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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 22, 2012

 

February 22, 2012                                                                                             12-08
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
___________________________________
PRODUCT
Organique by Himalaya Nourishing Night Cream for All Skin Types 3.38 Fl oz/ 100 ml. 24 bottles per case. Recall # F-0774-2012
CODE
 Batch #S691001 (exp date 01/2013) and Batch #S691002 (exp date 05/2013). The batch number is located on the bottom of the bottle.
RECALLING FIRM/MANUFACTURER
Himalaya USA, Houston, TX, by press release on December 30, 2011 and letters dated January 6, 2012. Firm initiated recall is ongoing.
REASON
The bacteria staphylococcus aureus and fungus were found present in samples of Nourishing Night Cream and were traced to the bottle's pump components.
VOLUME OF PRODUCT IN COMMERCE
3877 bottles of Lot #S691001 and 114 bottles of Lot #S691002
DISTRIBUTION
Nationwide and Brazil, Canada, Korea, Mexico, and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Bin Bin brand rice crackers. Product labeling reads in part:" Bin Bin***Snow Rice Crackers***Net Wt: 5.3 oz. (150G)". Recall # F-0753-2012
 
2) Bin Bin brand rice crackers. Product labeling reads in part:" Bin Bin***Rice Crackers***Net Wt: 15.8 oz. (450G)". Recall # F-0754-2012
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ameripec Inc., Buena Park, CA, by press release on February 1, 2012.
Manufacturer: Namchow Thailand Ltd, Wattana, Bangkok, Thailand. FDA Initiated recall is ongoing.
REASON
An analysis by CFIA had results for presence of eggs in the product, undeclared for eggs.
VOLUME OF PRODUCT IN COMMERCE
1580 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Half & Half distributed under the following label names: Umpqua and Dutch Bros. Recall # F-0755-2012;
 
2) Whip Cream distributed under the following label name: Umpqua. Recall # F-0756-2012;
 
3) Buttermilk distributed under the following label name: Umpqua. Recall # F-0757-2012;
 
4) Orange Juice distributed under the following label name: Umpqua. Recall # F-0758-2012;
 
5) Orange Fruit drink distributed under the following label name: Umpqua. Recall # F-0759-2012;
 
6) Fruit Punch Fruit drink distributed under the following label name: Umpqua. Recall # F-0760-2012;
 
7) Grape Fruit drink distributed under the following label name: Umpqua. Recall # F-0761-2012;
 
8) Blue Raspberry Fruit drink distributed under the following label name: Umpqua. Recall # F-0762-2012;
 
9) Whole Milk distributed under the following label names: Umpqua, Dutch Bros., Cascade, Great Value, Lady Lee, Market of Choice, Dairy Queen, and Sherm's. Recall # F-0763-2012;
 
10) Reduced Fat Milk distributed under the following label names: Umpqua, Dutch Bros., Cascade, Great Value, Lady Lee, Market of Choice, Dairy Queen, and Sherm's. Recall # F-0764-2012;
 
11) 1% Lowfat Milk distributed under the following label names: Umpqua, Dutch Bros., Cascade, Great Value, Lady Lee, Market of Choice, Dairy Queen, and Sherm's. Recall # F-0765-2012;
 
12) Fat Free Milk distributed under the following label names: Umpqua, Dutch Bros., Cascade, Great Value, Lady Lee, Market of Choice, Dairy Queen, and Sherm's. Recall # F-0766-2012;
 
13) 2% Acidophilus Milk distributed under the following label names: Umpqua, Dutch Bros., Cascade, Great Value, Lady Lee, Market of Choice, Dairy Queen, and Sherm's. Recall # F-0767-2012;
 
14) Flavored Milk: Chocolate Dutch Style distributed under the following label names: Umpqua, Dutch Bros., and Great Value. Recall # F-0768-2012;
 
15) Flavored Milk: Chocolate 2% Reduced Fat distributed under the following label names: Umpqua, Dutch Bros., and Great Value. Recall # F-0769-2012;
 
16) Flavored Milk: Chocolate Fat Free distributed under the following label names: Umpqua, Dutch Bros., and Great Value. Recall # F-0770-2012;
 
17) Flavored Milk: Strawberry distributed under the following label names: Umpqua, Dutch Bros., and Great Value. Recall # F-0771-2012
CODE
1) and 2) Expiration date of September 5, 2010 and earlier;
3) Expiration date of September 10, 2010 and earlier;
4) thru 17) Expiration date of September 15, 2010 and earlier.
RECALLING FIRM/MANUFACTURER
Umpqua Dairy Products Co, Roseburg, OR, by telephone and press release on August 18, 2010. Oregon Initiated recall is ongoing.
REASON
Environmental swabbing of processing equipment tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR, WA, CA
___________________________________
PRODUCT
1) Egg salad sandwiches, sold under brand name of Quick Cafe', 5.68 oz Quick Cafe' Egg Salad Wedge. Keep Refrigerated. Recall # F-0772-2012;
 
2) Egg salad sandwiches, sold under brand name of TakeAway Cafe', 7.66 oz TakeAway Cafe' Egg Salad Sandwich. Keep Refrigerated. Recall # F-0773-2012
CODE
1) Use By Dates, 2/1/2012, 2/2/2012, 2/3/2012 & 2/4/2012;
2) Use by Dates, 2/1/2012, 2/2/2012, 2/3/2012, 2/4/2012, 2/5/2012, 2/6/2012 & 2/7/2012
RECALLING FIRM/MANUFACTURER
Greencore USA Cincinnati Plant, Cincinnati, OH, by letters on February 2, 2012. Firm Initiated recall is ongoing.
REASON
Recall due to possible contamination of Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
168 5.68 oz Quick Cafe Egg sandwiches and 2) 1,010 7.66 oz.
DISTRIBUTION
IL, IN, KY, OH & TN
___________________________________
PRODUCT
1) MUNIA brand CHURI (Dry) Fish, Trichiurus savala, 200 GM, PRODUCT OF BANGLADESH --- The MUNIA brand CHURI dry fish is packaged in a sealed plastic bag. Recall # F-0787-2012
 
2) noya brand BOYAL DRY FISH, Net Wt. 200 gm, Product of Bangladesh --- The noya brand BOYAL DRY FISH is packaged in a sealed plastic bag. Recall # F-0788-2012
CODE
1) Best Before April-2013;
2) Best Before Dec. 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Four Star Import & Distribution Inc., Brooklyn, NY, by press release on November 23, 2011. 
Manufacturer: Equity Green, Chittagong, Bangladesh. New York initiated recall is complete.
REASON
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ, VA
___________________________________
PRODUCT
1) Bio Gaudiano Brand Stuffed Olives with Almonds, Glass jar all sizes. Product of Italy. Recall # F-0789-2012;
 
2) Gaudiano Brand Almond Stuffed Olives in Oil, packaged in can 4700ml. Product of Italy. Recall # F-0790-2012
COD
All lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pure Italian, Watertown, MA, by telephone on October 31, 2011 and by visit and press release on November 2, 2011. 
Manufacturer: F.Lli Gaudiano, Foggi, Italy. Firm initiated recall is complete.  
REASON
Stuffed Olives with Almonds are associated with illnesses of Clostridium botulinum in Finland.
VOLUME OF PRODUCT IN COMMERCE
19 glass jars; 69 cans
DISTRIBUTION
MA
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
House of Meats Shell Macaroni Salad 5 lb Plastic Tubs. Recall # F-0749-2012
CODE
Batch/Lot # 00512, BEST IF USE BY DATE 02112; Batch/Lot # 01212, BEST IF USE BY DATE 02812; Batch/Lot # 02312, BEST IF USE BY DATE 03912 & Batch/Lot # 02612, BEST IF USE BY DATE 04212
RECALLING FIRM/MANUFACTURER
Smith-Family Frosted Foods, Tiffin, OH, by telephone and visit on January 27, 2012. FDA initiated recall is ongoing.
REASON
The product contains undeclared colors - FD&C Yellow # 5, FD&C Yellow # 6, and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
140/5 lb tubs
DISTRIBUTION
OH
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
BETA CAROTENE, USP, in 5 grams (NDC 38779-0414-3), 25 grams (NDC 38779-0414-4), and 100 grams bottles (38779-0414-5). Recall # F-0752-2012
CODE
5 g: lot 72548/C (exp. 10/11); 25 g: lot 72548/B (exp. 10/11); 100 g: lot 72548/A (exp. 10/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medisca Inc., Plattsburgh, NY, by letters dated July 28, 2011 and August 22, 2011.
Manufacturers: Medisca Inc, Plattsburgh, NY;
ZHT Sci-Tech(Beijing)Co.,LTD., District, Beijing, China, Beijingsh, China. Firm initiated recall is complete.
REASON
The test results confirmed that the subject lots were no longer within USP specifications and the materials have significantly degraded prior to the expiration date.
VOLUME OF PRODUCT IN COMMERCE
5 grams: 9 bottles; 25 grams: 13 bottles; 100 grams: 3 bottle
DISTRIBUTION
AR, CA, CO, FL, IL, LA, MA, NC, NJ, NV, NY, OH, OK, OR
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
 
None
 
FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension), 1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-600-10. Recall # D-1204-2012
 
2) Bicillin L-A (penicillin G benzathine injectable suspension), 1,200,000 units per 2 mL, Ten Syringes (2 mL size), Rx only. NDC 60793-701-10. Recall # D-1205-2012;
 
3) GONAL- f RFF Pen (follitropin alfa injection) 900 IU/1.5 mL, For Subcutaneous injection, Rx only, NDC 44087-1114-1. Recall # D-1206-2012;
 
4) PULMOZYME (DORNASE ALFA) INHALATION SOLUTION, 30 Ampules, NDC 50242-100-40. Recall # D-1207-2012;
 
5) Rebif (Interferon beta-1a) 44 mcg/0.5 mL, 12 Single-use prefilled syringes, NDC 44087-0044-3. Recall # D-1208-2012;
 
6) VSL #3 DS (DOUBLE STRENGTH), 20 SACHETS, Prescription only, Product Code 45749-017-82, NDC 45749-017-82, Recall # D-1209-2012
CODE
1) Lot #: 60746;  
2) Lot #: 61331;
3) Lot #: BA002807;
4) Lot #: 867896;
5) Lot #: AU000878;
6) Lot #: 2448A11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinray Inc., Whitestone, NY, by telephone on June 15, 2011 and by e-mail and fax on June 24, 2011.
Manufacturers: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN;
Genentech Inc., South San Francisco, CA. Firm initiated recall is complete.
REASON
Temp Abuse: Kinray Inc. is recalling these products because a refrigeration unit at their distribution facility malfunctioned, causing the temperature to rise above the storage specification.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NY, NJ, and MA
___________________________________
PRODUCT
OFIRMEV, (acetaminophen) injection, 1000 mg/100 mL, (10 mg/mL, For Intravenous Use Only, Rx Only, NDC 43825-102-01, is supplied in a 100mL glass vial, containing 1000mg acetaminophen (10mg/mL) OFIRMEV (acetaminophen), NDC 43825-102-01. Recall # D-1210-2012
CODE
Lot V005710, Exp. 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cadence Pharmaceuticals, San Diego, CA, by press release and letters on February 6, 2012.
Manufacturer: Baxter Healthcare Corp, Cleveland, MS. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: An unidentified visible particle was found in one vial during routine stability testing.
VOLUME OF PRODUCT IN COMMERCE
33,336 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Assured Pain Relief for Arthritis, (Acetaminophen 650mg), 24 Caplets (NDC 45738-717-24);
2) Consumer's Choice Pain Relief for Arthritis, (Acetaminophen 650mg), a) 100 Caplets (NDC 45738-715-10), b) 24 Caplets (NDC 45738-715-24);
3) Preferred plus Acetaminophen for Arthritis (Acetaminophen 650mg), 100 Caplets (NDC 45738-716-10);
4) Quality Choice Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 63868-089-50), b) 100 Caplets (NDC 63868-089-01);
5) Select Brand Arthritis Pain Relief (Acetaminophen 650mg), a) 100 Caplets (NDC 15127-530-01) b) 24 Caplets (NDC 15127-530-24), c) 50 Caplets (NDC 15127-530-50);
6) Premier Value Arthritis Pain Relief (Acetaminophen 650mg), a) 50 Caplets (NDC 68019-019-45), b) 100 Caplets (NDC 68016-021-06). Recall # D-1211-2012
CODE
1) Lot # 10J745, Exp Date Sep-12; Lot # 10J746, Exp Date Sep-12; Lot # 10J747, Exp Date Sep-12; Lot # 10K798, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K814, Exp Date Oct-12; Lot # 10K799, Exp Date Oct-12; Lot # 10K816, Exp Date Oct-12; Lot # 10K861, Exp Date Oct-12; Lot # 10L861, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L862, Exp Date Nov-12; Lot # 10L863, Exp Date Nov-12; Lot # 10L891, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 11A061, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13 & Lot # 11G481, Exp Date Jul-13;
2) Lot # 10L889, Exp Date Nov-12; Lot # 10L890, Exp Date Nov-12; and Lot # 10L863, Exp Date Nov-12; Lot # 10L889, Exp Date Nov-12 & Lot # 11A062, Exp Date Jan-13;
3) Lot # 10K799, Exp Date Oct-12; Lot # 10L863, Exp Date Nov-12; Lot #, 11A061, Exp Date, Jan-13 & Lot # 11A062, Exp Date Jan-13;
4) Lot # 11A004, Exp Date Jan-13; Lot # 11A060, Exp Date Jan-13; Lot # 11H484, Exp Date Jul-13 & NDC 63868-089-50, Lot # 11A004, Exp Date Jan-13;
5) Lot # 10K816, Exp Date Oct-12; Lot #, 10L863, Exp Date, Nov-12; Lot # 11A004, Exp Date Jan-13; NDC 15127-530-24, Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13; Lot # 11A062, Exp Date Jan-13; Lot # 10K814, Exp Date Oct-12; Lot # 11A004, Exp Date Jan-13 & Lot # 11A062, Exp Date, Jan-13;
6) All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aphena Pharma Solutions LLC, Glasgow, KY, by letters on December 2, 2011.
Manufacturer: Advance Pharmaceutical Inc., Ronkonkoma, NY. Firm initiated recall is ongoing.
REASON
Marketed without an approved NDA/ANDA: The recall is due to incorrect dosage information indicated on the primary bottle and the outside carton labeling. The labeling contained the following information: take 2 caplets every 8 hours with water. This labeling exceeds the allowable monograph quantity of acetaminophen in an 8 hour period.
VOLUME OF PRODUCT IN COMMERCE
1,050,943 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg, 30-count bottles, Rx only; NDC 0173-0784-01; UPC 3 0173-0784-01 8. Recall # D-1212-2012;
 
2) DynaCirc CR (isradipine) Controlled Release Tablets, 10 mg, 30-count bottles, Rx only; NDC 0173-0785-01, UPC 3 0173-0785-01 5. Recall # D-1213-2012
CODE
1) Lot #: 10084536, Exp 12/12; 10102915, Exp 03/13; 10102916, Exp 06/13; 10107157, Exp 07/13; and 10108172, Exp 09/13;
 
2) Lot #: 10087732, Exp 01/13; 10091069, 10094639; Exp 03/13; 10102913, Exp 07/13; and 10109327, Exp 10/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter dated February 3, 2012. 
Manufacturers: Novartis Consumer Health, Lincoln NB;
Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
CGMP Deviations: These lots are being recalled due to compliance concerns regarding the level of cGMP compliance and procedural controls related to line clearance during the packaging process at the Novartis Consumer Health, site.
VOLUME OF PRODUCT IN COMMERCE
394,230 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Female One Series Vagifresh Moisturizing Gel, 2 fl. oz. (59mL) carton, Made in U.S.A. UPC Code: 689076499057. Recall # D-1214-2012;
 
2) Female One Series Vagifresh Ball, 3 tablets per carton, UPC Code: 689076499156. Recall # D-1215-2012
CODE
All Lots.
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S.A Far Ocean Group LLC, Alhambra, CA, by press was release on January 18, 2012 and by letter on January 25, 2012.
Manufacturer: Essential Pharmaceutical Corp, Pomona, CA. Firm initiated recall is ongoing.
REASON
1) Labeling: Product contains Undeclared Active Ingredient; The recall was initiated because Far Ocean Group has confirmed that the Vagifresh Gel contains Benzocaine, an active ingredient for many anesthetic drug products.
2) Microbial Contamination of Non-Sterile Products; Far Ocean Group and FDA lab analysis confirmed that the Vagifresh Ball contains bacteria that may be a potential health risk.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and China, South Africa, and Canada
 
FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated Tablets, NDC 50580-109-02. Recall # D-1216-2012;
 
2) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID),24 Coated Caplets, NDC 50580-110-03. Motrin IB***Ibuprofen Tablets, USP 200 mg*** 24+6 Coated Caplets***. Motrin IB 24 Count Coated Caplets, Motrin IB 24+6 Coated Caplets. Cartons of Motrin IB Coated Caplets were also included in the following displays: TYl ES/PM CAP 24s, Motrin CAP 24s CU (Display case UPC# 30300450753312); Tylenol Caplet 24/Motrin Caplet 24 (Display case UPC# 30300450749230); Tylenol RRG/PM 24s, Motrin CAP 24s CU (Display case UPC# 30300450754821); and TYl ES/PM/RRG/MOT IB/PM 24s DIST PK (Display case UPC# 30300450755873). Recall # D-1217-2012
CODE
1) Lot ADA069, Exp. 01/12; ALA168, Exp. 04/12; ALA244, Exp. 08/12; AMA286, Exp. 09/12; APA001, Exp. 09/12; ASA001, Exp. 10/12;
 
2) Lot ACA310, Exp. 12/11; ACA460, Exp. 01/12; ADA407, Exp. 02/12; AEA262, Exp. 03/12; AFA226, Exp. 04/12; AJA170, Exp. 03/12; ALA037, Exp. 07/12; ALA163, Exp. 04/12; AMA012, Exp. 08/12; AMA331, Exp. 05/12; AMA342, Exp. 08/12; APA035, Exp. 09/12; ASA082, Exp. 09/12; ASA123, Exp. 10/12; ASA285, Exp. 09/12; BDA238, Exp. 11/12; BDA260, Exp. 01/13; BDA383, Exp. 01/13; BEA065, Exp. 01/13; BEA148, Exp. 02/13; Exp. 03/13; BEA269, Exp. 03/13; BEA277, Exp. 03/13; BFA064, Exp.04/13; BFA144, Exp. 04/13; BFA244, Exp. 05/13; BHA078, Exp. 05/13; BHA147, Exp. 04/13; BHA167, Exp. 04/13; BHA198, Exp. 05/13; BJA164, Exp. 05/13; BJA221, Exp/. 06/13; BMA144, Exp. 08/13; BMA215, Exp. 08/13; BMA271, Exp. 08/13; BSA022, Exp. 07/13; BSA056, Exp. 10/13; CBA063, Exp. 12/13; CBA107, Exp. 12/13; CCA028, Exp. 01/14; CDA003, Exp. 02/14; CFA065, Exp. 01/14; CFA100, Exp. 01/14; CHA012, Exp. 01/14; CHA044, Exp. 01/14; CHA066, Exp. 01/14; CHA080, Exp. 05/14; CMA028, Exp. 05/14; CMA035, Exp. 05/14; CMA057, Exp. 05/14; CMA102, Exp. 06/14; CMA108, Exp. 05/14; ACA761, Exp. 01/12; ALA265, Exp. 08/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div Of McNeil-ppc, Inc, Fort, Washington, PA, by letter and WEB posting on December 21, 2011.
Manufacturer: Dr. Reddy's Laboratories Louisiana LLC, Shreveport, LA. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: McNeil is recalling these products because testing of product sample showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.
VOLUME OF PRODUCT IN COMMERCE
11,990,160 bottles
DISTRIBUTION
Nationwide and Puerto Rico, Bahamas, Belize, Fiji, Jamaica and Saint Lucia
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0528-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0529-12
CODE
1) Units: 84KS34668, 84KS34717, 84KS34741;
 
2) Units: 84KS34668, 84KS34668, 84KS34678, 84KS34678, 84KS34688, 84KS34698, 84KS34698, 84KS34703, 84KS34703, 84KS34717, 84KS34759, 84KS34759, 84KS34759, 84KS34765, 84KS34765
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone and letter on April 29, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0536-12
CODE
Unit: 221044653
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Las Vegas, NV, by telephone and follow-up letter on August 3, 2005.
Manufacturer: Green Valley Center, Henderson, NV. 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
CA
___________________________________
PRODUCT
Cornea. Recall # B-0633-12
CODE
Units: 070147OD, 070147OS
RECALLING FIRM/MANUFACTURER
Donor Network of Arizona, Phoenix, AZ, by telephone on August 24 and 27, 2007. Follow-up via letter dated October 16, 2007. Firm initiated recall is complete.
REASON
Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 Corneas
DISTRIBUTION
AZ
___________________________________
PRODUCT
Cornea. Recall # B-0634-12
CODE
Units: 070095OD, 070095OS
RECALLING FIRM/MANUFACTURER
Donor Network of Arizona, Phoenix, AZ, by telephone on May 23, 2007 and by letters dated June 4, 2007. Firm initiated recall is complete.
REASON
Human Cornea, with incomplete testing for relevant communicable diseases, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Cornea
DISTRIBUTION
AZ
___________________________________
PRODUCT
Cornea. Recall # B-0635-12
CODE
Units: 091354ODCEK; 091354OSCEK
RECALLING FIRM/MANUFACTURER
Minnesota Lions Eye Bank, Inc., Saint Paul, MN, by telephone on February 16, 2010 and March 5, 2010 and by letter on March 11, 2010. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor whose eligibility to donate was based on a hemodiluted sample, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN, OH
___________________________________
PRODUCT
Ortho Clinical Diagnostics, Inc. Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS - 50 ug Dose (250 IU*) NDC 0562-7806-01; UPC NDC0562780525, Product Code 780601. Recall # B-0636-12
CODE
MVP105A1 Expiration Date 11FEB2012, MVP106A1 Expiration Date 14FEB2013
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc., Raritan, NJ, by letters dated October 28, 2011. Firm initiated recall is ongoing.
REASON
Two lots of MICRhoGAM, partially mislabeled as RhoGAM, were distributed.
VOLUME OF PRODUCT IN COMMERCE
MVP105A1- 727 units; MVP106A1- 214 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cornea. Recall # B-0637-12
CODE
Units: 20110257 1:2; 20110257 2:2; 20110258 1:2; 20110258 2:2
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT Southwestern Medical Center, Dallas, TX, by telephone and by fax dated June 7, 2011, and by letter July 5, 2011. Firm initiated recall is complete.
REASON
Human Corneas, recovered from a donor with incomplete testing for relevant communicable disease and disease agents, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Human Cornea. Recall # B-0639-12
CODE
108141-OS Expiration Date: May I, 2008
RECALLING FIRM/MANUFACTURER
San Diego Eye Bank, San Diego, CA, by letter dated July 11, 2008. Firm initiated recall is complete.
REASON
Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents or diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Cornea. Recall # B-0640-12
CODE
Units: 1103084, 1103085
RECALLING FIRM/MANUFACTURER
Arkansas Lions Eye Bank & Laboratory, Little Rock, AR, by letter dated May 10, 2011. Firm initiated recall is ongoing.
REASON
Human corneas, recovered from a donor whose donor testing for relevant communicable disease agents was associated with a sample mix-up, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Cornea in Optisol GS. Recall # B-0641-12
CODE
Units: 068911; 069011
RECALLING FIRM/MANUFACTURER
Eye Bank For Sight Restoration, New York, Inc., New York, NY, by telephone on May 19, 2011 and by letters dated May 19, 2011. Firm initiated recall is complete.
REASON
Human corneas, recovered from a donor who was not adequately tested for relevant communicable disease agents or diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
NY
___________________________________
PRODUCT
Cornea in Optisol GS. Recall # B-0642-12
CODE
Units: 028609, 028709, 029109, 029209, 029809, 029909, 030309, 030409, 030709, 030809, 031309, 031409, 031709, 031809, 031909, 032109, 032209, 032609, 032809, 032909, 033409, 033509, 033609, 033709, 034009, 034109, 034209, 034309, 034609, 034709, 035309, 035609, 035709, 035809, 035909, 037109, 037209, 037309, 037409, 038509, 040909, 041009
RECALLING FIRM/MANUFACTURER
Eye Bank For Sight Restoration, Inc., New York, NY, by fax, telephone and letters dated March 20, 24 and April 20, 2009. Firm initiated recall is complete.
REASON
Corneas, recovered using excision instruments that had incomplete sterilization cycles, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
NY, CA, Dominican Republic, Venezuela, Mexico, Bolivia, Chile
___________________________________
PRODUCT
Alpha-1-Proteinase Inhibitor (Human). Recall # B-0653-12
CODE
Units: VNB5K015AAA, VNB5K015AAB, VNB5K015AAC, VNB5K015AAD, VNB5K015AAE, VNB5K014AA, VNB5K021AA, VNB5K022AA, VNB5K023AA, VNB5K028AB, VNB5K029AA, VNB5K031AA, VNB5K032AA, VNB5K033AAB, VNB5K033BAB, VNB5K035AA, VNB5K037AB, VNB5K039AA, VNB5K040AA, VNB5K040AB, VNB5K041AC, VNB5K042AA, VNB5K043AA, VNB5K044AA, VNB5K047AAA, VNB5K047BAA, VNB5K048AA, VNB5K049AA, VNB5K050AA, VNB5K051AA, VNB5K051AB, VNB5K052AA, VNB5K053AA, VNB5K056AA, VNB5K057AA, VNB5K058AA, VNB5K059AA, VNB5L001AA, VNB5L001AB, VNB5L002AA, VNB5L003AA, VNB5L004AA, VNB5L005AA, VNB5L006AA, VNB5L007AA, VNB5L008AA, VNB5L009AA, VNB5L009AAA, VNB5L010AA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Westlake Village, CA, by letter dated May 9, 2011.
Manufacturer: Baxter Healthcare Corporation - Baxter AG, Vienna, Austria. Firm initiated recall is ongoing
REASON
ARALAST NP (Alpha1- Proteinase Inhibitor (Human)), packaged with BAXJECT II Hi-Flow, and associated with particle formation in the reconstituted solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
approximately 122, 088
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Corneas, Recall # B-0659-12
CODE
Units: 2008086085, 2008086086, procured 8/22/2008
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Kansas City, MO, by fax on February 2, 2009. Firm initiated recall is complete.
REASON
Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, KS
___________________________________
PRODUCT
Hepatitis C Virus Encoded Antigen (Recombinant c200) CHIRON HCV c200 Antigen; Stock Number: 4392-801, 4392-802, 4392-805 (4392-805 only item distributed for this lot); (The product is for Further Manufacturing Use/Recombinant). Recall # B-0673-12
CODE
Lot # 127129
RECALLING FIRM/MANUFACTURER
Novartis Vaccine and Diagnostics, Inc., Emeryville, CA, by telephone, e-mail, and letter on December 12, 2011. Firm initiated recall is complete.
REASON
Hepatitis C Virus Encoded Antigen (For Further Manufacturing Use, formulated with a reduced concentration of Dithiothreitol (DTT) in the formulation buffer, was distributed.
VOLUME OF PRODUCT IN COMMERCE
560 mg
DISTRIBUTION
Great Britain
________________________________________
PRODUCT
Red Blood Cells. Recall # B-0674-12
CODE
Unit: W088411539285
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter dated November 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0676-12
CODE
Unit: W069111149738
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Flowood, MS, by facsimile on November 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0679-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0680-12
CODE
1) W117011504902 (2 units), W117011504169;
2) Unit: W117011500004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on December 7, 2011 and by letter dated December 7, 2011. 
Manufacturer: Blood Centers of the Pacific - Santa Rosa Center, Santa Rosa, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Corneas procured 7/5/2007 for human transplant. Recall # B-0683-12.
CODE
Units: 20070717, 20070718
RECALLING FIRM/MANUFACTURER
Kansas Eye Bank & Cornea Research Center, Inc., Wichita KS, by letters dated May 27, 2010. Firm initiated recall is complete.
REASON
Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
Egypt, IN
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma. Recall # B-0527-12
CODE
Units: 40500409002, 40500401300, 40500382495, 40500377776, 40500354574, 40500339534, 40500334848, 40500413271, 40500397080, 40500297670, 40500329774, 40500290523, 40500068236, 40500078629, 40500071515, 40500034482, 40500025172, 40500021163, 40500046563, 40500098507, 40500019805, 40500012531, 40500087453, 40500091997, 40500058310, 40500114175, 40500109421, 40500101876, 40500147778, 40500141077, 40500155903
RECALLING FIRM/MANUFACTURER
Csl Plasma Inc, Knoxville, TN, by fax or electronic mail on May 24, 2011. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process, for which the donors were not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
NC, IL, Germany and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0535-12
CODE
Unit: W149508100402
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone and fax on November 11, 2008. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire amount of Optisol added during component preparation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0550-12
CODE
Units: 0550670416; 0550669265; 0550667866; 0550666533; 0550665751; 0550663993; 0550663439; 0550662137; 0550660840; 0550659994; 0550658696; 0550657917; 0550656629; 0550655800; 0550654483; 0550653188; 0550651895; 0550651251; 0550659871; 0550649269; 0550647761; 0550647226; 0550643241; 0550642748; 0550619944; 0550619290; 0550618043; 0550617398
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Portland, OR, by letter dated June 20, 2008. Manufacturer: Zlb Plasma Services, Boca Raton, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred for unsuitable test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
NC, Germany and Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Deglycerolized Leukocytes Reduced. Recall # B-0591-12;
2) Red Blood Cells Deglycerolized. Recall # B-0592-12;
3) Red Blood Cells Rejuvenated Deglycerolized. Recall # B-0593-12;
4) Red Blood Cells Rejuvenated Deglycerolized Leukocytes Reduced Irradiated. Recall # B-0594-12
CODE
1) Units: 084J90911, 033GR52274, 084FT77211, 084K58706, 084Z88455, 006GL46986;
2) Units: 1668210298, 1271570009, 116KC24821, 1271391458, 116LP53919;
3) Units: U084GF01987, 084GF02053, 084Q91049, 084GF01192;
4) Unit: 084Z66470
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by fax on January 11, 2006 and follow-up letter dated January 12, 2006. Firm initiated recall is complete.
REASON
Blood products, held at an unacceptable temperature during component preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Allergenics - Other "STAR Tree". Number of units involved for each product: 1 set (3 vials). Labeling reads in part: "Allergenic Extract Prescription Formula U.S. FDA Lic 467***Name Gutierrez, Patrick Contents 5 mL vial(s) Concentration Conc. (1:20) - 1:2,000 (5mL) ***". Recall # B-0638-12
CODE
Lot No. AO51545A Expiration Dae: 03/22/06
RECALLING FIRM/MANUFACTURER
Allermed Laboratories, Inc., San Diego, CA, by telephone on June 13, 2005. Firm initiated recall is complete.
REASON
Prescription set of 3 allergenic vials of "STAR Tree", labeled as "PA Tree," was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 set = 3 vials
DISTRIBUTION
CA
___________________________________
PRODUCT
Immune Globulin Intravenous (Human). Recall # B-0649-12
CODE
LE09K005AB Exp. Date: March 9, 2012; LE08K015AS Exp. Date: September 15, 2012, LE08K021AB Exp. Date: December 1, 2012 LE08L012AB-Exp. Date: March 29, 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Westlake Village, CA, by letters dated September 14, 2011. 
Manufacturer: Baxter Biosciences, Lessines, Belgium. Firm initiated recall is ongoing.
REASON
GAMMAGARD S/D [Immune Globulin Intravenous (Human)] 5g, misbranded with an incorrect dilution volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
9,531 (US) 3000 (Russia)
DISTRIBUTION
Nationwide, Russia
___________________________________
PRODUCT
1) Immune Globulin Intravenous (Human), 10% Liquid. Recall # B-0650-12;
2) Immune Globulin Intravenous (Human). Recall # B-0651-12;
3) Albumin (Human). Recall # B-0652-12
CODE
1) Units: GMGN004791, GMGN004791, GMGM005041, GMGM005041, GMGN004791, GMGP005071, GMGN004791;
2) Units: GMGK105491, GMGL105351;
3) Units: B1NA0TX002, B1NA0TX003, B1NA0TX002, B1NB1VT002
RECALLING FIRM/MANUFACTURER
Grifols Biologicals Inc., Los Angeles, CA, by letter on June 22, 2011. Firm initiated recall is ongoing.
REASON
Blood Derivatives, lacking assurance of proper temperature storage during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
FL, TN
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0675-12
CODE
Units: W045111317840, W045111317843
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letters dated December 5, 2011 and December 22, 2011. Firm initiated recall is complete.
REASON
Blood products, prepared from plasma which was not frozen within 8 hours of phlebotomy, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0677-12
CODE
Unit: W069111145098
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Flowood, MS by facsimile on October 25, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0678-12
CODE
Units: 019FZ61073, 019GR73051, 019GR73073, 019GR73074, 019GH02023, 019GK97623
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on November 1, 2011 and November 3, 2011 and by letter dated November 3, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TN, KY
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR System, 1.5T Infinity TwinSpeed, Signa Lx; Signa Infinity MR System with EXCITE Technology, Excite II, Signa Excite 1.5T Expert; Signat 3T Infinity with Excite; Signa 3.0T with EXCITE; Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T; Signa HDx; Signa HDxt; Signa Vibrant; Signa HDi; Signa Horizon Cx aka MR/I; Discovery MR450; Discovery MR750; Optima MR450w; Signa Cvi, and Signa Nvi. The Optima MR45Ow is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. it is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis. Recall # Z-0148-2012
CODE
Lot #’s: 5147788-5, 5139394, and 5139394-2; 2199859 and 2202900-6; 5148810 and 5373011; 5148810-2 and 5373011-2; 5148810-3, 5148810, and 5373011
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter beginning September 15, 2011. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of missing labels on the alignment lasers.
VOLUME OF PRODUCT IN COMMERCE
4614 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use. Recall # Z-0351-2012.
CODE
Units: ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular Inc., Tempe, AZ, by letter on November 7, 2011. Firm initiated recall is ongoing.
REASON
Product’s damaged packaging trays.
VOLUME OF PRODUCT IN COMMERCE
64,570 units
DISTRIBUTION
Nationwide, Canada, Europe, LAPAC, and Australia
___________________________________
PRODUCT
1) Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0360-2012;
 
2) Ingenuity CT computed Tomography System, Model #728326, 510(k) #KK 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-0361-2012
CODE
1) Serial Numbers: 95504, 91003, 300030, 95130, and 95157;
2) Serial Numbers: 300010 and 30
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated October 10, 2011. Firm initiated recall is ongoing.
REASON
Software errors. A number of non-conformances were logged during in-house testing and external validation testing of Brilliance 64 and Ingenuity CT software version 4.0 Beta 2. The non-conformances are due to software errors identified in these device systems.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide, of Australia, China, Belgium, Israel, and Sweden
___________________________________
PRODUCT
Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; list 09K14. Recall # Z-0365-2012
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Molecular, Des Plaines, IL, by letter dated October 10, 2011. Firm initiated recall is ongoing.
REASON
Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.
VOLUME OF PRODUCT IN COMMERCE
432 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1. A medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from variety of imaging devices. Recall # Z-0388-2012
CODE
Vital ID 10013 10079 10082 10092 10099 10104 10112 10117 10126 10127 10141 10149 10150 10158 10161 10174 10186 10199 10200 10210 10224 10225 10226 10227 10236 10250 10276 10300 10305 10306 10327 10351 10355 10359 10364 10380 10394 10395 10396 10400 10409 10412 10413 10415 10416 10418 10432 10437 10478 10487 10491 10499 10533 10539 10574 10575 10592 10607 10610 10613 10633 10635 10637 10656 10664 10665 10671 10685 10691 10697 10698 10709 10729 10732 10737 10739 10741 10748 10753 10767 10796 10798 10800 10802 10806 10827 10834 10859 10870 10878 10879 10880 10898 10921 10968 10991 11033 11088 11093 11119 11129 11136 11150 11165 11168 11178 11185 11233 11235 11252 11260 11262 11263 11269 11271 11280 11287 11289 11310 11316 11333 11342 11359 11366 11401 11404 11412 11444 11483 11513 11544 11555 11597 11613 11623 11684 11696 11776 11827 11888 11922 11941 11991 12043 12118 12122 12226 27622 27658 27674 27694 27729 27766 27774 27833 27849 27879 27889 27893 27908 27933 27958 27992 27994 28041 28076 28179 28194 28228 28236 28243 28263 28356 28405 28455 28470 28510 28516 28547 28552 28559 28567 28582 28603 28667 28668 28716 28724 28746 28808 28882 28914 28915 28917 28920 28921 28939 28956 28958 29007 29009 29010 29017 29024 29025 29026 29087 29088 29097 29154 29155 29156 29157 29158 29167 29229 29271 29281 29290 29340 29341 29351 29372 29373 29375 29376 29507 29546 29551 29557 29569 29570 29573 29574 29583 29586 29601 29603 29606 29607 29609 29610 29623 40108 40117 40131 40163 40176 40192 40284 40295 40325 40513 40565 40614 40617 40647 40706 40714 40722 40739 40771 40926 41109 41145 41194 41230 41256 41439 41461 41507 41539 41596 41674 41981 42093 42153 42521 42873 42934 43369 43503 43536 43557 43635 43669 43720 45759 45960 46274 46672 47454 47920 48344 52042 52976 53018 53025 53033 53055 53117 53175 53194 53196 53197 53443 53535 53537 53544 53672 53673 53744 53745 53748 53897 53898 54012 54022 54102 54318 54821 54822 54827 54830 54863 54945 55005 55008 55063 55302 55327 55375 55901 56015 56185 57343 28591 40391
RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by letter dated November 11, 2011. Firm initiated recall is ongoing.
REASON
Vital Images has found two issues that may display incorrect Standard Update Values (SUV) when viewing certain PET/CT images. This issue affects the VitreaCore PET/CT feature for Vitrea Enterprise Suite 1.2, 1.3, 6.0, 6.1, including all updates to those versions.
VOLUME OF PRODUCT IN COMMERCE
338 (233 US)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. To absorb menstrual or other vaginal discharge. Recall # Z-0393-2012
CODE
Lot numbers (found in the red box located on bottom of package): AC129321X, AC129421X, AC129521X, AC129621X, AC129721X, AC129821X, AC129921X 36 count: AC129325X, AC129425X, AC129525X, AC129625X, AC129725X, AC129825X, AC129925X
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark Corp., Roswell, GA, by letter, dated November 9, 2011. Manufacturer: Kimberly Clark Corp., Conway Mills, Conway, AR. Firm initiated recall is ongoing.
REASON
A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.
VOLUME OF PRODUCT IN COMMERCE
1,400 cases (216 tampons per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT ***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws). Model #- 72-1000. Recall # Z-0447-2012
CODE
Serial #'s: 000007, 000009, 000010, 000011, 000012, 000013, 000017, 0G0014, 0G0018, 0G0019, 0K0001, 0K0003, 0K0006, 0K0007, 0K0008, 0K0009, 0K0011, 0K0012, 0K0013, 0K0014, 0K0015, 0K0016, 0K0017, 0K0019, 0K0020, 0K0021, 0K0022, 0L0001, 0L0002, 0L0003, 0L0004, 0L0005, 0L0006, 0L0007, 0L0008, 0L0009, 0L0010, 0L0011, 0L0014, 0L0015, 0L0016, 0L0017, 0L0018, 0L0019, 0L0020, 0L0022, 0L0023, 0L0024, 0L0026, 0L0028, 0L0029, 0L0030, 0L0031, 0L0032, 0L0033, 0L0034, 0L0035, 0L0037, 0L0038, 0L0039, 0L0041, 0L0042, 0L0044, 0L0045, 0L0046, 1A0004, 1A0005, 1A0012, 1A0014, 1A0016, 1A0019, 1A0020, 1A0021, 1A0022, 1A0024, 1A0026, 1A0028, 1A0031, 1A0033, 1A0034, 1A0036, 1A0037, 1A0041, 1A0042, 1A0043, 1A0044, 1A0046, 1A0047, 1A0048, 1A0051, 1A0052, 1A0053, 1A0055, 1A0056, 1A0057, 1A0059,1A0062, 1A0064, 1A0067, 1A0069, 1A0070, 1A0072, 1A0073, 1A0079, 1A0081, 1A0084, 1A0085, 1A0086, 1A0088, 1A0089, 1A0090, 1A0091, 1A0093, 1A0095, 1A0096, 1A0097, 1A0098, 1A0099, 1A0100, 1A0101, 1A0102, 1A0103, 1A0105, 1A0106, 1A0107, 1A0108, 1A0113, 1A0117, 1A0118, 1A0119, 1A0120, 1A0123, 1A0125, 1A0126, 1A0127, 1A0128, 1A0129, 1A0130, 1A0131, 1A0133, 1A0134, 1A0135, 1A0136, 1A0137, 1A0138, 1A0142, 1A0144, 1A0145, 1A0148, 1A0149, 1A0152, 1A0153, 1A0156, 1A0158, 1A0171, 1A0174, 1A0176, 1A0198, 1B0010, 1C0004, 1C0014, 1C0023, 1C0025, CK 0030, CK0011, CK0024, CK0025, CK0026, CK0027, CK0028, CK0029, CK0032, CK0033
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letter dated July 8, 2011. Firm initiated recall is ongoing.
REASON
Recall due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
VOLUME OF PRODUCT IN COMMERCE
161 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ThermoSuit. Temperature reduction in patients where clinically indicated; Monitoring of patient temperature. Recall # Z-0456-2012
CODE
Units: 510 K K061023 N0110PD N0108NI N0068JH N0109PD N0103NE N0106NI N0065JH N0104NI N0105NI
RECALLING FIRM/MANUFACTURER
Recalling Firm: Life Recovery Systems HD, LLC, Waldwick, NJ, by letters dated October 24, 2011.  
Manufacturer: Nexcore Technology, Inc., Waldwick, NJ. Firm initiated recall is ongoing.
REASON
ThermoSuit System Model TSP-50 Pump/Controller may have corrosion on the temperature circuit board which may result in incorrect patient temperature reading.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Varian Unique Single Energy Linear Accelerator, C-Series Clinac or Trilogy, versions 7.x and 8.x, Reference/FSCA Identifier: CP-0661; Model Numbers: H14, H18, H27, H29; Varian Unique Single Energy Linear Accelerator: The UNIQUE is a Single Energy Linear Accelerator intended to be used for conventional radiotherapy and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0483-201;
 
2) Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x. The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0692-2012
CODE
1) H140001 ,H140145 ,H140711 ,H140772 ,H140832 ,H140893 ,H140958 ,H271265 ,H271742 ,H272014 ,H272235 ,H272416 ,H272858 ,H140011 ,H140146 ,H140712 ,H140773 ,H140833 ,H140895 ,H140959 ,H271277 ,H271755 ,H272016 ,H272236 ,H272418 ,H272859 ,H140018 ,H140147 ,H140713 ,H140774 ,H140834 ,H140896 ,H140962 ,H271293 ,H271760 ,H272023 ,H272237 ,H272421 ,H272860 ,H140025 ,H140148 ,H140714 ,H140775 ,H140835 ,H140897 ,H140963 ,H271308 ,H271762 ,H272029 ,H272239 ,H272422 ,H272862 ,H140026 ,H140150 ,H140715 ,H140776 ,H140836 ,H140898 ,H180455 ,H271334 ,H271763 ,H272031 ,H272240 ,H272423 ,H272864 ,H140027 ,H140151 ,H140716 ,H140777 ,H140837 ,H140899 ,H182000 ,H271362 ,H271773 ,H272033 ,H272243 ,H272425 ,H272866 ,H140029 ,H140152 ,H140717 ,H140778 ,H140838 ,H140900 ,H182001 ,H271370 ,H271780 ,H272035 ,H272250 ,H272426 ,H272868 ,H140031 ,H140153 ,H140718 ,H140779 ,H140839 ,H140901 ,H182002 ,H271378 ,H271783 ,H272043 ,H272259 ,H272427 ,H272872 ,H140038 ,H140154 ,H140719 ,H140780 ,H140840 ,H140902 ,H182003 ,H271385 ,H271785 ,H272045 ,H272260 ,H272428 ,H272873 ,H140039 ,H140201 ,H140720 ,H140781 ,H140841 ,H140903 ,H182005 ,H271393 ,H271797 ,H272049 ,H272271 ,H272432 ,H272876 ,H140043 ,H140202 ,H140721 ,H140782 ,H140842 ,H140904 ,H182006 ,H271407 ,H271801 ,H272050 ,H272277 ,H272434 ,H272885 ,H140045 ,H140203 ,H140722 ,H140783 ,H140843 ,H140905 ,H182007 ,H271413 ,H271802 ,H272052 ,H272283 ,H272438 ,H272889 ,H140046 ,H140204 ,H140723 ,H140784 ,H140844 ,H140906 ,H182008 ,H271414 ,H271811 ,H272062 ,H272290 ,H272440 ,H272890 ,H140047 ,H140205 ,H140724 ,H140785 ,H140845 ,H140907 ,H182009 ,H271420 ,H271825 ,H272064 ,H272291 ,H272444 ,H272893 ,H140048 ,H140206 ,H140725 ,H140786 ,H140846 ,H140908 ,H182010 ,H271425 ,H271831 ,H272069 ,H272293 ,H272445 ,H272899 ,H140058 ,H140207 ,H140726 ,H140787 ,H140847 ,H140909 ,H182011 ,H271429 ,H271833 ,H272078 ,H272299 ,H272446 ,H272905 ,H140062 ,H140208 ,H140727 ,H140788 ,H140848 ,H140910 ,H182012 ,H271438 ,H271835 ,H272081 ,H272301 ,H272454 ,H272908 ,H140067 ,H140209 ,H140728 ,H140789 ,H140849 ,H140911 ,H182013 ,H271439 ,H271838 ,H272085 ,H272302 ,H272456 ,H272909 ,H140070 ,H140210 ,H140729 ,H140790 ,H140850 ,H140912 ,H182014 ,H271440 ,H271845 ,H272086 ,H272306 ,H272458 ,H272910 ,H140071 ,H140211 ,H140730 ,H140791 ,H140851 ,H140913 ,H182016 ,H271443 ,H271853 ,H272089 ,H272307 ,H272460 ,H272911 ,H140073 ,H140212 ,H140731 ,H140792 ,H140852 ,H140914 ,H182017 ,H271452 ,H271856 ,H272111 ,H272309 ,H272462 ,H272912 ,H140076 ,H140213 ,H140732 ,H140793 ,H140853 ,H140915 ,H182018 ,H271490 ,H271858 ,H272115 ,H272310 ,H272464 ,H272914 ,H140077 ,H140214 ,H140733 ,H140794 ,H140854 ,H140916 ,H182019 ,H271497 ,H271860 ,H272118 ,H272311 ,H272466 ,H272922 ,H140078 ,H140215 ,H140734 ,H140795 ,H140855 ,H140917 ,H182020 ,H271502 ,H271862 ,H272129 ,H272313 ,H272469 ,H272926 ,H140079 ,H140216 ,H140735 ,H140796 ,H140856 ,H140918 ,H182021 ,H271507 ,H271866 ,H272134 ,H272318 ,H272470 ,H272932 ,H140088 ,H140217 ,H140736 ,H140797 ,H140857 ,H140919 ,H182022 ,H271515 ,H271870 ,H272136 ,H272321 ,H272473 ,H272933 ,H140090 ,H140218 ,H140737 ,H140798 ,H140858 ,H140920 ,H182023 ,H271519 ,H271872 ,H272137 ,H272324 ,H272476 ,H272936 ,H140092 ,H140219 ,H140738 ,H140799 ,H140859 ,H140921 ,H182030 ,H271523 ,H271875 ,H272138 ,H272325 ,H272479 ,H272938 ,H140096 ,H140220 ,H140739 ,H140800 ,H140860 ,H140922 ,H182032 ,H271526 ,H271877 ,H272143 ,H272326 ,H272480 ,H272941 ,H140097 ,H140221 ,H140740 ,H140801 ,H140861 ,H140923 ,H260905 ,H271531 ,H271879 ,H272153 ,H272327 ,H272488 ,H272946 ,H140098 ,H140222 ,H140742 ,H140802 ,H140862 ,H140924 ,H260909 ,H271534 ,H271881 ,H272155 ,H272328 ,H272491 ,H272951 ,H140101 ,H140223 ,H140743 ,H140803 ,H140863 ,H140925 ,H260922 ,H271559 ,H271890 ,H272156 ,H272329 ,H272492 ,H272953 ,H140107 ,H140224 ,H140744 ,H140804 ,H140864 ,H140926 ,H260924 ,H271582 ,H271893 ,H272157 ,H272333 ,H272494 ,H272956 ,H140109 ,H140225 ,H140745 ,H140805 ,H140865 ,H140927 ,H260925 ,H271587 ,H271895 ,H272158 ,H272336 ,H272497 ,H272960 ,H140111 ,H140226 ,H140746 ,H140806 ,H140866 ,H140929 ,H260928 ,H271588 ,H271896 ,H272159 ,H272339 ,H272500 ,H272961 ,H140113 ,H140227 ,H140747 ,H140807 ,H140867 ,H140930 ,H260931 ,H271593 ,H271903 ,H272162 ,H272341 ,H272801 ,H272963 ,H140114 ,H140228 ,H140748 ,H140808 ,H140868 ,H140931 ,H260936 ,H271594 ,H271905 ,H272163 ,H272343 ,H272803 ,H272964 ,H140115 ,H140229 ,H140749 ,H140809 ,H140869 ,H140932 ,H260940 ,H271602 ,H271906 ,H272168 ,H272345 ,H272804 ,H272968 ,H140116 ,H140230 ,H140750 ,H140810 ,H140870 ,H140933 ,H260942 ,H271607 ,H271918 ,H272169 ,H272346 ,H272805 ,H272971 ,H140117 ,H140231 ,H140751 ,H140811 ,H140871 ,H140934 ,H260946 ,H271618 ,H271921 ,H272172 ,H272349 ,H272806 ,H272973 ,H140118 ,H140232 ,H140752 ,H140812 ,H140872 ,H140935 ,H260949 ,H271624 ,H271926 ,H272173 ,H272354 ,H272811 ,H272978 ,H140119 ,H140233 ,H140753 ,H140813 ,H140873 ,H140936 ,H260950 ,H271626 ,H271931 ,H272174 ,H272355 ,H272816 ,H272981 ,H140121 ,H140234 ,H140754 ,H140814 ,H140874 ,H140937 ,H260951 ,H271628 ,H271935 ,H272178 ,H272359 ,H272820 ,H272982 ,H140122 ,H140235 ,H140755 ,H140815 ,H140875 ,H140938 ,H260952 ,H271635 ,H271941 ,H272179 ,H272360 ,H272822 ,H272985 ,H140124 ,H140236 ,H140756 ,H140816 ,H140876 ,H140939 ,H260953 ,H271640 ,H271942 ,H272180 ,H272362 ,H272824 ,H272986 ,H140125 ,H140237 ,H140757 ,H140817 ,H140877 ,H140940 ,H270767 ,H271662 ,H271951 ,H272184 ,H272365 ,H272825 ,H272987 ,H140129 ,H140238 ,H140758 ,H140818 ,H140878 ,H140941 ,H270788 ,H271663 ,H271954 ,H272187 ,H272370 ,H272826 ,H272990 ,H140132 ,H140239 ,H140759 ,H140819 ,H140879 ,H140942 ,H270794 ,H271664 ,H271961 ,H272188 ,H272372 ,H272827 ,H272993 ,H140133 ,H140240 ,H140760 ,H140820 ,H140881 ,H140943 ,H271041 ,H271669 ,H271964 ,H272195 ,H272377 ,H272828 ,H272996 ,H140134 ,H140700 ,H140761 ,H140821 ,H140882 ,H140944 ,H271066 ,H271678 ,H271972 ,H272197 ,H272380 ,H272834 ,H272999 ,H140135 ,H140701 ,H140762 ,H140822 ,H140883 ,H140945 ,H271105 ,H271681 ,H271973 ,H272202 ,H272381 ,H272837 ,H273003 ,H140136 ,H140702 ,H140763 ,H140823 ,H140884 ,H140947 ,H271157 ,H271691 ,H271974 ,H272203 ,H272388 ,H272841 ,H273004 ,H140137 ,H140703 ,H140764 ,H140824 ,H140885 ,H140948 ,H271158 ,H271693 ,H271975 ,H272204 ,H272394 ,H272842 ,H273006 ,H140138 ,H140704 ,H140765 ,H140825 ,H140886 ,H140949 ,H271159 ,H271711 ,H271976 ,H272209 ,H272397 ,H272846 ,H273011 ,H140139 ,H140705 ,H140766 ,H140826 ,H140887 ,H140950 ,H271167 ,H271712 ,H271993 ,H272216 ,H272401 ,H272847 ,H273016 ,H140140 ,H140706 ,H140767 ,H140827 ,H140888 ,H140951 ,H271194 ,H271713 ,H271994 ,H272219 ,H272405 ,H272848 ,H273026 ,H140141 ,H140707 ,H140768 ,H140828 ,H140889 ,H140952 ,H271214 ,H271714 ,H272000 ,H272220 ,H272407 ,H272849 ,H273027 ,H140142 ,H140708 ,H140769 ,H140829 ,H140890 ,H140953 ,H271227 ,H271720 ,H272001 ,H272223 ,H272410 ,H272854 ,H273029 ,H140143 ,H140709 ,H140770 ,H140830 ,H140891 ,H140956 ,H271242 ,H271724 ,H272003 ,H272226 ,H272412 ,H272856 ,H273030 ,H140144 ,H140710 ,H140771 ,H140831 ,H140892 ,H140957 ,H271258 ,H271729 ,H272009 ,H272231 ,H272413 ,H272857 ,H273031 ,H273032 ,H273133 ,H273197 ,H290501 ,H291030 ,H291094 ,H291158 ,H291220 ,H293306 ,H293369 ,H293432 ,H293494 ,H293558 ,H273035 ,H273134 ,H273198 ,H290503 ,H291031 ,H291095 ,H291159 ,H291221 ,H293307 ,H293370 ,H293433 ,H293495 ,H293559 ,H273036 ,H273135 ,H273199 ,H290504 ,H291032 ,H291096 ,H291160 ,H291222 ,H293308 ,H293371 ,H293434 ,H293496 ,H293560 ,H273039 ,H273136 ,H273200 ,H290505 ,H291034 ,H291097 ,H291161 ,H291223 ,H293309 ,H293372 ,H293435 ,H293497 ,H293561 ,H273040 ,H273137 ,H273201 ,H290508 ,H291035 ,H291098 ,H291162 ,H291224 ,H293310 ,H293373 ,H293436 ,H293498 ,H293562 ,H273041 ,H273138 ,H273202 ,H290509 ,H291036 ,H291099 ,H291163 ,H291225 ,H293311 ,H293374 ,H293437 ,H293499 ,H293563 ,H273042 ,H273139 ,H273203 ,H290510 ,H291037 ,H291101 ,H291164 ,H291226 ,H293312 ,H293375 ,H293438 ,H293500 ,H293564 ,H273048 ,H273140 ,H273204 ,H290511 ,H291038 ,H291102 ,H291165 ,H291227 ,H293313 ,H293376 ,H293439 ,H293501 ,H293565 ,H273049 ,H273141 ,H273205 ,H290512 ,H291039 ,H291103 ,H291166 ,H291228 ,H293314 ,H293377 ,H293440 ,H293502 ,H293566 ,H273052 ,H273142 ,H273206 ,H290517 ,H291040 ,H291104 ,H291167 ,H291229 ,H293315 ,H293378 ,H293441 ,H293503 ,H293567 ,H273053 ,H273143 ,H273208 ,H290519 ,H291041 ,H291105 ,H291168 ,H291230 ,H293316 ,H293379 ,H293442 ,H293504 ,H293568 ,H273055 ,H273144 ,H273209 ,H290520 ,H291042 ,H291106 ,H291169 ,H291231 ,H293317 ,H293380 ,H293443 ,H293505 ,H293569 ,H273056 ,H273145 ,H273210 ,H290530 ,H291043 ,H291107 ,H291170 ,H291232 ,H293318 ,H293381 ,H293444 ,H293506 ,H293570 ,H273057 ,H273146 ,H273547 ,H290533 ,H291044 ,H291108 ,H291171 ,H291233 ,H293319 ,H293382 ,H293445 ,H293507 ,H293571 ,H273063 ,H273147 ,H273711 ,H290538 ,H291045 ,H291109 ,H291172 ,H291234 ,H293320 ,H293383 ,H293446 ,H293508 ,H293572 ,H273064 ,H273148 ,H273929 ,H290540 ,H291046 ,H291111 ,H291173 ,H291235 ,H293321 ,H293384 ,H293447 ,H293509 ,H293573 ,H273065 ,H273149 ,H290186 ,H290541 ,H291047 ,H291112 ,H291174 ,H291236 ,H293323 ,H293385 ,H293448 ,H293510 ,H293574 ,H273066 ,H273150 ,H290192 ,H290547 ,H291048 ,H291113 ,H291175 ,H291237 ,H293324 ,H293386 ,H293449 ,H293511 ,H293575 ,H273072 ,H273151 ,H290201 ,H290548 ,H291049 ,H291114 ,H291176 ,H291238 ,H293325 ,H293387 ,H293450 ,H293512 ,H293576 ,H273075 ,H273152 ,H290208 ,H290549 ,H291050 ,H291115 ,H291177 ,H291239 ,H293326 ,H293388 ,H293451 ,H293513 ,H293577 ,H273077 ,H273153 ,H290222 ,H290550 ,H291051 ,H291116 ,H291178 ,H291240 ,H293327 ,H293389 ,H293452 ,H293514 ,H293578 ,H273080 ,H273155 ,H290224 ,H290551 ,H291052 ,H291117 ,H291179 ,H291241 ,H293328 ,H293390 ,H293453 ,H293515 ,H293579 ,H273082 ,H273156 ,H290233 ,H290552 ,H291053 ,H291118 ,H291180 ,H291242 ,H293329 ,H293391 ,H293454 ,H293516 ,H293581 ,H273083 ,H273157 ,H290241 ,H290553 ,H291054 ,H291119 ,H291181 ,H291243 ,H293330 ,H293392 ,H293455 ,H293517 ,H293583 ,H273084 ,H273158 ,H290243 ,H290554 ,H291055 ,H291120 ,H291182 ,H291244 ,H293331 ,H293393 ,H293456 ,H293518 ,H293584 ,H273086 ,H273159 ,H290248 ,H290555 ,H291056 ,H291121 ,H291183 ,H291245 ,H293332 ,H293394 ,H293457 ,H293519 ,H293585 ,H273088 ,H273160 ,H290249 ,H290556 ,H291057 ,H291122 ,H291184 ,H291246 ,H293333 ,H293395 ,H293458 ,H293520 ,H293586 ,H273089 ,H273162 ,H290256 ,H290557 ,H291059 ,H291123 ,H291185 ,H291247 ,H293334 ,H293396 ,H293459 ,H293521 ,H293587 ,H273092 ,H273163 ,H290262 ,H290558 ,H291060 ,H291124 ,H291186 ,H291248 ,H293335 ,H293397 ,H293460 ,H293522 ,H293588 ,H273093 ,H273164 ,H290272 ,H290559 ,H291061 ,H291125 ,H291187 ,H291249 ,H293336 ,H293398 ,H293461 ,H293523 ,H293589 ,H273100 ,H273165 ,H290274 ,H290560 ,H291062 ,H291126 ,H291188 ,H291250 ,H293337 ,H293399 ,H293462 ,H293524 ,H293590 ,H273101 ,H273166 ,H290278 ,H290561 ,H291063 ,H291127 ,H291189 ,H291251 ,H293338 ,H293401 ,H293463 ,H293525 ,H293591 ,H273102 ,H273167 ,H290282 ,H290600 ,H291064 ,H291128 ,H291190 ,H291252 ,H293339 ,H293402 ,H293464 ,H293527 ,H293592 ,H273103 ,H273168 ,H290287 ,H291001 ,H291065 ,H291129 ,H291191 ,H291253 ,H293340 ,H293403 ,H293465 ,H293528 ,H293593 ,H273104 ,H273169 ,H290295 ,H291002 ,H291066 ,H291130 ,H291192 ,H291254 ,H293341 ,H293404 ,H293466 ,H293529 ,H293594 ,H273105 ,H273170 ,H290304 ,H291003 ,H291067 ,H291131 ,H291193 ,H291255 ,H293342 ,H293405 ,H293467 ,H293530 ,H293595 ,H273106 ,H273171 ,H290308 ,H291004 ,H291068 ,H291132 ,H291194 ,H291256 ,H293343 ,H293406 ,H293468 ,H293531 ,H293596 ,H273107 ,H273172 ,H290313 ,H291005 ,H291069 ,H291133 ,H291195 ,H291257 ,H293344 ,H293407 ,H293469 ,H293532 ,H293597 ,H273108 ,H273173 ,H290317 ,H291006 ,H291070 ,H291134 ,H291196 ,H291258 ,H293345 ,H293408 ,H293470 ,H293533 ,H293598 ,H273109 ,H273174 ,H290321 ,H291007 ,H291071 ,H291135 ,H291197 ,H291259 ,H293346 ,H293409 ,H293471 ,H293534 ,H293599 ,H273110 ,H273175 ,H290326 ,H291008 ,H291072 ,H291136 ,H291198 ,H291260 ,H293347 ,H293410 ,H293472 ,H293535 ,H293600 ,H273111 ,H273176 ,H290341 ,H291009 ,H291073 ,H291137 ,H291199 ,H291261 ,H293348 ,H293411 ,H293473 ,H293536 ,H293601 ,H273112 ,H273177 ,H290352 ,H291010 ,H291074 ,H291138 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,H294755 ,H294818 ,H294884 ,H294950 ,H295017 ,H295082 ,H295151 ,H295241 ,H294496 ,H294564 ,H294628 ,H294690 ,H294756 ,H294820 ,H294885 ,H294951 ,H295018 ,H295083 ,H295152 ,H295242 ,H294497 ,H294565 ,H294629 ,H294691 ,H294757 ,H294821 ,H294886 ,H294952 ,H295019 ,H295084 ,H295154 ,H295244 ,H294498 ,H294567 ,H294630 ,H294692 ,H294758 ,H294822 ,H294887 ,H294953 ,H295020 ,H295085 ,H295155 ,H295245 ,H294499 ,H294568 ,H294631 ,H294693 ,H294759 ,H294823 ,H294888 ,H294954 ,H295021 ,H295086 ,H295156 ,H295246 ,H294500 ,H294569 ,H294632 ,H294694 ,H294760 ,H294824 ,H294889 ,H294955 ,H295022 ,H295087 ,H295157 ,H295247 ,H294501 ,H294570 ,H294633 ,H294695 ,H294761 ,H294825 ,H294890 ,H294956 ,H295023 ,H295089 ,H295158 ,H295248 ,H294502 ,H294571 ,H294634 ,H294696 ,H294762 ,H294826 ,H294891 ,H294957 ,H295024 ,H295090 ,H295159 ,H295249 ,H294503 ,H294572 ,H294635 ,H294697 ,H294763 ,H294827 ,H294892 ,H294958 ,H295025 ,H295091 ,H295160 ,H295250 ,H294504 ,H294573 ,H294636 ,H294698 ,H294764 ,H294828 ,H294893 ,H294959 ,H295026 ,H295093 ,H295161 ,H295252 ,H294505 ,H294574 ,H294637 ,H294699 ,H294765 ,H294829 ,H294894 ,H294960 ,H295027 ,H295094 ,H295162 ,H295254 ,H294506 ,H294575 ,H294638 ,H294700 ,H294766 ,H294830 ,H294895 ,H294961 ,H295028 ,H295095 ,H295163 ,H295255 ,H294507 ,H294576 ,H294639 ,H294701 ,H294767 ,H294831 ,H294896 ,H294962 ,H295029 ,H295096 ,H295169 ,H295265;
 
2) H140002 H140087 H180135 H180273 H180463 H180554 H180623 H180685 H180747 H180809 H180868 H181026 H181085 H140003 H140089 H180143 H180274 H180466 H180555 H180624 ,H180686 ,H180748 ,H180810 ,H180869 H181027 H181086 H140004 H140091 ,H180144 ,H180275 ,H180467 ,H180556 H180625 H180687 H180749 H180811 ,H180870 ,H181028 ,H181087 ,H140005 H140093 H180148 H180283 H180469 ,H180559 ,H180626 ,H180688 ,H180750 H180812 H180871 H181029 H181088 ,H140006 ,H140094 ,H180157 ,H180287 H180470 H180560 H180627 H180689 ,H180751 ,H180813 ,H180872 ,H181030 H181089 H140007 H140095 H180159 ,H180290 ,H180471 ,H180561 ,H180628 H180690 H180752 H180814 H180873 ,H181031 ,H181090 ,H140008 ,H140099 H180161 H180291 H180472 H180562 ,H180629 ,H180691 ,H180753 ,H180815 H180874 H181032 H181091 H140009 ,H140100 ,H180166 ,H180292 ,H180473 H180564 H180630 H180692 H180754 ,H180816 ,H180875 ,H181033 ,H181092 H140010 H140102 H180167 H180293 ,H180474 ,H180566 ,H180631 ,H180694 H180755 H180817 H180876 H181034 ,H181093 ,H140012 ,H140103 ,H180171 H180294 H180475 H180568 H180632 ,H180695 ,H180756 ,H180818 ,H180877 H181035 H181094 H140014 H140105 ,H180175 ,H180295 ,H180476 ,H180569 H180633 H180696 H180757 H180819 ,H180878 ,H181036 ,H181095 ,H140015 H140106 H180178 H180296 H180477 ,H180570 ,H180634 ,H180697 ,H180758 H180820 H180879 H181037 H181096 ,H140016 ,H140108 ,H180179 ,H180298 H180478 H180572 H180635 H180698 ,H180759 ,H180821 ,H180880 ,H181038 H181097 H140017 H180328 H180493 ,H180584 ,H180645 ,H180708 ,H180769 ,H180831 H180891 H181048 H181107 ,H140034 ,H180004 ,H180208 ,H180329 ,H180494 H180585 H180646 H180709 ,H180770 ,H180832 ,H180892 ,H181049 ,H181108 H140035 H180007 H180209 ,H180404 ,H180498 ,H180587 ,H180647 ,H180710 H180771 H180833 H180894 ,H181050 ,H181109 ,H140036 ,H180008 ,H180210 H180405 H180499 H180588 ,H180649 ,H180711 ,H180772 ,H180834 ,H180895 H181051 H181110 H140037 ,H180016 ,H180214 ,H180406 ,H180501 ,H180589 H180650 H180713 H180773 ,H180835 ,H180896 ,H181052 ,H181111 ,H140040 H180019 H180215 H180407 ,H180507 ,H180590 ,H180651 ,H180714 ,H180774 H180836 H180897 H181053 ,H181112 ,H140041 ,H180025 ,H180217 ,H180409 H180509 H180591 H180652 ,H180715 ,H180775 ,H180837 ,H180898 ,H181055 H181113 H140042 H180028 ,H180218 ,H180411 ,H180510 ,H180592 ,H180653 H180716 H180776 H180838 ,H180899 ,H181056 ,H181114 ,H140044 ,H180040 H180220 H180412 H180511 ,H180593 ,H180654 ,H180717 ,H180777 ,H180839 H180901 H181057 H181115 ,H140049 ,H180043 ,H180221 ,H180414 ,H180514 H180594 H180655 H180718 ,H180778 ,H180840 ,H180907 ,H181058 ,H181116 H140050 H180044 H180222 ,H180417 ,H180515 ,H180595 ,H180656 ,H180719 H180779 H180841 H181000 ,H181059 ,H181117 ,H140051 ,H180048 ,H180225 H180420 H180517 H180596 ,H180657 ,H180720 ,H180780 ,H180842 ,H181001 H181060 H181118 H140052 ,H180049 ,H180226 ,H180424 ,H180518 ,H180597 H180658 H180721 H180781 ,H180843 ,H181002 ,H181061 ,H181119 ,H140053 H180050 H180228 H180425 ,H180519 ,H180598 ,H180659 ,H180722 ,H180782 H180844 H181003 H181062 ,H181120 ,H140054 ,H180052 ,H180229 ,H180426 H180520 H180599 H180660 ,H180723 ,H180783 ,H180845 ,H181004 ,H181063 H181121 H140055 H180056 ,H180233 ,H180427 ,H180521 ,H180600 ,H180661 H180724 H180784 H180847 ,H181005 ,H181064 ,H181123 ,H140056 ,H180058 H180235 H180433 H180522 ,H180601 ,H180662 ,H180725 ,H180785 ,H180848 H181006 H181065 H181124 ,H140057 ,H180059 ,H180236 ,H180434 ,H180527 H180602 H180663 H180726 ,H180786 ,H180849 ,H181007 ,H181066 ,H181125 H140059 H180065 H180237 ,H180437 ,H180528 ,H180603 ,H180664 ,H180727 H180788 H180850 H181008 ,H181067 ,H181126 ,H140060 ,H180066 ,H180238 H180440 H180529 H180604 ,H180665 ,H180729 ,H180789 ,H180851 ,H181009 H181068 H181127 H140061 ,H180073 ,H180240 ,H180441 ,H180532 ,H180605 H180667 H180730 H180791 ,H180852 ,H181010 ,H181069 ,H181128 ,H140063 H180080 H180242 H180442 ,H180533 ,H180606 ,H180669 ,H180731 ,H180792 H180853 H181011 H181070 ,H181129 ,H140064 ,H180083 ,H180243 ,H180444 H180534 H180607 H180670 ,H180733 ,H180793 ,H180854 ,H181012 ,H181071 H181130 H140065 H180087 ,H180245 ,H180445 ,H180535 ,H180608 ,H180671 H180734 H180794 H180855 ,H181013 ,H181072 ,H181132 ,H140066 ,H180098 H180249 H180446 H180536 ,H180610 ,H180672 ,H180735 ,H180796 ,H180856 H181014 H181073 H181133 ,H140068 ,H180099 ,H180250 ,H180447 ,H180538 H180611 H180673 H180736 ,H180798 ,H180857 ,H181015 ,H181074 ,H181134 H140069 H180102 H180254 ,H180449 ,H180539 ,H180612 ,H180674 ,H180737 H180799 H180858 H181016 ,H181075 ,H181135 ,H140072 ,H180103 ,H180255 H180450 H180541 H180614 ,H180675 ,H180738 ,H180800 ,H180859 ,H181017 H181076 H181136 H140074 ,H180104 ,H180256 ,H180451 ,H180542 ,H180615 H180676 H180739 H180801 ,H180860 ,H181018 ,H181077 ,H181137 ,H140075 H180107 H180257 H180453 ,H180543 ,H180616 ,H180678 ,H180740 ,H180802 H180861 H181019 H181078 ,H181138 ,H140080 ,H180115 ,H180258 ,H180454 H180544 H180617 H180679 ,H180741 ,H180803 ,H180862 ,H181020 ,H181079 H181139 H140082 H180116 ,H180260 ,H180456 ,H180548 ,H180618 ,H180680 H180742 H180804 H180863 ,H181021 ,H181080 ,H181140 ,H140083 ,H180117 H180262 H180457 H180549 ,H180619 ,H180681 ,H180743 ,H180805 ,H180864 H181022 H181081 H181141 ,H140084 ,H180122 ,H180268 ,H180459 ,H180550 H180620 H180682 H180744 ,H180806 ,H180865 ,H181023 ,H181082 ,H181142 H140085 H180124 H180271 ,H180460 ,H180551 ,H180621 ,H180683 ,H180745 H180807 H180866 H181024 ,H181083 ,H181143 ,H140086 ,H180129 ,H180272 H180462 H180553 H180622 ,H180684 ,H180746 ,H180808 ,H180867 ,H181025 H181084 H181145 H181146 ,H181210 ,H270260 ,H270447 ,H270634 ,H270783 H270894 H271101 H271225 ,H271320 ,H271409 ,H271499 ,H271575 ,H181147 H181211 H270261 H270451 ,H270635 ,H270785 ,H270895 ,H271102 ,H271228 H271322 H271410 H271500 ,H271576 ,H181148 ,H181212 ,H270267 ,H270452 H270639 H270787 H270897 ,H271103 ,H271229 ,H271325 ,H271411 ,H271501 H271577 H181149 H181214 ,H270271 ,H270454 ,H270641 ,H270789 ,H270898 H271104 H271231 H271327 ,H271412 ,H271503 ,H271578 ,H181150 ,H181215 H270273 H270455 H270644 ,H270793 ,H270899 ,H271107 ,H271233 ,H271328 H271415 H271504 H271580 ,H181151 ,H181218 ,H270277 ,H270458 ,H270645 H270796 H271000 H271108 ,H271234 ,H271329 ,H271416 ,H271505 ,H271581 H181152 H181220 H270280 ,H270461 ,H270646 ,H270800 ,H271002 ,H271109 H271235 H271330 H271417 ,H271506 ,H271583 ,H181153 ,H181222 ,H270281 H270462 H270647 H270801 ,H271004 ,H271110 ,H271236 ,H271331 ,H271419 H271508 H271584 H181154 ,H181223 ,H270282 ,H270464 ,H270649 ,H270803 H271005 H271111 H271238 ,H271332 ,H271421 ,H271509 ,H271586 ,H181155 H181224 H270285 H270466 ,H270651 ,H270804 ,H271009 ,H271113 ,H271239 H271333 H271422 H271510 ,H271589 ,H181156 ,H181225 ,H270290 ,H270470 H270652 H270805 H271013 ,H271114 ,H271241 ,H271336 ,H271423 ,H271511 H271590 H181157 H181228 ,H270297 ,H270473 ,H270653 ,H270806 ,H271015 H271115 H271245 H271337 ,H271424 ,H271512 ,H271591 ,H181158 ,H181230 H270302 H270474 H270654 ,H270812 ,H271016 ,H271116 ,H271247 ,H271338 H271426 H271513 H271592 ,H181159 ,H189999 ,H270303 ,H270476 ,H270656 H270813 H271017 H271120 ,H271248 ,H271339 ,H271428 ,H271514 ,H271595 H181160 H260916 H270307 ,H270477 ,H270660 ,H270817 ,H271019 ,H271121 H271250 H271340 H271430 ,H271516 ,H271596 ,H181161 ,H260917 ,H270310 H270479 H270661 H270820 ,H271020 ,H271127 ,H271251 ,H271342 ,H271431 H271517 H271597 H181162 ,H260923 ,H270314 ,H270482 ,H270662 ,H270821 H271021 H271132 H271256 ,H271344 ,H271434 ,H271518 ,H271598 ,H181163 H260926 H270323 H270483 ,H270664 ,H270822 ,H271023 ,H271135 ,H271257 H271345 H271435 H271520 ,H271599 ,H181164 ,H260932 ,H270324 ,H270486 H270665 H270823 H271024 ,H271137 ,H271259 ,H271347 ,H271436 ,H271521 H271600 H181165 H260938 ,H270332 ,H270487 ,H270667 ,H270825 ,H271025 H271141 H271260 H271349 ,H271437 ,H271522 ,H271601 ,H181166 ,H260939 H270335 H270489 H270669 ,H270826 ,H271026 ,H271142 ,H271263 ,H271350 H271441 H271525 H271603 ,H181167 ,H260944 ,H270338 ,H270490 ,H270670 H270827 H271029 H271143 ,H271264 ,H271351 ,H271442 ,H271527 ,H271604 H181168 H260947 H270341 ,H270491 ,H270675 ,H270828 ,H271031 ,H271144 H271266 H271355 H271444 ,H271528 ,H271605 ,H181170 ,H270010 ,H270344 H270495 H270681 H270829 ,H271032 ,H271145 ,H271267 ,H271356 ,H271445 H271529 H271606 H181171 ,H270021 ,H270345 ,H270498 ,H270682 ,H270833 H271034 H271149 H271269 ,H271357 ,H271447 ,H271530 ,H271608 ,H181172 H270026 H270351 H270499 ,H270684 ,H270836 ,H271035 ,H271151 ,H271270 H271358 H271448 H271532 ,H271609 ,H181173 ,H270027 ,H270352 ,H270500 H270686 H270837 H271037 ,H271152 ,H271272 ,H271359 ,H271449 ,H271533 H271610 H181174 H270029 ,H270353 ,H270501 ,H270690 ,H270838 ,H271038 H271154 H271273 H271360 ,H271450 ,H271535 ,H271611 ,H181175 ,H270030 H270356 H270502 H270692 ,H270840 ,H271039 ,H271155 ,H271274 ,H271361 H271451 H271536 H271612 ,H181176 ,H270038 ,H270360 ,H270503 ,H270693 H270842 H271042 H271161 ,H271276 ,H271363 ,H271453 ,H271537 ,H271613 H181177 H270045 H270364 ,H270504 ,H270698 ,H270844 ,H271043 ,H271166 H271280 H271364 H271454 ,H271538 ,H271614 ,H181178 ,H270047 ,H270370 H270505 H270699 H270846 ,H271044 ,H271172 ,H271281 ,H271365 ,H271456 H271539 H271615 H181179 ,H270073 ,H270371 ,H270511 ,H270700 ,H270852 H271051 H271178 H271282 ,H271366 ,H271457 ,H271540 ,H271616 ,H181180 H270079 H270373 H270512 ,H270705 ,H270854 ,H271052 ,H271182 ,H271283 H271367 H271458 H271541 ,H271617 ,H181181 ,H270088 ,H270378 ,H270513 H270708 H270857 H271055 ,H271183 ,H271284 ,H271368 ,H271459 ,H271542 H271619 H181182 H270096 ,H270383 ,H270516 ,H270710 ,H270858 ,H271056 H271184 H271285 H271369 ,H271461 ,H271543 ,H271620 ,H181183 ,H270101 H270384 H270518 H270714 ,H270859 ,H271059 ,H271185 ,H271287 ,H271371 H271462 H271544 H271621 ,H181184 ,H270106 ,H270385 ,H270520 ,H270716 H270861 H271061 H271189 ,H271289 ,H271372 ,H271464 ,H271545 ,H271622 H181185 H270110 H270386 ,H270522 ,H270718 ,H270863 ,H271062 ,H271190 H271290 H271374 H271465 ,H271546 ,H271627 ,H181187 ,H270111 ,H270391 H270525 H270719 H270864 ,H271063 ,H271191 ,H271291 ,H271375 ,H271466 H271547 H271629 H181188 ,H270118 ,H270392 ,H270526 ,H270725 ,H270865 H271067 H271192 H271292 ,H271376 ,H271467 ,H271548 ,H271630 ,H181189 H270126 H270395 H270529 ,H270726 ,H270866 ,H271068 ,H271193 ,H271294 H271377 H271468 H271550 ,H271631 ,H181190 ,H270134 ,H270398 ,H270532 H270727 H270867 H271071 ,H271195 ,H271295 ,H271379 ,H271470 ,H271551 H271632 H181191 H270138 ,H270399 ,H270535 ,H270728 ,H270868 ,H271072 H271197 H271296 H271380 ,H271472 ,H271552 ,H271633 ,H181192 ,H270201 H270401 H270539 H270732 ,H270869 ,H271073 ,H271198 ,H271297 ,H271381 H271473 H271553 H271634 ,H181193 ,H270209 ,H270410 ,H270540 ,H270733 H270871 H271075 H271199 ,H271298 ,H271382 ,H271474 ,H271554 ,H271636 H181194 H270211 H270416 ,H270542 ,H270735 ,H270872 ,H271076 ,H271200 H271299 H271383 H271475 ,H271555 ,H271637 ,H181195 ,H270215 ,H270418 H270544 H270737 H270873 ,H271080 ,H271201 ,H271300 ,H271384 ,H271476 H271557 H271638 H181196 ,H270216 ,H270419 ,H270550 ,H270739 ,H270875 H271082 H271204 H271302 ,H271386 ,H271477 ,H271558 ,H271639 ,H181197 H270219 H270421 H270601 ,H270746 ,H270877 ,H271083 ,H271205 ,H271303 H271387 H271478 H271561 ,H271641 ,H181198 ,H270227 ,H270425 ,H270602 H270749 H270878 H271085 ,H271207 ,H271304 ,H271388 ,H271479 ,H271562 H271642 H181199 H270228 ,H270426 ,H270606 ,H270751 ,H270879 ,H271086 H271208 H271305 H271389 ,H271481 ,H271563 ,H271643 ,H181200 ,H270229 H270427 H270607 H270752 ,H270880 ,H271088 ,H271209 ,H271306 ,H271390 H271483 H271564 H271645 ,H181201 ,H270230 ,H270428 ,H270613 ,H270755 H270882 H271091 H271210 ,H271307 ,H271392 ,H271484 ,H271565 ,H271646 H181202 H270232 H270430 ,H270615 ,H270757 ,H270883 ,H271092 ,H271211 H271309 H271395 H271485 ,H271566 ,H271647 ,H181203 ,H270235 ,H270431 H270622 H270761 H270884 ,H271093 ,H271212 ,H271312 ,H271398 ,H271487 H271567 H271648 H181204 ,H270244 ,H270435 ,H270623 ,H270762 ,H270885 H271094 H271216 H271314 ,H271399 ,H271488 ,H271568 ,H271649 ,H181205 H270245 H270437 H270624 ,H270763 ,H270886 ,H271095 ,H271217 ,H271315 H271401 H271492 H271570 ,H271650 ,H181206 ,H270251 ,H270438 ,H270625 H270766 H270888 H271097 ,H271218 ,H271316 ,H271402 ,H271493 ,H271571 H271651 H181207 H270252 ,H270439 ,H270627 ,H270777 ,H270889 ,H271098 H271222 H271317 H271403 ,H271494 ,H271572 ,H271652 ,H181208 ,H270255 H270443 H270631 H270781 ,H270891 ,H271099 ,H271223 ,H271318 ,H271404 H271495 H271573 H271653 ,H181209 ,H270256 ,H270446 ,H270632 ,H270782 H270892 H271100 H271224 ,H271319 ,H271406 ,H271498 ,H271574 ,H271654 H271655 ,H271739 H271816 ,H271901 ,H271983 ,H272071 ,H272149 ,H272251 H272348 H272447 H272865 ,H272957 ,H273062 ,H271656 ,H271740 ,H271817 H271902 H271984 H272072 ,H272150 ,H272253 ,H272350 ,H272448 ,H272867 H272958 H273067 H271657 ,H271741 ,H271818 ,H271904 ,H271985 ,H272073 H272151 H272254 H272351 ,H272449 ,H272869 ,H272959 ,H273068 ,H271658 H271743 H271819 H271907 ,H271986 ,H272074 ,H272152 ,H272255 ,H272352 H272450 H272870 H272962 ,H273069 ,H271659 ,H271744 ,H271820 ,H271908 H271987 H272075 H272154 ,H272256 ,H272353 ,H272451 ,H272871 ,H272965 H273070 H271660 H271746 ,H271821 ,H271909 ,H271988 ,H272076 ,H272160 H272257 H272356 H272452 ,H272875 ,H272966 ,H273071 ,H271666 ,H271747 H271822 H271910 H271989 ,H272077 ,H272161 ,H272258 ,H272357 ,H272453 H272877 H272967 H273074 ,H271667 ,H271748 ,H271823 ,H271911 ,H271990 H272079 H272164 H272261 ,H272358 ,H272455 ,H272878 ,H272969 ,H273078 H271670 H271749 H271824 ,H271912 ,H271991 ,H272080 ,H272165 ,H272262 H272361 H272457 H272879 ,H272970 ,H273079 ,H271671 ,H271750 ,H271826 H271913 H271992 H272082 ,H272166 ,H272263 ,H272363 ,H272459 ,H272880 H272972 H273081 H271672 ,H271751 ,H271827 ,H271914 ,H271996 ,H272083 H272167 H272264 H272364 ,H272461 ,H272881 ,H272974 ,H273085 ,H271673 H271752 H271828 H271915 ,H271997 ,H272084 ,H272170 ,H272265 ,H272366 H272463 H272882 H272975 ,H273087 ,H271674 ,H271753 ,H271829 ,H271916 H271998 H272087 H272171 ,H272266 ,H272367 ,H272465 ,H272883 ,H272976 H273090 H271675 H271754 ,H271830 ,H271917 ,H271999 ,H272088 ,H272175 H272268 H272368 H272467 ,H272884 ,H272977 ,H273091 ,H271676 ,H271756 H271832 H271919 H272002 ,H272090 ,H272176 ,H272269 ,H272369 ,H272468 H272886 H272979 H273094 ,H271677 ,H271757 ,H271834 ,H271920 ,H272004 H272091 H272177 H272270 ,H272371 ,H272471 ,H272887 ,H272980 ,H273095 H271679 H271758 H271836 ,H271922 ,H272005 ,H272092 ,H272181 ,H272272 H272373 H272472 H272888 ,H272983 ,H273097 ,H271680 ,H271759 ,H271837 H271923 H272006 H272093 ,H272182 ,H272273 ,H272374 ,H272475 ,H272891 H272984 H273098 H271682 ,H271761 ,H271839 ,H271924 ,H272007 ,H272094 H272183 H272274 H272375 ,H272477 ,H272892 ,H272988 ,H273099 ,H271683 H271764 H271840 H271925 ,H272010 ,H272095 ,H272185 ,H272276 ,H272376 H272478 H272894 H272989 ,H290001 ,H271684 ,H271765 ,H271841 ,H271927 H272011 H272096 H272186 ,H272278 ,H272378 ,H272482 ,H272895 ,H272991 H290003 H271685 H271766 ,H271842 ,H271928 ,H272012 ,H272097 ,H272189 H272279 H272379 H272483 ,H272896 ,H272992 ,H290004 ,H271686 ,H271768 H271843 ,H271929 H272013 ,H272098 ,H272190 ,H272280 ,H272382 ,H272484 H272897 H272994 H290014 ,H271687 ,H271769 ,H271844 ,H271930 ,H272015 H272099 H272191 H272281 ,H272383 ,H272485 ,H272898 ,H272995 ,H290026 H271688 H271770 H271846 ,H271932 ,H272017 ,H272100 ,H272192 ,H272282 H272384 H272489 H272900 ,H272997 ,H290030 ,H271689 ,H271771 ,H271847 H271933 H272018 H272101 ,H272193 ,H272284 ,H272385 ,H272490 ,H272901 H272998 H290031 H271692 ,H271772 ,H271848 ,H271934 ,H272019 ,H272102 H272194 H272285 H272386 ,H272493 ,H272902 ,H273000 ,H290032 ,H271695 H271774 H271849 H271936 ,H272020 ,H272103 ,H272196 ,H272286 ,H272387 H272495 H272903 H273001 ,H290033 ,H271696 ,H271775 ,H271850 ,H271937 H272021 H272104 H272198 ,H272287 ,H272389 ,H272496 ,H272904 ,H273002 H290034 H271697 H271776 ,H271851 ,H271938 ,H272022 ,H272106 ,H272199 H272288 H272390 H272800 ,H272906 ,H273005 ,H290104 ,H271698 ,H271777 H271852 H271939 H272024 ,H272107 ,H272200 ,H272289 ,H272391 ,H272802 H272907 H273007 H290105 ,H271699 ,H271778 ,H271854 ,H271940 ,H272025 H272108 H272201 H272292 ,H272392 ,H272807 ,H272913 ,H273008 ,H290109 H271700 H271779 H271855 ,H271943 ,H272026 ,H272109 ,H272205 ,H272294 H272393 H272808 H272915 ,H273010 ,H290110 ,H271701 ,H271781 ,H271857 H271944 H272027 H272110 ,H272206 ,H272295 ,H272395 ,H272809 ,H272916 H273012 H290111 H271702 ,H271782 ,H271859 ,H271945 ,H272028 ,H272112 H272207 H272296 H272396 ,H272810 ,H272917 ,H273013 ,H290113 H271703 H271784 H271861 H271946 ,H272030 ,H272113 ,H272208 ,H272297 H272398 H272812 H272918 H273014 ,H290114 ,H271704 ,H271786 ,H271863 ,H271947 H272032 H272114 H272210 ,H272298 ,H272399 ,H272813 ,H272919 ,H273017 H290116 H271705 H271787 ,H271864 ,H271948 ,H272034 ,H272116 ,H272211 H272300 H272400 H272814 ,H272920 ,H273018 ,H290118 ,H271706 ,H271788 H271865 H271949 H272036 ,H272117 ,H272212 ,H272303 ,H272402 ,H272815 H272921 H273019 H290121 ,H271707 ,H271789 ,H271867 ,H271950 ,H272038 H272119 H272213 H272304 ,H272403 ,H272817 ,H272923 ,H273020 ,H290122 H271708 H271790 H271868 ,H271952 ,H272039 ,H272121 ,H272215 ,H272305 H272404 H272818 H272924 ,H273021 ,H290123 ,H271709 ,H271791 ,H271869 H271953 H272040 H272122 ,H272217 ,H272308 ,H272406 ,H272819 ,H272925 H273022 H290125 H271710 ,H271792 ,H271871 ,H271955 ,H272041 ,H272123 H272218 H272312 H272408 ,H272821 ,H272927 ,H273023 ,H290128 ,H271715 H271793 H271873 H271956 ,H272046 ,H272124 ,H272221 ,H272314 ,H272409 H272823 H272928 H273024 ,H290130 ,H271716 ,H271794 ,H271874 ,H271957 H272047 ,H272125 H272222 ,H272315 ,H272411 ,H272829 ,H272929 ,H273025 H290132 ,H271717 H271795 ,H271876 ,H271958 ,H272048 ,H272126 ,H272224 H272316 ,H272414 H272830 ,H272930 ,H273028 ,H290135 ,H271718 ,H271796 H271878 ,H271959 H272051 ,H272127 ,H272227 ,H272317 ,H272415 ,H272831 H272931 ,H273033 H290137 ,H271719 ,H271798 ,H271880 ,H271960 ,H272053 H272128 ,H272228 H272319 ,H272417 ,H272833 ,H272934 ,H273034 ,H290138 H271722 ,H271799 H271882 ,H271962 ,H272054 ,H272130 ,H272229 ,H272320 H272419 ,H272836 H272935 ,H273037 ,H290139 ,H271723 ,H271800 ,H271883 H271963 ,H272055 H272131 ,H272230 ,H272322 ,H272420 ,H272838 ,H272937 H273038 ,H290141 H271725 ,H271803 ,H271884 ,H271965 ,H272056 ,H272132 H272232 ,H272323 H272424 ,H272839 ,H272939 ,H273043 ,H290145 ,H271726 H271804 ,H271885 H271967 ,H272057 ,H272133 ,H272233 ,H272330 ,H272429 H272840 ,H272940 H273044 ,H290151 ,H271727 ,H271805 ,H271886 ,H271968 H272058 ,H272135 H272234 ,H272331 ,H272430 ,H272843 ,H272942 ,H273045 H290152 ,H271728 H271806 ,H271887 ,H271969 ,H272059 ,H272139 ,H272238 H272332 ,H272431 H272844 ,H272943 ,H273046 ,H290154 ,H271731 ,H271807 H271888 ,H271970 H272060 ,H272140 ,H272241 ,H272334 ,H272433 ,H272845 H272944 ,H273047 H290155 ,H271732 ,H271808 ,H271889 ,H271971 ,H272061 H272141 ,H272242 H272335 ,H272435 ,H272850 ,H272947 ,H273050 ,H290156 H271733 ,H271809 H271891 ,H271977 ,H272063 ,H272142 ,H272244 ,H272337 H272436 ,H272851 H272948 ,H273051 ,H290157 ,H271734 ,H271810 ,H271892 H271978 ,H272065 H272144 ,H272245 ,H272338 ,H272437 ,H272852 ,H272949 H273054 ,H290158 H271735 ,H271812 ,H271894 ,H271979 ,H272066 ,H272145 H272246 ,H272340 H272439 ,H272853 ,H272950 ,H273058 ,H290159 ,H271736 H271813 ,H271897 H271980 ,H272067 ,H272146 ,H272247 ,H272342 ,H272441 H272855 ,H272952 H273059 ,H290160 ,H271737 ,H271814 ,H271898 ,H271981 H272068 ,H272147 H272248 ,H272344 ,H272442 ,H272861 ,H272954 ,H273060 H290161 ,H271738 H271815 ,H271899 ,H271982 ,H272070 ,H272148 ,H272249 H272347 ,H272443 H272863 ,H272955 ,H273061 ,H290162 ,H290164 ,H290280 H290357 ,H290531 H290165 ,H290281 ,H290359 ,H290532 ,H290166 ,H290283 H290360 ,H290534 H290168 ,H290284 ,H290363 ,H290535 ,H290173 ,H290285 H290364 ,H290536 H290175 ,H290286 ,H290365 ,H290537 ,H290176 ,H290288 H290366 ,H290539 H290181 ,H290289 ,H290367 ,H290542 ,H290182 ,H290290 H290368 ,H290543 H290185 ,H290291 ,H290369 ,H290544 ,H290187 ,H290292 H290370 ,H290545 H290189 ,H290293 ,H290373 ,H290546 ,H290191 ,H290296 H290374 ,H292832 H290193 ,H290297 ,H290377 ,H290194 ,H290299 ,H290378 H290195 ,H290301 H290380 ,H290196 ,H290302 ,H290382 ,H290197 ,H290305 H290383 ,H290198 H290306 ,H290384 ,H290203 ,H290307 ,H290385 ,H290206 H290309 ,H290387 H290209 ,H290310 ,H290388 ,H290210 ,H290311 ,H290389 H290211 ,H290312 H290390 ,H290212 ,H290314 ,H290393 ,H290213 ,H290315 H290394 ,H290214 H290316 ,H290395 ,H290215 ,H290318 ,H290396 ,H290216 H290319 ,H290398 H290217 ,H290320 ,H290404 ,H290219 ,H290322 ,H290406 H290220 ,H290323 H290408 ,H290223 ,H290324 ,H290409 ,H290225 ,H290325 H290410 ,H290226 H290327 ,H290411 ,H290227 ,H290328 ,H290412 ,H290229 H290329 ,H290413 H290231 ,H290330 ,H290415 ,H290235 ,H290331 ,H290416 H290236 ,H290332 H290417 ,H290237 ,H290333 ,H290424 ,H290239 ,H290334 H290425 ,H290240 H290335 ,H290426 ,H290242 ,H290336 ,H290427 ,H290244 H290337 ,H290500 H290246 ,H290338 ,H290502 ,H290247 ,H290339 ,H290506 H290250 ,H290340 H290507 ,H290255 ,H290342 ,H290513 ,H290257 ,H290343 H290514 ,H290258 H290344 ,H290515 ,H290259 ,H290345 ,H290516 ,H290260 H290346 ,H290518 H290261 ,H290347 ,H290521 ,H290264 ,H290348 ,H290522 H290265 H290349 H290523 ,H290266 ,H290350 ,H290524 ,H290268 ,H290351 H290525 ,H290269 H290353 H290526 H290271 H290354 H290527 H290275 H290355 H290528 H290279 H290356 H290529
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated November 28, 2011 and December 16, 2011. Firm initiated recall is ongoing.
REASON
An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
VOLUME OF PRODUCT IN COMMERCE
5714 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
1) LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles. Recall # Z-0640-2012;
 
2) LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO. Hand activated sealer/dividers that can be used to seal vessels up to and including 7 mm. lymphatics, and tissue bundles. Recall # Z-0641-2012
CODE
1) Lot numbers: S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X;
 
2) Lot numbers: S1CB010X, S1CB011X, S1DB001X, S1DB002X, S1EB012P, S1EB013P, S1EB014P, S1FB031PX, S1FB032PX, S1FB033PX, S1FB035X, S1FB036X, S1FB037X, S1FB038X, S1FB039X, S1FB049X, S1FB050X, S1FB051X, S1GB005X, S1GB006X, S1GB007X, S1HB010, S1HB011, S1HB012, S1HB013P. S1CB001, S1CB002, S1CB003, S1CB004, S1CB005, S1CB006, S1CB007R, S1CB008X, S1CB009X, S1CB012RX, S1CB013PRX, S1CB014PRX, S1CB015PRX, S1CB016PRX, S1CB017PRX, S1CB018PRX, S1CB019PRX, S1CB020PRX, S1CB021PRX, S1CB022PRX, S1CB023PRX, S1CB024PRX, S1CB025PRX, S1DB006X, S1DB007X, S1DB008X, S1DB009X, S1DB010X, S1DB011X, S1DB012X, S1DB013X, S1DB014X, S1DB015X, S1DB016X, S1DB017X, S1DB018X, S1DB019X, S1DB020X, S1DB021X, S1DB022X, S1DB023X, S1EB001X, S1EB002X, S1EB003X, S1EB004X, S1EB005X, S1EB006X, S1EB007RX, S1EB008RX, S1EB009X, S1EB010RX, S1EB011RX, S1EB016P, S1EB017P, S1EB018P, S1EB019P, S1EB020P, S1EB021P, S1EB022P, S1EB023P, S1EB024P, S1EB025P, S1EB026P, S1EB027P, S1EB028P, S1EB029P, S1EB030P, S1EB031P, S1EB032P, S1EB033P, S1EB034P, S1EB035P, S1EB036P, S1EB037P, S1EB038P, S1EB039P, S1EB040P, S1EB041P, S1EB042P, S1FB001P, S1FB005PX, S1FB006PX, S1FB007PX, S1FB008PX, S1FB009PX, S1FB010PX, S1FB011PX, S1FB012PX, S1FB013PX, S1FB014PX, S1FB015PX, S1FB016PX, S1FB017PX, S1FB027PX, S1FB028PX, S1FB029PX, S1FB040X, S1FB041X, S1fb042X, S1FB043X, S1FB044X, S1FB045X, S1FB046X, S1FB047X, S1FB048X, S1FB052X, S1GB001X, S1GB002X, S1GB003x, S1GB004X, S1GB009X, S1GB010X, S1GB011X, S1GB012X, S1GB013X, S1GB014X, S1GB015X, S1GB016X, S1GB017X, S1GB018X, S1HB002, S1HB003, S1HN004, S1HB005, S1HB006, S1HB007, S1HB008, S1HB009P, S1HB014P, S1HB015P, S1HB016P, S1HB017P, S1HB018P, S1HB019, S1HB021X, S1HB022X, S1HB023X, S1HB024X, S1HB027PX, S1HB028PX, S1HB029PX, S1HB031X, S1HB032X, S1HB033X, S1JB034X, S1JB035X, S1JB036X, S1JB038PX, S1JB041X, S1JB042X, S1JB043X, S1JB044PX, S1JB045PX, S1JB046X, S1JB047X, S1JB048X
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien, PLC, Boulder, CO, by letter dated November 9, 2011.
Manufacturer: Covidien Medical Products (Shanghai) Manufacturing LLC, Shanghai, China. Firm initiated recall is ongoing.
REASON
Retaining pins in handle assembly may disengage and fall into surgical field or compromise handle unlatching.
VOLUME OF PRODUCT IN COMMERCE
120,810 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads, NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Lens, 38% water and 62% Polymacon immersed in saline. Caution : To ensure that your contacts stay comfortable and your vision stay clear, ask your eye-care professional for product instruction. ***DIA. 14.0mm B.C 8.6mm***Rxonly STERILE***FDA 510K Cleared Made in Korea***Power : Plane Color : Blue Angelic The color contact lens colors are: Aqua, blue, blue sapphire, dark gray, dark violet, gray, green, hazel, honey, jade, magic angel, misty blue, misty green, misty hazel, pearl gray, pure hazel, sky blue, sweet gray, turquoise, violet, black out, vein, night, white cat, red cat devil, blue angelic, white out, hot red spider web, psycho, cruller, solid yellow, and blue wheel. prescription contact lens. Barcode on label: Bottle: No barcode, Box: 8 806048 000468. Recall # Z-0642-2012;
 
2) Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR CONTACT LENSES Give yourself a whole new look***Contents : Two sterile color contact lenses(62% Polymacon, 38% Water) Immersed in saline and one lens case. Caution : To ensure that your contacts stay comfortable and your Vision stay clear, a1) sk your eye-care professional for product instruction. Made in Korea Distributed by EYEZONE***1023 FDA 510K CLEARED***STERILE***B.C 8.6mm DIA. 14.0mm***8 806048 000468. The color contact lens colors are: Black out, vein, night, white cat, red cat devil, blue angelic, white out, and hot red. prescription contact lens. Barcode on label: Bottle: No barcode, box: 8 806048 000468. Recall # Z-0643-2012
CODE
1) LOT: BD54 EXP 2014/09, include all lots;
2) LOT. BD53, EXP. 2014/08, include all lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eyezone, Santa Fe Springs, CA, by letter dated November 9, 2011 and December 16, 2011,
Manufacturer: Bescon Co., Ltd., Cheonan-City, Republic Of South Korea. Firm initiated recall is ongoing.
REASON
Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.
VOLUME OF PRODUCT IN COMMERCE
24,628 total pairs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Allen C-Flex Head Positioning System non-invasive medical device used to support a patient's head during spine surgery Catalog Numbers: A-70700 and A-70701-2. Recall #Z-0655-2012
CODE
Units: A128573, A157480, A164957, A165624, A179587, A200505, A200508, A203121, A203123, A203124, A203126, A205717, A205730, A205731, A207969, A207970, A207971, A207973, A208274, A208275, A208277, A208278, A208932, A208933, A208934, A209578, A210915, A210916, A210917, A210919, A210920, A214252, A214253, A214254, A214255, A214256, A214582, A214583, A214584, A215498, A215489, A215499, A215500, A216459, A216460, A216461, A217594, A217595, A217596, A217597, A218945, A219496, A219623, A219624, A220031, A220032, A220033, A220664, A220665, A222121, A222122, A222123, A222394, A223961, A223962, A223963, A223964, A224084, A224085, A224144, A224145, A225106, A225107, A225553, A225554, A22555, A225972, A225973, A226214, A226215, A226216, A226217, A226218, A226910
RECALLING FIRM/MANUFACTURER
Allen Medical Systems, Inc., Acton, MA, by letter dated November 18, 2011. Firm initiated recall is ongoing.
REASON
C-Flex Polar Head Positioner may have an adjustment screw loosen and affect load capacity
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Model 750 24' MRI Reusable/Disposable Circuit Accessory for use with Model 750 Portable Ventilator. Recall # Z-0717-2012
CODE
p/n 802-1750-05, no expiration; 802-17850-24
RECALLING FIRM/MANUFACTURER
Impact Instrumentation, Inc., West Caldwell, NJ, by letters dated October 19, 2011. Firm initiated recall is ongoing.
REASON
Product does not have a 510(k).
REASON
Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.
VOLUME OF PRODUCT IN COMMERCE
564 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista System. Catalog number DF33A. Recall # Z-0772-2012
CODE
Lot numbers: GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237.
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated November 2011. Firm initiated recall is ongoing.
REASON
Siemens has confirmed the potential for falsely elevated creatinine results when processing tests from a well that has been punctured.
VOLUME OF PRODUCT IN COMMERCE
31,680 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis. Recall # Z-0776-2012
CODE
Serial number: 1496-029792.
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, LLC, Issaquah, WA, by visit on July 13, 2011. Firm initiated recall is complete.
REASON
Due to software error.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326). Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall # Z-0845-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on October 10, 2011. Firm initiated recall is ongoing.
REASON
The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state
VOLUME OF PRODUCT IN COMMERCE
548 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0848-2012;
 
2) Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0849-2012;
 
3) Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0850-2012;
 
4) Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0851-2012;
 
5) Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0852-2012;
 
6) Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0853-2012;
 
7) Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0854-2012;
 
8) Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. Recall # Z-0855-2012
CODE
1) 6301-07-100; all lots;
2) 6301-07-101; all lots;
3) 6301-07-102; all lots;
4) 6301-07-103; all lots;
5) 6301-10-104; all lots;
6) 6301-10-105; all lots;
7) 6301-10-106; all lots;
8) 6301-10-107; all lots
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated December 20, 2011. Firm initiated recall is ongoing.
REASON
The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene, Durasul, patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used by the surgeon can lead to insufficient fixation where it reduces the fatigue strength by 50-60%. Design differences as compared to other all-poly patella designs including a smaller cement groove contact area, the shape of the edge of the cement grooves, and smaller pegs affect the fracture fatigue strength. Also, it is hypothesized that a free-handed unlevel resection of the patella bone could result in residual stresses that reduce the fixation integrity of the patella implant.
VOLUME OF PRODUCT IN COMMERCE
111,454 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system. Recall # Z-0860-2012
CODE
Serial number 1273.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated December 12, 2011.  
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Part Number: 0505-585-000 Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy. Recall # Z-0862-2012
CODE
Lot: 11223012 13G
RECALLING FIRM/MANUFACTURER
Stryker Puerto Rico, Arroyo, PR, by letter dated December 7, 2011. Firm initiated recall is ongoing
REASON
Product was packaged with a four inch needle in stead of the correct five inch needle. There is a potential that the needle may not be able to reach the fracture site, which may require additional medical intervention. In addition, if the stylet needs to be changed and the additional stylet that comes in the package is used, this additional stylet is one inch longer than the needle. which could lead to a more serious injury and require additional medical intervention.
VOLUME OF PRODUCT IN COMMERCE
46 boxes (184units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4 mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12100805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Recall #Z-0877-2012;
 
2) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102604 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0878-2012;
 
3) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102605 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0879-2012;
 
4) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102606 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0880-2012;
 
5) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102611 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0881-2012;
 
6) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102613 --- Made in the USA--- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0882-2012;
 
7) AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0883-2012;
 
8) AngioDynamics Morpheus Smart PICC CT 55cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102617 --- Made in the USA ---  indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0884-2012;
 
9) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0885-2012;
 
10) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0886-2012;
 
11) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102812 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0887-2012;
 
12) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102813 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0888-2012;
 
13) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102821 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0889-2012;
 
14) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102829 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0890-2012;
 
15) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104605 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0891-2012;
 
16) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104606 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0892-2012;
 
17) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104612 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0893-2012;
 
18) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104805 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0894-2012;
 
19) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104813 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0895-2012;
 
20) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104814 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0896-2012;
 
21) AngioDynamics Morpheus Smart PICC CT 65cm 5F Dual Lumen --- Max CT Flow Rate: 4mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104821 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0897-2012;
 
22) AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12104830 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0898-2012;
 
23) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/SEC --- Catalog No.: 12110904 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0899-2012;
 
24) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110917 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0900-2012;
 
25) AngioDynamics Morpheus Smart PICC CT 6F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 6mL/sec --- Catalog No.: 12110918 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0901-2012;
 
26) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110919 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0902-2012;
 
27) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110923 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0903-2012;
 
28) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110929 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0904-2012;
 
29) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 65cm --- Max CT Flow Rate: 4mL/sec --- Catalog No.: 12110934 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0905-2012;
 
30) AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0906-2012;
 
31) AngioDynamics Morpheus Smart PICC CT with Stylet 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110937 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0907-2012;
 
32) AngioDynamics Morpheus Smart PICC CT 6F Triple Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110941 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0908-2012;
 
33) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52100602 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0909-2012;
 
34) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102618 --- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0910-2012;
 
35) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA--- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0911-2012;
 
36) AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Recall # Z-0912-2012
CODE
1) FG Lot Numbers: 553481, 554552;
2) FG Lot Number: 552392, 554557;
3) FG Lot Number: 551897, 552393, 552394, 553196, 553197, 554085, 554558, 554559;
4) FG Lot Number: 550962, 551912, 552395, 555170;
5) FG Lot Number: 551899, 553211, 553482, 55408;
6) FG Lot Number: 554561;
7) FG Lot Number: 553483;
8) FG Lot Number: 555930;
9) FG Lot Number: 551900, 552398, 552399, 553200, 554077, 554563;
10) FG Lot Number: 553486;
11) FG Lot Number: 553480, 554088;
12) FG Lot Number: 552440;
13) FG Lot Number: 553193;
14) FG Lot Number: 553487;
15) FG Lot Number: 552444, 553205, 553488, 554079;
16) FG Lot Number: 552445;
17) FG Lot Number: 553948, 554090;
18) FG Lot Number: 55244;
19) FG Lot Number: 553213;
20) FG Lot Number: 552450, 553208, 554091, 557219;
21) FG Lot Number: 553949;
22) FG Lot Number: 554081;
23) FG Lot Number: 551915, 553495;
24) FG Lot Number: 552452, 553216;
25) FG Lot Number: 552454, 554541, 554576;
26) FG Lot Number: 551529, 553405, 554573;
27) FG Lot Number: 552455, 553217;
28) FG Lot Number: 551762, 552457;
29) FG Lot Number: 552459, 551536, 553499;
30) FG Lot Number: 553333, 553760, 558278;
31) FG Lot Number: 553761;
32) FG Lot Number: 553218, 554092;
33) FG Lot Number: 553407, 554413;
34) FG Lot Number: 554082, 554554;
35) FG Lot Number: 552387, 553194;
36) FG Lot Number: 552388, 553291, 554555, 555166
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated January 5, 2012.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
VOLUME OF PRODUCT IN COMMERCE
10,392 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
FloWire Doppler Guide wires. The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary and peripheral arteries to measure blood flow velocities during diagnostics angiography and/or interventional procedures. Part number 1400. Recall # Z-0935-2012
CODE
Serial numbers 011-0318-002; 011-01323-012; 011-01319-001; 011-01319-002, 011-01319-005, 011-01319-006; 011-01319-007; 011-01318-001, 011-01321-003, 011-01321-006; 011-01321-008; 011-01321-009; 011-01322-001, 011-01323-010
RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letters dated October 6, 2009. Firm initiated recall is complete.
REASON
Reports of no signal displayed on the monitor when FloWire Doppler Guide wires were connected to the Combomap.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide, Japan and Europe
___________________________________
PRODUCT
GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: -The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. -The detection, localization, and staging of tumors and diagnosing cancer patients. -Treatment planning and interventional radiology procedures. Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Recall # Z-0937-2012
CODE
Serial Number 7224; Serial Number 7217
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by telephone on October 24, 2011. Firm initiated recall is ongoing.
REASON
Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Broselow/Hinkle Pediatric Emergency System. The system supplies you with all the information and equipment needed for a young patients' emergency resuscitation requirements, all contained in a color coded, easy-to-use kit. Class 1 Exempt Device No Medical Device Listing Number exp date - 13 months from the date received by the distributor. Povidone Iodine Pads: The Povidone Iodine Pad is packaged in the Busse IV Start Kit that is included in the Intra Venous Module, which is contained in the Broselow products referenced below. Affected Armstrong product numbers: Kits: AE-4700, AE 4701, AE-4712, and PBL-PC-9A Modules: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, 7700GIV, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, and 7730GRN Affected Vital Signs product numbers: Kits: 7730ALS, 7730IALS, 7730FLY, 7730MOD Modules: 7700RIV2, 7700PIV2, 7700YIV2, 7700WIV2, 7700BIV2, 7700OIV2, 7700GIV2, 7730RED5, 7730PUR5, 7730YEL5, 7730WHI5, 7730BLU5, 7730ORG5, and 7730GRN5 Sub-Assembly: 7700RIV, 7700PIV, 7700YIV, 7700WIV, 7700BIV, 7700OIV, and 7700GIV. Recall # Z-0939-2012
CODE
Lot codes: 2008: 228F-366F 2009: 010K-258K and 010L-258L
RECALLING FIRM/MANUFACTURER
Vital Signs Devices, a GE Healthcare Co., Totowa, NJ, by letter dated October 17, 2011. Firm initiated recall is ongoing.
REASON
Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.
VOLUME OF PRODUCT IN COMMERCE
6675 units with 20166 pads in kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional. Intended to provide the patient greater comfort and a sense of security. Recall # Z-0943-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Stryker Medical Division of Stryker Corp., Portage, MI, by telephone and letters on December 5, 2011. Firm initiated recall is ongoing.
REASON
The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.
VOLUME OF PRODUCT IN COMMERCE
3 kits
DISTRIBUTION
MI, MA
___________________________________
PRODUCT
1) Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The Blanketrol II 48C System provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Blanketrol II 48 degree C does not contact the patient or the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Blanketrol II 48 Degree C System can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The 48C Blanketrol device is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48 degrees C.Recall # Z-0969-2012;
 
2) Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400MR. The 48 o ( Degree) C Hemotherm Dual Reservoir Heater/Cooler I provides a flow of temperature-controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm/cool the fluid that enters and exits a heat exchanger. The conductive heat/cool transfer is accomplished through any type of blood oxygenator/heat exchanger unit. The operator of the unit regulates the desired fluid temperature. Frequent observation of the actual blood/fluid temperature and body temperature is required. The Hemotherm does not contact the patient of the fluids; the water being circulated by the Hemotherm is separated from the fluid by the heat exchanger. To active temperatures above 42 Degrees C, the user must follow explicit instructions in to the owner's manual in order to activate the higher setting. Without following the explicit instructions, the device can only operate within the normal maximum temperature range of: 42 degrees C. The Hemotherm can be used with adult and pediatric patients for extracorporeal circulation of the patient's limb, entire body, or a chemo medication lavage of the abdominal area. The Hemotherm 48C device system is used to lower/raise the blood/fluid temperature and/or maintain blood/fluid temperature, as required, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit. This device is intended to hyperthermic treatment of AIDS and cancer patients and associated research. The device can be set to reach an upper temperature of: 48C. Recall # Z-0970-2012
CODE
1) Serial Numbers: 902-8645, 902-8646, 911-9426, 914-10001, 914-10140, 914-10177, 943-12074, 992-14052, 994-14290, 994-14291, 002-14541, 002-14545, 012-15024, 014-15260, 022-15490, 074-18981, 962-12825, and 874-6277;
 
2) Serial Numbers: 862-8586M, 882-9143M, 882-9163M, 914-9837M, 952-10505M, 973-10918M, 992-11343M, 002-11540M, 003-11585M, 003-11586M, 003-11592M, 003-11600M, 004-11830M, 004-11631M, 014-11807M, 0311-12041M, 042-12250M, 071-12654M, 071-12655M, 073-12117M, 972-10872M, 062-12536M, and 963-10737M.
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products Inc., Cincinnati, OH, by letter dated January 20, 2011. Firm initiated recall is ongoing.
REASON
The suspect hyper-hypothermia device systems sold to physicians for research and/or the treatment of AIDS and Cancer patients, were not appropriately cleared by the FDA prior to distribution.
VOLUME OF PRODUCT IN COMMERCE
20-Hemotherm 48C, 400M &400MR systems; and 16 Blanketrol II Model 222 & 222R 48C System units were distributed in U.S (rest shipped overseas).
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens CLINITEST hCG -Pregnancy Test (qualitative), Radio immunoassay,Human Chorionic Gonadotropin (hCG) test system. Package of 25. Product Code 1760/ Catalog# 06484105). For in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. Recall # Z-0972-2012
CODE
Lot Expiration 028619, 6/8/2012; 028924, 7/5/2012; 029997, 10/7/2012; 030240, 11/6/2012; 030431, 11/24/2012; 030602, 12/8/2012; 030826, 12/24/2012; 030998, 1/11/2013; 031332, 2/4/2013; 031460, 2/19/2013; 031662, 3/6/2013; 031798, 3/20/2013; 031924, 3/30/2013; 032180, 4/28/2013; and 032106, 4/19/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Healthcare Diagnostics, Tarrytown, NY, by letters beginning December 16, 2011.   
Manufacturer: Alfa Scientific Designs Inc., Poway, CA. Firm initiated recall is ongoing.
REASON
A potential for false positive or increase in borderline results with patients and commercially available negative control material.
VOLUME OF PRODUCT IN COMMERCE
48,578 Kits (25 tests / kit)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) AU Clinical Chemistry Analyzers: Model Number: AU400 Clinical Chemistry Analyzer, AU400(e) Clinical Chemistry Analyzer, AU480 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. Recall # Z-0974-2012;
 
2) AU Clinical Chemistry Analyzers: Model Number: AU600 Clinical Chemistry Analyzer, AU640 Clinical Chemistry Analyzer, AU640(e) Clinical Chemistry Analyzer, AU680 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. Recall # Z-0975-2012;
 
3) AU Clinical Chemistry Analyzers: Model Number: AU2700 Clinical Chemistry Analyzer . The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. Recall # Z-0976-2012;
 
4) AU Clinical Chemistry Analyzers: Model Number: AU5400 Clinical Chemistry Analyzer. The AU Clinical Chemistry Analyzers are fully automated photometric analyzers intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay. Recall # Z-0977-2012
CODE
All analyzer serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated April 27, 2011.
Manufacturer: Beckman Coulter Kk, Sunto-gun, Japan. Firm initiated recall is ongoing.
REASON
The AU Clinical Chemistry Analyzers may experience cuvette overflow.
VOLUME OF PRODUCT IN COMMERCE
8,225 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery. Recall # Z-0978-2012
CODE
Serial Numbers 0 - 10186
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letter on November 16, 2011.  Firm Initiated recall is ongoing.
REASON
Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece.
VOLUME OF PRODUCT IN COMMERCE
10187
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. Recall # Z-0979-2012;
 
2) EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. Recall # Z-0980-2012;
 
3) EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. Recall # Z-0981-2012;
 
4) EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. Recall # Z-0982-2012;
 
5) EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems. Recall # Z-0983-2012
CODE
1) Lot Numbers: 14050236, 14069164, 14085850, 14085852, 14089636, 14098511, 14102112, 14138785, 14142301, and 15091243;
 
2) Lot Numbers: 15214996M, 14070102A, 15177599, 15156690, 15156649, 15123384, 15111287, 15079216, 15076033, 15070702, 14138791, 14117351, 14117345, 14117339, 14113236, 14109201, 14102119, 14102116 14093807, 14091431, 14087720, 14081176, 14077787, 14076743, 14075452, 14071539, 14071538, 14068519, 14066570, 14064255, 14060307, 14058853, 14058117, 14056270, 14056269, 14053165, 14052248, 14052247, 14049472, 14043262, 14040370, 14039651, and 14036714
 
3) Lot Numbers: 15076036, 15076035, 15059708, 14113238, 14105865, and 13439370;
 
4) Lot Numbers: 15221536M, 15215004M, 15215001M, 15215000M, 15208579M, 15208577M, 15208574M, 14069262A, 14069168A, 14069084A, 15164269, 15164264, 15159917, 15159912, 15156608, 15148849, 15144223, 15128115, 15128113, 15119884, 15119883, 15116509, 15116506, 15103250, 15098193, 15098191, 15098190, 15095199, 15083389, 15083386, 15080818, 15080815, 15070703, 15067809, 15064960, 15032155, 15014525, 15014522, 15014521, 15010028, 15010027, 15007251, 15007250, 14152525, 14149131, 14149130, 14149129, 14146082, 14142307, 14138855, 14138853, 14138846, 14138795, 14120030, 14117394, 14117388, 14117385, 14117376, 14117371, 14117370, 14117356, 14113251, 14113249, 14109218, 14109216, 14102071, 14102068, 14097083, 14095220, 14093166, 14092574, 14091435, 14089642, 14089641, 14088995, 14087721, 14080304, 14080303, 14080302, 14079405, 14078387, 14078385, 14077789, 14075460, 14075459, 14071639, 14071638, 14071542, 14070108, 14068526, 14067399, 14065778, 14065064, 14065059, 14064262, 14064259, 14064258, 14063230, 14062655, 14062654, 14062652, 14062651, 14062042, 14062040, 14062039, 14062038, 14061249, 14060315, 14060311, 14058856, 14058855, 14057214, 14056275, 14056273, 14056272, 14053738, 14053167, 14052547, 14052249, 14051584, 14043263, 14042518, 14042517, 14038851, 14036716, 14036583, and 14036582;
 
5) Lot Numbers: 15219359M, 15219356M, 15214930M, 15214908M, 15214902M, 15208638M, 15208634M, 15208631M, 15208628M, 15208626M, 15208619M, 15208612M, 15208607M, 15208593M, 15205050M, 15205047M, 15205031M, 15205018M, 15204883M, 15199820M, 15199819M, 15199811M, 15199801M, 15199794M, 15199792M, 14069263A, 15171668, 15171665, 15171663, 15171652, 15169965, 15169957, 15169946, 15164293, 15164271, 15159938, 15159935, 15159922, 15156563, 15151976, 15148785, 15148772, 15144234, 15144151, 15144134, 15144119, 15136209, 15132418, 15128133, 15128123, 15124171, 15124167, 15123408, 15120034, 15120022, 15116441, 15103256, 15103255, 15098206, 15098200, 15098198, 15098195, 15095224, 15095223, 15095220, 15091259, 15091254, 15083409, 15081335, 15081333, 15076058, 15076049, 15076046, 15071044, 15070717, 15070708, 15067823, 15067817, 15057475, 15040868, 15035767, 15035766, 15032160, 15028721, 15028712, 15028708, 15028701, 15025094, 15021180, 15021179, 15021175, 15021168, 15021164, 15021163, 15021148, 15017983, 15010043, 15010040, 15010033, 15010006, 15009982, 15009980, 15009978, 15009975, 15007267, 15007261, 15007255, 15007254, 14152530, 14149138, 14149136, 14146104, 14146099, 14146095, 14146090, 14146086, 14146084, 14142340, 14142339, 14142335, 14142333, 14142326, 14142325, 14142324, 14142323, 14142322, 14142317, 14142316, 14142314, 14142312, 14142311, 14138878, 14138878, 14138871, 14138866, 14138865, 14138864, 14138860, 14138859, 14120108, 14120105, 14120100, 14120092, 14120078, 14120076, 14120075, 14120067, 14120062, 14120055, 14120015, 14120014, 14120010, 14120006, 14120002, 14120000, 14119986, 14119985, 14119977, 14117438, 14117431, 14117430, 14117429, 14117409, 14117406, 14117404, 14117400, 14117398, 14113274, 14113268, 14113262, 14113257, 14109239, 14109234, 14109231, 14109230, 14109229, 14109228, 14102076, 14099138, 14099135, 14098716, 14098709, 14098706, 14098530, 14098525, 14097835, 14095223, 14090358, 14089643, 14088997, 14088996, 14087736, 14087731, 14085863, 14085143, 14085142, 14085141, 14081912, 14081911, 14081907, 14081809, 14081808, 14081805, 14081804, 14081185, 14080312, 14080310, 14079411, 14078390, 14076755, 14076256, 14076254, 14076253, 14075465, 14075464, 14071644, 14071547, 14068530, 14066590, 14066582, 14065792, 14065065, 14064778, 14064271, 14064266, 14064265, 14063238, 14063236, 14063234, 14062663, 14062660, 14062044, 14061259, 14061256, 14060323, 14060321, 14060320, 14058864, 14058857, 14058125, 14058124, 14058122, 14057221, 14057220, 14053745, 14053740, 14053739, 14053728, 14053724, 14053709, 14053168, 14052551, 14050933, 14049476, 14043896, 14042520, 14039654, 14038050, 14029870, 14029043, 14028071, 14027237, 14025878, 14025127, 14019684, 14016117, and 13435854
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter dated November 22, 2010.  Firm initiated recall is complete.
REASON
Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fistula, precautionary measures should be taken when ablating on posterior wall of the left atrium in proximity to the esophagus. This issue affects only the IFU for the EZ Steer ThermoCool NAV Diagnostic/Ablation Catheter, not the catheter itself. Please note that these warnings and precautions are already included in the NaviStar ThermoCool Catheter IFU. Both of these potential complications, and procedural mitigations for avoiding them, are well documented in clinical and scientific literature.
VOLUME OF PRODUCT IN COMMERCE
24,713 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
VITROS Valproic Acid (VALP) Reagent, REF/Catalog No. 6801710. An in vitro diagnostic. For in vitro diagnostic use only. Used to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Recall # Z-0984-2012
CODE
Reagent Lots from Generation (GEN) 14: 1511-14-9637 (exp. 6/30/11), 1511-14-9776 (exp. 9/30/11), 1511-14-9894 (exp. 11/30/11), 1511-14-1094 (exp. 1/31/12), and 1511-14-1230 (exp. 4/30/12)
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated May 10, 2011. Firm initiated recall is ongoing.
REASON
Results using VITROS Chemistry Products VALP Reagent were negatively biased compared to other manufacturers. OCD confirmed that patient results were also affected by this issue.
VOLUME OF PRODUCT IN COMMERCE
Approximately 5836 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Integra OS Osteoconductive Scaffold Putty (a 2.5 cc Part numbers - IOS10125; b) 5 cc Part numbers - lOS10155). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process. Recall # Z-0986-2012
CODE
a) Lot numbers - N199416 and 215944; b) Lot numbers - 208500, 206504 and N216026
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp, Plainsboro, NJ, by letter on October 7, 2011. Firm initiated recall is ongoing.
REASON
Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. Used to do nuclear medicine diagnostic imaging of various body organs. Recall # Z-0988-2012
CODE
System Code # 882130, Serial # 10, 97, 101, 103, 104, 107-112, 116, 117, 119-121, 123, 125, 127, 130, 132, 133, 135, 138, 142-144, 149-151, 153-158, 162-164, 166, 169-173, 180, 181, 185, 186, 189, 193-204, 214, 215, 218, 219, 221-223, 227, 229-231, 233-237, 240, 242, 244-246, 249-251, 260-262, 264, 267, 272, 273, 275, 277, 280, 281, 283, 285, 291-293, 295, 297-300, 305, 308-310, 312, 316, 319-322, 326-332, 334-336, 338-340, 346, 347, 349, 351, 352, 354, 355, 358-363, 368-370, 374, 377-379, 385, 387, 388, 390-396, 401-407, 411, 412, 416-419, 426-432, 434, 437, 438, 442, 443, 445-447, 449, 452, 457-462, 464, 465, 468, 471, 474, 480-485, 487, 490-493, 495, 496, 499, 502, 503, 505, 508, 509, 511, 513-518, 520, 521, 523, 529, 530, 534, 543-546, 548-560, 562, 563, 569-572, 574-576, 580, 582, 583, 585, 586, 590, 594, 595, 597, 602-607, 611, 612, 618-621, 624-628, 630, 635, 636, 640, 641, 647-650, 654, 656-658, 660-665, 668-673, 675, 679, 681-684, 686, 687, 690-695, 697-699, 701-708, 711-719, 723-729, 733-736, 738, 739, 743-746, 749-753, 755, 756, 759, 760, 762, 764-767, 771-773, 776-778, 780, 781, 786, 789, 790-795, 797, 799, 801, 803-806, 808, 809, 811-814, 818, 820-822, 825-827, 831-834, 836, 837, 839, 840, 841, 843-845, 848, 849, 851-855, 857, 858, 860-862, 865-869, 872-874, 876-881, 884-886, 889, 893, 894, 900-903, 907-922, 924, 927-930, 932, 934, 938-941, 943, 944, 946-948, 951, 953, 954, 958-963, 965-967, 970, 972-980, 982, 983, 985, 986, 991-994, 996-1000, 1003-1008, 1010-1013, 1016, 1017, 1019, 1022, 1023, 2007, 2008, 211037, 2008-0068, 555A, & 778A. System Code #882140, Serial # 102, 134, 141, 146, 147, 159, 160, 161, 167, 175, 176, 190, 209, 210, 216, 225, 226, 257, 259, 268-270, 274, 289, 290, 302, 304, 314, 315, 318, 323, 333, 341, 343, 344, 348, 350, 364, 366, 381, 386, 409, 414, 420, 421, 423, 436, 441, 455, 463, 469, 472, 473, 488, 489, 497, 498, 501, 531, 532, 536-539, 565, 566, 578, 588, 589, 591, 596, 598-600, 608, 610, 613, 615, 616, 622, 631, 632, 634, 637, 653, 666, 674, 676-678, 685, 689, 700, 709, 710, 731, 732, 741, 742, 748, 757, 763, 768, 774, 785, 802, 810, 816, 819, 824, 828, 829, 830, 838, 846, 856, 863, 864, 870, 871, 875, 884, 891, 892, 898, 904, 905, 931, 933, 936, 942, 945, 949, 950, 952, 955-957, 964, 968, 981, 989, 990, 995, 1001, 1002, 1009, 1015, 1018, & 1021. System Code #882130/40, Serial #184, 730, 122, 136, 254, 255, 284, 614, 696, 874, 906, & 984. System Code #882140/882130, Serial #113, 148, 152, 178, 179, 187, 188, 217, 238, 243, 247, 248, 278, 288, 345, 367, 371, 373, 380, 384, 389, 397, 397, 399, 408, 413, 415, 435, 439, 439, 440, 453, 477-479, 486, 504, 512, 525, 526, 528, 533, 535, 540, 547, 564, 567, 568, 577, 579, 581, 638, 639, 644, 645, 651, 652, 659, 667, 680, 747, 758, 815, 850, 859, 882, 883, 890, 896, 897, 899, 925, & 969.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH,  by letters on November 15, 2011, Firm initiated recall is ongoing.
REASON
Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.
VOLUME OF PRODUCT IN COMMERCE
795 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Zoll pedi.padz Reduced Energy Multi-Function Electrodes (MFE) Part number: 8900-0401 Used in connection with Zoll M Series and E series Defibrillators specifically for pediatric patients. Recall # Z-1011-2012
CODE
Lot Numbers 0510 thru 4511
RECALLING FIRM/MANUFACTURER
Bio-Detek, Inc., Pawtucket, RI, by letter dated December 30, 2011. Firm initiated recall is ongoing.
REASON
Lack of an adequate silicone seal around the periphery of the attenuator enclosure may allow fluid to enter.
VOLUME OF PRODUCT IN COMMERCE
3,080 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1. Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Recall # Z-1012-2012
CODE
1. Lot # Z13-927A, expiration date 2/1/2014; 2. 03001-02 Periophil Biphasic, Lot # Z13-927B, expiration date 2/1/2014. 3. 03001-01 Periophil Biphasic, Lot # Z13-926A, expiration date 2/1/2014. 4. 03001-01 Periophil Biphasic, Lot # N13-925C, expiration date 1/31/2014. 5. 03003-01 Periobase Biphasic, Lot # N13-925B, expiration date 1/31/2014. 6. 03002-01 Periobone Biphasic, Lot # N13-925A, expiration date 1/31/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cytophil, Inc., East Troy, WI, by letter dated January 11, 2012.
Manufacturers: Cytophil, Inc., East Troy, WI;
Steris Isomedix Services, Libertyville, IL. Firm initiated recall is ongoing.  
REASON
Devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
547
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Temporary Pacing Wire, BIPOLAR, Models a) BM, b) V, c) VE and d) VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less. Recall # Z-1038-2012
CODE
a) Lot numbers 1101044-10, 1012035-10, 1012036-10, 1011128-10, 1101023-10, 1101134-10, 1102035-10, 1102061-10, 1009089-10; b) Lot number: 1103066-10; c) Lot numbers: 1101055-10, 1101008-10; d) Lot numbers: 1011092-10, 1011148-20, 1012038-10, 1101021-10, 1101136-10
RECALLING FIRM/MANUFACTURER
European Custom Manufacturing B.V, Gemert, Netherlands, by letter dated May 2, 2011 and by e-mail and or telephone between April 18 and 21, 2011. Firm initiated recall is complete.
REASON
The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.
VOLUME OF PRODUCT IN COMMERCE
2,120 individual units (106 boxes)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201. The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment. The corrected units will have controller software version MDC V3.6 pack G. Recall # Z-1042-2012
CODE
Serial numbers: 181011001, 181011009, 181011005, 181011003, 250811007, 28101108, 151111011, 211111007, 251111006 and 251111004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, by e-mail on December 21,2011.   
Manufacturer: Leica Microsystems (Schweiz) Ag, Heerbrugg, Switzerland. Firm initiated recall is complete.
REASON
Leica Microsystems received complaints stating that the zoom function of the Leica M822 surgical microscope locked up during use.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide, Austraila, Japan, Korea, Pakistan, Romania, South Africa, Switzerland and Turkey
___________________________________
PRODUCT
SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. Catalog #73113. Recall # Z-1045-2012
CODE
Lot number: 1105104545
RECALLING FIRM/MANUFACTURER
Recalling Firm: bioMerieux, Inc., Durham, NC, by letter dated December 21, 2011.
Manufacturer: Biomerieux Brasil, Rio De Janeiro, Brazil.
REASON
Reports of false negative results in organism identification.
VOLUME OF PRODUCT IN COMMERCE
100 kits
DISTRIBUTION
CA
___________________________________
PRODUCT
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-asectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Recall # Z-1046-2012
CODE
Serial Numbers: 300003, 300004, 300005, and 300010
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated December 08, 2011. Firm initiated recall is ongoing.
REASON
A 'gap' is created in the side covers when the gantry of the device is tilted to +30 degrees (forward tilt). A hazard to the operator/user presents itself if the operator puts his or her fingers or hand inside the gap and the gantry tilt is returned in position while the fingers or hand of the user are still in the gap.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide, Australia and Germany
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A , 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set CD ROM - 1 Calibrator/Diluent Set Whole Blood Primer, 6 x 1 mL Sample vials, 2 x 100 Instruction Manual. Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP). Catalog number: 270-2716. Recall # Z-0399-2012
CODE
Lot 70211322; 70211432, 70211440; exp 3/31/2012
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter dated October 25, 2011. Firm initiated recall is ongoing.
REASON
It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin. Recall # Z-0694-2012
CODE
Lot #1029402
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merz Aesthetics, Inc., Franksville, WI, by telephone on December 16, 2011 and letter dated January 6, 2012.
Manufacturer: Tsk Laboratory, Tochigi City, Japan. Firm initiated recall is ongoing.
REASON
Recall due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
5 boxes (20 units per box)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. Recall # Z-0873-2012;
 
2) Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. Recall # Z-0874-2012
CODE
1) Lot # 7964576;
2) Lot # 7964590
RECALLING FIR/MANUFACTURER
Micro Therapeutics Inc, dba ev3 Neurovascular, Irvine, CA, by March 1, 2010. Firm initiated recall is complete.
REASON
ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide, the UK and France
 
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT
1) Iams ProActive Health Puppy, 7 lb, 8 lb and 17.5 lb bags, UPC: 1901410208, 1901402305 and 1901401848. Recall # V-036-2012;
 
2) Iams ProActive Health Smart Puppy Large Breed, 17.5 lb and 40 lb bags, UPC: 1901401861 and 1901419840. Recall # V-037-2012;
 
3) Iams ProActive Health Lamb Meal & Rice Adult Dog Food, 46 lb, 6.1 lb, 35 lb, 35 lb, 40 lb and 15 lb bags, UPC: 1901404558, 1901403733, 1901403704, 1901403737, 1901411940 and 1901403735. Recall # V-038-2012;
 
4) Iams Proactive Health Original with Chicken Cat Food, 33 lb, 6.8 lb, 20 lb, 4 lb and 20 lb bags, UPC: 1901410533, 1901403915, 1901460807, 1901410504 and 1901410520.
Recall # V-039-2012;
 
5) Eukanuba Senior Dog Food Large Breed, 16.5 lb and 30 lb bags, UPC: 1901404240 and 1901427030. Recall # V-040-2012
CODE
1) Lot Codes: 12794177D2, 12794177D3, 12784177 I6, 12794177K1 and 12794177K2;
 
2) Lot Code: 12784177J6, 12794177J1, 12794177J1 and 12794177J2;
 
3) Lot Codes: 12794177J3, 12794177I3, 12794177I4, 12794177J3, 12794177J3, 12794177J4, 12794177J3 and 12794177J4;
 
4) Lot Codes: 12784177F2, 12784177F3, 12784177D3, 12784177D4, 12784177K4, 12784177K5, 12784177I4, 12784177I5 and 12784177K5;
 
5) Lot Codes: 12784177K4, 12784177J5 and 12784177J6
RECALLING FIRM/MANUFACTURER
Procter & Gamble The Iams Co. Henderson, via verbal and email on November 22, 2012. North Carolina Initiated recall is ongoing,
REASON
Product contains high levels of Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
49863 bags (various sizes)
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2012.
 
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