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U.S. Department of Health and Human Services

Safety

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Enforcement Report for January 6, 2010

January 6, 2010
10-01

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
1) Supreme Protein brand Caramel Nut Bars, 96 g, 50 g and 20 g; 96g UPC 6 39373 02004 2; 50g UPC 6 39372 02058 5; 20g UPC 6 39372 02147 6. Recall # F-0298-2010;

2) Supreme Protein brand Peanut Butter Crunch Bars; 86 g, 43 g and 20 g. 86g UPC 6 39372 02120 9; 43 g UPC 6 39372 02129 2; 20g UPC 6 39372 02148 3. Recall # F-0299-2010;

3) Original Supreme Protein brand Carmel Nut Energy Bars, 96 gr. UPC 6 39372 02058 5 The product referred to as "Caramel Nut (Energy)" is the product labeled "Original" (as compared to that labeled "Carb Conscious"). Supreme Protein's original bar had been termed "Energy" and then after releasing the "Carb Conscious" version, the company renamed the first product "Original." No product has been labeled "Energy" since well before the affected products were produced, but Supreme Protein's distributors and retailers still refer to the product as the "Energy" product when ordering, and that is also what that bar is still called internally at the company. Accordingly, Supreme Protein thought it important to identify the affected product by this, now colloquial, name. Recall # F-0300-2010
CODE
1) Caramel Nut Bars, 96g: B8225A B8231A B8257A B8264A B8266A B8274A B8275A B8283A B8285A B8296A B8299A B8301A B8311A B8329A B8336A B8347A B8354A B9006A B9012A; Caramel Nut Bar 50g, B8218A B8231A B8261A B8274A B8296A B8322A B8324A B8354A B8285A - Canadian distribution only Caramel Nut Roll 20g, B8225A B8252A B8255A B8266A B8283A B8285A B8296A B8357A B9006A;

2) 86g: B8219A B8238A B8246A B8266A B8275A B8291A B8302A B8311A B8315A B8331A B8336A B8343A B8353A B9006A B9013A; Peanut Butter 43g, B8238A B8252A B8259A B8266A B8315A B8343A B8353A B8252A - Canadian Distribution only B8323A - Canadian Distribution only. Peanut Butter 20g, B8255A B8266A B8275A B9006A;

3) B8218A B8240A B8257A B9012A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Supreme Protein, Manasquan, NJ, by press release on January 20, 2009, and reissued on January 23 and letter on January 22, 2009. 
Manufacturer: Belmont Confections, Youngstown, OH. Firm initiated recall is ongoing.
REASON
Possible contamination: Product made with peanut paste from Georgia facility that has positive tests for salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
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PRODUCT 
365 Everyday Value Dry Roasted & Salted Pistachios, California Grown, Premium, Tree-Ripened, Net Wt 16 oz (1 lb/454g); UPC 99482-40435. Recall # F-0716-2010
CODE
Best Before dates of 07/08/2009 GL1, 07/08/2009 GL2, and 11/27/2009 GL1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Brand 365, LLC, Austin, TX, by e-mail and press release on April 1, 2009
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is complete.
REASON
Product has pistachios recalled by Setton of Terra Bella, which have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
14,157 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Frito-Lay brand Salted Pistachios, Net Wt. 1 3/4 oz. (49.6 g); UPC #28400 03888. Recall # F-0717-2010
CODE
Sell-by dates of 14 Jul 09 through 29 Dec 09. (Canada products have a Sell-by date of 09 AU 04 through 09 DE 15).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frito Lay, Inc., Plano, TX, press release on March 31, 2009.
Manufacturer: John B. Sanfilippo & Son Inc., Elgin, IL. Firm initiated recall is complete.
REASON
Firm received pistachios recalled by Setton Pistachio of Terra Bella, Inc. due to possible Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
4,459,944 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Pistachio nuts, salted in shell. 1.5 oz and 1 lb. plastic heat-sealed packages. UPC code for 1.5 oz package is 051943500607. No UPC code on 1 lb. package. Recall # F-0718-2010
CODE
"Sell By Date" ranging from 07 30 09 through 12 17 09
RECALLING FIRM/MANUFACTURER
Tillimook Country Smoker & Confections Inc., Bay City OR, by telephone on April 6, 2009 and April 7, 2009, and press release and letter sent by email dated April 7, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
30, 240 - 1.5 oz packages, and 125 - 1 lb bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Pistachios, Roasted and Salted in Shell. Products are packaged in 3.0 oz packages - UPC 41373-01415, and 4.5 oz packages - UPC 41373-01611, blue double laminated plastic bags with a clear see-through window. The label includes "Powers SNACK TIME HIGH ENERGY SNACKS Pistachios Net Wt. Best By Date". Ingredients include: Pistachios Roasted & Salted, in shell. Recall # F-0719-2010
CODE
Best By Dates 07 NOV 2008 through 02 APR 2009; Best By Dates 07 NOV 2008 through 02 APR 2009
RECALLING FIRM/MANUFACTURER
Powers Candy & Nut Co., Spokane, WA, by telephone and press release dated April 8, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6142 cases of 4.5 oz bags and 885 cases of 3 oz bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) In-Shell Dry Roasted Salted Pistachio Nuts; packaged in plastic bags (except) where noted under the following labels and sizes: a) Fisher Dry Roasted Pistachios Natural, item P78440, Net Wt 1.75 oz (49g), 12/case, UPC 0 70690 78440 5; b) Fisher Bulk Natural California Pistachios in poly-lined boxes, item 94203, Net Wt 25 lbs, UPC 1 00 72261 94203; c) Flavor Tree Snack Foods Inshell Salted Pistachios, item 02727, Net Wt 16 oz (49g) PET jar, 12/case, UPC 0 72261 02727 0; d) Archer Farms Roasted Pistachios Salted, item 07341, Net Wt. 10.50 oz. PET jar, 12/case, UPC 0 85239 08430 4; e) item 06966, Net Wt. 16 oz. plastic clamshell tub, 12/case, UPC 0 85239 71551 2; f) item 07377, Net Wt. 24 oz. PET jar, 6/case, UPC 0 85239 80350 9; g) item 08833, Net Wt. 14 oz. PET jar, 6/case, UPC 0 85239 95288 7. Recall # F-0720-2010

2) Archer Farms Raw Mixed Nuts, Unsalted, includes cashews, almonds, pistachios, hazelnuts & walnuts; sold in the following sizes and containers; a) item 03849, Net Wt. 2.25 oz. plastic bag, 12/case, UPC 0 85239 08268 3; b) item 07343, Net Wt. 11.25 oz. PET jar, 12/case, UPC 0 85239 08508 0; c) item 07376, Net Wt. 30 oz. PET jar, 6/case, UPC 0 85239 08119 8. Recall # F-0721-2010;

3) Raw Pistachio Kernels; packaged in plastic bags (except) where noted under the following labels and sizes: a) Fisher Natural Pistachio Kernels , item 91659, Net Wt 32 oz (2 LB) 907g, 3/case, UPC 0 70690 91659 2; b) Fisher Bulk Pistachio Kernel Whole in poly-lined boxes, item 72576, Net Wt 25 Lbs (400 oz.), UPC 0 00 70690 46106 1; c) Bulk Pistachio Kernel Whole in poly-lined boxes, item 70542, Net Wt 5 Lbs (80 oz.), UPC 0 00 70690 46019 4. Recall # F-0722-2010
CODE
1) a) Lot numbers Best By 08 25 09 HK1, 09 17 09 HK1, 10 14 09 HK1 and 10 17 09 HI1; b) lot numbers 8301FG7P, 8329FH7A, 8343KU7B and *** 9062FH7C; c) lot numbers Best Before 08 12 2009 HG1, 10 16 2009 HG1 and 07 21 2009 HG1; d) lot numbers Best By 06 JAN 2010 GA1, 15 DEC 2009 GJ1, 15 JAN 2010 GA1, 24 NOV 2009 GJ1 and 24 NOV 2009 GJ2; e) lot numbers Best By 23 SEP 2009 HP1 and *** 28 JU 2009 HP1; f)  lot numbers Best By 03 OCT 2009 GK2, 23 MAR 2010 GK1, 23 MAR 2010 GK2, 24 FEB 2010 GK1, 24 NOV 2009 GK1, 24 NOV 2009 GK2, 26 JAN 2010 GK1 and *** 04 MAR 2010 GK2; g) lot number Best By 23 APR 2009 HG1;

2) a) Lot numbers Best By 09 JUL 2009 HO2, 09 OCT 2009 HO2; b) lot numbers Best By 16 SEP 2009 GJ1, 26 SEP 2009 GJ1, 07 OCT 2009 GJ1, 08 OCT 2009 GJ1, 25 NOV 2009 GJ2, 29 DEC 2009 GJ1, 19 JAN 2010 GA1; c) lot numbers Best By 27 OCT 2009 GK1, 27 OCT 2009 GK2, 20 NOV 2009 GK1;

3) a) Lot number Best By 12/16/09 R1; b) lot numbers 8280FH7A, 8296FH7O, 8343SB8A and 9005SB8C; c) lot numbers 8276KU7A, 8365SB8C, 8277HF8B, 8353SB8B, 8353GN8D and 9012SB8D, BEST BY 10/3/09 HF1 and BEST BY 12/18/09 GN1
RECALLING FIRM/MANUFACTURER
John B. Sanfilippo & Son Inc., Elgin, IL, by press releases on March 31, 2009, April 1, 2009, April 2, 2009, April 7, 2009 and April 8, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios that have been recalled by Setton because they may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
139,533 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Golden Harvest Pistachio Kernels Dry Roasted/Salted, Net Wt. 16 oz. (454g) and Net Wt. 5 lb. (2270g). Recall # 0762-2010;

2) Supreme Nut Mix, Net Wt. 5 lb. (2270g), and Net Wt. 25 lb. Recall # 0763-2010;

3) Executive Nut Mix, Net Wt. 5 lb. (2270g), and Net Wt. 25 lb. Recall # 0764-2010;

4) Golden Trail Mix, Net Wt. 5 lb. (2270g). Recall # F-0765-2010
CODE
1) PLU 65;
2); 3); 4) No lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Texas Pecan Co., Dallas, TX, by fax on March 30, 2009 and press release on April 10, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
605 pounds
DISTRIBUTION
TX
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PRODUCT 
White Truffle Pate - a vegan pate. Product is packaged in 1.1 lb. loafs (units). 12 per case (13.2 lbs. per case). Product is wrapped in plastic wrap with a kraft paper overwrap and tied with a string. Product has a Company Item code 31840, and no UPC codes. Product is shipped frozen. First three ingredients: Organic expeller pressed palm oil, walnuts, vital wheat gluten. Case Label includes "Original Field Roast Grain Meat Co. White Truffle Country Pate Item #31840". Units are not labeled individually; however, a specification sheet is included with each case and reads "Field Roast Item # 31840 White Truffle Country Pate Pack: 12 x 1.5 lbs, 18 lbs Frozen Shelf Life: 8 months Shipped: Frozen Thawed Shelf Life: 10 days. Recall # F-0766-2010
CODE
Juliann date codes: 08349 and 09077 (2 digit year, 3 digit number of day in that year)
RECALLING FIRM/MANUFACTURER
The Field Roast Grain Meat Co., Seattle, WA, by telephone on April 9, 2009 and follow-up letter dated April 15, 2009. Firm initiated recall is complete.
REASON
Product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
14 cases which is 168 loaves (units)
DISTRIBUTION
WA, OR, UT
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PRODUCT 
1) Pistachios. Garlic pistachios, Net Wt. 2.5 oz. Label includes "Just Eat It! Werner GOURMET SNACKS GARLIC Pistachios USA. UPC code: 7 09972 80074 7. First three ingredients include: Pistachios, Garlic Powder, and Salt. Recall # F-0767-2010;

2) Pistachios. Jalapeno pistachios, Net Wt. 2.5 oz. Label includes "Just Eat It! Werner GOURMET SNACKS Jalapeno Pistachio's USA. UPC code: 7 09972 80097 6. First three ingredients include: Pistachios, Salt, and Paprika color. Recall # F-0768-2010
CODE
1) Best By Dates Jan. 5 2010 through April 1 2010;
2) Best By Dates Jan. 5 2010 through April 1 2010
RECALLING FIRM/MANUFACTURER
Werner Gourmet Meat Snacks, Tillamook, OR, by telephone, and letter dated April 7, 2009 and by press release on April 9, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
744 cases (12 bags/case) for a total of 8,928 bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Healthwise Peanut Butter Bar packaged 7 bars per box. Recall # F-0769-2010;

2) Healthwise Double Peanut Butter with Carmel Bar packaged 7 bars per box. Recall # F-0770-2010
CODE
1) Lot 08330;
2) Lot 08329
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutritional Resources Inc., Grovetown, GA, by letter and follow-up telephone on January 21, 2009. 
Manufacturer: Belmont Confections Inc., Youngstown, OH. Firm initiated recall iscomplete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
22,036 Peanut Butter Bars & 10,892 Double Peanut Butter Bars
DISTRIBUTION
Nationwide
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PRODUCT 
1) Shedd's Country Crock Side Dishes DELUXE Cheddar Broccoli Rice; 21-ounce (1 lb 5oz / 595 g) plastic tub inside a paperboard sleeve. UPC 027400218316. Shipping case of 6 tubs has UPC 00027400218309. Recall # F-0771-2010;

2) Shedd's Country Crock Side Dishes DELUXE Four Cheese Pasta; 20-ounce (1 lb 4 oz / 567 g) plastic tub inside a paperboard sleeve. UPC 027400230875. Shipping case of 6 tubs has UPC 00027400230851. Recall # F-0772-2010
CODE
1) Best-By dates of NOV 29 09 through to JAN 16 10;
2) Best By dates of DEC 05 09 through to JAN 16 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ, by press release and letters on November 20, 2009.
Manufacturer: Reser's Fine Foods Potato Plant, Topeka, KS. Firm initiated recall is ongoing.
REASON
Product may contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
60,558 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Pecan pieces, fancy medium/large, roasted, no salt, "Fisher" brand. Packed in vacuum seal bags in cardboard boxes, 30 lbs each. Side of the case labeled: Fisher PECAN PCS MED/LRG R/NSGMI#2517110000., Item number 93082. Recall # F-0773-2010
CODE
Lot 9125SA8A
RECALLING FIRM/MANUFACTURER
John B Sanfilippo & Son, Inc., Selma, TX, by telephone on July 6, 2009. Firm initiated recall is complete.
REASON
Product has the potential to contain salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,273 cases
DISTRIBUTION
MI
___________________________________
PRODUCT 
1) Clif Bar Crunchy Peanut Butter bar 68g, UPC 7-22252-10120-4, all packs and sizes. Also distributed to Canada, with UPC 7-22252-12008-3, and the UK with UPC 7-22252-10908-8. First 5 ingredients on label read: "Organic Brown Rice Syrup, ClifPro...., Organic Rolled Oats, Organic Evaporated Cane Juice, Organic Peanut butter...Peanut Flour". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0856-2010;

2) Clif Bar Chocolate Chip Peanut Crunch bars, 68g, UPC 7-22252-10130-3. All packs and sizes. Also distributed to Canada, with UPC 7-22252-12009-0. First 5 ingredients on label read: "Organic Brown Rice Syrup, ClifPro, Organic Rolled Oats, Organic Evaporated Cane Juice, Organic Peanut butter...Chocolate Chips". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0857-2010;

3) Clif Bar Peanut Toffee Buzz bars, 68g, UPC 7-22252-10240-9. All packs and sizes. Also distributed to Canada with UPC 7-22252-12028-1. First 5 ingredients on label read: "Organic Brown Rice Syrup, ClifPro...., Organic Rolled Oats, Dry Roasted Peanuts, ClifCrunch...". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0858-2010;

4) CLIF Kid Organic ZBaR Peanut Butter bar, 36 g, UPC 7-22252-19412-1. First 3 ingredients on label read: "Organic Peanut Butter..., Organic Evaporated Cane Juice Syrup, Organic Rolled Oats". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0859-2010;

5) Clif Builder's Peanut Butter bar, 20g, UPC # 7-22252-60141-4. Also distributed to Canada, with UPC 7-22252-60641-9. First 3 ingredients on label read: "Soy Protein Isolate, Chicory Syrup, Organic Brown Rice Syrup". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0860-2010;

6) Luna Nutz Over Chocolate Bar, 48g, UPC 7-22252-10310-9. Also distributed to Canada and the UK with UPC 7-22252-22002-8. First 5 ingredients on label read: "LunaPro..., Organic Brown Rice Syrup, Organic Coating, Organic Peanut Butter, Vegetable Glycerin". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0861-2010;

7) Luna Peanut Butter Cookie, 48g, UPC 7-22252-10061-0. First 5 ingredients on label read: "LunaPro..., Organic Brown Rice Syrup, Organic Coating, Organic Peanut butter, Inulin...". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0862-2010;

8) Clif Mojo Mountain Mix bar, 45g, UPC 7-22252-10561-5. First 3 ingredients on label read: "Organic Brown Rice Syrup, Organic Peanuts, Organic Raisins". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0863-2010;

9) Clif Mojo Mixed Nuts bar, 45g, UPC 7-22252-10531-8. First 3 ingredients on label read: "Organic Brown Rice Syrup, Dry Roasted Almonds, Soy Rice Crisps". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0864-2010;

10) Clif Mojo Peanut Butter Pretzel bar, 45g, UPC 7-22252-12629-0. First 3 ingredients on label read: "Organic Brown Rice Syrup, Organic Dry Roasted Peanuts, Soy Rice Crisps...". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0865-2010;

11) Clif Mojo Honey Roasted Peanut bar, 45g, UPC 7-22252-10501-1. First 3 ingredients on label read: "Organic Dry Roasted Peanuts, Organic Brown Rice Syrup, Honey Roasted Peanuts...” Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0866-2010;

12) Clif Mojo Dipped Chocolate Peanut Bar, 45g, UPC 7-22252-12630-6. First 5 ingredients on label read: "Organic Dry Roasted Peanuts, Organic Brown Rice Syrup, Honey Roasted Peanuts...Soy Rice Crisps...Organic Pretzels...” Evaporated Cane Juice, Organic Peanut butter...Chocolate Chips". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0867-2010;

13) Clif Mojo Dipped Peanut Butter & Jelly bar, 45g UPC 7-22252-12631-3. First 6 ingredients on label read: "Organic Dry Roasted Peanuts, Organic Brown Rice Syrup, Organic Coating..., Soy Rice Crisps..., Organic Peanut Butter, Organic Dry Roasted Soybeans". Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0868-2010;

14) Clif Mojo Dipped Fruit & Nut Bar, 45g, UPC 7-22252-12632-0. First 5 ingredients on label read: "Organic Brown Rice Syrup, Organic Coating..., Soy Rice Crisps...” Manufactured using raw material supplied by PCA Georgia and/or Texas facilities. Recall # F-0869-2010
CODE
1) Sell By/Best By dates 09OCT08 to 31DEC09, Canadian expiry dates 2008OC04 to 2009DE31, UK Best Before Dates 07NOV2008 to 31DEC2009;

2) Sell By/Best By dates 09OCT08 to 31DEC09, Canadian expiration dates 2008OC04 to 2009DE31;

3) Sell By/Best By dates 09OCT08 to 31DEC09, Canadian Expiry Dates 2008OC04 to 2009DE31;

4) Best by dates 21OCT08 to 31DEC09;

5) Sell By dates 20SEP08 to 31DEC09, Canadian expiry dates 2009MA06 to 2009DE31;

6) Best By dates 28OCT08 to 31DEC09, Canadian Expiry and UK Expiry dates 2008OC28 to 2009DE31;

7) Best By dates 28OCT08 to 31DEC09;

8) Best by Dates 01SEP07 to 31OCT09;

9)  Best by Dates 01SEP07 to 31OCT09;

10) Best by Dates 01SEP07 to 31OCT09;

11) Best by Dates 01SEP07 to 31OCT09;

12) Best by Dates 01SEP07 to 31OCT09;

13) Best by Dates 01SEP07 to 31OCT09;

14) Best by Dates 01SEP07 to 31OCT09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Clif Bar, Berkeley, CA, by press release, telephone and e-mail on January 19, 2009 and by press release on January 30, 2009.
Manufacturer: Bloomfield Bakers, Azusa, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
approximately 12,252,854 packaging units
DISTRIBUTION
Nationwide, Canada and the UK
___________________________________
PRODUCT 
1) Treasure Harvest Roasted Blanched Peanuts: Item Numbers: 2622-5 (5lb), 2625-5 (5lb), 2622-30 (30lb), 2625-30 (30lb), Fresh Start Roasted Blanched Peanuts: Item Numbers: 2622-12. Recall # F-0941-2010;

2) Goody Goody Trail Mix (5 lb) item 3511-5; Good Goody Trail Mix (25 lb) item 3511-25; Goody Goody Trail Mix (4 oz) item 3511-5; Goody Goody Trail Mix (12 oz) item 3511-12. Recall # F-0942-2010;

3) Hollywood Trail Mix (5 lb) item 3506-5; Hollywood Trail Mix (25 lb) item3506-25; Hollywood Trail Mix (12 oz) item 3506-12. Recall # F-0943-2010;

4) Roasted Trail Mix (5 lb) item 3505-5Roasted Trail Mix (25 lb) item 3505-25, 3505-5. Recall # F-0944-2010;

5) Tropical Trail Mix (25 lb) item 3509-25, 8300-9033; Tropical Trail Mix (4 lb) item 3509-5. Recall # F-0945-2010;

6) Oriental Trail Mix (20 lb) item 7575-20. Recall # F-0946-2010;

7) Roasted Salted Trail Mix (5 lb) item 3533-12, 9021-9033; Roasted Salted Trail Mix (25 lb) item 3533-25, 9021-9033; Roasted Salted Trail Mix (4 oz) item 3533-24. Recall # F-0947-2010;

8) Yogurt Trail Mix (5 lb) item 3508-5; Yogurt Trail Mix (25 lb) item 3508-25. Recall # F-0948-2010;

9) Sweet and Salty Trail Mix (10 oz) item 3537-24. Recall # F-0949-2010;

10) Roasted Fancy Trail Mix (12/12 oz) item 3505-12. Recall # F-0950-2010;

11) Small Roasted Diced Peanuts (30 lb) item 2619-30. Recall # F-0951-2010
CODE
1) 8300-9033;

2) Item Numbers: 3511-5, 3506-5, 3505-5, 3511-25, 3506-25, 3505-5, 3509-25, 7575-20, 3533-12, 3533-25, 3533-24, 3508-5, 3508-25, 3506-12, 3511-5, 3511-12, 3505-12, 3509-5, 3511-4 & 3537-24 Item 3511-5, 8300-9033; 3511-25, 8300-9033; 3511-5, 8300-9300; 3511-12, 8300-9033;

3) 3506-5, 8300-9033; 3506-25, 8300-9033; 3506-12, 8300-9033;

4) 8300-9033;

5) 8300-9033;

6) 9021-9033;

7) 3533-12, 9021-9033; item 3533-25, 9021-9033;

8) 3508-5, 9021-9033; 3508-25, 9021-9033;

9) 3537-24, 9027-9033;

10) 8300-9300;

11) None
RECALLING FIRM/MANUFACTURER
Western Mixers Produce & Nuts, Inc., Los Angeles, CA, by telephone on March 21, 2009 and by letter on March 31, 2009. Firm initiated recall is complete.
REASON
Firm's peanuts and trail mix may contain peanuts from PCA.
VOLUME OF PRODUCT IN COMMERCE
3664 cases
DISTRIBUTION
AZ, CA, KS, MA, NV, OH, OR, TX, VA, WA, WY
___________________________________
PRODUCT 
Optifast Honey Nut 'n Oat Nutritional Bars, Carton UPC CODE 0-43900-39017-8, (14-1.59 oz, 45g Bars, Net Wt 22.2 oz (630g). Each case consists of six (6) fully labeled paperboard cartons, each of which contains fourteen (14) individually wrapped bars not labeled for retail sale, for a total of 84 bars per case. Recall # F-0952-2010
CODE
0397A EXP FEB 08, 1317A EXP MAY 08, 1577A EXP JUN 08, 3247A EXP NOV 08, 0538A EXP FEB 09, 1998A EXP JUN 09, 2198A EXP AUG 09, 2618A EXP SEP 08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle Healthcare Nutrition, Minnetonka, MN, by press release on February 3, 2009.
Manufacturer: Creative Energy Foods LLC, Oakland, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,448 cases or 26,688 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) 5 oz., UPC number 0 2774800209 7 and 10 oz, UPC number 0 2774800710 8 reads: "Klein Family Farms Arroyo Seco OF CALIFORNIA Gourmet Quality Trail Mix With Cranberries & Pecans Net Wt....First 3 ingredients on labels read: "Cranberries....Raisins, Peanuts". Packaging is a poly bag inside a fiber carton, 12 per case. Product was manufactured using peanuts from PCA's Texas facility. Recall # F-0953-2010;

2) 5 oz. UPC number 0 27748 00215 8 and 10 oz. UPC number 0 27748 00715 3 reads: "Klein Family Farms Arroyo Seco of California Gourmet Quality Rainbow Mix with Almonds Net Wt. First 2 ingredients on labels read: Raisin, Chocolate Flavored Drops". Packaging is a poly bag inside a fiber carton, 12 per case. Product was manufactured by Klein Brothers using peanuts from PCA's Texas facility. Recall # F-0954-2010;

3) "Klein Family Farms Arroyo Seco OF CALIFORNIA Gourmet Quality Oriental Mix With Wasabi Peas Net Wt. 3.75 Oz. (106.3g). First ingredient on labels read: "Wasabi Grn Peas..." Labels also read: "Ingredients may contain products from Malaysia and Japan". Packaging is a poly bag inside a fiber carton, 12 per case. Product was manufactured by Klein Brothers using peanuts from PCA's Texas facility. UPC # 0 27748 00200 4. Recall # F-0955-2010
CODE
1) 5 oz., BEST BY DATE 02-28-09 with case lot number 25209-2/28/09; 10 oz., BEST By dates of 2/28/09 and 4/14/09 with case lot numbers 25209-2/28/09 and 25209-4/14/09;

2) 5 oz., BEST BY DATES 2/28/09 and 4/14/09 with case lot numbers 25215-2/28/09 and 25215-4/14/09; 10 oz., BEST BY DATES of 2/28/09, 4/14/09 and 5/5/09 with case lot numbers 25215-2/28/09, 25215-4/14/09 and 25215-5/5/09;

3) BEST By dates of 3/17/09, 4/11/09 and 4/23/09 with case lot numbers 25200-3/17/09, 25200-4/4/11/09 and 25200-4/23/09
RECALLING FIRM/MANUFACTURER
Klein Bros. Ltd., Stockton, CA, by letters on March 10, 2009, March 6, 2009, March 18, 2009 and by press release on March 31, 2009 and a faxed letter on April 13, 2009. Firm initiated recall is complete.
REASON
Trail Mixes were manufactured using roasted salted peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
474 cases of 12 = 5,688 packages: Trail Mix = 1104, Rainbow Mix = 1,560, Oriental Mix = 3024
DISTRIBUTION
CA, WA, OR
___________________________________
PRODUCT 
Caramel Chocolate Truffle Hot Chocolate Mix for two, # 3204, Net Weight 5.5 ounces/155 grams. Allergens: Milk, Soy, SKU# 3204 UPC 0 94522 01015 9. Product can be packaged individually or in an assortment of 3 different products. Assortment package contains 4 ea of Caramel Chocolate Truffle Hot Chocolate Mix # 3204 (Recalled Item), Triple Chocolate Fudge Hot Chocolate Mix # 3203 (Not Recalled), and White Chocolate Raspberry Hot Chocolate Mix # 3202 (Not Recalled). Recall # F-0956-2010
CODE
All products distributed between January 2007 and November 2, 2009
RECALLING FIRM/MANUFACTURER
Pelican Bay Ltd, Inc., Dunedin, FL, by press release dated November 3, 2009 and letters dated November 5, 2009.
Firm initiated recall is ongoing.
REASON
Product labeling does not declare a Tree Nut Allergen.
VOLUME OF PRODUCT IN COMMERCE
20,272 cones
DISTRIBUTION
Nationwide, Canada, United Kingdom, Japan, and the Netherlands
___________________________________
PRODUCT 
Sea Cove brand 61/70 Cooked Shrimp, Product of Indonesia --- Product is frozen, cooked peeled and deveined tail off IQF (Individually Quick Frozen) shrimp. --- Labeling not available yet. Recall # F-0957-2010
CODE
Pack dates 10-22-08, 10-24-08, 10-28-08, 10-31-08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Crystal Cove Seafood,Floral Park, NY, by telephone on October 27, 2009 and by letter dated November 2, 2009.
Manufacturer: Pt. Panca Mitra Multiperdana, Situbondo, Indonesia. Firm initiated recall is ongoing.
REASON
The product was found to be contaminated with Listeria monocytogenes based on in-house testing by the sole direct consignee.
VOLUME OF PRODUCT IN COMMERCE
600 cases (6000 lbs.)
DISTRIBUTION
MN

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________

PRODUCT
Tylenol Arthritis Pain, (acetaminophen), extended-release caplets, 650 mg, 100 count bottles with EZ-open cap, NDC 50580-112-21. Recall # D-137-2010
CODE
Lot 08BMC020-Exp. 11/30/2010, 07CMCO11-Exp. 1/31/2010, 07DMC024-Exp. 1/31/2010, 07HMC051-Exp. 1/31/2010, 07JMC064-Exp. 1/31/2010, 07DMC022-Exp. 2/28/2010, 07GMC038-Exp.2/28/2010, 08AMC002-Exp.2/28/2010, 07FMC032-Exp.3/31/2010, 07FMC033-Exp. 3/31/2010, 07GMC039-Exp. 4/30/2010, 07HMC045-Exp. 4/30/2010, 07HMC053-Exp. 5/31/2010, 07XMC055-Exp5/31/2010, 07JMC069-Exp. 6/30/2010, 07JMC070-Exp.6/30/2010, 07XMC058-Exp.6/30/2010, 07XMC062-Exp.6/30/2010, 08AMC005-Exp. 6/30/2010, 07JMC071-Exp. 7/31/2010, 08CMC026-Exp. 9/30/2010, 08DMC029-Exp.1/31/2011, 08EMC037-Exp. 2/28/2011, 08EMC039-Exp. 2/28/2011; 08FMC044-Exp. 2/28/2011, 08FMC045-Exp. 3/31/2011, 08GMC050-Exp. 3/31/2011, 08GMC053-Exp. 4/30/2011, 08GMC063-Exp. 4/30/2011, 08GMC065-Exp 4/30/2011, 08KMC124-Exp. 5/31/2011, 08XMC093-Exp. 7/31/2011, 08XMC094-Exp. 7/31/2011, 08XMC095-Exp. 7/31/2011, 08JMC103-Exp. 8/31/2011, 08JMC109-ExP. 8/31/2011, 08JMCll0-Exp. 8/31/2011, 08JMC111-Exp. 8/31/2011, 08KMC127-Exp. 8/31/2011, 08KMC131-Exp. 10/31/2011, 08KMC132-Exp. 10/31/2011, 09AMC010-Exp. 10/31/2011, 09BMC034-Exp. 12/31/2011, 09CMC036-Exp. 12/31/2011, 09CMC040-Exp. 1/31/2012, 09CMC041-Exp.1/31/2012, 09EMC075-Exp. 2/28/2012, 09EMC076-Exp. 2/28/2012, 09GMC096-Exp. 2/28/2012, 09GMC097-Exp. 2/28/2012, 09EMC079-Exp. 3/31/2012, 09GMC099-Exp. 4/30/2012, 09XMC116-Exp. 5/31/2012, 09JMC118-Exp. 7/31/2012, 09JMC126-Exp. 7/31/2012, 09XMC114-Exp. 7/31/2012, 09KMC133-Exp.9/30/2012, 09KMC134-Exp.10/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by website on November 6, 2009, press release on December 18, 2009 and by letters on November 9, 2009 and December 18, 2009.
Manufacturer:  McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2, 4, 6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
6,329,760 bottles
DISTRIBUTION
Nationwide, United Arab Emirates (UAE), and Kuwait
___________________________________
PRODUCT
Milk of Magnesia (magnesium hydroxide), 1200 mg Saline Laxative, Cherry Liquid 12 FL oz, NDC # 59779-949-40, UPC 5042807094. Recall # D-138-2010
CODE
9DK0168, 9DK0376, 9EK0118, 9EK0173, 9EK0367, 9EK0525, 9FK0044, 9FK0256, 9FK0425, 9FK0521, 9GK0049, 9GK0308, 9GK0436, 9GK0668, 9HK0106, 9HK0285, 9HK0372 and 9JK0126
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter on November 24, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Label mix-up; Product is labeled as sugar-free but it actually contains sugar.
VOLUME OF PRODUCT IN COMMERCE
72,840 bottles
DISTRIBUTION
Nationwide

  RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0314-10
CODE
Unit: 18FG39903
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone and electronic notification on July 29, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-0343-10
CODE
Unit: 003KK63076
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile and e-mail on November 17, 2008 and by letter dated November 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0345-10
CODE
Unit: 01GJ16697
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile and electronic notification on December 23, 2008.
Manufacturer: American Red Cross Blood Services, Albany, NY. 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
PA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0354-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0356-10
CODE
1) Unit: 011KY30467;
2) Units: 011LE36084, 011KV25525, 011KY27758
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile on September 26, 2008 and letter dated October 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR, TN, MO
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0357-10
CODE
Unit: 01FT28699 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by telephone on July 24, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0360-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0362-10
CODE
1) 20X40824;
2) 20X40824, 20Z22013
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City UT, by e-mail and facsimile on July 16, 2009 and by letter dated July 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC, ID

___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0363-10; 
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0364-10
CODE
1) Units: 2534539 (Part A), 2534539 (Part C);
2) Units: 2534645, 2534539 (Part B)
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated January 11, 2009. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0365-10
CODE
Unit: 36J02415
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Columbia, SC, by facsimile on February 5, 2009, by letter dated April 8, 2009, and by electronic notification on April 8, 2009.
Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. 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
SC
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0367-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0368-10
CODE
1) and 2) Unit: 36FL33751
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by facsimile and telephone on March 16, 2009 and by letters dated March 16, 2009 and July 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0372-10
CODE
Unit: 53FL48764
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, by facsimile on June 17, 2009 and by e-mail on July 29, 2009. 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
MD
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0378-10
CODE
Recall # 20LQ10290
RECALLING FIRM/MANUFACTURER
American National Red Cross, Boise, ID, by telephone and electronic notification on April 20, 2009 and by facsimile on April 23, 2009.  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 Leukocytes Reduced. Recall B-0379-10
CODE
Unit: 20Z24800
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile on June 8, 2009 and by letter dated July 18, 2009. 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
PA, UT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0389-10
CODE
Units: 18FG29295, 18FY71217
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by facsimile and electronic notification on July 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, MI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0391-10
CODE
W117009181150 (2 units), W117008152737 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by letter dated July 28, 2009. 
Manufacturer: Blood Centers of the Pacific- Peninsula Center, Millbrae, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0388-10
CODE
Unit: 17GK64782
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile and electronic notification on July 17, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0315-10
CODE
Unit: 18FG39903
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone and electronic notification on July 29, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0344-10
CODE
Unit: 003KK63076
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile and e-mail on November 17, 2008 and by letter dated November 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0346-10
CODE
Unit: 01GJ16697
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile and electronic notification on December 23, 2008.
Manufacturer: American Red Cross Blood Services, Albany, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0355-10
CODE
Units: 011KY30467, 011LE36084, 011KV25525, 011KY27758
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile on September 26, 2008 and letter dated October 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0358-10;
2) Red Blood Cells. Recall # B-0359-10
CODE
1) Units: 9488231, 9525167;
2) Units: 9488231, 9525088, 9525113, 9525167, 9531085, 9531099
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Ocala, FL, by telephone on April 29, 2009 and by letter dated May 8, 2009. 
Manufacturer: Florida's Blood Centers, Inc., Sumterville, FL. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0361-10
CODE
Unit: 20Z22013
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City UT, by e-mail and facsimile on July 16, 2009 and by letter dated July 20, 2009. 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
NC, ID
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0366-10
CODE
Unit: 36J02415
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Columbia, SC, by facsimile on February 5, 2009, by letter dated April 8, 2009, and by electronic notification on April 8, 2009.
Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0373-10
CODE
Unit: 53FL48764
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, by facsimile on June 17, 2009 and by e-mail on July 29, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall B-0377-10
CODE
Recall # 20LQ10290
RECALLING FIRM/MANUFACTURER
American National Red Cross, Boise, ID, by telephone and electronic notification on April 20, 2009 and by facsimile on April 23, 2009.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0380-10
CODE
Unit: 20Z24800
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile on June 8, 2009 and by letter dated July 18, 2009. 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
PA, UT
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0387-10
CODE
Unit: 17GK64782
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile and electronic notification on July 17, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0390-10
CODE
Units: 18FG29295, 18FY71217
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by facsimile and electronic notification on July 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT 
1) Siemens Biograph mCt-X, model number 10248670. Medical Imaging Equipment. Recall # Z-0162-2010;

2) Siemens Biograph mCT-S 40, model number 10248671. Medical Imaging Equipment. Recall # Z-0163-2010;

3) Siemens Biograph mCT-S 64, model number 10248672. Medical Imaging Equipment. Recall # Z-0164-2010
CODE
1) Serial numbers: 1001, 1002 and 1003;
2) Serial number 1001;
3) Serial numbers: 1002 and 1003
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA Inc., Knoxville, TN, by letter dated September 3, 2009. Firm initiated recall is ongoing.
REASON
In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL, OH, Germany, France and Hong Kong
___________________________________
PRODUCT 
Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case. A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device. Product code 2C8864. Recall # Z-0487-2010
CODE
Lot number UR09E21238
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, letter dated November 3, 2009.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico S.A., Aibonito, PR. Firm initiated recall is ongoing.
REASON
The tubing may separate from the distal Clearlink Y-site of the set, which could result in patient injury if the separation occurs during patient use.
VOLUME OF PRODUCT IN COMMERCE
173 cases
DISTRIBUTION
AL, CA, CO, FL, GA, IL, KY, LA, MI, MS, MO, NV, NM, OH, TN, TX, UT, WI, Canada and New Zealand
___________________________________
PRODUCT
1) Lactosorb System 2.0MM Adjustable Self-Drilling Tap, REF: 915-2075, Non-Sterile Product. Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone. Recall # Z-0489-2010;

2) Lactosorb System 1.5MM Adjustable Self-Drilling Tap for Power Driver, REF: 915-2185, Non-Sterile Product, LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone. Recall # Z-0490-2010
CODE
1) Lot Number: 064350;
2) Lot Number: 885580
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by telephone and e-mail beginning September 2009. Firm initiated recall is ongoing.
REASON
Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
FL, MO, KS, Brazil and China
___________________________________
PRODUCT 
GE Healthcare, Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging Systems. Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Recall # Z-0540-2010
CODE
Serial Numbers: 567819BU8 553647BU9 572635BU1 554557BU9 577013BU6 553645BU3 554559BU5 554554BU6 570810BU2 575321BU5 561974BU7 561975BU4 552392BU3 576688BU6 0CLINIC-6 566788BU6 568141BU6 576766BU0 549882BU9 561354BU2 559228BU2 569784BU2 559230BU8 559229BU0 559232BU4 558488BU3 560201BU6 553915BU0 567597BU0 570811BU0 555791BU3 555795BU4 558485BU9 561968BU9 561973BU9 549588BU2 554561BU1 558484BU2 574676BU3 560203BU2 555794BU7 556324BU2 558482BU6 565971BU9 560199BU2 560200BU8 554555BU3 575318BU1 576574BU8 00CLINIC3 556326BU7 556328BU3 555793BU9 555792BU1 558483BU4 561971BU3 558481BU8 553916BU8 570809BU4 566407BU3 567820BU6 573589BU9 553216BU3 559231BU6 553917BU6 561970BU5 561969BU7 577012BU8 561753BU5 551152BU2 549881BU1 556327BU5 00CLINIC4 CLINICAL2 554562BU9 558489BU1 553646BU1 550100BU2 573164BU1 574334BU9 554563BU7 556322BU6 561355BU9 561356BU7 569351BU0 578479BU8 554556BU1 560202BU4 554560BU3 570231BU1 551164BU7 558486BU7 556329BU1 556331BU7 558487BU5 568140BU8 566406BU5 578416BU0 558490BU9 554558BU7 556323BU4 561353BU4 576361BU0 561972BU1 552393BU1 566180BU6 561967BU1 569498BU9 556330BU9 CLINICAL 1 570095BU0 561754BU3 553918BU4 and 556325BU9
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 14, 2009.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a potential limit switch failure with Innova 2121IQ and 3131IQ (Biplane) systems that may impact patient safety. A potential limit switch failure could occur due to collision between the lateral plane of Innova Positioner and other equipment in the room. This collision may break the x-ray and positioning switches, and may not allow exam completion. To date, no injury has been reported related to this condition.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide, Yemen, United Kingdom, Taiwan, Singapore, Russia, Romania, Malaysia, Lybia, Japan, Italy, Ireland, Indonesia, India, Germany, France, Egypt, Chile , Canada and Bahrain
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PRODUCT 
i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentist, oral surgeon or other physician needs 3D information of high contrast objects. Recall # Z-0543-2010
CODE
Serial Numbers: ICU070427, ICU070428, ICU070429, ICU070430, ICU070432, ICU070433, ICU070434, ICU070435, ICU070436, ICU070437, ICU070438, ICU070439, ICU070440, ICU070441, ICU070442, ICU070443, ICU070445, ICU070446, ICU070447, ICU070448, ICU070449, ICU070451, ICU070452, ICU070453, ICU070454, ICU070455, ICU070456, ICU070457, ICU070458, ICU070459, ICU070460, ICU070461, ICU070462, ICU070463, ICU070464, ICU070465, ICU070466, ICU070467, ICU070468, ICU070469, ICU070470, ICU070471, ICU070472, ICU070473, ICU070474, ICU070475, ICU070476, ICU070477, ICU070478, ICU070479, ICU070480, ICU070481, ICU070482, ICU070483, ICU070484, ICU070485, ICU070486, ICU070487, ICU070488, ICU070489, ICU070490, ICU070491, ICU070492, ICU070493, ICU070494, ICU070495, ICU070497, ICU070498, ICU070499, ICU070500, ICU070501, ICU070502, ICU070503, ICU070505, ICU070506, ICU070507, ICU070508, ICU070509, ICU070510, ICU070512, ICU070513, ICU070514, ICU070515, ICU070516, ICU070517, ICU070518, ICU070519, ICU070520, ICU070521, ICU070522, ICU070523, ICU070524, ICU070525, ICU070527, ICU070528, ICU070529, ICU070530, ICU070531 and ICU070532
RECALLING FIRM/MANUFACTURER
Imaging Sciences International, LLC, Hatfield, PA, by letter dated October 30, 2009. Firm initiated recall is ongoing.
REASON
Overhead carriage drops quickly.
VOLUME OF PRODUCT IN COMMERCE
98 units
DISTRIBUTION
Nationwide, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan
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PRODUCT
1) Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours. Recall # Z-0544-2010;

2) Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmonary bypass procedures lasting up to 6-hours. Recall # Z-0545-2010
CODE
1) Serial Numbers: KP01, KP15, LA05, LA12, LA19, LC02, LC09, LC23, LD02, LD09, LD16, LD30, LE06, LE08, LE13, LE20, LE27, LE29, LF04 and LF07;

2) Serial Numbers: KN10, KN26, KP08, LA05, LA12, LA19, LA22, LA26, LC12, LC16, LD16, LD23, LE01, LE15, LE22, LE29 and LF07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on July 06, 2009.
Manufacturer: Terumo Cardiovascular Corp., Elkton, MD. Firm initiated recall is ongoing.
REASON
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
VOLUME OF PRODUCT IN COMMERCE
31,162 units
DISTRIBUTION
Nationwide

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PRODUCT 
Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial, craniofacial and sternotomy applications. Recall # Z-0546-2010
CODE
Serial Numbers: A3275-03, A7094-01, B1536-06, B1536-07, B3532-02, B8465-09, C3472-08, C7120-02, C7255-01, D1646-02, D1972-01, D1972-04, D2604-01, D2604-04, D4212-05, D5683-03, D6441-01, D6504-05, P00197407, P00204906, P00360920 - P00360924, P00363252 - P00363256, P00364049 - P00364052, P00365059 - P00365061, P00365786 - P00365792, P00365794, P00365799, P00365800, P00368100 - P00368103, P00369724 - P00369726, P00369728, P00372167 - P00372171, T-1035-07, T2648-02, T3188-06 and T5016-02
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, Fort Worth, TX, by letter dated November 30, 2009. Firm initiated recall is ongoing.
REASON
Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
Nationwide, Great Britain, Brazil, Turkey, Singapore and the Netherlands
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PRODUCT
Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Recall # Z-0547-2010
CODE
Lot Numbers: 544202, 545693 and 546614
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Maple Grove, MN, by letter dated November 20, 2009. Firm initiated recall is ongoing.
REASON
It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009.
VOLUME OF PRODUCT IN COMMERCE
274 units
DISTRIBUTION
Nationwide, Canada, France, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Taiwan and Turkey
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PRODUCT 
Hill-Rom Affinity Four Birthing Bed; Model P3700B. Intended to be used as birthing beds for women of child bearing age in a labor, delivery, recovery or postpartum setting in acute care. Recall # Z-0548-2010
CODE
All beds distributed between 11/27/06 and 6/18/08. Serial Numbers: H299AA4675, H299AA4676, H299AA4679, H299AA4681, H331AA4786, H331AA4787, H331AA4788, H332AA4789, H332AA4790, H332AA4791, H332AA4792, H332AA4793, H332AA4794, H332AA4795, H333AA4796, H333AA4797, H333AA4798, H333AA4799, H333AA4800, H333AA4802, H334AA4803, H334AA4804, H334AA4805, H334AA4807, H334AA4808, H334AA4809, H334AA4810, H335AA4801, H335AA4811, H335AA4812, H335AA4813, H335AA4814, H338AA4822, H338AA4823, H338AA4824, H338AA4825, H338AA4826, H338AA4829, H339AA4831, H339AA4832, H339AA4833, H339AA4835, H339AA4836, H339AA4837, H339AA4838, H339AA4839, H339AA4840, H340AA4841, H340AA4842, H340AA4843, H340AA4844, H340AA4845, H340AA4846, H340AA4849, H340AA4850, H340AA4851, H340AA4852, H341AA4853, H341AA4854, H341AA4855, H341AA4856, H341AA4857, H341AA4860, H341AA4861, H342AA4862, H342AA4863, H342AA4864, H342AA4865, H342AA4868, H342AA4870, H345AA4874, H345AA4875, H345AA4876, H345AA4877, H345AA4879, H345AA4880, H345AA4881, H346AA4883, H346AA4884, H346AA4887, H346AA4889, H347AA4891, H347AA4892, H347AA4893, H347AA4895, H347AA4897, H347AA4899, H347AA4901, H348AA4903, H348AA4905, H348AA4907, H348AA4908, H348AA4910, H348AA4912, H348AA4913, H349AA4917, H349AA4919, H352AA4931, H352AA4933, H353AA4934, H354AA4950, H354AA4951, H355AA4955, H355AA4959, H356AA4964, H356AA4968, I002AA4976, I002AA4980, I002AA4981, I003AA4985, I003AA4987, I003AA4988, I004AA4995, I004AA4997, I004AA4998, I004AA5000, I005AA5006, I005AA5009, I008AA5016, I008AA5017, I008AA5018, I008AA5024, I009AA5026, I009AA5027, I009AA5028, I009AA5029, I009AA5031, I010AA5048, I010AA5049, I011AA5050, I011AA5051, I012AA5070, I015AA5071, I015AA5072, I015AA5073, I015AA5074, I015AA5075, I015AA5076, I015AA5077, I015AA5078, I015AA5080, I016AA5081, I016AA5082, I016AA5084, I016AA5085, I026AA5171, I026AA5172, I029AA5173, I029AA5174, I029AA5175, I029AA5176, I029AA5177, I029AA5178, I029AA5179, I029AA5180, I029AA5181, I029AA5182, I033AA5217, I033AA5218, I033AA5219, I033AA5220, I033AA5221, I033AA5222, I036AA5223, I036AA5225, I036AA5226, I036AA5227, I036AA5228, I036AA5229, I036AA5230, I043AA5267, I043AA5268, I043AA5269, I043AA5270, I043AA5271, I043AA5272, I043AA5273, I044AA5274, I046AA5282, I046AA5283, I046AA5290, I046AA5291, I047AA5292, I047AA5293, I047AA5301, I050AA5311, I050AA5312, I050AA5313, I050AA5314, I051AA5319, I051AA5320, I051AA5321, I051AA5322, I051AA5324, I052AA5325, I052AA5327, I052AA5328, I052AA5329, I052AA5330, I052AA5331, I052AA5332, I052AA5333, I052AA5334, I053AA5335, I053AA5336, I053AA5338, I053AA5339, I053AA5341, I053AA5342, I053AA5343, I053AA5344, I054AA5345, I054AA5346, I054AA5347, I054AA5348, I054AA5349, I054AA5350, I057AA5361, I058AA5368, I058AA5369, I058AA5370, I058AA5371, I058AA5372, I058AA5374, I059AA5375, I059AA5376, I059AA5377, I059AA5378, I059AA5379, I059AA5380, I059AA5382, I059AA5383, I059AA5384, I059AA5385, I060AA5386, I060AA5387, I060AA5388, I060AA5388, I060AA5389, I060AA5390, I060AA5395, I061AA5397, I061AA5402, I061AA5403, I061AA5404, I064AA5405, I064AA5406, I064AA5407, I064AA5408, I064AA5409, I064AA5410, I064AA5412, I064AA5413, I064AA5415, I064AA5416, I064AA5417, I065AA5419, I065AA5421, I065AA5422, I065AA5423, I065AA5424, I065AA5425, I065AA5426, I065AA5428, I065AA5429, I065AA5430, I066AA5431, I066AA5433, I066AA5434, I066AA5436, I066AA5437, I066AA5438, I066AA5439, I066AA5440, I066AA5441, I066AA5442, I067AA5444, I067AA5445, I067AA5446, I067AA5448, I067AA5449, I067AA5451, I067AA5452, I067AA5453, I067AA5454, I067AA5455, I067AA5457, I068AA5458, I068AA5459, I068AA5460, I068AA5461, I068AA5462, I068AA5467, I071AA5473, I071AA5476, I071AA5477, I071AA5478, I071AA5479, I071AA5480, I071AA5483, I071AA5484, I071AA5486, I072AA5487, I072AA5488, I072AA5489, I072AA5492, I072AA5494, I072AA5495, I072AA5496, I072AA5501, I073AA5502, I073AA5503, I073AA5505, I073AA5506, I073AA5507, I073AA5508, I073AA5509, I073AA5511, I073AA5512, I073AA5513, I073AA5514, I073AA5515, I073AA5517, I074AA5518, I074AA5519, I074AA5524, I074AA5525, I074AA5527, I074AA5528, I074AA5529, I074AA5530, I074AA5531, I074AA5532, I075AA5535, I075AA5536, I075AA5537, I075AA5538, I075AA5539, I075AA5540, I075AA5541, I075AA5543, I075AA5544, I076AA5547, I076AA5549, I078AA5550, I078AA5552, I078AA5553, I078AA5555, I078AA5556, I078AA5557, I078AA5558, I078AA5559, I078AA5560, I078AA5561, I078AA5562, I079AA5563, I079AA5564, I079AA5565, I079AA5566, I079AA5567, I079AA5568, I079AA5569, I079AA5570, I079AA5571, I079AA5572, I079AA5573, I079AA5574, I079AA5575, I080AA5576, I080AA5577, I080AA5578, I080AA5579, I080AA5580, I080AA5582, I080AA5584, I080AA5585, I080AA5586, I080AA5587, I080AA5590, I080AA5591, I081AA5592, I081AA5595, I081AA5596, I081AA5597, I081AA5598, I081AA5599, I081AA5602, I081AA5604, I081AA5605, I081AA5607, I081AA5609, I081AA5610, I082AA5612, I082AA5613, I082AA5615, I082AA5616, I082AA5618, I082AA5621, I082AA5623, I082AA5624, I082AA5625, I085AA5626, I085AA5627, I085AA5628, I085AA5629, I085AA5630, I085AA5631, I085AA5632, I085AA5635, I085AA5636, I085AA5637, I085AA5639, I086AA5641, I087AA5642, I087AA5643, I087AA5644, I087AA5647, I087AA5649, I087AA5650, I088AA5655, I088AA5656, I088AA5658, I088AA5660, I088AA5661, I088AA5662, I088AA5663, I088AA5664, I088AA5666, I089AA5669, I089AA5676, I089AA5679, I092AA5680, I092AA5681, I092AA5683, I093AA5684, I093AA5685, I093AA5686, I093AA5687, I093AA5688, I093AA5690, I093AA5691, I093AA5693, I093AA5695, I094AA5698, I094AA5700, I094AA5703, I094AA5704, I094AA5708, I095AA5712, I095AA5713, I095AA5716, I095AA5719, I095AA5721, I099AA5726, I099AA5727, I099AA5728, I099AA5729, I099AA5730, I099AA5731, I099AA5732, I099AA5733, I099AA5735, I099AA5736, I099AA5737, I099AA5738, I099AA5739, I100AA5742, I100AA5744, I100AA5745, I100AA5746, I100AA5748, I100AA5749, I100AA5752, I100AA5753, I100AA5754, I100AA5755, I100AA5756, I101AA5757, I101AA5758, I101AA5759, I101AA5760, I101AA5763, I101AA5764, I101AA5765, I101AA5766, I101AA5767, I101AA5768, I101AA5769, I101AA5770, I102AA5773, I102AA5775, I102AA5777, I102AA5779, I102AA5785, I102AA5787, I103AA5788, I103AA5789, I103AA5791, I103AA5792, I103AA5793, I103AA5796, I103AA5800, I103AA5802, I106AA5804, I106AA5805, I106AA5806, I106AA5809, I106AA5811, I106AA5812, I106AA5813, I106AA5814, I106AA5815, I106AA5816, I106AA5817, I106AA5818, I107AA5819, I107AA5820, I107AA5821, I107AA5822, I107AA5823, I107AA5824, I107AA5825, I107AA5826, I107AA5827, I107AA5828, I107AA5829, I107AA5830, I107AA5831, I107AA5832, I107AA5833, I108AA5834, I108AA5835, I108AA5836, I108AA5837, I108AA5838, I108AA5839, I108AA5841, I108AA5842, I109AA5850, I109AA5856, I109AA5858, I110AA5863, I110AA5864, I110AA5866, I110AA5867, I110AA5868, I110AA5869, I110AA5870, I110AA5871, I110AA5873, I110AA5874, I110AA5875, I113AA5876, I113AA5877, I113AA5878, I113AA5879, I113AA5880, I113AA5881, I113AA5882, I113AA5884, I113AA5885, I113AA5886, I113AA5887, I113AA5889, I113AA5890, I113AA5891, I114AA5892, I114AA5893, I114AA5895, I114AA5896, I114AA5897, I114AA5898, I114AA5899, I115AA5909, I116AA5927, I116AA5929, I116AA5930, I116AA5931, I116AA5932, I116AA5933, I116AA5934, I116AA5935, I117AA5936, I117AA5937, I117AA5938, I117AA5940, I117AA5941, I117AA5942, I117AA5943, I117AA5945, I117AA5946, I117AA5947, I117AA5948, I120AA5952, I120AA5954, I120AA5956, I120AA5957, I120AA5959, I120AA5960, I120AA5961, I120AA5962, I120AA5963, I120AA5965, I121AA5967, I121AA5968, I121AA5969, I121AA5971, I121AA5972, I121AA5973, I121AA5974, I121AA5976, I121AA5980, I121AA5982, I122AA5986, I122AA5988, I122AA5990, I122AA5993, I122AA5994, I122AA5997, I123AA6000, I123AA6001, I123AA6003, I123AA6005, I123AA6007, I123AA6008, I123AA6009, I123AA6010, I123AA6011, I123AA6012, I123AA6013, I123AA6014, I123AA6015, I123AA6016, I124AA6017, I124AA6019, I124AA6021, I124AA6022, I124AA6024, I124AA6026, I124AA6028, I124AA6030, I124AA6031, I127AA6032, I127AA6033, I127AA6034, I127AA6035, I127AA6036, I127AA6037, I127AA6038, I127AA6041, I127AA6042, I127AA6045, I127AA6046, I127AA6047, I128AA6050, I128AA6051, I128AA6052, I128AA6053, I128AA6054, I128AA6055, I129AA6065, I129AA6067, I129AA6069, I129AA6070, I129AA6071, I129AA6072, I129AA6073, I129AA6075, I129AA6076, I129AA6077, I130AA6081, I130AA6085, I130AA6086, I130AA6091, I131AA6096, I131AA6103, I131AA6104, I131AA6106, I134AA6113, I134AA6114, I134AA6115, I134AA6119, I134AA6121, I134AA6122, I134AA6123, I134AA6124, I134AA6125, I134AA6129, I135AA6134, I135AA6137, I135AA6139, I135AA6140, I135AA6141, I135AA6142, I135AA6143, I135AA6144, I136AA6146, I136AA6147, I136AA6148, I136AA6149, I136AA6150, I136AA6151, I136AA6152, I136AA6153, I136AA6155, I136AA6157, I136AA6158, I137AA6165, I138AA6179, I138AA6190, I141AA6195, I141AA6197, I141AA6198, I141AA6199, I141AA6200, I141AA6201, I141AA6206, I142AA6213, I142AA6215, I142AA6216, I142AA6217, I142AA6218, I142AA6219, I142AA6220, I142AA6221, I143AA6223, I144AA6246, I144AA6247, I144AA6249, I144AA6250, I144AA6251, I144AA6252, I144AA6253, I145AA6264, I145AA6265, I145AA6266, I149AA6268, I149AA6269, I149AA6270, I149AA6271, I149AA6272, I149AA6273, I149AA6274, I149AA6276, I149AA6277, I150AA6279, 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J044AA8069, J044AA8070, J044AA8071, J045AA8072, J045AA8073, J045AA8075, J045AA8079, J045AA8081, J045AA8082, J046AA8089, J046AA8090, J046AA8091, J049AA8092, J049AA8094, J049AA8095, J049AA8095, J049AA8096, J049AA8097, J049AA8098, J049AA8098, J049AA8099, J049AA8100, J049AA8101, J050AA8102, J050AA8103, J050AA8104, J050AA8104, J050AA8105, J050AA8106, J050AA8106, J050AA8107, J050AA8108, J050AA8109, J050AA8110, J050AA8110, J050AA8111, J051AA8112, J051AA8113, J051AA8114, J051AA8114, J051AA8115, J051AA8115, J051AA8116, J052AA8123, J052AA8127, J056AA8143, J056AA8144, J056AA8145, J056AA8146, J056AA8147, J056AA8148, J056AA8150, J057AA8153, J057AA8155, J057AA8156, J057AA8157, J057AA8159, J057AA8161, J058AA8167, J058AA8168, J058AA8169, J058AA8172, J058AA8177, J059AA8180, J059AA8182, J059AA8183, J059AA8186, J059AA8187, J059AA8189, J059AA8191, J059AA8194, J060AA8199, J060AA8201, J060AA8207, J060AA8210, J060AA8211, J063AA8213, J063AA8215, J063AA8216, J063AA8217, J063AA8218, J063AA8221, J063AA8222, J063AA8226, J067AA8287, J067AA8288, J067AA8289, J067AA8291, J070AA8293, J070AA8294, J070AA8295, J070AA8296, J070AA8297, J070AA8298, J070AA8299, J070AA8300, J070AA8301, J070AA8302, J070AA8303, J070AA8304, J070AA8305, J070AA8306, J071AA8307, J071AA8308, J071AA8310, J071AA8311, J071AA8312, J071AA8313, J071AA8314, J071AA8315, J071AA8316, J071AA8317, J071AA8318, J071AA8319, J071AA8320, J071AA8321, J072AA8322, J072AA8323, J072AA8324, J072AA8325, J072AA8326, J072AA8327, J072AA8328, J072AA8329, J072AA8330, J072AA8331, J072AA8332, J072AA8333, J072AA8334, J072AA8335, J072AA8336, J072AA8338, J073AA8339, J073AA8340, J073AA8341, J073AA8342, J073AA8343, J073AA8344, J073AA8345, J073AA8346, J073AA8347, J073AA8349, J073AA8351, J073AA8352, J073AA8353, J074AA8354, J074AA8355, J074AA8356, J074AA8357, J074AA8358, J074AA8359, J074AA8360, J074AA8361, J074AA8362, J074AA8363, J074AA8364, J074AA8365, J074AA8366, J074AA8369, J074AA8370, J074AA8371, J074AA8372, J074AA8373, J077AA8374, J077AA8375, J077AA8376, J077AA8377, J077AA8378, J077AA8380, J077AA8381, J077AA8382, J077AA8383, J077AA8384, J077AA8386, J077AA8387, J077AA8388, J077AA8389, J077AA8391, J077AA8392, J078AA8394, J078AA8395, J078AA8396, J078AA8397, J078AA8398, J078AA8399, J078AA8400, J078AA8401, J078AA8402, J078AA8403, J078AA8404, J078AA8405, J078AA8406, J078AA8407, J078AA8408, J078AA8409, J079AA8412, J079AA8415, J079AA8416, J079AA8418, J079AA8420, J079AA8422, J080AA8430, J080AA8432, J080AA8435, J080AA8437, J080AA8438, J080AA8440, J080AA8444, J084AA8445, J084AA8446, J084AA8447, J084AA8448, J084AA8449, J084AA8450, J084AA8453, J084AA8455, J084AA8456, J085AA8460, J085AA8461, J085AA8463, J085AA8465, J085AA8468, J085AA8469, J086AA8470, J086AA8476, J086AA8477, J086AA8478, J086AA8483, J086AA8486, J087AA8489, J087AA8492, J087AA8495, J087AA8496, J087AA8500, J087AA8501, J088AA8507, J088AA8510, J088AA8514, J088AA8516, J088AA8519, J091AA8523, J091AA8524, J091AA8525, J091AA8526, J091AA8527, J091AA8528, J091AA8529, J091AA8530, J091AA8531, J092AA8532, J092AA8533, J092AA8534, J092AA8535, J092AA8538, J093AA8540, J093AA8542, J093AA8544, J093AA8548, J094AA8550, J094AA8553, J094AA8555, J094AA8560, J095AA8562, J095AA8564, J095AA8566, J095AA8568, J095AA8570, J098AA8571, J098AA8572, J098AA8573, J098AA8574, J098AA8575, J098AA8576, J098AA8577, J098AA8578, J098AA8579, J099AA8580, J099AA8581, J099AA8582, J099AA8583, J099AA8584, J099AA8585, J099AA8586, J099AA8587, J099AA8588, J099AA8589, J099AA8590, J100AA8592, J100AA8593, J100AA8594, J100AA8595, J100AA8597, J100AA8599, J101AA8602, J101AA8603, J101AA8604, J101AA8605, J101AA8606, J101AA8607, J102AA8608, J102AA8609, J102AA8610, J102AA8613, J102AA8615, J102AA8617, J102AA8618, J105AA8619, J105AA8620, J105AA8621, J105AA8623, J105AA8627, J105AA8628, J106AA8633, J106AA8635, J106AA8637, J106AA8638, J106AA8639, J107AA8640, J107AA8641, J107AA8643, J107AA8644, J107AA8646, J107AA8648, J107AA8649, J107AA8650, J108AA8651, J108AA8654, J108AA8656, J108AA8658, J108AA8659, J108AA8660, J109AA8661, J109AA8662, J109AA8663, J109AA8665, J109AA8666, J109AA8667, J109AA8668, J109AA8669, J112AA8671, J112AA8672, J112AA8673, J112AA8674, J112AA8675, J112AA8676, J112AA8677, J112AA8678, J112AA8679, J112AA8680, J113AA8681, J113AA8682, J113AA8683, J113AA8685, J113AA8686, J113AA8690, J114AA8691, J114AA8692, J114AA8693, J114AA8695, J114AA8697, J114AA8698, J114AA8699, J115AA8702, J115AA8704, J115AA8705, J115AA8706, J115AA8708, J115AA8710, J116AA8713, J116AA8715, J116AA8717, J116AA8718, J116AA8719, J116AA8720, J119AA8721, J119AA8722, J119AA8723, J119AA8724, J119AA8725, J119AA8726, J119AA8727, J119AA8730, J120AA8731, J120AA8732, J120AA8733, J120AA8734, J120AA8735, J120AA8736, J120AA8737, J120AA8738, J120AA8739, J120AA8740, J121AA8741, J121AA8743, J121AA8745, J121AA8746, J121AA8747, J121AA8748, J121AA8749, J122AA8752, J122AA8753, J122AA8754, J122AA8755, J122AA8756, J122AA8757, J122AA8758, J122AA8759, J122AA8760, J122AA8761, J123AA8762, J123AA8763, J123AA8764, J123AA8765, J123AA8766, J123AA8767, J123AA8768, J123AA8771, J126AA8772, J126AA8773, J126AA8774, J126AA8775, J126AA8776, J126AA8777, J126AA8778, J126AA8779, J126AA8780, J126AA8781, J127AA8782, J127AA8783, J127AA8784, J127AA8785, J127AA8786, J127AA8787, J127AA8788, J127AA8789, J127AA8790, J127AA8791, J128AA8794, J128AA8796, J128AA8797, J128AA8800, J128AA8802, J129AA8803, J129AA8804, J129AA8805, J129AA8806, J129AA8807, J129AA8808, J129AA8810, J129AA8811, J129AA8812, J129AA8813, J130AA8814, J130AA8815, J130AA8816, J130AA8819, J130AA8821, J130AA8823, J133AA8825, J133AA8826, J133AA8827, J133AA8828, J133AA8829, J133AA8831, J133AA8832, J134AA8833, J134AA8834, J134AA8835, J134AA8836, J134AA8837, J134AA8838, J134AA8839, J134AA8840, J134AA8841, J134AA8843, J135AA8844, J135AA8846, J135AA8849, J135AA8850, J135AA8851, J136AA8855, J137AA8865, J137AA8872, J137AA8873, J140AA8874, J140AA8875, J140AA8877, J140AA8878, J140AA8879, J140AA8880, J140AA8881, J141AA8886, J142AA8896, J143AA8904, J143AA8907, J143AA8909, J143AA8910, J143AA8911, J143AA8912, J143AA8913, J144AA8914, J144AA8916, J144AA8917, J144AA8918, J144AA8919, J144AA8920, J144AA8921, J144AA8922, J144AA8923, J148AA8925, J148AA8926, J148AA8927, J148AA8928, J148AA8929, J148AA8930, J148AA8931, J148AA8932, J148AA8933, J149AA8934, J149AA8935, J149AA8937, J149AA8938, J149AA8939, J149AA8941, J149AA8942, J149AA8943, J149AA8944, J149AA8945, J150AA8946, J150AA8947, J150AA8948, J150AA8949, J150AA8950, J150AA8951, J150AA8952, J150AA8953, J150AA8954, J150AA8955, J151AA8956, J151AA8957, J151AA8958, J151AA8959, J151AA8965, J154AA8967, J154AA8969, J154AA8970, J154AA8971, J154AA8972, J154AA8973, J154AA8974, J154AA8975, J154AA8976, J154AA8977, J155AA8979, J155AA8980, J155AA8981, J155AA8982, J155AA8983, J155AA8984, J155AA8985, J155AA8988, J155AA8990, J155AA8991, J156AA8992, J156AA8993, J156AA8994, J156AA8995, J156AA8996, J156AA8999, J156AA9001, J156AA9004, J157AA9005, J157AA9008, J157AA9009, J157AA9012, J157AA9013, J158AA9017, J158AA9019, J158AA9021, J158AA9023, J158AA9024, J158AA9030, J161AA9032, J161AA9033, J161AA9034, J161AA9035, J161AA9036, J161AA9037, J161AA9038, J161AA9039, J161AA9040, J161AA9042, J161AA9043, J161AA9044, J162AA9045, J162AA9046, J162AA9047, J162AA9048, J162AA9049, J162AA9050, J162AA9051, J162AA9052, J162AA9054, J162AA9056, J163AA9061, J163AA9066, J164AA9072, J164AA9076, J164AA9079, J165AA9086, J165AA9087, J165AA9090, J168AA9099, J168AA9100, J168AA9101, J168AA9102, J168AA9103, J168AA9104, J168AA9105, J168AA9106, J168AA9108, J168AA9109, J168AA9110, J169AA9111, J169AA9112, J169AA9113, J169AA9114, J169AA9115, J169AA9116, J169AA9119, J169AA9120, J170AA9122, J170AA9124, J170AA9125, J170AA9126, J170AA9127, J170AA9128, J170AA9130, J170AA9131, J170AA9132, J170AA9133, J170AA9135 and J170AA9136
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated November 16, 2009. Firm initiated recall is ongoing.
REASON
The brakes may not hold or lock.
VOLUME OF PRODUCT IN COMMERCE
2,551 (US), 4171 (OUS)
DISTRIBUTION
Nationwide, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Netherlands, Poland, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Syria, Thailand, Turkey and United Arab Emirates
___________________________________
PRODUCT
Delta/Delta XL Monitors with Omega S Package. Catalog numbers MS18597 and MS18596. Recall # Z-0582-2010
CODE
Catalog numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated November 2009.
Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing.
REASON
Monitor is rebooting/resetting.
VOLUME OF PRODUCT IN COMMERCE
4,188 units
DISTRIBUTION
CA, CO, CT, ID, IN, KY, MS, NY, OK, WI, United Arab Emirates, Argentina, Austria, Australia, Bosnia Herz, Belgium, Benin, Brunei Darussalam, Bolivia, Brazil, Belarus, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, Great Britain, Greece, Hong Kong, Croatia, Hungary, Ireland, India, Iran, Italy, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Lithuania, Latvia, Libya, Morocco, Mexico, Malaysia, Netherlands, Norway, Nepal, Oman, Poland, Portugal, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovak Republic, Thailand, Turkey, Taiwan, Ukraine, Venezuela, Vietnam, and South Africa
___________________________________
PRODUCT 
1) Symbia S Series SPECT System; Single-Photon Emission Computed Tomography.  Part: 8717741. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Recall # Z-0583-2010;

2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography). Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. a) Part: 8717733, b) Part: 10275007, c) Part 10275008, d) Part: 10275009, e) Part 10275010. Recall # Z-0584-2010
CODE
1), Serial Numbers: 1006, 1007, 1008, 1009, 1019, 1021, 1022, 1024, 1032, 1033, 1034, 1035, 1038, 1044, 1045, 1049, 1051, 1054, 1057, 1058, 1062, 1067, 1069, 1073, 1081, 1082, 1083, 1088, 1092, 1094, 1095, 1103, 1104, 1115, 1116, 1121, 1124, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1145, 1149, 1150, 1151, 1152, 1156, 1157, 1159, 1160, 1161, 1162, 1163, 1167, 1169, 1179, 1181, 1182, 1183, 1184, 1186, 1187, 1190, 1191, 1197, 1199, 1201, 1207, 1211, 1214, 1215, 1216, 1220, 1224, 1225, 1229, 1230, 1232, 1242, 1243, 1245, 1246, 1252, 1253, 1254, 1255, 1258, 1267, 1269, 1271, 1275, 1277, 1282, 1288, 1293, 1299, 1304, 1312, 1313, 1317, 1320, 1321, 1322, 1323, 1327, 1329, 1331, 1332, 1334, 1343, 1348, 1349, 1363, 1364, 1366, 1368, 1372, 1376, 1380, 1385, 1386, 1387, 1389, 1392, 1398, 1399, 1402, 1404, 1405, 1409, 1411 and 1412;

2) a) Serial Numbers: 1015, 1027, 1037, 1046, 1061, 1065, 1068, 1072, 1074, 1076, 1077, 1078, 1092, 1095, 1102, 1120, 1121, 1122, 1127, 1128, 1131, 1136, 1143, 1145, 1146, 1148, 1151, 1153, 1169, 1171, 1172, 1174, 1175, 1179, 1190 and 1192; b) Serial Numbers: 1021, 1030, 1034, 1039, 1052, 1060, 1061, 1064, 1065, 1070, 1071, 1074, 1079, 1085, 1091, 1093, 1098; c) serial number 1003, 1005, 1011, 1013, 1014, 1015, 1023, 1038, 1039, 1044, 1046, 1056, 1065, 1066, 1068, 1071, 1072, 1076, 1082, 1084, 1094, 1097 and 1105; d) Serial Numbers: 1003, 1004, 1008, 1009, 1015, 1026, 1027, 1033, 1034, 1037, 1040, 1047, 1053, 1058, 1066 and 1071; and e) Serial Numbers: 1008, 1011, 1018, 1026 and 1029
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated November 18, 2009 and December 11, 2009.
Manufacturer: Advanced Input Devices Inc., Coeur D Alene, ID. Firm initiated recall is ongoing.
REASON
Some of the hand controllers of the Symbia S & T systems are missing a resistor switch, and the absence of the switch may lead to unintended system motion during camera set up activities.
VOLUME OF PRODUCT IN COMMERCE
232 units
DISTRIBUTION
Nationwide, Algeria, Australia, Austria, Belgium, Canada, Chile, China, Finland, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Mexico, Netherlands, Norway, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Spain, Sweden, Taiwan, Turkey, Venezuela and Vietnam
___________________________________
PRODUCT 
1) Maquet Servo Ventilator 300/300A (SV300) Siemens - Elema AB. Ventilators within the specific range that are marked with one of the following labels are already equipped with the new type of pressure transducer. 1. Upgrade EM008/02/1; 2. Upgrade SV300 66 82 745 SV900 66 82 747. Recall # Z-0588-2010;

2) Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden Ventilators within the specified serial number range, that are marked with on of the following labels on the inside of the lid of the pneumatic unit are exempted since they have already been fitted with a new type of the pressure transducer. 1. Upgrade EMO 12/02/1; 2. Upgrade SV300 6682-745 SV900 66 82 747. Recall # Z-0589-2010
CODE
1) Serial numbers 00410-24999;
2) Serial Numbers 010001-188499
RECALLING FIRM/MANUFACTURER
Recalling Firm: MAQUET Inc., Wayne, NJ, by letters commencing November 17, 2009 and ending November 23, 2009.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
Some Servo Ventilators 300/300A and Servo Ventilator 900C/D/E should not be used with a system that may generate negative pressure below -100 cm H2O (Closed system suctioning) due to the risk of damaging the ventilator's pressure transducers.
VOLUME OF PRODUCT IN COMMERCE
SV300 - 7847 units, SV900- 8438 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 6, 2010

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