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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 23, 2011

March 23, 2011                                                                                        11-12

 

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS II
_________________________________________
PRODUCT
Colored pigments in 5 gram, 3 gram and 1.5 gram clear plastic screw top jars with sticker labeling, varieties include: ADD; All Star Pink; Aurora; Breast Cancer Collection; Brenda; Brendas Lemonade; Candy Collection Pink; Cotton Candy; Cupcake; Finger Food; Flight Club; Fran; GLADD Collection Light Pink/Salmon; Gold Digger; Glenda; House of Horrors; Jack; Jenn; Jennifer Nazi; Kimberly; Kiss This; Little Girls Collection; Mad Hatter; Mallory; Mattes Collection Light Pink; Mattes Collection Dark Pink; Michigan Avenue; Oyster Shell; Pink Pistol; Poodle Skirt; Profanity; Roxie; Sarah; Seuss Pink; Shannon; Tattoo Collection Pink; Tragic Glamour; True Blood Pink; Yalena Collection Pinks; 80s Red; 80s Pink; 80s Orange; 80s Yellow; 80s Green; 80s Purple; Altered States; GLADD Collection Orange; GLADD Collection Pink; Mo Love; Oh Kristine!; Oompa Loompa; Scream-O. Recall # F-0569-2011
CODE
All pink pigments with the manufacture date between 2006 through 2010.
RECALLING FIRM/MANUFACTURER
Glittersniffer Cosmetics, Dearborn Heights, MI, by letter on firm’s website and on the firm’s facebook page on or about December 24, 2010 and by letters on February 7, 2011. Firm initiated recall is ongoing.
REASON
The firm is recalling products which contain ingredients that are not approved for use around the eye.
VOLUME OF PRODUCT IN COMMERCE
500 units
DISTRIBUTION
Nationwide, Canada, UK, Taiwan, Australia, Denmark, Spain Brazil

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
_______________________________________
PRODUCT
Fresh Cilantro, tied in bunches with twist ties with the names of 1) Ocean Mist; 2) Nature's Reward - labeled as Steinbeck/Hilltown; 3) Tanimura & Antle and 4) Queen Victoria. Recall # F-0565-2011
CODE
1) Lot codes on cartons: 16CISF1J 2 011311 16CISF1J 2 011411; 2) codes on cartons: 05013 22 16 10, 05014 22 16 10; 3) code on carton: 22 01 13 151348 22 01 14 151348; 4) 16520132 16 10 22 16520142 16 10 22
RECALLING FIRM/MANUFACTURER
Sabor Farms LLC, Salinas, CA, by telephone and letter on January 26, 2011 and press release on January 28, 2011. Firm initiated recall is ongoing.
REASON
USDA Agricultural Marketing Services tested fresh cilantro and found it to be positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1976 cases
DISTRIBUTION
CA
___________________________________________
PRODUCT
Ian's Wheat Free, Gluten Free French Bread Pizza 8 oz UPC code 7-49512-91572-2. Recall # F-0567-2011
CODE
Use-by date of 28 Aug 2011
RECALLING FIRM/MANUFACTURER
Ian's Natural Foods, Inc., Framingham, MA, by letter and press release on January 24, 2011. Firm initiated recall is ongoing.    
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
120 packages       
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
Peppermint Tea Leaves are packaged in bulk polywoven bag. The Peppermint Leaf Cut & Sift is packaged in a polywoven bag has a net weight 22 lbs. The Peppermint Leaf Tea Bag Cut is packaged in a polywoven bag has a net wt. 44 lbs. The bulk bag's orange label stated: "Peppermint Leaf Cut & Sift***Certified Organic***AB-10-830-OPL C/S***Net Wt: 22 Lbs.-10 kgs***Country of Origin: USA***Peppermint Leaf Cut & Sift***Certified Organic***AB-10-831-OPL C/S***Net Wt: 22 Lbs.-10 kgs***Country of Origin: USA***". Peppermint Leaf Tea Bag Cut***Certified Organic***AB-10-832-OPL TBC***Net Wt: 44 Lbs. 20 kgs***Country of Origin: USA***". Peppermint Leaf Tea Bag Cut***Certified Organic***AB-10-833-OPL TBC***Net Wt: 44 Lbs. 20 kgs***Country of Origin: USA***". Recall # F-0582-2011
CODE
Lot codes: AB-10-830-OPL C/S, AB-10-831-OPL C/S, AB-10-832-OPL TBC, and AB-10-833-OPL TBC. Code interpretation: AB-10-830-OPL C/S: AB represent the firm; 10 represent the crop year (10 = 2010), 830 represent a sequential production lot number, OPL represent the product code (OPL = organic peppermint leaf), C/S identify the product format (C/S = cut & sift). AB-10-831-OPL C/S: AB represent the firm; 10 represent the crop year (10 = 2010), 831 represent a sequential production lot number, OPL represent the product code (OPL = organic peppermint leaf), C/S identify the product format (C/S = cut & sift). AB-10-832-OPL TBC: AB represent the firm; 10 represent the crop year (10 = 2010), 832 represent a sequential production lot number, OPL represent the product code (OPL = organic peppermint leaf), TBC identify the product format (TBC = Tea Bag Cut). AB-10-833-OPL TBC: AB represent the firm; 10 represent the crop year (10 = 2010), 833 represent a sequential production lot number, OPL represent the product code (OPL = organic peppermint leaf), TBC identify the product format (TBC = Tea Bag Cut).
RECALLING FIRM/MANUFACTURER
Aromatics, Inc., Mesa, WA, by telephone on February 15, 2011 and February 28, 2011 and by letter on March 1, and March 2, 2011. Firm initiated recall is ongoing.
REASON
There is a potential that Peppermint tea leaves are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
40, 084 lbs
DISTRIBUTION
Nationwide
_______________________________________
PRODUCT
1) 50/50 Blend Baby Spinach/Spring Mix 7 oz, Clamshell brand Names: Northeast Fresh, Roche Bros, Signature, Gold Quality. Recall # F-0586-2011;

2) Baby Arugula, 7 oz, Clamshell, 3 lb bag Brand Names: Gold Quality, Roche Bros, Northeast Fresh. Recall # F-0587-2011;

3) Baby Romaine 7 oz, 5 oz Clamshell Brand Names: Gold Quality, Hannaford/Sweetbay Northeast Fresh, Roche Bros, Signature, Wegmans. Recall # F-0588-2011;

4) Baby Spinach 7 oz, 5 oz, 24 oz Clamshell 4 lb. bag Brand Names: Gold Quality, Hannaford/Sweetbay Northeast Fresh, Roche Bros, Signature, Wegmans. Recall # F-0589-2011;

5) Organic Baby Spinach with Ranch Dressing and Fork 3.5 ounce, Clamshell Brand Names: Nature's Promise, Olivia's Organics. Recall # F-0590-2011;

6) Crispy Hearts of Romaine Crunch 6 oz Clamshell Brand Names: Olivia's Organics. Recall # F-0591-2011;

7) Organic Baby Romaine 5 oz , 7 oz, 11 oz, 16 oz Clamshell Brand Names: Natures Promise, Olivia’s Organics, Wegmans. Recall # F-0592-2011;

8) Organic Microwaveable Spinach 9 oz bag Brand Names: Noreast. Recall # F-0593-2011;

9) Spring Mix 5 oz, 7 oz, 16 oz Clamshell Brand Names: Gold Quality, Hannaford/Sweetbay, Northeast Fresh, Roche Bros., Signature, Wegmans. Recall # F-0594-2011;

10) Microwaveable Spinach 9 oz bag Brand Names: Gold Quality. Recall # F-0595-2011;

11) Organic 50/50 Blend Baby Spinach/Spring Mix 5 ounce, 7 ounce, 11 oz Clamshell Brand Names: Natures Place, Nature Promise, Olivia's Organics. Recall # F-0596-2011;

12) Organic Asian Salad, 5 oz Clamshell Brand Names: Wegmans. Recall # F-0597-2011;

13)  Organic Baby Arugula 5 oz, 7 oz, clamshell Brand Names: Hannafords/Sweetbay, Nature's Place, Nature's Promise, Olivia’s Organics, Wegmans. Recall # F-0598-2011;

14) Organic Baby Spinach 5 oz, 7 oz, 11 oz, 16 oz clamshell; 4 lb bag Brand Names: Nature's Place, Nature's Promise, Olivia's Organics, Wegmans. Recall # F-0599-2011;

15) Organic Caesar Salad Kit with Caesar Supreme Dressing and Croutons, 10.75 oz Clamshell Organic Caesar Salad Kit with Caesar Supreme Dressing and Fork, 5.5 oz Clamshell Brand names: Natures Promise , Olivia's Organics. Recall # F-0600-2011;

16) Organic Herb Salad 5 oz Clamshell Organic Spring Mix with Herbs, 7 oz Clamshell Brand Names: Nature’s Place, Natures Promise, Olivia's Organics, Wegmans. Recall # F-0601-2011;

17) Organic Mixed Greens 5 oz, 11 oz,, 16 oz. clamshell and 3 Pound Bag Brand Name: OLIVIA'S Organics. Recall # F-0602-2011;

18) Organic Spinach & Field Mix 5 oz, 11 oz Clamshell Brand name: Wegmans. Recall # F-0603-2011;

19) Organic Spinach, Arugula & Radicchio Blend 5 oz Clamshell Brand Name: Wegmans. Recall # F-0604-2011;

20) Organic Spring Mix 5 oz, 7 oz, 16 oz Clamshell Brand Names: Hannaford/Sweetbay, Nature’s Promise, Wegmans. Recall # F-0605-2011;

21) Organic Sweet Baby Lettuce, 5 oz, 7 oz Clamshell Brand Names: Nature’s Promise, Wegmans. Recall # F-0606-2011;

22) Organic Tangy Spinach 7 oz Clamshell Brand Names: Nature’s Promise. Recall # F-0607-2011;

23) Spinach 10 oz Bag, 10 lb. bag Brand names: Northeast Fresh, Wegmans. Recall # F-0608-2011;

24) Organic Spring Mix with Balsamic Vinaigrette Dressing and Fork 3 oz Clamshell, Brand Name: Olivia’s Organics. Recall # F-0609-2011;

25) Sweet Baby Lettuce 7 oz Clamshell Brand Names: Gold Quality, Northeast Fresh Roche Bros Signature. Recall # F-0610-2011;

26) Tangy Spinach Blend 7 oz Clamshell Brand Name: Signature. Recall # F-0611-2011
CODE
Best If Used by dates no later than Jan 15, 2011
RECALLING FIRM/MANUFACTURER
State Garden, Inc., Chelsea, MA, recall by telephone on January 24, 2011 and press release on January 26, 2011. Rhode Island initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
135,825 units
DISTRIBUTION
CT, NH NY, MA, MD, ME, NC, NY, PA, RI, VT

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________________
PRODUCT
Ians Wheat Free, Gluten Free Mac and No Cheese - 8 ounce boxes UPC code 7-49512-43670-8. Recall # F-0566-2011
CODE
Use-by date of 26 Aug 2011
RECALLING FIRM/MANUFACTURER
Ian's Natural Foods, Inc., Framingham, MA, by letter and press release on January 24, 2011. Firm initiated recall is ongoing.    
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
372 packages       
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Blueberry Pie 10" Net Wt. 2 lb. 15 oz. frozen, in plastic container, shipped in a brown cardboard carton with other assorted pies, UPC 07491 31116. Recall # F-0568-2011
CODE
Lot codes: 070110 - 123110
RECALLING FIRM/MANUFACTURER
United Pies Of Elkhart, Inc., Elkhart, IN, by telephone and letter dated January 18, 2011. FDA initiated recall is ongoing.
REASON
The firms’ blueberry pie contains wheat but does not declare the allergen wheat on the product label. The label does declare flour.
VOLUME OF PRODUCT IN COMMERCE
79 pies
DISTRIBUTION
IN

________________________________________
PRODUCT
Peppermint Organic Herbal Tea measured and sold (from bulk) in retail stores, mail and the internet. The product contains brewing instructions on package label. Recall # F-0583-2011
CODE
Product sold between November 30, 2010 and February 16, 2011.
RECALLING FIRM/MANUFACTURER
Teavana Corp., Atlanta, GA, by e-mail and telephone on February 16, 2011, February 28, 2011 and by press release on March 3, 2011. Firm initiated recall is ongoing.
REASON
Product was repackaged from a lot received from Aromatics, Inc., that is being recalled due to possible Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
2,659 lbs
DISTRIBUTION
FL, MD and Mexico
_______________________________________
PRODUCT
Asian Gourmet Rice Crackers Cheese, Net Wt. 3.5 oz (100g), Serving Size 18 pieces; Product of China; UPC 076606710889. Recall # F-0584-2011
CODE
All Lots distributed between 2/15/10-2/15/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haddon House Foods Products Inc., Medford, NJ, by e-mail on February 22, 2011 and a press release on February 23, 2011.
Manufacturer: Guangzhou Yong Want Foods Ltd, Guangzhou, China. Firm initiated recall is ongoing.
REASON
Asian Gourmet Cheese Rice Crackers are being recalled due to undeclared milk and colors, FD&C yellow # 5 and # 6.
VOLUME OF PRODUCT IN COMMERCE
18,813 cases (12 packages per case)
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Frozen dessert made with milk and 'Oreo" chocolate cookies packaged in 6.5 oz plastic cups with a plastic lid. Recall # F-0585-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Limbelcito, Inc, Aguadilla, PR, by telephone on September 13, 2010. Firm initiated recall is ongoing.
REASON
Undeclared wheat and soy lecithin in ingredients label.
VOLUME OF PRODUCT IN COMMERCE
106 each
DISTRIBUTION
PR
_________________________________________
PRODUCT
Vanilla flavored artisan cookies called "Mantecaditos", labeled in part: ***LOS GENUINOS***MANTECADITOS***Sabrosos***MANTECADITOS*** Recall # F-0612-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Los Genuinos, Inc., Bayamon, PR, by telephone on January 19, 2011. FDA initiated recall is ongoing.
REASON
Undeclared FD&C Yellow#5 discovered during an FDA inspection.
VOLUME OF PRODUCT IN COMMERCE
2,500 bags/6 oz each
DISTRIBUTION
PR
_______________________________________
PRODUCT
Mini Sugar Cookie, Frozen Cookie Dough, Approx. 504 ct. (count) , 28.35 lbs (12.86kg), Item# 01189928, UPC 029519183806. Recall # F-0613-2011
CODE
Lot Codes: 10-201, 10-217, 10-246, 10-256, 10-271, 10-280, 10-282, 10-283, 10-288, 10-289, 10-295, 10-302, 10-303, 10-309, 10-310, 10-316, 10-317, 10-331, 10-332, 10-354, 10-362, 10-363, 1-006, 1-043, 1-047, 1-052
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dawn Food Products, Jackson, MI, by letter on February 23, 2011.
Manufacturer: Countryside Baking Inc. A Dawn Food Products Co., Irvine, CA, Firm initiated recall is ongoing.
REASON
The recall was initiated because the affected cookies were topped with a sanding sugar that contains artificial red, blue, and yellow colors that are not listed on the case label or finished product ingredient declaration. These undeclared colors may pose a risk to individuals who are sensitive to food colorings.
VOLUME OF PRODUCT IN COMMERCE
38,793 cases
DISTRIBUTION
FL, PA, UT, IN, LA, MO, NC, NY, GA, IL, OK, CA, TX, WI, OH, and WY

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
_________________________________________
PRODUCT
DURO EXTEND capsules, Proprietary Blend 500 mg (L-Arginine, Velvet Deer (antler), Maca extract (root), Rhodiola Rosea, Sasparilla. Other Ingredients: Gelatin and FD&C Blue #1 and FD&C Red#40 and Titanium Dioxide, Cellulose, Magnesium Stearate, Silica. 1-count blisters (UPC 7 18122 35161 9) displayed in 12-count and 24-count trays, 3-count bottles, and 10-count bottles (UPC 7 18122 35151 0). Recall # D-380-2011
CODE
All lots, Expiration dates 03/11 to 06/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intelli Health Products, LLC, Odessa, FL, by letters dated October 27, 2010 and November 29, 2010 and press release dated October 27, 2010 and December 2, 2010.
Manufacturer: Metaugus Inc., Cedartown, GA. FDA initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Laboratory analysis of this product found the presence of Sulfoaildenafil and analogue of sildenafil which is an FDA approved drug used in the treatment of male erectile dysfunction making Duro Extend an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
1,066,020 capsules
DISTRIBUTION
Nationwide and Trinidad/Tobago and Germany

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I I
_________________________________
PRODUCT
Alcohol-Free Hand Sanitizer Foam; brand names: 1) Smart San Alcohol - Free Hand Sanitizer Foam, 1250 mL and 250 mL, bottles, NDC Numbers: 59900-118-06 and NDC #5990-118-12; and 2) MEDITIZE Alcohol-Free Hand Sanitizer Foam, 1250 mL bottles, NDC #50803-118-01. Recall # D-278-2011
CODE
PL0086 MEDITIZE, Lot Code: 10139 1, Exp. Date: 5/12. Product: PL0086 MEDITIZE Lot Code: 10140 1, Exp. Date: 5/12. Product: SMA0026U-CAN SmartSan Lot Code: 101401, Exp. Date: 5/12. Product:: SMA0026U SmartSan, Lot Code: 10140 1, Exp. Date: 5/12 Product: SMA0034U SmartSan, Lot Code: 09346 1, Exp. Date: 12/11. Product:: SMA0026U SmartSan, Lot Code: 09290 1, Exp. Date: 10/11. Product : SMA0026U SmartSan, Lot Code: 09289A 2 , Exp Date: 10/11. Product: SMA0026U SmartSan, Lot Code: 09289 1, Exp. Date: 10/11. Product: SMA0026U SmartSan, Lot Code: 09289 2, Exp. Date: 10/11.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Sanitizers Inc., Penn Valley, CA, by telephone on November 17, 2010, and letters dated December 14, 2010.
Manufacturer: Best Sanitizers Inc., Walton, KY. Firm initiated recall is complete.
REASON
Microbial contamination of additional brand named Non-sterile Products: Non-Alcohol Foaming Hand sanitizer may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
1361 cases: MEDITIZE=251 cases x 6x1250 mL; and SmartSan=1110 cases
DISTRIBUTION
Nationwide and Canada
______________________________________
PRODUCT
Heimlich Natural Clear Cream, 30 ml, jar, sold as a cosmetic. Recall # D-373-2011
CODE
B-0294 (Exp 05/2012)
RECALLING FIRM/MANUFACTURER
Recalling Firm: C&C Natural Solution Corp., Brooklyn, NY, by letter dated February 9, 2011.
Manufacturer: Heimlich Natural Products, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
Labeling: Product contains undeclared active ingredient; FDA analysis revealed the presence of up to 0.037% Betamethasone Valerate, a corticosteroid.
VOLUME OF PRODUCT IN COMMERCE
864 boxes
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL, 1 Pint (473 mL), Grape Flavor, Rx, NDC 0603-1685-58, NDA 77-785. Recall # D-374-2011;

2) Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL, 1 Pint (473 mL), Cherry Flavor, Rx, NDC 0603-1684-58, NDA 77-785. Recall # D-375-2011
CODE
1) Lot Numbers: L051J10A, exp. 10/12; L108D10A, exp. 06/10; L024L09A, exp 11/11; L025L09A, exp. 11/11; L026L09A, exp. 11/11; L027L09A, exp. 11/11; L031F09A, exp. 6/11; L032F09A, exp. 6/11; and L00509B, exp. 2/11;

2) Lot numbers: L088G10A, exp. 9/12; L088H10A, exp 10/12; L089H10A, exp. 10/12; L022F10A, exp. 6/12; L023F10A, exp. 7/12; L037L09A, exp. 11/11; L038L09A, exp 11/11; L049L09A, exp. 11/11; L090K10A, exp. 11/12; L170D10A, exp. 06/12; and L038L09B, exp. 11/11
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters on February 24, 2011. FDA initiated recall is ongoing.
REASON
Below specification for dissolution at 3 month time point.
VOLUME OF PRODUCT IN COMMERCE
142,367 units
DISTRIBUTION
Nationwide
______________________________________
PRODUCT
Carbamazepine Tablets USP, 200 mg, Rx only, 1) NDC: NDC: 0093-1233-93; 100 Unit-dose Tablets (10x10s); 2) NDC: 0093-1233-19, individual blister pack. Recall # D-381-2011
CODE
Lot number: 092246A, Exp: 2/11; Lot number: 092571A, Exp: 4/11; Lot number: 092926A, Exp: 5/11; Lot number: 092931A, Exp. 7/11; Lot number: 093199A, Exp: 7/11; Lot number: 094039A, Exp: 10/11; Lot number: 094899A, Exp: 1/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on February 16, 2011.
Manufacturer: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: may not meet dissolution specifications over product shelf life.
VOLUME OF PRODUCT IN COMMERCE
16,869 units
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
Nutropin AQ {somatropin (rDNA origin) injection} Nutropin AQ pen a) 10 kit, and b) 20 kit. Each kit contains on Nutropin Pen 10 or 20 injection device, one pen case, one passive shield, one active shield, 10 pen needles, three alcohol prep pads and user instructions. Recall # D-385-2011
CODE
a) Lot/batch numbers: 703162, 706770, 713297, 713298, 783068, 791856, 808626, 833838; b) lot/batch numbers: 702990, 704070, 704965, 706717, 704964, 706718, 704993, 744216, 783067,804405, 831013, 791855, 804404, 833837
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genentech Inc., South San Francisco, CA, by letters on February 22, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Microbial contamination of non-sterile products: Nutropin AQ kits contain alcohol wipes that have been recalled by Triad Group, Hartland, WI due to Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
45,164 Kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
_________________________________________
PRODUCT
CVS Pharmacy, Gentle Laxative Suppositories Bisacodyl USP, 4 Suppositories (10 mg each), NDC 50730-1004-0, Active Ingredient (in each suppository) Bisacodyl USP, 10 mg....Stimulant Laxative, Inactive Ingredient hydrogenated vegetable oil, catalogue number 33-1004-CVS, UPC 05042814686. Recall # D-360-2011
CODE
Lot Number OJ163, Expiration 9/2012
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by letters dated November 16 and November 23, 2010. Firm initiated recall is complete.
REASON
Product has low concentrations of Bisacodyl.
VOLUME OF PRODUCT IN COMMERCE
73 cases /2628 cartons, 4 suppositories per carton
DISTRIBUTION
Nationwide
_________________________________________
PRODUCT
1) Shopko Children’s Allergy Oral Solution, Cherry Flavor, 4 oz bottles, Item Number 9259326, labeled in part ***Alcohol Free***UPC 40009259326. Recall # D-376-2011;

2) Shopko Children’s Pain Reliever Oral Solution, Cherry Flavor, 4 oz bottles, Item Number 227567, labeled in part ***Alcohol Free***UPC 4000227567. Recall # D-377-2011;

3) Shopko Tussin DM Adult Cough Formula, 8 oz bottles, Item Number 20202412, labeled in part ***Alcohol Free***UPC 40020202412. Recall # D-378-2011;

4) Shopko Tussin CF Cough and Cold, 8 oz bottles, Item Number 6469621, labeled in part ***Alcohol Free***UPC 40006469621. Recall # D-379-2011
CODE
1) Lot 02931, Exp 9/12;
2) Lot 03191, Exp 10/12;
3) Lot 02991, Exp 9/12;
4) Lot 03061, Exp 10/12
RECALLING FIRM/MANUFACTURER
Celeste Contract Packaging, LLC, Easton, MD, by letters on February 3, 2011. Firm initiated recall is ongoing.
REASON
Products are misbranded; Products are labeled as alcohol free but were manufactured with flavorings that may contain low levels of alcohol.
VOLUME OF PRODUCT IN COMMERCE
12,120 bottles
DISTRIBUTION
NE, WI, ID
____________________________________________
PRODUCT
Lorazepam, 1 mg tablet, unit dose pouches,10 pouches per robot ready bag, Rx only, NDC 0781-1404-05, Item #77777222225. Recall # D-382-2011
CODE
Lot # 3020518 Exp. Date 02/03/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lake Erie Medical & Surgical Supply Inc., Holland, OH, by telephone on February 8, 2011 and letter on February 8, 2011.
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV. Firm initiated recall is ongoing.
REASON
Label Mixup; label incorrectly states manufacturer as Sandoz Inc. with NDC 0781-1404-05 but should correctly state manufacturer as Mylan Pharmaceutical with NDC 0378-2457-10.
VOLUME OF PRODUCT IN COMMERCE
600 kits/1 pouch/10/1 mg tablets
DISTRIBUTION
PA
________________________________________
PRODUCT
Tom's of Maine Clean & Gentle with Fluoride Peppermint Flavor (sodium monofluorophosphate 0.76%), Net Wt. 147.4g (5.2 oz) tube. Recall # D-383-2011
CODE
Lot H1030, Lot H1031, Lot H1032; all exp 04/11
RECALLING FIRM/MANUFACTURER
Tom's of Maine, Inc., Sanford, ME, by letter dated February 8, 2011. Firm initiated recall is ongoing.
REASON
Product lacks stability: Product stability is not assured through expiration for fluoride.
VOLUME OF PRODUCT IN COMMERCE
31,632 tubes
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
Benev Acne Spot Treatment AST-2 - 1.2 Fl. oz. (35 ml) bottles - NDC-66102-10112. Recall # D-384-2011
CODE
Units: B10197B, B10224A, B10244B, B10279B, B10293C, B10307A
RECALLING FIRM/MANUFACTURER
BENEV Company Inc., Mission Viejo, CA, by telephone, and letter on/about December 14, 2010. FDA initiated recall is ongoing.
REASON
Product was recalled due to CGMP Deviations. Accelerated stability testing of the product by the firm showed degradation of the Active Pharmaceutical Ingredient (API).
VOLUME OF PRODUCT IN COMMERCE
151 units
DISTRIBUTION
Nationwide, Hong Kong, Norway, New Zealand

________________________________________
PRODUCT
1) Lisinopril Tablets USP, 10 mg, RX only, 1000 tablets, NDC 0172-3759-80. Recall # D-386-2011;

2) Lisinopril Tablets USP, 20 mg a)100 count bottle (NDC 0172-3760-60), b) 500 count bottle (NDC 0172-3760-70), c) 1000 count bottle (NDC 0172-3760-80), Rx only. Recall # D-387-2011;

3) Lisinopril Tablets USP, 40 mg, a) 100 count bottle (NDC 0172-3761-60), b) 500 count bottle (NDC0172-3761-70), Rx only. Recall # D-388-2011
CODE
1) Lot #'s TE05051, Exp. 5/2012; TE05061, Exp, 5/2012; TE05094, Exp. 5/2012; TE05098, Exp. 5/2012; TE05108, Exp. 5/2012; TE06021, Exp. 6/2012; TE06022; Exp. 6/2012; and TE06209, Exp. 7/2012;

2) a) Lot #'s TE07109, Exp. 7/2012 and TE08053, Exp. 8/2012; b) Lot #'s TE07110, Exp.7/2012, TE07118, Exp.7/2012, TE07127, Exp.7/2012; c) Lot #'s TE07237, TE07238, TE07263, TE07271, TE07272 all exp.7/2012, TE07309, TE07310, TE07311, TE08052, TE08108, TE08120, TE08129, TE08139, all exp.08/2012, TE08204, TE08205, TE09080, all exp 9/2012;

3) a) Lot #'s TE04168A, Exp. 4/2012; TE04203A, Exp, 4/2012; TE04221A, Exp. 4/2012; TE06208, Exp. 7/2012; TE06225, Exp. 7/2012; TE07218, Exp. 7/2012; and TE07219; Exp. 8/2012, b) Lot #'s TE04168B, TE04203B, TE04221B all exp. 04/2012, TE06065, TE06066, TE06072, TE06083, TE06084, TE06119, TE06132, TE06176, TE06177, TE06178 all exp. 06/2012, TE06207, TE07019, TE07052, TE07092, TE07093, TE07095, TE07136, TE07148, TE07161, all exp. 07/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on January 25, 2011.  
Manufacturer: Emcure Pharmaceuticals Limited, Pune, Maharashtra, India. Firm initiated recall is ongoing.  
REASON
Discoloration: Some tablets may exhibit areas of discoloration.
VOLUME OF PRODUCT IN COMMERCE
42618/117560/153959
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
____________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0999-11
CODE
Unit: W051510130546
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter on January 27, 2011. 
Manufacturer: Memorial Blood Centers, Minneapolis, MN. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1005-11;
2) Red Blood Cells. Recall # B-1006-11
CODE
1) Unit: W038510807153;
2) Unit: W038510805603
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on January 31, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, GA, TN
_________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1007-11;
2) Cryoprecipitated AHF Pooled. Recall # B-1008-11
CODE
1) Unit: W037910122705;
2) Unit: W037910110978
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by letter on October 13, 2010 and January 19, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of Hepatitis after age 11, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IA
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1011-11
CODE
Unit: 35KV27147
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone and letter on January 5, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA, VA
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1019-11;
2) Fresh Frozen Plasma. Recall # B-1020-11
CODE
1) and 2) Unit: W089810452582
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by letter dated January 11, 2011, by facsimile on January 20, 2011, by e-mail on January 31, 2011, and by telephone on February 2, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, VA
_________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1022-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1023-11
CODE
1) Unit: W120610045457;
2) Unit: W120610184099
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by facsimile on January 18, 2011. 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
2 units
DISTRIBUTION
MI
____________________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1024-11
CODE
Unit: W1151110446298
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 5, 2011. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1025-11;
2) Recovered Plasma. Recall # B-1026-11;
3) Plasma Frozen Cryoprecipitated Reduced. Recall # B-1027-11;
4) Cryoprecipitated AHF. Recall # B-1028-11;
5) Red Blood Cells. Recall # B-1029-11;
6) Fresh Frozen Plasma. Recall # B-1030-11
CODE
1) Units: W089810100836, LE31725;
2) Units: W089810100826, LE31725;
3) and 4) Unit: LE28365;
5) Units: LE28365, LE20688, LE16050, LE14475;
6) Units: LE20688, LE16050, LE14475
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by letter dated January 11, 2011, by facsimile on January 12, 2011 and February 1, 2011, by e-mail, and by telephone on February 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NJ, D.C., MD, VA

____________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1032-11;
2) Fresh Frozen Plasma. Recall # B-1033-11;
3) Platelets. Recall # B-1034-11
CODE
1), 2), and 3) Unit: 9672925
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on January 4, 2011. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX, NJ
________________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1039-11;
2) Recovered Plasma. Recall # B-1040-11
CODE
1) and 2) LJ42986
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter and electronic interface on October 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland

_________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1044-11
CODE
Unit: 021LL75149
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by telephone and facsimile on July 6, 2010 and by facsimile on July 21, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
____________________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1059-11;
2) Cryoprecipitated AHF Pooled. Recall # B-1060-11
CODE
1) Unit: W037710006220;
2) Unit: W037710501119
 RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated December 14, 2010 and by telephone on December 14, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, OH
________________________________________
PRODUCT
Source Plasma. Recall # B-1061-11
CODE
Units: 3270142416, 3270141973, 3270141530, 3270141043, 3270140642, 3270138490, 3270138956, 3270137888, 3270136540, 3270136202, 3270135577, 3270135328, 3270133670
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Indianapolis, IN, by facsimile on February 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NC
_________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1062-11
CODE
Unit: 20KV19402
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on December 11, 2010 and by letters dated December 11, 2010 and February 16, 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
UT

____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1064-11
CODE
Unit: W040810106654
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc., Jackson, TN, by letter dated February 4, 2011, telephone on February 22, 2011 and fax on February 23, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1065-11
CODE
Units: W11631073601600; W11631073601600
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone and fax on November 5, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not undergo quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1067-11
CODE
Unit: W039908001561
RECALLING FIRM/MANUFACTURER
North Colorado Medical Center BB, Greeley, CO, by telephone on February 3, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1068-11
CODE
Unit: W035209156087Y
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on February 16, 2011 and by letter dated February 17, 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
Austria, TX
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1073-11
CODE
Unit: 041LZ37552
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by facsimile and shared interface system on October 30, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, AL
________________________________________
PRODUCT
1) Plasma Cryoprecipitated Reduced. Recall # B-1075-11;
2) Cryoprecipitated AHF Pooled. Recall # B-1076-11;
3) Blood and Blood Products for Reprocessing. Recall # B-1077-11;
4) Red Blood Cells Leukocytes Reduced. Recall # B-1078-11
CODE
1) Unit: W038110253656;
2) Unit: W038110987259;
3) Unit: W038110344770;
4) Units: W038110253656, W038110344770
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter on January 7, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL
_________________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1079-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1080-11
CODE
1) and 2) Unit: W125610441193
RECALLING FIRM/MANUFACTURER
Blood Bank Of San Bernardino And Riverside Counties, San Bernardino, CA, by electronic mail on December 29, 2010 and on January 5, 2011, a second notification was sent by electronic mail and letter. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, CA
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduce. Recall # B-1082-11
CODE
Unit: 24GH05900
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by fax on January 2, 2011. 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, KY
____________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1091-11
CODE
Unit: W087910806147
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by facsimile on January 28, 2011.
Manufacturer: Nebraska Community Blood Bank, Lincoln, NB. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit
DISTRIBUTION
FL
________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1092-11
CODE
Unit: W158010501717
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by visit and by follow-up electronic message on January 27, 2011. 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
UT
_________________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1093-11
CODE
Units: W036310000089 (part 1), W036310000089 (part 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on February 1, 2011.
Manufacturer: BloodCenter of Wisconsin, Inc, Waukesha, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
____________________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1125-11
CODE
Unit: W084910003071
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone and facsimile on November 21, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
_______________________________________
PRODUCT
Source Plasma. Recall # B-0988-11
CODE
Unit: 5220077872
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Evansville, IN, by electronic mail on February 16, 2011. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor whose arm inspection was not documented on the day of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
________________________________________
PRODUCT
Recovered Plasma. Recall # B-0989-11
CODE
Unit: T99024
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by facsimile on July 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, FL
_________________________________________
PRODUCT
Recovered Plasma. Recall # B-0998-11
CODE
Unit: 011KE67824
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by letter on December 9, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
________________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1000-11
CODE
Unit: W089810205757
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by telephone on January 6, 2011, and by letter on January 11, 2011. Firm initiated recall is complete.
REASON
Blood product, which failed to meet the minimum specification for hematocrit and red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
D.C.
____________________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1002-11;
2) Red Blood Cells. Recall # B-1003-11;
3) Platelets Pooled Leukocytes Reduced. Recall # B-1004-11
CODE
1) and 2) Unit: W120610320231;
3) Unit: W120610380321
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by fax on January 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported a history of mononucleosis with associated jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, MI
_________________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1031-11
CODE
Unit: W039511406079
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA, by telephone and facsimile on January 4, 2011. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
____________________________________________
PRODUCT
Source Leukocytes. Recall # B-1035-11
CODE
Unit: 9672925
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and fax on January 4, 2011. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, NJ
_________________________________________
PRODUCT
Source Plasma. Recall # B-1066-11
CODE
Unit: 10PWIG0350
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Stevens Point, WI, electronically on February 4, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
____________________________________________
PRODUCT
Recovered Plasma. Recall # B-1069-11
CODE
Unit: W035209156087Y
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on February 16, 2011 and by letter dated February 17, 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
Austria, TX
____________________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1070-11;
2) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-1071-11
CODE
1) W035410072071; W035410005727;
2) Units: W035410011913; W035410011913; W035409008681
RECALLING FIRM/MANUFACTURER
Community Blood Center dba Community Tissue Services, Dayton, OH, by telephone on February 9, 2011. Firm initiated recall is complete.
REASON
Blood products, leukoreduced after the specified post collection time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH

____________________________________________
PRODUCT
Recovered Plasma. Recall # B-1074-11
CODE
Unit: 041LZ37552
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by facsimile and shared interface system on October 30, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, AL
____________________________________________
PRODUCT
Recovered Plasma. Recall # B-1081-11
CODE
Unit: 24GH05900
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by fax on January 2, 2011. 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, KY
____________________________________________
PRODUCT
Source Leukocytes. Recall # B-1084-11
CODE
Unit: W066211000420
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on February 8, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I
____________________________________________
PRODUCT
1) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511046001. AC FLEXLINK PLUS 6MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1480-2011;

2) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511054001. AC FLEXLINK PLUS 8MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1481-2011;

3) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511038001. AC FLEXLINK PLUS 10MM CANNULA. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1482-2011;

4) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510970001. AC FLEXLINK PLUS INF 6/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1483-2011;

5) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510988001. AC FLEXLINK PLUS SET 6/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1484-2011;

6) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510961001. AC FLEXLINK PLUS SET 6/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1485-2011;

7) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511003001. AC FLEXLINK PLUS SET 8/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1486-2011;

8) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511020001. AC FLEXLINK PLUS SET 8/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1487-2011;

9) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510996001. AC FLEXLINK PLUS SET 8/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1488-2011;

10) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510945001. AC FLEXLINK PLUS SET 10/40 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1489-2011;

11) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510953001. AC FLEXLINK PLUS SET 10/70 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1490-2011;

12) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05510937001. AC FLEXLINK PLUS SET 10/100 10PK. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1491-2011;

13) ACCU-CHEK FlexLink Plus, subcutaneous infusion set. Part Number 05511089001. An infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. Made in Germany. Recall # Z-1492-2011
CODE
Lots: GWX 001 up to GWX 206 and GWY 001 up to GWY 033
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Insulin Delivery Systems Inc., Fishers, IN, by letters dated February 21, 2011.  
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON
There is the potential to kink or bend the cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. This can lead to under delivery and elevation of blood glucose levels
VOLUME OF PRODUCT IN COMMERCE
1,454,918 infusion sets
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
____________________________________________
PRODUCT
1) Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1499-2011;

2) Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1500-2011;

3) Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1501-2011;

4) Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1502-2011;

5) Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1503-2011;

6) Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1504-2011;

7) Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1505-2011;

8) Applied Medical's LAP CHOLE KIT; Model Number: K0491; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1506-2011;

9) Applied Medical's LAP CHOLE KIT; Model Number: K0492; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1507-2011;

10) Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1508-2011;

11) Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1509-2011;

12) Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1510-2011;

13) Applied Medical's LAP CHOLE KIT; Model Number: K0630; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1511-2011;

14) Applied Medical's LAP CHOLE KIT; Model Number: K0684, The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1512-2011;

15) Applied Medical's LAP CHOLE KIT; Model Number: K2114; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1513-2011;

16) Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136. The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1514-2011;

17) Applied Medical's LAP CHOLE KIT; Model Number: K2154; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1515-2011;

18) Applied Medical's LAP CHOLE; Model Number: K2155; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1516-2011;

19) Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184; The device is used to close a clip in order to legate a tubular structure or vessel in laparoscopic and general surgical procedures. Recall # Z-1517-2011
CODE
1) Lot Numbers: 1118775, 1118776, 1118777, 1119556, 1119558,1119559, 1119565, 1119566, 1119567;
2) Lot Number: 1120791;      
3) Lot Number: 1122206;
4) Lot Number: 1121985;
5) Lot Number: 1121907;
6) Lot Number: 1121687;
7) Lot Number: 1121989;
8) Lot Number: 1121822;
9) Lot Number            s: 1121504, 1122116;
10) Lot Number: 1121903;
11) Lot Number: 1121811;
12) Lot Number: 1121587;
13) Lot Number: 1122117;
14) Lot Number: 1122194;
15) Lot Number: 1121706;
16) Lot Number: 1121401;
17) Lot Numbers: 1121612, 1121974, 1121863, 1122208;
18) Lot Number: 1121372;
19) Lot Numbers: 1121545, 1121972, 1121973, 1121962, 1122267
RECALLING FIRM/MANUFACTURER
Applied Medical Resources Corp., Rancho Santa Margarita, CA, by letter dated September 10, 2010, and by Applied Medical on September 16, 2010. Firm initiated recall is complete.
REASON
Potential defect in the jaws, possibly resulting in jaw breakage.
VOLUME OF PRODUCT IN COMMERCE
2,843 units
DISTRIBUTION
Nationwide, Australia, Europe, Japan, and Kuwait
_________________________________________
PRODUCT
MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management; Part # 10568605. Recall # Z-1572-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on January 11, 2011.  
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.
REASON
The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Germany and Japan
____________________________________________
PRODUCT
1) Plum A+ Single Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11.3 d) list 20679 - Hospira MedNet Software e) list 20792 - Driver The Plum A+ dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield� needleless protection systems makes the Plum A+ a convenient and cost-effective infusion system. Recall # Z-1644-2011;

2) Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software Plum A+3 Triple Channel Infusion Pumps; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software. Recall # Z-1645-2011;

3) Plum A+ Hyperbaric Single Channel Infusion Pumps; list 11005 The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers. Recall # Z-1646-2011
CODE
1) a) Serial numbers 0013120009 through 0099072443; b) Serial numbers 0012570148 through 0012579183; c) Serial numbers 0013840001 through 0013890171; d) Serial numbers 0015441019 through 0015459165; e) Serial numbers 0016061001 through 0018787700;

2) a) Serial numbers 0013740156 through 0013741025; b) Serial numbers 0014040001 through 0018627599; c) Serial numbers 0015541001 through 0019616461;

3) Serial numbers 0016792201 through 0018807578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated February 14, 2011. 
Manufacturers: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica;
Hospira Inc, Morgan Hill, CA. FDA initiated recall is ongoing.
REASON
Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.
VOLUME OF PRODUCT IN COMMERCE
167,595 pumps
DISTRIBUTION
Nationwide and Internationally

________________________________________
PRODUCT
TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues. Recall # Z-1649-2011
CODE
Serial no. 110319 110126 110055 110034 110083 110140 110336 110009 110129 110072 110037 110169 110014 110212 110287 110130 110332 110333 110233 110340 110133 110341 110208 110143 110314 110170 110275 110260 110109 110131 110315 110294 110146 110259 110263 110117 110077 110347 110123 110111 110189 110151 110157 110261 110297 110171 110018 110136 110267 110330 110211 110299 110071 110162 110305 110246 110300 110200 110075 110327 110326 110164 110337 110304 110085 110229 110093 110063 110199 110113 110107 110184 110172 110049 110183 110205 110036 110076 110052 110182 110289 110237 110065 110291 110288 110301 110178 110265 110159 110302 110088 110150 110293 110278 110148 110068 110078 110236 110153 110181 110241 110295 110064 110114 110058 110303 110296 110249 110266 110308 110137 110290 110285 110335 110207 110156 110069 110079 110310 110191 110110 110240 110313 110128 110245 110325 110324 110307 110317 110321 110194 110061 110142 110228 110167 110292 110342 110306 110334 110051 110177 110206 110017 110108 110008 110120 110264 110257 110180 110329 110060 110106 110038 110013 110081 110311 110040 110028 110125 110179 110053 110115 110033 110031 110283 110074 110165 110195 110217 110187 110002 110161 110160 110144 110006 110098 110175 110050 110025 110225 110204 110210 110262 110214 110067 110222 110047 110198 110202 110193 110012 110149 110048 110349 110221 110318 110097 110203 110239 110119 110090 110298 110215 110244 110258 110277 110084 110256 110007 110312 110023 110132 110201 110027 110322 110343 110016 110145 110320 110056 110026 110250 110039 110190 110282 110216 110066 110029 110035 110209 110242 110280 110281 110091 110346 110286 110284 110099 110094 110186 110122 110105 110272 110185 110331 110168 110248 110273 110054 110155 110234 110020 110243 110174 110041 110100 110271 110059 110116 110251 110188 110224 110255 110230 110042 110252 110309 110135 110238 110247 110134 110073 110015 110095 110101 110316 110218 110220 110219 110045 110024 110328 110268 110154 110173 110152 110092 110176 110057 110276 110087 110138 110086 110269 110127 110213 110166 110005 110030 110227 110003 110022 110104 110323 110139 110032 110254 110339 110019 110112 110118 110082 110141 110089 110348 110223 110192 110046 110196 110103 110004 110096 110253 110044 110021, and 110158
RECALLING FIRM/MANUFACTURER
TomoTherapy Inc., Madison, WI, letter dated January 26, 2011. Firm initiated recall is ongoing.
REASON
It was determined that the Treatment Planning Station (TPS) can potentially under dose.
VOLUME OF PRODUCT IN COMMERCE
326 units
DISTRIBUTION
Nationwide and Internationally
________________________________________
PRODUCT
1) Philips Allura Xper Systems with Velara Generator, x-ray system. Recall # Z-1654-2011;

2) Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. Recall # Z-1655-2011;

3) Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Recall # Z-1656-2011;

4) Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Recall # Z-1657-2011
CODE
1) Site Numbers: 107504, 107506, 107600, 107743, 107860, 109628, 110118, 110853, 110922, 111066, 111067, 111119, 111606, 112650, 113746, 641599, 700503, 701464, 702078, 702471, 703328, 703331, 703410, 703411, 703486, 703531, 704179, 704448, 704467, 704503, 704695, 704913, 704966, 704975, 704982, 704987, 704998, 705283, 705355, 705357, 705409, 705424, 705652, 705696, 705706, 705714, 705719, 705764, 705781, 705841, 705889, 705935, 705941, 705942, 705956, 706000, 706033, 706034, 706158, 706192, 706231, 706261, 706292, 706293, 706400, 706417, 706418, 706433, 706435, 706487, 706490, 706523, 706537, 706546, 706565, 706567, 706581, 706601, 706635, 706741, 706768, 706788, 706838, 706851, 706900, 706918, 706945, 706947, 706960, 706970, 706973, 706975, 706978, 707001, 707029, 707047, 707066, 707068, 707075, 707089, 707116, 707126, 707131, 707133, 707137, 707144, 707154, 707173, 707177, 707188, 707193, 707198, 707202, 707215, 707222, 707223, 707226, 707230, 707246, 707257, 707315, 707326, 707375, 707379, 707415, 707531, 707573, 707617, 707624, 707655, 707666, 707668, 707669, 707708, 707728, 707730, 707732, 707736, 707737, 707743, 707753, 707757, 707768, 707794, 707817, 707863, 707887, 707904, 707914, 707915, 707916, 707926, 707951, 707973, 707977, 707989, 707997, 708004, 708069, 708140, 708222, 708224, 708271, 708279, 708408, 708503, 708504, 708508, 708524, 708533, 708534, 708559, 708601, 708624, 708625, 708626, 708631, 708649, 708691, 708696, 708698, 708741, 708749, 708765, 708784, 708786, 708788, 708874, 708915, 708954, 708983, 709012, 709073, 709077, 709102, 709141, 709151, 709172, 709173, 709201, 709223, 709259, 709270, 709329, 709368, 709403, 709405, 709418, 709420, 709437, 709477, 709506, 709536, 709633, 709651, 709653, 709662, 709670, 709692, 709730, 709766, 709778, 709795, 709799, 709822, 709858, 709861, 709877, 709878, 709885, 709898, 709901, 709905, 709941, 709955, 709981, 709996, 710009, 710021, 710068, 710100, 710138, 710167, 710181, 710195, 710198, 710212, 710215, 710216, 710306, 710315, 710316, 710345, 710366, 710394, 710395, 710396, 710414, 710421, 710472, 710475, 710477, 710495, 710527, 710539, 8000573, 8000999, 8001801, 9000027, 9000029, 9000044, 9000062, 9000064, 9000134, 9000142, 9000165, 9000173, 9000200, 9000255, 9000276, 9000285, 9000293, 9000294, 9000306, 9000337, 9000363, 9000365, 9000371, 9000394, 9000474, 9000506, 9000533, 9000550, 9000571, 9000576, 9000577, 9000624, 9000627, 9000643, 9000649, 9000657, 9000659, 9000675, 9000676, 9000682, 9000699, 9000701, 9000702, 9000704, 9000705, 9000710, 9000716, 9000738, 9000757, 9000758, 9000833, 9000902, 9000934, 9000939, 9000963, 9000964, 9000966, 9000970, 9000981, 9001014, 9001021, 9001027, 9001030, 9001044, 9001046, 9001059, 9001086, 9001097, 9001098, 9001120, 9001146, 9001150, 9001180, 9001187, 9001253, 9001307, 9001318, 9001428, 9001451, 9001453, 9001495, 9001516, 9001533, 9001534, 9001556, 9001577, 9001578, 9001582, 9001599, 9001608, 9001609, 9001653, 9001660, 9001688, 9001697, 9001699, 9001721, 9001748, 9001774, 9001780, 9001806, 9001867, 9001909, 9001911, 9001921, 9001941, 9001947, 9001960, 9001972, 9001981, 9001982, 9001983, 9001996, 9002005, 9002009, 9002015, 9002016, 9002034, 9002036, 9002040, 9002117, 9002136, 9002186, 9002194, 9002200, 9002202, 9002281, 9002328, 9002337, 9002342, 9002347, 9002377, 9002415, 9002416, 9002418, 9002451, 9002462, 9002463, 9002476, 9002524, 9002525, 9002540, 9002549, 9002585, 9002644, 9002670, 9002677, 9002680, 9002742, 9002902, 9002913, 9002954, 9002963, 9002974, 9002985, 9002995, 9002997, 9003005, 9003016, 9003038, 9003051, 9003054, 9003057, 9003070, 9003073, 9003086, 9003090, 9003091, 9003094, 9003097, 9003103, 9003136, 9003152, 9003166, 9003178, 9003210, 9003218, 9003220, 9003240, 9003241, 9003370, 9003408, 9003432, 9003447, 9003498, 9003513, 9003543, 9003571, 9003610, 9003612, 9003613, 9003621, 9003627, 9003628, 9003630, 9003659, 9003742, 9003759, 9003760, 9003775, 9003777, 9003783, 9003806, 9003904, 9003960, 9003961, 9004020, 9004024, 9004039, 9004041, 9004044, 9004047, 9004054, 9004092, 9004093, 9004098, 9004130, 9004154, 9004159, 9004189, 9004207, 9004221, 9004248, 9004270, 9004278, 9004590, 9004621, 9004666, 9004667, 9004704, 9004734, 9004847, 9004866, 9004974, 9005002, 9005015, 9005084, 9005087, 9005093, 9005096, 9005099, 9005112, 9005166, 9005238, 9005245, 9005246, 9005247, 9005264, 9005287, 9005433, 9005434, 9005557, 9005572, 9005629, 9005633, 9005669, 9005692, 9005713, 9005731, 9005736, 9005739, 9005779, 9005802, 9005822, 9005825, 9005836, 9005839, 9005840, 9005846, 9005849, 9005877, 9005878, 9005879, 9005883, 9005907, 9005923, 9005944, 9005946, 9005953, 9005966, 9006058, 9006123, 9006162, 9006201, 9006235, 9006252, 9006260, 9006296, 9006325, 9006333, 9006351, 9006361, 9006375, 9006380, 9006381, 9006382, 9006400, 9006401, 9006414, 9006468, 9006469, 9006484, 9006652, 9006653, 9006655, 9006687, 9006688, 9006689, 9006702, 9006713, 9006728, 9006730, 9006748, 9006892, 9006913, 9006918, 9006920, 9006932, 9006934, 9006935, 9006964, 9006974, 9006995, 9006996, 9007032, 9007105, 9007119, 9007158, 9007195, 9007204, 9007247, 9007268, 9007285, 9007287, 9007289, 9007291, 9007306, 9007309, 9007327, 9007341, 9007356, 9007357, 9007358, 9007371, 9007395, 9007416, 9007419, 9007445, 9007470, 9007471, 9007489, 9007493, 9007503, 9007511, 9007523, 9007528, 9007540, 9007541, 9007542, 9007552, 9007630, 9007676, 9007773, 9007857, 9007896, 9007898, 9007923, 9007924, 9007978, 9008000, 9008030, 9008129, 9008145, 9008154, 9008168, 9008219, 9008264, 9008301, 9008315, 9008341, 9008347, 9008356, 9008396, 9008415, 9008439, 9008455, 9008498, 9008520, 9008561, 9008567, 9008642, 9008645, 9008656, 9008657, 9008659, 9008665, 9008667, 9008687, 9008746, 9008767, 9008770, 9008777, 9008798, 9008799, 9008803, 9008812, 9008813, 9008817, 9008819, 9008822, 9008824, 9008840, 9008849, 9008883, 9008884, 9008894, 9008901, 9008912, 9008917, 9008923, 9008939, 9008952, 9008956, 9008957, 9008970, 9008975, 9008978, 9008981, 9008983, 9008986, 9008991, 9009019, 9009020, 9009033, 9009041, 9009042, 9009062, 9009073, 9009076, 9009083, 9009089, 9009092, 9009093, 9009102, 9009104, 9009107, 9009112, 9009117, 9009121, 9009143, 9009172, 9009300, 9009403, 9009432, 9009458, 9009482, 9009566, 9009568, 9009582, 9009587, 9009609, 9009616, 9009694, 9009705, 9009708, 9009715, 9009804, 9009859, 9009969, 9009982, 9010031, 9010037, 9010039, 9010040, 9010054, 9010100, 9010133, 9010135, 9010141, 9010142, 9010162, 9010411, 9010455, 9010556, 9010557, 9010591, 9010607, 9010656, 9010675, 9010723, 9010749, 9010750, 9010764, 9010784, 9010791, 9010794, 9010832, 9010878, 9010888, 9010909, 9010914, 9010943, 9011169, 9011203, 9011220, 9011364, 9011454, 9011455, 9011490, 9011495, 9011585, 9011784, 9011785, 9011813, 9011890, 9011904, 9011973, 9011974, 9011976, 9012149, 9012159, 9012172, 9012245, 9012298, 9012325, 9012326, 9012345, 9012367, 9012379, 9012409, 9012410, 9012470, 9012506, 9012507, 9012511, 9012558, 9012637, 9012807, 9012903, 9012936, 9013075, 9013126, 9013131, 9013132, 9013158, 9013179, 9013190, 9013208, 9013227, 9013228, 9013341, 9013405, 9013418, 9013434, 9013508, 9013512, 9013541, 9013563, 9013565, 9013566, 9013569, 9013571, 9013578, 9013637, 9013666, 9013684, 9013687, 9013719, 9013741, 9013745, 9013749, 9013794, 9013842, 9013877, 9014033, 9014081, 9014126, 9014130, 9014207, 9014240, 9014247, 9014306, 9014358, 9014440, 9014445, 9014453, 9014454, 9014466, 9014472, 9014483, 9014485, 9014492, 9014574, 9014633, 9014812, 9014847, 9014857, 9014858, 9014877, 9014911, 9014919, 9014920, 9014926, 9014991, 9015022, 9015145, 9015274, 9015341, 9015353, 9015497, 9015560, 9015703, 9015711, 9015760, 9015800, 9015933, 9015936, 9015940, 9016036, 9016043, 9016044, 9016089, 9016095, 9016111, 9016134, 9016138, 9016148, 9016178, 9016183, 9016222, 9016538, 9016635, 9016741, 9016750, 9016887, 9016977, 9017051, 9017084, 9017149, 9017510, 900006301, 900038901, 900193902, 900254701, 900300901, 900316602, 900363301, 900375801, 900440701, 900469701, 900470101, 900711003, 900788703, 900788801, 900788901, 900881101, 900962901, 901014901, 901040101, 901072501, 901073501, 901087801, 901252001, 901304001, 901418701, 4501441152, 4501587095, 4501588477, 4501588640, 4501588673, 4501588712, 4501588728, 4501588740, 4501588745, 4501588767, 4501588788, 4501588811, 4501588812, 4501588814, 4501588815, 4501588816, 4501588818, 4501588821, 4501588892, 4501588913, 4501588935, 4501588937, 4501588941, 4501588943, 4501588948, 4501588952, 4501588967, 4501588975, 4501588978, 4501589118, 4501589130, 4501589140, 4501589222, 4501589300, 4501589403, 4501589409, 4501589424, 4501589431, 4501589466, 4501589477, 4501589485, 4501589486, 4501589500, 4501589508, 4501589514, 4501589534, 4501589548, 4501589582, 4501589586, 4501589603, 4501589609, 4501589617, 4501589634, 4501589682, 4501589793, 4501589813, 4501589817, 4501589845, 4501589896, 4501589902, 4501589934, 4501589957, 4501589966, 4501589973, 4501589978, 4501589985, 4501590031, 4501590050, 4501590068, 4501590078, 4501590087, 4501590116, 4501590143, 4501590150, 4501590175, 4501590327, 4501590342, 4501590406, 4501590418, 4501590431, 4501590438, 4501590444, 4501590537, 4501590557, 4501591114, 4501591125, 4501591135, 4501591214, 4501594662, 4501594663, 4501599666, 4501603502, 4501604140, 4501604603, 4501604611, 4501605536, 4501606100, 4501610847, 4501617050, 4501617713, 4501619125, 4501624336, 4501625693, 4501630432, 4501635887, 4501637136, 4501637153, 4501642227, 4501644834, 4501646767, 4501646964, 4501648296, 4501650119, 4501650299, 4501650347, 4501650348, 4501650617, 4501652218, 4501652796, 4501660614, 4501664109, 4501665074, 4501666386, 4501666883, 4501669316, 4501669419, 4501674199, 4501675211, 4501677381, 4501677382, 4501678380, 4501681681, 4501682653, 4501684048, 4501684350, 4501684358, 4501685302, 4501688170, 4501689105, 4501696022, 4501697137, 4501702474, 4501706989, 4501707701, 4501708522, 4501712020, 4501712957, 4501715931, 4501716292, 4501728057, 4501728369, 4501732670, 4501733907, 4501735356, 4501737549, 4501738598, 4501741065, 4501743504, 4501752086, 4501756343, 4501761285, 4501764579, 4501766203, 4501771078, 4501771860, 4501772605, 4501778995, 4501780348, 4501783426, 4501786520, 4501791568, 4501794908, 4501794918, 4501795113, 4501796729, 4501796801, 4501797413, 4501801638, 4501801791, 4501802539, 4501803196, 4501803649, 4501803885, 4501804318, 4501804409, 4501806416, 4501808201, 4501814863, 4501815102, 4501816280, 4501817263, 4501819434, 4501819762, 4501820484, 4501820885, 4501821092, 4501821145, 4501821528, 4501821810, 4501823252, 4501823527, 4501823847, 4501826610, 4501833043, 4501833230, 4501834147, 4501840633, 4501841699, 4501843043, 4501847472, 4501848970, 4501849202, 4501849459, 4501850073, 4501850134, 4501854647, 4501855339, 4501855786, 4501856152, 4501856429, 4501856718, 4501856939, 4501861235, 4501862751, 4501864382, 4501864648, 4501865202, 4501865649, 4501865844, 4501866404, 4501866406, 4501866690, 4501867542, 4501868233, 4501868321, 4501871046, 4501873128, 4501876883, 4501879499, 4501880511, 4501882052, 4501882161, 4501885231, 4501886702, 4501887228, 4501888021, 4501888026, 4501889065, 4501889615, 4501889864, 4501891327, 4501893543, 4501896453, 4501896530, 4501900579, 4501902837, 4501912805, 4501913766, 4501915090, 4501915092, 4501918198, 4501919406, 4501920982, 4501921749, 4501923256, 4501923270, 4501923273, 4501928410, 4501935573, 4501937090, 4501943760, 4501951336, 4501953927, 4501956923, 4501958333, 4501958740, 4501960261, 4501962576, 4501962745, 4501963040, 4501963109, 4501963603, 4501965284, 4501972237, 4501974318, 4501975560, 4501985611, 4501985723, 4501987365, 4501987497, 4501987851, 4501989832, 4501990609, 4501992150, 4501992476, 4501992548, 4501992616, 4501992816, 4501995362, 4502000053, 4502000351, 4502001015, 4502005490, 4502006137, 4502008695, 4502011857, 4502013596, 4502013971, 4502014639, 4502016741, 4502024493, 4502030297, 4502030800, 4502033800, 4502038427, 4502038822, 4502049920, 4502051967, 4502054362, 4502060187, 4502060485, 4502068544, 4502070130, 4502070737, 4502070842, 4502083334, 4502088937, 4502092037, 4502092652, 4502120324, 4502136390, 4502136442, 4502137289, 4502139339, 4502147236, 4502148716, 4502153190, 4502157713, 4502159389, 4502160047, 4502160291, 4502160362, 4502169500, 4502170090, 4502170678, 4502172378, 4502172385, 4502172386, 4502172631, 4502173725, 4502174591, 4502175027, 4502176021, 4502176181, 4502176326, 4502177380, 4502187033, 4502187301, 4502188224, 4502193700, 4502197684, 4502198743, 4502204187, 4502209771, 4502210001, 4502211356, 4502214714, 4502215017, 4502217373, 4502234063, 4502239158, 4502239492, 4502239498, 4502240111, 4502240328, 4502241700, 4502243798, 4502253433, 4502259648, 4502264496, 4502267640, 4502270920, 4502281132, 4502282785, 4502283143, 4502283145, 4502283147, 4502284327, 4502285395, 4502293404, 4502302336, 4502317362, 4502317740, 4502317928, 4502338886, 4502339736, 4502340508, 4502342737, 4502350531, 4502353808, 4502362328, 4502370382, 4502370869, 4502373087, 4502389545, 4502389930, 4502390004, 4502402183, 4502403637, 4502413812, 4502415674, 4502435305, 4502461956, 4502478354, 4502516662, 4502516943, 4502518671, 4502522889, 4502526713, 4502541077, 4502560095, 4502592027, 4502599485, 4502613641, 4502623188, 4502626658, 4502632423, 4502642845, 4502643471, 4502649335, 4502650407, 4502653528, 4502659830, 4502678621, 4502679315, 4502694380, 4502695009, 4502701224, 4502702201, 4502711268, 4502711355, 4502711731, 4502718269, 4502719421, 4502725243, 4502725567, 4502725849, 4502738876, 4502740036, 4502752333, 4502766129, 4502766405, 4502768860, 4502769531, 4502773611, 4502779633, 4502785755, 4502795432, 4502796511, 4502798755, 4502804123, 4502805967, 4502821704, 4502853862, 4502854670, 4502861957, 4502863870, 4502864760, 4502865444, 4502872092, 4502873844, 4502875082, 4502887653, 4502888041, 4502898375, 4502901460, 4502902608, 4502905384, 4502906221, 4502906324, 4502906337, 4502907005, 4502923393, 4502923673, 4502924132, 4502933738, 4502933855, 4502941663, 4502949046, 4502954732, 4502957203, 4502960777, 4502961265, 4502962584, 4502981052, 4502981188, 4502981809, 4502981861, 4502984810, 4502987377, 4502988907, 4502989319, 4502990772, 4502991965, 4502999001, 4503000213, 4503003054, 4503015935, 4503016381, 4503032598, 4503041085, 4503044579, 4503048567, 4503049939, 4503051095, 4503052748, 4503059874, 4503090774, 4503116441, 4503134249, 4503160906, and 804440029239;

2) Site Numbers: 10104, 10105, 10107, 10166, 10277, 10288, 10313, 10325, 10329, 10390, 10391, 10403, 10414, 10430, 10431, 10439, 10440, 10441, 10442, 10454, 10455, 10463, 10465, 10478, 10482, 10483, 10495, 13043, 13106, 13107, 13108, 13113, 13114, 13117, 13230, 13240, 13259, 13290, 13292, 13294, 13296, 13511, 13530, 13595, 13596, 13631, 13633, 13688, 13719, 13720, 13734, 13883, 13890, 13891, 13914, 13915, 13941, 13953, 13954, 13980, 13990, 13992, 13993, 13994, 13997, 14021, 14068, 14145, 14147, 14168, 17476, 17500, 17504, 17596, 17599, 25973, 25974, 26007, 26064, 26072, 26109, 26118, 26158, 26159, 26161, 26166, 26179, 26217, 26218, 26264, 26286, 26288, 26289, 26293, 26295, 35427, 35463, 35485, 35591, 37908, 37923, 37970, 38062, 38109, 38110, 38182, 38199, 38201, 38203, 38204, 38205, 38261, 38276, 38290, 38298, 38329, 38352, 38355, 38356, 38358, 38359, 38373, 38378, 38385, 38386, 38387, 38389, 38425, 38426, 38437, 38531, 38532, 38533, 38554, 38592, 38637, 38681, 38702, 38703, 38704, 38705, 38718, 38719, 38728, 38754, 38788, 38789, 38790, 38792, 38795, 38903, 38926, 38932, 38933, 38935, 38948, 40390, 40938, 41017, 41019, 41021, 41026, 41027, 41050, 41079, 41080, 41103, 41104, 41109, 41115, 41117, 41128, 41129, 41137, 41141, 41142, 41145, 41151, 41152, 41154, 41163, 41164, 41222, 41242, 41266, 41267, 41269, 41272, 41273, 41330, 41336, 41340, 41341, 41423, 41455, 41458, 41478, 41479, 44609, 44712, 44714, 44752, 44774, 44779, 44784, 44825, 44854, 44857, 44860, 44966, 44973, 44978, 45000, 45026, 45045, 45047, 45051, 45059, 45072, 45104, 47106, 47127, 47138, 47139, 50222, 50223, 50224, 50310, 50311, 50312, 50332, 50335, 50339, 50345, 50371, 50373, 50374, 50375, 50389, 50392, 50405, 50419, 50433, 50438, 52451, 52463, 52464, 52465, 52466, 52470, 52477, 52479, 52480, 52482, 52488, 59366, 59390, 59418, 59422, 59501, 59520, 59552, 59610, 59611, 59659, 59698, 59699, 59709, 62493, 62508, 62519, 62528, 62531, 62544, 62559, 62606, 62627, 62639, 62668, 62670, 62671, 62775, 62776, 62779, 62785, 62787, 62792, 62805, 62833, 62835, 62871, 62891, 62892, 62921, 62942, 62948, 62951, 62967, 62968, 62969, 62976, 62998, 62999, 68154, 68156, 68168, 68211, 68214, 74080, 76198, 76214, 76219, 76325, 76360, 76365, 76378, 76380, 76397, 76398, 76411, 76455, 76459, 76462, 76465, 76471, 76484, 76486, 76489, 76490, 76499, 76500, 76505, 76510, 76514, 76520, 76521, 76522, 76527, 76545, 76546, 76555, 76557, 76558, 76559, 76560, 76572, 76574, 76576, 76577, 76580, 76830, 76831, 76832, 76867, 76870, 76872, 76873, 76885, 76886, 76933, 76941, 76953, 76955, 76962, 76986, 80305, 80310, 80315, 80320, 80322, 80323, 80325, 80327, 80330, 82514, 82517, 82519, 82520, 82521, 82523, 82526, 82537, 82539, 82542, 82543, 82575, 82576, 82577, 82591, 82592, 82593, 82608, 82609, 82612, 82615, 82633, 82635, 82637, 82640, 82643, 82661, 82663, 82664, 82665, 82676, 82691, 82696, 82699, 82706, 82709, 82719, 82814, 82822, 82824, 82825, 82909, 82915, 82916, 82917, 82950, 83019, 83024, 83026, 83028, 83040, 83042, 83054, 83081, 83309, 83310, 83313, 83322, 83324, 83326, 83327, 83375, 83399, 83605, 83632, 83663, 83664, 83665, 83667, 83670, 83807, 83823, 83833, 83834, 83838, 83842, 83855, 83862, 83882, 83903, 83904, 83924, 83926, 83927, 83949, 83996, 84378, 84430, 84431, 84436, 84443, 84444, 84445, 84447, 84466, 84467, 84468, 84481, 84482, 84487, 84489, 84713, 84716, 84721, 84734, 84791, 84823, 84826, 84827, 84828, 84829, 84838, 84843, 84998, 85004, 85008, 85010, 85013, 85015, 85018, 85041, 85054, 85057, 85058, 85087, 85092, 85093, 85094, 85095, 85096, 85106, 85107, 85126, 85128, 85129, 85130, 85133, 85135, 85137, 85150, 85169, 85179, 85190, 85195, 85197, 85409, 85415, 85416, 85488, 85497, 85498, 85499, 85501, 85503, 85633, 85634, 85635, 85637, 85638, 85639, 85640, 85641, 85643, 85676, 85689, 85692, 86008, 86057, 86061, 86063, 86065, 86066, 86087, 86088, 86126, 86129, 86135, 86144, 86145, 86149, 86169, 86171, 86172, 86183, 86189, 86196, 86252, 86253, 86272, 86289, 86290, 86295, 86296, 86319, 86320, 86322, 86332, 86341, 86360, 86367, 86415, 86419, 86421, 86424, 86427, 86429, 86431, 86433, 86435, 86437, 86456, 86488, 86494, 86495, 86502, 86506, 86537, 86539, 86540, 86561, 86571, 86572, 86575, 86576, 86577, 86578, 86580, 86581, 86583, 86584, 86598, 86603, 86914, 86933, 86934, 86935, 86953, 86971, 86972, 86981, 86982, 86985, 86989, 86991, 86992, 86993, 86994, 87013, 87023, 87024, 87055, 87068, 87069, 87084, 87179, 87300, 87315, 87316, 87317, 87318, 87324, 87339, 87359, 87364, 87366, 87528, 87530, 87532, 87603, 91650, 100262, 100316, 100319, 100328, 100432, 100434, 100450, 100470, 100475, 100477, 100496, 100504, 100519, 100521, 100585, 100587, 100607, 100610, 100613, 100630, 100631, 100641, 100643, 100645, 100656, 100658, 100683, 100685, 100701, 100704, 100708, 100713, 100714, 100744, 100783, 100788, 100810, 100811, 100812, 100823, 100839, 100840, 100841, 100861, 100862, 100863, 100864, 100865, 100866, 100869, 100875, 100881, 100913, 100945, 100948, 100949, 100950, 100959, 100961, 101000, 101006, 101036, 101040, 101073, 101077, 101078, 101110, 101135, 101136, 101139, 101160, 101205, 101208, 101216, 101238, 101239, 101309, 101433, 101434, 101485, 101564, 101565, 101566, 101567, 101577, 101582, 101583, 101589, 101606, 101607, 101609, 101610, 101612, 101613, 101615, 101617, 101618, 101619, 101620, 101928, 101938, 101941, 101945, 101949, 101965, 101966, 101971, 101973, 101974, 102000, 102001, 102009, 102037, 102039, 102083, 102094, 102103, 102158, 102160, 102161, 102162, 102166, 102179, 102180, 102193, 102243, 102248, 102334, 102348, 102487, 102493, 102502, 102521, 102523, 102555, 102558, 102563, 102572, 102575, 102589, 102629, 102631, 102632, 102650, 102661, 102664, 102673, 102675, 102676, 102677, 102710, 102715, 102723, 102746, 102776, 102785, 102793, 102809, 102817, 102823, 102842, 102863, 102868, 102870, 102874, 102908, 102936, 102937, 102944, 102945, 102949, 102953, 102974, 102983, 102995, 103002, 103004, 103005, 103021, 103022, 103026, 103029, 103034, 103063, 103070, 103133, 103144, 103147, 103148, 103169, 103170, 103182, 103183, 103193, 103201, 103211, 103212, 103213, 103214, 103231, 103237, 103238, 103240, 103241, 103246, 103248, 103255, 103257, 103266, 103270, 103281, 103283, 103287, 103290, 103327, 103335, 103355, 103356, 103371, 103379, 103381, 103382, 103420, 103445, 103446, 103447, 103448, 103456, 103481, 103494, 103512, 103518, 103520, 103554, 103557, 103581, 103594, 103599, 103650, 103709, 103712, 103714, 103721, 103722, 103743, 103746, 103763, 103776, 103793, 103812, 103819, 103823, 103828, 103829, 103830, 103831, 103860, 103879, 103891, 103900, 103901, 103926, 103929, 103957, 103991, 104021, 104033, 104056, 104057, 104062, 104076, 104077, 104107, 104111, 104145, 104148, 104169, 104170, 104177, 104187, 104194, 104198, 104201, 104335, 104337, 104341, 104382, 104383, 104384, 104385, 104402, 104403, 104411, 104412, 104413, 104414, 104415, 104416, 104418, 104424, 104426, 104427, 104440, 104441, 104463, 104511, 104513, 104516, 104529, 104539, 104580, 104581, 104627, 104630, 104797, 104799, 104865, 104884, 104885, 104909, 104933, 104943, 104974, 104976, 104978, 105098, 105153, 105243, 105254, 105294, 105299, 105305, 105309, 105389, 105399, 105404, 105422, 105489, 105511, 105514, 105583, 105703, 105731, 105733, 105736, 105737, 105773, 250005, 250042, 250046, 250073, 250083, 250084, 250146, 250149, 250298, 250299, 250300, 250333, 250338, 250454, 250550, 250581, 250674, 504530, 504904, 521359, 522511, 543444, 557726, 557729, 557740, 557746, 557761, 557762, 557770, 557772, 557773, 557778, 557780, 557790, 557795, 557802, 557808, 557809, 557810, 557834, 557839, 557840, 557841, 557842, 557864, 557866, 557890, 557907, 557908, 557926, 557934, 557937, 557939, 557956, 557957, 557974, 557984, 557986, 557997, 558005, 558021, 558028, 558029, 558030, 558032, 558036, 558037, 558121, 558122, 558145, 558148, 558149, 558167, 558168, 558169, 558178, 558180, 558182, 558183, 558187, 558192, 558198, 558199, 558261, 558265, 558268, 558271, 558278, 558286, 558287, 558299, 558323, 558350, 558378, 558383, 41701751, 43568695, 49788214, 49788949, 49788952, 49789163, 49789164, 49794087, 49794089, 49794485, 49794687, 49794702, 51324694, 51324699, 51324716, and 51324768;

3) Site Numbers: 505345, 505346, 506236, 530589, 530777, 532140, 532151, 532213, 532703, 533473, 533559, 534247, 535714, 535767, 536019, 536091, 536146, 536720, 536935, 537083, 537669, 537787, 539598, 539990, 540252, 541263, 543272, 544059, 545014, 545156, 545198, 545841, 546031, 546578, 549417, 551519, 551714, 553287, 553435, 553838, 554283, 554284, 554633, 554640, 556197, 556369, 557258, 41444651, 41445097, 41445127, 41445131, 41445221, 41445237, 41445464, 41445652, 41445800, 41445927, 41455927, 41643223, 41783749, 41849575, 41954854, 42549980, 42799914, 42892004, 42892024, 42892425, 43319037, 43386703, 43443091, 43453378, 43721197, 44146025, 44401636, 44653739, 44654723, 45629333, 47130091, 47190569, 47413010, 47607148, 47783855, 49136896, 49144094, 49903432, 50003342, 50037841, and 50416595;

4) Site Numbers: 520020, 522220, 533112, 533314, 533471, 535257, 539106, 541490, 547017, 547348, 549798, 553676, 42036161, 42383151, 43180366, and 43680651

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters on October 15, 2010.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
VOLUME OF PRODUCT IN COMMERCE
2,658 units
DISTRIBUTION
Nationwide
____________________________________________
PRODUCT
Toshiba DUA-450F Kalare Radiographic Tilting Table. Recall # Z-1675-2011
CODE
Last 4 of serial number: 2033, 2034, 2036, 2037, 2038, 2039, 2040, 2041, 2043, 2044, 2045, 2046, 2047, 2048, 2050, 2051, 2052, 2053, 2056, 2059, 2060, 2061, 2062, 2063, 2064, 2065, 2066, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2075, 2076, 2077, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2095, 2096, 2098, 2099, 2100, 2107, 2108, 2109, 2111, 2112, 2113, 2114, 2115, 2116, 2117, 2118, 2120, 2121, 2123, 2124, 2125, 2126, 2127, 2129, 2130, 2131, 2132, 2133, 2134, 2135, 2136, 2137, 2138, 2140, 2141, 2142, 2144, 2145, 2146, 2147, 2148, 2149, 2152, 2153, 2154, 2155, 2157, 2160, 2161, 2162, 2165, 2166, 2168, 2169, 2170, 2171, 2173, 2175, 2176, 2177, 2178, 2179, 2180, 2181, 2182, 2183, 2185, 2186, 2187, 2188, 2189, 2190, 2192, 2193, 2194, 2195, 2196, 2198, 2199, 2200, 2201, 2203, 2204, 2205, 2206, 2208, 2209, 2210, 2211, 2212, 2214, 2215, 2216, 2217, 2218, 2219, 2220, 2221, 2222, 2223, 2224, 2226, 2227, 2228, 2229, 2232, 2233, 2234, 2236, 2237, 2238, 2239, 2240, 2241, 2243, 2244, 2245, 2246, 2247, 2249, 2250, 2252, 2253, 2254, 2255, 2257, 2258, 2259, 2260, 2261, 2262, 2263, 2264, 2265, 2266, 2267, 2268, 2269, 2270, 2271, 2272, 2273, 2274, 2275, 2276, 2277, 2278, 2279, 2280, 2281, 2282, 2284, 2285, 2287, 2292, 2295, 2296, 2297, 2001, 2002, 2003, 2004, 2005, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, 2030, 2031, 2156, 2213, 2283, 2288, 2289, 2290, 2293, 2294, 2298, 2299, 2300, 2301, 2242, 2139, 2302, 2303, 2304
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter dated July 8, 2010.
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement.
VOLUME OF PRODUCT IN COMMERCE
238 systems
DISTRIBUTION
Nationwide

________________________________________
PRODUCT
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011
CODE
Software Version CRS Remote_7.8_HL
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated February 10, 2011.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.
REASON
A discrepancy in the validation testing which resulted in the product not performing as intended.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
________________________________________
PRODUCT
Osteomatrix bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use. Recall # Z-1677-2011
CODE
OMG10/Lot # 0809D110 OMG10/Lot # 0307I208
RECALLING FIRM/MANUFACTURER
Biostructures, LLC, Newport Beach, CA, by email on June 15, 2010. Firm initiated recall is complete.
REASON
The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.
VOLUME OF PRODUCT IN COMMERCE
248 units
DISTRIBUTION
MI, OH, MD, CA, TX, UT
_________________________________________
PRODUCT
Stryker Stiletto Electrosurgical Probe (E-Probe); Model number: 0270-070-550, 0270-070-551, 0270-070-552, 0270-070-553, 0270-070-554, 0270-070-555. Recall # Z-1704-2011
CODE
Units: 09158FE2, 09161FE2, 09164FE2, 09170FE2, 09174FE2, 09176FE2, 09219FE2, 09226FE2, 09233FE2, 09339FE2, 09264FE2, 09204FE2, 09205FE2, 09210FE2, 09211FE2, 09217FE2, 09120FE2, 09170FE2, 09181FE2, 09181FE2P, 09175FE2, 09209FE2, and 09167FE2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by letters on February 25, 2010.
Manufacturer: Stryker Puerto Rico, LTD, Arroyo, Pr. Firm initiated recall is ongoing.
REASON
The heat shrink, PTFE E-Probe Tip were out of specification (OOS) in the longitudinal change (+5% -20%).
VOLUME OF PRODUCT IN COMMERCE
31,014 units
DISTRIBUTION
Nationwide, Australia, Canada, Germany, Greece, Iberia, Korea, Switzerland, and Newbury

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS III
________________________________________
PRODUCT
LUCAS 2 Chest Compression System. Designed to uninterrupted chest compressions at a consistent rate and depth. Recall # Z-1664-2011
CODE
Serial Numbers for 546 UNITS DISTRIBUTED BY PHYSIO-CONTROL IN THE US: 30090182, 30090188, 30090216, 30090232, 30090242, 30090273, 30090275, 30090276, 30090277, 30090278, 30090279, 30090280, 30090281, 30090282, 30090284, 30090285, 30090286, 30090305, 30090314, 30090318, 30090325, 30090327, 30090328, 30090331, 30090333, 30090335, 30090426, 30090428, 30090429, 30090430, 30090432, 30090433, 30090434, 30090436, 30090437, 30090438, 30090439, 30090440, 30090442, 30090443, 30090445, 30090448, 30090449, 30090450, 30090451, 30090452, 30090453, 30090454, 30090457, 30090458, 30090459, 30090460, 30090461, 30090471, 30090499, 30090500, 30090501, 30090502, 30090503, 30090504, 30090505, 30090506, 30090507, 30090508, 30090509, 30090510, 30090511, 30090512, 30090513, 30090514, 30090515, 30090516, 30090517, 30090550, 30090564, 30090565, 30090566, 30090567, 30090568, 30090569, 30090575, 30090577, 30090580, 30090581, 30090583, 30090584, 30090629, 30090633, 30090653, 30090661, 30090665, 30090666, 30090670, 30090671, 30090672, 30090673, 30090674, 30090675, 30090676, 30090677, 30090678, 30090679, 30090680, 30090681, 30090682, 30100752, 30100753, 30100754, 30100755, 30100756, 30100757, 30100758, 30100759, 30100760, 30100761, 30100762, 30100763, 30100764, 30100765, 30100816, 30100817, 30100818, 30100819, 30100820, 30100821, 30100822, 30100823, 30100824, 30100825, 30100826, 30100827, 30100828, 30100829, 30100830, 30100831, 30100832, 30100834, 30100835, 30100838, 30100839, 30100840, 30100841, 30100842, 30100843, 30100844, 30100845, 30100846, 30100847, 30100848, 30100849, 30100850, 30100851, 30100852, 30100853, 30100854, 30100856, 30100858, 30100859, 30100860, 30100861, 30100863, 30100867, 30100868, 30100873, 30100898, 30100909, 30100944, 30100945, 30100946, 30100947, 30100948, 30100949, 30100950, 30100951, 30100952, 30100953, 30100954, 30100955, 30100956, 30100957, 30100958, 30100959, 30100960, 30100961, 30100962, 30100963, 30100964, 30100965, 30100966, 30100967, 30100968, 30100969, 30100970, 30100971, 30100972, 30100973, 30100974, 30100975, 30100976, 30100977, 30100978, 30100979, 30100980, 30100982, 30100983, 30100984, 30100986, 30101060, 30101062, 30101063, 30101064, 30101065, 30101066, 30101067, 30101074, 30101075, 30101077, 30101084, 30101085, 30101086, 30101087, 30101088, 30101124, 30101125, 30101160, 30101170, 30101171, 30101172, 30101173, 30101174, 30101175, 30101176, 30101177, 30101178, 30101179, 30101180, 30101181, 30101182, 30101183, 30101184, 30101185, 30101186, 30101187, 30101188, 30101189, 30101190, 30101191, 30101192, 30101193, 30101194, 30101195, 30101196, 30101197, 30101198, 30101199, 30101200, 30101201, 30101202, 30101203, 30101204, 30101205, 30101206, 30101207, 30101208, 30101209, 30101210, 30101211, 30101212, 30101213, 30101214, 30101215, 30101216, 30101217, 30101218, 30101219, 30101220, 30101221, 30101222, 30101223, 30101224, 30101225, 30101226, 30101227, 30101228, 30101229, 30101230, 30101231, 30101232, 30101233, 30101234, 30101235, 30101236, 30101237, 30101252, 30101254, 30101265, 30101266, 30101267, 30101268, 30101276, 30101277, 30101278, 30101279, 30101280, 30101281, 30101282, 30101283, 30101284, 30101285, 30101286, 30101287, 30101288, 30101290, 30101292, 30101293, 30101294, 30101295, 30101333, 30101334, 30101337, 30101338, 30101343, 30101344, 30101345, 30101346, 30101347, 30101349, 30101350, 30101351, 30101353, 30101354, 30101355, 30101356, 30101380, 30101381, 30101382, 30101386, 30101388, 30101389, 30101391, 30101392, 30101393, 30101394, 30101395, 30101396, 30101397, 30101398, 30101399, 30101400, 30101401, 30101402, 30101403, 30101404, 30101405, 30101406, 30101407, 30101408, 30101409, 30101411, 30101412, 30101413, 30101414, 30101452, 30101453, 30101455, 30101456, 30101457, 30101459, 30101460, 30101463, 30101464, 30101465, 30101473, 30101475, 30101476, 30101481, 30101495, 30101496, 30101497, 30101503, 30101504, 30101505, 30101506, 30101507, 30101508, 30101509, 30101510, 30101511, 30101512, 30101513, 30101514, 30101515, 30101516, 30101517, 30101518, 30101519, 30101520, 30101521, 30101522, 30101523, 30101524, 30101525, 30101526, 30101527, 30101528, 30101529, 30101530, 30101531, 30101532, 30101533, 30101534, 30101535, 30101536, 30101537, 30101538, 30101539, 30101540, 30101541, 30101542, 30101544, 30101545, 30101547, 30101548, 30101549, 30101551, 30101553, 30101554, 30101555, 30101556, 30101557, 30101559, 30101560, 30101573, 30101576, 30101577, 30101578, 30101579, 30101584, 30101607, 30101609, 30101610, 30101611, 30101612, 30101614, 30101615, 30101616, 30101617, 30101618, 30101620, 30101621, 30101622, 30101623, 30101624, 30101661, 30101662, 30101663, 30101665, 30101666, 30101667, 30101668, 30101670, 30101673, 30101674, 30101675, 30101676, 30101677, 30101678, 30101679, 30101681, 30101682, 30101683, 30101690, 30101696, 30101698, 30101701, 30101704, 30101705, 30101706, 30101707, 30101709, 30101724, 30101725, 30101726, 30101727, 30101728, 30101729, 30101730, 30101731, 30101732, 30101733, 30101734, 30101735, 30101736, 30101737, 30101751, 30101752, 30101762, 30101788, 30101789, 30101790, 30101791, 30101792, 30101793, 30101794, 30101795, 30101796, 30101797, 30101798, 30101799, 30101800, 30101805, 30101806, 30101808, 30101811, 30101814, 30101815, 30101816, 30101817, 30101818, 30101820, 30101821, 30101865, 30101866, 30101867, 30101868, 30101869, 30101870, 30101871, 30101872, 30101873, 30101874, 30101875, 30101876, 30101878, 30101879, 30101880, 30101881, 30101882, 30101883, 30101885, 30101887, 30101919, 30101921, 30101923, 30101927, and 30101928. SERIAL NUMBERS FOR 892 UNITS DISTRIBUTED BY PHYSIO-CONTROL TO THEIR FOREIGN CONSIGNEES: 30090054, 30090055, 30090059, 30090060, 30090061, 30090062, 30090063, 30090064, 30090065, 30090067, 30090068, 30090069, 30090070, 30090071, 30090072, 30090073, 30090074, 30090075, 30090076, 30090077, 30090078, 30090079, 30090080, 30090081, 30090082, 30090083, 30090084, 30090085, 30090087, 30090088, 30090111, 30090112, 30090113, 30090114, 30090115, 30090116, 30090117, 30090141, 30090142, 30090164, 30090165, 30090166, 30090168, 30090169, 30090171, 30090172, 30090173, 30090174, 30090175, 30090178, 30090180, 30090181, 30090183, 30090184, 30090185, 30090186, 30090187, 30090189, 30090190, 30090191, 30090192, 30090193, 30090194, 30090195, 30090196, 30090197, 30090198, 30090199, 30090206, 30090208, 30090209, 30090213, 30090221, 30090223, 30090224, 30090225, 30090226, 30090228, 30090233, 30090235, 30090237, 30090238, 30090239, 30090240, 30090241, 30090243, 30090244, 30090245, 30090246, 30090247, 30090248, 30090249, 30090250, 30090251, 30090252, 30090253, 30090254, 30090255, 30090256, 30090257, 30090258, 30090259, 30090260, 30090261, 30090262, 30090263, 30090264, 30090265, 30090266, 30090267, 30090268, 30090269, 30090270, 30090271, 30090272, 30090274, 30090283, 30090287, 30090288, 30090289, 30090290, 30090291, 30090292, 30090293, 30090294, 30090295, 30090296, 30090297, 30090298, 30090299, 30090300, 30090301, 30090302, 30090303, 30090304, 30090306, 30090307, 30090308, 30090309, 30090310, 30090311, 30090312, 30090313, 30090317, 30090319, 30090320, 30090321, 30090323, 30090324, 30090329, 30090330, 30090332, 30090334, 30090336, 30090337, 30090338, 30090339, 30090340, 30090341, 30090342, 30090343, 30090344, 30090345, 30090346, 30090347, 30090348, 30090349, 30090350, 30090351, 30090352, 30090353, 30090354, 30090355, 30090356, 30090357, 30090358, 30090359, 30090360, 30090361, 30090362, 30090363, 30090364, 30090365, 30090366, 30090367, 30090368, 30090369, 30090370, 30090371, 30090372, 30090373, 30090374, 30090375, 30090376, 30090377, 30090378, 30090379, 30090380, 30090381, 30090382, 30090383, 30090384, 30090385, 30090386, 30090387, 30090388, 30090389, 30090390, 30090391, 30090392, 30090393, 30090394, 30090395, 30090396, 30090397, 30090398, 30090399, 30090400, 30090401, 30090402, 30090403, 30090404, 30090405, 30090406, 30090407, 30090408, 30090409, 30090410, 30090411, 30090412, 30090413, 30090414, 30090415, 30090416, 30090417, 30090418, 30090419, 30090420, 30090421, 30090422, 30090423, 30090424, 30090425, 30090427, 30090455, 30090456, 30090462, 30090463, 30090464, 30090524, 30090525, 30090526, 30090527, 30090528, 30090536, 30090544, 30090547, 30090548, 30090551, 30090552, 30090553, 30090554, 30090556, 30090559, 30090560, 30090561, 30090562, 30090563, 30090585, 30090586, 30090587, 30090589, 30090590, 30090591, 30090592, 30090593, 30090594, 30090595, 30090596, 30090597, 30090598, 30090599, 30090600, 30090601, 30090602, 30090603, 30090604, 30090605, 30090606, 30090607, 30090608, 30090609, 30090610, 30090611, 30090612, 30090613, 30090614, 30090615, 30090634, 30090637, 30090640, 30090641, 30090642, 30090643, 30090644, 30090646, 30090647, 30090650, 30090651, 30090652, 30090654, 30090655, 30090656, 30090657, 30090658, 30090659, 30090660, 30090662, 30090663, 30090664, 30090694, 30090695, 30090696, 30090697, 30090698, 30090699, 30090700, 30090701, 30090702, 30090703, 30090704, 30090705, 30090706, 30090707, 30090708, 30090710, 30090711, 30090712, 30090713, 30090714, 30100766, 30100767, 30100768, 30100769, 30100770, 30100771, 30100772, 30100773, 30100774, 30100775, 30100776, 30100777, 30100778, 30100779, 30100780, 30100781, 30100782, 30100783, 30100784, 30100785, 30100786, 30100787, 30100788, 30100789, 30100790, 30100791, 30100792, 30100793, 30100794, 30100795, 30100796, 30100797, 30100798, 30100799, 30100800, 30100801, 30100802, 30100803, 30100804, 30100805, 30100806, 30100807, 30100808, 30100809, 30100810, 30100811, 30100812, 30100813, 30100814, 30100815, 30100862, 30100870, 30100871, 30100872, 30100874, 30100875, 30100882, 30100883, 30100884, 30100885, 30100886, 30100887, 30100888, 30100889, 30100890, 30100891, 30100892, 30100893, 30100894, 30100895, 30100896, 30100897, 30100899, 30100900, 30100901, 30100902, 30100903, 30100904, 30100905, 30100906, 30100907, 30100908, 30100910, 30100911, 30100912, 30100913, 30100914, 30100915, 30100916, 30100917, 30100918, 30100919, 30100920, 30100921, 30100922, 30100923, 30100924, 30100925, 30100926, 30100927, 30100928, 30100929, 30100930, 30100931, 30100932, 30100933, 30100934, 30100935, 30100936, 30100937, 30100938, 30100939, 30100940, 30100941, 30100942, 30100943, 30100987, 30100988, 30100989, 30100990, 30100991, 30100992, 30100993, 30100994, 30100995, 30100996, 30100997, 30101000, 30101001, 30101002, 30101003, 30101004, 30101005, 30101006, 30101007, 30101008, 30101009, 30101029, 30101036, 30101046, 30101055, 30101056, 30101057, 30101058, 30101059, 30101061, 30101068, 30101069, 30101070, 30101071, 30101072, 30101073, 30101076, 30101078, 30101079, 30101080, 30101081, 30101082, 30101083, 30101089, 30101092, 30101093, 30101094, 30101095, 30101096, 30101097, 30101098, 30101099, 30101100, 30101101, 30101102, 30101103, 30101104, 30101105, 30101106, 30101107, 30101108, 30101109, 30101110, 30101111, 30101112, 30101113, 30101114, 30101115, 30101116, 30101117, 30101118, 30101119, 30101120, 30101122, 30101123, 30101126, 30101128, 30101129, 30101130, 30101131, 30101132, 30101133, 30101136, 30101138, 30101143, 30101144, 30101147, 30101149, 30101150, 30101151, 30101152, 30101153, 30101154, 30101159, 30101239, 30101244, 30101245, 30101246, 30101248, 30101249, 30101251, 30101255, 30101256, 30101257, 30101258, 30101259, 30101260, 30101261, 30101262, 30101263, 30101264, 30101269, 30101270, 30101271, 30101272, 30101273, 30101274, 30101275, 30101291, 30101296, 30101297, 30101298, 30101299, 30101300, 30101301, 30101302, 30101304, 30101305, 30101306, 30101307, 30101308, 30101309, 30101310, 30101311, 30101312, 30101313, 30101314, 30101316, 30101317, 30101318, 30101320, 30101321, 30101322, 30101323, 30101324, 30101325, 30101326, 30101327, 30101328, 30101329, 30101330, 30101331, 30101332, 30101337, 30101340, 30101341, 30101348, 30101358, 30101359, 30101360, 30101361, 30101362, 30101363, 30101364, 30101365, 30101366, 30101367, 30101368, 30101369, 30101370, 30101371, 30101372, 30101373, 30101374, 30101375, 30101376, 30101377, 30101378, 30101379, 30101415, 30101416, 30101417, 30101418, 30101419, 30101420, 30101421, 30101422, 30101423, 30101424, 30101425, 30101426, 30101427, 30101428, 30101429, 30101430, 30101431, 30101434, 30101435, 30101436, 30101437, 30101438, 30101439, 30101440, 30101441, 30101442, 30101443, 30101444, 30101445, 30101446, 30101447, 30101448, 30101449, 30101450, 30101451, 30101454, 30101458, 30101461, 30101462, 30101466, 30101467, 30101468, 30101469, 30101470, 30101471, 30101472, 30101474, 30101477, 30101478, 30101479, 30101480, 30101482, 30101483, 30101484, 30101485, 30101486, 30101487, 30101488, 30101490, 30101491, 30101492, 30101493, 30101494, 30101498, 30101499, 30101500, 30101501, 30101502, 30101552, 30101561, 30101562, 30101563, 30101564, 30101565, 30101566, 30101567, 30101568, 30101569, 30101570, 30101571, 30101572, 30101574, 30101575, 30101580, 30101581, 30101582, 30101583, 30101585, 30101586, 30101587, 30101588, 30101589, 30101590, 30101591, 30101592, 30101593, 30101594, 30101595, 30101596, 30101597, 30101598, 30101599, 30101600, 30101602, 30101603, 30101604, 30101605, 30101606, 30101608, 30101613, 30101625, 30101626, 30101627, 30101628, 30101629, 30101631, 30101632, 30101633, 30101634, 30101635, 30101636, 30101637, 30101638, 30101639, 30101640, 30101641, 30101642, 30101643, 30101644, 30101645, 30101646, 30101647, 30101648, 30101649, 30101650, 30101651, 30101652, 30101653, 30101654, 30101655, 30101656, 30101657, 30101658, 30101659, 30101660, 30101684, 30101685, 30101686, 30101687, 30101688, 30101689, 30101691, 30101692, 30101693, 30101694, 30101695, 30101697, 30101699, 30101700, 30101702, 30101703, 30101708, 30101710, 30101711, 30101712, 30101713, 30101714, 30101715, 30101716, 30101717, 30101718, 30101719, 30101720, 30101721, 30101722, 30101723, 30101738, 30101739, 30101740, 30101741, 30101742, 30101743, 30101745, 30101746, 30101747, 30101748, 30101749, 30101750, 30101753, 30101754, 30101755, 30101756, 30101757, 30101758, 30101759, 30101760, 30101761, 30101764, 30101768, 30101771, 30101773, 30101775, 30101776, 30101778, 30101779, 30101781, 30101783, 30101786, 30101787, 30101801, 30101802, 30101803, 30101804, 30101813, 30101819, 30101822, 30101823, 30101824, 30101825, 30101826, 30101827, 30101828, 30101829, 30101830, 30101832, 30101833, 30101834, 30101835, 30101836, 30101837, 30101838, 30101839, 30101840, 30101841, 30101846, 30101848, 30101850, 30101851, 30101852, 30101853, 30101854, 30101855, 30101856, 30101857, 30101858, 30101859, 30101860, 30101893, 30101909, 30101910, 30101911, 30101912, 30101913, 30101914, 30101916, 30101930, and 30101932. SERIAL NUMBERS FOR 224 DEMO UNITS OWNED by PHYSIO-CONTROL: 30090026, 30090027, 30090028, 30090029, 30090031, 30090032, 30090033, 30090034, 30090035, 30090086, 30090089, 30090090, 30090091, 30090092, 30090093, 30090094, 30090095, 30090096, 30090097, 30090098, 30090099, 30090100, 30090102, 30090103, 30090104, 30090105, 30090106, 30090108, 30090109, 30090110, 30090118, 30090119, 30090120, 30090121, 30090122, 30090123, 30090124, 30090125, 30090126, 30090127, 30090128, 30090129, 30090130, 30090131, 30090132, 30090133, 30090134, 30090135, 30090136, 30090137, 30090138, 30090139, 30090140, 30090143, 30090144, 30090145, 30090146, 30090147, 30090148, 30090149, 30090150, 30090151, 30090152, 30090153, 30090154, 30090155, 30090156, 30090157, 30090158, 30090160, 30090161, 30090162, 30090163, 30090167, 30090170, 30090200, 30090201, 30090202, 30090203, 30090204, 30090205, 30090207, 30090210, 30090211, 30090212, 30090214, 30090215, 30090217, 30090218, 30090219, 30090220, 30090222, 30090227, 30090229, 30090230, 30090231, 30090234, 30090236, 30090326, 30090441, 30090444, 30090446, 30090447, 30090466, 30090467, 30090468, 30090469, 30090470, 30090472, 30090473, 30090474, 30090475, 30090476, 30090477, 30090478, 30090479, 30090480, 30090481, 30090482, 30090483, 30090484, 30090485, 30090486, 30090487, 30090488, 30090489, 30090490, 30090491, 30090492, 30090493, 30090494, 30090495, 30090496, 30090497, 30090498, 30090518, 30090519, 30090520, 30090521, 30090522, 30090523, 30090529, 30090530, 30090531, 30090532, 30090533, 30090534, 30090535, 30090537, 30090538, 30090539, 30090540, 30090541, 30090542, 30090543, 30090545, 30090546, 30090549, 30090555, 30090557, 30090558, 30090570, 30090571, 30090572, 30090573, 30090574, 30090576, 30090578, 30090579, 30090582, 30090588, 30090616, 30090617, 30090618, 30090619, 30090620, 30090621, 30090622, 30090623, 30090624, 30090625, 30090626, 30090627, 30090628, 30090630, 30090631, 30090632, 30090635, 30090636, 30090638, 30090639, 30090645, 30090683, 30090684, 30090685, 30090686, 30090687, 30090688, 30090689, 30090690, 30090691, 30090692, 30090693, 30100880, 30100881, 30100985, 30101090, 30101091, 30101289, 30101335, 30101336, 30101339, 30101342, 30101352, 30101383, 30101384, 30101385, 30101387, 30101390, 30101410, 30101619, 30101669, 30101672, and 30101680. SERIAL NUMBERS FOR 181 UNITS DISTRIBUTED BY JOLIFE, SWEDEN: 30090016, 30090018, 30090019, 30090020, 30090021, 30090022, 30090023, 30090024, 30090025, 30090030, 30090036, 30090037, 30090038, 30090039, 30090040, 30090041, 30090042, 30090043, 30090044, 30090045, 30090046, 30090047, 30090048, 30090049, 30090050, 30090051, 30090052, 30090053, 30090056, 30090057, 30090058, 30090101, 30090107, 30090159, 30090315, 30090316, 30090322, 30090431, 30090431, 30090435, 30090465, 30090648, 30090649, 30090667, 30090668, 30090669, 30090709, 30090715, 30090716, 30090717, 30090718, 30090719, 30090720, 30090721, 30090722, 30090723, 30090724, 30090725, 30090726, 30090727, 30090728, 30090729, 30090730, 30090731, 30090732, 30090733, 30090734, 30090735, 30090736, 30090737, 30090738, 30090739, 30090740, 30100741, 30100742, 30100743, 30100744, 30100745, 30100746, 30100747, 30100748, 30100749, 30100750, 30100751, 30100833, 30100836, 30100837, 30100855, 30100857, 30100864, 30100865, 30100866, 30100869, 30100876, 30100877, 30100878, 30100879, 30100998, 30100999, 30101010, 30101011, 30101012, 30101013, 30101014, 30101015, 30101016, 30101017, 30101018, 30101019, 30101020, 30101021, 30101022, 30101023, 30101024, 30101025, 30101026, 30101027, 30101028, 30101030, 30101031, 30101032, 30101033, 30101034, 30101035, 30101037, 30101038, 30101039, 30101040, 30101041, 30101042, 30101043, 30101044, 30101045, 30101047, 30101048, 30101049, 30101050, 30101051, 30101052, 30101053, 30101054, 30101121, 30101127, 30101134, 30101135, 30101137, 30101139, 30101140, 30101141, 30101142, 30101145, 30101146, 30101148, 30101155, 30101156, 30101157, 30101158, 30101161, 30101162, 30101163, 30101164, 30101165, 30101166, 30101167, 30101168, 30101169, 30101238, 30101240, 30101241, 30101242, 30101243, 30101247, 30101250, 30101253, 30101303, 30101315, 30101319, 30101432, 30101433, 30101766, and 30101886
RECALLING FIRM/MANUFACTURER
Jolife AB, Lund, Sweden, by letter dated February 2011. Firm initiated recall is ongoing.
REASON
LUCAS 2 Chest Compression System may have malfunctions resulting from the failure of a hood probe on the device that connects to the battery. The device may stop in fail safe mode and the LEDs will start flickering or the device will switch off.
VOLUME OF PRODUCT IN COMMERCE
1,843 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY – CLASS III
_________________________________________
PRODUCT
Planet Dog Eats - Salmon Seafood Chowder Organic Dog Treats. Treats are packaged 6 x 14-ounce packages per box. Recall # V-113-2011
CODE
Best Buy Date 11/1/11, 14 ounces
RECALLING FIRM/MANUFACTURER
Recalling Firm: Planet Dog Wholesale LLC, Portland, ME, by e-mail on January 19, 2011.
Manufacturer: Dawg, Robbie, Brooklyn, NY. Firm initiated recall is ongoing.
REASON
Pantry bugs found in dog treats.
VOLUME OF PRODUCT IN COMMERCE
97 to end consumers, 2,952 remaining at firm
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MARCH 23, 2011

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