017; TS8387R5/0000672198, 0000678739, 0000682603, 0000687077, 0000687868, 0000693054, 0000694123, 0000708408, 0000714897, 0000720194, 0000727368; TS8388R3/0000662094, 0000662908, 0000663937, 0000664737, 0000665616, 0000666464, 0000667103, 0000670937, 0000672282, 0000672916, 0000675107, 0000675976, 0000677752, 0000677759, 0000683314; TS8388R4/0000679863, 0000680660, 0000680793, 0000681468, 0000682586, 0000685070, 0000685755, 0000685761, 0000687710, 0000688985, 0000689006, 0000690154, 0000691109, 0000692110, 0000692964, 0000694600, 0000694812, 0000696192, 0000698353, 0000699548, 0000700720, 0000701976, 0000703005, 0000704024, 0000705314, 0000707032, 0000708114, 0000709031, 0000710369, 0000711245, 0000712246, 0000713766, 0000714784, 0000716292, 0000718393, 0000720218, 0000721463, 0000724872, 0000727255; TS8390R3/0000667287, 0000671481; TS8390R4/0000693263;  TS8390R5/0000702343, 0000725136; TS8397R5/0000725229; TS9412R4/0000680661, 0000686889, 0000700908, 0000700973, 0000704567, 0000715042, 0000721788; TS9416R1/0000666539; TS9416R2/0000676111, 0000689000, 0000696021, 0000709244, 0000711304, 0000721652, 0000723021; TS9420R4/0000724092; TS9422R35/0000673932, 0000677981, 0000683408, 0000688056, 0000690443, 0000698349, 0000699661, 0000702214, 0000709158, 0000713968, 0000726432, 0000727315; TS9423R2/0000666496, 0000686906; TS9423R3/0000674357, 0000682606, 0000693024, 0000696183, 0000703124, 0000724042; TS9425R38/0000675106, 0000687713, 0000687714, 0000696016, 0000705319, 0000707057, 0000716291, 0000726244; TS9749R27/0000680595, 0000683301, 0000690189, 0000695318, 0000699634, 0000712301, 0000713764, 0000716440, 0000720350, 0000724869, 0000726185; TS9781R11/0000665814; TS9781R12/0000676648, 0000681386, 0000691170, 0000700771, 0000711279, 0000725107; TS9800R30/0000674358, 0000674384, 0000675218, 0000681373, 0000685110, 0000690494, 0000701004, 0000711333, 0000721759; TS9806R11/0000665848, 0000667330, 0000673003; TS9807R23/0000683377, 0000685753, 0000692010, 0000700929, 0000712471, 0000725186; TS9818R23/000066738;  TS9818R24/0000680577, 0000684938, 0000692020, 0000712468, 0000725015; TS9824R16/0000712413, 0000723728, 0000725097; TS9917R27/0000662927; TS9950R21/0000675998, 0000685758, 0000698361, 0000717504; TS9959R12/0000662196, 0000673917, 0000683368, 0000689970; TS9959R13/0000693279, 0000697811, 0000707165, 0000710353, 0000723942; XP41BT/9904032; XP41T/9866739, 9874914
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic International Trade Inc, Brooklyn Park, MN, by letter on May 5, 2008.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V, Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulmonary bypass procedures. Medtronic's heparin supplier recently reported that it had provided some batches of heparin to Medtronic which were contaminated with OSCS. Medtronic has no evidence linking the use of Trillium-coated CPB products to OSCS related adverse events. Customers were informed of this because OSCS is not intended to be a component material of Trillium Coating and because OSCS has been reported to cause patient adverse events when injectable formulations of contaminated heparin are given in sufficient doses.
VOLUME OF PRODUCT IN COMMERCE
59,500 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - FC 500 with UPS, Automated differential cell counter; Part
    Number: 626553; Recall # Z-2016-2008;
b) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - FC 500 120V, Automated differential cell counter; Part Number
    6605628; Recall # Z-2017-2008;
c) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1 single user, Automated differential cell
    counter; Part Number 722396; Recall # Z-2018-2008;
d) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1 single user upgrade, Automated differential
    cell counter; Part Number 722395; Recall # Z-2019-2008;
e) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1, 3 User Pack, Automated differential cell
    counter; Part Number 722397; Recall # Z-2020-2008;
f) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1, 5 User Pack, Automated differential cell
    counter; Part Number 722398; Recall # Z-2021-2008;
g) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1, 15 User Pack, Automated differential cell
    counter; Part Number 722399; Recall # Z-2022-2008;
h) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1, 5 network user with Romlock, Automated
    differential cell counter; Part Number 722593; Recall # Z-2023-2008;
i) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated
    differential cell counter; Part Number 722594; Recall # Z-2024-2008;
j) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and
    2.2 - CXP analysis SW V2.1, 15 network user with Romlock, Automated
    differential cell counter; Part Number 722595; Recall # Z-2025-2008;
k) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2 Single User, Automated differential
    cell counter; Part Number 774197; Recall # Z-2026-2008;
l) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2 Single User Upgrade, Automated
    differential cell counter; Part Number 774198; Recall # Z-2027-2008;
m) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential
    cell counter; Part Number 774199; Recall # Z-2028-2008;
n) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential
    cell counter; Part Number 774200; Recall # Z-2029-2008;
o) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2, 15 User, Automated differential
    cell counter; Part Number 774201; Recall # Z-2030-2008;
p) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User Network, Automated
    differential cell counter; Part Number 774178; Recall # Z-2031-2008;
q) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
    and 2.2 - SW Kit, CXP Analyis SW V2.2, 10 User Network, Automated
    differential cell counter; Part Number 774179; Recall # Z-2032-2008;
r) Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1
     and 2.2 - SW Kit, CXP Analyis SW V2.2, 15 User Network, Automated
    differential cell counter; Part Number 774180; Recall # Z-2033-2008
CODE
Version 2.1 and 2.2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on  May 3 2007.
Manufacturer: Applied Cytometry, Sheffield, United Kingdom. Firm initiated recall is complete.
REASON
Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
VOLUME OF PRODUCT IN COMMERCE
501 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT 
EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information, Recall # Z-1571-2008
CODE
Serial Numbers: 11743701 to 11743705 11837701 to 11837705 11906701 to 11906705 12006701 to 12006710 12124701 to 12124710 12315701 to 12315705 12427801 to 12427805
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on February 25, 2008.
Manufacturer: Hitachi Medical Corporation, Chiyoda-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
Miscalculation reading. A software error in the firm's EUB-5500/HI VISION diagnostic scanning system causes a miscalculation of the left ICA/CCA ratio when using the Carotid Calculation package for patient scans.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JULY 30, 2008

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