• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for September 17, 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.

September 17, 2008
08-37

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
a)  Pfaltzgraff Villa della Luna pattern Soup/Cereal Bowls sold as part of a set or
    individually. Soup/Cereal Bowl dimensions: 24 oz., 2.75 inches high and 6.625
    inches in diameter, Recall # F-547-8;
b) Pfaltzgraff Villa della Luna pattern Dinner Plates sold as part of a set or individually.
    Dinner Plate dimensions: 11 ½ inches in diameter and 1.3125 inches high., Recall #
    F-548-8;
c) Nautica J Class pattern Red Dinner Plates sold as part of a set or individually.
    J Class Red Dinner Plate: 11 ¼ inches in diameter, 1 inch in height (bottom to top),
    Recall # F-549-8;
d) Nautica J Class pattern Red Salad Plates sold as part of a set or individually. J Class
    Red Salad Plate: 9 inches in diameter, 7/8 inches in height (bottom to top), Recall #
    F-550-8
CODE
N/A
RECALLING FIRM/MANUFACTURER
Lifetime Brands, Inc., Garden City, NY, by press release, e-mail and letters on April 28, 2008. Firm initiated recall is ongoing.
REASON
Private laboratory testing revealed that the products contained elevated levels of leachable lead and/or cadmium.
VOLUME OF PRODUCT IN COMMERCE
102,470 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Cocoa Peanut Butter Spheres sweetened crunchy corn cereal, packaged in 13-oz.
    boxes, 12/case, under the following brand names: (1) Best Choice Peanut Butter
    Cocoa Spheres; (2) Food Club Peanut Butter Coco Loco; (3) Hannaford PB&C;
    (4) HyVee Cocoa Peanut Butter Spheres Cereal; (5) Kroger Cocoa & Peanut Butter
    Fusion; (6) Laura Lynn PB&C Peanut Butter & Cocoa; (7) Market Basket PB&C
    Peanut Butter & Cocoa; (8) Meijer Peanut Butter Cup; (9) Millville Cocoa Peanut
    Butter Spheres; (10) Ralston Foods PB&C Peanut Butter & Cocoa; (11) Spartan
    Puffed Peanut Butter & Cocoa; (12) Roundys Cocoa Peanut Butter Crunch;
    (13) Chocolate Peanut Butter Puffs; (14) Shop 'n Save Cocoa Peanut Butter Spheres;
    (15) Shur Fine Cocoa Peanut Butter Spheres; (16) Sunny Select Cocoa Peanut Butter
    Spheres; (17) Winn Dixie peanut butter cocoa spheres, Recall # F-551-8;
b) Peanut Butter Crisp Crunch sweetened corn and oat cereal, packaged in 15-oz.
    boxes, 14/case, under the following brand names: (1) Hill Country Fare Peanut
    Butter Crisp Crunch; (2) Jewel Peanut Butter Crisp Crunch; (3) Laura Lynn Peanut
    Butter Crisp; (4) Market Basket Peanut Butter Crisp Crunch; (5) Peanut Butter
    Crunch, Recall # F-552-8;
c) Crisp Crunch Berry Treets sweetened corn and oat cereal, packaged in 15-oz. boxes
    (14/case) and 32-oz. bags (8/case), under the following brand names: (1) Albertsons
    Crisp Crunch Berry, 15-oz; (2) Best Choice Berry Bits Crisp Crunch, 15-oz.;
    (3) Chef's Review Berry Treets, 32-oz.; (4) Disney Magic Selections Incredible
    Berry Crunch, 15-oz.; (5) Fred Meyer Crisp Berry Crunch, 32-oz.; (6) Fry's Crisp
    Berry Crunch, 32-oz.; (7) Jewel Crisp Crunch Berry, 15-oz.; (8) Kroger Crisp Berry
    Crunch, 15-oz. & 32-oz; (9) Laura Lynn Crisp Crunch Berry Treets, 15-oz. and
    32-oz.; (10) Market Basket Berry Crisp Crunch, 15-oz; (11) Millville Kid's Krunch,
    15-oz.; (12) Pathmark Berry Crisp Crunch, 15-oz.; (13) Ralphs Crisp Berry Crunch,
    32-oz.; (14) Ralston Foods Crisp Crunch Berry Treets, 15-oz.; (15) Ralston Foods
    Berry Treets, 32-oz.; (16) Roundys Crisp Crunch Berry Treets, 32-oz.;
    (17) Fruit Berry Crunch, 15-oz; (18) Schnucks Crisp Crunch Berry Treets, 32-oz;
    (19) Shaw's Crisp Crunch Berry, 15-oz.; (20) Shur Fine Berry Crisp Crunch, 15-oz.;
    (12) Sunny Select Berry Treets, 15-oz.; (13) Wegmans Berry Corn Crunch, 15-oz.;
    (14) Western Family Berried Treasure, 15-oz.; (15) Winn Dixie Fruity Crunchies,
    15-oz., Recall # F-553-8;
d) Kookies multigrain cereal packaged in 12.25-oz. boxes (10-ct. cases except for
     Millville and Save-A-Lot, which are 12-ct. cases), under the following brand names:
    (1) Albertsons Mini Cookies; (2) Best Choice Koo-Kies; (3) Flavorite Koo-Kies;
    (4) Hannaford Koo-Kies!; (5) Jewel Mini Cookies; (6) Laura Lynn Koo-Kies;
    (7) Market Basket Cookie Factory; (8) Millville Kookies; (9) Price Rite Mini Cookie
    Bites; (10) Chocolate Chip Crunch; (11) Shaw's Mini Cookies; (12) Shop 'n Save
    Koo-Kies; (13) Shop Rite Scrunchy Mini Cookie Bites; (14) Winn Dixie Chippers,
    Recall # F-554-8
CODE
a) OCT2908L, OCT3008L, OCT3108L, NOV0108L, NOV0208L, NOV0308L,
    NOV2008L, NOV2108L, NOV2608L, NOV2708L, NOV2808L, NOV2908L,
    NOV3008L, DEC0108L;
b) NOV1908L;
c) NOV1208L, NOV 1308L, NOV1408L, NOV1508L, NOV1608L, NOV1708L,
    NOV1808L, NOV1908L;
d) NOV0808L, NOV0908L, NOV1008L, NOV1108L, NOV1208L
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ralston Foods, Division Ralcorp Holdings, Inc., Saint Louis, MO, by e-mail on December 14, 2007 and March 19, 2008.
Manufacturer: Ralston Foods, Inc., Lancaster, OH. Firm initiated recall is complete.
REASON
Illnesses are associated with consumption of cereals that have an off-taste.
VOLUME OF PRODUCT IN COMMERCE
114,792 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT

  1. Tri Vitamins with Fluoride Chewable Tablets, Vitamin A 2500 IU, Vitamin C 60 mg, Vitamin D 400 IU, Fluoride 1.0 mg, 100 tablets, Rx only, Actavis/Amide NDC 52152-002-02; Qualitest NDC: 0603-6300-21; Major NDC: 0904-7810-60, Recall # D-306-2008;
  2. Phenazopyridine Hydrochloride Tablets, USP 100 mg; Packaged in 100 and 1000 count bottles, Also manufactured as Pyridium (Phenazopyridine HCL Tablets, USP;
         Actavis/Amide NDC; 52152-003-02 (100 count); NDC 52152-003-05 (1000 count).
         Warner Chilcott NDC: 0430-0180-24, Recall # D-307-2008;
  3. Phenazopyridine Hydrochloride Tablets, USP 200 mg;. Packaged in 100 and 1000 count bottles Also manufactured as Pyridium (Phenazopyridine HCL Tablets, USP),   
          Activis/Amide NDC: 52152-004-02 (100 count), 52152-004-05 (1000 count: Warner
          Chilcott NDC: 0410-0181-24 (100 count only) Recall # D-308-2008;
     4) Dexchlorpheniramine Maleate Time Release Tablets, 4 mg, Rx only, 100 Tablets,
          NDC: 52152-014-02, Recall # D-309-2008;
     5) Dexchlorpheniramine Maleate Time Release Tablets, 6 mg, Rx only, 100 Tablets,  
          NDC 52152-015-02, Recall # D-310-2008;
     6) Amigesic (Salsalate) Tablets, 500 mg, Rx only, NDC 52152-019-02 -100 count; and
          NDC 52152-019-04 - 500 count bottles, Recall # D-311-2008;
     7)  Amigesic (Salsalate) Caplets, 750 mg, Rx only, NDC 52152-020-02 - 100 count
          bottles;  and NDC 52152-020-04 - 500 count bottles, Recall # D-312-2008;
    8) Yohimbine HCL Tablets, 5.4 mg, Rx only, NDC 52152-032-02 - 100 count
           bottles; NDC 52152-032-05 - 1000 count bottles, Recall # D-313-2008;
     9) Multi Vita-Bets with 0.5 mg F and Fe Chewable Tablets, Multivitamin, Mineral &
         Fluoride Supplementation, Rx only, 100 Tablet bottles, Recall # D-314-2008;
    10) Multi Vita-Bets with 1.0 mg F and Fe Chewable Tablets, Multivitamin, Mineral &
         Fluoride Supplementation, Rx only, 100 Tablet bottles; NDC 52152-038-02,
         Recall # D-315-2008;
    11) Vitaplex Tablets Film-coated tablets, 100 and 500 count bottles, Rx only,
         Amide/Actavis, NDC 52152-076-02 - 100 count bottles; Amide/Actavis NDC 52152-
         076-04 - 500 count bottles. Also packaged for: Major, as formula B Tablets, 100 count
         bottles, NDC 0904-2630-60; IVAX, as B-Plex Tablets, 100 count bottles, NDC 0182-
         4062-01; Everett, as Strovite, 100 count bottles, NDC 0642-0200-10, Recall # D-316-
         2008;
    12) Vitaplex Plus Tablets, Film coated tablets, Rx only, 100 and 500 count bottles,
         Actavis/Amide NDC 52152-077-02 - 100 count bottles; URL as B-Complex Plus
         Tablets, NDC 0677-1704-01 - 100 count bottles; Actavis/Amide NDC 52152-077-04
         - 500 count bottles, Recall # D-317-2008;
    13) Vitacon Forte Capsules, Therapeutic Vitamins-Minerals, 100 and 500 count bottles,
          Rx only, NDC 52152-078-02 - 100 count bottles; NDC 52152-078-04 - 500 count
         bottles, Recall # D-318-2008;
    14) Choline Magnesium Trisalicylate Tablets, (Salicylate content), 500 mg, 100 count
         bottles, Rx only, (Present as 293 mg of choline salicylate combined with 362 mg of
         magnesium salicylate to provide 500 mg. salicylate content), Amide NDC 52152-084-
         02; Ivax NDC 0182-1899-01 and Qualitest as Tricosal Tablets, NDC 0603-6215-21;
         All 100 count bottles, Recall # D-319-2008;
    15) Choline Magnesium Trisalicylate Tablets, (Salicylate content) 750 mg, 100 count
          bottles, 750 mg, Rx only, (Present as 440 mg of choline salicylate combined with
          544 mg of magnesium salicylate to provide 750 mg. salicylate content),
          Actavis/Amide NDC 52152-085-02; IVax NDC 0182-1895-01 and Qualitest as
         Tricosal Tablets NDC 0603-6216-21, Recall # D-320-2008;
    16) Choline Magnesium Trisalicylate Tablets, (Salicylate content) 1000 mg,
          100 count bottle, Rx only, (Present as 587 mg of choline salicylate combined
          with 725 mg of magnesium salicylate to provide 1000 mg salicylate content);
          Amide NDC 52152-086-02, Qualitest NDC 0603-6217-21; 100 count bottles,
          Recall # D-321-2008;
    17) Methenamine Mandelate Tablets. USP 0.5 g, film coated, Rx only, Actavis/Amide
          NDC 52152-111-02 - 100 count bottles: Actavis/Amide NDC 52152-111-05 –
          1000 count bottles; URL NDC 067701681-01 - 100 count bottles; Warner Chilcott
          NDC 0430-0166-24 - 100 count bottles, Recall # D-322-2008;
    18) Methenamine Mandelate Tablets. USP, 1 gram, 100 and 1000 count bottles, film
          coated, Rx only, Actaive/Amide NDC 52152-112-02 - 100 count bottles;
          Actavis/Amide NDC 52152-112-05 - 1000 count bottles; URL NDC 067701682-01 –
          100 count bottles; Warner Chilcott as Mandelamine (Methenamine Mandelate
          Tablets, USP), NDC 0430-0167-24 - 100 count bottles, Recall # D-323-2008;
    19) Bellamine-S Tablets, (Phenobarbital, USP 40mg, Ergotamine Tartrate, USP 0.6mg
          and Levorotatory alkaloids of belladona 0.2mg), 100 tablets, Rx only, Amide
          NDC 52152-115-02; Major NDC 0904-2548-60, Recall # D-324-2008;
    20) Meclizine HCL Chewable Tablets, 25 mg, Antiemetic, Prevents motion sickness,
          100 and 100 tablets bottles, Amide NDC 05152-117-02 - 100 count bottles;
          Amide NDC 52152-117-05 - 1000 count bottles; Goldline NDC 0182-0571-01 –
          100 count bottles;, Recall # D-325-2008;
    21) Sodium Fluoride Tablets, 0.5 mg F, Rx only, Half Strength from 1.1 mg Sodium
          Fluoride, 1000 count bottles, Actavis NDC 52152-128-05, Recall # D-326-2008;
    22) Sodium Fluoride Tablets, USP 1.0 mg F, 1000 count bottles, Full Strength, From
          2.2 mg. Sodium Fluoride, Actavis NDC 52152-128-05; URL NDC 067701678-10,
          Recall # D-327-2008;
    23) Amitex PSE Tablets (Guaifenesin and Pseudoephedrine Hydrochloride Tablets 600
          mg/120 mg), 100 and 500 count bottles, Rx only, NDC 52152-130-02 -100 count
          bottles; NDC 52152-130-04 - 500 count bottles, Recall # D-328-2008;
    24) Amibid DM Tablets (Guaifenesin and Dextromethorphan Hydrobromide 600 mg/
          30 mg), 100 and 250 count bottles, Rx only, Amide NDC 52152-139-02 - 100 count
          bottles; Amide NDC 52152-139-03 - 250 count bottles; Ivax NDC 0182-1042-01 –
          100 count bottles, Recall # D-329-2008;
    25) Hyoscyamine Sulfate Tablets 0.125 mg; Rx only, 100 tablets, Amide/Actavis
          NDC 52152-143-02 - 100 count bottles; Major NDC 0904-2496-60, Recall #
          D-330-2008;
    26) Hyoscyamine Sulfate Tablets SL 0.125 mg, 100 tablets bottles, Rx only,
          sublingual/oral/chewable, Actavis/Amide NDC 52152-155-02; Major NDC 0904-
          5120-60, Recall # D-331-2008;
    27) Hyoscyamine Sulfate Tablets SR 0.375 mg, Extended Release Tablets, 100 count
          bottles, Rx only, Actavis/Amide NDC 52152-156-02, Recall # D-332-2008;
    28) Phenazopyridine Hydrochloride Tablets 95 mg, Bulk labeled for Actavis - Totowa
          (Amide) for Johnson & Johnson, Recall # D-333-2008;
    29) Oxycodone Hydrochloride Tablets, USP 5 mg, Rx only, 100 count bottle,
          NDC 52152-165-02, Recall # D-334-2008;
    30) Oxycodone Hydrochloride Capsules, (oxycodone hydrochloride immediate –
          release), 5 mg,100 capsules, Rx only, NDC 52152-187-02, Recall # D-335-2008;
    31) Prenatal Rx Tablets, Multivitamin and Multimineral Supplement with Betacarotene,
          1 mg Folic Acid and 54 mg Iron, 200 and 500 count bottles, film coated tablets,
          NDC 52152-171-20 - 200 count bottles; NDC 52152-171-04 - 500 count bottles,
          Recall # D-336-2008;.
    32) Codeine Phosphate and Guaifenesin Tablets 10 mg/300 mg, 100 Tablets bottles,
          Rx only, NDC 52152-172-02, Recall # D-337-2008;
    33) Prenatal Plus w/27 mg, Iron Tablets, Multivitamin/Multimineral Supplement,
          Rx only, 100 & 500 Tablets, For use before, during and after pregnancy,
          Amide/Actavis NDC 52152-178-02 - 100 count bottles; Amide/Actavis NDC
          52152-178-04 - 500 count bottles; URL NDC 06077-1689-01 - 100 count bottles;
          Qualitest, NDC 0603-5361-21 - 100 count bottles, D-338-2008;
    34) Pyridium Plus, Each Tablet contains phenazopyridine hydrochloride (Pyridium)
          150 mg, hyoscyamine hydrobromide 0.3 mg and butabarbital 15 mg, Rx only,
          30 tablets, NDC 0430-0182-15, Recall # D-339-2008;
    35) NataFort Prenatal Multivitamin Tablet with Iron, for Use before, during and after
          pregnancy, Patient Starter kit (5 Tablets in Unit-dose Package) NDC 0430-0226-97;
          and 90 tablets blister cards (18 unit dose card of 5 tablets each and 9 unit dose cards
          of 10 tablets each), NDC 0430-0226-40, Recall # D-340-2008;
    36) Meperidine HCL and Promethazine HCL Capsules, 100 Capsules bottle, Rx only,
          NDC 52152-190-02, Recall # D-341-2008;
    37) NataChew Chewable Prenatal Multivitamin Tablet with Iron, 90 Tablets, Rx only,
          for Use before, During and After Pregnancy, NDC 0430-0227-23, Recall # D-342-
          2008;
    38) Guaifenesin and Dextromethorphan HBr ER Tablets, 1200 mg/60 mg, Rx only,
          100 tablets bottle, NDC 52152-246-02, Recall # D-343-2008;
    39) Prenatal Formula 3 Prenatal Vitamins, USP, 100 and 500 Tablets bottle, Rx only,
          NDC 52152-248-02, Recall # D-344-2008;
    40) New Ami-Tex LA Tablets (Phenylephrine Hydrochloride and Guaifenesin
          30 mg/600 mg), Rx only, 100 Tablets bottle, NDC 52152-253-02,
          Recall # D-345-2008;
    41) Multifol Tablets Vitamin, Iron, Calcium, Rx only 10 x 10 Unit dose pack,
          100 tablets; NDC 51991-126-11, Recall # D-346-2008
    CODE
    1) Lot codes: 60617A1, Exp 07/08; 70479A1, Exp. 06/09; Lot code 60617A1,
        Exp -7/08; 70479A2, Exp. 06/09; Lot codes 60617A1, Exp 07/08, 070479A1,
        Exp 06/09;
    2) Lot codes: 060976B1, Exp. 11/08; 70539B1, Exp. 07/09; 80069B1, Exp 01/10;
    3) All lots within expiry;
    4) Lot code 60471A1, Exp. 5/09;
    5) Lot codes: 51035A1, Exp 12/08; 5599A!, Exp. 07/08; 5599A2, Exp. 07/08;
    6) Lot 60452A2, Exp 5/08; 60965A2, Exp. 11/08; Lot 60452A1, Exp 5/08;
         60965A1, Exp 11/08;
    7) Lot 5509A2, Exp 6/08; 60457A2, Exp May 08, 60673A2, Exp. 7/08; 60969A2, Exp.
         11/08; 70191A2, Exp. 3/09; Lot 5509A1, Exp 6/08; 60457A1, Exp. 5/08; 60673A1,
         Exp. 7/08; 60969A1, Exp 11/08; 70191A1, Exp/ 3/09;
     8) Lot 5681A2, Exp. 8/08; 5681A3, Exp. Aug 08; Lot 5681A1, Exp 8/08;
     9) Lot 60538A1, Exp 6/08; 60720A1, Exp. 8/08; 60879A1, Exp 10/08; 61001A1,
         Exp. 11/08; 61139A1, Exp 12/08; 70190A1, Exp 3/09; 70190A2, Exp. 3/09;
         70379A1, Exp. 5/09; 70526A1, Exp. 6/08; 70742A1, Exp 9/09; 70921A1,
         Exp. 11/09; 71044A1, Exp 1/10; 80206A1, Exp. 3/10;
    10) Lot code: 60510A1, Exp. 6/08; 60913A1, Exp. 10/08; 70185A1, Exp 53/09;
         70602A1, Exp 7/09; 70922A1, Exp 11/09; 80208A1, Exp 3/10;
    11) thru 37), All lots within expiry;
    16) Lot code 60881A1, Exp 10/08;
    32) Lot numbers 60265A1, Exp. 5/08 and 70040A1, Exp 1/09;
    33) All lots within expiry;
    34) Lot 60688A1, Exp. 8/08;
    38) Lot 60469A1, Exp. May 08;
    39) Lot 60920A1, Exp. 10/08;
    40) Lot code 60651A1, Exp 8/08;
    41) All lots within expiry
    RECALLING FIRM/MANUFACTURER
    Actavis Totowa LLC, Totowa, NJ, by letters on June 6, 2008. Firm initiated recall is ongoing.
    REASON
    cGMP Deviation
    VOLUME OF PRODUCT IN COMMERCE
    Unknown

DISTRIBUTION

Nationwide
___________________________________
PRODUCT 
Longs brand Fruit Flavor Polacrilex Nicotine Gum, 4 mg (nicotine) 40 pieces, stop smoking aid, NDC 12333-0097-0, Recall # D-352-2008
CODE
Lots 7LE0794, 7LE0966, 7LV0510, 7ME0761, 8LE0737, 8BE0247, 8BE0911, 8CE0237, 8CE0719 and 8CV0473; EXP 06/2009
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by visit on May 19/20-2008. Firm initiated recall is complete.
REASON
Misbranded; side panel directions incorrectly state "if you smoke less than 25 cigarettes a day; use Nicotine Polacrilex Gum, 4mg" panel should correctly state "if you smoke less than 25 cigarettes a day; use Nicotine Polacrilex Gum, 2mg".
VOLUME OF PRODUCT IN COMMERCE
5,320 cartons
DISTRIBUTION
CA
___________________________________
PRODUCT 
a) Mandelamine Hafgrams (Methenamine Mandelate Tablets), 0.5 gram, film coated,
    Rx only, 100 Tablet bottles; NDC 0430-0166-24, Recall # D-353-2008;
b) Mandelamine (Methenamine Mandelate Tablets), 1.0 gram, film coated, Rx only,
    100 Tablets; NDC 0430-167-24, Recall # D-354-2008;
c) Pyridium Tablets (phenazopyridine HCl Tablets, USP), 100 mg, Rx only, 100 tablets,
    NDC 0430-180-24, Recall # D-355-2008;
d) Pyridium Tablets (phenazopyridine HCl Tablets, USP), 200 mg, Rx only, 100 tablets,
    NDC 0430-0181-24, Recall # D-356-2008;
e) Pyridium Plus Tablets (phenazopyridine HCl) Each tablet contains phenzopyridine
    hydrochloride (Pyridium) 150 mg, hyoscyamine hydrobromide 0.3 mg, butabarbital
    15 mg, 30 Tablets, Rx only, NDC 0430-181-15, Recall # D-357-2008;
f) NataFort Prenatal Multivitamin Tablet with Iron, Rx only, For use before, during and
    after pregnancy, 90 Tablets (18 unit dose cards of 5 tablets each), or 9 unit dosed
    cards of 10 tablets). Also sample pack of 5 tablets in a Unit dose package.
    NDC 0430-0226-40; NDC 0430-227-97 (Sample 5 pack), Recall # D-358-2008;
g) NataChew Chewable Prenatal Multivitamin Tablet with Iron, For use before,
    during and after pregnancy, Rx only, 90 Tablets; NDC 0430-0227-23,
    Recall # D-359-2008
CODE
a) Lot codes: 5719A1, Exp 8/31/08; 60727A1, Exp. 8/31/09, 70743A1, Exp. 9/30/10;
b) Lot codes: 5720A1, Exp. 8/31/08; 60728A1, Exp. 8/31/09; 70140A1, Exp. 02/28/10;
    70482A1, Exp. 6/30/10; 70662A1, Exp. 9/30/10;
c) Lot codes: 80069B1, Exp. 1/31/10; 60976B1, Exp. 11/30/08; 70539B1, Exp. 7/31/09;
d) Lot codes: 60832B1, Exp. 9/30/08; 70659B1, Exp. 09/30/09;
e) Lot code 60688A1, Exp. 8/31/08;
f) Lot code 60996A2, Exp. 11/30/08; 60996A4, Exp. 11/30/08; 60997A1, Exp. 11/30/08;
    60997A2, Exp 11/30/08; 70368A1, Exp. 4/30/09; 70368A4, Exp. 4/30/09;
    70631A1, Exp. 8/31/09; Lot codes: 60996A1, Exp. 11/30/08; 70368A2, Exp. 4/30/09;
    70368A3, Exp. 4/30/09;
g) Lot Codes: 60726A1, Exp. 8/31/08; 70041A1, Exp. 2/28/09; 70358A1, Exp. 4/30/09;
    70902A1, Exp. 10/31/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warner Chilcott Inc., Rockaway, NJ, by letters on June 23, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviations; Lack of stability indicating test methods.
VOLUME OF PRODUCT IN COMMERCE
189,233 (bottles and blister packs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Lisinopril Tablets, USP, 10 mg, 1000 Tablets bottle, Rx only; NDC 0185-0101-10, Recall # D-360-2008
CODE
Lot # MK071070
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on/about June 23, 2008 and July 16, 2008.
Manufacturer: Sandoz, Inc., Wilson, NC. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance; embedded metal was discovered in a tablet.
VOLUME OF PRODUCT IN COMMERCE
1,922 bottles/1000 tablets
DISTRIBUTION
MO
___________________________________
PRODUCT 
a) B-Plex Tablets, Multi-vitamin tablets, 100 tablets bottle, Rx only, NDC 0182-4062-01,
    Recall # D-361-2008;
b) Choline Magnesium Trisalicyate, 750 mg, 100 tablets bottle, Rx only,
    Recall # D-362-2008;
c) Choline Magnesium Trisalicyate, 500 mg, 100 tablets bottle, Rx only,
    Recall # D-363-2008
CODE
a) Lot # 60687A2, Exp. 08/2008 Lot # 60904A3, Exp. 10/2008 Lot # 61045A2,
    Exp. 11/2008 Lot # 70184A3, Exp. 02/2009;
b) Lot # 60951A1 Exp. 11/2008;
c) Lot # 5437A1 Exp. 06/2008 and 70062A1, Exp. 01/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on June 13, 2008.
Manufacturer: Actavis Totowa LLC, Totowa, NJ. Firm initiated recall is ongoing.
REASON
cGMP Deviations; Lack of stability indicating methods by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
7,075 bottles
DISTRIBUTION
AL, FL,GA, IL, KY, LA, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, VA and WA
___________________________________
PRODUCT 
Flecainide Acetate Tablets, 150 mg, 100 count bottles, Rx only, Recall # D-365-2008
CODE
Unit: 070669
RECALLING FIRM/MANUFACTURER
Recalling Firm: Graceway Pharmaceuticals LLC, Bristol, TN, by letter on June 26, 2008.
Manufacturer: 3M Drug Delivery Systems, Northridge, CA. Firm initiated recall is ongoing.
REASON
Defective container; missing cap liners.
VOLUME OF PRODUCT IN COMMERCE
12,563 units
DISTRIBUTION
WV

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Midodrine Hydrochloride Tablets, 2.5 mg, 100 tablets, Rx only; Catalog number: 00185-0090-01, Recall # D-364-2008
CODE
Lot #: MK017696
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letters on/about June 19, 2008.
Manufacturer: Sandoz, Inc., Wilson, NC. Firm initiated recall is ongoing.
REASON
Subpotent; 6 month stability
VOLUME OF PRODUCT IN COMMERCE
5,271 bottles (100 count per bottle)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1580-08
CODE
Unit: 29KX37434
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA, by letter on August 8, 2007. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1624-08
CODE
Unit: 3708137
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on October 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1662-08
CODE
Units: 9892315 (Split Unit)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on January 17, 2007. Firm initiated recall is complete.
REASON
Blood products, with positive bacterial detection testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma, Recall # B-1758-08
CODE
Unit: KZ009071
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on February 15, 2006 and by letter on February 20, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), but was labeled as testing negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1909-08
CODE
Unit: 2257833
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on February 15, 2008. Firm initiated recall is complete.
REASON
A blood product, collected from a donor who had traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1910-08
CODE
Unit: X65863
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on April 9, 2008. 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
TN
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1911-08
CODE
Unit: 026FW13701 (Split Unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on April 14, 2008 and follow-up letter dated April 17, 2008.
Manufacturer: The American National Red Cross, Mobile, AL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1929-08
CODE
Units: 2154194, 2155480
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on March 20, 2007. 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
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1930-08
CODE
Unit: 2066363
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on April 16, 2007. 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
TN
___________________________________
PRODUCT 
Source Plasma, Recall # B-1931-08
CODE
Units: I50030205, I50030026, I50029722, I50029554, I50029254, I50029089, I50028727, I50028547, I50028086, I50027821, I50027575, I50027364, I50027080, I50026824, I50026477, I50026357, I50026050, I50025387, I50025017, I50024651, I50024498, I50024057, I50023950, I50023567, I50023399, I50023132, I50023001, I50022533, I50022502, I50021976, I50025548
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by fax on April 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1933-08
CODE
Unit: 2233797
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on February 20, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1936-08
CODE
Unit: 72F852313
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 15, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1937-08
CODE
Unit: 4987935
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and fax on June 18, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1938-08
CODE
Unit: 72F585612
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on April 2, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1939-08
CODE
Units: 71V06854X, 71V667615
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on April 3, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1942-08
CODE
Unit: 72F243600
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on April 24, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1943-08
CODE
Unit: 72F011573
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on April 16, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1956-08
CODE
Unit: 2809914
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on April 28, 2008 and follow-up letter dated June 19, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1957-08
CODE
Unit: F55109
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on June 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1962-08
CODE
Unit: 2244329 (Split unit)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on February 1, 2007. 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
TN
___________________________________
PRODUCT 
a) Red Blood Cells, Recall # B-1963-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1964-08
CODE
a) Unit: KX22541;
b) Units: KX19482, KX20297, KX21620
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter on September 4, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1965-08
CODE
Unit: KX06255
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter or fax on April 30, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

PRODUCT 
a) Recovered Plasma-for use in manufacturing non-injectables, Recall # B-1966-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1967-08
CODE
a) and b) Unit: LC92399
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter on June 9, 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
TN
___________________________________
PRODUCT 
Red Blood Cells (Apheresis), Recall # B-1968-08
CODE
Unit: T25778
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by letter dated April 3, 2008. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1969-08
CODE
Units: G71998, G71925
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax and follow-up letter on April 7, 2008. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1970-08;
CODE
Unit: 8789633
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone and e-mail on April 21, 2008. 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
IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1973-08
CODE
Unit: 040GG03899
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by fax on April 10, 2008. 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
IL
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-1974-08;
b) Fresh Frozen Plasma, Recall # B-1975-08
CODE
a) and b) Units: 040GK63221
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by fax on April 11, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1980-08
CODE
Unit: E11775
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saint Joseph, MI, by fax on June 6, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-2000-08
CODE
Unit: 7413902
RECALLING FIRM/MANUFACTURER
Marquette General Hospital, Inc., Marquette, MI, by letter dated May 23, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
a) Recovered Plasma, Recall # B-1927-08
b) Red Blood Cells Leukocytes Reduced, Recall # B-1928-08
CODE
a) and b) Unit: W25024
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by email or fax on June 24, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a bone graft within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, Switzerland
___________________________________
PRODUCT 
Source Plasma, Recall # B-1934-08
CODE
Unit: KZ037457
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax on March 11, 2008. 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
Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1935-08
CODE
Unit: DQ043241
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Johnson City, TN, by fax on March 6, 2008. 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
NC
___________________________________
PRODUCT 
a) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1940-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1941-08
CODE
a) Units: 3648984 (Split Unit), 3648988 (Split Unit);
b) Units: 3648987, 3648989, 3648990, 3648986
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on April 17, 2008 and by fax on April 18, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1971-08
CODE
Unit: 8789633
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone and e-mail on April 21, 2008. 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
Austria
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1972-08
CODE
Unit: 040GG03899
RECALLING FIRM/MANUFACTURER
American National Red Cross HOA Blood Services Region, Peoria, IL, by fax on April 10, 2008. 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
IL, CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________
PRODUCT 
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest. Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Part number: 3200731-003, 3200731-027, and A3200731-003, Recall # Z-2341-2008
CODE
Serial No’s: 30975799, 30975800, 30976004, 30976005, 30976011, 30976016, 30976020, 30976021, 30976024, 30976025, 30976027, 30976028, 30976030, 30976031, 30976035, 30976042, 30976050, 30976051, 30976052, 30976053, 30976059, 30976060, 30976062, 30976064, 30976066, 30976067, 30976068, 30976071, 30976075, 30976080, 30976081, 30976083, 30976084, 30976087, 30976089, 30976092, 30976093, 30976094, 30976096, 30976105, 30976106, 30976107, 30976110, 30976112, 30976114, 30976122, 30976126, 30976127, 30976129, 30976132, 30976136, 30976139, 30976141, 30976142, 30976143, 30976145, 30976147, 30976148, 30976151, 30976155, 30976157, 30976160, 30976162, 30976163, 30976166, 30976169, 30976171, 30976172, 30976173, 30976177, 30976180, 30976181, 30976182, 30976194, 30976195, 30976197, 30976200, 30976205, 30976207, 30976210, 30976211, 30976216, 30976217, 30976220, 30976224, 30976232, 30976240, 30990985, 31029332, 31029333, 31029334, 31029335, 31029336, 31029337, 31029338, 31029339, 31029340, 31029341, 31029342, 31029344, 31029346, 31029347, 31029348, 31029349, 31029350, 31029351, 31029355, 31029356, 31029357, 31029358, 31029359, 31029360, 31029361, 31029362, 31029363, 31029364, 31029365, 31029367, 31029368, 31029369, 31029371, 31029373, 31029375, 31029377, 31029381, 31029387, 31029390, 31029392, 31029401, 31469750, 34574276, 34634407, 34636114, 34637837, 34637879, 34638012, 34640657, 34641247, 34645809, 34701718, 34705207, 34705216, 34709423, 34709424, 34709425, 34709428, 34709429, 34709435, 34709436, 34709437, 34709442, 34709444, 34709454, 34709459, 34709462, 34709464, 34709475, 34709495, 34709496, 34709503, 34709507, 34709510, 34709513, 34709514, 34709515, 34709525, 34709527, 34709528, 34709531, 34709532, 34709536, 34709537, 34709538, 34709540, 34709542, 34710243, 34710249, 34710256, 34710258, 34710263, 34710265, 34710268, 34710276, 34710278, 34710284, 34710304, 34710307, 34710308, 34710310, 34710311, 34710312, 34710313, 34710318, 34712073, 34712074, 34738595, 34738601, 34738606, 34738610, 34738611, 34738616, 34739021, 34739031, 34739035, 34739040, 34739050, 34739068, 34740405, 34740464, 34740555, 34740565, 34740597, 34741052, 34741073, 34741088, 34741105, 34741106, 34741301, 34741313, 34741318, 34741319, 34741332, 34741341, 34741359, 34741369, 34741373, 34741382, 34741389, 34741392, 34741393, 34741394, 34742520, 34742530, 34742531, 34742538, 34742539, 34742540, 34742542, 34742552, 34742558, 34742609, 34742612, 34742613, 34742614, 34742640, 34742649, 34742652, 34742654, and 34743762
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by telephone on August 28, 2008 and by letter dated August 2008. Firm initiated recall is ongoing.
REASON
The device is configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators have a cover over the shock button making the button inaccessible by the user.
VOLUME OF PRODUCT IN COMMERCE
249 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT 
a) IMPAX® 4.1, Catalog Number: LHZQN007; IMPAX ® 4.5, Catalog Number:
    LZTJM; IMPAX ® 5.0, Catalog Number: L3CJE; IMPAX ® 5.1 Catalog Number:
    L4AW6; IMPAX ® 5.2, Catalog Number: L4EM2; IMPAX ® 6.0, Catalog Number:
    L73V4; IMPAX ® 6.2, Catalog Number: EWMDT; Picture Archiving and
    Communications systems (PACs), used in the acceptance, transfer, display, storage
    and digital processing of medical images, Recall # Z-1243-2008;
b) WEB1000 Versions 3.1, Catalog Number: LD5GQ001; 4.1, Catalog Number:
    LZS5R, LZS9Z, LZTA4 and 5.1, Catalog Number: L7DOS, L7DLPU; Picture
    Archiving and Communications systems (PACs), used in the acceptance, transfer,
    display, storage and digital processing of medical images, Recall # Z-1244-2008
CODE
a) IMPAX® 4.1, IMPAX ® 4.5, IMPAX ® 5.0, IMPAX ® 5.1 IMPAX ® 5.2,
    IMPAX ® 6.0, IMPAX ® 6.2;
b) WEB1000 version 3.1, WEB1000 version 4.1, and WEB1000 version 5.1
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letters on May 14, 2007 and June 7, 2007. Firm initiated recall is ongoing.
REASON
Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
VOLUME OF PRODUCT IN COMMERCE
946 units
DISTRIBUTION
 Nationwide and Canada
___________________________________
PRODUCT 
IMPAX® 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1245-2008
CODE
Software version IMPAX 6.2.1
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letters on/about June 28, 2007. Firm initiated recall is ongoing.
REASON
Text and images may not be synchronized.
VOLUME OF PRODUCT IN COMMERCE
154 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Stryker Digital Capture System Ultra (SDC Ultra), Model Number 240-050-988, Stryker Endoscopy, image and video archiving system, Recall # Z-1316-2008
CODE
Serial numbers: 07H041654 - 08A069464, PP1.04
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters dated February 14, 2008. Firm initiated recall is ongoing.
REASON
Patient Identification numbers and names may be applied to images from another patient due to a software issue. This failure mode can only occur when the pre-load function of the SDC ultra is used.
VOLUME OF PRODUCT IN COMMERCE
814 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610, Recall # Z-1318-2008
CODE
Lots: 218606, 218614 and 217595
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated February 12, 2008.
Manufacturer: Accellent Orthopedics, Brimfield, MA. Firm initiated recall is ongoing.
REASON
The instrument will not mate with its stem.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
 1) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901000, 10mm, 5.5mm dia x 100mm, size: 10mm x
     100mm, for spinal fixation, Recall # Z-1408-2008;
 2) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901010, 10mm, 5.5mm dia x 110mm, size: 10mm x
     110mm, for spinal fixation, Recall # Z-1409-2008;
 3) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901020, 10mm, 5.5mm dia x 120mm, size: 10mm x
     120mm, for spinal fixation, Recall # Z-1410-2008;
 4) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901040, 10mm, 5.5mm dia x 40mm, size: 10mm x
     40mm, for spinal fixation, Recall # Z-1411-2008;
 5) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901045, 10mm, 5.5mm dia x 45mm, size: 10mm x
     45mm, for spinal fixation, Recall # Z-1412-2008;
 6) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901060, 10mm, 5.5mm dia x 60mm, size: 10mm x
     60mm, for spinal fixation, Recall # Z-1413-2008;
 7) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901070, 10mm, 5.5mm dia x 70mm, size: 10mm x
     70mm, for spinal fixation, Recall # Z-1414-2008;
 8) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901080, 10mm, 5.5mm dia x 80mm, size: 10mm x
     80mm, for spinal fixation, Recall # Z-1415-2008;
 9) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
     Stabilization Device, REF 7901090, 10mm, 5.5mm dia x 90mm, size: 10mm x
     90mm, for spinal fixation, Recall # Z-1416-2008;
10) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901500, 15mm, 5.5mm dia x 100mm, size: 15mm x
     100mm, for spinal fixation, Recall # Z-1417-2008;
11) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901510, 15mm, 5.5mm dia x 110mm, size: 15mm x
      110mm, for spinal fixation, Recall # Z-1418-2008;
12) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901520, 15mm, 5.5mm dia x 120mm, size: 15mm x
      120mm, for spinal fixation, Recall # Z-1419-2008;
13) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901545, 15mm, 5.5mm dia x 45mm, size: 15mm x
      45mm, for spinal fixation, Recall # Z-1420-2008;
14) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic   
      Stabilization Device, REF 7901560, 15mm, 5.5mm dia x 60mm, size: 15mm x
      60mm, for spinal fixation, Recall # Z-1421-2008;
15) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901570, 15mm, 5.5mm dia x 70mm, size: 15mm x
      70mm, for spinal fixation, Recall # Recall # Z-1422-2008;
16) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901580, 15mm, 5.5mm dia x 80mm, size: 15mm x
      80mm, for spinal fixation, Recall # Z-1423-2008;
17) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7901590, 15mm, 5.5mm dia x 90mm, size: 15mm x
      90mm, for spinal fixation, Recall # Z-1424-2008;
18) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881000, 10mm, 5.5mm dia x 100mm, size: 10mm x
      100mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
      Recall # Z-1425-2008;
19) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881010, 10mm, 5.5mm dia x 110mm, size: 10mm x
      110mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
      Recall # Z-1426-2008;
20) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881020, 10mm, 5.5mm dia x 120mm, size: 10mm x
      120mm, for spinal fixation, not for distribution in the U.S.A. or its territories,
      Recall # Z-1427-2008;
21) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881040, 10mm, 5.5mm dia x 40mm, size: 10mm x
      40mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1428-2008;
22) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic   
       Stabilization Device, REF 7881060, 10mm, 5.5mm dia x 60mm, size: 10mm x
      60mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
       Recall # Z-1429-2008;
23) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881070, 10mm, 5.5mm dia x 70mm, size: 10mm x
      70mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
     Recall # Z-1430-2008;
24) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic  
      Stabilization Device, REF 7881080, 10mm, 5.5mm dia x 80mm, size: 10mm x
      80mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
     Recall #   Z-1431-2008;
25) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881090, 10mm, 5.5mm dia x 90mm, size: 10mm x
      90mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1432-2008;
26) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881500, 15mm, 5.5mm dia x 100mm, size: 15mm x
      100mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1433-2008;
27) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881510, 15mm, 5.5mm dia x 110mm, size: 15mm x
      110mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1434-2008;
28) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881520, 15mm, 5.5mm dia x 120mm, size: 15mm x
      120mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1435-2008;
29) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881545, 15mm, 5.5mm dia x 45mm, size: 15mm x
      45mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1436-2008;
30) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881560, 15mm, 5.5mm dia x 60mm, size: 15mm x
      60mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1437-2008;
31) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881570, 15mm, 5.5mm dia x 70mm, size: 15mm x
      70mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1438-2008;
32) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881580, 15mm, 5.5mm dia x 80mm, size: 15mm x
      80mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1439-2008;
33) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic
      Stabilization Device, REF 7881590, 15mm, 5.5mm dia x 90mm, size: 15mm x
      90mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1440-2008;
34) Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic,  
      Stabilization Device, REF 7881045, 10mm, 5.5mm dia x 45mm, size: 10mm x
      45mm, not for distribution in the U.S.A. or its territories, for spinal fixation,
      Recall # Z-1441-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on December 12, 2007.
Manufacturer: Warsaw Orthopedic, Inc. dba Medtronic Sofamor Danek,
Warsaw, IN. Firm initiated recall is ongoing.
REASON
Breaks: Shear failure of the cable component of the system.
VOLUME OF PRODUCT IN COMMERCE
7,970 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT 
GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00. Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe, Recall # Z-1526-2008
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm; Datex - Ohmeda, Inc., Madison , WI, by letter on July 2, 2007.  
Manufacturer: Acutronic Medical Systems Ag, Hirzel, Switzerland. Firm initiated recall is ongoing.
REASON
Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engström Care station may result in the sensors providing invalid values and alarm messages when exposed to high flow rates.
VOLUME OF PRODUCT IN COMMERCE
 394 (197 boxes and 2 Flow sensors/box)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) VARIANT ß-thalassemia Short Program Hemoglobin Testing System, Model
    Number 270-0019 (250 tests), with ß-thalassemia ROM card lot PA 62600,
    PIN 2700104, Recall # Z-1588-2008;
b) VARIANT ß-thalassemia Short Program Hemoglobin Testing System, Model
    Number 270-0002 (500 tests), with ß-thalassemia ROM card lot PA 62600,
    PIN 2700104, Recall # Z-1589-2008
CODE
a) Lot number 70080440;
b) Lot numbers: 70080140 and 70080276
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA,  by letter on March 18, 2008. Firm initiated recall is ongoing.
REASON
Some product ROM cards have an incorrect program loaded and are unable to be updated.
VOLUME OF PRODUCT IN COMMERCE
64 kits and 140 ROM cards
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Hill-Rom 100 Low Bed; Model No. P3930, Recall # Z-1603-2008
CODE
All units
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated April 8, 2008. Firm initiated recall is ongoing.
REASON
The upper deck may collapse to its lowest position and the caster brakes may fracture if the bed is moved while the brakes are locked.
VOLUME OF PRODUCT IN COMMERCE
753 Beds
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Gamma3 System Set Screwdriver, Flexible Shaft; 4mm. This product is non-sterile,
    Orthopedic Device. The Gamma3 Locking Nail Systems are Intramedullary short
    and long fixation nails intended for control of rotation and shortening of fractured
    femurs. The screwdriver is used to place the set screw in the nail; Product number:
    1320-0231, Recall # Z-1626-2008;
b) Gammas Set Screwdriver Instrument Set, Orthopedic Device. The Gamma3
    Locking Nail Systems are Intramedullary short and long fixation nails intended for
    control of rotation and shortening of fractured femurs. The screwdriver is used to
    place the set screw in the nail. Product number: 1320-6000, Recall # Z-1627-2008
CODE
a) Lot Code on Package label K409181, Lot code engraved on Screwdriver: K968226;
    Lot code on package label: K610297, Lot code engraved on Screwdriver: K782153;
    Lot code on package label; K645667, Lot code engraved on screwdriver: K533686;
    Lot code on package label: K688034, Lot code engraved on screwdriver: K887079;
    Lot code on package label: K878962, Lot code engraved on screwdriver: K533686;
b) Lot code engraved on screwdrivers: K887079 and K782153
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on February 22, 2008.
Manufacturer: Stryker Gmbh, Kiel, Germany. Firm initiated recall is ongoing.
REASON
Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option; Part number 9896 002 04432, Recall # Z-1642-2008
CODE
All products
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on March 22, 2004.  
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
ND, FL, KY, MN, VA, ME, PA, NJ, CT, TX, CA, OH, TN, OR, GA, NY, SC, MO, WA, IL
___________________________________
PRODUCT 
a) i-CAT Classic 3D Dental Imaging System; Part number 9140-0000-0000,
    Recall # Z-1645-2008;
b) i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold
    under a private label as KaVo 3D eXam; Part number 1-10-1-0. The KaVo part
    number is K1-10-3-0, Recall # Z-1646-2008
CODE
All devices; All manuals
RECALLING FIRM/MANUFACTURER
Imaging Sciences, International, Inc., Hatfield, PA, by letters dated March 19, 2008. Firm initiated recall is ongoing.
REASON
Incorrect scatter information in the manual.
VOLUME OF PRODUCT IN COMMERCE
1,203 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Urethral Warming System-Galil Medical Warming Catheter. The product is contained within prostate kits. This product is used in cryosurgery to prevent freezing of tissue; Catalog number ASMCH0340 sold within kits with the following part numbers: FPRPR4570, FPRPR4508, FPRPR3008, FPRPR4070, FPRPR353, and FPRPR4003, Recall # Z-1698-2008
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galil Medical, Plymouth Meeting, PA, by telephone and letter in April 2008.
Manufacturer: Galil Medical Ltd, Yokneam, Israel. Firm initiated recall is complete.
REASON
The warming catheter was manufactured with the inlet and outlet tubes switched.
VOLUME OF PRODUCT IN COMMERCE
541 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile,
    Recall # Z-1699-2008;
b) Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile,
    Recall # Z-1700-2008;
c) Custom Kit, REF: K05-00843, Revision L, Sterile, Recall # Z-1701-2008
CODE
a) Lot Number F594282;
b) Lot Number F603790;
c) Lot Number F580867
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on April 15, 2008. Firm initiated recall is ongoing.
REASON
Convenience kits may be non-sterile due to inadequate package sealing.
VOLUME OF PRODUCT IN COMMERCE
139 kits
DISTRIBUTION
MO, Japan
___________________________________
PRODUCT 
PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core; Model PT3B; Catalog Number 600-10301, Recall # Z-1752-2008
CODE
Serial Number: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, PT3B-344
RECALLING FIRM/MANUFACTURER
EKOS Corporation, Bothell, WA, by letters dated February 20, 2008, by visit in March 2008 and by letters on April 17, 2008. Firm initiated recall is ongoing.
REASON
Potential for unit to burn patient.
VOLUME OF PRODUCT IN COMMERCE
218 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part Numbers: COHERENCE AG Therapist, 5863506 COHERENCE Therapist System, 7339125 COHERENCE Impression Therapist, 7341410 Primeview 3i, 7341428 AG Therapist 3rd Party V&R, 7345411 Impression Therapist 3rd Party V&R, 7345429 syngo based WS for 3rd Party V&R, 7345437 Coherence Therapist 2.0, 8139839 Primveview 3i 2.0, 8139847 Coherence Therapist 2.1, 8147667 and Primeview 3i 2.1, 8147675, Recall # Z-1768-2008
CODE
All Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and PrimeView 3i R2.1. System.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters on September 19, 2007. Firm initiated recall is ongoing.
REASON
Images may potentially shift, causing an incorrect alignment of the patient, which may result in a dose to the wrong location. It was discovered through the complaint handling process that a potential image shift issue can occur after using the interactive shift tool and filtering tool due to incorrect consideration of the flat panel alignment.
VOLUME OF PRODUCT IN COMMERCE
143 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction, Recall # Z-1782-2008
CODE
Lot Number 305240
RECALLING FIRM/MANUFACTURER
Biomet Sports Medicine, Ontario, CA, by letters on May 2, 2008. Firm initiated recall is ongoing.
REASON
EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-10mm 904781 L305250. Actual product enclosed may be EZLoc 7-8mm.
VOLUME OF PRODUCT IN COMMERCE
160 units
DISTRIBUTION
Nationwide, Internationally
___________________________________
PRODUCT 
PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2, Recall # Z-1784-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Abbott Spine, Austin, TX, by telephone and e-mails beginning on April 17, 2008. Firm initiated recall is ongoing.
REASON
Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use, Recall # Z-1785-2008
CODE
Lot/Serial # 209392, 209402, 235162, 276612, 510931 and 964111
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letter on April 11, 2008. Firm initiated recall is ongoing.
REASON
Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Psi-Tec Tubing, 12'; 10/box; Part Number PT-5558, Recall # Z-1790-2008;
b) Autofuse Tubing, DIS SI; Part Number AFTU-DS; Recall # Z-1791-2008;
c) i-Vac Tubing, 8'; 10/box; Part Number B-5558; Recall # Z-1792-2008;
d) Lamis Tubing Set, 9'; 10/box; Part Number LAM-TUBING; Recall # Z-1793-2008;
e) Y Tubing Set, 9'; 10/box; Part Number LAM-Y; Recall # Z-1794-2008;
f) Irrigation Tubing, 25'; Part Number 5120-25; Recall # Z-1795-2008;
g) Psi-Tec Syringe Pump Infiltration Tubing, 10'; 10/box; Part Number PT-INF-T; 
    Recall # Z-1796-2008;
h) Contour Genesis Infiltration Tubing, 13'; Part Number CG-INF-T;
    Recall # Z-1797-2008;
i) Contour Genesis Inf/IR Tubing; Part Number CG-UT; Recall # Z-1798-2008;
j) Contour Genesis Aspiration Tubing, 12'; Part Number CG-PT-5558;
    Recall # Z-1799-2008
CODE
a) Lot #: PT4900, PT4904, PT5906, PT5908, PT5912, PT5916, PT5920, PT5922,
    PT5924, PT5928, PT5930, PT5932, PT5934, PT5938, PT5940, PT5942, PT5944,
    PT5950, PT5952, PT5956, PT5958, PT5968, PT5970, PT5974, PT5976, PT5984,
    PT6986, PT6988, PT6990, PT6994, PT6996, PT6998, PT6102, PT6108, PT6110,
    PT6114, PT6116, PT6118, PT6122, PT6124, PT6130, PT6134, PT6140, PT6142,
    PT6148, PT6150, PT6152, PT6158, PT6164, PT6168, PT7174, PT7176, PT7178,
    PT7180, PT7182, PT7184, PT7186, PT7188, PT7190, PT7196, PT7198, PT7200,
    PT7206, PT7210, PT7212, PT7216, PT7218, PT7222, PT7220, PT7226, PT7228,
    PT7230, PT7232, PT7234, PT7238, PT7240, PT7244, PT7246, PT7250, PT7252,
    PT7254, PT7266, PT7270, PT7272, PT7274, PT7276, PT7278, PT7280, PT7286,
    PT8288, PT8296, PT8298, PT8300, PT8306, PT8308, PT8310, and PT8312;
b) Lot # AF4900, AF4904, AF5906, AF5908, AF5912, AF5916, AF5920, AF5922,
    AF5924, AF5928, AF5932, AF5934, AF5938, AF5942, AF5944, AF5950, AF5952,
    AF5956, AF5958, AF5970, AF5974, AF5976, AF5984, AF6986, AF6988, AF6990,
    AF6994, AF6996, AF6998, AF6102, AF6108, AF6110, AF6114, AF6116, AF6122,
    AF6126, AF6130, AF6134, AF6140, AF6148, AF6152, AF6158, AF6164, AF6170,
    AF7176, AF7182, AF7190, AF7196, AF7198, AF7200, AF7206, AF7210, AF7216,
    AF7218, AF7222, AF7226, AF7230, AF7234, AF7238, AF7240, AF7246, AF7250,
    AF7258, AF7264, AF7270, AF7272, AF7278, AF7286, AF8288, AF8292, AF8298,
    AF8300, AF8308 and AF8310;
c) Lot #: HI4900, HI4904, HI5906, HI5908, HI5912, HI5916, HI5920, HI5922, HI5924,
    HI5928, HI5930, HI5932, HI5934, HI5938, HI5940, HI5942, HI5944, HI5952,
    HI5956, HI5958, HI5974, HI5976, HI5984, HI6986, HI6988, HI6990, HI6994,
    HI6996, HI6998, HI6102, HI6108, HI6110, HI6114, HI6116, HI6122, HI6126,
    HI6130, HI6138, HI6144, HI6148, HI6154, HI6158, HI6164, HI7176, HI7178,
    HI7180, HI7182, HI7188, HI7202, HI7212, HI7204, HI7222, HI7226, HI7230,
    HI7240, HI7248, HI7254, HI7270, HI7272, HI7280, HI8292, HI8296, HI8304 and
    HI8316;
d) Lot #: LA4900, LA4904, LA5906, LA5908, LA5912, LA5916, LA5920, LA5922,
    LA5924, LA5928, LA5930, LA5932, LA5934, LA5938, LA5940, LA5942,
    LA5944, LA5952, LA5956, LA5958, LA5970, LA5974, LA5976, LA5984,
    LA6986, LA6988, LA6990, LA6994, LA6998, LA6102, LA6108, LA6110,
    LA6114, LA6116, LA6124, LA6130, LA6132, LA6140, LA6148, LA6152,
    LA6160, LA6168, LA7174, LA7178, LA7182, LA7184, LA7188, LA7190,
    LA7194, LA7198, LA7200, LA7206, LA7218, LA7226, LA7238, LA7240,
    LA7244, LA7248, LA7266, LA7272, LA7274, LA7276, LA8288, LA8292,
    LA8296, LA8298 and LA8312;
e) Lot #: LY4900, LY5906, LY5912, LY5920, LY5924, LY5928, LY5932,
    LY5938, LY5944, LY5952, LY5974, LY5984, LY6988, LY6994, LY6996,
    LY6102, LY6108, LY6110, LY6116, LY6130, LY6150, LY6164, LY7174,
    LY7180, LY7190, LY7200, LY7212, LY7222, LY7238, LY7248, LY7268,
    LY7282, LY8298, LY8300 and LY8310;
f) Lot #: LS4904, LS4904, LS5908, LS5916, LS5922, LS5928, LS5934, LS5942,
    LS5956, LS5970, LS5974, LS5976, LS6988, LS6994, LS6998, LS6108, LS6114,
    LS6124, LS6138, LS6148, LS6154, LS6168, LS7176, LS7178, LS7180, LS7184,
    LS7190, LS7202, LS7218, LS7232, LS7244, LS7258, LS7280 and LS8304;
g) Lot #: IN4900, IN5906, IN5916, IN5922, IN5928, IN5934, IN5942, IN5950,
    IN5956, IN5970, IN5974, IN5984, IN6986, IN6990, IN6996, IN6998, IN6108,
    IN6114, IN6126, IN6142, IN6158, IN6168, IN7176, IN7196, IN7202, IN7240,
    IN7268 and IN8292;
h) Lot #: CI4900, CI5906, CI5912, CI5920, CI5929, CI5924, CI5930, CI5932,
    CI5938, CI5940, CI5942, CI5944, CI5948, CI5950, CI5952, CI5958, CI5970,
    CI5976, CI6986, CI6996, CI6998, CI6108, CI6114, CI6124, CI6126, CI6134,
    CI6140, CI6172, CI7178, CI7182, CI7192, CI7200, CI7202, CI7204, CI7216,
    CI7218, CI7228, CI7246, CI7248, CI7268, CI7280, CI8292, CI8298, CI8308
    and CI8312;
i)  Lot #: CY5906, CY5912, CY5920, CY5924, CY5932, CY5938, CY5944,
    CY5952, CY5958, CY5974, CY5976, CY6986, CY6990, CY6996, CY6102,
    CY6110, CY6114, CY6126, CY6148, CY6154, CY6170, CY7184, CY7188,
    CY7190, CY7206, CY7218, CY7226, CY7240, CY7252, CY7264, CY7278,
    CY8288 and CY8316;
j) All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Texas, Inc., Irving, TX, by letter on April 21, 2008.
Manufacturer: Byron Medical, Tucson, AZ. Firm initiated recall is ongoing.
REASON
During packaging integrity validation, it was found that various product packages could fail, compromising the sterility of the devices.
VOLUME OF PRODUCT IN COMMERCE
Approximately 70,000 boxes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system, Recall # Z-1800-2008;
b) Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system, Recall # Z-1801-2008;
c) Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system, Recall # Z-1802-2008;
d) Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system, Recall # Z-1803-2008;
e) Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system; Recall # Z-1804-2008;
f) Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system; Recall # Z-1805-2008;
g) Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system; Recall # Z-1806-2008;
h) Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For
    manufacturing, processing or repacking. Product is used to transfer contrast media
    and saline from a container to a patient's vascular system; Recall # Z-1807-2008
CODE
a) Lot Number F605813;
b) Lot Number F604048;
c) Lot Number F607413;
d) Lot Number F605310;
e) Lot Number F604890;
f) Lot Number F607531;
g) Lot Number F604893;
h) Lot Number F604759
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on April 8, 2008. Firm initiated recall is complete.
REASON
Convenience kits may contain non-filtered drip chambers.
VOLUME OF PRODUCT IN COMMERCE
865 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Abbott Free Style Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter, Recall # Z-1813-2008
CODE
Part numbers/Serial numbers/Exp. Date: CAT12050-01/0618625/Jul08; M70449-03/0703325/Feb09; CAT12450-01 (70345-02)/0618129/Jun08; CAT70450-01/0700815/Jan09; CAT70447-02/0628646/Oct08; CAT12450-01 (70345-02)/0627030/Sep08; CAT70450-02/0703019/Jan09; CAT12050-02/0703118/Jan09; CAT12050-03/0715129/May09
RECALLING FIRM/MANUFACTURER
Abbott Diabetes Care, Inc., Alameda, CA, by letters, visits or telephone on April 24, 2008. Firm initiated recall is ongoing.
REASON
Flaws in strip voltage continuity may result in frequency of an Error 3 (“Er3”) message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.
VOLUME OF PRODUCT IN COMMERCE
2,954,900 strips
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L; Recall # Z-1814-2008
CODE
Lot Code: K05L310; Lot Code K05L224
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on November 8, 2005. Firm initiated recall is complete.
REASON
Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator
    (DSD-1000), REF CV2000, 9 cm, Sterile; Recall # Z-1817-2008;
b) ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000),
    REF UM210, 7 cm, Sterile; Recall # Z-1818-2008
CODE
a) Lot Number: 080154;
b) Lot Number: 080205
RECALLING FIRM/MANUFACTURER
Clinical Innovations, LLC, Murray, UT, by letter on May 12, 2008. Firm initiated
recall is ongoing.
REASON
Inadequate package seal could compromise sterility.
VOLUME OF PRODUCT IN COMMERCE
760 units
DISTRIBUTION
CA, CO, FL, MO, OR, VA, Mexico, UK
___________________________________
PRODUCT 
a) Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization
    Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2
    (Part Number: 54004); Recall # Z-1819-2008;
b) Allez Spine Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization
    Tray (Part Number: 30013); Recall # Z-1820-2008
CODE
a) Serial /System Numbers: 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013,
    014, 015, 017, 019, 020, 021, 023, 024, 025, 029, 030, 031, 032, 034, 035, 036, 038,
    039, 040, 041, 042, 043, 044, 045, 048, 049, 050, 051, 053, 054, 055, 056, 057, 059,
    060, 061, 062, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 076, 077,
    079, 080;
b) Serial /System Numbers: DM0001, DM0002
RECALLING FIRM/MANUFACTURER
Allez Spine, LLC, Irvine, CA, by a safety notice on April 14, 2008. Firm initiated recall is ongoing.
REASON
This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.
VOLUME OF PRODUCT IN COMMERCE
66 systems
DISTRIBUTION
Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT
___________________________________
PRODUCT 
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 859570001036), Daisy Chain (UPC 859570001029), Color Play (UPC 859570001043) and Cherry Blossom (UPC 859570001012), Recall # Z-1821-2008
CODE
All codes and devices manufactured between June 22 to December 20, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Psi Health Solutions, Pacific Grove, CA, by telephone, e-mail and letter on April 26, 2008.
Manufacturer: Asia Expo Consultants, Limited, Wanchai, Hong Kong SAR. Firm initiated recall is ongoing.
REASON
Product was marketed before its 510(k) application cleared.
VOLUME OF PRODUCT IN COMMERCE
21,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Headset Model Number RTC-2K for use with the Serene Sound Digital MRI
    Compatible High Fidelity Stereo Sound System. Model Number: RTC-2K;  
    Recall # Z-1823-2008;
b) Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI
    Compatible High Fidelity Stereo Sound System. Model Number RTC-551-070;
    Recall # Z-1824-2008
CODE
a) Serial No: a) 124-09606 b) 064-10057 c) 064-09863 d) 064-10066 e) 064-09801
    f) 064-10055 g) 064-10268 h) 064-09932 i) 124-09624 j) 064-09768 k) 064-09988
    l) 064-10226 m) 064-09971 n) 064-09793 o) 064-09837 p) 104-09763 q) 064-10050
    r) 124-10193 s) 064-10059 t) 064-10034;
b) Serial No: a) 064-10288 b) 064-10279 c) 114-09556 d) 124-09898 e) 104-09995
    f) 064-10220 g) 064-10286 h) 124-09491 i) 104-09828 j) 064-10229 k) 064-10211
    l) 064-10241 m) 064-10214 n)064-09983 o) 064-10243 p) 064-10289 q) 064-10207
    r) 064-10132 s) 104-09872 t) 064-10221 u) 064-10127 v) 064-10215 w) 104-09966
    x) 064-10263 y) 124-10116 z) 124-09983 aa) 124-09600 bb) 114-09613 cc) 064-09479
RECALLING FIRM/MANUFACTURER
Resonance Technology, Inc., Northridge, CA, by letter on May 14, 2007. Firm initiated recall is complete.
REASON
Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; Recall # Z-1825-2008
CODE
Software version 2.0
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 9, 2008. Firm initiated recall is ongoing.
REASON
Incorrect measurement of the aortic length in certain cases of aneurysm during the use of the aorta protocol or customized protocol of the Centricity AW Suite 2.0 running on the Centricity RA 1000 or RA600/CA1000 workstations.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis; Recall # Z-1826-2008
CODE
Software version: 3.0.0.X, 3.0.1.X, 3.0.2.X, and 3.0.3.X
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated May 5, 2008. Firm initiated recall is ongoing.
REASON
A software anomaly results in incorrect study date and time information being displayed in the report screen and title, which may result in a potential patient misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP; Recall # Z-1827-2008
CODE
Software versions 4.0.2-4.0.5 & 4.1.0-4.1.2
RECALLING FIRM/MANUFACTURER
MIMvista Corp, Cleveland, OH, by telephone on April 23, 2008. Firm initiated recall is ongoing.
REASON
In MIM (4.0.2-4.0.5) and MIM (4.1.0-4.1.2) versions, there is an error that may occur during the calculation of statistics using the SUV Tool or Contour Statistics. It will occur only under the following specific circumstance: A fusion of a primary volume which has a Z-Axis slice separation larger than that of the secondary volume and statistics are reported on the secondary volume.
VOLUME OF PRODUCT IN COMMERCE
221 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Covidien/ Mallinckrodt CT9000 /CT9000 ADV (J-Bow component 241300). Model Number:  241300 injector suspension system, is an accessory to a device. The device is catalog numbers 9021M, 9023M, ADV9021, ADV9021M, ADV9024M, ADVEL9021, ADVEL9O21M, ADVEL9123, ADV9124M, ADVEL19021M, ADW9021, ADVI9021M, ADVI9023, ADVI9023M, ADW9024, ADWC9021, ADWC9021MOB, ADWC9023, ADWC9024, ADVUCI9021, ADWCI90210B, contrast media delivery system for diagnostic imaging, and contains the main injector; Recall # Z-1828-2008
CODE
PN'S: 800001, 800003, 800005, 800006, 800007, 820003, 820004, 820005, 820006, 820007, 820014, 820016, 820035, 820036
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc, Cincinnati, OH, by letter on April 14, 2008.
Manufacturer: McMahon Medical, Inc., San Diego, CA. Firm initiated recall is ongoing.
REASON
The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.
VOLUME OF PRODUCT IN COMMERCE
2,546 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is
    intended for use for percutaneously remove the recovery filter or facilitate the
    retrieval of foreign objects from the peripheral vascular system;
    Recall # Z-1854-2008;
b) Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is
    intended for use for percutaneously remove the recovery filter or facilitate the
    retrieval of foreign objects from the peripheral vascular system;
    Recall # Z-1855-2008
CODE
a) All lots with expiry dates between May 2008 and February 2011.
    Serial Numbers: GFPD1574 GFPD2170 GFPD1576 GFPD4227 GFPD1575
    GFPD2171 GFPD4228 GFPD4229 GFPD4230 GFPD4723 GFPD4724 GFPD4725
    GFPD4727 GFPD4728 GFPD4729 GFPD2172 GFPD4726 GFPE3233 GFPE3234
    GFPE3236 GFPE3235 GFPE3238 GFPE3237 GFPE3239 GFPE3240 GFPE3241
    GFPE3242 GFPE3243 GFPE3244 GFPE3245 GFPF2336 GFPF4114 GFPF4115
    GFPF4116 GFPF4117 GFPF4118 GFPF4119 GFPF4121 GFPF4122 GFPF4123
    GFPF4120 GFPF4124 GFPF4125 GFPF4126 GFPF4127 GFPF4108 GFPF4109
    GFPF4110 GFPF4111 GFPF4112 GFPF4113 GFPH0443 GFPH0444 GFPH0445
    GFPH0446 GFPH0449 GFPH0447 GFPH0448 GFPH0450 GFPH0451 GFPH0452
    GFPH0453 GFPH0454 GFPH0455 GFPH0457 GFPH0456 GFPH0458 GFPK2806
    GFPK2807 GFPK2808 GFPK2809 GFPK2810 GFPK2811 GFPK2812 GFPK2813
    GFPK2814 GFPK2815 GFPK4721 GFPK4722 GFPL4248 GFPL4249 GFPL4250
    GFPL4251 GFPL4252 GFPL4253 GFPL4254 GFPL4255 GFPL4256 GFPL4257
    GFPL4258 GFPL4259 GFPL4261 GFPL4260 GFQA3500 GFQA3501 GFQA3502
    GFQA3503 GFQA3504 GFQA3505 GFQA3512 GFQA3514 GFQA3516
    GFQB1627 GFQB1628 GFQA3518 GFQB1629 GFQB1630 GFQB1631 GFQB3492
    GFQB3493 GFQB3494 GFQB3495 GFQB3496 GFQB3497 GFQB3499 GFQB3498
    GFQB3500 GFQB3501 GFQB3502 GFQB3503 GFQB3504 GFQB3505 GFQB3506
    GFQC4378 GFQC4379 GFQC4382 GFQC4380 GFQC4381 GFQD0077 GFQD0078
    GFQD0079 GFQD0080 GFQD0081 GFQD0082 GFQD2039 GFQD2038
    GFQD2040 GFQD3742 GFQD3744 GFQD3745 GFQD3739 GFQD3740
    GFQD3741 GFQD3746 GFQD3747 GFQD3749 GFQE4409 GFQE4410
    GFQE4724 GFQE4725 GFQF0388 GFQF0389 GFQF0392 GFQF4296 GFQF4297
    GFQF4288 GFQF4289 GFQG2518 GFQG2841 GFQG3368 GFQG3369 GFQG3370
    GFQG3371 GFQG3367 GFQG3372 GFQH2309 GFQH3845 GFQH3846 GFQI0229
    GFQI0230 GFQI0231 GFQI0232 GFQI3507 GFQI3508 GFQJ0020 GFQJ0442
    GFQJ0443 GFQJ0444 GFQJ0445 GFQJ0446 GFQJ0432 GFQI3994 GFQI3995
    GFQJ4114 GFQJ4115 GFQJ4637 GFQJ4638 GFQJ4641 GFQJ4642 GFQJ4646
    GFQJ4644 GFQJ4645 GFQK3057 GFQK3788 GFQL0324 GFQL0249 GFQL0250
    GFQL0322 GFQL0323 GFQL0711 GFQL2631 GFQL2632 GFQL0731 GFQL2633
    GFQL4073 GFQL4074 GFQL4075 GFQL4076 GFQL4077 GFQL4078 GFRA3887
    GFRA3888 GFRA5030 GFRA5031 GFRA5032 GFRB0123 GFRB0124 GFRC0529
    GFRC0530 GFRC0531 GFRC0532 GFRC0533 GFRC0534 GFRC0535 GFRC2639
    GFRC2628 GFRC2629 GFRC2631 GFRC2632 GFRC2633 GFRC2634 GFRC2635
    GFRC2630 GFRC2636 GFRC2637 GFRC2638 GFRD3500 GFRD3501 GFRD3502
    GFRE1347 GFRE1349 GFRE1350 GFRE1351 GFRE1422 GFRE1423 GFRE1424
    GFRE4483 GFRE4484 GFRE4485 GFRE4486 GFRE4487 GFRE4488 GFRE4489
    GFRE4490 GFRE4491 GFRE4492 GFRE4493 GFRE4494 GFRE4495 GFRE4496
    GFRE4497 GFRE4498 GFRF3639 GFRF3640 GFRF3641 GFRF3642 GFRF3643
    GFRF3644 GFRF3645 GFRF3646 GFRF3647 GFRF3648 GFRF3649 GFRG2502
    GFRG2503 GFRG2505 GFRG2504 GFRG2506 GFRG2507 GFRG2508 GFRH4779
    GFRH4781 GFRH4780 GFRH4783 GFRH4782 GFRH4784 GFRH4785
    GFRH4786 GFRI0045 GFRI3372 GFRI3373 GFRJ4044 GFRI3380 GFRI3381
    GFRJ4045 GFRI3379 GFRI3382 GFRI3383 GFRJ4046 GFRJ4047 GFRJ4048
    GFRJ4049 GFRK3903 GFRK3904 GFRK3905 GFRL0039 GFSA2453 GFSA2452
    GFSB0182;
b) All lots with expiry dates between May 2008 and February 2011. Serial Numbers:
    GFRL3426 GFRL3425 GFRL3438 GFRL3439 GFRL3443 GFRL3445 GFRL3448
    GFRL3424 GFRL3436 GFRL3437 GFSA0555 GFSA0027 GFSA0556 GFSA0557
    GFSA0560 GFSA0610 GFSA0611 GFSA0612 GFSA0613 GFSA0614 GFSA0615
    GFSA0644
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular, Inc., Tempe, AZ, by letter on May 9, 2008. Firm initiated recall is ongoing.
REASON
This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body.
VOLUME OF PRODUCT IN COMMERCE
12,679 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Weck, DuraHook", Catalog #382800, 1/4" (6mm) Neuro Elastic Retractors,
    Sterile, Rx only, Recall # Z-1856-2008;
b) Weck, DermaHook", Catalog #382805, 1/2" (12mm) Neuro Elastic Retractors,
    Sterile, Rx only, Recall # Z-1857-2008
CODE
All manufacturing dates from 4/1/2006 through 3/19/2008;
    Lot numbers: 01A0800425, 01L0700008, 01L0700339, 01M0700052, 1996009,
    2217638, T1206007, T1207101, T1207481, T1209127, T1209524, T1212329,
    T1212657, T1224116, T1224887, T1226599, T1228526, T1230381, T1232347,
    T1238489, T1240283, T1242666, T1244664, T1245240,T1238489, T1248506,
    T1249506, T1253534,T1255173, T1259102, T1278101, T1279049;
b) All manufacturing dates from 4/1/2006 through 3/19/2008;
    Lot numbers: 01A0800086, 01A0800168, 01A0822216, 01A0800323,
     01L0700096, 01L0700257, 1996021, 2230335, 2614566, T1206008, T1206537,
    T1209084, T1209085, T1209525, T1211001, T1211685, T1212658, T1223079,
    T1226004, T1227679, T1229934, T1231416, T1233264, T1234305, T1236177,
    T1239174, T1242796,T1243832, T1243833, T1243834, T1247442, T1250478,
    T1251531, T1252452, T1254316, T1255368, T1256381, T1257718, T1258301,
    T1266798, T1267798, T1268854, T1269783, T1270679, T1271622, T1277206,
    T1277284, T1279907
RECALLING FIRM/MANUFACTURER
Recalling Firm: Telefeix Medical, Durham, NC, by letter on/about May 12, 2008.
Manufacturer: Hudson RCI Tecate S.de R.L. de C.V., Teleflex Medical, Tecate, B.C., Mexico. Firm initiated recall is ongoing.
REASON
The bands are breaking within the sealed packaging or in use prior to the expiration dates.
VOLUME OF PRODUCT IN COMMERCE
14,255 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Physio-Control LIFEPAK® 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation operations. When clinically indicated, the LIFEPAK 12 defibrillator/monitor allows the operator to deliver a brief, high-energy shock to the heart of the patient. Operators may pre-configure the device to reduce complexity during normal operation. Part Number 3010178-010, DVLP12-02-000102, UVLP12-02-000022, VLP12-02-000021, VLP12-02-000022, VLP12-02-000023, VLP12-02-000057, VLP12-02-000058, VLP12-02-000059, VLP12-02-000099, VLP12-02-000100, VLP12-02-000107, VLP12-02-000110, VLP12-02-000242, VLP12-02-000287, VLP12-02-000296, VLP12-02-000317, VLP12-02-000338, VLP12-02-000411, VLP12-02-000449, VLP12-02-000577, VLP12-02-000800, VLP12-02-000801, VLP12-02-000876, VLP12-02-000983, VLP12-02-000985, VLP12-02-001029, VLP12-02-001038, VLP12-02-001168, VLP12-02-001253, VLP12-02-001366, VLP12-02-001387, VLP12-02-001430, VLP12-02-001449, VLP12-02-001460, VLP12-02-002163, VLP12-02-002175, VLP12-02-002222, VLP12-02-002250, VLP12-02-002860, VLP12-02-003223, VLP12-02-003585, VLP12-02-003809, VLP12-02-003979, VLP12-02-004055, VLP12-02-004221, VLP12-02-004354, VLP12-02-006000, VLP12-02-006011, VLP12-02-006012, VLP12-02-006013, VLP12-02-006018, VLP12-02-006020, VLP12-02-006021, VLP12-02-006030, VLP12-02-006033, VLP12-02-006036, VLP12-02-006037, VLP12-02-006042, VLP12-02-006044, VLP12-02-006057, VLP12-02-006060, VLP12-02-006064, VLP12-02-006067, VLP12-02-006076, VLP12-02-006077, VLP12-02-006081, VLP12-02-006086, VLP12-02-006087, VLP12-02-006088, VLP12-02-006097, VLP12-02-006101, VLP12-02-006103, VLP12-02-006107, VLP12-02-006110, VLP12-02-006114, VLP12-02-006119, VLP12-02-006159, VLP12-02-006176, VLP12-02-006179, VLP12-02-006181, VLP12-02-006196, VLP12-02-006199, VLP12-02-006202, VLP12-02-006210, VLP12-02-006223, VLP12-02-006226, VLP12-02-006234, VLP12-02-006238, VLP12-02-006256, VLP12-02-006263, VLP12-02-006266, VLP12-02-006267, VLP12-02-006268, VLP12-02-006269, VLP12-02-006275, VLP12-02-006290, VLP12-02-006304, VLP12-02-006306, VLP12-02-006312, VLP12-02-006315, VLP12-02-006322, VLP12-02-006329, VLP12-02-006333, VLP12-02-006343, VLP12-02-006349, VLP12-02-006359, VLP12-02-006365, VLP12-02-006366, VLP12-02-006367, VLP12-02-006373, VLP12-02-006393, VLP12-02-006396, VLP12-02-006398, VLP12-02-006414, VLP12-02-006423, VLP12-02-006437, VLP12-02-006455, VLP12-02-006457, VLP12-02-006475, VLP12-02-006478, VLP12-02-006483, VLP12-02-006487, VLP12-02-006500, VLP12-02-006531, VLP12-02-006542, VLP12-02-006555, VLP12-02-006565, VLP12-02-006576, VLP12-02-006577, VLP12-02-006578, VLP12-02-006593, VLP12-02-006600, VLP12-02-006615, VLP12-02-006623, VLP12-02-006624, VLP12-02-006644, VLP12-02-006647, VLP12-02-006686, VLP12-02-006687, VLP12-02-006723, VLP12-02-006747, VLP12-02-006748, VLP12-02-006757, VLP12-02-006780, VLP12-02-006789, VLP12-02-006823, VLP12-02-006836, VLP12-02-006845, VLP12-02-006863, VLP12-02-006911, VLP12-02-006922, VLP12-02-006941, VLP12-02-006945, VLP12-02-006965, VLP12-02-007013, VLP12-02-007028, VLP12-02-007029, VLP12-02-007066, VLP12-02-007098, VLP12-02-007133, VLP12-02-007143, VLP12-02-007170, VLP12-02-007174, VLP12-02-007189, VLP12-02-007209, VLP12-02-007211, VLP12-02-007212, VLP12-02-007213, VLP12-02-007214, VLP12-02-007215, VLP12-02-007217, VLP12-02-007218, VLP12-02-007220, VLP12-02-007222, VLP12-02-007228, VLP12-02-007231, VLP12-02-007241, VLP12-02-007270, VLP12-02-007280, VLP12-02-007312, VLP12-02-007330, VLP12-02-007340, VLP12-02-007351, VLP12-02-007355, VLP12-02-007357, VLP12-02-007359, VLP12-02-007364, VLP12-02-007368, VLP12-02-007369, VLP12-02-007370, VLP12-02-007373, VLP12-02-007374, VLP12-02-007375, VLP12-02-007379, VLP12-02-007384, VLP12-02-007387, VLP12-02-007394, VLP12-02-007399, VLP12-02-007408, Recall # Z-1858-2008
CODE
SN: 36285363, 36285396, 36285399, 36255174, 36255175, 36255176, 36255177, 36255178, 36176270, 36176271, 36176272, 36176273, 36176274, 36185900, 36150660, 36183667, 36183668, 36183669, 36183670, 36183671, 36183672, 36183673, 36217503, 36217504, 36175110, 36175111, 36175112, 36175113, 36175114, 36175115, 36175116, 36175117, 36175118, 36175119, 36175120, 36175121, 36175122, 36175123, 36175124, 36175125, 36175126, 36175127, 36175211, 36175212, 36175213, 36176278, 36183819, 36183820, 36183821, 36186386, 36186387, 36186389, 36186390, 36213282, 36213283, 36201095, 36201096, 36266477, 36266478, 36278215, 36278216, 36262903, 36262904, 36262905, 36255134, 36255135, 36255136, 36255139, 36255141, 36265918, 36255061, 36271596, 36271597, 36271598, 36271599, 36262898, 36262899, 36174623, 36174624, 36174625, 36174626, 36174627, 36174628, 36174629, 36174630, 36174631, 36174632, 36174633, 36174634, 36174635, 36174636, 36174637, 36174638, 36174639, 36174640, 36183216, 36183217, 36262662, 36262664, 36262665, 36262666, 36262667, 36262668, 36262669, 36262670, 36262671, 36266244, 36260617, 36260618, 36150802, 36213255, 36213256, 36213257, 36213258, 36213259, 36213260, 36213261, 36213262, 36255990, 36271561, 36271562, 36271563, 36271564, 36271565, 36271566, 36271567, 36271568, 36271569, 36271570, 36271571, 36271572, 36271573, 36271574, 36271575, 36271576, 36271577, 36271578, 36271579, 36271580, 36233648, 36233649, 36278171, 36285371, 36285372, 36285373, 36285374, 36285375, 36285376, 36285377, 36285378, 36285379, 36285380, 36285381, 36285382, 36285383, 36285384, 36285385, 36285386, 36285387, 36285388, 36285389, 36175216, 36175217, 36175218, 36175219, 36175220, 36175221, 36175222, 36175223, 36175224, 36175225, 36175226, 36175227, 36175228, 36175229, 36175230, 36175231, 36175232, 36175233, 36186049, 36186050, 36186051, 36186052, 36186053, 36186054, 36186055, 36186056, 36186057, 36186058, 36186059, 36186060, 36186061, 36186062, 36186063, 36186064, 36186065, 36186066, 36186067, 36186068, 36186069, 36186070, 36186071, 36186072, 36186073, 36186074, 36186075, 36186076, 36186077, 36186078, 36186079, 36186080, 36186081, 36186082, 36186083, 36186084, 36186085, 36186086, 36186087, 36186088, 36186089, 36186090, 36275217, 36275218, 36275219, 36275220, 36275221, 36275222, 36275223, 36275224, 36275225, 36275226, 36275227, 36275228, 36275229, 36275230, 36275231, 36275232, 36275233, 36275234, 36275235, 36275236, 36278943, 36278944, 36286152, 36286153, 36286154, 36286155, 36286156, 36286157, 36286158, 36286159, 36286160, 36286161, 36207354, 36207355, 36213235, 36260588, 36260589, 36260590, 36264237, 36260558, 36260559, 36260560, 36260561, 36260562, 36278072, 36260608, 36260555, 36303448, 36285366, 36285367, 36285368, 36285369, 36285370, 36163725, 36163726, 36163729, 36163731, 36163732, 36164283, 36164284, 36164285, 36233640, 36233641, 36233642, 36233643, 36233644, 36233645, 36233646, 36233647, 36174037, 36258693, 36234012, 36257753, 36303573, 36303574, 36303575, 36303576, 36303577, 36303578, 36303579, 36303580, 36303581, 36303582, 36303583, 36303584, 36303585, 36303586, 36303587, 36303588, 36303589, 36303590, 36303591, 36303592, 36304249, 36304250, 36304251, 36304252, 36304253, 36304254, 36304255, 36304256, 36304257, 36304258, 36304259, 36304260, 36304261, 36304262, 36304263, 36304264, 36304265, 36304266, 36304267, 36304268, 36304269, 36304270, 36304271, 36304272, 36304273, 36304274, 36304275, 36304276, 36304277, 36304278, 36181926, 36181927, 36181928, 36181929, 36233639, 36310266, 36310267, 36310268, 36310269, 36310270, 36310271, 36310272, 36310274, 36310275, 36310276, 36257706, 36204620, 36254098, 36174066, 36304245, 36304246, 36304247, 36304248, 36286147, 36286148, 36286149, 36286150, 36286151, 36204612, 36204613, 36254067, 36254068, 36254069, 36254070, 36254071, 36262699, 36262700, 36278170, 36303443, 36218081, 36218082, 36218083, 36254047, 36232224, 36233627, 36303399, 36303400, 36303401, 36303402, 36303403, 36303404, 36303405, 36303406, 36303407, 36303408, 36303409, 36303410, 36303411, 36303412, 36303413, 36303414, 36303415, 36303416, 36303417, 36303418, 36303419, 36303420, 36303421, 36303422, 36213288, 36302088, 36204624, 36204625, 36204626, 36204655, 36204656, 36204657, 36204658, 36204659, 36204660, 36204661, 36256174, 36256175, 36256176, 36256177, 36256178, 36262681, 13393841, 11789924, 11175777, 36213559, 36213560, 36213561, 36213562, 36213563, 36213564, 36213565, 36213566, 36213567, 36213568, 36213569, 36213570, 36213571, 36213572, 36213573, 36213574, 36213575, 36213576, 36213577, 36213578, 36213579, 36213580, 36213581, 36213582, 36213583, 36213584, 36213585, 36213586, 36213587, 36213588, 36213589, 36213590, 36213591, 36213592, 36213593, 36213594, 36213595, 36213596, 36213597, 36213598, 36150717, 36150718, 36150719, 36150720, 36152481, 36152482, 36152483, 36152484, 36152485, 36153037, 36153038, 36153039, 36153040, 36153041, 36153042, 36153043, 36153044, 36153045, 36153046, 36153047, 36153048, 36153049, 36153050, 36153051, 36153052, 36153053, 36153054, 36153055, 36153056, 36153057, 36153058, 36153059, 36153060, 36153061, 36153062, 36153063, 36153064, 36153065, 36153066, 36153067, 36153068, 36153069, 36153070, 36153071, 36153072, 36153073, 36153074, 36153075, 36243683, 36243684, 36270444, 36270445, 36270446, 36270441, 36243695, 36243696, 36243697, 36243698, 36243699, 36278150, 36265931, 36265921, 36286216, 36262920, 36262921, 36266317, 36266369, 36266316, 36235221, 36235222, 36235223, 36235224, 36235225, 36235226, 36235227, 36235228, 36235229, 36235230, 36235231, 36235232, 36235233, 36235234, 36235235, 36235236, 36235237, 36235238, 36235239, 36235240, 36235241, 36235242, 36235243, 36235244, 36235245, 36235246, 36235247, 36235248, 36232173, 36232174, 36224529, 36224530, 36263676, 36247201, 36247202, 36247203, 36247204, 36247205, 36247206, 36247207, 36247208, 36247209, 36247210, 36247211, 36247212, 36247213, 36199480, 36199481, 36199482, 36199483, 36199484, 36199485, 36199486, 36199487, 36164681, 36201103, 36278910, 36278911, 36278912, 36278913, 36278914, 36278915, 36278916, 36278917, 36278918, 36278919, 36278920, 36278921, 36278922, 36278923, 36278924, 36278925, 36255167, 36255168, 36255169, 36282196, 36224667, 36278982, 36263673, 36281309, 36282214, 36282215, 36282218, 36282219, 36282220, 36282221, 36278968, 36204714, 36255057, 36164692, 36164693, 36164694, 36164695, 36199489, 36222822, 36222823, 36222824, 36233623, 36258300, 36218019, 36218020, 36218021, 36218022, 36218023, 36218024, 36218025, 36218026, 36218027, 36218028, 36218029, 36218030, 36218031, 36218032, 36218033, 36218034, 36218035, 36218036, 36218037, 36218038, 36218039, 36218040, 36218041, 36218042, 36218043, 36218044, 36218045, 36218046, 36218047, 36218048, 36218049, 36218050, 36218051, 36218052, 36218053, 36255014, 36255017, 36255018, 36255019, 36255021, 36258454, 36258455, 36258456, 36258457, 36258458, 36258459, 36258460, 36258462, 36258463, 36258464, 36258465, 36258466, 36258467, 36258468, 36263593, 36174721, 36186731, 36281308, 36186147, 36254368, 36264202, 36266463, 36254362, 36204731, 36254336, 36232180, 36278948, 36278949, 36207368, 36285393, 36286201, 36258477, 36258478, 36258479, 36222767, 36222768, 36278935, 36278936, 36204703, 36234017, 36234831, 36164649, 36286179, 36278132, 36254227, 36232167, 36259087, 36259088, 36259089, 36260549, 36204677, 36201060, 36264233, 36277771, 36258193, 36278069, 36254116, 36266387, 36282201, 36282202, 36282206, 36282207, 36278899, 36278900, 36278901, 36278902, 36278903, 36278904, 36278905, 36278906, 36278907, 36258185, 36286144, 36254053, 36285390, 36285391, 36157248, 36157249, 36157250, 36157511, 36157512, 36157513, 36232184, 36232148, 36274789, 36213160, 36213167, 36213225, 36256389, 36269114, 36269115, 36269118, 36269121, 36269128, 36254051, 36256353, 36256356, 36256364, 36281307, 36213326, 36264471, 36264472, 36232159, 36232189, 36232219, 36232223, 36232227, 36232231, 36233614, 36233617, 36233630, 36266209, 36224691, 36236461, 36236462, 36282195, 36207351, 36207352, 36213319, 36254042, 13910305, 12704440, 12516803, 12516802, 11969626, 11969625, 11790995, 36255610, 36266484, 36266485, 36255596, 36282234, 36282235, 36282236, 36282237, 36282238, 36282239, 36282240, 36282241, 36282242, 36282243, 36282244, 36282245, 36282246, 36282247, 36282248, 36282249, 36282250, 36282251, 36282252, 36282253, 36213321, 36213322, 36255595, 36255599, 36255604, 31576530, 14063313, 13788399, 8594124, 36258262, 36231662, 36231663, 36231664, 36231665, 36231666, 36231667, 36231668, 36231669, 36231670, 36231671, 36231672, 36231673, 36231674, 36231675, 36231676, 36231677, 36231678, 36231679, 36231680, 36231681, 36231682, 36234046, 36243716, 36243717, 36243718, 36243719, 36243720, 36243721, 36243722, 36243723, 36243724, 36243725, 36243726, 36243727, 36243728, 36243729, 36243730, 36243731, 36243732, 36243733, 36243734, 36243735, 36251472, 36251473, 36251474, 36251475, 36251476, 36251477, 36251478, 36251479, 36243706, 36270456, 36213477, 36207371, 36157251, 36157252, 36157253, 36157254, 36157255, 36157256, 36163125, 36163126, 36163127, 36163430, 36174665, 36174666, 36174667, 36174694, 36174695, 36174696, 36181303, 36181304, 36181305, 36181306, 36181307, 36181308, 36181309, 36181310, 36181311, 36181312, 36181313, 36181314, 36181315, 36181316, 36181317, 36181318, 36181319, 36181320, 36181321, 36181322, 36181323, 36181324, 36183679, 36183680, 36183681, 36183682, 36183683, 36183684, 36183685, 36183686, 36183687, 36183688, 36183689, 36183690, 36183691, 36183692, 36185777, 36185778, 36185779, 36185780, 36185781, 36185782, 36185980, 36185981, 36185982, 36185983, 36185984, 36185985, 36185986, 36185987, 36185988, 36185989, 36185990, 36185991, 36185992, 36185993, 36185994, 36185995, 36185996, 36185997, 36185998, 36185999, 36186000, 36186001, 36186002, 36186003, 36186004, 36186005, 36186006, 36186007, 36186008, 36186009, 36186010, 36186011, 36186012, 36186013, 36257776, 36257777, 36257778, 36257779, 36257780, 36257781, 36257782, 36257783, 36257784, 36257785, 36257786, 36257787, 36257788, 36257789, 36257790, 36257791, 36257741, 36257742, 36257743, 36257744, 36257745, 36257746, 36257747, 36257748, 36257749, 11316919, 11316918, 8571666, 112807, 36278952, 36278960, 36243688, 36254259, 36258438, 36227565, 36229549, 36229592, 36227345, 36302015, 36302018, 36302036, 36302037, 36212427, 36212429, 36212431, 36212453, 36212466, 36182225, 36234827, 36234868, 36234896, 36195633, 36233905, 36234899, 36234900, 36238197, 36238239, 36238254, 36255550, 36274537, 36274540, 36227565, 36156753, 36156798, 36156799, 36204582, 36200742, 36204604, 11402841, 11402842, 11402843, 36200733, 36200734, 36200738, 36265943, 36265944, 36265945, 36265946, 36265947, 36265948, 36265949, 36265951, 36265952, 36267416, 36176592, 36212441, 36212442, 36229549, 36229592, 36212467, 36234875, 36234877, 36173955, 9642655, 9709174, 9709176, 11656114, 11656115, 36207397, 36207398, 36225371, 36227488, 36227489, 36229602, 36231480, 36238304, 36238264, 36194091, 36176284, 36176285, 36176286, 36176287, 36181921, 36181922, 36181923, 36207440, 36207442, 36207443, 36207452, 36172107, 36172108, 36172109, 36172110, 36172111, 36204605, 36227316, 36227317, 36227318, 36227319, 36227320, 36227321, 36227322, 36227323, 36238185, 36238351, 36241513, 11711945, 11711946, 11711947, 11711948, 11711949, 11711950, 11711951, 11576879, 11576880, 11576881, 11576882, 36265966, 36306679, 36167748, 10996724, 11241880, 36274570, 36234878, 36234880, 36234889, 36195632, 36194147, 36194149, 36194157, 36194146, 36229627, 36229630, 36229631, 36229632, 36229633, 36229634, 36229635, 36229636, 36229637, 36229638, 36229639, 36229640, 36229641, 36229642, 36229643, 36229644, 36229645, 36229646, 36229647, 36229648, 36229649, 36229650, 36229651, 36229652, 36229653, 36229654, 36229655, 36229656, 36229657, 36229658, 36229659, 36229660, 36231846, 36227345, 36266095, 36204743, 36205330, 36205333, 36205337, 36207383, 36207384, 36204744, 36205329, 36205331, 36205338, 36278845, 36278846, 36257971, 36238190, 36238303, 36234898, 36238196, 36238215, 36238218, 36238219, 36238221, 36238249, 36170039, 36170045, 36170046, 36173680, 36173681, 36173682, 36173683, 36173684, 36173685, 36173686, 36173687, 36173688, 36173689, 36173690, 36173692, 36173693, 36173694, 36173695, 36173697, 36173698, 36173699, 36173700, 36173701, 36173702, 36173703, 36173704, 36173705, 36173956, 36173957, 36173958, 36227591, 36227631, 36173986, 36170017, 36170018, 36194133, 36194134, 36231582, 36231583, 36227462, 36234834, 36241076, 36227444, 36274548, 36274549, 36270437, 36302768, 36238329, 36238352, 36227562, 36227590, 36195628, 36303440, 36233889, 36227331, 36227332, 36227333, 36227334, 36227335, 36212501, 36194112, 36194119, 36194120, 36194121, 36194122, 36194123, 36194124, 36194142, 36194145, 36238263, 36241555, 36205332, 36301981, 11246582, 36274742, 36266109, 36266113, 9898739, 11329515, 36278850, 36270429, 36270430, 36212444, 36266103, 36167746, 36302038, 36302039, 36266673, 36266990, 36204603, 36278838, 36173983, 36306697, 36213542, 36213548, 36309944, 36266689, 36266691, 36238198, 36238211, 36270424, 36270425, 36163131, 36163162, 36163439, 36172238, 36172239, 36172240, 36172267, 36207376, 36229599, 36229600, 36169913, 36170014, 36170022, 36192946, 36192947, 36266686, 36204725, 36204726, 36274555, 36234005, 36238302, 36306687, 36183122, 36207404, 36207416, 36207420, 36207441, 36212428, 36212432, 36212436, 36212469, 36212470, 36212487, 36212492, 36212498, 36163163, 36182396, 36231824, 36231825, 36229665, 36182381, 36182388, 36204687, 36204697, 36227341, 36173989, 36173990, 36176103, 36240901, 36240902, 36302015, 36302018, 36302036, 36302037, 12439581, 12439582, 12439649, 36266114, 36266119, 36266120, 36266121, 36266126, 36267307, 36204600, 12437549, 36238230, 36229544, 36194148, 36227574, 36266685, 36205336, 36207417, 36207418, 36207419, 36212427, 36212429, 36212431, 36212453, 36212466, 36212430, 31533324, 36227447, 36212462, 36241546, 36194155, 36195626, 36195627, 36195629, 36195630, 36201116, 36302051, 11108635, 11145972, 36172266, 36172275, 36174568, 36176884, 36302803, 36302804, 36302805, 36170041, 36233908, 12734960, 13092386, 13102395, 36212461, 36234876, 36227679, 36274574, 36234894, 36234895, 36212424, 36212509, 36172261, 36172262, 36172263, 36306693, 36234829, 36238296, 36238297, 36241514, 10487043, 36231828, 36231829, 36176102, 36176105, 36170029, 36266687, 36229684, 36229685, 36229686, 36229687, 36229688, 36229690, 36182397, 36241547, 36238255, 36241558, 36238235, 36233913, 36176106, 36233884, 11735830, 11735832, 11735834, 11735835, 11735836, 11896923, 36172247, 36172248, 36172249, 36172250, 36172251, 36270435, 36270436, 36241556, 36241557, 36213541, 36238206, 36182225, 36309945, 36309946, 36309947, 36309948, 36309952, 36309953, 36238267, 36241531, 36234827, 36234868, 36234896, 36266684, 36212450, 36193275, 36194111, 36234828, 36170021, 36233903, 36233904, 36233961, 36193274, 36194151, 36194213, 36195631, 36195634, 36233891, 36229585, 36229586, 36167671, 36234897, 36156731, 36212468, 36212505, 13601705, 36170044, 36170043, 36266111, 36212507, 36212513, 36227618, 9898671, 13978203, 11427794, 11427795, 12539641, 30572994, 36233911, 36156730, 36156732, 36234879, 36274569, 36303748, 36303749, 36156790, 36152511, 12916278, 36183534, 36183535, 36185799, 36170038, 36276927, 36212451, 36212446, 36213153, 36212437, 36170040, 36205334, 36205335, 36227454, 36227455, 36227456, 36192823, 36192824, 36192856, 12222828, 36212449, 36212500, 11763411, 36192985, 36192986, 36182231, 36182310, 36182313, 36182346, 36227329, 36301978, 36266672, 36267185, 36267308, 36204750, 36204755, 36195633, 36229593, 36229595, 36229689, 36229691, 36229694, 36229695, 36229696, 36229697, 36229698, 36229699, 36229589, 36229588, 36229590, 36229615, 36274541, 36238273, 36207392, 36167667, 36227566, 36265961, 36227463, 36251945, 36251946, 36251947, 36156795, 36156796, 36238234, 36241532, 36241539, 36170042, 9731552, 36192905, 36192931, 36227678, 36227680, 36227681, 36227682, 36227683, 36227684, 36227685, 36227686, 36227687, 36227688, 36229596, 36270411, 36217789, 36266688, 36266704, 36233905, 36234899, 36234900, 36238197, 36238239, 36238254, 11366028, 11366029, 11926413, 11989509, 13086995, 13086996, 13955652, 13963103, 30606450, 36302050, 36182327, 36176889, 36238238, 36306688, 36306700, 11693630, 36173691, 36173696, 36173706, 36173953, 36173954, 36174016, 36238223, 36181559, 12371117, 12371118, 12371119, 36251941, 36251942, 11025131, 11106124, 11106128, 13025505, 11025129, 11256361, 36200722, 36200723, 36200724, 36200725, 36200726, 36200727, 36200728, 36200729, 36200730, 36200731, 36200732, 36200735, 36200736, 36200737, 36200739, 36200740, 36200741, 36200743, 36201975, 36201976, 36201978, 36203035, 36200744, 36266124, 13433377, 36182347, 36192804, 36192805, 36233895, 36233896, 36233897, 36233898, 36233899, 36233900, 36301986, 36301987, 36306665, 36234000, 36175985, 36176101, 36192930, 36192984, 36274580, 12433773, 12437231, 13422371, 36192803, 36192890, 36192904, 36241538, 36167799, 36170030, 36212421, 36212422, 36212423, 36212425, 36212426, 36176104, 36163164, 36170023, 10100952, 36212508, 36214148, 36214149, 36214150, 36214151, 36204608, 36227337, 36212506, 36229542, 36255550, 36302750, 36266107, 36302795, 36302783, 36278841, 36182345, 36182357, 12447739, 36274561, 36274564, 36194080, 36227466, 36227459, and 36207377.
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letters starting on May 8, 2008 and May 16, 2008. Firm initiated recall is ongoing.
REASON
The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.
VOLUME OF PRODUCT IN COMMERCE
1,710 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT 
Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport. The following Models within the 35A series were subject to recall: (35-A, 35-AST, 35-A+, 35ITA, 35-ITDS, 35-ANM, 35-A+ST, 35-SL, 35-ITIB, 35-L);  Recall # Z-1859-2008
CODE
Serial Numbers: 07047767 07047768 07047769 07047770 07047771 07048489 07049108 07049109 07049111 07049112 07049113 07049114 07049115 07049116 07049118 07049119 07049120 07049122 07049123 07049124 07049166 07049167 07049168 07049169 07049170 07049171 07049172 07049173 07049174 07049175 07049176 07049177 07049178 07049179 07049180 07049181 07049182 07049183 07049723 07049724 07049726 07049727 07049728 07049729 07049730 07049731 07049732 07049733 07049734 07049735 07049736 07049737 07049775 07049776 07049777 07049778 07049779 07049780 07049781 07049782 07049783 07049784 07050473 07050474 07050475 07050476 07050477 07050478 07050479 07050480 07050481 07050482 07050483 07050484 07050485 07050486 07050487 07050488 07050489 07050490 07050491 07050492 07050493 07050494 07050495 07050496 07050497 07050564 07050565 07050566 07051124 07051144 07051145 07051146 07051147 07051148 07051149 07051150 07051151 07051152 07051153 07051154 07051155 07051156 07051157 07051158 07051159 07051160 07051161 07051162 07051163 07051878 07051879 07051880 07051881 07051882 07051883 07051884 07051885 07051886 07051887 07051928 07051929 07051930 07051931 07051932 07051933 07051935 07051936 07051937 07051938 07051939 07051940 07051941 07051942 07051943 07051944 07051945 07051946 07051947 07052491 07052492 07052493 07052494 07052495 07052496 07052497 07052498 07052499 07052500 07052501 07052502 07052503 07052504 07052543 07052544 07052545 07052546 07052547 07052548 07052549 07052550 07052551 07052552 07052553 07052554 07052555 07052556 07052557 07052639 07052693 07053218 07053219 07053220 07053221 07053222 07053223 07053258 07053259 07053260 07053261 07053262 07053263 07053264 07053265 07053266 07053267 07053268 07053269 07053270 07053271 07053272 07053273 07053274 07053275 07053276 07053277 07053278 07054057 07054059 07054060 07054071 07054074 07055360 07055361 07055364 07055365 07055366 07055367 07055368 07055953 07055958 07055960 07055964 07055965 07055966 07055967 07056805 07056807 07056808 07056809 07056810 07056811 07056812 07056813 07056814 07056815 07056816 07056817 07056818 07056819 07056820 07056821 07056822 07056823 07056824 07056825 07056826 07056827 07057297 07057298 07057301 07057302 07057303 07057304 07057305 07057306 07057308 07057309 07057310 07057311 07057314 07057317 07057321 07057322 07057323 07057966 07058028 07058617 07058620 07058626 07058673 07058676 07059925 07059928 07059929 07059931 07059932 07059933 07059934 07059935 07059938 07059939 07060434 07060435 07060437 07060438 07060439 07060440 07060441 07060442 07060449 07060457 07060459 07060460 07060461 07060462 07060463 07060464 07060465 07060466 07060467 07061019 07061020 07061029 07061030 07061031 07061039 07061040 07061041 07061042 07061043 07061046 07061047 07061049 07061050 07061051 07061052 07061059 07061060 07061067 07061068 07061069 07061070 07061072 07061073 07061074 07061075 07061076 07061077 07061078 07061086 07061087 07061089 07061090 07061091 07061092 07061093 07061094 07061097 07061098 07061101 07061103 07061104 07061105 07061106 07061107 07061114 07061115 07061116 07061118 07061173 07061712 07061713 07061714 07061715 07061716 07061717 07061718 07061720 07061721 07061722 07061723 07061724 07061725 07061726 07061727 07061728 07061729 07061730 07061733 07061735 07061736 07061737 07061738 07061739 07061740 07061742 07061745 07061747 07061748 07061749 07061750 07061751 07061752 07061753 07061759 07061760 07061761 07061762 07061763 07061764 07061767 07061768 07061769 07061771 07062345 07062346 07062347 07062348 07062349 07062350 07062351 07062352 07062353 07062354 07062355 07062356 07062357 07062358 07062359 07062360 07062361 07062362 07062363 07062364 07062365 07062368 07062369 07062370 07062371 07062372 07062373 07062374 07062381 07062382 07062383 07062384 07062564 07062565 07062577 07063284 07063285 07065704 07065705 07065706 07066543 07066544 07066545 07066546 07066547 07066548 07066549 07067804 07067805 08069464 08069465 08071534 08071535 08071536 08071537 08071553 08071554 08071555 08073210 08073211 08073212 08073213 08073214 08073215 08073216 08073217 08073218 08073219 08074231 08074232 08074233 08074234 08074235 08074236 888113814 888113815 888113816 888113817 888113818 888113819 888113820 888113821 888113822 888113823 888113824 888113825 888113826 888113827 888113828 888113829 888113830 888113831 888113832 BBB113833 BBB113834 BBB113835 8BB113836 BBB113837 BBB113838 BBB113839 BBB113840 BBB113841 BBB113842 BBB113843 BBB113844 BBB113845 BBB113846 BBB113847 BBB113848 BBB113849 BBB113850 BBB113851 BBB113852 BBB113853 BBB113854 BB8113855, and 8BB113856
RECALLING FIRM/MANUFACTURER
Femo-Washington, Inc., Wilmington, OH, by letter on May 16, 2008. Firm initiated recall is ongoing.
REASON
A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher.
VOLUME OF PRODUCT IN COMMERCE
783 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Stella Interdental Osteotome, 4 mm, 6 mm and 8 mm. Model numbers: 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting); Recall # Z-1871-2008
CODE
Lot numbers: 381250, 381251, 439970, 381240, 356510, 513250 and 354320
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, Fl, by letter and email on April 16, 2008. Firm initiated recall is ongoing.
REASON
The working tips of the Stella Osteotomes are thicker than specification.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
MO, NM, TX, Canada, Germany
___________________________________
PRODUCT 
a) Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm,
    REF FEMII012V, Recall # Z-1893-2008;
b) Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter,
    8 Fr. x 11.5 cm, REF DIIFEMII008V; Recall # Z-1894-2008
CODE
a) Lot 58458668;
b) Lot 58458813
RECALLING FIRM/MANUFACTURER
Edwards Lifesciences Research Medical, Inc., Midvale, UT, by Sales representatives and by letter dated February 22, 2008. Firm initiated recall is ongoing.
REASON
Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/15 cm, sterile;
    REF 26-226, UPN M001262260. The product is used with a radiofrequency
    generator for the thermal coagulation necrosis of soft tissues, including partial or
    complete ablation of nonresectable liver lesions; Recall # Z-1913-2008;
b) Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile;
    REF 26-227, UPN M001262270. The product is used with radiofrequency
    generator for the thermal coagulation necrosis of soft tissues, including partial or
    complete ablation of nonresectable liver lesions; Recall # Z-1914-2008;
c) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/15 cm, sterile;
    REF 26-228, UPN M001262280. The product is used with radiofrequency
    generator for the thermal coagulation necrosis of soft tissues, Including partial or
    complete ablation of nonresectable liver lesions; Z-1915-2008;
d) Boston Scientific LeVeen SuperSlim Needle Electrode, 3.0 cm/25 cm, sterile,
    REF 26-229, UPN M001262290. The product is used with radiofrequency
    generator for the thermal coagulation necrosis of soft tissues, including partial or
    complete ablation of nonresectable liver lesions; Recall # Z-1916-2008
CODE
a) All lots. Lots: 0007754221, 0007756536, 0007760602, 0007773373, 0007773795, 0007795354, 0007795671, 0007829946, 0007860541, 0007924564, 0007929069, 0007935435, 0007935641, 0007935927, 0007967967, 0007973448, 0007973449, 0007983095, 0007999035, 0008029591, 0008029965, 0008047351, 0008055911, 0008100038, 0008100039, 0008119923, 0008119924, 0008138446, 0008142890, 0008142891, 0008147540, 0008165769, 0008165770, 0008165771, 0008181500, 0008198428, 0008198430, 0008202143, 0008229896, 0008246451, 0008246452, 0008247161, 0008250918, 0008250919, 0008262976, 0008262977, 0008279250, 0008287295, 0008632162, 0008633030, 0008678724, 0008715160, 0008745079, 0008745080, 0008745081, 0008745084, 0008745085, 0008757525, 0008764755, 0008815843, 0008815844, 0008840208, 0008842737, 0008843687, 0008855834, 0008865948, 0008870965, 0008885317, 0008922049, 0008922050, 0008922051, 0008962320, 0008971482, 0008976593, 0008993095, 0009012204, 0009012205, 0009012206, 0009034730, 0009059144, 0009070216, 0009081512, 0009092663, 0009103629, 0009103630, 0009103631, 0009104111, 0009275204, 0009277201, 0009277202, 0009288930, 0009292225, 0009294911, 0009295272, 0009295273, 0009330954, 0009344590, 0009352769, 0009386363, 0009409068, 0009429873, 0009449403, 0009457082, 0009464931, 0009488649, 0009501969, 0009520948, 0009538053, 0009554399, 0009568323, 0009595705, 0009595853, 0009609675, 0009622354, 0009645946, 0009662038, 0009679969, 0009696743, 0009711986, 0009726408, 0009726409, 0009731711, 0009747000, 0009749812, 0009776800, 0009784043, 0009800139, 0011001910, 0011007735, 0011017381, 0011027710, 0011036114, 0011042782, 0011083691, 0011111662, 0011300194, 0011303965, 0011312752 and 0011442784;
b) All lots. Lots: 0007754222, 0007757352, 0007774377, 0007778866, 0007787319, 0007802363, 0007819373, 0008025066, 0008033462, 0008119925, 0008126720, 0008139108, 0008167709, 0008187490, 0008189883, 0008191619, 0008272777, 0008274731, 0008301843, 0008900347, 0009106193, 0009261704, 0009261705, 0009261706, 0009275205, 0009292249, 0009344591, 0009382115, 0009422549, 0009437649, 0009446512, 0009464930, 0009505685, 0009532051, 0009569176, 0009595712, 0009647788, 0009663657, 0009749621, 0009783669, 0009799393, 0009993406 0011311216 and 0011517938;
c) Lots 0007685394, 0007688596, 0007690044, 0007693080, 0007710763, 0007717197, 0007718494, 0007757593, 0007769794, 0007778476, 0007798277, 0007799684, 0007815133, 0007819730, 0007820171, 0007820172, 0007830174, 0007873593, 0007874184, 0007874890, 0007877715, 0007936157, 0007836928, 0007961474, 0007998646, 0007999036, 0008014012, 0008047352, 0008047353, 0008051302, 0008051303, 0008053104, 0008056115, 0008119926, 0008122051, 0008123318, 0008126721, 0008139109, 0008144855, 0008144856, 0008160440, 0008162356, 0008167710, 0008170365, 0008170367, 0008181522, 0008195334, 0008195335, 0008198429, 0008221414, 0008222839, 0008222840, 0008235405, 0008237665, 0008237666, 0008237667, 0008247423, 0008257786, 0008258696, 0008258699, 0008283450, 0008309810, 0008309811, 0008611256, 0008611257, 0008640930, 0008645586, 0008645587, 0008874668, 0008764670, 0008764671, 0008764752, 0008837286, 0008845099, 0008851900, 0008852673, 0008860247, 0008865949, 0008874114, 0008886780, 0008898275, 0008927405, 0008962637, 0008966750, 0009066657, 0009067960, 0009080979, 0009102282, 0009106194, 0009124609, 0009129138, 0009136775, 0009154345, 0009159632, 0009190228, 0009281907, 0009282082, 0009290027, 0009292248, 0009292259, 0009331890, 0009335084, 0009382659, 0009405438, 0009423826, 0009456695, 0009460988, 0009466719, 0009479846, 0009498167, 0009505686, 0009520950, 0009538556, 0009555435, 0009564540, 0009573301, 0009591819, 0009609676, 0009639173, 0009658206, 0009677181, 0009690998, 0009711580, 0009716581, 0009730011, 0009730774, 0009746025, 0009763711, 0009779996, 0009795358, 0009802808, 0009806552, 0009806775, 0011004782, 0011020014, 0011035229, 0011035231, 0011042783, 0011083692, 0011135307, 0011135308, 0011165361, 0011165362, 0011165363, 0011249434, 0011249435, 0011286830, 0011300195, 0011303966, 0011312232, 0011312233, 0011312234, 0011314618, 0011378176, 0011405138, 0011428065, 0011428066, 0011428067 and 0011446252;
d) Lots: 8382, 0007772112, 0007799189, 0007810726, 0007873053, 0007916555, 0008034686, 0008123319, 0008135736, 0008135737, 0008144857, 0008147541, 0008185484, 0008189884, 0008206704, 0008271342, 0008396414, 0008428150, 0008470440, 0008546755, 0008625282, 0008815837, 0008839480, 0008845098, 0008865219, 0008870962, 0008891504, 0008971484, 0009070215, 0009080832, 0009107193, 0009125675, 0009137173, 0009154346, 0009160546, 0009299951, 0009303596, 0009333564, 0009385351, 0009429552, 0009446553, 0009457083, 0009488650, 0009498166, 0009564539, 0009569175, 0009606078, 0009623181, 0009647789, 0009663658, 0009711987, 0009734050, 0009750637, 0009783670, 0009800137, 0009802809, 0011038755, 0011299942 and 0011311215
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter on April 30, 2008. Firm initiated recall is complete.
REASON
The cannula may become detached from its correct orientation inside the handle and may prevent retraction of the tines.
VOLUME OF PRODUCT IN COMMERCE
20,966 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
DST-XL Model 1002375 is a multi-head, whole body gamma camera with infrared body contouring and anti-collision computed tomography system; Recall # Z-2008-2008
CODE
211 0000000DSTX002 0000000DSTX003 0000000DSTX004 178 174 156 119 000000000A/255 000000000B/171 183 138 0000000DSTX008 000000000B/175 246 000000000D/207 00A108/168/331 0000000DSTX020 0000000DSTX010 000000000D/127 126 0000000000A252 0000000DSTX019 UNK10023750070 0000000DSTX016 204 000000000A/217 1461 000000000A/213 167 209 000000000A/241 000000000A/242 9833 154 9759 00000000097/63 00000000097/04 128 000000000A/166 112 0000271/119/28 000000000A/249 0000000136/300 0000000000A117 0000000#258097 9745 000226/116/273 149 00000000098/32 208 9747 000000000A/223 9723 9806 135 106 210 0000000000B186 132 0000000000A162 9737 142 159 000131/288/295 229 000000000A/190 000000000A/219 9756 158 000000000A/238 000000000A/195 9549 000000000A/191 9758 0000000DSTX014 0000000DSTX017 195 000000XL129601 0000000DSTX015 150 165 000000XL069502 134 225 A/229 222 000000DSTXL001 237 111 SMSA100801 122 194 000282/123/284 000304/144/308 000A104/A157/3 98410147 00000000A/1035 000250/109/257 180 UNKNOWN 000000000A/189 212 0000000000A226 223 000A202/A193/C 000113/259/275 113 181 164 A/245 A/249 000A102/161/32 000160/A101/32 000285/130/290 000293/135/297 000J2/229/A463 000182/124/357 000A205/200/C3 151 99370248 240 215 000000000A/195 152 168
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letters dated March 10, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
A cable failure associated with the arm or gantry rotation of the DST-XL Camera that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) Physio-Control LIFEPAK® 20 defibrillator/monitor. This product is an external
    defibrillator sold internationally and domestically; Device Part Number:
    3202459-061, 3202487-015, 3202487-073, 3202487-075, 3202487-078,
    3202487-079, 3202487-100, 3202488-036, 3202488-038 and 3202488-040;
    Recall # Z-2009-2008;
b) Physio-Control LIFEPAK® 20e defibrillator/monitor. This product is an external
    defibrillator sold internationally only; Device Part Number: 3202488-053;
    Recall # Z-2010-2008;
c) Keypad replacement for LIFEPAK20 or LIFEPAK20e. This product is an external
    defibrillator; Recall # Z-2011-2008
CODE
a) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093; Device SN number: 31013593, 31018361, 31521701, 32358182, 33035378, 35506844, 35506880, 35506886, 35506887, 35512605, 35514416, 35719026, 35719588, 35719590, 35719593, 35740798, 35740799, 35742042, 35742271, 35742274, 35744129, 35744131, 35744132, 35744133, 35744201, 35744905, 35744912, 35744913, 35744914, 35744917, 35744919, 35744921, 35744931, 35744933, 35744934, 35744935, 35744939, 35744940, 35744941, 35746673, 35746683, 35746685, 36090252, 36090256, 36090257, 36090258, 36090259, 36090262, 36090264, 36090265, 36090266, 36090268, 36090269, 36090270, 36090272, 36090273, 36090274, 36090275, 36090278, 36090279, 36090280, 36090281, 36090285, 36090286, 36090287, 36090289, 36090290, 36093885, 36101738, 36101739, 36101740, 36101742, 36101743, 36101745, 36101746, 36133741, 36133760, 36137373, 36139003, 36139004, 36139008, 36139015, 36139016, 36139017, 36139018, 36139019, 36139022, 36139027, 36139028, 36139029, 36139030, 36139032, 36141368, 36141385, 36141389, 36141390, 36141403, 36141404, 36141405, 36142719, 36142720, 36142721, 36142724, 36142727, 36142732, 36143803, 36143804, 36143816, 36143817, 36143818, 36143819, 36143820, 36143821, 36143822, 36143824, 36143827, 36143831, 36143832, 36143833, 36143834, 36143835, 36143836, 36143837, 36143838, 36143839, 36143840, 36143841, 36143842, 36143843, 36143844, 36143845, 36143846, 36143847, 36143850, 36143851, 36146450, 36146451, 36146452, 36146454, 36146455, 36146457, 36146458, 36146459, 36146460, 36146461, 36146463, 36146464, 36146465, 36146467, 36146469, 36146470, 36146471, 36146472, 36146473, 36146474, 36146475, 36146476, 36146477, 36146478, 36146479, 36146480, 36146482, 36146483, 36146484, 36153459, 36153460, 36153463, 36163333, 36163334, 36163335, 36163340, 36163341, 36163349, 36163351, 36163353, 36163354, 36163420, 36163423, 36164927, 36164928, 36164930, 36164931, 36164932, 36164934, 36164936, 36164937, 36164938, 36164942, 36164943, 36164949, 36164950, 36164951, 36164953, 36164956, 36164957, 36164961, 36164962, 36164963, 36164964, 36164966, 36164967, 36164968, 36164969, 36164970, 36164971, 36164972, 36164973, 36164974, 36164976, 36164977, 36164978, 36164979, 36164980, 36164981, 36164982, 36164983, 36168841, 36168842, 36168843, 36168844, 36168846, 36168847, 36168848, 36168849, 36168850, 36168851, 36168852, 36168853, 36168854, 36168855, 36168856, 36168857, 36168858, 36168859, 36168860, 36168861, 36168862, 36168863, 36168864, 36168865, 36168866, 36168867, 36168868, 36168869, 36168870, 36168871, 36168872, 36168873, 36168874, 36168875, 36168876, 36168877, 36168878, 36168880, 36168881, 36168882, 36168883, 36168884, 36168885, 36168886, 36168887, 36168888, 36168889, 36168890, 36168891, 36168892, 36168893, 36172860, 36172861, 36172862, 36172863, 36172864, 36172865, 36172866, 36172867, 36172868, 36172869, 36172870, 36172871, 36172872, 36172873, 36172874, 36172875, 36172876, 36172877, 36172878, 36172879, 36172880, 36172881, 36172882, 36172883, 36172884, 36172885, 36172886, 36172887, 36172888, 36172889, 36172890, 36172891, 36172892, 36172893, 36172894, 36172895, 36172896, 36172897, 36172898, 36172899, 36172900, 36172901, 36172902, 36172903, 36172904, 36172905, 36172906, 36172907, 36172908, 36172909, 36172910, 36172911, 36172912, 36172914, 36172915, 36172916, 36172918, 36172919, 36172920, 36172921, 36172922, 36172923, 36175050, 36175051, 36175052, 36175053, 36175054, 36175055, 36175056, 36175057, 36175058, 36175059, 36175060, 36175061, 36175062, 36175063, 36175064, 36175065, 36175066, 36175067, 36175068, 36175069, 36175070, 36175071, 36175072, 36175073, 36175074, 36175075, 36175077, 36175078, 36175079, 36175080, 36175081, 36175082, 36175083, 36175084, 36175085, 36175086, 36175087, 36175088, 36175089, 36175090, 36175091, 36175092, 36175093, 36175094, 36175095, 36175096, 36175097, 36175098, 36175099, 36175100, 36175101, 36175102, 36175103, 36178241, 36178242, 36178246, 36178247, 36178248, 36178249, 36178250, 36178251, 36178252, 36178254, 36178255, 36178256, 36178257, 36178258, 36178259, 36178261, 36178263, 36178278, 36178835, 36178836, 36178837, 36178838, 36178839, 36178840, 36178841, 36178842, 36178843, 36178844, 36178845, 36178847, 36178848, 36178849, 36178850, 36178851, 36178852, 36179224, 36179225, 36179227, 36179228, 36179229, 36179232, 36179233, 36179234, 36179235, 36179236, 36183644, 36183645, 36183646, 36186161, 36186162, 36186163, 36186165, 36186166, 36186168, 36186169, 36186170, 36186171, 36186173, 36186174, 36186175, 36186176, 36186177, 36186179, 36186180, 36186181, 36186184, 36186185, 36186187, 36186188, 36186191, 36186192, 36186195, 36186196, 36186197, 36186198, 36186199, 36186201, 36186204, 36186206, 36186207, 36186208, 36186209, 36186210, 36186219, 36188677, 36188678, 36188679, 36188680, 36188682, 36188683, 36188684, 36188687, 36188688, 36188689, 36188691, 36188692, 36188693, 36188694, 36188695, 36188696, 36188697, 36188698, 36188699, 36188702, 36188751, 36188753, 36188754, 36188755, 36188756, 36188757, 36188758, 36188759, 36188760, 36188761, 36188762, 36188763, 36188764, 36188765, 36188766, 36188767, 36188768, 36188769, 36188770, 36188771, 36188772, 36188773, 36188774, 36190699, 36190700, 36190701, 36190702, 36190703, 36190704, 36190705, 36190706, 36190707, 36190708, 36190709, 36190710, 36190711, 36190713, 36190714, 36190715, 36190716, 36190717, 36190718, 36200457, 36200459, 36200460, 36200461, 36200462, 36200463, 36200467, 36200468, 36200470, 36231195, 36231199, 36231204, 36231206, 36231895, 36231896, 36231902, 36231904, 36231944, 36231946, 36231948, 36231951, 36231952, 36232023, 36232024, 36232025, 36232026, 36232027, 36232028, 36232029, 36232030, 36232031, 36232257, 36232258, 36232259, 36232260, 36232261, 36232262, 36232474, 36232476, 36232477, 36232479, 36232480, 36232481, 36232482, 36232483, 36233781, 36233782, 36233783, 36233796, 36233797, 36233798, 36233799, 36233800, 36233801, 36233802, 36233803, 36233805, 36234054, 36234055, 36234056, 36234058, 36234060, 36234062, 36234063, 36234064, 36234343, 36234344, 36234345, 36234525, 36234526, 36234528, 36234529, 36234530, 36234531, 36234532, 36234636, 36234637, 36234639, 36234645, 36234647, 36236441, 36236442, 36244526, 36244527, 36244528, 36244529, 36244579, 36244581, 36244582, 36244583, 36244586, 36244588, 36244590, 36244591, 36244592, 36244593, 36244594, 36244595, 36244596, 36244598, 36244600, 36244601, 36245174, 36245176, 36245177, 36245178, 36245179, 36245181, 36245182, 36245183, 36245184, 36245185, 36245186, 36245188, 36245189, 36245190, 36245191, 36245192, 36245193, 36245194, 36245195, 36245196, 36245197, 36245198, 36245199, 36245201, 36245204, 36245205, 36245208, 36245209, 36245210, 36253898, 36253899, 36253900, 36253901, 36253902, 36253904, 36253905, 36253906, 36253907, 36253908, 36253909, 36253910, 36253911, 36253912, 36253914, 36253915, 36253916, 36253917, 36253918, 36253919, 36253920, 36253921, 36253922, 36253923, 36253924, 36253925, 36253926, 36253927, 36253928, 36253929, 36253930, 36253931, 36253932, 36253933, 36253934, 36253936, 36253937, 36253938, 36253939, 36253940, 36253941, 36253942, 36253943, 36253944, 36253945, 36253946, 36253947, 36253948, 36253949, 36253950, 36253951, 36253952, 36253953, 36253954, 36253955, 36253956, 36253957, 36253958, 36253959, 36257336, 36257338, 36257339, 36257341, 36257342, 36257361, 36257362, 36257363, 36257364, 36257365, 36257366, 36257368, 36257369, 36257370, 36257372, 36257373, 36257374, 36257375, 36257376, 36257378, 36257379, 36257380, 36257381, 36257383, 36257387, 36257388, 36257389, 36257390, 36257392, 36257393, 36257394, 36257395, 36257396, 36257397, 36257398, 36257399, 36257400, 36259179, 36260824, 36260825, 36260826, 36260827, 36260828, 36260829, 36260830, 36260831, 36260832, 36260833, 36260834, 36260835, 36260836, 36260837, 36260838, 36260839, 36260840, 36260841, 36260842, 36260843, 36260845, 36260846, 36260847, 36260848, 36260849, 36260850, 36260851, 36260852, 36260853, 36260854, 36260855, 36260856, 36260857, 36260858, 36260859, 36260860, 36260861, 36260862, 36260863, 36260864, 36260865, 36260866, 36260867, 36260868, 36260869, 36260870, 36260871, 36260872, 36260873, 36264639, 36264640, 36264641, 36264642, 36264643, 36264644, 36264645, 36264646, 36264647, 36264648, 36264649, 36264650, 36264653, 36264654, 36264655, 36264656, 36264657, 36264658, 36264660, 36264662, 36264663, 36264664, 36264666, 36264668, 36264669, 36264670, 36264671, 36264672, 36264674, 36264676, 36264678, 36264680, 36264681, 36264684, 36264686, 36264687, 36264689, 36264690, 36264692, 36264693, 36264695, 36267500, 36267501, 36267502, 36267503, 36267504, 36267505, 36267506, 36267507, 36267508, 36267510, 36267512, 36267513, 36267514, 36267515, 36267516, 36267517, 36267518, 36267519, 36267520, 36267521, 36267523, 36267524, 36267525, 36267526, 36267528, 36267529, 36267530, 36270152, 36270153, 36270155, 36270157, 36270158, 36270162, 36270163, 36270165, 36270166, 36270167, 36270168, 36270169, 36270170, 36270171, 36270175, 36270178, 36270180, 36273072, 36273077, 36273078, 36273079, 36273080, 36273081, 36273082, 36273085, 36273087, 36273090, 36273092, 36273093, 36273094, 36273095, 36273096, 36273934, 36273935, 36273937, 36273939, 36273979, 36273980, 36273981, 36273983, 36273984, 36273987, 36273988, 36273989, 36273990, 36273992, 36273993, 36273994, 36273995, 36273997, 36273998, 36273999, 36274000, 36274001, 36274002, 36274003, 36274006, 36274688, 36274689, 36274694, 36274695, 36274696, 36274698, 36274700, 36274702, 36274703, 36274705, 36274707, 36274708, 36274711, 36274713, 36274913, 36274914, 36274915, 36274916, 36274917, 36274920, 36274921, 36280952 and 36280953;

b) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093; Device SN: 36053634, 36053641, 36053642, 36053647, 36053651, 36053653, 36053654, 36082047, 36082048, 36082049, 36082050, 36082051, 36082054, 36102742, 36102743, 36102744, 36102745, 36102746, 36107743, 36107744, 36107746, 36107747, 36109647, and 36109667;

c) Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Customers who received the effected keypad will not be able to identify the unit based on lot code unless they retained the original product labeling.
RECALLING FIRM/MANUFACTURER
Physio Control, Inc. Redmond, WA, by letters on May 13, 2008. Firm initiated recall is ongoing.
REASON
A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE
1,315 keypads in LifePak units and 78 independent keypads
DISTRIBUTION
Nationwide, Germany, Netherlands, Canada, Australia, Hong Kong
___________________________________
PRODUCT 
Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Correct Overflow lid: Medela CH-6341 Baar Switzerland Art. No. 077.0440, Small lid with conical patient connection 6-10mm and overflow protection device.(Incorrect overflow lid is Medela P/N: 077.0450); Recall # Z-2168-2008
CODE
Serial #: 1163101 - 1163120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter April 2008.
Manufacturer: Medela AG Medical Technology, Baai, Switzerland. Firm initiated recall is ongoing.
REASON
Some Medela Vario 18 Vacuum Pumps were provided with an incorrect suction Jar Lid that did not have the correct conical connection for the Vacuum Tube.
VOLUME OF PRODUCT IN COMMERCE
1,500 units (20 affected)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a)  Medtronic Synchromed II Programmable Pump, 20 ml Pumps Model 8637-20.
    The implantable Medtronic SynchroMed II Programmable Pump is part of the
    SynchroMed II Infusion System designed to contain and administer prescribed
    drugs to a specific site. The implantable components of the SynchroMed II
    Infusion System include the pump, catheter, and catheter accessories;
    Recall # Z-2181-2008;
b) Medtronic Synchromed II Programmable Pump, 40 ml Pumps Model 8637-40.
    The implantable Medtronic SynchroMed II Programmable Pump is part of the
    SynchroMed II Infusion System designed to contain and administer prescribed
    drugs to a specific site. The implantable components of the SynchroMed II
    Infusion System include the pump, catheter, and catheter accessories;
    Recall # Z-2182-2008
CODE
a) NGP300011H- NGP307363H NGP307409H NGP307456H NGP307464H NGP307466H NGP307467H NGP307473H NGP307481H NGP307482H NGP307485H NGP307486H NGP307487H NGP307488H NGP307489H NGP307490H NGP307491H NGP307493H NGP307494H NGP307495H NGP307496H NGP307499H NGP307500H NGP307501H NGP307502H NGP307503H NGP307504H NGP307505H NGP307506H NGP307507H NGP307508H NGP307509H NGP307510H NGP307511H NGP307518H NGP307519H NGP307520H NGP307522H NGP307523H NGP307525H NGP307532H NGP307539H NGP307542H NGP307547H NGP307550H NGP307553H NGP307554H NGP307556H NGP307558H NGP307559H NGP307562H NGP307564H NGP307566H NGP307567H NGP307568H NGP307570H NGP307572H NGP307574H NGP307575H NGP307577H NGP307579H NGP307581H NGP307582H NGP307583H NGP307584H NGP307587H NGP307591H NGP307593H NGP307594H NGP307595H NGP307596H NGP307597H NGP307598H NGP307600H NGP307602H NGP307603H NGP307604H NGP307606H NGP307608H NGP307609H NGP307612H NGP307614H NGP307616H NGP307618H NGP307619H NGP307620H NGP307621H NGP307623H NGP307624H NGP307625H NGP307626H NGP307627H NGP307628H NGP307629H NGP307633H NGP307634H NGP307636H NGP307640H NGP307642H NGP307643H NGP307644H NGP307645H NGP307646H NGP307647H NGP307648H NGP307649H NGP307652H NGP307654H NGP307655H NGP307657H NGP307658H NGP307659H NGP307660H NGP307662H NGP307663H NGP307853H NGP309113H, and NGP309162H;

b) NGV300002H - NGV405839H NGV405840H NGV405842H NGV405843H NGV405844H NGV405848H NGV405849H NGV405850H NGV405853H NGV405854H NGV405856H NGV405858H NGV405859H NGV405860H NGV405861H NGV405862H NGV405870H NGV405871H NGV405873H NGV405874H NGV405875H NGV405877H NGV405879H NGV405880H NGV405883H NGV405884H NGV405888H NGV405890H NGV405896H NGV405897H NGV405898H NGV405899H NGV405900H NGV405901H NGV405902H NGV405903H NGV405904H NGV405905H NGV405906H NGV405907H NGV405908H NGV405909H NGV405911H NGV405913H NGV405915H NGV405916H NGV405917H NGV405919H NGV405920H NGV405922H NGV405928H NGV405929H NGV405930H NGV405931H NGV405932H NGV405934H NGV405935H NGV405936H NGV405937H NGV405939H NGV405942H NGV405943H NGV405944H NGV405946H NGV405947H NGV405949H NGV405951H NGV405952H NGV405957H NGV405959H NGV405961H NGV405963H NGV405964H NGV405965H NGV405967H NGV405968H NGV405969H NGV405970H NGV405971H NGV405972H NGV405973H NGV405974H NGV405975H NGV405976H NGV405978H NGV405979H NGV405980H NGV405981H NGV405982H NGV405983H NGV405985H NGV405990H NGV405992H NGV405994H NGV405995H NGV405996H NGV405997H NGV405999H NGV406001H NGV406002H NGV406006H NGV406008H NGV406010H NGV406011H NGV406012H NGV406013H NGV406014H NGV406015H NGV406016H NGV406017H NGV406018H NGV406021H NGV406022H NGV406023H NGV406024H NGV406025H NGV406028H NGV406029H NGV406030H NGV406031H NGV406032H NGV406033H NGV406034H NGV406037H NGV406038H NGV406039H NGV406040H NGV406041H NGV406044H NGV406046H NGV406047H NGV406048H NGV406049H NGV406050H NGV406051H NGV406052H NGV406053H NGV406054H NGV406055H NGV406056H NGV406058H NGV406059H NGV406060H NGV406061H NGV406062H NGV406063H NGV406064H NGV406066H NGV406067H NGV406068H NGV406069H NGV406071H NGV406072H NGV406073H NGV406075H NGV406076H NGV406078H NGV406080H NGV406082H NGV406083H NGV406084H NGV406085H NGV406086H NGV406087H NGV406089H NGV406090H NGV406091H NGV406092H NGV406094H NGV406095H NGV406096H NGV406097H NGV406099H NGV406100H NGV406101H NGV406104H NGV406105H NGV406106H NGV406107H NGV406108H NGV406109H NGV406110H NGV406112H NGV406113H NGV406114H NGV406117H NGV406118H NGV406119H NGV406122H NGV406123H NGV406125H NGV406126H NGV406127H NGV406128H NGV406129H NGV406131H NGV406132H NGV406133H NGV406134H NGV406135H NGV406137H NGV406164H NGV406169H NGV406174H NGV406187H NGV406227H NGV406627H NGV406747H NGV407899H NGV407906H, and NGV408059H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letters dated May 2008.
Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. Firm initiated recall is ongoing.
REASON
SynchroMed II pumps (non-implanted) may have been manufactured without propellant.
VOLUME OF PRODUCT IN COMMERCE
11,920 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
a) AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree
    Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO.
    Manufactured in U.S.A. The AMPLATZER Delivery System was designed to
    facilitate attachment, loading, delivery and deployment of the AMPLATZER
    Septal Occluder and comprised of a delivery sheath, dilator, loading device,
    plastic vise and delivery cable; Recall # Z-2192-2008;
b) AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. Manufactured in U.S.A.
    A triple lumen balloon catheter with 3 radiopaque marker bands located inside the
    balloon to allow for radiographic measurement. The center of the balloon contains
    a pair of marker bands 0.4 mm apart and one marker band 15 mm proximal of that
    pair. The AMPLATZER Sizing Balloon II is intended for use in those patients with
    cardiovascular defects wherein accurate measurement of the defect is important to
    select the appropriately sized occluder device; Recall # Z-2193-2008
CODE
a) Lot number M07K29-32;
b) Lot number M08B11-34
RECALLING FIRM/MANUFACTURER
AGA Medical Corp, Golden Valley, MN, by letter on April 28, 2008. Firm initiated recall is ongoing.
REASON
AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility.
VOLUME OF PRODUCT IN COMMERCE
10 delivery systems, 131 Sizing Balloons
DISTRIBUTION
Nationwide, Brazil, Greece, Netherlands, Portugal, Slovakia
___________________________________
PRODUCT 
Varis Aria Radiation Oncology Version 8.1. The device is designed to assist the operator in providing accurate treatment setups for each patient by monitoring parameters and preventing the device from commencing radiation treatment plan inappropriately; Recall # Z-2194-2008
CODE
Serial numbers: HIT0002, HIT0004M, HIT0005, HIT0028, HIT0043M, HIT0052, HIT0064, HIT0097M, HIT0467, HIT0468, HIT0480M, HIT0468, HIT0480M, HIT0486, HIT0487, HIT0490, HIT0492, HIT0507, HIT0860, HIT0863, HIT0864, HIT0870M, HIT0890, HIT0909, HIT0910, HIT0912, HIT1132, HIT1151, HIT1152, HIT1155, HIT1157, HIT1159, HIT1168, HIT1172, HIT1356, HIT1359, HIT1363, HIT1369, HIT1373, HIT1381, HIT1390, HIT1394, HIT1544, HIT1548, HIT1551, HIT1558, HIT1571, HIT1573, HIT1577, HIT0107, HIT0121, HIT0124, HIT0125, HIT0145, HIT0147, HIT0170, HIT0227, HIT0249, HIT0270, HIT0288, HIT0300, HIT0314, HIT0318, HIT0321, HIT0326, HIT0339, HIT0346, HIT0350, HIT0351, HIT0355M, HIT0368, HIT0378, HIT0381, HIT0396, HIT0401, HIT0402, HIT0414, HIT0416, HIT0419, HIT0426, HIT0436M, HIT0437, HIT0461, HIT0515, HIT0522, HIT0525M, HIT0547, HIT0565, HIT0587, HIT0588, HIT0624, HIT0633, HIT0650, HIT2651, HIT0660, HIT0671, HIT0681, HIT0682, HIT0689, HIT0711, HIT0712, HIT0739, HIT0750, HIT0754, HIT0771, HIT0782, HIT0787, HIT0797, HIT0804, HIT0810, HIT0812, HIT0840, HIT0843, HIT0844, HIT0848, HIT0856, HIT0858, HIT0925, HIT0944, HIT0949M, HIT0950, HIT0951, HIM, HIT0951R1, HIT2956, HIT0962, HIT0968, HIT0977, HIT0993, HIT1006, HIT1010, HIT1016, HIT1024, HIT1027, HIT1043, HIT1047, HIT1052, HIT1058, HIT1062, HIT1064, HIT1072, HIT1082, HIT1087, HIT1093, HIT1098, HIT1110M, HIT1115, HIT1116, HIT1121, HIT1122, HIT1128, HIT1190, HIT1200, HIT1208, HIT1215, HIT1216, HIT1225, HIT1231, HIT1235, HIT1243, HIT1245, HIT1247, HIT1250, HIT1252, HIT1260, HIT1264, HIT1267, HIT1269, HIT1273, HIT1275, HIT1277, HIT1278, HIT1284, HIT1288, HIT1296, HIT1298, HIT1303, HIT1306, HIT1315, HIT1317, HIT1321, HIT1323, HIT1329, HIT1343, HIT1353, HIT1398, HIT1399, HIT1402, HIT1404, HIT1410, HIT1413, HIT1415, HIT1421, HIT1423, HIT1426, HIT1432, HIT1433, HIT1435, HIT1438, HIT1443, HIT1444, HIT1451, HIT1458M, HIT1464, HIT1469, HIT1473, HIT1478, HIT1481, HIT1483, HIT1486 , HIT1493, HIT1496, HIT1505, HIT1506, HIT1518M, HIT1521, HIT1526, HIT1539, HIT1541, HIT1579, HIT1584, HIT1592, HIT1594, HIT1597, HIT1599, HIT1604, HIT1606, HIT1614, HIT1616, HIT1623, HIT1626, HIT1628, HIT1632, HIT1635, HIT1639, HIT1644, HIT1658, HIT1660, HIT1662, HIT1678, HIT1679, and HIT1712
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Oncology Systems, Palo Alto, CA, by letter on May 21, 2008. Firm initiated recall is ongoing.
REASON
Dose delivery may be altered after import from a third party planning system during radiation therapy.
VOLUME OF PRODUCT IN COMMERCE
241 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Update Instructions "TH003/08/S" applies to Siemens brand SIMIVIEW 3000, SIMVIEW NT, and MEV ASIM S systems; Part Number: 5488460; The product is indicated for use in Radiation therapy simulation; Recall # Z-2196-2008
CODE
All codes
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter and on-site visit on June 25, 2008. Firm initiated recall is ongoing.
REASON
The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling inadvertent motion and serious injury may result.
VOLUME OF PRODUCT IN COMMERCE
300 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body; Recall # Z-2225-2008
CODE
000000000R1597 000000000R5210 000000000R5871 00000007557YR2 00000007496YR3 00000010285YR5 00000008560YR5 00000009025YR8 0000000B523YR3 00000006697YR7 00000007562YR2 00000005539YR2 00000006662YR1 00000007568YR9 00000007108YR4 00000007497YR1 00000007542YR4 00000008116YR6 00000008322YR0 00000008384YR0 00000009538YR0 00000010300YR2 00000007114YR2 00000006604YR3 00000008325YR3 00000009872YR3 00000006557YR3 00000009534YR9 00000007563YR0 00000009854YR1 00000006722YR3 00000007541YR6 00000008376YR6 00000008317YR0 00000008099YR4 00000009006YR8 00000007126YR6 00000008351YR9 00000010283YR0 00000009009YR2 00000005981YR6 00000008100YR0 00000006710YR8 00000008098YR6 00000007890YR7 00000006594YR6 00000008539YR9 00000007871YR7 00000007564YR8 00000005992YR3 00000007556YR4 00000007498YR9 00000007878YR2 00000007565YR5 00000007877YR4 00000007100YR1 00000008993YR* 00000007097YR9 00000009436YR7 00000009419YR3 00000006698YR5 00000007530YR9 00000009858YR2 00000009082YR9 00000007551YR5 00000007870YR9 00000007508YR5 00000009539YR8 00000008404YR6 00000006713YR2 00000008339YR4 00000008396YR4 00000009773YR3 00000009576YR0 00000008352YR7 00000006707YR4 00000006678YR7 00000007582YR0 00000007882YR4 00000007887YR3 00000010511YR4 00000006558YR1 00000009566YR1 00000008197YR6 00000007087YR0 00000007859YR2 00000009060YR5 00000008387YR3 00000009461YR5 00000008342YR8 00000005564YRO 00000007133YR2 00000005537YR6 00000006737YR1 00000006757YR9 00000010160YR0 00000010396YR0 00000005564YR0 00000005532YR7 00000009052YR2 00000007532YR5 00000006690YR2 00000008355YR0 00000006691YR0 00000007099YR5 00000006574YR8 00000009545YR5 00000005970YR9 00000007858YR4 00000007856YR8 00000006682YR9 00000008338YR6 00000005927YR5 00000007549YR9 00000007122YR5 00000006696YR9 00000006715YR7 00000009979YR6 00000009553YR9 00000010525YR4 00000005222YR5 00000010132YR9 00000010432YR3 00000010284YR8 00000010048YR7 00000009618YR0 00000009421YR9 00000009848YR3 00000009578YR6 00000006738YR9 00000009084YR5 00000007866YR7 00000007865YR9 00000007514YR3 00000010045YR3 00000009587YR7 00000009986YR1 00000009766YR7 00000006721YR5 00000009531YR5 00000010028YR9 00000006600YR1 00000010395YR2 00000006727YR2 00000010134YR5 00000007544YR0 00000010289YR7 00000005548YR3 00000007547YR3 00000007555YR6 00000007853YR5 00000006572YR2 00000006670YR4 00000006673YR8 00000008332YR9 00000009867YR3 00000005974YR1 00000006669YR6 00000009982YR0 00000009774YR1 00000010163YR4 00000005215TR9 00000009049YR8 00000007117YR5 00000008378YR2 00000008373YR3 00000007594YR5 00000006716YR5 00000009617YR2 00000008391YR5 00000008059YR8 00000005216YR7 00000006566YR4 00000008337YR8 00000008392YR3 00000009007YR6 00000005536YR8 00000009775YR8 00000007572YR1 00000009599YR2 00000007862YR6 00000007507YR7 00000006570YR6 00000006708YR2 00000006714YR0 00000009845YR9 00000007591YR1 00000007561YR4 00000008335YR2 00000009438YR3 00000007579YR6 00000009547YR1 00000008327YR9 00000009028YR2 00000008061YR4 00000006667YR0 00000006556YR5 00000010059YR4 00000006660YR5 00000006568YR0 00000008359YR2 00000010153YR5 00000009571YR1 00000006743YR9 00000009990YR3 00000006733YR0 00000007884YR0 00000009455YR7 00000009070YR4 00000008380YR8 00000008385YR7 00000007116YR7 00000010144YR4 00000009019YR1 00000010063YR6 00000009062YR1 00000007109YR2 00000009593YR5 00000009564YR6 00000007867YR5 00000007539YR0 00000007520YR0 00000006705YR8 00000009031YR6 00000007090YR4 00000009081YR1 00000007864YR2 00000010302YR8 00000007863YR4 00000005990YR7 00000008372YR5 00000010393YR7 00000009973YR9 00000009627YR1 00000008530YR8 00000007554YR9 00000009847YR5 00000008318YR8 00000009057YR1 00000007869YR1 00000009026YR6 00000008367YR5 00000007892YR3 00000007540YR8 00000006665YR4 00000006562YR3 00000009053YR0 00000007115YR9 00000009865YR7 00000009642YR0 00000009846YR7 00000009459YR9 00000009573YR7 00000006577YR1 00000008364YR2 00000006661YR3 00000005525YR1 00000008394YR9 00000009080YR3 00000007516YR8 00000010140YR2 00000008319YR6 00000008528YR2 00000005559YR0 00000009565YR3 00000009442YR5 00000006726YR4 00000007577YR0 00000006573YR0 00000005220YR9 00000008354YR3 00000008347YR7 00000007588YR7 00000006555YR7 00000008377YR4 00000009581YR0 00000006583YR9 00000009018YR3 00000005543YR4 00000008103YR4 00000008537YR3 00000008534YR0 00000008314YR7 00000009030YR8 00000008561YR3 00000007575YR4 00000009047YR2 00000009083YR7 00000007845YR1 00000007534YR1 00000009454YR0 00000007107YR6 00000009572YR9 00000008123YR2 00000008542YR3 00000008323YR8 00000007505YR1 00000007518YR4 00000009037YR3 00000010168YR3 00000007531YR7 00000009837YR6 00000006595YR3 00000007101YR9 00000007105YR0 00000008991YR2 00000008311YR3 00000008549YR8 00000008532YR4 00000007134YR0 00000009450YR8 00000008358YR4 00000007570YR5 00000010060YR2 00000008366YR7 00000007566YR3 00000010035YR4 00000005982YR4 00000007098YR7 00000007528YR3 00000009001YR9 00000009763YR4 00000008362YR6 00000006694YR4 00000008097YR8 00000005555YR8 00000008402YR0 00000010627YR8 00000010157YR6 00000009984YR6 00000009864YR0 00000009619YR8 00000006725YR6 00000007088YR8 00000007112YR6 00000007111YR8 00000007123YR3 00000008122YR4 00000006672YR0 00000008350YR1 00000008527YR4 00000009032YR4 00000008992YR0 00000008371YR7 00000009027YR4 00000009579YR4 00000010037YR0 00000009561YR2 00000007504YR4 00000010031YR3 00000010487YR7 00000008557YR1 00000006706YR6 00000007092YR0 00000007574YR7 00000008195YR0 00000007503YR6 00000008986YR2 00000006754YR6 00000008990YR4 00000277444MR6 00000279066MR5 00000278393MR4 00000277641MR7 00000280066MR2 00000274886MR1 00000280365MR8 00000276657MR4 00000279414MR7 00000273383MRO 00000281158MR6 00000280778MR2 00000282865MR5 00000274740MR0 00000277535MR1 00000279464MR2 00000279447MR7 00000276184MR9 00000281828MR4 00000278605MR1 00000278800MR8 00000278554MR1 00000280921MR8 00000283517MR1 00000280253MR6 00000280251MR0 00000276680MR6 00000278041MR9 00000280252MR8 00000276457MR9 00000285493MR3 00000280065MR4 00000276656MR6 00000277917MR1 00000277534MR4 00000279400MR6 00000280364MR1 00000273632MR0 00000279910MR4 00000274742MR6 00000000000001 00000279067MR3 00000276245MR8 00000284034MR6 00000278391MR8 00000279166MR3 00000280775MR8 00000000000000 00000281825MR0 00000283346MR5 00000280249MR4 00000278606MR9 00000275537MR9 00000277779MR5 00000279909MR6 00000286339MR7 00000279882MR5 00000278164MR9 00000285490MR9 00000027810MR1 00000281863MR1 00000278799MR2 00000283458MR8 00000284493MR4 00000274887MR9 00000278103MR7 00000280857MR4 00000282383MR9 00000279908MR8 00000282508MR1 00000275526MR2 00000285589MR8 00000279461MR8 00000276163MR3 00000280777MR4 00000281467MR1 00000278223MR3 00000280328MR6 00000273631MR2 00000279563MR1 00000284872MR9 00000280325MR2 00000279616MR7 00000284562MR6 00000285496MR6 00000283516MR3 00000279398MR2 00000280068MR8 00000276243MR3 00000285167MR3 00000272922MR6 00000285437MR0 00000285166MR5 00000276244MR1 00000278039MR3 00000278801MR6 00000278556MR6 00000281375MR6 00000278315MR7 00000280366MR6 00000283773MR0 00000278221MR7 00000284650MR9 00000278674MR7 00000282003MR3 00000278676MR2 00000285674MR8 00000284869MR5 00000276265MR6 00000280673MR5 00000275647MR6 00000278851MR1 00000284234MR2 00000280000MR1 00000279068MR1 00000276266MR4 00000275967MR8 00000275648MR4 00000282549MR5 00000280781MR6 00000283745MR8 00000274744MR2 00000275046MR1 00000275968MR6 00000278397MR5 00000281341MR8 00000276434MR8 00000284261MR5 00000280780MR8 00000285053MR5 00000275465MR3 00000268369MR6 00000260651MR5 000000HDMR2329 000000HDMR2927 00000HDMR22498 00000HDMR10281 00000HDMR10273 00000HDMR20270 00000HDMR10462 000000HDMR2471 000000HDMR3334 000000HDMR2613 000000HDMR3288 000000HDMR2438 00000HDMR20181 000000HDMR2441 00000HDMR20228 000000HDMR2872 00000HDMR20034 00000276073MR4 00000001568422 000000HDMR2901 000000HDMR2799 00000HDMR20056 000000HDMR3407 00000DDDM10670 00000HDMR20044 00000HDMR20171 000000HDMR2444 00000HDMR10788 00000HDMR10322 000000HDMR2936 00000HDMR20294 000000HDMR2531 00000HDMR20219 00000HDMR20235 000000HDMR2829 000000HDMR2893 00000HDMR20018 000000HDMR2528 00000HDMR20061 00000HDMR10743 00000HDMR11028 000000HDMR2686 00000HDMR20206 000000HDMR2508 00000HDMR20142 00000HDMR20050 00000HDMR20151 000000HDMR2515 00000HDMR10404 000000HDMR2641 000000HDMR2888 00000HDMR20158 000000HDMR2998 00000275160MR0 000000HDMR3089 00000HDMR20276 00000HDMR20065 00000HDMR20053 000000HDMR2451 000000HDMR2463 000000HDMR2553 000000HDMR2689 000000HDMR2335 00000001516299 000000HDMR2482 00000275157MR6 00000HDMR20070 00000273807MR8 000000HDMR3373 000000HDMR1111 000000HDMR3298 00000HDMR10291 000000HDMR1005 00000HDMR10846 000000HDMR3048 000000HDMR3262 000000HDMR2591 000000HDMR2651 000000HDMR2675 00000HDMR10831 00000HDMR10334 00000HDMR10548 00000275162MR6 0000HDMR127452 000000HDMR2522 000000HDMR2344 000000HDMR2803 000000HDMR2626 00000HDMR20236 00000HDMR10739 000000HDMR1130 000000HDMR2993 00000273127MR1 00000HDMR20128 000000HDMR3088 00000HDMR20043 00000HDMR10368 00000274350MR8 00000275283MR0 00000HDMR10489 00000HDMR20084 00000HDMR10986 00000HDMR20059 000000HDMR1098 00000HDMR20068 000000HDMR3221 000000HDMR2404 00000HDMR10440 000000HDMR2560 00000HDMR10412 000000HDMR2822 00000275173MR3 000000HDMR3355 000000HDMR2448 00000275279MR8 000000HDMR2612 000000HDMR2660 00000HDMR10938 00000274359MR9 00000HDMR10764 000000HDMR2397 000000HDMR2523 00000HDMR20073 00000HDMR20289 000000HDMR2428 00000HDMR20248 000000HDMR2623 000000HDMR2756 00000276057MR7 000000HDMR2517 000000HDMR3109 000000HDMR2804 00000HDMR10351 000000HDMR3272 00000HDMR10719 00000HDMR20274 000000HDMR3299 00000HDMR20172 00000HDMR20293 000000HDMR3263 00000HDMR20047 000000HDMR2592 00000HDMR10471 00000HDMR20036 000000HDMR3050 000000HDMR2981 000000HDMR2758 000000HDMR2789 000000HDMR2524 000000HDMR2890 000000HDMR2773 000000HDMR3337 000000HDMR2873 000000HDMR2729 00000005127452 000000HDMR2904 00000HDMR10356 000030485C4228 000000HDMR2948 00000HDMR20291 000000HDMR3316 00000HDMR20269 00000HDMR10711 00000HDMR20189 000000HDMR2418 000000HDMR2755 000000HDMR3128 000000HDMR2831 00000HDMR20272 000000HDMR3199 000000HDMR3130 00000HDMR10477 000000HDMR2958 000000HDMR3459 00000HDMR20178 00000HDMR10878 00000HDMR20089 00000HDMR10787 00000HDMR20099 000000HDMR2769 000000HDMR2917 00000HDMR20290 00000HDMR19996 000000HDMR2395 000000HDMR3003 000000HDMR2483 000000HDMR2696 00000274392MR0 00000HDMR10343 000000HDMR2747 00000HDMR20246 00000HDMR10417 00000273839MR1 00000275236MR8 000000HDMR3301 000000HDMR3542 00000276031MR2 000000HDMR2313 00000273119MR8 000000HDMR2882 000000HDMR2902 00000275237MR6 00000274385MR4 00000HDMR20012 00000273832MR6 00000276038MR7 00000274383MR9 00000275168MR3 00000276042MR9 00000276102MR1 000000HDMR2572 000000HDMR2600 000000HDMR3028 000000HDMR3077 000000HDMR2835 000000HDMR2544 00000275151MR9 00000273132MR1 000000HDMR3452 00000275113MR9 00000275120MR4 00000275107MR1 00000HDMR10623 000000HDMR2521 000000HDMR2808 000000HDMR2779 000000HDMR2695
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by letter in August 2008, Firm initiated recall is ongoing.
REASON
Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.
VOLUME OF PRODUCT IN COMMERCE
720 units estimate
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT 
DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, in vitro diagnostic; Recall # Z-1319-2008
CODE
Lot number: 6122656, Exp: 20090705
RECALLING FIRM/MANUFACTURER
Recalling Firm: BD Diagnostic Systems / Lee Laboratories, Grayson, GA, by letter dated August 2007.
Manufacturer: Difco Laboratories, Inc., Detroit, MI. Firm initiated recall is ongoing.
REASON
Incorrect result: The product exhibited decreased fluorescence when testing with the homologous control organism.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide Distribution and Canada
___________________________________
PRODUCT 
a) ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
    with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011
    or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number
    10032746, 10037592, 10032746, 10037591 or 10038202; Recall # Z-1766-2008;
b) Sonoline Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A,
    with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011
    or 3-Scape Imaging, Field Upgrade, PN 07472520. Material number 5936518,
    8653771 or 10037593; Recall # Z-1767-2008
CODE
a) Serial numbers 113452 113554 113555 113556 113645 113904 114264 114276 114415 114566 114651 114672 114673 114678 114723 114729 114730 114745 114756 114783 114788 114797 114798 114803 114812 114824 114826 114841 114865 114868 114869 114875 114892 114893 114896 114900 114904 114907 114913 114915 114922 114924 114925 114929 114933 114936 114970 114976 114990 114998 115001 115012 115017 115022 115034 115037 115053 115060 115085 115087 115090 115105 115120 115121 115127 115128 115139 115157 115160 115161 115168 115175 115180 115183 115188 115190 115201 115217 115221 115242 115246 115252 115260 115275 115276 115279 115286 115288 115290 115291 115292 115306 115308 115327 115330 115349 115396 115402 115420 115427 115428 115433 115436 115443 115446 115454 115455 115458 115459 115462 115464 115465 115473 115475 115479 115481 115486 115489 115493 115498 115501 115503 115512 115523 115540 115555 115561 115562 115574 115576 115579 115602 115618 113249001 113344001 113423001 113458001 113593001 113731001 113735001 113887001 114252001 10741001 112079001 112376001 112534001 113038001 5000 5001 112978 113029 113048 113051 113052 113053 113068 113075 113092 113101 113105 113124 113131 113145 113147 113148 113204 113257 113259 113288 113299 113371 113407 113411 113414 113462 113469 113483 113540 113557 113584 113627 113640 113664 113672 113674 113682 113684 113694 113708 113715 113722 113756 113759 113767 113769 113780 113785 113790 113808 113809 113831 113832 113846 113849 113850 113851 113852 113855 113863 113873 113917 113980 113981 114012 114043 114052 114059 114061 114164 114271 114274 114313 114356 114363 114364 114369 114373 114401 114406 114412 114423 114461 114474 114475 114481 114482 114500 114581 114590 114595 114597 114655 114669 114671 114699 114703 114721 114738 114743 114744 114753 114760 114764 114775 114777 114787 114790 114792 114793 114796 114799 114802 114807 114809 114818 114819 114820 114827 114828 114831 114833 114835 114838 114842 114843 114844 114845 114847 114848 114849 114850 114851 114860 114861 114863 114864 114874 114876 114878 114880 114881 114882 114883 114885 114886 114890 114891 114894 114895 114899 114901 114908 114918 114920 114921 114927 114935 114937 114941 114942 114943 114944 114945 114950 114951 114954 114955 114956 114957 114960 114961 114962 114965 114973 114975 114977 114981 114984 114986 114991 114993 114996 115002 115006 115008 115010 115013 115018 115019 115028 115029 115030 115032 115033 115038 115039 115040 115041 115042 115043 115044 115045 115047 115050 115052 115054 115061 115070 115074 115082 115094 115098 115102 115103 115106 115108 115111 115112 115144 115146 115147 115149 115150 115151 115156 115158 115164 115172 115174 115189 115191 115192 115196 115199 115202 115205 115207 115209 115210 115216 115219 115228 115235 115238 115240 115245 115247 115251 115253 115254 115257 115258 115262 115263 115264 115266 115270 115273 115282 115289 115293 115296 115299 115300 115301 115302 115309 115312 115315 115316 115317 115319 115321 115322 115324 115326 115329 115336 115337 115346 115348 115350 115353 115356 115357 115360 115366 115367 115369 115375 115376 115377 115385 115391 115394 115397 115398 115416 115422 115444 115472 115478 115488 115494 115499 115510 115513 115514 115519 115521 115527 115529 115530 115535 115541 115542 115544 115551 115552 115556 115557 115558 115559 115565 115567 115570 115580 115582 115591 115592 115601 115604 115607 115610 115612 115617 115628 115169001;
b) Serial numbers 10163 10524 11148 11149 11150 110920 111158 111270 111287     111377 111389 111514 111558 111584 111712 111871 112317 112322 112388     112809 10188001 10437001 10566001 10604001 10669001 11008001 11047001      111552001 111692001 112081001 112081002 112087001 112089001 112117001
112178001 112182001 112306001 112360001 112384001 112554001 112597001 112697001 112704001 112743001 112744001 112776001 112859001 10722
111456 112288 112608
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by site visits on March 21, 2008. Firm initiated recall is ongoing.
REASON
Software issues may result in distorted images and inaccurate measurements, which could lead to a misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
539 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Ev3 IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF VT-5-60-135, Use before 2010-07. The IntraCoil is indicated for use in peripheral arteries in the leg in which balloon angioplasty has been applied. The InraCoil stent is indicated for placement in flexing regions and a tortuous lesion; Recall # Z-1815-2008
CODE
Lot Number: 4401432
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by visit on April 4, 2008. Firm initiated recall is ongoing.
REASON
Incorrect Label: An IntraCoil 5mm x 40 mm stent was labeled as a 5 mm x 60 mm stent (VT-5-40-135 was labeled as VT-5-60-135),
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Boston Scientific Flexima Biliary Stent System, 200 cm long, .035” (0.89 mm), sterile, REF 3921, UNP M00539210. System is used for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone; Recall # Z-2105-2008
CODE
Lot: 11374425
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter on April 2, 2008, Firm initiated recall is complete.
REASON
Rapid Exchange Biliary Stent may be mislabeled as Flexima Biliary Stent, which has a different delivery system included in the package.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5 mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System... Size: 3.5 mm x 14.0 mm Locking Cortical Screw... REF COL-3140-S LOT W46772...Product is used as an orthopedic implant; Recall # Z-2135-2008
CODE
Work order number/Lot: W46772 (W=work order, ###=sequential number); Expiration date: 2012-02 (Year/Month)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR, by fax or e-mail on August 9, 2007.
Manufacturer Firm: Eagle Medical Inc., Paso Robles CA. Firm initiated recall is ongoing.
REASON
Product mislabeled. The inner sticky labels for the patient identified the product incorrectly as a Cortical screw (non-locking). The product package was labeled correctly.
VOLUME OF PRODUCT IN COMMERCE
400 screws
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
AxSYM Rubella IgG Reagent Pack; List 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella, Recall # Z-2175-2008
CODE
Lots: 61151M101 (exp. 12/28/08), 61151M100 (exp. 12/28/08), 60943M101 (exp. 09/22/08), 60943M100 (exp. 09/22/08), 58296M101 (exp. 10/05/08), 58296M100 (exp. 10/05/08), 58295M101 (exp. 09/22/08), 58295M100 (exp. 09/22/08), 58294M101 (exp. 09/01/08), 58294M100 (exp. 09/01/08), 57577M201 (exp. 08/10/08), 57577M200 (exp. 08/10/08), 56659M201 (exp. 07/21/08), 56659M200 (exp. 07/21/08), 56323M101 (exp. 06/30/08), 56323M100 (exp. 06/30/08), 55922M100 (exp. 06/20/08), 55922M101 (exp. 06/20/08), 55921M101 (exp. 06/09/08), and 55921M100 (exp. 06/09/08)
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on June 2, 2008. Firm initiated recall is ongoing.
REASON
An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.
VOLUME OF PRODUCT IN COMMERCE
33,486 reagent kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINES - CLASS II

___________________________________
PRODUCT 
Butler Butaject (Phenylbutazone Injection), 200 mg/mL, For Horses Only, packaged in 100-mL bottles, 12 bottles/case, ANDA #200-371, NDC #11695-4144-1, Recall # V-247-2008
CODE
Lot 081144, Exp. 06/10, and 081342, Exp. 08/10
RECALLING FIRM/MANUFACTURER
Sparhawk Labs Inc, Lenexa, KS, by telephone on August 15, 2008 and by letter dated August 18, 2008. Firm initiated recall is ongoing.
REASON
A statement on the label instructs the drug is for intravenous administration, but a different section of the label says it is for intrauterine use.
VOLUME OF PRODUCT IN COMMERCE
8,388/100-ml. bottles
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR SEPTEMBER 17, 2008

###