Enforcement Report

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.

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February 15, 2006
06-07

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

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PRODUCT
Robert's American Gourmet WHEAT FREE CHAOS, Mixed Chips, Gluten Free, Made With Organic Corn and Cheese, Net wt. 6 oz., Ingredients: Organic Corn, Organic Cornmeal, Safflower Oil, Corn Syrup, Salt, Organic Cheese (Milk, Salt, Lactic Acid, Enzymes, Disodium Phosphate, Annatto Paprika), Brown Sugar, Cane Sugar, Whey, Tomato, Onion, Citric Acid, Mustard, Garlic, Yeast, Maltodextrin, Cayenne Powder, Spices, Baking Soda, Lecithin, Natural Flavor. The product is packaged in a sealed plastic bag. UPC #15665 41025 5, Recall # F-067-6
CODE
SELL BY MAR2806
RECALLING FIRM/MANUFACTURER
Robert's American Gourmet P.O. Box 326 Sea Cliff, NY, by letter dated November 17, 2005 and by press release and letters dated January 17, 2006. Firm initiated recall is ongoing.
REASON
Packages labeled as Wheat Free Chaos (mixed chips) actually contained pretzels with undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
153 cases (12 -- 6 oz. packages per case)
DISTRIBUTION
NJ, PA, MA, CT, ME, NH, IN, GA, and CA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
a) Vicodin ES, Hydrocodone bitartrate and
acetaminophen tablets, USP, 7.5mg/750 mg.
500 count bottles. CIII Recall # D-165-6;
b) Vicodin Tablets, (hydrocodone bitartrate and
acetaminophen, USP 5mg/500mg), in 500 count,
white plastic bottles. CIII, Recall # D-166-6
CODE
a) Lot Number: 05VICE5019, Exp. 6/2008;
05VICE5020, Exp. 6/2008;
05VICE5021, Exp. 6/2008;
05VICE5022 Exp. 6/2008;
b) Lot Code: 05VICR5011, 7/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, North Chicago, IL, by letters on January 23, 2005.
Manufacturer: Abbott Laboratories, Whippany, NJ. Firm initiated recall is ongoing.
REASON
Defective Container: tamper-evident foil seal is partially adhered on some bottles.
VOLUME OF PRODUCT IN COMMERCE
11,576 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

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PRODUCT
Human Tissue for Transplantation, Recall # B-0339-6;
CryoGraft, Lateral Meniscus-Bone Left;
CryoGraft, Semitendinosus/Gracilis Tendon;
CryoGraft, Tibialis Tendon
CODE
Unit numbers: 7266180, 7266176, 7265993
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by telephone and by letter dated April 19, 2004. Firm initiated recall is ongoing.
REASON
Human tissues, associated with complaints of recipient infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues
DISTRIBUTION
CA, CO, GA, IL, MI, MO, NV, PA, TX, UT, and VA

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PRODUCT
CryoVein, Femoral Vein,
CryoVein, Saphenous Vein,
CryoGraft, Pericardium, Recall # B-0341-6
CODE
Tissue numbers: 7980084, 7987683, 8040669
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated December 19, 2003, and follow-up letter dated March 10, 2004. Firm initiated recall is complete.
REASON
Human tissues for transplantation, procured from donors for whom the companion sample from a different site was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues
DISTRIBUTION
FL, GA, and NY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Human Tissue for Transplantation, Recall # B-0340-6;
CryoGraft, Achilles Tendon;
CryoGraft, Hemi Patellar Tendon;
CryoGraft, Tibialis Tendon;
CryoVein, Saphenous Vein;
CryoVein, Femoral Vein with Valve;
CryoVein, Femoral Vein SG
CODE
Unit numbers: 7193219, 6676523, 7209164, 7189821, 6565379, 7076122, 7187980, 6688659, 7408841
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by telephone and by letter dated April 19, 2004. Firm initiated recall is ongoing.
REASON
Human tissues, associated with complaints of recipient infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 tissues
DISTRIBUTION
CA, CO, GA, IL, MI, MO, NV, PA, TX, UT, and VA

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PRODUCT
Cryoprecipitated AHF, Recall # B-0515-6
CODE
Unit number: 6870437
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by facsimile on March 17, 2005. Firm initiated recall is complete.
REASON
Blood product, that may have contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

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PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0529-6
CODE
Unit number: 2822036
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on August 13, 2005.
Manufacturer: LifeSource Norridge, Norridge, IL. Firm initiated recall is complete.
REASON
Blood product, contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

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PRODUCT
Cryoprecipitated AHF, Recall # B-0534-6
CODE
Unit number: 2100748
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by telephone on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells Leukoreduced that were contaminated with Staphylococcus aureus and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

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PRODUCT
Source Plasma, Recall # B-0572-6
CODE
Unit numbers: 04MINB2058, 04MINB2492, 04MINE3631, 05MINA0118, 05MINA0916, 05MINA1192, 05MINA1760, and 05MINA2250
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Muncie, IN, by facsimile on July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of receiving a tattoo within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA and NC

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PRODUCT
Source Plasma, Recall # B-0573-6
CODE
Unit numbers: 0200280783, 0200280653, and 0200278423
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Norman, OK, by facsimile on February 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY

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PRODUCT
Source Plasma, Recall # B-0574-6
CODE
Unit numbers: KLN012294, KLN012436, KLN012734, KLN012930, KLN013204, KLN013566, KLN013965, KLN014124, KLN014446, KLN014670, KLN015078, KLN015313, KLN015995, KLN016235, 0150000377, 0150001161, 0150001502, 0150002036, 0150002120, 0150002742, 0150002968, 0150003516, 0150004120, 0150004371, 0150005017, 0150005300, 0150005872, 0150008344, 0150008597, 0150009346, 0150009652, 0150010407, 0150010642, 0150011560, 0150011853, 0150012440, 0150012779, and 0150013294 [
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on or about February 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Spain

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0575-6
CODE
Unit number: R38790
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, IN, by personal visit on September 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly used for the hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

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PRODUCT
a) Red Blood Cells, Recall # B-0576-6;
b) Recovered Plasma, Recall # B-0577-6
CODE
a) Unit numbers: 122134238, 182095664, 182100934,
182115897, 182123958, 182142593, and 182148636;
b) Unit numbers: 122134238, 182095664, 182100934,
182115897, 182123958, 182142593, and 182148636
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by letter dated December 24, 1997. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV) but were collected from a donor who had previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
IL, NB, TX, WY, Austria and Switzerland

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PRODUCT
Red Blood Cells, Recall # B-0579-6
CODE
Unit number: 5123019
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, East Orange, NJ, by telephone on February 16, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

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PRODUCT
Red Blood Cells, Recall # B-0580-6
CODE
Unit number: 6212498
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, East Orange, NJ, by telephone on May 30, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0593-6;
b) Recovered Plasma, Recall # B-0594-6
CODE
a) and b) Unit number: 06LF56125
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by facsimile on April 25, 2003 or by letter dated April 25, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

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PRODUCT
a) Red Blood Cells, Recall # B-0595-6;
b) Recovered Plasma, Recall # B-0596-6
CODE
a) and b) Unit number: 06GH52625
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by electronic notification on June 4, 2004 or by letter dated June 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred due to a history of non-sexual exposure to Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland

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PRODUCT
a) Red Blood Cells, Recall # B-0598-6;
b) Platelets, Recall # B-0599-6;
c) Recovered Plasma, Recall # B-0600-6
CODE
a) Unit numbers: 06LV10862, 06FL56970, 06FL43899,
06FL41862, 06FL39033;
b) Unit number: 06FL56970;
c) Unit numbers: 06LV10862, 06FL62327, 06FL56970,
06FL43899, 06FL41862, 06FL39033
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by facsimile on December 16, 2002 or by letter dated December 16, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA

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PRODUCT
Human Tissue for Transplantation
a) Hemi Patella Tendon Tissues;
b) Achilles Tendon Tissue;
c) Tibialis Tendon Anterior;
d) Tibialis Tendon Posterior;
e) Femoral Head/Neck
Recall # B-0615-6
CODE
a) Tissue numbers: 057019-005, 057019-006, 057019-007,
057019-008;
b) Tissue number: 057019-003;
c) Tissue numbers: 057019-013, 057019-014;
d) Tissue numbers: 057019-011, 057019-012;
e) Tissue numbers: 057019-025, 057019-026
RECALLING FIRM/MANUFACTURER
Bone Bank Allografts, San Antonio, TX, by telephone, facsimile transmission, and letter dated August 1, 2005. Firm initiated recall is complete.
REASON
Human tissues, recovered from a donor with discordant Hepatitis B Virus (HBsAg) test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
AK, AZ, IL, IN, MD, OK, and PA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0632-6;
b) Plasma, Frozen, Recall # B-0633-6
CODE
a) and b) Unit numbers: 10043-5297, 10759-3902
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

CORRECTION

In the September 28, 2005 Enforcement Report, 05-39, Recall number B-2373-5, Class III, Red Blood Cells Leukoreduced Irradiated, Unit number 6886646 was omitted from the original recall.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0607-6;
CODE
Unit numbers: 35P43398, 35P43400, 35P43401, 35P43402, 35P43404, 35P43406, 35P43407, 35P47868, 35P47872, 35P47873, 35P47875, 35P47876, 35P47879, 35P47882, 35P47885, 35P47887, 35P47889, 35P47890, 35P47891, 35Z14793 (split unit), 35Z14796, 35Z14798, 35Z16900, 35Z16901 (split unit), 35Z16902
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on August 8, 2005. Firm initiated recall is complete.
REASON
Platelets, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NJ and PA

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PRODUCT
Source Plasma, Recall # B-0613-6
CODE
Unit number: SA135000
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on July 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0636-6
CODE
Unit number: 21KP54905
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, Id, by letter dated January 6, 2004.
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Platelets, which were not stored under continuous agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

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PRODUCT
a) Disney Days Hunny Cool Ring Teether
Style # Y1447, Recall # Z-0455-06;
b) Disney Baby Sift Cool Ring Teether
Style # Y1470, Recall # Z-0456-06;
c) Disney Baby Soft Cool Ring Teether
Style # Y1490, Recall # Z-0457-06;
d) The First Years Cool Animal Teether/Fish, Zebra and
Dinosaur designs Style # Y1473, Recall # Z-0458-06;
e) The First Years Floating Friend Teether
Style # Y1474, Recall # Z-0459-06;
f) Sesame Beginnings Chill & Chew Teether
Style # Y3095, Recall # Z-0460-06
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: RC2 Brands Inc., The First Years, Stoughton, MA, by letters on January 27, 2006.
Manufacturer: Yi Shing Co. Ltd, Hong Kong, China. Firm initiated recall is ongoing.
REASON
Liquid filled infant teething ring contaminated with Pseudomonas aeruginosa and Pseudomonas putida.
VOLUME OF PRODUCT IN COMMERCE
352,445 units
DISTRIBUTION
Nationwide, Canada, UK, Australia, Mexico

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer. Recall # Z-0449-06
CODE
Product Code -- Lot: PCDD1---- UHG068; UJG096; UJG110; UJG131; UJG149; UKG264; ULG335; ULG316; ULG313; ULG342; ULG374; ULG385; ULG409; UMG490; UMG492; PCDM1 ---- UJG078; UJG082; UJG085; UJG087; UJG109; ULG103; ULG101; ULG095; ULG125; UJG128; ULG139; UJG142; UKG184; UKG183; UKG181; UKG175; UKG161; UKG187; UKG203; UKG201; UEG883; UKG231; UKG239; UKG241; UKG279; UKG253; UKG250; UKG243; UKG267; UKG266; UKG256; ULG309; ULG287; ULG328; ULG311; ULG370; ULG369; ULG340; ULG337; ULG393; ULG399; ULG400; ULG373; ULG401; ULG405; UMG424; UMG425; UMG426; UMG448; UMG449; UMG479; UMG478; UMG477; UMG473; UMG450; UMG504; UMG486; PCDN1 ----- UHG056; UHG059; UHG072; UHG054; UJG075; UJG077; UJG088; UJG092; UJG099; UJG107; UJG134; UJG129; UJG122; UJG144; UJG154; UJG156; UJG160; UKG176; UKG170; UKG169; UKG166; UKG177; UKG190; UKG198; UKG215; UKG213; UKG220; UKG222; UKG225; UKG233; UKG248; UKG260; ULG308; ULG305; ULG289; ULG285; ULG281; ULG278; ULG272; ULG271; ULG269; ULG331; ULG321; ULG317; ULG315; ULG344; ULG343; ULG346; ULG352; ULG371; ULG368; ULG365; ULG361; ULG359; ULG341; ULG390; ULG392; ULG394; ULG396; UMG432; UMG427; ULG413; UMG438; UMG445; UMG472; UMG471; UMG459; UMG456; UMG455; UMG476; UMG493; UMG505; UMG509; PCDL1 ----- UMG489; UMG483; UMG468; UMG451; UMG431; ULG408; UMG429; UMG430; ULG398; ULG397; ULG381; ULG339; ULG354; ULG355; ULG306; ULG319; ULG332; ULG193; ULG298; ULG279; ULG275; UKG255; UKG229; UKG227; UKG226; UKG168; UKG173; UKG178; UJG117; UJG094; UHG053; UHG069; UJG080; UHG060; UJG073; PCDH1 ----- UMG475; UMG481; UMG494; UMG436; UMG437; UMG454; UMG458; UMG457; UMG423; UMG433; UMG414; UMG415; ULG375; ULG376; ULG377; ULG391; ULG406; ULG372; ULG349; ULG348; ULG336; ULG327; ULG310; ULG304; ULG300; ULG288; ULG276; UKG265; UKG252; UKG218; UKG219; UKG230; UKG217; UKG205; UKG204; UKG186; UKG174; UKG167; UKG163; UJG157; UJG145; UJG143; UJG141; UJG127; UJG100; UJG098; UJG115; UJG114; UJG108; UJG084; PCDB1 ------ ULG323; ULG296; UEG886; UEG884; UJG116; UJG108; UJG104; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG323; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG079; UJG089; UHG065; UJG076; UHG067; PCDG1 ----- UMG482; UMG498; UMG499; UMG500; UMG441; UMG469; UMG470; UMG442; UMG447; UMG446; ULG402; UMG416; UMG419; UMG420; UMG421; UMG422; ULG384; ULG386; ULG387; ULG395; ULG356; ULG366; ULG367; ULG338; ULG329; ULG326; ULG325; ULG274; ULG334; ULG307; ULG299; ULG294; ULG288; ULG284; ULG283; UKG258; UKG259; UKG263; ULG277; UEG885; UKG234; UKG244; UKG245; UKG254; UKG196; UKG210; UKG197; UKG191; UKG193; UKG162; UKG179; UKG180; UJG146; UJG148; UJG153; UJG159; UJG132; UJG130; UJG124; UJG121; UJG105; UJG113; UJG091; UJG086; UJG083; UHG012; UHG063; UHG061; UHG047; UHG071; UHG064; UHG058; UHG055; PCDT1 ----- UMG488; UMG485; UMG491; UMG452; UMG453; UMG435; ULG407; ULG410; UMG417; UMG428; UMG434; ULG363; ULG364; ULG389; ULG345; ULG357; ULG358; ULG291; ULG273; UKG257; UKG236; UKG221; UKG208; UKG209; UKG192; UKG171; UJG137; UJG111; UJG074; UHG057; UHG051; PCDR1 ----- UMG487; UMG502; UMG474; UMG480; ULG333; ULG347; ULG301; ULG290; ULG282; UKG228; UKG237; UKG240; UKG195; UKG172; UJG147; UJG150; UJG140; UJG138; UJG136; UJG123; UJG102; UJG093; UJG090; UHG070; UHG062; UHG046; UHG052; PCDW1 ----- UMG495; UMG496; UMG444; UMG443; ULG412; UMG418; ULG378; ULG388; ULG380; ULG379; ULG360; ULG320; ULG297; ULG292; ULG280; UKG261; UKG251; UKG247; UKG189; UEG887; UKG206; UKG202; UKG188; UJG120; UJG151; UJG133; UHG029; PCDJ1 ------- UMG484; UMG497; UMG439; UMG440; ULG383; ULG382; ULG403; ULG404; ULG362; ULG353; ULG350; ULG351; ULG330; ULG314; ULG312; UKG238; ULG303; ULG318; ULG270; ULG268; UKG262; UKG246; UKG235; UKG232; UKG199; UKG212; UKG211; UKG200; UKG199; UKG185; UKG194; UKG182; UKG165; UKG164; UJG155; UJG152; UJG119; UJG165; UJG118; UJG112; UJG097; UJG081; UHG066.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by letter on January 4, 2006.
Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.
REASON
Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.
VOLUME OF PRODUCT IN COMMERCE
18,270 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
TraXis Vue Spinal Implant System, Part #2601-090921. Recall # Z-0502-06
CODE
Lot number: 2010292
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Spine, Austin, TX, by telephone and letters on or about November 2, 2005.
Manufacturer: RMS Company, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
Implants were manufactured without radiographic markers.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
AquaPak Sterile Water for Inhalation, USP, 760 mL blow-molded plastic bottle for use with a respiratory gas humidifier; 10 bottles per case; catalog #037-00, Recall # Z-0503-06
CODE
Lot number 150150, exp. 2009-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated December 1, 2005.
Manufacturer: Hudson Respiratory Care, Inc., Arlington Heights, IL. Firm initiated recall is ongoing.
REASON
Teleflex Medical determined that the distribution center shipped unreleased product which did not pass validated sterility test requirements.
VOLUME OF PRODUCT IN COMMERCE
1,050 units
DISTRIBUTION
CO, NB, OR, MN, CA, PA, MI, LA, OK and TX

_______________________________
PRODUCT
a) Hospira Latex Free Blood Secondary Set,
26 inch with Secure Lock; Made in Costa Rica,
list 4602-58, Recall # Z-0504-06;
b) LifeShield Latex-Free Primary I.V. Set,
Convertible Pin, 83 inch, with Backcheck Valve
and 2 Clave Ports, Piggyback with Option-Lok;
Made in Costa Rica, list 19229-48,
Recall # Z-0505-06;
c) Hospira Transpac IV Monitoring Kit, 60 inch
disposable transducer monitoring kit with
second stopcock by transducer, continuous
flush device and drip chamber; Made in
Costa Rica, list 42584-04-05, Recall # Z-0506-06
CODE
a) Lot 35-092-5H;
b) Lot 36-073-5H;
c) Lot 35-434-5G
RECALLING FIRM/MANUFACTURER
Hospira Inc., Lake Forest, IL, by letter dated January 9, 2006. Firm initiated recall is ongoing.
REASON
The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
VOLUME OF PRODUCT IN COMMERCE
109 sets
DISTRIBUTION
Unknown -- product stolen

______________________________
PRODUCT
a) Baxter Continuous Epidural Anesthesia Trays that
contain BD Catheter Connectors; Sterile, single
use only kits containing an epidural needle,
epidural catheter, glass LOR syringe and
non-latex components for the preparation and
insertion of the epidural needle and catheter;
Recall # Z-0507-06;
b) Baxter Combined Epidural Anesthesia Trays that
contain BD Catheter Connectors; Sterile, single
use only kits containing a spinal needle, an
epidural needle, epidural catheter, glass LOR
syringe and non-latex components for the
preparation and insertion of the spinal needle
or epidural needle and catheter,
Recall # Z-0508-06;
c) Baxter Epidural Anesthesia Trays that contain
BD Catheter Connectors; Sterile, single use
only kits containing an epidural needle, epidural
catheter, glass LOR syringe and non-latex
components for the preparation and insertion
of the epidural needle and catheter,
Recall # Z-0509-06
CODE
a) Product code 1T1571, lot GD822999;
product code 1T1672, lot GD822908;
product code 1T2574, lot GD822791;
product code1T2673, lot GD822619;
product code 1T5681, lot GD822536;
b) product code 1T5771, lot GD822783;
product code 2T2076, lot GD822932;
product code 2T2097, lot GD822940;
product code 2T2201, lot GD822817;
product code 2T2215, lot GD822825;
c) product code 2T0609, lot GD822585;
product code 2T2263, lot GD822874;
product code 2T2367, lots GD822551
and GD822981;
product code 2T2386, lot GD822452
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, by letters dated January 10, 2006.
Manufacturer: Baxter Healthcare Corporation, Cleveland, MS. Firm initiated recall is ongoing.
REASON
The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
VOLUME OF PRODUCT IN COMMERCE
4,660 trays
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Boston Scientific brand Zero Tip Nitinol
Stone Retrieval Basket, 12 mm, 1.9 Fr.,
sterile, latex free; Catalog no. 390-104,
Recall # Z-0510-06;
b) Boston Scientific brand Zero Tip Nitinol
Stone Retrieval Basket, 12 mm, 120 cm, 1.9 Fr.,
sterile, latex free; Catalog no. 390-105,
Recall # Z-0511-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Spencer, IN, by letter dated December 20, 2005. Firm initiated recall is ongoing.
REASON
The basket wire assembly may detach from the drive wire while in the patient.
VOLUME OF PRODUCT IN COMMERCE
41,317 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Elecsys Troponin T; catalog number 2017644, Recall # Z-0512-06
CODE
Lot 171924-02
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corporation, Indianapolis, IN, by letter dated January 31, 2006. Firm initiated recall is ongoing.
REASON
A false negative result may be reported.
VOLUME OF PRODUCT IN COMMERCE
3,116 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Product is 1.0 cc Regenaform® RT. SINGLE PATIENT
USE ONLY. Recall # Z-0481-06;
b) OPTEFORM Allografts of varying sizes. SINGLE PATIENT
USE ONLY. Recall # Z-0482-06;
c) Product is OPTEFORM Allograft Paste of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0483-06;
d) OPTEFORM® RT Moldable Allograft of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0484-06;
e) Osteofil + RT Allograft Paste in varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0485-06;
f) Osteofil Allograft Paste (Bio) of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0486-06;
g) Osteofil IC Syringeable of varying sizes. SINGLE
PATIENT USE ONLY. Recall # 0487-06;
h) Osteofil ICM Moldable Strip of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0488-06;
i) Osteofil RT, ICM Allograft Paste of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0489-06;
j) OSTEOFIL® DBM Paste of varying sizes. SINGLE
PATIENT USE ONLY. Recall # Z-0490-06;
k) OsteoPack 3 FZ 22cc. SINGLE PATIENT USE ONLY.
Recall # Z-0491-06;
l) Regenafil IC. SINGLE PATIENT USE ONLY.
Recall # Z-0492-06;
m) REGENAFORM RT Allograft Paste, 1cc. SINGLE
PATIENT USE ONLY. Recall # Z-0493-06;
n) Product is REGENAFORM® Allograft Moldable Blocks,
of varying sizes. SINGLE PATIENT USE ONLY.
Recall # Z-0494-06;
o) Product is RTI Allograft Paste of varying sizes.
SINGLE PATIENT USE ONLY. Recall # Z-0495-06;
p) Product is REGENAFIL® Allograft Paste, Syringe,
0.5cc. SINGLE PATIENT USE ONLY. Recall # 0496-06;
q) Product is 1.0cc flowable paste from donor
approved for distribution in Italy. SINGLE
PATIENT USE ONLY. Recall # Z-0497-06;
r) Product is OPTEFIL Allograft Paste of varying
sizes. SINGLE PATIENT USE ONLY. Recall
# Z-0498-06;
s) Product is OPTEFIL Allograft Paste, Syringe
of varying sizes. SINGLE PATIENT USE ONLY.
Recall # Z-0499-06;
t) Product is OPTEFORM® Allograft Full Disc,
5 x 90mm, 32cc, Frozen. SINGLE PATIENT USE
ONLY, Recall # Z-0500-06;
u) Product is 2.0 cc Opteform® RT. SINGLE
PATIENT USE ONLY. Recall # Z-0501-06
CODE
2879130 2879131 2879132 2879133 2879134 2879135 2879136 2879137 2879138 2879139 2879350 2879351 2879352 2879353 2879354 2879355 2879440 2879441 2879442 2879443 2879444 2879445 2879446 2879447 2879448 2879449 2879450 2879451 2879452 2879453 2879454 2879455 2879456 2879457 2879458 2879459 2886780 2886781 2886782 2886783 2886784 2886785 2886786 2886787 2886788 2886789 2886950 2886951 2886952 2886953 2886954 2886955 2886956 2886957 2886958 2886959 2962280 2962281 2962282 2962283 2962284 2962285 2962286 2962287 2962288 2962289 2963820 2963821 2963822 2963823 2963824 2963825 2963826 2963827 2963828 2963829 2963910 2963911 2963912 2963913 2963914 2963915 2963916 2963917 2963918 2963919 2963990 2963991 2963992 2963993 2963994 2963995 2963996 2963997 2963998 2963999 2965900 2965901 2965902 2965903 2965904 2965905 2965906 2965907 2965908 2965909 2965910 2965911 2965912 2965913 2965914 2965915 2965916 2965917 2965918 2974861 2974862 2974863 2974864 2974865 2974866 2974867 2974868 2974869 2974870 3021827 3021829 3021830 3021831 3021832 3021833 3021834 3021836 3021877 3021878 3021882 3021883 3021885 3023281 3023282 3023283 3023284 3023285 3023286 3023287 3023288 3023289 3030571 3030572 3030573 3030574 3031471 3031473 3031474 3031475 3031476 3031477 3031478 3031479 3031480;
0756898 0756899 0774572 0829702 0829703 0829704 0829705 0829706 0829757 0829758 0829759 0829760 0829761 0849054 0849055 0849056 0849057 0849058 0849144 0849145 0849146 0849147 0849148 0849159 0849160 0849161 0849162 0849163 0849230 0849231 0849232 0849233 0849234 0850462 0850463 0850469 0850470 0850471 0852636 0852637 0852638 0852639 0852640 1483739 1483740 1483741 1483742 1494117 1494118 1494119 1494122 1494240 2121702 2121703 2121704 2121705 2121706 2121907 2121908 2121909 2121910 2121911 2121922 2121923 2121924 2121925 2121926 2125258 2125339 2125340 2125341 2125342 2125343 2147725 2147727 2147825 2147827 2147829 2147905 2147906 2147907 2147908 2147909 2147930 2147931 2147932 2147933 2147980 2147981 2147982 2147983 2147984 2147995 2147996 2147997 2147998 2147999 2151766 2151767 2151768 2151769 2151770 2151781 2151782 2151783 2151784 2151785 2151827 2151828 2151829 2151830 2151966 2151967 2151968 2151969 2151970 2153117 2153118 2153119 2153120 2153346 2153347 2153348 2153349 2153350 2153359 2153360 0843158 0843159 0843160 0843161 0843162 2124913 2124914 2124968 2124969 2124971 2124972 2135208 2135209 2135210 2135211 2135212 2135273 2135274 2135275 2135276 2135277 2135284 2135285 2135286 2135287 2135308 2135309 2135310 2135311 2135312 2135318 2135319 2135320 2135478 2142436 2142437 2142438 2142439 2145001 2145002 2145003 2145004 2145005 2145131 2145132 2145133 2145134 2145135 2161531 2161532 2161533 2161534 2161686 2161687 2161688 2161689 2161690 2166675 2166676 2188866 2188969 2188970 2188971 0837098 0837099 0837100 0837101 0837102 0837477 0837478 0837479 0837480 2040067 2040068 2040069 2174843 2174844 2174845 2174846 2174847 2995331 2995332 2995333 2995334 2997901 2997902 2997903 2997904 2997905 2997906 2997907 2997908 2997909 2997910;
3043561 3043562 3043563 3043564 3043565 3043566 3043567 3043568 3043569 3043570 3047041 3047042 3047043 3051158 3051159 3051160 3051193 3051194 3051195 3051196 3051197 3051198 3051199 3051491 3051493 3051495 3051497 3050703 3050705 3050706 3050710 3056760 3060591 3027677 3027678 3027679 3044581 3044582 3044583 3044584 3044585 3044586 3044587 3044588 3044589 3044590 3044931 3044932 3044933 3044934 3044935 3044936 3044937 3044938 3044939 3044940 3044941 3044942 3044943 3044944 3044945 3044946 3044947 3044948 3044949 3044950 3045571 3045572 3045573 3045574 3045575 3045576 3045941 3045942 3045943 3045944 3045946 3045947 3045948 3045949 3046341 3046342 3046343 3046344 3046345 3046346 3046347 3046348 3046349 3046350 3046531 3046532 3046533 3046534 3046535 3046536 3046537 3046538 3046539 3046540 3046621 3046622 3046623 3046624 3046625 3046626 3046627 3046628 3046629 3046630 3046661 3046662 3046663 3046664 3046665 3046666 3046667 3046668 3046669 3046670 3046671 3046672 3046673 3046674 3046675 3046676 3046677 3046678 3046679 3046680 3046731 3046732 3046733 3046734 3046735 3046736 3046737 3046738 3046739 3046740 3046831 3046832 3046833 3046834 3046835 3046836 3046837 3046838 3046839 3046840 3046971 3046972 3046973 3046974 3046975 3046976 3046977 3046978 3046979 3046980 3046981 3046982 3046983 3046984 3046985 3046986 3046987 3046988 3046989 3046990 3047401 3047402 3047403 3047404 3047405 3047406 3047407 3047408 3047409 3047410 3051101 3051102 3051103 3051104 3051105 3051161 3051162 3051163 3051164 3051165 3051166 3051167 3051168 3051169 3051170 3051221 3051222 3051223 3051224 3051226 3051227 3051228 3051229 3051230 3051231 3051232 3051233 3051234 3051235 3051236 3051237 3051238 3051239 3051240 3051241 3051242 3051243 3051244 3051245 3051246 3051247 3051248 3051249 3051250 3051271 3051272 3051273 3051274 3051275 3051276 3051277 3051278 3051279 3051280 3051381 3051382 3051383 3051384 3051385 3051386 3051387 3051388 3051389 3051390 3051422 3051423 3051424 3051425 3051426 3051427 3060550 3060551 3060552;
2613431 2613432 2613433 2613434 2613435 2613436 2613437 2613438 2613439 2613440 2613901 2613902 2613903 2613904 2613905 2613906 2613907 2614881 2614882 2614883 2614884 2614885 2614886 2614887 2614888 2614889 2614890 2653106 2653107 2653108 2654250 2654251 2654252 2654253 2654254 2654255 2654256 2654257 2654258 2654259 2699840 2699841 2699842 2699843 2485231 2485232 2485233 2485234 2485235 2485236 2485237 2485238 2485239 2485240 2595521 2595522 2595921 2595922 2595923 2595924 2595925 2595926 2595927 2595928 2595929 2595930 2978531 2978532 2978533 2978534 2978535 2978536 2978537 2978538 2978539 2978540 2983613 2983614 2983615 2983616 2983831 2983832 2983842 2983843 2983844 2984801 2984802 2984803 2984804 2984805 2984806 2984807 2984808 2984809 2984810 2985721 2985722 2985723 2985724 2985725 2985726 2985727 2985728 2985729 2985730 2985791 2985792 2985793 2985794 2985795 2985796 2985797 2985798 2985799 2985800 2985911 2985912 2985913 2985914 2985915 2985916 2985917 2985918 2985919 2985920 2985991 2985992 2985993 2985994 2985995 2985996 2985997 2985998 2985999 2986000 2986841 2986842 2986843 2986844 2986845 2986846 2986847 2986848 2986849 2986850 2986861 2986862 2986863 2986864 2986865 2986866 2986867 2986868 2986869 2986870 2987907 2987908 2999921 2999922 2999923;
2488121 2488122 2488123 2488124 2488125 2488126 2488127 2488128 2488130 2497251 2497252 2497253 2497253 2497254 2497255 2497256 2497257 2497258 2497259 2497260 2497361 2497362 2497363 2497364 2497365 2497366 2497367 2497368 2497369 2497370 2501782 2501783 2501784 2501785 2501786 2501787 2501788 2501789 2501790 2501791 2501791 2501832 2501833 2501834 2501835 2501836 2501837 2501838 2501839 2501840 2501841 2501872 2501873 2501874 2501875 2501876 2501877 2501878 2501879 2501880 2501881 2502191 2502192 2502193 2502194 2502195 2502196 2502197 2502198 2502199 2502200 2559851 2559852 2559853 2559854 2559855 2559856 2559857 2559858 2559859 2559951 2559952 2559953 2559954 2559955 2559956 2559957 2559958 2559959 2559960 2559991 2559992 2559993 2559994 2559995 2559996 2559997 2559998 2559999 2560000 2560071 2560072 2560073 2560074 2560075 2560076 2560077 2560078 2560079 2560080 2560221 2560222 2560223 2560224 2560225 2560226 2560227 2560228 2560229 2560230 2560273 2560274 2560275 2560276 2560277 2560278 2560279 2560280 2560471 2560472 2560473 2560474 2560475 2560476 2560477 2560478 2560479 2560480 2561641 2561642 2561643 2561645 2561646 2561647 2561648 2561649 2561650 2561841 2561842 2561843 2564571 2564572 2564573 2564574 2564575 2564576 2564577 2564578 2564579 2564580 2564591 2564592 2564593 2564594 2564595 2564596 2564598 2564599 2564600 2565581 2565582 2565583 2565584 2565585 2565586 2565587 2565588 2565589 2565971 2565972 2565973 2565974 2565975 2565976 2565977 2565978 2565979 2565980 2613351 2613352 2613353 2613354 2613355 2613356 2613358 2613359 2613461 2613462 2613463 2613465 2613466 2613467 2613468 2613469 2613470 2613524 2613525 2613526 2613527 2613528 2613529 2613908 2613909 2613910 2613931 2613932 2613933 2613934 2613935 2613936 2613937 2613938 2613939 2613940 2613971 2613972 2613974 2613975 2613976 2613977 2613978 2613979 2613980 2614371 2614372 2614373 2614374 2614375 2614376 2614377 2614551 2614552 2614553 2614554 2614555 2614556 2614558 2614591 2614592 2614593 2614594 2614595 2614596 2614597 2614599 2614891 2614892 2614893 2614894 2614895 2614896 2614899 2614900 2614982 2614984 2614989 2614990 2616221 2616222 2616223 2616224 2616227 2616228 2616229 2616230 2616491 2616492 2616493 2616494 2616495 2616496 2616497 2616500 2620221 2620223 2620225 2620227 2620229 2620271 2620272 2620276 2620277 2620278 2620279 2620280 2689161 2689163 2689165 2689166 2689168 2689169 2689371 2689372 2689373 2689374 2689375 2689376 2689378 2690294 2690295 2690297 2690299 2690300 2690301 2690303 2692921 2692922 2692923 2692926 2692927 2692928 2692929 2692939 2713197 2713198 2713199 2713200 2713202 2713203 2713228 2713230 2713231 2713232 2713234 2713235 2713236 2713388 2713389 2713390 2713391 2713392 2713393 2713394 2713395 2713396 2713427 2713428 2713429 2713430 2713431 2713433 2713434 2713435 2713436 2718753 2718754 2718755 2718756 2718758 2718760 2718791 2718793 2718794 2718795 2718796 2718798 2718800 2718931 2718932 2718934 2718935 2718936 2718937 2718940 2718961 2718962 2718965 2718969 2718970 1901774 1901775 1901776 1901777 1901778 1901779 1901780 1901781 1901782 1901783 1901804 1901805 1901806 1901807 1901808 1901809 1901810 1901811 1901812 1901813 1909226 1909227 1909228 2679851 2679852 2689260 2689261 2689262 2689263 2689264 2689265 2689266 2689267 2689268 2689269 2692940 2692941 2692942 2692943 2692944 2692945 2692946 2692947 2692948 2692949;
1700271 1700272 1700273 1700274 1700275 1700276 1700277 1700278 1700279 1700280 1879091 1879092 1879093 1879094 1879095 1879096 1879097 1879098 1879099 1879100 1907051 1907052 1907053 1907054 1907055 1907056 1907057 1907058 1907059 1907060 1907141 1907142 1907143 1907144 1907145 1907146 1907147 1907148 1907149 1907150 1951240 1951241 1951242 1951243 1951244 1951245 2436853 2436854 2436855 2436856 2436857 2436858 2436859 2436860 2436861 2436862 2442511 2442512 2442513 2442514 2442515 2442516 2442517 2442518 2442519 2442520 2442581 2442582 2442583 2442584 2442585 2442586 2442587 2442588 2442589 2442590 2443901 2443902 2443903 2443904 2443905 2443906 2443907 2443908 2443909 2443910 2444551 2444552 2444553 2444554 2444555 2444557 2444558 2444559 2444560 2446181 2446182 2446183 2446184 2446185 2446186 2446187 2446188 2446190 2446491 2446492 2446493 2446494 2446495 2446496 2446497 2446498 2446499 2446500 2446851 2446852 2446853 2446854 2446855 2446856 2446857 2446858 2446859 2446860 2446911 2446912 2446913 2446914 2446915 2446916 2446917 2446918 2446919 2446920 2446951 2446952 2446953 2446954 2446955 2446956 2446957 2446958 2446959 2446960 2446971 2446972 2446973 2446974 2446975 2446976 2446977 2446978 2446979 2446980 2446981 2446982 2446983 2446984 2446985 2446986 2446987 2446988 2446989 2446990 2456961 2456962 2456963 2456964 2456965 2456966 2456967 2456968 2456969 2456970 2822090 2822091 2822092 2822093 2822094 2822095 2822096 2822097 2822098 2822099 2822460 2822461 2822462 2822463 2822464 2822465 2822466 2822467 2822468 2822469 2823610 2823611 2823612 2823613 2823614 2823615 2823616 2823617 2823618 2823619 2823850 2823851 2823852 2823853 2823854 2823855 2823856 2823857 2823858 2823859 2824090 2824091 2824092 2824093 2824094 2824095 2824096 2824097 2824098 2824099 2824320 2824321 2824322 2824323 2824324 2824325 2824326 2824327 2824328 2824329 2158083 2184601 2184602 2184603 2184604 2184605 2184606 2184607 2184608 2184609 2184610 2190451 2190452 2190453 2190454 2190455 2190471 2190472 2190473 2190474 2190475 2190476 2190477 2190478 2190479 2190480 2835023 2835029 2839737 2158050 2158051 2158052 2158053 2158054 2158055 2158056 2158057 2158058 2158059 2158060 2158061 2158062 2158063 2158064 2158065 2158066 2158067 2158068 2158069 2158070 2158071 2158072 2158073 2158074 2158075 2158076 2158077 2158078 2158079 2158080 2158081 2158082 2614476 2614477 2614478 2614479 2614729 2614730 2616471 2616472 2616473 2616474 2616475 2616476 2616477 2616478 2616479 2616480 2622781 2622783 2622784 2622785 2622786 2622787 2622788 2622789 2622790 2700000 2700001 2700002 2700003 2700004 2700005 2700006 2700007 2700008 2700009 2713098 2713099 2713100 2713101 2713102 2713103 2713104 2713105 2713106 2713307 2713308 2713309 2713310 2713311 2713312 2713313 2713314 2713315 2713316 2720173 2720174 2720175 2720176 2720177 2720178 2720179 2720180 2720181 2720182 2732530 2732531 2732532 2732533 2732534 2732535 2732536 2732537 2732538 2732539 2732690 2732691 2732692 2732693 2732694 2732695 2732696 2732697 2842690 2842691 2842692 2842693 2842694 2842695 2842696 2842697 2842698 2842699 2844190 2844191 2844193 2847760 2847763 2847766 2847767 2848514 2848515;
2250274 2250275 2250276 2443591 2443592 2443593 2443594 2443595 2444941 2444942 2444943 2444944 2444945 2444946 2444947 2444948 2444949 2444950 2446231 2446232 2446233 2446234 2446235 2446236 2446237 2446238 2446239 2446240 2000898 2000899 2000900 2000901 2000902 2000903 2000952 2000953 2000954 2000955 2000956 2000957 2000958 2000959 2000960 2000961 2000962 2000963 2000964 2000965 2000966 2000967 2000968 2000969 2250269 2250270;
2511671 2511672 2511673 2511674 2511675 2511676 2511677 2511678 2614471 2614472 2614473 2614474 2614475 2614721 2614722 2614723 2614724 2614725 2614726 2614727 2614728 2730530 2730531 2730532 2730533 2730534 2730535 2730536 2730537 2742463 2742464 2742465 2742466 2746363 2746364 2746365 2746366 2746367 2746368 2746369 2747870 2764991 2764992 2764993 2764994 2764995 2764996 2764997 2764998 2764999 2766699 2766700 2766701 2766702 2766703 2766704 2924612 2924613 2924730 2924731 2924732 2924733 2924734 2924735 2924736 2924737 2924738 2924739 2184631 2184633 2184634 2184635 2184636 2184637 2184638 2184639 2184640 2185751 2185752 2185753 2185754 2185755 2185756 2185757 2185758 2185759 2185760 2275371 2275372 2275373 2275374 2275375 2275376 2275377 2275378 2275379 2275380 2277521 2277522 2277523 2277524 2277525 2277526 2277527 2277528 2697923 2697924 2697925 2697926 2697927 2697928 2697929 2699572 2699573 2699574 2699575 2699576 2699577 2699732 2699733 2699734 2699735 2699736 2699737 2699738 2701392 2701393 2703640 2703961 2703962 2703963 2703964 2703965 2703966 2703967 2730383 2730384 2730385 2730386 2730387 2730388 2749681 2749682 2749683 2749684 2749685 2749686 2749687 2749688 2754459 2754460 2754461 2754462 2754463 2788895 2788896 2788897 2894236 2924780 2924781 2924782 2924783 2924784 2924785 2924786 2924787 2924788 2924933 2926150 2926151 2926152 2926153 2926154 2926155 2926156 2926157 2926158 2926159 2945532 2945533 2945534 2945535 2945536 2945537 2945538 2946230 2946231 2946232 2946233 2946234 2946235 2946236 2946237 2946238 2946239 2946350 2946351 2946352 2946353 2946354 2946355 2946356 2946357 2946358 2946359 2955822 2955823 2955824 2955825 2955826 2955827 2955828 2955829 2959010 2959011 2959012 2959013 2959014 2959015 2959016 2959017 2959018 2959019 2964612 2964613 2964614 2985046 2985048 2985049 2985112 2985113 2985114 2985115 2985116 2985117 2985118 2985119 2985120 2985393 3003673 3003674 3003675 3003676 3003677 3003678;
1942724 1942725 1942726 1942727 1942728 1942729 1942730 1942731 1942732 1942733 2348778 2348779 2348780 2348782 2348783 2348786 2348787 2353581 2353582 2353583 2353584 2353585 2353586 2353587 2353588 2353589 2355891 2355892 2357191 2357192 2357194 2357195 2357197 2357199 2357200 2357352 2357353 2357354 2357355 2357356 2357357 2357358 2357359 2555281 2555282 2555283 2555284 2555285 2555286 2702230 2702231 2702232 2707030 2707031 2707032 2707033 2707034 2707035 2707036 2707037 2707038 2707039 2707080 2707081 2707082 2707083 2707084 2707085 2707086 2707087 2707088 2707089 2736580 2736582 2736583 2736584 2745510 2745511 2745512 2745513 2745514 2745515 2745516 2745517 2745518 2745519 2745810 2745811 2745812 2745813 2745815 2745816 2745817 2790531 2792751 2792752 2792753 2792754 2792755 2792756 2801580 2801581 2819213 2819214 2819215 2819216 2819217 2819218 2819219 2822200 2822201 2822202 2822203 2822204 2822205 2822206 2822207 2822208 2822209 2822690 2822691 2822692 2822693 2822694 2822695 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3005597 3005598 3005599 3005600 3007581 3007582 3007583 3007584 3007585 3007586 3007587 3007588 3007589 3007590 3007621 3007622 3007624 3007625 3007626 3007627 3007628 3007629 3007630 3013741 3013742 3013743 3013744 3013746 3013747 3013748 3013749 3013750 3013781 3013782 3013784 3013785 3013786 3013787 3013788 3013790 3013961 3013962 3013963 3013964 3013965 3013966 3013967 3013968 3013969 3013970 2880362 2880363 2880364 2880365 2880366 2880367 2880368 2908994 2910330 2910331 2910332 2910333 2910334 2910335 2910336 2910337 2910338 2910339 2927630 2927631 2927633 2927634 2927635 2927636 2927637 2927638 2927639 2927910 2927911 2927912 2927914 2927915 2927916 2962764 2962766 2649790 2649791 2649792 2649793 2649794 2649795 2649796 2649797 2649798 2649799 2654240 2654241 2654242 2654243 2654244 2654245 2654246 2654247 2654248 2654249 2663020 2663021 2663022 2663023 2663024 2663025 2663026 2663027 2663028 2663029 2663141 2663142 2663143 2663144 2663170 2663171 2663172 2663173 2663174 2663175 2663176 2663177 2663178 2663179 2679590 2679592 2679593 2679594 2679595 2679596 2679597 2679598 2679599 2689190 2689191 2689192 2689193 2689194 2689195 2689196 2689197 2689198 2689199 2690374 2690375 2691490 2691491 2725370 2725371 2725372 2725373 2725375 2725376 2725377 2725378 2725379 2726260 2726261 2726264 2726265 2726266 2729450 2729451 2729452 2729453 2729454 2729455 2729456 2729457 2730720 2730721 2730722 2730725 2730727 2730729 2730760 2730761 2730762 2730764 2730765 2730766 2730767 2730768 2732600 2732601 2732603 2732604 2732605 2732607 2732608 2732609 2732870 2732871 2732874 2732876 2732878 2732900 2732901 2732902 2732903 2732905 2732906 2732907 2732908 2732909 2739050 2739051 2739052 2739053 2739054 2739055 2739056 2739057 2739058 2739059 2745750 2745751 2745752 2745753 2745754 2745755 2745756 2745757 2745758 2745759 2745980 2745981 2745982 2745983 2745984 2745985 2745986 2748180 2748181 2748182 2748183 2748184 2748185 2748187 2748188 2748189 2748200 2748201 2748202 2748203 2748204 2748205 2748206 2748207 2748208 2748209;
2819000 2819001 2819002 2819003 2819004 2819005 2819006 2819007 2819008 2819009 2819080 2819081 2819082 2819083 2819084 2819085 2819086 2819087 2819088 2819089 2819470 2819471 2819472 2819473 2819474 2819475 2819476 2819477 2819478 2819479 2820000 2820001 2820002 2820003 2820004 2820005 2820110 2820111 2820112 2820113 2820114 2820115 2820116 2820117 2820118 2820119 2820210 2820211 2820212 2820213 2820214 2820215 2820216 2820217 2820218 2820219 2820430 2820431 2820432 2820433 2820434 2820435 2820436 2820437 2820438 2820439 2820440 2820441 2820442 2820443 2820444 2820445 2820446 2820447 2820448 2820449 2820480 2820481 2820482 2820483 2820484 2820485 2820486 2820487 2820488 2820489 2821340 2821341 2821342 2821343 2821344 2821345 2821346 2821347 2821348 2821349 2821350 2821351 2821352 2821353 2821354 2821355 2821356 2821357 2821358 2821359 2821480 2821481 2821482 2821483 2821484 2821485 2821486 2821487 2821488 2821489 2821500 2821501 2821502 2821503 2821504 2821505 2821506 2821507 2821508 2821509 2821936 2821937 2821938 2821939 2824520 2824521 2824522 2824523 2824524 2824525 2824526 2824527 2824528 2824529 2824802 2824803 2824804 2824805 2824806 2824807 2824808 2824809 2824810 2824811 2824812 2824813 2824814 2824815 2824816 2824817 2824818 2824819 2824820 2824821 2824822 2824823 2824824 2824825 2824826 2824827 2824828 2824829 2824830 2824831 2824882 2824883 2824884 2824885 2824886 2824887 2824888 2824889 2824890 2824891 2824982 2824983 2824984 2824985 2824986 2824987 2824988 2824989 2824990 2824991 2825360 2825361 2825362 2825363 2825364 2825365 2825366 2825367 2825368 2825369 2728210 2728211 2728212 2728213 2728214 2728215 2728216 2728217 2728218 2728219 2729190 2729191 2729192 2729194 2729195 2735390 2735391 2735392 2735393 2735394 2735395 2764520 2764521 2764522 2764523 2764524 2764525 2764526 2764527 2764528 2764529 2766656 2766657 2766659 2766660 2769420 2769421 2769422 2769423 2769424 2769425 2769426 2769427 2769428 2769429 2826080 2826082 2826083 2826084 2826087 2826088 2826089 2826190 2826191 2826192 2826194 2826196 2826198 2826199 2826220 2826221 2826222 2826223 2826224 2826225 2826226 2826227 2826228 2826320 2826321 2826322 2826324 2826326 2826327 2826329 2826400 2826401 2826402 2826403 2826404 2826406 2826408 2826409 2831060 2831061 2831063 2831065 2831067 2831340 2831342 2831344 2831345 2831346 2831348 2831350 2831353 2831354 2831355 2831357 2831358 2831359 2831420 2831421 2831422 2831423 2831424 2831425 2831426 2831427 2831429 2833250 2833253 2833254 2833323 2833324 2833325 2833328 2833329 2833380 2833381 2833382 2833383 2833384 2833386 2833388 2833389 2835290 2835291 2835293 2835296 2835297 2835298 2835300 2835302 2835303 2835304 2835305 2835306 2835307 2835308 2835691 2835692 2835695 2835696 2835698 2835699 2729620 2729621 2729622 2729623 2729624 2729625 2729626 2729627 2729628 2729629 2770951 2770952 2770953 2770954 2770955 2774620 2774621 2774622 2774623 2774624 2774625 2774626 2774627 2774628 2774629 2774881 2774882 2774883 2774884 2774885 2774889 2777760 2777761 2777762 2777763 2777764 2777765 2777766 2777767 2777768 2777769 2777790 2777791 2777792 2777793 2777794 2777795 2777796 2777797 2777798 2777799 2779040 2779041 2779042 2779043 2779044 2779045 2779046 2779047 2779048 2779049 2779490 2779491 2779492 2779493 2779494 2779495 2779496 2779497 2779498 2779499 2796951 2796952 2796953 2796954 2796955 2796956 2796957 2796958 2796959 2796960;
2726001 2726002 2726003 2730281 2730282 2730283;
2396521 2396522 2396523 2396524 2396525 2396526 2396527 2396528 2396529 2397301 2397302 2397303 2397304 2397305 2397306 2397307 2397308 2397309 2397310 2000878 2000879 2000880 2000881 2000882 2000883 2000884 2000885 2000886 2000887 2000888 2000889 2000890 2000891 2000892 2000893 2000894 2000895 2000896 2000897 2158322 2158324 2158325 2158326 2158327 2158329;
3047051 3047052 3047053 3047054 3047055 3047056 3047057 3047058 3047059 3047060 3049351 3049352 3049353 3049354 3049355 3049356 3049357 3049358 3049359 3049360 3049421 3049422 3049423 3049424 3049425 3049426 3049427 3049428 3049429 3049430 3049471 3049472 3049473 3049474 3049475 3049476 3049477 3049478 3049479 3049480 3056740 3056817 3056818 3056819 3056820 3056981 3056982 3056983 3056984 3056985 3056986 3056987 3056988 3056989 3056990 3057141 3057142 3057143 3057144 3057145 3057146 3057147 3057148 3057149 3057150 3057161 3057162 3057163 3057165 3057166 3057167 3057168 3057169 3057170 3057241 3057242 3057243 3057244 3057245 3057246 3057248 3057249 3057250 3057251 3057252 3057253 3057254 3057255 3057256 3057257 3057258 3057259 3057260 3057281 3057282 3057283 3057284 3057285 3057286 3057287 3057288 3057289 3057290 3057915 3057917 3057918 3057919 3057920 3057921 3057922 3057923 3057924 3057985 3057986 3057987 3057988 3057989 3057990 3057991 3057992 3057993 3057994 3059151 3059152 3059153 3059154 3059155 3059156 3059157 3059158 3059159 3059160 3059521 3059522 3059523 3059524 3059525 3059526 3059527 3059528 3059529 3059530 3059621 3059622 3059623 3059624 3059625 3059626 3059627 3059628 3059629 3059630 3060574 3060575 3060576 3064501 3064502 3064503 3064504 3064505 3064506 3064507 3064508 3064509 3064510 3064561 3064562 3064563 3064564 3064565 3064566 3064567 3064568 3064569 3064570 3064761 3064762 3064763 3064764 3064765 3064766 3064767 3064768 3064769 3064770 3064781 3064782 3064783 3064785 3064786 3064787 3064788 3064789 3064790 3064821 3064822 3064823 3064824 3064826 3064827 3064828 3064829 3064830 3064881 3064882 3064884 3064885 3064886 3064887 3064888 3064889;
2825210 2825211 2825212 2825213 2825214 2825215 2825216 2825217 2825218 2825219 2828500 2828501 2828502 2828590 2828591 2828592 2828593 2828594 2828595 2828596 2828597 2828598 2828599 2828600 2828601 2828602 2828603 2828604 2828605 2828606 2828607 2828608 2828609 2828640 2828641 2828642 2828643 2828644 2828645 2828646 2828648 2828649 2828820 2828821 2828822 2828823 2828824 2828825 2828826 2828827 2828828 2828829 2831070 2831071 2831072 2831073 2831074 2831075 2831076 2831077 2831078 2831079 2831090 2831091 2831092 2831093 2831094 2831096 2831097 2831098 2831099 2831150 2831151 2831152 2831153 2831154 2831155 2831156 2831157 2831158 2831159 2834480 2834481 2834482 2834483 2834484 2834485 2834486 2834487 2834488 2834489 2835022 2835110 2835111 2835112 2835113 2835114 2835115 2835116 2835117 2835118 2835119 2835320 2835321 2835322 2835323 2835324 2835325 2835326 2835327 2835328 2835329 2835720 2835721 2835722 2835723 2835724 2835725 2835726 2835727 2835728 2835729 2835730 2835731 2835732 2835733 2835734 2835735 2835736 2835737 2835738 2835739 2836030 2836031 2836032 2836033 2836034 2836035 2836036 2836037 2836038 2836039 2836130 2836131 2836132 2836133 2836134 2836135 2836136 2836137 2836138 2836139 2836150 2836151 2836152 2836153 2836154 2836155 2836156 2836157 2836158 2836159 2836490 2836491 2836492 2836493 2836494 2836495 2836496 2836498 2836499 2837000 2837001 2837002 2837003 2837004 2837005 2837006 2837007 2837008 2837009 2837050 2837051 2837052 2837053 2837054 2837055 2837056 2837057 2837058 2837059 2837060 2837061 2837062 2837063 2837064 2837065 2837066 2837067 2837068 2837069 2837090 2837091 2837092 2837093 2837094 2837095 2837096 2837097 2837098 2837099 2837170 2837171 2837172 2837173 2837174 2837175 2837176 2837177 2837178 2837179 2839620 2839621 2839622 2839623 2839624 2839625 2839626 2839627 2839628 2839629 2841890 2841891 2841892 2841893 2841894 2841895 2841896 2841897 2841898 2841899 2842080 2842081 2842082 2842083 2842084 2842085 2842086 2842087 2842088 2842089 2842170 2842171 2842172 2842173 2842174 2842175 2842176 2842177 2842178 2842179 2844150 2844151 2844152 2844153 2844154 2844155 2844156 2844157 2844158 2844159 2844160 2844161 2844162 2844163 2844164 2844165 2844166 2844167 2844168 2844169 2844240 2844241 2844242 2844243 2844244 2844245 2844246 2844247 2844248 2844249 2846312 2846313 2846314 2846315 2846316 2846317 2846318 2846319 2846320 2846321 2846432 2846433 2846434 2846435 2846436 2846437 2846438 2846439 2846440 2846441 2846452 2846453 2846454 2846455 2846456 2846457 2846458 2846459 2846460 2846461 2858100 2858101 2858102 2858103 2858104 2858105 2858106 2858107 2858108 2858109 2858230 2858231 2858232 2858233 2858234 2858235 2858236 2858237 2858238 2858239 2858310 2858311 2858312 2858313 2858314 2858315 2858316 2858317 2858318 2858319 2858978 2858979 2858980 2858981 2858982 2858983 2858984 2858985 2858986 2858987 2880020 2880021 2880022 2880023 2880024 2880025 2880026 2880027 2880028 2880029 2880090 2880091 2880092 2880093 2880094 2880095 2880096 2880097 2880098 2880099 2880400 2880401 2880402 2880403 2880404 2880405 2880406 2880407 2880408 2880409 2881910 2881911 2881912 2881913 2881914 2881915 2881916 2881917 2881918 2881919 2886799 2902808 2902809 2902810 2902811 2902812 2902928 2902929 2902930 2902931 2902932 2902933 2902934 2902935 2902936 2902937 2903090 2903091 2903092 2903093 2903094 2903095 2903096 2903097 2903098 2903099 2903190 2903191 2903192 2903193 2903194 2903195 2903196 2903197 2903198 2903199 2903340 2903341 2903342 2903343 2903344 2903345 2903346 2903347 2903348 2903349 2903360 2903361 2903362 2903363 2903364 2903365 2903366 2903367 2903368 2903369 2904130 2904131 2904132 2904133 2904134 2904135 2904136 2904137 2904138 2904139 2904350 2904351 2904352 2904353 2904354 2904355 2904356 2904357 2904358 2904359 2904440 2904441 2904442 2904443 2904444 2904445 2904446 2904447 2904448 2904449 2826060 2826061 2826062 2826063 2826064 2826065 2826066 2826067 2826068 2826069 2831010 2831011 2831012 2831013 2831014 2831015 2831016 2831017 2831018 2831019 2835650 2835651 2835652 2835653 2835654 2835655 2835656 2835657 2835658 2835659 2835810 2835811 2835812 2835813 2835814 2835815 2835816 2835817 2835818 2835819 2842840 2842841 2842842 2842843 2842844 2842845 2842846 2842847 2842848 2842849 2844080 2844081 2844082 2844083 2844084 2844085 2844086 2844087 2844088 2844089 2844480 2844481 2844482 2844483 2844484 2844485 2844486 2844487 2844488 2844489 2822374 2822375 2822376;
2819380 2819382 2819383 2819384 2819386 2819387 2819388 2820151 2820153 2820154 2820156 2820157 2820158 2820159 2820281 2820282 2820283 2820284 2820285 2820286 2820287 2820288 2820289 2820341 2820343 2820520 2820521 2820523 2820525 2820526 2820527 2820528 2820529 2822391 2822392 2822393 2822394 2822395 2822396 2822397 2822398 2822840 2822841 2822844 2822845 2822846 2822847 2822849 2822860 2822861 2822862 2822863 2822864 2822865 2822867 2822868 2822869 2822990 2822991 2822992 2822995 2822997 2822998 2822999 2824351 2824356 2824358 2824359 2824972 2824974 2824976 2824977 2824980 2824981 2825230 2825231 2825233 2825234 2825235 2825236 2825238 2825239 2825310 2825312 2825313 2825314 2825315 2825317 2825318 2827841 2827842 2827843 2827844 2827846 2827847 2827848 2827849 2828930 2828931 2828932 2828934 2828935 2828936 2828937 2828938 2828939 2831133 2831135 2831136 2831139 2835180 2835182 2835183 2835184 2835185 2835186 2835188 2835189 2835471 2835479 2836210 2836211 2836212 2836214 2836215 2836216 2836218 2837142 2837143 2837144 2837145 2837147 2837148 2837149 2841740 2841741 2841742 2841743 2841744 2841746 2841747 2841748 2841811 2841812 2841813 2841816 2841819 2841822 2841824 2841825 2841829 2841860 2841863 2841864 2841865 2841869 2841980 2841981 2841984 2841988 2842860 2842861 2842863 2842864 2842865 2842866 2842867 2842868 2842869 2842880 2842881 2842883 2842884 2842885 2842889 2842901 2842903 2842905 2842909 1942715 1942716 1942717 1942719 1942720 1942721 1942722 2878543 2878544 2878545 2878546 2878548 2878549 1942714 2764410 2764411 2764412 2764413 2764414 2821780 2821781 2821782 2821783 2821784 2821785 2821786 2821787 2821788 2823650 2823651 2823652 2823653 2823654 2823655 2823656 2823657 2823658 2823659 2825130 2825131 2825132 2825133 2825134 2825135 2825136 2825137 2825138 2825139 2847641 2847643 2847649 2870100 2870101 2870102 2870103 2870104 2870105 2870106 2870107 2870108 2870109 2870454 2870455 2443516 2443520 2443741 2443745 2726490 2726491 2726492 2726493 2666749 2672330 2672332 2672390 2672391 2672393 2672394 2672395 2672396 2672397 2672398 2672399 2672400 2672401 2672402 2672403 2672404 2672405 2672406 2672407 2672409 2673830 2673831 2673832 2673833 2673834 2673835 2673836 2673839 2674111 2674112 2674113 2674114 2674116 2674117 2674118 2674119 2713227 2718751 2718752 2718757 2718759 2718792 2718933 2718938 2718963 2718967 2718968;
2389280 2389281 2389282 2389283 2389284 2389285 2389286 2389287 2389288 2389289 2395001 2395002 2395003 2395004 2395005 2395006 2395007 2395008 2395009 2395010 2395021 2395022 2395023 2395024 2395025 2395026 2395027 2395028 2395029 2395030 2395141 2395142 2395143 2395144 2395145 2395146 2395147 2395148 2395149 2395150 2395301 2395302 2395303 2395304 2395305 2395306 2395307 2395308 2395309 2395310 2396221 2396222 2396223 2396224 2396225 2396226 2396227 2396228 2396229 2396230 2396321 2396322 2396323 2396324 2396325 2396326 2396327 2396328 2396329 2396330 2396371 2396372 2396373 2396374 2396375 2396376 2396377 2396378 2396379 2396380 2396401 2396402 2396403 2396404 2396405 2396406 2396407 2396408 2396409 2396410 2396421 2396422 2396423 2396424 2396425 2396426 2396427 2396428 2396429 2396430 2396531 2396532 2396533 2396534 2396535 2396536 2396537 2396538 2396539 2396540 2397051 2397052 2397053 2397054 2397055 2397056 2397057 2397058 2397059 2397060 2397071 2397072 2397073 2397074 2397075 2397076 2397077 2397078 2397079 2397080 2397321 2397322 2397323 2397324 2397325 2397326 2397327 2397328 2397329 2397330 2764320 2764321 2764322 2764323 2764324 2764325 2764326 2764327 2764328 2764329 2764370 2764371 2764372 2764373 2764374 2764375 2764376 2764377 2764378 2764379 2764460 2764461 2764462 2764463 2764464 2764465 2764466 2764467 2764468 2764469 2801600 2801601 2801602 2801603 2801604 2801605 2801606 2801607 2801608 2801609 2820250 2820251 2820252 2820253 2820254 2820255 2820256 2820257 2820258 2820259 2821120 2821121 2821122 2821123 2821124 2821125 2821126 2821127 2821128 2821129 2821210 2821211 2821212 2821213 2821214 2821215 2821216 2821217 2821218 2821219 2821230 2821231 2821232 2821233 2821234 2821235 2821236 2821237 2821238 2821239 2821470 2821471 2821472 2821473 2821474 2821475 2821476 2821477 2821478 2821479 2824610 2824611 2824612 2824613 2824614 2824615 2824616 2824617 2824618 2824619 2824772 2824773 2824774 2824775 2824776 2824777 2824778 2824779 2824780 2825290 2825291 2825292 2825293 2825294 2825295 2825296 2825297 2825298 2825299 2846352 2846353 2846354 2846355 2846356 2846357 2846358 2846359 2846360 2846361 2846382 2846383 2846384 2846385 2846386 2846387 2846388 2846389 2846390 2846391 2858000 2858001 2858002 2858003 2858004 2858005 2858006 2858007 2858008 2858009 2858040 2858041 2858042 2858043 2858044 2858045 2858046 2858047 2858048 2858049 2858080 2858081 2858082 2858083 2858084 2858085 2858086 2858087 2858090 2858091 2858092 2858093 2858094 2858095 2858096 2858097 2858098 2858099 2858350 2858351 2858352 2858353 2858354 2858355 2858356 2858357 2858358 2858359 2858440 2858441 2858442 2858443 2858444 2858445 2858446 2858447 2858448 2858449 2864468 2864469 2864470 2864471 2864472 2864473 2864474 2864475 2864476 2864477 2865860 2865861 2865862 2865863 2865864 2865865 2865866 2865867 2865868 2865869 2865883 2865884 2865885 2865886 2865887 2865888 2865889 2865950 2865951 2865952 2865953 2865954 2865955 2865956 2865957 2865958 2865959 2879030 2879031 2879032 2879033 2879034 2879035 2879036 2879037 2879038 2879039 2879040 2879041 2879042 2879043 2879044 2879045 2879046 2879047 2879048 2879049 2879060 2879061 2879062 2879063 2879064 2879065 2879066 2879068 2879069 2879080 2879081 2879082 2879083 2879084 2879086 2879087 2879088 2879140 2879141 2879142 2879143 2879144 2879145 2879146 2879147 2879148 2879149 2879240 2879241 2879242 2879243 2879244 2879245 2879246 2879247 2879248 2879249 2879370 2879371 2879372 2879373 2879375 2879376 2879377 2879378 2879379 2879430 2879431 2879432 2879433 2879434 2879435 2879436 2879437 2879438 2879439 2886750 2886751 2886752 2886753 2886754 2886755 2886756 2886757 2886758 2886759 2900930 2900931 2900932 2900933 2900934 2900935 2900936 2900937 2900938 2900939 2902040 2902041 2902042 2902043 2902044 2902045 2902046 2902047 2902048 2902049 3021777 3021778 3021779 3021780 3021781 3021782 3021783 3021784 3021785 3021786 3021917 3021918 3021919 3021920 3021921 3021922 3021923 3021924 3021925 3021926 3021947 3021948 3021949 3021950 3021951 3021952 3021953 3021954 3021955 3021956 3022871 3022872 3022873 3022874 3022875 3022876 3022877 3022878 3022879 3022880 3024038 3024039 3024040 3024041 3024042 3024043 3024044 3024045 3024046 3024047 3024178 3024179 3024180 3024181 3024182 3024183 3024184 3024185 3024186 3024187 3024188 3024189 3024190 3024191 3024192 3024193 3024194 3024195 3024196 3024197 3024731 3024732 3024733 3024734 3024735 3024736 3024737 3024738 3024739 3024740 3024741 3024742 3024743 3024744 3024745 3024746 3024747 3024748 3024749 3024750 3024921 3024922 3024923 3024924 3024925 3024926 3024927 3024928 3024929 3024930 3030584 3030585 3030586 3030587 3031421 3031422 3031423 3031424 3031425 3031426 3031427 3031428 3031429 3031430 3031441 3031442 3031443 3031444 3031445 3031446 3031447 3031448 3031449 3031450 2764189 2764250 2764251 2764252 2764253 2764254 2764255 2764256 2764257 2764258 2764259 2829290 2829291 2829292 2829293 2829294 2829295 2829296 2829297 2829298 2829299 2829360 2829361 2829362 2829363 2829364 2829365 2829366 2829367 2829368 2829369 2833436 2833437 2833438 2833439 2858220 2858221 2858222 2858223 2858224 2858225 2858226 2858227 2858228 2858229 2858299 2389490 2389491 2389492 2389493 2389494 2389495 2389496 2389497 2389498 2389499 2389500 2395281 2395282 2395283 2395284 2395285 2395286 2395287 2395288 2395289 2395290 2395291 2395292 2395293 2395294 2395295 2395296 2395297 2395298 2395299 2395300 2396021 2396022 2396023 2396024 2396025 2396026 2396027 2396028 2396029 2396030 2396481 2396482 2396483 2396484 2396485 2396486 2396487 2396488 2396489 2396490 2396611 2396612 2396613 2396614 2396615 2396616 2396617 2396618 2396619 2396620 2396811 2396812 2396813 2396814 2396815 2396816 2396817 2396818 2396819 2396820 2396831 2396832 2396833 2396834 2396835 2396836 2396837 2396838 2396839 2396840 2396981 2396982 2396983 2396984 2396985 2396987 2396988 2396989 2396990 2397021 2397022 2397023 2397024 2397025 2397026 2397027 2397028 2397029 2397030 2397031 2397032 2397033 2397034 2397035 2397036 2397037 2397038 2397039 2397040 2397041 2397042 2397043 2397044 2397045 2397046 2397047 2397048 2397049 2397050 2397081 2397082 2397083 2397084 2397085 2397086 2397087 2397088 2397089 2397090 2397121 2397122 2397123 2397124 2397125 2397126 2397127 2397128 2397129 2397130 2397271 2397272 2397273 2397274 2397275 2397276 2397277 2397278 2397279 2397280 2397311 2397312 2397313 2397314 2397315 2397316 2397317 2397318 2397319 2397320 2879410 2879411 2879412 2879413 2879414 2879415 2879416 2879417 2879418 2879419 2879420 2879421 2879422 2879423 2879424 2879425 2879426 2879427 2879428 2879429 2886920 2886921 2886922 2886923 2886924 2886925 2886926 2886927 2886928 2886929 2886940 2886941 2886942 2886943 2886944 2886945 2886946 2886947 2886948 2886949 2886970 2886971 2886972 2886973 2886974 2886975 2886976 2886977 2886978 2886979 3021736 3021776 3021837 3024152 3024154 3030705 3031791 3031793;
2679850 2689160 2689162 2689164 2689167 2689370 2689377 2690296 2690298 2690302 2692920 2692925 2692931 2692932 2692933 2692934 2692935 2692936 2692937;
3043361 3043362 3043364 3043365 3043366 3043367 3043368 3043369 3043370 3043441 3043443 3043445 3043446 3043471 3043472 3043473 3043475 3043476 3043477 3043479 3026931 3026932 3026934 3026935 3026937 3026939 3027181 3027185 3027187 3027189 3027462 3027463 3032194 3032196 3032200 3034771 3034776 3034777 3034779 3034780 3034851 3034852 3034853 3034854 3034855 3034857 3034858 3034859 3034860 3035411 3035412 3035414 3035415 3035416 3035417 3035418 3035420 3035951 3035952 3035953 3035954 3035959;
2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 2995321 2995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 2995330 2999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 2999700 2999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 2718736 2718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 2559757 2559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 2560036 2560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 2610523 2610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 2610542 2610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 2610581 2610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 2610604 2610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 2610613 2610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 2610762 2610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 2666740 2666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748;
2956993 2956994;
2667541 2667542 2667543 2667548 2667981 2667983 2667984 2667985 2667987 2667988 2667989 2669552 2669553 2669554 2669556 2669559 2669633 2669636 2669639 2669640 2669965 2669967 2669968 2669969 2669981 2669983 2669985
RECALLING FIRM/MANUFACTURER
Regeneration Technologies, Inc., Alachua, FL, by letter on October 14, 2005. Firm initiated recall is ongoing.
REASON
The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
VOLUME OF PRODUCT IN COMMERCE
5,320
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 2006

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