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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 14, 2010

April 14, 2010                                                                                        10-14

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Gold Coast Natural Flavor Enhancer, Gold Coast Ingredients #314740R. Recall # F-1656-2010
CODE
Lot #99734
RECALLING FIRM/MANUFACTURER
Gold Coast Ingredients, Inc., Commerce, CA, by letters on February 27, 2010 and March 1, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
160 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Ranch House Dressing in carton stating Stone Mill Foods Net Wt 8 lb. 2/8 lb. cartons/case UPC 54627.20327. Recall # F-1657-2010;

2) Reser's Ranch Dip in 4 oz. plastic cups, 12/4 oz/case UPC 71117.17050; Reser's Creamy Ranch Dip in 8 oz. cups, 12/8 oz. cups/case UPC 71117.00171; Reser's Creamy Ranch Dip in 8 lb cartons, 2/8 lb/case UPC 17771.16981. Recall # F-1658-2010;

3) Reser's Creamy Clam Dip in 8 oz. cups, UPC 71117.00240 12/8 oz/case. Recall # F-1659-2010;

4) Reser's French Onion Dip in 8 oz. cups, 12/8 oz/case UPC 71117.00243. Recall # F-1660-2010;

5) RESER'S Cheese & Bacon Dip in 8 oz. plastic cups, UPC 71117.00249 12/8 oz/case. Recall # F-1661-2010;

6) Red Potato Salad with Dill: a) The Deli Counter Red Potato With Dill Salad Net Wt 16 oz, 12/16 oz./case UPC 21130.06741; b) Red Potato Salad with Dill for Safeway Net Wt 5 lb, 2/5 lb. plastic tubs/case UPC 71117.06031. Recall # F-1662-2010;

7) WAL*MART DELI Red Skin Potato Salad Net wt 16 oz. in plastic container 12/16 oz. containers/case UPC 81131.91681; 32 oz in plastic container, 6/32 oz. containers/case UPC 81131.91687. Recall # F-1663-2010;

8) RESER'S Ranch Dressing in 2/8 lb. cartons/ case UPC 71117.14751. Recall # F-1664-2010
CODE
1) Use by date codes 1/23/2010 through 4/27/2010;

2) 4 oz. USE by codes 4/29/2010 through 6/5/2010; 8 oz Use by codes of 5/12/2010 through 6/9/2010; 8 lb. Use by codes 5/2/2010 through 6/4/2010;

3) Use by codes of 3/22/2010 through 6/5/2010;

4) Use by codes of 3/1/2010 through 6/5/2010;

5) Use by codes of 4/2/2010 through 5/27/2010;

6) a) Use by codes 3/14/2010 through 4/10/2010; b) Use by codes 2/24/2010 through 4/5/2010;

7) Use by codes 12/27/09 through 4/6/2010;

8) Use by codes 4/25/2010 through 6/5/2010
RECALLING FIRM/MANUFACTURER
Reser’s Fine Foods, Inc. Beaverton, OR, by e-mail, telephone, and press release on March 3, 2010. Firm initiated recall is complete.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
55,159 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1006005, HMF/Dry Roast Seasoning No MSG Added; 250 lb. Recall # F-1665-2010
CODE
Lots 909504-1T, 909504-3T, and 912657-1T
RECALLING FIRM/MANUFACTURER
Circle U Foods, Inc, Fort Worth, TX, by e-mail on February 26, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,500 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
Jehling Shrimp Primavera w/Linguini Stir Fry: COMPLETE MEAL With Oriental Style Vegetables, Shrimp, Linguini and Gourmet Sauce 22oz (1 lb 6 oz) 623g Gusset Bag. Recall # F-1666-2010
CODE
BEST BY: SEP 1 11 (M103.99CT)
RECALLING FIRM/MANUFACTURER
Gourmet Express, Greenville, KY, by letters on March 17, 2010. Firm initiated recall is ongoing.
REASON
The firm had a third party laboratory report a positive result for Salmonella from their production lot.
VOLUME OF PRODUCT IN COMMERCE
945 cases/8/22 oz bags

DISTRIBUTION
IL, IN, MD, MO, OH, PA
___________________________________
PRODUCT
1) IFF Carrollton Net Wt 50.000 lbs. 22.680 KG seasoning Italian Sausage Seasoning 77273. Recall # F-1667-2010;

2) IFF Carrollton seasoning Taco Snack Seasoning GCAS 95068187, custom packaged up to 50 lbs. Recall # F-1668-2010;

3) IFF Carrollton seasoning Achiote Seas (IFF SN504224) 2915205 55504 SN504224, custom packaged up to 50 lbs. Recall # F-1669-2010;

4) IFF Carrollton seasoning Broccoli Cheese Soup 3549605, custom packaged up to 50 lbs. Recall # F-1670-2010;

5) IFF Carrollton seasoning Vegetable Beef Concentrate 3475202, custom packaged up to 50 lbs. Recall # F-1671-2010;

6) IFF Carrollton seasoning Chicken Noodle Soup Seasoning 3543108 / 110051, custom packaged up to 50 lbs. Recall # F-1672-2010;

7) IFF Carrollton seasoning Spicy Italian Seasoning 96055302, custom packaged up to 50 lbs. Recall # F-1673-2010;

8) IFF Carrollton seasoning Pizza Topping Seasoning #72038 96052038, custom packaged up to 50 lbs. Recall # F-1674-2010;

9) IFF Carrollton seasoning Chicken Noodle Soup 3543110 / 110107, custom packaged up to 50 lbs. Recall # F-1675-2010;

10) IFF Carrollton seasoning Nat Beef Flavor K108935000, custom packaged up to 50 lbs. Recall # F-1676-2010;

11) IFF Carrollton seasoning Chipotle Seasoning for BBQ Sauce 2030, custom packaged up to 50 lbs. Recall # F-1677-2010;

12) IFF Carrollton seasoning Chili's Southwestern Seasoning 3065610, custom packaged up to 50 lbs. Recall F-1678-2010;

13) IFF Carrollton seasoning Beef Topping Seasoning # 2657201 96052657, custom packaged up to 50 lbs. Recall # F-1679-2010;

14) IFF Carrollton seasoning Hamburger Seasoning #2680501 96052680, custom packaged up to 50 lbs. Recall # F-1680-2010;

15) IFF Carrollton seasoning Steak Burger Seasoning 3005001, custom packaged up to 50 lbs. Recall # F-1681-2010;

16) IFF Carrollton seasoning Juarez's Chicken Meat 61021, custom packaged up to 50 lbs. Recall # F-1682-2010;

17) IFF Carrollton seasoning Chili Seasoning 3417301 / 110034, custom packaged up to 50 lbs. Recall # F-1683-2010;

18) IFF Carrollton seasoning Turkey Pizza Topping Seasoning 3257101, custom packaged up to 50 lbs. Recall # F-1684-2010;

19) IFF Carrollton seasoning Garden Vegetable Seas SN570666 55500, custom packaged up to 50 lbs. Recall # F-1685-2010;

20) IFF Carrollton seasoning Sausage Seasoning (IFF 3220101) 43064607, custom packaged up to 50 lbs. Recall # F-1686-2010;

21) IFF Carrollton seasoning FM Taco Seasoning #2525901 96058196, custom packaged up to 50 lbs. Recall # F-1687-2010;

22) IFF Carrollton seasoning Hamburger Topping Seasoning 3386403 / 200234, custom packaged up to 50 lbs. Recall # F-1688-2010;

23) IFF Carrollton seasoning Lays Smokey Bacon LSO CDA Seas 30019052, custom packaged up to 50 lbs. Recall # F-1689-2010;

24) IFF Carrollton seasoning Pork Base Seasoning (IFF 77291) 77291, custom packaged up to 50 lbs. Recall # F-1690-2010;

25) IFF Carrollton seasoning Rice Seasoning 3265901, custom packaged up to 50 lbs. Recall # F-1691-2010;

26) IFF Carrollton seasoning Foodmaker Taco Seasoning 78196, custom packaged up to 50 lbs. Recall # F-1692-2010;

27) IFF Carrollton seasoning Taco Bueno Chili 2557807, custom packaged up to 50 lbs. Recall # F-1693-2010;

28) IFF Carrollton seasoning Juarez Chili Con Carne Seasoning 61022, custom packaged up to 50 lbs. Recall # F-1694-2010;

29) IFF Carrollton seasoning Beef Seasoning #76299 96056299, custom packaged up to 50 lbs. Recall # F-1695-2010;

30) IFF Carrollton seasoning Chili Cheese Snack Seasoning SN817663, custom packaged up to 50 lbs. Recall # F-1696-2010;

31) IFF Carrollton seasoning Vegetable Base SN802512, custom packaged up to 50 lbs. Recall # F-1697-2010;

32) IFF seasoning Beef Patty Seasoning 3465302 / 200244, custom packaged up to 50 lbs. Recall # F-1698-2010;

33) IFF Carrollton seasoning Bean Sauce Seasoning #2 #76185 96057685, custom packaged up to 50 lbs. Recall # F-1699-2010;

34) IFF Carrollton seasoning Cheeseburger Snack Seas GCAS 98590816, custom packaged up to 50 lbs. Recall # F-1700-2010
CODE
1) Lot code: 0003307809;

2) Lot codes: 0003086850, 0003086852, 0003086850, 0003157978, 0003157973, 0003157976, 0003203018, 0003203019;

3) Lot codes: 0003193525 and 0003193524;

4) Lot code: 0003167418;

5) Lot code: 0003167423;

6) Lot codes: 0003133955 and 0003203032;

7) 7) Lot code: 0003303401;

8) Lot codes: 0003242621, 0003308254, 0003308252, 0003308255, and 0003308253;

9) Lot codes: 0003249704 and 0003292796;

10) Lot code: 0003303113;

11) Lot code: 0003274023;

12) Lot codes: 0003241839 and 0003287185;

13) Lot codes: 0003276550 and 0003287257;

14) Lot codes: 0003282375 and 0003310265;

15) Lot code: 0003251384;

16) Lot code: 0003275971;

17) Lot codes: 0003228014, 0003244625 and 0003287207;

18) Lot codes: 0003244941 and 0003268377;

19) Lot code: 0003221482;

20) Lot code: 0003221241;

21) Lot codes: 0003198608, 0003198610, 0003198611, 0003198613, 0003198606, 00032343000, 0003234151, 0003234149, 0003234152, and 0003234308;

22) Lot codes: 0003214727, 0003228885, 0003249749, 0003270574, and 0003303084;

23) Lot codes: 0003200539, 0003205998, 0003205938, 0003205937, and 0003273478;

24) Lot code: 0003203048;

25) Lot codes: 0003183696, 0003203051, 0003217320, 0003239314;

26) Lot codes: 0003167518, 0003167520, 0003170599, 0003170601, 0003190673, 0003190674, 0003190678, 0003190680, 0003219346, 0003219345, 0003244391, 0003226334, 0003244394, 0003244390, 0003244397, and 0003244399;

27) Lot codes: 0003167421, 0003186370, 0003231466, 0003276769, and 0003247230;

28) Lot codes: 0003173165 and 0003225139;

29) Lot codes: 0003141394, 0003175567, 0003249311, and 0003290140;

30) Lot code: 0003136604;

31) Lot codes: 0003251378, 0003134703, 0003152936, 0003167384, 0003228017, and 0003290008;

32) Lot codes: 0003129428, 0003134702, 0003190836, 0003214713, 0003228909, and 0003303082;

33) Lot codes: 0003119878, 0003140898, 0003247263, 0003247462, 0003262736;

34) Lot codes: 0003115527, 0003139192, 0003139193
RECALLING FIRM/MANUFACTURER
International Flavors & Fragrances, Inc., Carrollton, TX, by e-mail on March 5, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
161,894.25 kg
DISTRIBUTION
TX, IA, KS, LA, OH, TN, CA, AZ, MD, IL, MA, PA and Canada

___________________________________
PRODUCT
Homemade Gourmet Tortilla Soup Mix 1.96 oz (55.6g) sold individually and as part of two kits: Let's Make Dinner Collection (stock #40.1032) and $800 pre-select order for consultants (stock #37.0320). Recall # F-1701-2010
CODE
Lot codes: S1004812411 and S1004912111
RECALLING FIRM/MANUFACTURER
Hg Food Llc Homemade Gourmet, Canton, TX, by e-mail and telephone beginning March 3, 2010. Firm initiated recall is ongoing.
REASON
Product manufactured using Hydrolyzed Vegetable Protein (HVP) recalled by Basic Food Flavors, Inc.
VOLUME OF PRODUCT IN COMMERCE
320 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Quaker Snack Mix Baked Cheddar Flavored Packaged sizes: 8 oz (UPC: 2840005304) and 1.75 oz (UPC: 2840008407). Recall # F-1702-2010
CODE
Sell-by dated: June 15, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frito Lay, Inc. Plano, TX, by visit starting March 10, 2010 and by press release.
Manufacturer: Roskam Baking Company, Grand Rapids, MI.  Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
691,648 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Mama Fu's asian house Thai Red Curry Sauce for Institutional Use Only Keep Refrigerated. Case Net Wt 30 lbs (13.61 kg), 4 (1 gallon) jugs per case. UPC: 845790000270; SKU: 1103018. Recall # F-1703-2010
CODE
Internal # 1223032
RECALLING FIRM/MANUFACTURER
CFI Foods dba Chefco Foods, Arlington, TX, by telephone and e-mail on March 2, 2010. Firm initiated recall is complete.
REASON
Product was made with Hydrolyzed Vegetable Proteins (HVP) recalled by Basic Food Flavors because it has the potential to contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
26 cases
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Spreadables Gourmet cheese spread Crab Creole, packaged in 7 oz. (198g) plastic tubs 6/case & 32 oz (2.0 lbs) (906g) plastic tub 3/case. Recall # F-1704-2010

2) Spreadables Gourmet cheese spread Shrimp Scampi, packaged in 7 oz. (198g) plastic tubs 6/case & 32 oz (2.0 lbs) (906g) plastic tub 3/case. Recall # F-1705-2010
CODE
1) Sell by Dates: 7oz. tub 5/9/20, 5/2/10, 4/25/10, 5/23/10, 3/21/10, 3/14/10, 5/26/10. 2 lb tub 5/9/10, 5/2/10, 4/25/10, 3/29/10, 5/16/10, 3/21/10, 3/14/10;

2) Sell by Dates: 7oz. tub 5/23/10, 5/16/10, 3/29/10; 2 lb. 5/16/10, 5/23/10, 4/11/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Emmi-Roth Kase USA Ltd, Monroe, WI, by e-mail on March 6, 2010 and letters and telephone on March 8, 2010. 
Manufacturer: Family Fresh Pack, LLC, Belleville, WI. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
266 units
DISTRIBUTION
FL, IL, MA, NJ, PA, WI

___________________________________
PRODUCT
1) 868220 SPM/ Chicken Flavor WONF is a dry ingredient packaged in plastic lined paper bag; Item code: 80265, Quantity: 22.680Kg, (50 lbs). Recall # F-1706-2010;

2) 868748 CB/N&A FLAVOR GRAVY TYPE is a dry ingredient packaged in plastic lined paper bag; Item code: 102693, Quantity: 22.680Kg, (50 lbs). Recall # F-1707-2010
CODE
1) Lot #7634642, Best by 08/01/2010;
2) Lot #7642776K, Best Before :02/03/2011
RECALLING FIRM/MANUFACTURER
Firmenich Inc., New Ulm, MN, by telephone and letter on March 1, 2010 and by letter on March 5, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,150 lbs
DISTRIBUTION
AR, IL
___________________________________
PRODUCT
1) BR4181D, Natural Beef Type Flavor, is a dry powder packaged in a Net Weight: 50 lb poly-lined cardboard box. Recall # F-1708-2010;

2) B2455D, Natural Beef Flavor, is a dry powder packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1709-2010;

3) BVN2390D, Vegetarian Beef Type Flavor, is a dry powder packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1710-2010;

4) BR1755D Beef Broth Flavor is a dry powder packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1711-2010;

5) VGP2299D Natural Chipotle Pepper Flavor is a dry powder packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1712-2010;

6) PH3115D Natural Ham Type Flavor is a dry powder packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1713-2010;

7) 1) BR1069D1 Roast Beef Type Flavor; 2) BR1069D Roast Beef Type Flavor; 3) BR3001D2 Roast Beef Type Flavor; 4) BR3001D Roast Beef Type Flavor; are all the same dry powder ingredients, packaged bulk in a Net Weight: 50 lb poly-lined cardboard boxes. Recall # F-1714-2010
CODE
1) Lot 020510F14 and 021510F02;

2) Lots 01050F05, 020410F11;

3) Lots 12169F02, 120810F02;

4) Lot 01180F03;

5) Lot 12289F03;

6) Lot 020510F13;

7) Lot Numbers: (BR1069D1) 12189F02 & 020810F03; (BR1069D) 021110F03 & 01280F08; (BR3001D2) 020510F32; (BR3001D) 12019F03, 01130F03, 020310F04
RECALLING FIRM/MANUFACTURER
Fontana Flavors, Inc., Janesville, WI, by telephone and letters on March 2, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
24,310 lbs
DISTRIBUTION
IA, IL, IN, LA, MO, WI
___________________________________
PRODUCT
1) Cucumber Dip (10oz), UPC 41130-38062. Recall # F-1715-2010;

2) Pesto Ranch Dip (10oz), UPC 41130-38063. Recall # F-1716-2010;

3) Spinach Dip (10oz), UPC 41130-38061. Recall # F-1717-2010;

4) Bulk Spinach Dip (4 and 5 lb pouches). Recall # F-1718-2010
CODE
All current use by dates.
RECALLING FIRM/MANUFACTURER
Orval Kent Food Co., Inc., Vista, CA, by telephone on March 2, 2010, and by press release on March 4, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
????
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Pacific Natural Spices Chicken Ravioli Seasoning, 50 lb Boxes, Blend #CFG-1252. Recall # F-1719-2010

2) Pacific Natural Spices Chicken Flavor HVP, 50 lb Box. Recall # F-1720-2010
CODE
1) Lot #BL-18417;
2) Lot #S-10518
RECALLING FIRM/MANUFACTURER
Pacific Spice Company, Inc., Commerce, CA, by letter on February 26, 2010. Firm initiated recall is onging.
REASON
The products were repacked and/or manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,800 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
Jeppi South of the Border Mix packed in 16 oz. clear cello bags, UPC: 10288999996. Recall # F-1721-2010
CODE
Lot # P02231006
RECALLING FIRM/MANUFACTURER
Recalling Firm: SCT Corp., Timonium, MD, by telephone, visit and letter on March 5, 2010.
Manufacturers: SCT, Corp., Timonium, MD; T H Foods Inc., Loves Park, IL; Flavor Systems Intl Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
52 lbs
DISTRIBUTION
MD

___________________________________
PRODUCT
1) Herb-ox Beef Flavor Bouillon Instant Broth & Seasoning; packaged in 4 gram packets; item 37384: Net Wt 1.13 oz. (32 g), 8 packet box, UPC 336303 9, case UPC 0 33600 37384 7; item 31075: Net Wt. 7.07 oz. (200 g), 50 packet box, UPC 33600 351883, case UPC 0 33600 31075 0. Recall # F-1722-2010;

2) Herb-ox Beef Flavor Instant Bouillon & Seasoning (Granules); item 42040: Net Wt 4.0 oz. (113 g) plastic jar, UPC 0 336203 0, case UPC 0 33600 42040 4. Recall # F-1723-2010;

3) Herb-ox Chicken Flavor Instant Bouillon & Seasoning (Granules); item 42041: Net Wt 4.0 oz. (113 g) plastic jar, UPC 0 336213 7, case UPC 0 33600 42041 1. Recall # F-1724-2010;

4) Herb-ox Chicken Flavor Bouillon Instant Broth & Seasoning; packaged in 4 gram packets; item 43085: Net Wt 1.13 oz. (32 g), 8 packet box, UPC 336313 6, case UPC 0 33600 43085 4; item 34793: Net Wt. 7.05 oz. (200 g) 50 packet box, UPC 0 33600 34793 0, case UPC 0 33600 30695 1. Recall # F-1725-2010;

5) Herb-ox Vegetable Flavor Bouillon Instant Broth & Seasoning; packaged in 4 gram packets; item 35562: Net Wt. 7.05 oz. (200 g) 50 packet box, UPC 0 33600 35562 1, case UPC 0 33600 31451 2. Recall # F-1726-2010
CODE
1) Lot MAR 2012 / V02220; lot V01190;
2) Lot FEB 2013 / V01210;
3) Lot FEB 2013 / V01200, FEB 2013 / V01250, MAR 2013 / V02030;
4) Lot FEB 2012 / V01280; lots V01290, V02040 and V02080;
5) Lot V02020
RECALLING FIRM/MANUFACTURER
Creative Contract Packaging Corp., LLC, Aurora, IL, by press release on March 5, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
13,990 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tastefully Simple brand Imitation Bacon Bacon in 3 different packages: a) .5 oz. plastic pouch, sold in a cardboard outer container labeled TASTEFULLY SIMPLE The Trio. Box contains three different pouches of product, (one each of bacon bacon, garlic garlic and onion), 12 boxes/case; b) 4.25 net wt. plastic bottle, 12 bottles/case; and c) .5 oz. clear plastic Sample pouch with a white printed labeled Not for Retail Sale, 500 pouches/case. Recall # F-1727-2010
CODE
a) Lot 1223 on each pouch (lot code located on the back of individual pouch and on the box); b) Lot 1230, 1231 and 1234; c) Lot 1222
RECALLING FIRM/MANUFACTURER
Conifer Specialties, Inc., Woodinville, WA, by e-mail and telephone on March 1, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
a) 224 cases; b) 432 cases; c) 4 cases
DISTRIBUTION
MN
___________________________________
PRODUCT
Olde Westport Spice & Trading Co. Garden Harvest Special Blend Seasoning, packaged in 5- and 10-oz. jars and 20-oz. bags. Recall # F-1728-2010
CODE
The product is not coded.
RECALLING FIRM/MANUFACTURER
Olde Westport Spice & Trading Co., Inc., Goodland, KS, by press release and telephone on March 10, 2010.
Manufacturer: Olde Westport Spice & Trading Co., Inc., Olathe, KS. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
47/5-oz. jars, 140/10-oz. jars, and 33/20-oz. bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Sazon Natural Beef Flavor # 1002 48 lbs. net, 50 lbs. gross.  Recall # F-1729-2010;

2) Sazon Natural Chicken Flavor # 1001 53 lbs. net, 55 lbs gross. Recall # F-1730-2010; 

3) Mother Murphy's Labs Nat Flavor Grilled Beef; 50 lbs. net, 52 lbs gross. Type 1052.
Recall # F-1731-2010; 

4) Mother Murphy's Labs Natural Flavor Bacon Type  50 lbs. net, 52 lbs gross;
Type 1140. Recall # F-1732-2010;

5) Givaudan Flavor Blend # 1049; Net Wt. 50 lb., tare 2.2 lbs, gross 52.2 lbs. TCode 46306;
Recall # F-1733-2010;

6) Concord Foods Hydrolyzed Vegetable Protein #2408; Net Wt. 55 lbs., Gross Wt. 57 pounds. Code 20045. Recall # F-1734-2010;

7) Aurochem Concord Foods Hydrolyzed Vegetable Protein #2407; 36 x 55 lbs. net, 57 lbs. gross each. Recall # F-1735-2010
CODE
1) Code # R040, Lot numbers 100108, 091111;
2) Code R039 Lot number 091201;
3) Lot numbers 110113, 091120 and 100209;
4) Lot numbers 091215, 091117;
5) Lot numbers 100106, 091104;
6) Lot numbers: 090917, 100121;
7) Lot Number 091209
RECALLING FIRM/MANUFACTURER
Sterling Food Flavorings LLC, Dayton, NJ, by telephone in early March and by letters on March 5, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
170,015 lbs
DISTRIBUTION
NC, FL, OH, MA, NY
___________________________________
PRODUCT
Fresca Sauce Salsa Fresca Contains: Soy and Wheat Perishable Keep Frozen 5LBS A16908 MFG: 23FEB10***10-054-03 Fresca Sauce A 16908*** ***Keep Frozen Handle With Care Packed For Institutional Use. Recall # F-1736-2010
CODE
09-310-02 through 10-060-03; Lot#10-054-03
RECALLING FIRM/MANUFACTURER
Ready Food, Inc., DBA Main Plant, Denver, CO, by letter March 2, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
414 cases; 12,420 lbs
DISTRIBUTION
MN, IL, NE, VA, MI, CO

___________________________________
PRODUCT
1) Product label reads in part: "OREGON SPICE COMPANY - Morasch Meats-Steak Blend, Fine No MSG Ingredients: HVP (Hydrolyzed Soy Protein, Corn Syrup Solids, Thiamine, HCL) Partially Hydrogenated Soybean Oil, Disodium Inosinate and Disodium Guanylate, Pepper, Salt, Garlic.*** Net Wt 50 lb (22.6 kg). Product is packed in 50 lb cardboard boxes with polyliner. Recall # F-1737-2010;

2) Product label reads in part: "OREGON SPICE COMPANY LDS Beef Stew Seasoning With Starch Ingredients: Modified Corn Starch, Salt, Hydrolyzed Soy Protein, Dextrose, Onion Powder, Caramel Color, Spices, Garlic Powder, Soybean Oil and Natural Flavor. (Contains: Soy), Net Wt 25 lbs (11.3kg). Product is packed in 25 lb cardboard boxes with polyliner. Recall # F-1738-2010
CODE
1) Lot # 100126;
2) Lot # 100216
RECALLING FIRM/MANUFACTURER
Regency Group, Inc., Portland, OR, by letter dated February 25, 2010 and by telephone and e-mail on February 26, 2010. Firm initiated recall is complete.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,900 lbs
DISTRIBUTION
OR, UT
___________________________________
PRODUCT
PrescriptFit Beef Soup, Net Wt. 33.38 oz. (953 g). Recall # F-1739-2010
CODE
Lot  # 1200901 and Lot # 1032901
RECALLING FIRM/MANUFACTURER
Hol-N-One, Inc., Fordyce, AR, by letter on February 26, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,080 units
DISTRIBUTION
MS

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Taste Maker/Reed Food Technology brand Chicken Base, Net Wt 20 lbs. Recall # F-1647-2010;

2) Humdinger Rice Seasoning, Net Wt 25 lbs. Recall # F-1648-2010;

3) Johnny Jam Herbal Dressing and Marinade, Net Wt: 50 lbs. Recall # F-1649-2010;

4) Black-eyed Pea brand, Chicken Base Seasoning, Net Wt: 20 lbs. Recall # F-1650-2010;

5) Black-eyed Pea brand, Green Bean Seasoning, Packed: 20/18 oz Bags, Net Wt: 22.5 lbs. Recall # F-1651-2010;

6) Black-eyed Pea brand, Seasoning, Packed: 30/18 oz Bags, Net Wt: 33.75 lbs. Recall # F-1652-2010;

7) O'Charleys brand, Special Herb Seasoning, Packed: 8/1 lbs., Net Wt: 8 lbs.  Recall # F-1653-2010;

8) Taste Maker/Reed Food Technology brand Brown Gravy Mix, Packed 8/16 ozs, Net Wt: 8 lbs. Recall # F-1654-2010;

9) Taste Maker/Reed Food Technology brand Ole South Chicken Breading, Net Wt: 25 lbs. Recall # F-1655-2010
CODE
1) Lot Number: 1002701F1;
2) Lot Numbers: 1004001E1 and 936301F1;
3) Lot Number 000401F1;
4) Lot Numbers: 1001501F1. 100501F1, 1002701E1;
5) Lot Numbers: 935501D1, 100801D1;
6) Lot Numbers: 1000801D1, 1000802D1, 1004801D1;
7) Lot Numbers: 1005301D1, 1003401E1, 1000601D1;
8) Lot Number: 1002601D1;
9) Lot Number: 1004601A1;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taste Maker Foods AKA Berclair Corp., Memphis, TN, by facsimile on February 23, 2010 and by facsimile and e-mail on February 26 and 27, 2010.
Manufacturer: Basic Food Flavors, Inc., North Las Vegas, NV. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
852 units
DISTRIBUTION
TX, LA, KY, IN, TN, MS

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Cleviprex (clevidipine butyrate) injectable emulsion (0.5 mg/mL); 25 mg/50 mL single use vials (NDC 65293-002-50) packaged in a 10-count carton (NDC 65293-002-55); 50 mg/100 mL single use vials (NDC 65293-002-00) packaged in a 10-count carton (NDC 65293-002-11); Rx only. Recall # D-398-2010
CODE
Lot #: 68-407-DJ, Exp 08/10; 68-408-DJ, Exp 08/11; 71-101-DJ and 71-106-DJ, Exp 11/11
RECALLING FIRM/MANUFACTURER
The Medicines Company, Parsippany, NJ, by press release and letters on March 17, 2010.
Manufacturer: Hospira, Inc., Clayton, NC. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: The firm is expanding the recall of Cleviprex to include four additional lots due to the potential presence of stainless steel particulates.
VOLUME OF PRODUCT IN COMMERCE
4,671 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Ipratropium Bromide Nasal Solution, 0.03%, 30 mL bottle, Rx only, NDC 60505-0826-1. Recall # D-399-2010

2) Ipratropium Bromide Nasal Solution, 0.06%, 15 mL bottle, Rx only, NDC 60505-0827-1. Recall # D-400-2010;

3) Fluticasone Propionate USP Nasal Spray, 50 mcg per spray, 16 g net fill weight, 120 Metered Sprays per bottle, Rx Only; NDC 60505-0829-1. Recall # D-401-2010
CODE
1) Lot: JK0843, Exp 01/12;
2) Lot: JK0840, Exp 12/11;  
3) Lot: JJ7064, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL, by first class mail and e-mail on March 16, 2010. 
Manufacturer: Apotex Inc., Richmond Hill, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): Product is being recalled due to possible contamination with metal fragments.
VOLUME OF PRODUCT IN COMMERCE
299,348 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IXEMPRA Kit (ixabepilone) for injection; 15 mg, Rx only. For intravenous infusion only. Each carton contains: 1 vial IXEMPRA (ixabepilone) for injection 15 mg; 1 vial DILUENT for IXEMPRA 8 mL; Refrigerate; NDC 0015-1910-12. Recall # D-405-2010
CODE
Lot number 8K017C, Exp. Nov 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick , by letters were mailed on March 23, 2010.
Manufacturer: Baxter Oncology GmbH, Halle/Westfalen, Germany. Firm initiated recall is ongoing.
REASON
Labeling Label Mix-Up: IXEMPRA vial within kits with lot number 8K017C is labeled as "Diluent for IXEMPRA for injection 8mL."
VOLUME OF PRODUCT IN COMMERCE
906 Vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Glycopyrrolate Tablets USP, 1 mg, 100 count bottle, Rx only. NDC# 64980-131-01. Recall # D-406-2010

2) Glycopyrrolate Tablets USP, 2 mg, 100 count bottle, Rx only. NDC# 64980-132-01. Recall # D-407-2010
CODE
1) Lot # & Exp date: CPA964 12/10; 100991 5/11; 101560 6/11;

2) Lot # & Exp date: CPL7117 1/10 CPE854 5/10 CPF878 6/10 CPL823 11/10 CPA965 12/10 CPA966 12/10 101039 5/11 101540 6/11
RECALLING FIRM/MANUFACTURER
Corepharma Llc, Middlesex, NJ, by telephone on February 16, 2010, followed by a letter on February 17, 2010. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: An investigation had determined that some lots of Glycopyrrolate 1 mg and 2 mg Tablets have the potential to exceed specifications for Impurity-I content over the shelf life of the product.
VOLUME OF PRODUCT IN COMMERCE
68,409 bottles
DISTRIBUTION
NJ
___________________________________
PRODUCT
Benadryl Allergy (Diphenhydramine HCL / Antihistamine), tablets, 25 mg, 148 Ultratab Tablets per bottle, NDC 505580-226-14. Recall # D-408-2010
CODE
Lots #'s: AAA422 Exp Date 11/30/2010, AJA094 Exp Date 5/31/2011, ABA392 Exp Date 11/30/2010, and ALA034 Exp Date 6/30/2011
RECALLING FIRM/MANUFACTURER
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, December 18, 2009 & January 15, 2010.  
Manufacturer: Mcneil Healthcare, Llc, 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
258,720 bottles
DISTRIBUTION
Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

___________________________________
PRODUCT
Simply Sleep Nightime Sleep Aid Contains Diphenhydramine HCL, caplets. 25 mg, 100 count bottle, NDC 50580-843-10. Recall # D-409-2010
CODE
Lots #'s: ADM015 Exp Date: 2/28/2011, ADM016 Exp Date 2/28/2011, AFM014 Exp Date 12/31/2010, AFM352 Exp Date 2/28/2011, AJM319 Exp Date 5/31/2011 , AJM364 Exp Date 7/31/2011 , ALM387 Exp Date 7/31/2011, AMM436 Exp Date 7/31/2011, and AMM438 Exp Date 10/31/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by web posting on November 6, 2009, press release on December 18, 2009 and letters on November 9, 2009, December 18, 2009 & January 15, 2010.
Manufacturer: Mcneil Healthcare, Llc, 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
1,173,744 bottles
DISTRIBUTION
Nationwide, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Tropical Breeze (Triclosan), anti-bacterial foaming soap, 18 fl. oz. Recall # D-402-2010
CODE
Batch number 1003201
RECALLING FIRM/MANUFACTURER
Zep Manufacturer, Atlanta, GA, by telephone on February 22, 2010. Firm initiated recall is complete.
REASON
The product will not meet its normal shelf life of two years due to the presence of spoilage organisms.
VOLUME OF PRODUCT IN COMMERCE
9,720 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Risperidone Tablets USP, 2 mg, 60-count bottle, Rx Only, NDC 5111-204-60. Recall # D-403-2010;

2) Risperidone Tablets USP, 4 mg, 60-count bottle, Rx Only, NDC 5111-206-60. Recall # D-404-2010
CODE
1) Batch # C82255, C82256, C82507, Exp 4/2010;

2) Batch # C82260, C82261, C82262, C82517, Exp 4/2010; Batch # C90426, Exp 10/2010; Batch # C95500, Exp. 9/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy'S Laboratories Inc., Bridgewater, NJ, by
Manufactuer: Dr. Reddy's Laboratories Limited, Anhdra Pradesh, India. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out of Specification results for impurities at the 18 month time point.
VOLUME OF PRODUCT IN COMMERCE
78,876 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0458-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0459-10;
3) Plasma Frozen Within 24 hours (FP24). Recall # B-0460-10;
CODE
1) Unit: 003LK21499;
2) Units: 03KW26270, 003LK21499;
3) Unit: 03KW26270
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone and facsimile on March 27, 2009 and by letters dated March 27, 2009 and May 29, 2009. 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
4 units
DISTRIBUTION
GA, AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0768-10
CODE
Unit: 003E68576
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile and electronic (LOGIC)  on November 28, 2007 and by letter on November 29, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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-0829-10
CODE
Unit: 2916925
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on October 29, 2009. 
Manufacturer: Blood Centers of the Pacific - Cupertino Center, Cupertino, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis- 7d Leukocytes Reduced. Recall # B-0889-10
CODE
Unit: 9919347
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter on March 28, 2008. Firm initiated recall is complete.
REASON
Blood product, found to be contaminated with Corynebacterium species and Staphylococcus species using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0892-10
CODE
Unit: 003FG61564
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile and electronic (LOGIC) on May 4, 2007 and by letter on May 9, 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
SC  

___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0921-10;
2) Cryoprecipitated AHF. Recall # B-0922-10;
3) Fresh Frozen Plasma. Recall # B-0923-10;
4) Plasma Frozen within 24 hours (FP24). Recall # B-0924-10;
5) Red Blood Cells. Recall # B-0925-10;
6) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0926-10;
7) Plasma Cryoprecipitate Reduced. Recall # B-0927-10
CODE
1) Uanits: 040FV20572, 040FV20573, 040FV20575, 040FV20576, 040FV20580, 040FV20581, 040FV20583, 040FW42763, 040FY52466, 040FY52467, 040FY52469, 040FY52470, 040FY52471, 040FY52472, 040FY52479, 040FY52480, 040FY52481, 040FY52482, 040FY52483, 040FY52485, 040FY52486, 040FZ37560, 040FZ37767, 040FZ37773, 040FZ37808, 040GE99339, 040GE99342, 040GE99346, 040GE99353, 040GE99374, 040GG09346, 040GJ73393, 040GJ73396, 040GJ73398, 040GJ73399, 040GJ73410, 040GJ73411, 040GJ73415, 040GJ73416, 040GM13796, 040GM13847, 040GS94724, 040GS94726, 040GS94864, 040GS94916, 040GT64381, 040GT64383, 040GT64384, 040GT64385, 040GZ07866, 040GZ07888, 040GZ07892, 040GZ07911, 040GZ07924, 040GZ07975, 040GZ07979, 040GZ08202, 040LE26687, 040LE26692, 040LE26702, 040LE26705, 040LE26710, 040LT35510, 040LT35514, 040LT35515, 040LT35516, 040LT35521, 040LT35527, 040LT35528, 040LT35529, 040LT35531, 040LT35675, 040LZ29379, 040FJ64623, 040FJ64641, 040FJ64648, 040FJ64900, 040FJ64902, 040FJ64910, 040FJ64918, 040FJ64924, 040FL40274, 040FL40278, 040FL40280, 040FL40281, 040FL40289, 040FL40294, 040FN34730, 040FN34732, 040FN34737, 040FN34741, 040FN34744, 040FN34745, 040FN34749, 040FN34752, 040FN34754, 040FN34757, 040FV20425, 040FW42479, 040FW42491, 040FW42500, 040FW42502, 040FW42504, 040FX39040, 040FX39042, 040FX39049, 040FX39055, 040FX39058, 040FX39417, 040FX39421, 040FX39422, 040FX39423, 040FX39428, 040FX39433, 040FX39436, 040FX39438, 040FX39440, 040FY51458, 040FY52128, 040FY52129, 040FY52131, 040FZ37486, 040GE97422, 040GE97426, 040GE97434, 040GE97441, 040GE97485, 040GE97512, 040GE97515, 040GE97947, 040GE97965, 040GE97982, 040GE98007, 040GE98029, 040GE98074, 040GE98099, 040GE99317, 040GF84695, 040GF84696, 040GF84704, 040GF84706, 040GF84715, 040GF84718, 040GF84726, 040GF84730, 040GF84733, 040GF84738, 040GF84745, 040GF84749, 040GF84751, 040GF84757, 040GF84928, 040GF84932, 040GF84958, 040GF84962, 040GF84993, 040GG08094, 040GG08100, 040GG08109, 040GG08115, 040GG08118, 040GG08123, 040GG08449, 040GG08451, 040GG08467, 040GG08468, 040GG08485, 040GG08489, 040GG08499, 040GG08527, 040GG08544, 040GG09242, 040GG09248, 040GG09252, 040GH84565, 040GH84568, 040GH84571, 040GH84573, 040GH84577, 040GH84580, 040GH84584, 040GH84590, 040GH84593, 040GH84598, 040GH84607, 040GH84608, 040GH85239, 040GH85245, 040GH85286, 040GH85299, 040GH85303, 040GH85316, 040GH85321, 040GH85326, 040GH85329, 040GH85343, 040GH85347, 040GH85389, 040GH85417, 040GH85425, 040GH85438, 040GH85446, 040GH85533, 040GH85535, 040GH85536, 040GH85548, 040GH85555, 040GH85561, 040GH85563, 040GH85565, 040GH85568, 040GH85571, 040GH85573, 040GH85575, 040GH85577, 040GH85579, 040GH86093, 040GH86099, 040GH86134, 040GK73527, 040GK73529, 040GK73530, 040GK73536, 040GK73537, 040GK73540, 040GK73544, 040GK73547, 040GK73548, 040GK73968, 040GK73973, 040GK73974, 040GK73980, 040GK73982, 040GK73986, 040GK73989, 040GK73992, 040GK73993, 040GK74007, 040GK74009, 040GK74012, 040GK74016, 040GK74017, 040GK74027, 040GL17893, 040GL17895, 040GL17906, 040GL17914, 040GL17916, 040GL17924, 040GL17926, 040GL17929, 040GL18956, 040GL18959, 040GM12588, 040GM12590, 040GM12591, 040GM12592, 040GM12594, 040GM12595, 040GM12596, 040GM12597, 040GM12600, 040GM12602, 040GM12604, 040GM12606, 040GM12607, 040GM12613, 040GM12614, 040GM12928, 040GM12931, 040GM12934, 040GM12940, 040GM12941, 040GM12949, 040GM12953, 040GM12956, 040GN23504, 040GN23509, 040GN23519, 040GN23523, 040GN23718, 040GN23735, 040GQ11157, 040GQ11170, 040GQ11181, 040GQ11192, 040GQ11194, 040GQ11253, 040GQ11258, 040GQ11259, 040GQ11265, 040GQ11267, 040GQ11277, 040GR90737, 040GR91032, 040GR91035, 040GR91043, 040GR91052, 040GR91053, 040GR91055, 040GR91057, 040GR91434, 040GR91440, 040GR91454, 040GR91462, 040GR91464, 040GR91470, 040GR91481, 040GR91491, 040GR91495, 040GS93365, 040GS93368, 040GS93370, 040GS93374, 040GS93393, 040GS93430, 040GS93456, 040GS93585, 040GS93586, 040GS93591, 040GS93603, 040GS93609, 040GS93615, 040GS93619, 040GS93626, 040GS93945, 040GS93947, 040GS93951, 040GS93953, 040GS93960, 040GS93968, 040GS93969, 040GS93973, 040GS93976, 040GS93977, 040GT63918, 040GV58863, 040GV58866, 040GV58869, 040GV58872, 040GV58877, 040GV58885, 040GV58887, 040GV58892, 040GV59003, 040GV59005, 040GV59024, 040GV59029, 040GV59048, 040GV59052, 040GV59053, 040GV59054, 040GW69176, 040GW69179, 040GW69182, 040GW69185, 040GW69188, 040GW69194, 040GW69200, 040GW69201, 040GW69205, 040GW69208, 040GW69730, 040GW69742, 040GX66515, 040GX66756, 040GX66761, 040GX66763, 040GX66769, 040GX66776, 040GX66779, 040GX66783, 040GX66784, 040GX66788, 040KL07343, 040KL07347, 040KL07350, 040KL07353, 040KL07357, 040KL07359, 040KL07361, 040KL07363, 040KL07367, 040KL07369, 040KL07372, 040KM06703, 040KM06705, 040KM06707, 040KM06711, 040KM06712, 040KM06714, 040KM06717, 040KN04150, 040KN04151, 040KN04155, 040KN04157, 040KN04159, 040KN04170, 040KN04175, 040KN04179, 040KN04180, 040KN04197, 040KN04201, 040KN04204, 040KN04206, 040KN04211, 040KN04214, 040KN04217, 040LE25915, 040LE25917, 040LE25918, 040LE25921, 040LE25923, 040LE25929, 040LE25933, 040LE26473, 040LL06444, 040LL06446, 040LL06451, 040LL06454, 040LL06459, 040LT33409, 040LT33410, 040LT33412, 040LT33415, 040LT33416, 040LT33417, 040LT33418, 040LT33419, 040LT33422, 040LT33521, 040LT33523, 040LT33526, 040LT33527, 040LT33533, 040LT33534, 040LT33539, 040LT33540, 040LT33541, 040LT33542, 040LT33546, 040LT33547, 040LT33550, 040LT33693, 040LT33694, 040LT33695, 040LT33697, 040LT33698, 040LT33701, 040LT33702, 040LT33703, 040LT33704, 040LT33706, 040LT33710, 040LT33711, 040LT33712, 040LT33714, 040LT33715, 040LT33717, 040LT33718, 040LT33719, 040LT33721, 040LT33724, 040LT33725, 040LT34548, 040LT35186, 040LT35517, 040LT35678, 040LV15944, 040LV15946, 040LV15948, 040LV15954, 040LV15955, 040LV15956, 040LW35735, 040LW35737, 040LW35739, 040LW35741, 040LW35746, 040LX14916, 040LX14919, 040LX14922, 040LX14923, 040LX14924, 040LX14926, 040LX15027, 040LX15032, 040LX15038, 040LX15041, 040LX15051, 040LX15054, 040LX15057, 040LX15356, 040LX15365, 040LX15369, 040LX15380, 040LX15388, 040LX15407, 040LY13726, 040LZ28726, 040LZ28743, 040LZ28752, 040LZ28758, 040LZ28775, 040LZ28779, 040LZ28782, 040LZ28792, 040FJ64897, 040FL40285, 040FL40290, 040FW42506, 040FY52468, 040GG09344, 040GH85288, 040GH85332, 040GS93948, 040GX66531, 040LV15949;

2) Units: 040FN34730, 040FN34732, 040FN34737, 040FN34741, 040FN34745, 040FN34749, 040FN34757, 040FV20425, 040FV20446, 040FW42767, 040FZ37556, 040FZ37557, 040FZ37558, 040FZ37560, 040FZ37561, 040FZ37565, 040FZ37767, 040FZ37778, 040FZ37798, 040GE97390, 040GE97410, 040GE97441, 040GE97473, 040GE99317, 040GE99329, 040GE99342, 040GE97391, 040GE97395, 040GE97396, 040GE97397, 040GE97399, 040GE97404, 040GE97420, 040GE97422, 040GE97426, 040GE97429, 040GE97480, 040GE97491, 040GE97499, 040GE97503, 040GE97523, 040GE97525, 040GE97544, 040GE97553, 040GE97556, 040GE99310, 040GE99315, 040GE99325, 040GE99351, 040GF84688 040GF84696, 040GF84704, 040GF84726, 040GF84733, 040GF84738, 040GF84745, 040GF84757, 040GG08086, 040GG08094, 040GG08101, 040GG08109, 040GG08115, 040GG08121, 040GG08123, 040GG09217, 040GG09242, 040GG09248, 040GG09252, 040GH85387, 040GH85389, 040GH85399, 040GH85401, 040GH85417, 040GH85420, 040GH85425, 040GH85431, 040GH86099, 040GH86134, 040GK73982, 040GK73986, 040GK73989, 040GK74007, 040GK74009, 040GK74016, 040GK74017, 040GK74027, 040GM12931, 040GM12940, 040GM12953, 040GM12928, 040GM12934, 040GM12937, 040GM12941, 040GM12949, 040GM12956, 040GM12959, 040GM13780, 040GM13805, 040GM13842, 040GM13845, 040GN23514, 040GN23519, 040GN23713, 040GN23715, 040GN23723, 040GN23730, 040GN23534, 040GN23735, 040GQ11139, 040GQ11151, 040GQ11157, 040GQ11170, 040GQ11175, 040GQ11183, 040GQ11190, 040GQ11192, 040GQ11194, 040GQ11229, 040GQ11232, 040GQ11249, 040GQ11253, 040GQ11258, 040GQ11259, 040GQ11261, 040GQ11265, 040GQ11267, 040GQ11270, 040GQ11275, 040GR91032, 040GR91033, 040GR91035, 040GR91036, 040GR91039, 040GR91440, 040GR91043, 040GR91044, 040GR91046, 040GR91052, 040GR91055, 040GR91057, 040GR91437, 040GS93365, 040GS93368, 040GS93370, 040GS93374, 040GS93377, 040GS93403, 040GS93405, 040GS93411, 040GS93414, 040GS93422, 040GS93429, 040GS93430, 040GS93433, 040GS93436, 040GS93440, 040GS93442, 040GS93446, 040GS93452, 040GS93612, 040GS93615, 040GS93619, 040GS93626, 040GS94916, 040GT63898, 040GV58863, 040GV58866, 040GV58869, 040GV58872, 040GV58877, 040GV58881, 040GV58885, 040GV58887, 040GV58892, 040GW69176, 040GW69182, 040GW69179, 040GW69188, 040GW69194, 040GW69200, 040GW69201, 040GW69205, 040GW69208, 040GW69893, 040GZ07377, 040GZ07877, 040GZ07880, 040GZ07884, 040GZ07886, 040GZ07888, 040GZ07911, 040GZ07974, 040GZ07979, 040LE25915, 040LE25917, 040LE25918, 040LE25923, 040LE25933, 040LE25935, 040LE26687, 040LE26688, 040LE26692, 040LE26702, 040LT33409, 040LT33410, 040LT33412, 040LT33414, 040LT33415, 040LT33416, 040LT33417, 040LT33418, 040LT33419, 040LT33422, 040LT33527, 040LT33545, 040LT33546, 040LT33547, 040LT33549, 040LT33550, 040LT33693, 040LT33694, 040LT33695, 040LT33698, 040LT33701, 040LT33702, 040LT33703, 040LT33704, 040LT33706, 040LT33710, 040LT33711, 040LT33714, 040LT33715, 040LT33717, 040LT33718, 040LT33719, 040LT33721, 040LT33723, 040LT33724, 040LT33725, 040LT33726, 040LT33727, 040LT34548, 040LT35176, 040LT35186, 040LT35189, 040LT35190, 040LT35510, 040LT35515, 040LT35516, 040LT35517, 040LT35521, 040LT35522, 040LT35527, 040LT35529, 040LT35531, 040LT35687, 040LT35175, 040LT35177, 040LT35514, 040LT35528, 040LT35678, 040LT35688, 040LX14916, 040LX14923, 040LX14926, 040LX15032, 040LX15038, 040LX15041, 040LX15051, 040LX15054, 040LX15356, 040LX15357, 040LX15359, 040LX15362, 040LX15364, 040LX15365, 040LX15369, 040LX15374, 040LX15380, 040LX15384, 040LX15386, 040LX15388, 040LX15390, 040LX15392, 040LX15394, 040LX15397, 040LX15400, 040LX15407, 040LX15409, 040LZ28726, 040LZ28743, 040LZ28752, 040LZ28775, 040LZ28779, 040LZ28792, 040GF84740, 040GF84751, 040GH85398, 040GN23718, 040GN23720, 040GS93409, 040GS93456, 040LX15057;

3) Units: 040FJ64918, 040FX39048, 040FX39058, 040FX39063, 040FX39067, 040GF84984, 040GG09338, 040GL17906, 040GL17916, 040GL17929, 040GR90719, 040GR90726, 040GR90733, 040GW69742, 040GX66776, 040GX66779, 040GX66788, 040KM06703, 040KM06709, 040KM06711, 040KN04151, 040KN04157, 040KN04159, 040KN04197, 040KN04204, 040KN04211, 040KN04214, 040LV15954, 040LV15955, 040LW35735, 040GS93980 (4 units);

4) Units: 040FC22037, 040FJ64621, 040FJ64633, 040FJ64637, 040FJ64658, 040FJ64892, 040FJ64894, 040FJ64902, 040FJ64908, 040FJ64914, 040FJ64915, 040FJ64919, 040FJ64926, 040FJ64927, 040FJ64932, 040FL40280, 040FV20582, 040FW41936, 040FW41939, 040FW41940, 040FW41941, 040FW42479, 040FW42487, 040FW42490, 040FW42500, 040FX39035, 040FX39042, 040FX39049, 040FX39055, 040FX39408, 040FX39417, 040FX39433, 040FY51452, 040FY51456, 040FY51459, 040FY52102, 040FY52104, 040FY52114, 040FY52119, 040FY52125, 040FY52466, 040FY52467, 040FY52469, 040FY52470, 040FY52472, 040FY52473, 040FY52479, 040FY52480, 040GE98073, 040GE98099, 040GE99374, 040GG08499, 040GH84584, 040GH84577, 040GH84590, 040GH84593, 040GH85242, 040GH85282, 040GH85299, 040GH85316, 040GH85535, 040GH85536, 040GH85538, 040GH85544, 040GH85546, 040GH85548, 040GH85553, 040GH85555, 040GH85565, 040GH85568, 040GH85571, 040GH85573, 040GH85575, 040GJ73393, 040GJ73415, 040GK73547, 040GK73548, 040GL18960, 040GM12591, 040GM12592, 040GM12594, 040GM12595, 040GM12596, 040GM12597, 040GM12600, 040GM12604, 040GR90699, 040GR90702, 040GR90705, 040GR90728, 040GS93945, 040GS93947, 040GS93962, 040GS93951, 040GS93960, 040GV59039, 040GW69565, 040GW69568, 040GW69570, 040GW69571, 040GW69730, 040GX66509, 040GX66751, 040GX66761, 040GX66763, 040KL07343, 040KL07347, 040KL07350, 040KL07361, 040KL07363, 040LT35670, 040LZ29379; 

5) Units: 040FW42758, 040FY52488, 040FZ37556, 040FZ37561, 040FZ37565, 040GE99310, 040GE99315, 040GE99325, 040GE99329, 040GE99334, 040GJ73405, 040GJ73412, 040GM13773, 040GM13775, 040GM13778, 040GM13780, 040GM13805, 040GM13842, 040GM13845, 040GS93589, 040GS94705, 040GT64550, 040GW69873, 040GW69877, 040GW69879, 040GW69891, 040GW69893, 040GW69896, 040GW69898, 040GZ07974, 040GZ07982, 040GZ07986, 040LT35522, 040LT35670, 040FC22037, 040FC22044, 040FC22047, 040FC22073, 040FC22076, 040FC22078, 040FJ64621, 040FJ64625, 040FJ64633, 040FJ64637, 040FJ64658, 040FJ64892, 040FJ64906, 040FJ64908, 040FJ64914, 040FJ64915, 040FJ64919, 040FJ64926, 040FJ64927, 040FJ64932, 040FV20446, 040FW41936, 040FW41938, 040FW41939, 040FW41940, 040FW41941, 040FW41942, 040FW42490, 040FW42494, 040FW42495, 040FW42499, 040FX39035, 040FX39036, 040FX39048, 040FX39063, 040FX39067, 040FX39408, 040FY51452, 040FY51454, 040FY51456, 040FY51459, 040FY52102, 040FY52104, 040FY52106, 040FY52109, 040FY52114, 040FY52119, 040GE97390, 040GE97391, 040GE97395, 040GE97396, 040GE97397, 040GE97399, 040GE97404, 040GE97410, 040GE97420, 040GE97429, 040GE97473, 040GE97480, 040GE97491, 040GE97503, 040GE97523, 040GE97525, 040GE97544, 040GE97553, 040GE97556, 040GE98073, 040GF84688, 040GF84922, 040GF84972, 040GF84982, 040GG08086, 040GG08121, 040GG08511, 040GG09217, 040GG09222, 040GG09332, 040GG09338, 040GH85237, 040GH85242, 040GH85251, 040GH85387, 040GH85398, 040GH85399, 040GH85401, 040GH85420, 040GH85532, 040GH85538, 040GH85542, 040GH85544, 040GH85546, 040GK73550, 040GN23514, 040GN23531, 040GN23534, 040GN23705, 040GN23708, 040GN23713, 040GN23715, 040GN23720, 040GN23723, 040GN23730, 040GQ11139, 040GQ11151, 040GQ11190, 040GQ11229, 040GQ11232, 040GQ11249, 040GQ11261, 040GQ11275, 040GR90689, 040GR90694, 040GR90698, 040GR90699, 040GR90701, 040GR90702, 040GR90705, 040GR90711, 040GR90717, 040GR90719, 040GR90723, 040GR90726, 040GR90728, 040GR90733, 040GR90734, 040GR90738, 040GR91033, 040GR91039, 040GR91044, 040GR91046, 040GR91834, 040GS93377, 040GS93380, 040GS93391, 040GS93400, 040GS93403, 040GS93405, 040GS93409, 040GS93411, 040GS93414, 040GS93429, 040GS93433, 040GS93436, 040GS93440, 040GS93442, 040GS93446, 040GS93452, 040GS93601, 040GT63898, 040GV59017, 040GX66509, 040GX66520, 040GX66751, 040GX66754, 040GZ07377, 040LT33414, 040LT33727, 040LT35175, 040LT35176, 040LT35177, 040LT35189, 040LX15357, 040LX15359, 040LX15362, 040LX15384, 040LX15386, 040LX15394, 040LX15397, 040LX15400;

6) Units: 040GE99351, 040GS93961, 040GZ07926, 040LX15371, 040FW42760, 040GE99359, 040GZ07877, 040GZ07880, 040GZ07886, 040GZ07910, 040LT35509, 040LT35687, 040LT35688, 040FV20428, 040FY51460, 040FY52125, 040FY52135, 040GE97476, 040GF84984, 040GF84998, 040GG08101, 040GG09334, 040GH85276, 040GH85282, 040GH85291, 040GH85312, 040GM12937, 040GM12959, 040GQ11166, 040GQ11175, 040GQ11183, 040GR91036, 040GS93396, 040GS93962, 040GS93965, 040GV59020, 040GV59031, 040GV59035, 040GV59039, 040LE25935, 040LE26453, 040LE26455, 040LT33545, 040LT33723, 040LT33726, 040LT35190, 040LX15374, 040LX15375, 040LX15390, 040LX15392, 040LX15409;

7) Units: 040LT33695, 040LT33717, 040GH85425, 040GH85431, 040LT33714, 040LX15392, 040LX15409
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria IL, by telephone on February 28, 2009 and letters dated March 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,228 units
DISTRIBUTION
CT, GA, IL, KY, MD, MN, MO, NE, NJ, OH, PA, TN, WI, IA, AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0928-10
CODE
Unit: 7131630 (2 units)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 9, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Coryneform bacterium, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0929-10
CODE
Unit: 7131091 (2 units)
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on September 26, 2007. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Coryneform bacterium, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0930-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0931-10
CODE
1) and 2) Unit: 151707011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on October 11, 2007.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0932-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0933-10
CODE
1) and 2) Unit: 151838299
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on December 17, 2007.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0936-10
CODE
Unit: 154833198 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 26, 2007.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0937-10
CODE
Unit: 158307101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 26, 2007.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a  donor taking the medication Methotrexate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0938-10
CODE
Unit: 151709609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on November 21, 2007.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0939-10
CODE
Unit: W041508030236G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on September 17, 2008.
Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. 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
NM
___________________________________
PRODUCT
Source Plasma. Recall # B-0940-10
CODE
Units: TA2116335, TA2117150, TA2117722, TA2122331, TA2122648, TA2122997, TA2123393, TA2123754, TA2124490, TA2124830, TA2125357, TA2125580, TA2126755, TA2126924, TA2152311, TA2153097, TA2153570, TA2156097, TA2156360, TA2156841, TA2157014, TA2157741, TA2157989, TA2158463, TA2158771, TA2159323, TA2159636, TA2160119, TA2160428, TA2160894, TA2161686, TA2161899, TA2162263, TA2162493, TA2168627, TA2169090, TA2169350, TA2169804, TA2170153, TA2170506, TA2170817, TA2172249, TA2172467, TA2172866, TA2173118, TA2173607, TA2173797, TA2174295, TA2174497
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail, facsimile, and letter on July 14, 2008. 
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
England
___________________________________
PRODUCT
Source Plasma. Recall # B-0941-10
CODE
Units: TA2096960, TA2097400, TA2097886, TA2098088, TA2098563, TA2098839, TA2099376, TA2099607, TA2100253, TA2100564, TA2100970, TA2101419, TA2101865, TA2102055, TA2102483, TA2102892, TA2103425, TA2103613, TA2104142, TA2104533, TA2105677, TA2106040, TA2106501, TA2106950, TA2107483, TA2107829, TA2108527, TA2108876, TA2109396, TA2109644, TA2110222, TA2110414, TA2111039, TA2111361, TA2111798, TA2112148, TA2112569, TA2112997, TA2113421, TA2113792, TA2114211, TA2114623, TA2114967, TA2115584, TA2115779, TA2116313, TA2116589, TA2118202, TA2118606, TA2118984, TA2119342, TA2119569, TA2120063, TA2120360, TA2120645, TA2121209, TA2121354, TA2121841, TA2122101, TA2122585, TA2122847, TA2123335, TA2123550, TA2124104, TA2124317, TA2124801, TA2126217, TA2126523, TA2127038, TA2127206, TA2127786, TA2128075, TA2128730, TA2129090, TA2129655, TA2129802, TA2130330, TA2130737, TA2131315, TA2131647, TA2132264, TA2132585
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail, facsimile, and letter dated July 16, 2008. 
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of being stuck with a dirty needle, were distributed.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
England

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0942-10
CODE
Unit: 18FG27387
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on August 12, 2008, by e-mail on August 20, 2008 and by letter dated August 22, 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
MI  
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0947-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0948-10
CODE
1) and 2) Unit: 18FX92066
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone and electronic notification on February 27, 2008, and by letter dated March 31, 2008. 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, MI
___________________________________
PRODUCT
Cornea. Recall # B-0951-10
CODE
Unit: OB200808371, L01
RECALLING FIRM/MANUFACTURER
Medical Eye Bank of Maryland and Washington Eye Bank, Baltimore, MD, by e-mail on September 10, 2008. Firm initiated recall is complete.
REASON
Human tissue, recovered from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 cornea
DISTRIBUTION
TN
___________________________________
PRODUCT
Source Plasma, Recall # B-0967-10
CODE
Units: TA0001771, TA0001853, TA0002016, TA0002191, TA0002541, TA0002752, TA0003267, TA0003958, TA0004091, TA0005462, TA0005604, TA0005891, TA0005993, TA0006221, TA0006362, TA0006587, TA0007471, TA0007571, TA0007802, TA0007907, TA0008243, TA0008354, TA0009535, TA0009674, TA0009964, TA0010106, TA2082273, TA2082864, TA2082997, TA2083547, TA2083790, TA2084182, TA2084388, TA2084839, TA2085268, TA2085681, TA2091101, TA2091651, TA2121282, TA2121504, TA2122082, TA2122230, TA2122658, TA2122904, TA2123340, TA2123643, TA2124176, TA2124371, TA2125030, TA2125302, TA2125735, TA2126385, TA2127604, TA2128014, TA2128863, TA2133032, TA2137021, TA2137865, TA2138788, TA2139170, TA2139596, TA2140023, TA2140521, TA2140809, TA2141235, TA2141675, TA2142088, TA2142454, TA2142990, TA2143484, TA2145094, TA2147140, TA2147759, TA2147982, TA2148541, TA2148809, TA2149347, TA2149640, TA2150286, TA2150655, TA2151236, TA2151530, TA2152078, TA2152435, TA2152929, TA2153213, TA2153675, TA2154353, TA2154695, TA2156102, TA2156386, TA2156937, TA2157019, TA2157554, TA2157691, TA2158248, TA2158554, TA2159059, TA2159326, TA2159988, TA2161833, TA2161983, TA2163445, TA2163682, TA2164053, TA2164439, TA2164735, TA2166498, TA2166673, TA2167524, TA2167951, TA2168236, TA0010463, TA0010660, TA0010873, TA0011081, TA0011373, TA0011512, TA0011770, TA0011899, TA0012233, TA0012380, TA0012658, TA2000743, TA2002067, TA2005366, TA2005456, TA2005739, TA2005865, TA2006117, TA2006262, TA2006598, TA2006816, TA2006963, TA2007212, TA2007366, TA2007598, TA2007830, TA2008080, TA2008301, TA2008481, TA2008750, TA2040447, TA2040773, TA2041012, TA2041327, TA2041669, TA2042024, TA2042376, TA2042657, TA2043131, TA2043531, TA2043869, TA2044262, TA2044828, TA2045124, TA2045484, TA2045671, TA2046025, TA2046221, TA2046584, TA2046827, TA2047125, TA2047419, TA2047755, TA2048060, TA2048410, TA2048741, TA2049067, TA2049388, TA2049780, TA2049980, TA2050441, TA2050646, TA2051124, TA2051302, TA2051787, TA2051967, TA2052391, TA2052610, TA2053081, TA2053236, TA2053754, TA2053986, TA2054428, TA2054601, TA2055070, TA2055154, TA2055732, TA2055938, TA2056529, TA2056808, TA2057165, TA2057538, TA2057971, TA2058170, TA2058791, TA2059048, TA2059555, TA2059756, TA2060185, TA2060480, TA2061078, TA2061243, TA2061725, TA2061995, TA2062442, TA2062722, TA2063169, TA2063441, TA2063946, TA2064222, TA2064801, TA2065074, TA2065472, TA2065757, TA2066223, TA2066559, TA2066976, TA2067271, TA2067886, TA2068061, TA2068622, TA2068767, TA2069323, TA2069504, TA2069958, TA2070293, TA2070716, TA2070978, TA2071457, TA2071720, TA2072170, TA2072418, TA2072916, TA2073156, TA2073711, TA2073917, TA2074364, TA2074761, TA2077162, TA2077705, TA2078000, TA2078424, TA2078632, TA2079107, TA2079764, TA2080030, TA2080367, TA2080581, TA2080890, TA2081735, TA2082014
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail, facsimile, and letter on July 9, 2008 and July 14, 2008. 
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
253 units
DISTRIBUTION
NC, England, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0968-10
CODE
Unit: 53GK55480
RECALLING FIRM/MANUFACTURER
American National Red Cross – Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and letter dated September 30, 2008. Firm initiated recall is complete.
REASON
Blood product, with a low platelet yield, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0969-10
CODE
Unit: 035W21967
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Roanoke, VA, by telephone and by a letter dated June 20, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-0970-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0971-10
CODE
1) Units: 53R41729,
2) Units: 53R41729, 53FN20097
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by electronic notification on July 18, 2007 and by letter dated July 20, 2007. 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
D.C., MD   
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0973-10
CODE
Unit: 2448152
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated November 8, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Source Plasma. Recall # B-0974-10
CODE
Unit: 2040083482
RECALLING FIRM/MANUFACTURER
Recalling Firm: PlasmaCare, Inc., Cincinnati, OH, by facsimile on September 18, 2007.
Manufacturer: PlasmaCare, Inc., Columbus, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have an annual physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0975-10
CODE
Unit: 2040036874
RECALLING FIRM/MANUFACTURER
Recalling Firm: PlasmaCare, Inc., Cincinnati, OH, by facsimile on September 20, 2007.
Manufacturer: PlasmaCare, Inc., Columbus, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

___________________________________
PRODUCT
1) Red Blood Cells, Leukocytes Reduced. Recall # B-0976-10;
2) Platelets, Pooled, Leukocytes Reduced. Recall # B-0977-10;
3) Plasma Frozen Within 24 hours (FP24). Recall # B-0978-10
CODE
1) and 3) Unit: 13GV90319;
2) Pool #576 (containing units 13GV90319, 13GV90314, 13GV90325, 13KF14788, 13KF14801)
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on August 21, 2008 and by letter dated September 5, 2008. 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
MI, OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0984-10
CODE
Unit: W038609790822
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by electronic mail on December 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-0985-10
CODE
Unit: 4210370845
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Omaha, NE, by letter on September 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0986-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0987-10
CODE
1) and 2) Unit: 012FZ89836
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter on September 2, 2009.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0988-10;
2) Platelets. Recall # B-0989-10;
3) Fresh Frozen Plasma. Recall # B-0990-10
CODE
1), 2), and 3) Unit: LV13198
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated January 25, 2005 and October 28, 2005 and facsimile on March 10, 2009 and January 19, 2010. 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
TN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0991-10;
2) Platelets Leukocytes Reduced. Recall # B-0992-10
CODE
1) and 2) Unit: 13FF54353
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by letter on July 25, 2006 and follow-up letter dated August 3, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0993-10;
2) Fresh Frozen Plasma. Recall # B-0994-10;
3) Platelets, Leukocytes Reduced. Recall # B-0995-10
CODE
1) Units: 13GV53916 and 13GX96049;
2) and 3) Unit: 13GX96049
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on November 5, 2007 and follow-up letter dated November 21, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had medical history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI, OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0996-10
CODE
Unit: 18GX17549
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on January 15, 2008 and by follow-up letter dated January 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not meet acceptance criteria during donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma. Recall # B-0997-10
CODE
Units: 4150064695, 4150065189, 4150063943, 4150063597, 4150069709, 4150067080
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Wichita, KS, by letter on October 8, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Germany, IL
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0998-10;
2)  Platelets Pheresis Leukocytes Reduced. Recall # B-0999-10
CODE
1) and 2) Unit: 9170734
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter on September 28, 2009. Firm initiated recall is complete.
Manufacturer: Florida's Blood Centers, Inc., Fort Myers, FL. 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
___________________________________
PRODUCT
Source Plasma. Recall # B-1000-10
CODE
Units: MQ073496, MQ072824
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Columbia, MO, by fax on October 26, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1001-10
CODE
Unit: 084J19412
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by fax and email on October 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1003-10
CODE
Unit: W045009044766 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter on November 27, 2009. 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
MO, KS
___________________________________
PRODUCT
Source Plasma. Recall # B-1004-10 
CODE
Unit: 4530120527
RECALLING FIRM/MANUFACTURER
CSL Plasma Services, Inc., Melrose Park, IL, by letter on October 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1005-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1006-10
CODE
1) Unit: W089808208108;
2) Unit: W089809500034
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter on November 05, 2009. 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
NJ, VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1007-10
CODE
Unit: 2230346
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax on August 25, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1008-10
CODE
Units: W038608780743 (part 1 and 2), 7716427(part 1 and 2)
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax on August 25, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY, MA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1009-10
CODE
Unit: W089808007529
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by letter on September 23, 2009 and telephone on January 28, 2010. 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
MD
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1010-10; 
2) Red Blood Cells. Recall # B-1011-10
CODE
1) Units: 2223042, 2228108;
2) Unit: W038608281256
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax on August 25, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY, NJ
___________________________________
PRODUCT
Red Blood Cell. Recall # B-1012-10
CODE
Unit: 5313322
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by letter on April 20, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as antigen negative, was collected from a donor who subsequently tested antigen positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1013-10
CODE
Unit: 8999441
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by letter dated April 21, 2006. 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
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1014-10
CODE
Unit: 72H589631
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on August 27, 2008.
Manufacturer: LifeSouth Community Blood Centers, Lake City, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1015-10
CODE
Unit: 72H746315
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on August 21, 2008. 
Manufacturer: LifeSouth Community Blood Centers, Inc., Ocala, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1016-10
CODE
Unit: 72H320120
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on September 3, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1017-10
CODE
Unit: 72H582605
RECALLING FIRM/MANUFACTURER
Recall Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on July 23, 2008.  
Manufacturer: LifeSouth Community Blood Centers – Suwannee, Lake City, FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells, Recall # B-1019-10;
2) Fresh Frozen Plasma. Recall # B-1020-10
CODE
1) and 2) Unit: 2225872
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by email on July 30, 2008. Firm initiated recall is complete.
REASON
Blood products, which tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1021-10
CODE
Unit: W036509005783
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by fax on April 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1022-10;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1023-10
CODE
1) Units: 003P72292PART1, 003P72835PART1;
2) Unit: 003P72835PART2
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile transmission dated May 26, 2009. Firm initiated recall is complete.
REASON
Platelets, lacking assurance of leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1026-10
CODE
Unit: 012LW26397
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by facsimile and e-mail on September 29, 2009 and by letter dated October 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
NC   
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1031-10;
2) Platelets. Recall # B-1032-10;
3) Fresh Frozen Plasma. Recall # B-1033-10
CODE
1), 2), and 3) Unit: W288009006203
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by facsimile on September 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Coumadin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1043-10
CODE
Unit: 157034655
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by electronic notification on June 1, 2007, by letter dated June 20, 2007, and by facsimile on March 3, 2009. 
Manufacturer: REG#1649342#United Blood Services – Odessa, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1045-10;
2) Plasma Frozen Cryoprecipitated Reduced. Recall # B-1046-10;
3) Cryoprecipitated AHF. Recall # B-1047-10
CODE
1) 2) and 3) Unit: 3790617
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on November 13, 2009 and November 17, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-1048-10
CODE
Units: 4070160340, 4070156647, 4070144029, 4070143655
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Chattanooga, TN, by letter dated November 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing reactive for the hepatitis C virus (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Germany, IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1049-10
CODE
Unit: 6130318969
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., ZLB Plasma, Duluth, MN, by electronic notification on October 1, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1050-10
CODE
Unit: G09397
RECALLING FIRM/MANUFACTURER
Children's Hospital Orange County, Orange, CA, by telephone on October 6, 2009 and by letter dated October 6, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Soriatane, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1053-10
CODE
Units: W035409004457, W035409002037, W035409006322, W035409005358
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by telephone on December 4, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1071-10
CODE
Unit: 5497176
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on November 9, 2009.
Manufacturer: Oklahoma Blood Institute, East Central Oklahoma Blood Institute, Ada, OK. 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
OK
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1072-10;
2) Recovered Plasma. Recall # B-1073-10
CODE
1) and 2) Unit: W044409833398
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by letter dated October 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1074-10
CODE
Unit: 06GQ57511
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax and electronically on October 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1076-10
CODE
Unit: W036509106543
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter dated November 18, 2009 and fax on January 21, 2010. 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
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1079-10
CODE
Units: W127809202817 (Split Unit)
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on October 13, 2009 and letters dated October 13, 2009 and October 27, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Source Plasma. Recall # B-1080-10
CODE
Units: TA2165369; TA2165493; TA2165971; TA2166276; TA2166745; TA2168114; TA2168634; TA2169081; TA2170250; TA2170947; TA2171303; TA2170541
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by letter, email, and fax on July 11, 2008.
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
England
___________________________________
PRODUCT
Source Plasma. Recall # B-1081-10
CODE
1) Units: TA2155224; TA2155856
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by letter, e-mail and fax on July 25, 2008.
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received ear piercings, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
England
___________________________________
PRODUCT
Source Plasma. Recall # B-1082-10
CODE
Units: TA0001033; TA0001101
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax, letter and e-mail on July 28, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor possibly at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1083-10
CODE
Unit: 01FC92829
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by telephone and follow-up letter on October 15, 2009.  
Manufacturer: American National Red Cross, The New York- Penn Region, Syracuse, NY. 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
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-1084-10
CODE
Unit: 0050555577
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Beloit, WI, by letter on November 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0670-10
CODE
Unit: 017FS61854
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on March 11, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0767-10
CODE
Unit: 003E68576
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile and electronic (LOGIC) on November 28, 2007 and by letter on November 29, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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-0891-10
CODE
Unit: 003FG61564
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile and electronic (LOGIC) on May 4, 2007 and by letter on May 9, 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
1) Puros Block Allograft augmentation material, REF 68221, Block cortical-cancellous bone, 18mm X 15mm, 02/2014, Qty. 001, Sterile, RTI Z01015. Recall # B-0893-10

2) Right Medial Femoral Hemi-Condyle (Fresh Stored) 120mm x 68mm x 24mm. REF 002685. Recall # B-0894-10;

3) Lordotic ASR Cortical-Cancellous Block 8 x 11 x 11mm, Reorder: 345811, Biocleanse, Sterile. Recall # B-0895-10;

4) Tutoplast Pericardium 1.5 x 1.5cm Reorder 68250. Recall # B-0896-10
CODE
1) Lot 5163162 and 5163163;

2) SN 4448040, LOT 101059555, EXP 09/28/2008;

3) SN 4972517 thru 4972538, 4972540 thru 4972552, 4982013 thru 4982016. Expiration 01/16/2012, Lot# 101059555;

4) SN 5075238 thru 5075248, LOT 101059555, Expiration Date 12/2013
RECALLING FIRM/MANUFACTURER
RTI Biologics, Inc., Alachua, FL, by telephone on June 26, 2009, and e-mail and FedEx overnight on June 26, 2009 and June 29, 2009. Firm initiated recall is ongoing.
REASON
Tissue allografts, recovered from donors whose donor eligibility was determined using cadaveric plasma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 grafts
DISTRIBUTION
MA, CA, KY, TN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0943-10
CODE
Unit: 18FG27387
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on August 12, 2008, by e-mail on August 20, 2008 and by letter dated August 22, 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
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0945-10
CODE
Units: 152026052 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, American Samoa, AZ, by facsimile on February 18, 2008.
Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood products, for which the documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0946-10
CODE
Unit: 152022343 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on January 25, 2008. 
Manufacturer: United Blood Services - San Angelo, San Angelo, TX. Firm initiated recall is complete.
REASON
Blood products, manufactured without the entire quantity of additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0966-10
CODE
Units: 267893280; 267893547
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by fax and telephone on November 6, 2007.  
Manufacturer: United Blood Services, Hot Springs, AR. Firm initiated recall is complete.
REASON
Blood products, collected using a copper sulfate solution which had unacceptable specific gravity QC results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0972-10
CODE
Units: 53FN20097
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by electronic notification on July 18, 2007 and by letter dated July 20, 2007. 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-1002-10
CODE
Unit: 084J19412
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by fax and email on October 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1027-10
CODE
Unit: 012LW26397
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by facsimile and e-mail on September 29, 2009 and by letter dated October 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-1044-10
CODE
Unit: 157034655
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by electronic notification on June 1, 2007, by letter dated June 20, 2007, and by facsimile on March 3, 2009. 
Manufacturer: REG#1649342#United Blood Services – Odessa, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, Switzerland
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1054-10;
2) Platelets. Recall # B-1055-10;
3) Red Blood Cells. Recall # B-1056-10
CODE
1), 2), and 3) Unit: R45409
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on November 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1070-10
CODE
Units: W040709692157; W040709230409
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on July 8, 2009 and August 8, 2009 and follow up letter dated August 12, 2009. Firm initiated recall is complete.
REASON
Blood products, with insufficient red cell preservative solution added, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1075-10
CODE
Unit: 06GQ57511
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax and electronically on October 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1077-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1078-10
CODE
1) Unit: W230809609236;
2) Units: W230809204317; W230809306667
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by fax on August 19, 2009 and January 21, 2010. Firm initiated recall is complete.
REASON
Blood products, with unacceptably high hematocrits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) Powerheart 9300A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall # Z-1243-2010;

2) Powerheart 9300E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall # Z-1244-2010;

3) Powerheart 9300P automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic w/manual override. Color: Yellow. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes. Recall # Z-1245-2010;

4) Powerheart 9390A automated external defibrillator. This fully automatic model does not require the user to press a shock button in order for the device to deliver therapy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Fully automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall # Z-1246-2010;

5) Powerheart 9390E automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Cardiac Science. Product name: Powerheart. Device Operation: Semi-automatic. Color: Yellow. Voice Prompt Level: Extensive.(Extensive voice prompts provide more detailed instruction on device use, pad placement and CPR performance, as compared to the basic prompts.) CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall # Z-1247-2010;

6) Responder 2023440 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: GE. Product name: Responder. Device Operation: Semi-automatic w/manual override. Color: GE Gold. Voice Prompt Level: Basic. CPR Metronome: Yes. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: Yes. Recall # Z-1248-2010;

7) Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the user to press a shock button in order for the device to deliver defibrillation energy (when appropriate). Brand name: Burdick. Product name: Cardiovive. Device Operation: Semi-automatic. Color: Blue. Voice Prompt Level: Basic. CPR Metronome: No. Rescue Ready Indicator: Yes. Text Display: Yes. ECG Display: No. Recall # Z-1249-2010
CODE
1) Serial Numbers: 390599, 4027917, 4045272, 4045316, 4045329, 4045370, 4045379, 4117863, 4117907, 4118157, 4146718, 4146719, 4146721, 4146722, 4146726, 4146727, 4146729, 4146734, 4146744, 4146746, 4146751, 4146754, 4146759, 4154527, 4165042, 4166087, 4180911, 4180941, 4184166, 4184195, 4184246, 4189978, 4256127, 4256983, 4261787, 4263875, 4269480, 4269483, 4269484, 4269485, 4288023, 4288024, 4288025, 4288026, 4288030, 4288032, 4288035, 4288036, 4288037, 4288048, 4288049, 4288051, 4288052, 4288616, 4288617, 4288618, 4288619, 4288620, 4288621, 4288622, 4288623, 4288624, 4288625, 4288626, 4288627, 4288628, 4288629, 4288630, 4288631, 4288632, 4288633, 4288634, 4288635, 4288636, 4288637, 4288638, 4288639, 4288640, 4288641, 4288642, 4288643, 4288644, 4288649, 4288650, 4288651, 4288652, 4288653, 4288654, 4288655, 4288656, 4288657, 4288658, 4288659, 4288660, 4288661, 4288662, 4288663, 4288664, 4288665, 4288666, 4288667, 4288668, 4288669, 4288670, 4288671, 4288672, 4288673, 4288674, 4288675, 4288676, 4288677, 4288678, 4288679, 4288680, 4288681, 4288682, 4288683, 4288684, 4288685, 4288686, 4288687, 4288688, 4288689, 4288690, 4288691, 4288692, 4288693, 4288694, 4288695, 4288696, 4288697, 4288698, 4288699, 4288700, 4288701, 4288702, 4288703, 4288704, 4288705, 4288706, 4288707, 4288708, 4288709, 4288710, 4288711, 4288712, 4288713, 4288714, 4288715, 4288716, 4288717, 4288718, 4288719, 4288720, 4288721, 4288722, 4288723, 4288724, 4288725, 4288726, 4288727, 4288728, 4288729, 4288730, 4288731, 4288732, 4288733, 4288734, 4288735, 4288736, 4288737, 4288738, 4288739, 4288740, 4288741, 4288742, 4288743, 4288744, 4288745, 4288746, 4288747, 4288748, 4288749, 4288750, 4288751, 4288752, 4288753, 4288754, 4288755, 4288756, 4288757, 4288758, 4288759, 4288760, 4288761, 4288762, 4288763, 4288764, 4288765, 4288766, 4288767, 4288768, 4288769, 4288770, 4288771, 4288772, 4288773, 4288774, 4288775, 4288776, 4288777, 4288778, 4288779, 4288780, 4288781, 4288782, 4288783, 4288784, 4288785, 4288786, 4288787, 4288788, 4288794, 4288795, 4288796, 4288815, 4288818, 4288819, 4288820, 4288821, 4288822, 4288823, 4288824, 4288825, 4288826, 4288827, 4288828, 4288831, 4288894, 4288895, 4288896, 4288897, 4288900, 4288902, 4288904, 4288906, 4288907, 4288909, 4288912, 4288913, 4288914, 4288915, 4288923, 4288924, 4288925, 4288926, 4288933, 4288934, 4288951, 4288952, 4288965, 4289845, 4289846, 4289847, 4289848, 4289849, 4289850, 4289851, 4289852, 4289853, 4289854, 4289855, 4289857, 4289858, 4289862, 4289863, 4289865, 4289866, 4289867, 4289868, 4289869, 4289870, 4289871, 4289872, 4289873, 4289874, 4289902, 4289903, 4289904, 4289905, 4289978, 4289979, 4289980, 4289981, 4289982, 4289983, 4289984, 4289985, 4289986, 4289987, 4289988, 4289989, 4289990, 4289991, 4289992, 4289993, 4289994, 4289995, 4289996, 4289997, 4289999, 4290004, 4290005, 4290006, 4290007, 4290008, 4290009, 4290010, 4290011, 4290012, 4290013, 4290014, 4290015, 4290016, 4290017, 4290018, 4290019, 4290020, 4290021, 4290022, 4290023, 4290024, 4290025, 4290026, 4290027, 4290028, 4290029, 4290030, 4290031, 4290032, 4290033, 4290034, 4290035, 4290036, 4290037, 4290038, 4290039, 4290040, 4290041, 4290042, 4290043, 4290044, 4290045, 4290046, 4290047, 4290048, 4290049, 4290050, 4290051, 4290052, 4290053, 4290977, 4290978, 4290979, 4290980, 4292491, 4292493, 4292558, 4292564, 4292604, 4292605, 4292607, 4292608, 4292609, 4292610, 4292619, 4292620, 4292621, 4292663, 4292664, 4292667, 4292669, 4292682, 4292684, 4292685, 4292686, 4292688, 4292698, 4292700, 4292701, 4292704, 4292705, 4292706, 4292707, 4292708, 4292709, 4292710, 4292711, 4292712, 4292713, 4292717, 4292718, 4292719, 4292720, 4292722, 4292723, 4292725, 4292733, 4292736, 4292737, 4292738, 4292739, 4292740, 4292742, 4292743, 4292744, 4292745, 4292747, 4292748, 4292749, 4292750, 4292751, 4292752, 4292753, 4292754, 4292755, 4292760, 4292761, 4292762, 4292763, 4292764, 4292765, 4292766, 4292768, 4292770, 4292771, 4292772, 4292785, 4292786, 4292787, 4292788, 4292789, 4292790, 4292791, 4292848, 4292849, 4292853, 4292854, 4292855, 4292856, 4292857, 4292858, 4292875, 4292878, 4292879, 4292880, 4292881, 4292882, 4292883, 4292884, 4292885, 4292893, 4292894, 4292895, 4292896, 4292898, 4292899, 4292902, 4292903, 4292904, 4292905, 4292906, 4292907, 4292908, 4292909, 4292917, 4292918, 4292926, 4292927, 4292928, 4292929, 4292930, 4292931, 4292932, 4292933, 4292934, 4292935, 4292936, 4293029, 4293105, 4293111, 4293113, 4293114, 4293115, 4293116, 4293117, 4293118, 4293119, 4293120, 4293121, 4293122, 4293125, 4293126, 4293130, 4293131, 4293132, 4293133, 4293137, 4293138, 4293139, 4293140, 4293141, 4293142, 4293143, 4293144, 4293145, 4293146, 4293147, 4293148, 4293149, 4293150, 4293151, 4293152, 4293163, 4293165, 4293168, 4293170, 4293171, 4293172, 4293173, 4293176, 4296019, 4296021, 4296024, 4296031, 4296032, 4296033, 4296041, 4296043, 4296044, 4296052, 4296055, 4296074, 4296870, 4296871, 4296872, 4296873, 4296874, 4297529, 4297530, 4297547, 4297548, 4297549, 4297550, 4297551, 4297552, 4297553, 4297554, 4297555, 4297556, 4297557, 4297558, 4297559, 4297560, 4297561, 4297562, 4297563, 4297564, 4297565, 4297566, 4297567, 4297568, 4297569, 4297570, 4297571, 4297572, 4297573, 4297574, 4297590, 4297592, 4297820, 4297821, 4297822, 4297823, 4297824, 4297825, 4297826, 4297827, 4297828, 4297829, 4297830, 4297831, 4297832, 4297833, 4297835, 4297836, 4297837, 4297838, 4297839, 4297840, 4297841, 4297842, 4297843, 4297844, 4297845, 4297846, 4297847, 4297848, 4297849, 4297851, 4297854, 4297855, 4297856, 4297857, 4297858, 4297859, 4297860, 4297861, 4297862, 4297863, 4297864, 4297865, 4297866, 4297867, 4297868, 4297869, 4297870, 4297871, 4297872, 4297873, 4297874, 4297875, 4297876, 4297877, 4297878, 4297879, 4297880, 4297881, 4297882, 4297883, 4297886, 4297887, 4297888, 4297889, 4297890, 4297891, 4297892, 4297893, 4297894, 4297895, 4297896, 4297897, 4297898, 4297899, 4297900, 4297901, 4297902, 4297903, 4297904, 4297905, 4297906, 4297907, 4297908, 4297909, 4297910, 4297911, 4297912, 4297914, 4297915, 4297917, 4297918, 4297920, 4297921, 4297922, 4297923, 4297924, 4297927, 4297929, 4297930, 4297931, 4297935, 4297941, 4297942, 4297943, 4297945, 4297946, 4297947, 4297948, 4297949, 4297950, 4297951, 4297952, 4297953, 4297954, 4297955, 4297956, 4297957, 4297958, 4297959, 4297960, 4297961, 4297962, 4297963, 4297964, 4297965, 4297966, 4297967, 4297968, 4297969, 4297970, 4297971, 4297972, 4297973, 4297974, 4297975, 4297976, 4297977, 4297978, 4297979, 4297981, 4297982, 4297990, 4297991, 4297993, 4297994, 4297995, 4297997, 4297998, 4297999, 4298000, 4298001, 4298003, 4298004, 4298005, 4298012, 4298013, 4298014, 4298015, 4298016, 4298017, 4298018, 4298079, 4298214, 4298385, 4298386, 4298393, 4298394, 4298395, 4298396, 4298711, 4299011, 4299012, 4299013, 4299014, 4299015, 4299017, 4299018, 4299019, 4299020, 4299022, 4299024, 4299025, 4299044, 4299046, 4299205, 4299397, 4299517, 4299527, 4299529, 4299530, 4299531, 4299532, 4299533, 4299534, 4299551, 4299553, 4299562, 4299596, 4299606, 4299614, 4299615, 4299623, 4299628, 4299639, 4299660, 4299662, 4299703, 4299753, 4299757, 4299762, 4299764, 4300099, 4300100, 4300101, 4300102, 4300103, 4300115, 4300116, 4300117, 4300118, and 4300119;

2) Serial Numbers: 349459, 359843, 362291, 367918, 368382, 369353, 369801, 371376, 372131, 372154, 374613, 374789, 377556, 379554, 380028, 380050, 389512, 4009863, 4009927, 4009956, 4010104, 4010129, 4016987, 4025575, 4033557, 4044485, 4114715, 4149443, 4185183, 4266441, 4288097, 4288098, 4288099, 4288100, 4288101, 4288102, 4288103, 4288104, 4288105, 4288106, 4288120, 4288121, 4288122, 4288123, 4288126, 4288127, 4288128, 4288129, 4288130, 4288131, 4288132, 4288133, 4288134, 4288135, 4288136, 4288138, 4288139, 4288140, 4288142, 4288143, 4288144, 4288145, 4288146, 4288147, 4288148, 4288149, 4288150, 4288151, 4288152, 4288153, 4288154, 4288156, 4288157, 4288158, 4288159, 4288160, 4288161, 4288162, 4288163, 4288164, 4288165, 4288166, 4288168, 4288169, 4288170, 4288171, 4288172, 4288173, 4288174, 4288175, 4288176, 4288177, 4288178, 4288179, 4288180, 4288181, 4288182, 4288183, 4288184, 4288185, 4288186, 4288210, 4288211, 4288212, 4288213, 4288214, 4288215, 4288216, 4288217, 4288218, 4288219, 4288220, 4288221, 4288222, 4288223, 4288224, 4288225, 4288226, 4288227, 4288228, 4288229, 4288230, 4288231, 4288232, 4288233, 4288234, 4288235, 4288236, 4288237, 4288238, 4288239, 4288240, 4288241, 4288242, 4288243, 4288244, 4288245, 4288246, 4288247, 4288248, 4288249, 4288250, 4288251, 4288252, 4288253, 4288254, 4288255, 4288256, 4288257, 4288258, 4288259, 4288260, 4288261, 4288263, 4288264, 4288265, 4288266, 4288267, 4288268, 4288269, 4288270, 4288271, 4288272, 4288273, 4288274, 4288275, 4288276, 4288277, 4288278, 4288279, 4288280, 4288297, 4288298, 4288299, 4288300, 4288301, 4288302, 4288303, 4288304, 4288307, 4288308, 4288309, 4288310, 4288311, 4288315, 4288317, 4288318, 4288319, 4288320, 4288321, 4288322, 4288323, 4288325, 4288326, 4288327, 4288328, 4288329, 4288330, 4288331, 4288332, 4288333, 4288334, 4288335, 4288336, 4288337, 4288338, 4288339, 4288340, 4288341, 4288342, 4288343, 4288344, 4288345, 4288346, 4288347, 4288348, 4288349, 4288397, 4288398, 4288399, 4288402, 4288403, 4288405, 4288406, 4288408, 4288410, 4288411, 4288412, 4288413, 4288414, 4288418, 4288419, 4288431, 4288432, 4288433, 4288434, 4288435, 4288436, 4288437, 4288438, 4288446, 4288508, 4288509, 4288510, 4288513, 4288517, 4288518, 4288520, 4288521, 4288526, 4288527, 4288528, 4288532, 4288533, 4288536, 4288537, 4288538, 4288539, 4288541, 4288543, 4288544, 4288545, 4288546, 4288547, 4288550, 4288552, 4288553, 4288555, 4288558, 4288559, 4288567, 4288569, 4288570, 4288571, 4289116, 4289125, 4289126, 4289127, 4289129, 4289130, 4289131, 4289132, 4289133, 4289134, 4289136, 4289138, 4289141, 4289146, 4289147, 4289148, 4289153, 4289161, 4289164, 4289179, 4289180, 4289181, 4289182, 4289183, 4289184, 4289185, 4289186, 4289187, 4289188, 4289189, 4289190, 4289191, 4289192, 4289193, 4289194, 4289195, 4289197, 4289198, 4289199, 4289200, 4289202, 4289203, 4289204, 4289205, 4289206, 4289207, 4289208, 4289209, 4289210, 4289211, 4289221, 4289222, 4289223, 4289224, 4289225, 4289226, 4289227, 4289228, 4289229, 4289230, 4289231, 4289232, 4289233, 4289234, 4289235, 4289236, 4289237, 4289238, 4289239, 4289240, 4289241, 4289242, 4289243, 4289244, 4289245, 4289246, 4289247, 4289248, 4289249, 4289250, 4289251, 4289252, 4289253, 4289254, 4289255, 4289256, 4289257, 4289258, 4289259, 4289260, 4289261, 4289262, 4289263, 4289264, 4289265, 4289266, 4289267, 4289268, 4289269, 4289270, 4289271, 4289272, 4289273, 4289274, 4289275, 4289276, 4289277, 4289281, 4289283, 4289284, 4289286, 4289287, 4289288, 4289289, 4289290, 4289291, 4289292, 4289293, 4289294, 4289295, 4289296, 4289297, 4289298, 4289299, 4289300, 4289301, 4289302, 4289303, 4289304, 4289305, 4289306, 4289307, 4289308, 4289309, 4289310, 4289311, 4289312, 4289313, 4289314, 4289315, 4289316, 4289317, 4289318, 4289321, 4289323, 4289324, 4289325, 4289326, 4289327, 4289328, 4289330, 4289332, 4289334, 4289336, 4289339, 4289340, 4289342, 4289343, 4289358, 4289375, 4289376, 4289377, 4289378, 4289379, 4289380, 4289381, 4289382, 4289383, 4289384, 4289385, 4289390, 4289391, 4289392, 4289393, 4289394, 4289395, 4289396, 4289397, 4289398, 4289399, 4289400, 4289401, 4289402, 4289403, 4289404, 4289405, 4289406, 4289407, 4289408, 4289409, 4289411, 4289412, 4289413, 4289414, 4289415, 4289416, 4289417, 4289419, 4289420, 4289421, 4289423, 4289424, 4289426, 4289427, 4289428, 4289429, 4289430, 4289431, 4289432, 4289433, 4289434, 4289436, 4289437, 4289438, 4289439, 4289440, 4289441, 4289442, 4289443, 4289444, 4289445, 4289446, 4289447, 4289449, 4289450, 4289451, 4289452, 4289453, 4289454, 4289455, 4289458, 4289515, 4289537, 4289543, 4289544, 4289548, 4289549, 4289550, 4289553, 4289555, 4289556, 4289557, 4289559, 4289561, 4289563, 4289565, 4289566, 4289567, 4289568, 4289569, 4289570, 4289571, 4289574, 4289575, 4289576, 4289577, 4289578, 4289579, 4289580, 4289581, 4289582, 4289583, 4289584, 4289585, 4289586, 4289587, 4289588, 4293442, 4293443, 4293444, 4293445, 4293446, 4293447, 4293448, 4293449, 4293450, 4293451, 4293452, 4293453, 4293454, 4293455, 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4293789, 4293790, 4293791, 4293792, 4293793, 4293794, 4293795, 4293796, 4293797, 4293798, 4293799, 4293800, 4293801, 4293802, 4293803, 4293804, 4293805, 4293806, 4293807, 4293808, 4293809, 4293810, 4293811, 4293812, 4293813, 4293814, 4293815, 4293816, 4293817, 4293818, 4293819, 4293820, 4293821, 4293822, 4293823, 4293824, 4293825, 4293826, 4293827, 4293828, 4293829, 4293830, 4293831, 4293832, 4293833, 4293834, 4293835, 4293836, 4293837, 4293838, 4293839, 4293840, 4293841, 4293842, 4293843, 4293844, 4293845, 4293846, 4293847, 4293848, 4293849, 4293850, 4293851, 4293852, 4293853, 4293854, 4293855, 4293856, 4293857, 4293858, 4293859, 4293860, 4293861, 4293862, 4293863, 4293864, 4293865, 4293866, 4293867, 4293868, 4293869, 4293870, 4293883, 4293888, 4293905, 4293906, 4293907, 4293908, 4293909, 4293910, 4293911, 4293912, 4293913, 4293914, 4293915, 4293916, 4293917, 4293918, 4293919, 4293920, 4293921, 4293922, 4293923, 4293924, 4293925, 4293926, 4293927, 4293928, 4293929, 4293930, 4293931, 4293932, 4293933, 4293934, 4293935, 4293936, 4293937, 4293938, 4293939, 4293940, 4293941, 4294644, 4294645, 4294646, 4294647, 4294648, 4294649, 4294650, 4294651, 4294652, 4294653, 4294654, 4294655, 4294656, 4294657, 4294658, 4294659, 4294660, 4294661, 4294662, 4294663, 4294664, 4294665, 4294666, 4294667, 4294668, 4294669, 4294670, 4294671, 4294672, 4294673, 4294674, 4294675, 4294676, 4294677, 4294678, 4294679, 4294680, 4294681, 4294682, 4294683, 4294684, 4294685, 4294686, 4294687, 4294688, 4294689, 4294690, 4294691, 4294692, 4294693, 4294694, 4294695, 4294696, 4294697, 4294698, 4294699, 4294700, 4294701, 4294702, 4294703, 4294704, 4294705, 4294706, 4294707, 4294708, 4294709, 4294710, 4294711, 4294712, 4294713, 4294714, 4294715, 4294716, 4294717, 4294718, 4294719, 4294720, 4294721, 4294722, 4294723, 4294724, 4294725, 4294726, 4294727, 4294728, 4294729, 4294730, 4294731, 4294732, 4294733, 4294734, 4294735, 4294736, 4294737, 4294738, 4294739, 4294740, 4294741, 4294742, 4294743, 4294744, 4294745, 4294746, 4294747, 4294748, 4294749, 4294750, 4294751, 4294752, 4294753, 4294754, 4294755, 4294756, 4294757, 4294758, 4294759, 4294760, 4294761, 4294762, 4294763, 4294764, 4294765, 4294766, 4294767, 4294768, 4294769, 4294770, 4294771, 4294772, 4294773, 4294774, 4294775, 4294776, 4294777, 4294778, 4294779, 4294780, 4294781, 4294782, 4294783, 4294784, 4294785, 4294786, 4294787, 4294788, 4294789, 4294790, 4294791, 4294792, 4294793, 4294795, 4294797, 4294798, 4294799, 4294802, 4294803, 4294804, 4294805, 4294806, 4294807, 4294808, 4294812, 4294813, 4294815, 4294817, 4294818, 4294823, 4294826, 4294827, 4294828, 4294829, 4294834, 4294837, 4294839, 4294840, 4294842, 4294870, 4294871, 4294872, 4294873, 4294874, 4294875, 4294886, 4294892, 4294893, 4294894, 4294895, 4294896, 4294898, 4294900, 4294904, 4294907, 4294908, 4294909, 4294910, 4294911, 4294912, 4294914, 4294916, 4294917, 4294918, 4294919, 4294920, 4294921, 4294923, 4294924, 4294925, 4294926, 4294929, 4294935, 4294936, 4294946, 4294947, 4294955, 4294956, 4294957, 4294958, 4294959, 4294960, 4294961, 4294968, 4294969, 4294972, 4294973, 4294974, 4294976, 4294984, 4294994, 4294995, 4294996, 4294998, 4295000, 4295528, 4295529, 4295535, 4295537, 4295538, 4295540, 4295541, 4295542, 4295545, 4295546, 4295547, 4295548, 4295551, 4295552, 4295553, 4295554, 4295555, 4295559, 4295560, 4295561, 4295563, 4295564, 4295576, 4295577, 4295578, 4295579, 4295580, 4295583, 4295584, 4295585, 4295586, 4295587, 4295588, 4295589, 4295590, 4295591, 4295592, 4295593, 4295594, 4295595, 4295596, 4295597, 4295598, 4295599, 4295600, 4295601, 4295602, 4295603, 4295604, 4295605, 4295606, 4295607, 4295612, 4295613, 4295614, 4295619, 4295620, 4295621, 4295622, 4295623, 4295624, 4295625, 4295626, 4295627, 4295628, 4295629, 4295630, 4295631, 4295632, 4295633, 4295634, 4295635, 4295637, 4295638, 4295639, 4295640, 4295641, 4295642, 4295643, 4295644, 4295645, 4295646, 4295647, 4295648, 4295705, 4295706, 4295707, 4295708, 4295709, 4295710, 4295711, 4295712, 4295713, 4295714, 4295715, 4295716, 4295718, 4295719, 4295720, 4295721, 4295722, 4295725, 4295726, 4295734, 4295736, 4295737, 4295738, 4295739, 4295740, 4295742, 4295743, 4295744, 4295745, 4295746, 4295749, 4295751, 4295752, 4295753, 4295757, 4295760, 4295761, 4295762, 4295763, 4295764, 4295765, 4295766, 4295767, 4295770, 4295771, 4295772, 4295773, 4295774, 4295775, 4295776, 4295788, 4295789, 4295790, 4295791, 4295792, 4295793, 4295794, 4295795, 4295796, 4295797, 4295798, 4295799, 4295818, 4295819, 4295822, 4295829, 4295830, 4295832, 4295843, 4295844, 4295845, 4295846, 4295847, 4295848, 4295849, 4295850, 4295851, 4295852, 4295853, 4295854, 4295855, 4295856, 4295857, 4295858, 4295859, 4295860, 4295861, 4295862, 4295863, 4295864, 4295865, 4295866, 4295867, 4295889, 4295890, 4295891, 4295892, 4295893, 4295894, 4295895, 4295896, 4295897, 4295898, 4295899, 4295900, 4295901, 4295903, 4295904, 4295905, 4295906, 4295907, 4295908, 4295909, 4295910, 4295911, 4295912, 4295914, 4295916, 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4297492, 4297493, 4297494, 4297496, 4297497, 4297498, 4297499, 4297500, 4297501, 4297502, 4297503, 4297504, 4297505, 4297506, 4297507, 4297508, 4297509, 4297510, 4297511, 4297512, 4297513, 4297514, 4297518, 4300209, 4300210, 4300211, 4300212, 4300213, 4300214, 4300215, 4300216, 4300217, 4300218, 4300219, 4300220, 4300221, 4300222, 4300223, 4300224, 4300225, 4300226, 4300227, 4300228, 4300229, 4300230, 4300231, 4300232, 4300233, 4300234, 4300235, 4300236, 4300237, 4300238, 4300239, 4300240, 4300241, 4300242, 4300243, 4300244, 4300245, 4300246, 4300247, 4300248, 4300249, 4300250, 4300251, 4300252, 4300253, 4300254, 4300255, 4300256, 4300257, 4300258, 4300260, 4300261, 4300262, 4300263, 4300266, 4300267, 4300268, 4300269, 4300270, 4300271, 4300272, 4300273, 4300275, 4300276, 4300278, 4300279, 4300280, 4300281, 4300282, 4300284, 4300285, 4300286, 4300287, 4300288, 4300289, 4300290, 4300291, 4300292, 4300293, 4300294, 4300295, 4300296, 4300297, 4300298, 4300299, 4300300, 4300301, 4300302, 4300303, 4300304, 4300305, 4300306, 4300307, 4300308, 4300309, 4300310, 4300311, 4300312, 4300313, 4300314, 4300315, 4300316, 4300317, 4300318, 4300319, 4300320, 4300321, 4300322, 4300323, 4300324, 4300325, 4300326, 4300327, 4300328, 4300329, 4300330, 4300331, 4300332, 4300333, 4300334, 4300335, 4300336, 4300337, 4300338, 4300339, 4300340, 4300341, 4300342, 4300343, 4300344, 4300345, 4300346, 4300347, 4300348, 4300349, 4300350, 4300351, 4300352, 4300353, 4300354, 4300355, 4300356, 4300357, 4300358, 4300359, 4300360, 4300361, 4300362, 4300363, 4300364, 4300365, 4300366, 4300367, 4300376, 4300377, 4300378, 4300379, 4300383, 4300390, 4300391, 4300392, 4300393, 4300394, 4300395, 4300396, 4300397, 4300398, 4300399, 4300400, 4300401, 4300402, 4300403, 4300404, 4300405, 4300406, 4300407, 4300408, 4300409, 4300410, 4300411, 4300412, 4300413, 4300414, 4300415, 4300416, 4300417, 4300418, 4300419, 4300420, 4300421, 4300422, 4300423, 4300424, 4300425, 4300426, 4300427, 4300428, 4300429, 4300430, 4300431, 4300432, 4300433, 4300434, 4300435, 4300436, 4300437, 4300438, 4300439, 4300440, 4300441, 4300442, 4300443, 4300444, 4300445, 4300446, 4300447, 4300449, 4300450, 4300451, 4300452, 4300453, 4300454, 4300455, 4300456, 4300457, 4300458, 4300459, 4300460, 4300461, 4300462, 4300463, 4300464, 4300465, 4300466, 4300467, 4300468, 4300469, 4300470, 4300471, 4300472, 4300473, 4300474, 4300475, 4300476, 4300477, 4300478, 4300479, 4300480, 4300481, 4300482, 4300483, 4300484, 4300485, 4300486, 4300488, 4300511, 4300513, 4300518, 4300523, 4300538, 4300545, 4300546, 4300548, 4300549, 4300550, 4300553, 4300554, 4300559, 4300568, 4300616, 4300631, 4300645, 4300658, 4300724, 4300771, 4300773, 4300774, 4300775, 4300776, 4300777, 4300778, 4300779, 4300780, 4300781, 4300782, 4300783, 4300784, 4300785, 4300786, 4300787, 4300788, 4300789, 4300790, 4300791, 4300792, 4300793, 4300794, 4300795, 4300796, 4300797, 4300798, 4300800, 4300852, 4300853, 4300854, 4300855, 4300856, 4300857, 4300858, 4300860, 4300861, 4300862, 4300863, 4300864, 4300865, 4300866, 4300868, 4300869, 4300870, 4300872, 4300873, 4300874, 4300875, 4300877, 4300878, 4300879, 4300880, 4300881, 4300884, 4300885, 4300886, 4300887, 4300888, 4300889, 4300891, 4300894, 4300895, 4300896, 4300898, 4300899, 4300900, 4300904, 4300905, and 4300907;

3) Serial Numbers: 902334, 4033152, 4048119, 4174711, 4290692, 4290693, 4290694, 4290695, 4290696, 4290697, 4290698, 4290699, 4290700, 4290701, 4290702, 4290703, 4290704, 4290705, 4290706, 4290707, 4290708, 4290709, 4290710, 4290711, 4290712, 4290713, 4290714, 4290715, 4290716, 4290717, 4290718, 4290719, 4290720, 4290721, 4290722, 4290723, 4290724, 4290725, 4290726, 4290727, 4290728, 4290729, 4290730, 4290731, 4290732, 4290733, 4290734, 4290735, 4290736, 4290737, 4290738, 4290739, 4290740, 4290741, 4290742, 4290743, 4290744, 4290745, 4290748, 4290751, 4290752, 4290753, 4290754, 4290755, 4290756, 4290757, 4290758, 4290759, 4290760, 4290761, 4290762, 4290763, 4290764, 4290769, 4290770, 4290771, 4290772, 4290773, 4290774, 4290775, 4290776, 4290777, 4290778, 4290779, 4290780, 4290781, 4290782, 4290783, 4290784, 4290785, 4290786, 4290787, 4290788, 4290789, 4290790, 4293293, 4293294, 4293295, 4293296, 4293297, 4293298, 4293299, 4293301, 4293302, 4293303, 4293305, 4293307, 4293308, 4293309, 4293310, 4293311, 4293312, 4293313, 4293314, 4293315, 4293329, 4293332, 4293333, 4293334, 4293337, 4293340, 4293341, 4293344, 4293345, 4293346, 4293352, 4293353, 4293354, 4293355, 4293356, 4293357, 4293358, 4293359, 4293360, 4293361, 4293362, 4293363, 4293364, 4293365, 4293366, 4293367, 4293368, 4293369, 4293370, 4293371, 4293372, 4293373, 4293374, 4293375, 4293376, 4293377, 4293378, 4293379, 4293380, 4293381, 4293382, 4293383, 4293384, 4293385, 4293386, 4293387, 4293388, 4293389, 4293390, 4293391, 4293392, 4293393, 4293394, 4293395, 4293396, 4293397, 4293398, 4293399, 4293400, 4293402, 4293404, 4293406, 4293407, 4293408, 4293409, 4293410, 4293416, 4293418, 4293420, 4293421, 4293422, 4293423, 4293424, 4293425, 4293426, 4293427, 4293428, 4293429, 4293430, 4293431, 4293432, 4293433, 4293434, 4293435, 4293436, 4293437, 4293438, 4293439, 4293440, 4293441, 4298028, 4298559, 4298561, 4298562, 4298563, 4298564, 4298566, 4298567, 4298573, 4298577, 4298578, 4298582, 4298587, 4298588, 4298589, 4298590, 4298591, 4298592, 4298593, 4298594, 4298595, 4298596, 4298597, 4298598, 4298599, 4298600, 4298601, 4298602, 4298603, 4298604, 4298606, 4298608, 4298609, 4298610, 4298611, 4298612, 4298613, 4298614, 4298615, 4298616, 4298617, 4298618, 4298619, 4298620, 4298621, 4298622, 4298623, 4298624, 4298625, 4298626, 4298627, 4298628, 4298629, 4298630, 4298631, 4298632, 4298633, 4298634, 4298635, 4298636, 4298637, 4298638, 4298639, 4298640, 4298641, 4298642, 4298643, 4298644, 4298645, 4298646, 4298647, 4298648, 4298649, 4298650, 4298651, 4298652, 4298654, 4298655, 4298680, 4298682, 4298683, 4298684, 4298685, 4298686, 4298697, 4298698, 4298706, 4298707, 4298708, 4300965, 4300966, 4300967, 4300968, 4300969, 4300971, 4300972, 4300973, 4300974, 4300975, 4300976, 4300980, 4300981, 4300982, and 4300988;

4) Serial Numbers: 4124722, 4152972, 4183430, 4196741, 4243133, 4282982, 4282983, 4282984, 4282985, 4282986, 4282987, 4282988, 4282989, 4282990, 4282991, 4282992, 4282993, 4282994, 4282995, 4282996, 4282997, 4282998, 4282999, 4283000, 4283001, 4287592, 4287593, 4287594, 4287595, 4287596, 4287597, 4287598, 4287599, 4287600, 4287601, 4287602, 4287603, 4287604, 4287605, 4287606, 4287607, 4287608, 4287609, 4287610, 4287611, 4287612, 4287613, 4287614, 4287615, 4287616, 4287617, 4287618, 4287619, 4287620, 4287621, 4287622, 4287623, 4287624, 4287625, 4287626, 4287627, 4287628, 4287629, 4287630, 4287631, 4287632, 4287633, 4287634, 4287635, 4287636, 4287637, 4287638, 4287639, 4287640, 4287641, 4287642, 4287643, 4287644, 4287645, 4287646, 4287647, 4287648, 4287649, 4287650, 4287651, 4287652, 4287653, 4287654, 4287655, 4287656, 4287657, 4287658, 4287659, 4287660, 4287661, 4287662, 4287663, 4287664, 4287665, 4287666, 4287667, 4287668, 4287669, 4287670, 4287671, 4287672, 4287673, 4287674, 4287675, 4287676, 4287677, 4287678, 4287679, 4287680, 4287681, 4287682, 4287683, 4287684, 4287685, 4287686, 4287687, 4287688, 4287689, 4287690, 4287691, 4287692, 4287693, 4287694, 4287695, 4287696, 4287697, 4287698, 4287699, 4287700, 4287701, 4287702, 4287703, 4287704, 4287705, 4287706, 4287707, 4287708, 4287709, 4287710, 4287711, 4287712, 4287713, 4287714, 4287715, 4287716, 4287717, 4287718, 4287719, 4287720, 4287721, 4287722, 4287723, 4287724, 4287725, 4287726, 4287727, 4287728, 4287729, 4287730, 4287731, 4287732, 4287733, 4287734, 4287735, 4287736, 4287737, 4287738, 4287739, 4287740, 4287741, 4287742, 4287743, 4287744, 4287745, 4287746, 4287747, 4287748, 4287749, 4287750, 4287751, 4287752, 4287753, 4287754, 4287755, 4287756, 4287757, 4287758, 4287759, 4287760, 4287761, 4287762, 4287763, 4287764, 4287765, 4287766, 4287767, 4287768, 4287769, 4287770, 4287771, 4287772, 4287773, 4287774, 4287775, 4287776, 4287777, 4287778, 4287779, 4287780, 4287781, 4287782, 4287783, 4287784, 4287785, 4287786, 4287787, 4287788, 4287789, 4287790, 4287791, 4287792, 4287793, 4287794, 4287795, 4287796, 4287797, 4287798, 4287799, 4287800, 4287801, 4287802, 4287803, 4287804, 4287805, 4287806, 4287807, 4287808, 4287809, 4287810, 4287811, 4287812, 4287813, 4287814, 4287815, 4287816, 4287817, 4287818, 4287819, 4287820, 4287821, 4287822, 4287823, 4287824, 4287825, 4287826, 4287827, 4287828, 4287829, 4287830, 4287831, 4287832, 4287833, 4287834, 4287835, 4287836, 4287837, 4287838, 4287839, 4287840, 4287841, 4287842, 4287843, 4287844, 4287845, 4287846, 4287847, 4287848, 4287849, 4287850, 4287851, 4287852, 4287853, 4287854, 4287855, 4287856, 4287857, 4287858, 4287859, 4287860, 4287861, 4287862, 4287863, 4287864, 4287865, 4287866, 4287867, 4287868, 4287869, 4287870, 4287871, 4287872, 4287873, 4287874, 4287875, 4287876, 4287877, 4287878, 4287879, 4287880, 4287881, 4287882, 4287883, 4287884, 4287885, 4287886, 4287887, 4287888, 4287889, 4287890, 4287891, 4287892, 4287893, 4287894, 4287895, 4287896, 4287897, 4287898, 4287899, 4287900, 4287901, 4287902, 4287903, 4287904, 4287905, 4287906, 4287907, 4287908, 4287909, 4287910, 4287911, 4287912, 4287913, 4287914, 4287915, 4287916, 4287917, 4287918, 4287919, 4287920, 4287921, 4287922, 4287923, 4287924, 4287925, 4287926, 4287927, 4287928, 4287929, 4287930, 4287931, 4287932, 4287933, 4287934, 4287935, 4287936, 4287937, 4287938, 4287939, 4287940, 4287941, 4287942, 4287943, 4287944, 4287945, 4287946, 4287947, 4287948, 4287949, 4287950, 4287951, 4287952, 4287953, 4287954, 4287955, 4287956, 4287957, 4287958, 4287959, 4287960, 4287961, 4287962, 4287963, 4287964, 4287965, 4287966, 4287967, 4287968, 4287969, 4287970, 4287971, 4287972, 4287973, 4287974, 4287975, 4287976, 4287977, 4287978, 4287979, 4287980, 4287981, 4287982, 4287983, 4287984, 4287985, 4287986, 4287987, 4287988, 4287989, 4287990, 4287991, 4287992, 4287993, 4287994, 4287995, 4287996, 4287997, 4287998, 4287999, 4288000, 4288001, 4288002, 4288003, 4288004, 4288005, 4288006, 4288007, 4288008, 4288009, 4288010, 4288011, 4288012, 4288013, 4288014, 4288015, 4288016, 4288017, 4288018, 4288019, 4288020, 4288021, 4288022, 4288027, 4288028, 4288029, 4288031, 4288033, 4288034, 4288038, 4288039, 4288040, 4288041, 4288042, 4288043, 4288044, 4288045, 4288046, 4288047, 4288050, 4288053, 4288054, 4288055, 4288056, 4288057, 4288058, 4288059, 4288060, 4288061, 4288062, 4288063, 4288064, 4288065, 4288066, 4288067, 4288068, 4288069, 4288070, 4288071, 4288072, 4288073, 4288074, 4288075, 4288076, 4288077, 4288078, 4288079, 4288080, 4288081, 4288082, 4288083, 4288084, 4288085, 4288086, 4288087, 4288088, 4288089, 4288090, 4288091, 4288592, 4288593, 4288594, 4288595, 4288596, 4288597, 4288598, 4288599, 4288600, 4288601, 4288602, 4288603, 4288604, 4288605, 4288606, 4288607, 4288608, 4288609, 4288610, 4288611, 4288612, 4288613, 4288614, 4288615, 4288645, 4288646, 4288647, 4288648, 4288789, 4288790, 4288791, 4288792, 4288793, 4288797, 4288798, 4288799, 4288800, 4288801, 4288802, 4288803, 4288804, 4288805, 4288806, 4288807, 4288808, 4288809, 4288810, 4288811, 4288812, 4288813, 4288814, 4288816, 4288817, 4288832, 4288833, 4288834, 4288835, 4288836, 4288837, 4288838, 4288839, 4288840, 4288841, 4288842, 4288843, 4288844, 4288845, 4288846, 4288847, 4288848, 4288849, 4288850, 4288851, 4288852, 4288853, 4288854, 4288855, 4288856, 4288857, 4288858, 4288859, 4288860, 4288861, 4288862, 4288863, 4288864, 4288865, 4288866, 4288867, 4288868, 4288869, 4288870, 4288871, 4288872, 4288873, 4288874, 4288875, 4288876, 4288877, 4288878, 4288879, 4288880, 4288881, 4288882, 4288883, 4288884, 4288885, 4288886, 4288887, 4288888, 4288889, 4288890, 4288891, 4288910, 4288919, 4288927, 4288928, 4288929, 4288930, 4288931, 4288935, 4288936, 4288937, 4288938, 4288939, 4288940, 4288941, 4288942, 4288943, 4288944, 4288945, 4288946, 4288947, 4288948, 4288949, 4288950, 4288953, 4288954, 4288955, 4288956, 4288957, 4288958, 4288959, 4288960, 4288961, 4288962, 4288963, 4288964, 4288966, 4288967, 4288968, 4288969, 4288970, 4288971, 4288972, 4288973, 4288974, 4288975, 4288976, 4288977, 4288978, 4288979, 4288980, 4288981, 4288982, 4288983, 4288984, 4288985, 4288986, 4288987, 4288988, 4288989, 4288990, 4288991, 4288992, 4288993, 4288994, 4288995, 4288996, 4288997, 4288998, 4288999, 4289000, 4289001, 4289002, 4289004, 4289005, 4289006, 4289007, 4289008, 4289009, 4289010, 4289011, 4289012, 4289013, 4289014, 4289015, 4289016, 4289017, 4289018, 4289019, 4289020, 4289021, 4289022, 4289023, 4289024, 4289025, 4289026, 4289027, 4289028, 4289029, 4289030, 4289031, 4289032, 4289033, 4289034, 4289035, 4289036, 4289037, 4289038, 4289039, 4289040, 4289041, 4289042, 4289043, 4289044, 4289045, 4289046, 4289047, 4289048, 4289049, 4289050, 4289051, 4289052, 4289053, 4289054, 4289055, 4289056, 4289057, 4289058, 4289059, 4289060, 4289061, 4289062, 4289063, 4289064, 4289065, 4289066, 4289067, 4289068, 4289069, 4289070, 4289071, 4289072, 4289073, 4289074, 4289075, 4289076, 4289077, 4289078, 4289079, 4289080, 4289081, 4289082, 4289083, 4289084, 4289085, 4289086, 4289087, 4289088, 4289089, 4289090, 4289091, 4289592, 4289593, 4289594, 4289595, 4289596, 4289597, 4289598, 4289599, 4289600, 4289601, 4289602, 4289603, 4289604, 4289605, 4289606, 4289607, 4289608, 4289609, 4289610, 4289611, 4289612, 4289613, 4289614, 4289615, 4289616, 4289617, 4289618, 4289619, 4289620, 4289621, 4289622, 4289623, 4289624, 4289625, 4289626, 4289627, 4289628, 4289629, 4289630, 4289631, 4289632, 4289633, 4289634, 4289635, 4289636, 4289637, 4289638, 4289639, 4289640, 4289641, 4289642, 4289643, 4289644, 4289645, 4289646, 4289647, 4289648, 4289649, 4289650, 4289651, 4289652, 4289653, 4289654, 4289655, 4289656, 4289657, 4289658, 4289659, 4289660, 4289661, 4289662, 4289663, 4289664, 4289665, 4289666, 4289667, 4289668, 4289669, 4289670, 4289671, 4289672, 4289673, 4289674, 4289675, 4289676, 4289677, 4289678, 4289679, 4289680, 4289681, 4289682, 4289683, 4289684, 4289685, 4289686, 4289687, 4289688, 4289689, 4289690, 4289691, 4289692, 4289693, 4289694, 4289695, 4289696, 4289697, 4289698, 4289699, 4289700, 4289701, 4289702, 4289703, 4289704, 4289705, 4289706, 4289707, 4289708, 4289709, 4289710, 4289711, 4289712, 4289713, 4289714, 4289715, 4289716, 4289717, 4289718, 4289719, 4289720, 4289721, 4289722, 4289723, 4289724, 4289725, 4289726, 4289727, 4289728, 4289729, 4289730, 4289731, 4289732, 4289733, 4289734, 4289735, 4289736, 4289737, 4289738, 4289739, 4289740, 4289741, 4289742, 4289743, 4289744, 4289745, 4289746, 4289747, 4289748, 4289749, 4289750, 4289751, 4289752, 4289753, 4289754, 4289755, 4289756, 4289757, 4289758, 4289759, 4289760, 4289761, 4289762, 4289763, 4289764, 4289765, 4289766, 4289767, 4289768, 4289769, 4289770, 4289771, 4289772, 4289773, 4289774, 4289775, 4289776, 4289777, 4289778, 4289779, 4289780, 4289781, 4289782, 4289783, 4289784, 4289785, 4289786, 4289787, 4289788, 4289789, 4289790, 4289791, 4289792, 4289793, 4289794, 4289795, 4289796, 4289797, 4289798, 4289799, 4289800, 4289801, 4289802, 4289803, 4289804, 4289805, 4289806, 4289807, 4289808, 4289809, 4289810, 4289811, 4289812, 4289813, 4289814, 4289815, 4289816, 4289817, 4289818, 4289819, 4289820, 4289821, 4289822, 4289823, 4289824, 4289825, 4289826, 4289827, 4289828, 4289829, 4289830, 4289831, 4289832, 4289833, 4289834, 4289835, 4289836, 4289837, 4289838, 4289839, 4289840, 4289841, 4289842, 4289843, 4289844, 4289856, 4289859, 4289860, 4289861, 4289864, 4289875, 4289876, 4289877, 4289878, 4289879, 4289880, 4289881, 4289882, 4289883, 4289884, 4289885, 4289886, 4289887, 4289888, 4289889, 4289890, 4289891, 4289892, 4289893, 4289894, 4289895, 4289896, 4289897, 4289898, 4289899, 4289900, 4289901, 4289906, 4289907, 4289908, 4289909, 4289910, 4289911, 4289912, 4289913, 4289914, 4289915, 4289916, 4289917, 4289918, 4289919, 4289920, 4289921, 4289922, 4289923, 4289924, 4289925, 4289926, 4289927, 4289928, 4289929, 4289930, 4289931, 4289932, 4289933, 4289934, 4289935, 4289936, 4289937, 4289938, 4289939, 4289940, 4289941, 4289942, 4289943, 4289944, 4289945, 4289946, 4289947, 4289948, 4289949, 4289950, 4289951, 4289952, 4289953, 4289954, 4289955, 4289956, 4289957, 4289958, 4289959, 4289960, 4289961, 4289962, 4289963, 4289964, 4289965, 4289966, 4289967, 4289968, 4289969, 4289970, 4289971, 4289972, 4289973, 4289974, 4289975, 4289976, 4289977, 4289998, 4290000, 4290001, 4290002, 4290003, 4290054, 4290055, 4290056, 4290057, 4290058, 4290059, 4290060, 4290061, 4290062, 4290063, 4290064, 4290065, 4290066, 4290067, 4290068, 4290069, 4290070, 4290071, 4290072, 4290073, 4290074, 4290075, 4290076, 4290077, 4290078, 4290079, 4290080, 4290081, 4290082, 4290083, 4290084, 4290085, 4290086, 4290087, 4290088, 4290089, 4290090, 4290091, 4290792, 4290793, 4290794, 4290795, 4290796, 4290797, 4290798, 4290799, 4290800, 4290801, 4290802, 4290803, 4290804, 4290805, 4290806, 4290807, 4290808, 4290809, 4290810, 4290811, 4290812, 4290813, 4290814, 4290815, 4290816, 4290817, 4290818, 4290819, 4290820, 4290821, 4290822, 4290823, 4290824, 4290825, 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4299370, 4299371, 4299372, 4299373, 4299374, 4299375, 4299376, 4299377, 4299378, 4299379, 4299380, 4299381, 4299382, 4299383, 4299384, 4299385, 4299386, 4299387, 4299389, 4299390, 4299391, 4299392, 4299393, 4299394, 4299395, 4299398, 4299399, 4299400, 4299401, 4299402, 4299403, 4299404, 4299405, 4299406, 4299407, 4299408, 4299409, 4299410, 4299411, 4299412, 4299413, 4299414, 4299415, 4299416, 4299417, 4299418, 4299419, 4299420, 4299421, 4299422, 4299423, 4299424, 4299425, 4299426, 4299427, 4299428, 4299429, 4299430, 4299431, 4299432, 4299433, 4299434, 4299435, 4299436, 4299437, 4299438, 4299439, 4299440, 4299441, 4299442, 4299443, 4299444, 4299445, 4299446, 4299447, 4299448, 4299449, 4299450, 4299451, 4299452, 4299453, 4299454, 4299455, 4299456, 4299457, 4299458, 4299459, 4299460, 4299461, 4299462, 4299463, 4299464, 4299465, 4299466, 4299467, 4299468, 4299469, 4299470, 4299471, 4299472, 4299473, 4299474, 4299475, 4299476, 4299477, 4299478, 4299479, 4299480, 4299481, 4299482, 4299483, 4299484, 4299485, 4299486, 4299487, 4299488, 4299489, 4299490, 4299491, 4299492, 4299493, 4299494, 4299495, 4299496, 4299497, 4299498, 4299499, 4299500, 4299501, 4299502, 4299503, 4299504, 4299505, 4299506, 4299507, 4299508, 4299509, 4299728, 4299729, 4299730, 4299731, 4299732, 4299733, 4299734, 4299735, 4299736, 4299737, 4299738, 4299739, 4299740, 4299742, 4299743, 4299744, 4299745, 4299746, 4299747, 4299748, 4299749, 4299750, 4299751, 4299761, 4299765, 4299766, 4299767, 4299769, 4299770, 4299771, 4299772, 4299773, 4299777, 4299778, 4299779, 4299780, 4299781, 4299782, 4299783, 4299784, 4299785, 4299786, 4299787, 4299788, 4299789, 4299790, 4299791, 4299792, 4299793, 4299794, 4299795, 4299796, 4299797, 4299798, 4299799, 4299800, 4299801, 4299802, 4299803, 4299804, 4299805, 4299806, 4299807, 4299808, 4299809, 4299810, 4299811, 4299812, 4299813, 4299814, 4299815, 4299816, 4299817, 4299818, 4299819, 4299820, 4299821, 4299822, 4299823, 4299824, 4299825, 4299826, 4299827, 4299828, 4299829, 4299830, 4299831, 4299832, 4299833, 4299834, 4299835, 4299836, 4299837, 4299838, 4299841, 4299842, 4299843, 4299844, 4299845, 4299846, 4299847, 4299848, 4299849, 4299850, 4299851, 4299852, 4299853, 4299854, 4299855, 4299856, 4299857, 4299858, 4299859, 4299860, 4299861, 4299862, 4299863, 4299864, 4299865, 4299866, 4299867, 4299868, 4299869, 4299870, 4299871, 4299872, 4299873, 4299874, 4299875, 4299876, 4299877, 4299878, 4299879, 4299880, 4299881, 4299883, 4299884, 4299885, 4299886, 4299887, 4299889, 4299890, 4299891, 4299892, 4299893, 4299894, 4299895, 4299896, 4299897, 4299898, 4299899, 4299900, 4299901, 4299902, 4299903, 4299904, 4299905, 4299906, 4299907, 4299908, 4299909, 4299910, 4299911, 4299912, 4299913, 4299914, 4299915, 4299916, 4299917, 4299918, 4299919, 4299920, 4299921, 4299922, 4299923, 4299924, 4299925, 4299926, 4299927, 4299928, 4299929, 4299931, 4299932, 4299933, 4299934, 4299935, 4299936, 4299937, 4299938, 4299939, 4299941, 4299969, 4299970, 4299972, 4299973, 4299974, 4299975, 4299977, 4299980, 4299982, 4299985, 4299986, 4299988, 4299992, 4299997, 4300023, 4300048, 4300049, 4300050, 4300051, 4300052, 4300053, 4300054, 4300055, 4300056, 4300057, 4300058, 4300059, 4300060, 4300061, 4300062, 4300063, 4300064, 4300065, 4300068, 4300073, 4300074, 4300075, 4300076, 4300077, 4300078, 4300079, 4300080, 4300081, 4300082, 4300083, 4300084, 4300085, 4300086, 4300087, 4300088, 4300089, 4300090, 4300091, 4300092, 4300093, 4300094, 4300095, 4300096, 4300097, 4300150, 4300151, 4300154, 4300157, 4300159, 4300160, 4300161, 4300164, 4300165, 4300191, 4300192, 4300193, 4300195, 4300198, 4300199, 4300201, 4300202, 4300991, 4301001, 4301003, 4301011, 4301017, 4301024, 4301050, 4301051, 4301053, 4301054, 4301055, 4301056, 4301057, 4301058, 4301059, 4301061, 4301064, 4301065, 4301067, 4301068, 4301069, 4301070, 4301071, 4301072, 4301073, 4301076, 4301077, 4301078, 4301083, 4301089, 4301090, 4301091, 4301094, 4301095, 4301096, 4301097, 4301098, 4301101, 4301102, AND 4301103;

5) Serial Numbers: 4046748, 4171275, 4288092, 4288093, 4288094, 4288095, 4288096, 4288107, 4288108, 4288109, 4288110, 4288111, 4288112, 4288113, 4288114, 4288115, 4288116, 4288117, 4288118, 4288119, 4288155, 4288187, 4288188, 4288189, 4288190, 4288191, 4288192, 4288193, 4288194, 4288195, 4288196, 4288197, 4288198, 4288199, 4288200, 4288201, 4288202, 4288203, 4288204, 4288205, 4288206, 4288207, 4288208, 4288209, 4288281, 4288282, 4288283, 4288284, 4288285, 4288286, 4288287, 4288288, 4288289, 4288290, 4288291, 4288292, 4288293, 4288294, 4288295, 4288296, 4288305, 4288306, 4288312, 4288313, 4288314, 4288316, 4288324, 4288350, 4288351, 4288352, 4288353, 4288354, 4288355, 4288356, 4288357, 4288358, 4288359, 4288360, 4288361, 4288362, 4288363, 4288364, 4288365, 4288366, 4288367, 4288368, 4288369, 4288370, 4288371, 4288372, 4288373, 4288374, 4288375, 4288376, 4288377, 4288378, 4288379, 4288380, 4288381, 4288382, 4288383, 4288384, 4288385, 4288386, 4288387, 4288388, 4288389, 4288390, 4288391, 4288392, 4288393, 4288394, 4288400, 4288401, 4288420, 4288421, 4288422, 4288424, 4288425, 4288426, 4288427, 4288428, 4288429, 4288430, 4288439, 4288440, 4288441, 4288442, 4288443, 4288444, 4288445, 4288447, 4288448, 4288449, 4288450, 4288451, 4288452, 4288453, 4288454, 4288455, 4288456, 4288457, 4288458, 4288459, 4288460, 4288461, 4288462, 4288463, 4288464, 4288465, 4288466, 4288467, 4288468, 4288469, 4288470, 4288471, 4288472, 4288473, 4288474, 4288475, 4288476, 4288477, 4288478, 4288479, 4288480, 4288481, 4288482, 4288483, 4288484, 4288485, 4288486, 4288487, 4288488, 4288489, 4288490, 4288491, 4288492, 4288493, 4288494, 4288495, 4288496, 4288497, 4288498, 4288499, 4288500, 4288501, 4288502, 4288503, 4288504, 4288529, 4288572, 4288573, 4288574, 4288575, 4288576, 4288577, 4288578, 4288579, 4288580, 4288581, 4288582, 4288583, 4288584, 4288585, 4288586, 4288587, 4288588, 4288589, 4288590, 4288591, 4289092, 4289093, 4289094, 4289095, 4289096, 4289097, 4289098, 4289099, 4289100, 4289101, 4289102, 4289103, 4289104, 4289105, 4289107, 4289108, 4289109, 4289110, 4289112, 4289114, 4289115, 4289117, 4289118, 4289119, 4289120, 4289121, 4289122, 4289123, 4289124, 4289128, 4289135, 4289137, 4289139, 4289140, 4289142, 4289143, 4289144, 4289145, 4289149, 4289150, 4289151, 4289152, 4289154, 4289155, 4289156, 4289157, 4289158, 4289159, 4289160, 4289162, 4289166, 4289167, 4289168, 4289169, 4289170, 4289172, 4289173, 4289174, 4289175, 4289176, 4289177, 4289178, 4289212, 4289213, 4289214, 4289216, 4289217, 4289218, 4289220, 4289333, 4289335, 4289341, 4289344, 4289345, 4289346, 4289347, 4289348, 4289349, 4289350, 4289351, 4289352, 4289353, 4289354, 4289355, 4289356, 4289357, 4289359, 4289360, 4289361, 4289362, 4289363, 4289364, 4289365, 4289366, 4289367, 4289368, 4289369, 4289370, 4289371, 4289372, 4289373, 4289374, 4289386, 4289387, 4289388, 4289389, 4289418, 4289435, 4289459, 4289460, 4289461, 4289462, 4289463, 4289464, 4289465, 4289466, 4289467, 4289468, 4289469, 4289471, 4289472, 4289473, 4289475, 4289476, 4289477, 4289478, 4289479, 4289480, 4289481, 4289482, 4289483, 4289484, 4289485, 4289486, 4289487, 4289488, 4289489, 4289490, 4289491, 4289492, 4289493, 4289494, 4289495, 4289496, 4289497, 4289499, 4289500, 4289501, 4289502, 4289503, 4289504, 4289505, 4289506, 4289508, 4289509, 4289510, 4289511, 4289512, 4289513, 4289514, 4289516, 4289517, 4289518, 4289519, 4289520, 4289521, 4289522, 4289523, 4289524, 4289525, 4289526, 4289527, 4289528, 4289529, 4289530, 4289531, 4289532, 4289533, 4289535, 4289536, 4289538, 4289539, 4289540, 4289541, 4289542, 4289545, 4289546, 4289547, 4289589, 4289590, 4289591, 4293871, 4293872, 4293873, 4293874, 4293875, 4293876, 4293877, 4293878, 4293879, 4293880, 4293881, 4293882, 4293884, 4293885, 4293886, 4293887, 4293893, 4293894, 4293895, 4293896, 4293897, 4293899, 4293900, 4293904, 4294819, 4294820, 4294821, 4294822, 4294824, 4294825, 4294831, 4294832, 4294833, 4294835, 4294836, 4294838, 4294844, 4294845, 4294846, 4294847, 4294848, 4294849, 4294850, 4294851, 4294853, 4294854, 4294855, 4294856, 4294857, 4294858, 4294859, 4294860, 4294861, 4294862, 4294863, 4294864, 4294865, 4294866, 4294867, 4294868, 4294869, 4294876, 4294877, 4294878, 4294879, 4294880, 4294881, 4294882, 4294883, 4294884, 4294885, 4294887, 4294888, 4294889, 4294890, 4294891, 4294930, 4294931, 4294932, 4294933, 4294934, 4294937, 4294938, 4294939, 4294943, 4294944, 4294948, 4294949, 4294950, 4294951, 4294952, 4294953, 4294963, 4294964, 4294965, 4294966, 4294967, 4294970, 4294971, 4294975, 4294977, 4294978, 4294979, 4294980, 4294981, 4294982, 4294983, 4294985, 4294986, 4294987, 4294989, 4294990, 4294991, 4294992, 4294993, 4294997, 4294999, 4295001, 4295002, 4295003, 4295004, 4295005, 4295006, 4295007, 4295008, 4295009, 4295010, 4295011, 4295012, 4295013, 4295014, 4295015, 4295016, 4295017, 4295018, 4295520, 4295521, 4295523, 4295524, 4295525, 4295527, 4295530, 4295531, 4295532, 4295533, 4295534, 4295543, 4295544, 4295550, 4295556, 4295557, 4295558, 4295562, 4295565, 4295566, 4295567, 4295568, 4295569, 4295570, 4295571, 4295572, 4295573, 4295574, 4295575, 4295581, 4295582, 4295608, 4295609, 4295610, 4295611, 4295615, 4295616, 4295617, 4295618, 4295636, 4295649, 4295650, 4295651, 4295652, 4295653, 4295654, 4295655, 4295656, 4295657, 4295658, 4295659, 4295660, 4295661, 4295662, 4295663, 4295664, 4295665, 4295666, 4295667, 4295668, 4295669, 4295670, 4295671, 4295672, 4295673, 4295674, 4295675, 4295676, 4295677, 4295678, 4295679, 4295680, 4295681, 4295682, 4295683, 4295684, 4295685, 4295686, 4295687, 4295688, 4295689, 4295690, 4295691, 4295692, 4295693, 4295694, 4295695, 4295696, 4295697, 4295698, 4295699, 4295700, 4295701, 4295702, 4295703, 4295704, 4295747, 4295748, 4295750, 4295754, 4295755, 4295756, 4295758, 4295759, 4295768, 4295769, 4295777, 4295778, 4295779, 4295780, 4295781, 4295782, 4295783, 4295784, 4295785, 4295786, 4295787, 4295800, 4295801, 4295802, 4295803, 4295804, 4295805, 4295806, 4295807, 4295808, 4295809, 4295810, 4295811, 4295812, 4295813, 4295814, 4295815, 4295816, 4295817, 4295820, 4295821, 4295823, 4295824, 4295825, 4295826, 4295827, 4295828, 4295831, 4295833, 4295834, 4295835, 4295836, 4295837, 4295838, 4295839, 4295840, 4295841, 4295842, 4295868, 4295869, 4295870, 4295871, 4295872, 4295873, 4295874, 4295875, 4295876, 4295877, 4295878, 4295879, 4295880, 4295881, 4295882, 4295883, 4295884, 4295885, 4295886, 4295887, 4295888, 4295915, 4295936, 4295955, 4295956, 4295965, 4295966, 4295967, 4295968, 4295970, 4295972, 4295973, 4295974, 4295975, 4295976, 4295977, 4295978, 4295979, 4295980, 4295981, 4295982, 4295983, 4295984, 4295985, 4295986, 4295987, 4295988, 4295989, 4295990, 4295991, 4295992, 4295993, 4295994, 4295995, 4295996, 4295997, 4295998, 4295999, 4296000, 4296002, 4296003, 4296004, 4296005, 4296008, 4296009, 4296010, 4296012, 4296013, 4296014, 4296015, 4296016, 4296017, 4296018, 4297019, 4297020, 4297021, 4297022, 4297023, 4297024, 4297027, 4297028, 4297029, 4297030, 4297031, 4297032, 4297033, 4297034, 4297035, 4297036, 4297038, 4297040, 4297041, 4297042, 4297043, 4297044, 4297045, 4297046, 4297047, 4297048, 4297049, 4297050, 4297051, 4297052, 4297053, 4297055, 4297056, 4297057, 4297059, 4297093, 4297097, 4297102, 4297103, 4297105, 4297106, 4297107, 4297109, 4297110, 4297111, 4297112, 4297113, 4297114, 4297115, 4297116, 4297117, 4297118, 4297119, 4297120, 4297121, 4297122, 4297123, 4297125, 4297126, 4297127, 4297128, 4297129, 4297130, 4297131, 4297133, 4297134, 4297135, 4297136, 4297137, 4297138, 4297139, 4297140, 4297141, 4297142, 4297143, 4297149, 4297150, 4297151, 4297169, 4297170, 4297171, 4297172, 4297173, 4297174, 4297175, 4297176, 4297177, 4297190, 4297191, 4297192, 4297215, 4297216, 4297217, 4297218, 4297219, 4297221, 4297222, 4297223, 4297224, 4297225, 4297226, 4297227, 4297228, 4297229, 4297230, 4297231, 4297233, 4297251, 4297252, 4297253, 4297255, 4297256, 4297258, 4297259, 4297260, 4297261, 4297262, 4297264, 4297265, 4297291, 4297292, 4297293, 4297294, 4297295, 4297296, 4297297, 4297298, 4297299, 4297300, 4297301, 4297302, 4297303, 4297304, 4297305, 4297306, 4297307, 4297308, 4297309, 4297310, 4297311, 4297312, 4297313, 4297314, 4297316, 4297317, 4297319, 4297320, 4297321, 4297322, 4297323, 4297324, 4297325, 4297326, 4297327, 4297328, 4297329, 4297330, 4297331, 4297332, 4297333, 4297334, 4297335, 4297336, 4297337, 4297338, 4297339, 4297340, 4297341, 4297342, 4297343, 4297344, 4297346, 4297347, 4297348, 4297349, 4297350, 4297351, 4297352, 4297353, 4297354, 4297355, 4297356, 4297357, 4297359, 4297360, 4297362, 4297363, 4297364, 4297365, 4297366, 4297367, 4297368, 4297369, 4297371, 4297372, 4297374, 4297375, 4297376, 4297377, 4297378, 4297379, 4297380, 4297381, 4297382, 4297383, 4297384, 4297387, 4297388, 4297389, 4297390, 4297391, 4297392, 4297393, 4297394, 4297395, 4297396, 4297397, 4297398, 4297399, 4297404, 4297405, 4297408, 4297515, 4297516, 4297517, 4300368, 4300369, 4300370, 4300371, 4300372, 4300373, 4300374, 4300375, 4300380, 4300381, 4300382, 4300384, 4300385, 4300386, 4300387, 4300388, 4300389, and 4300723;

6) Serial Number: 048171;

7) Serial Number: 4104049
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Science Corp., Bothell, WA, by letters on February 3, 2010.
Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated recall is ongoing.   
REASON
A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
VOLUME OF PRODUCT IN COMMERCE
12,077 units
DISTRIBUTION
Nationwide, Australia, Belgium, Belize, Brazil, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Grenada, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, and Great Britain

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
1) DigitalDiagnost General radiographic examinations and applications wherever a solid state X-ray imaging device can be used. Recall # Z-0847-2010;

2) BuckyDiagnost General Radiography and Tomography examination of patients in supine, seated, or standing positions. Recall # Z-0848-2010;

3) EasyDiagnost Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography and Angiography examinations. Recall # Z-0849-2010
CODE
1) 2.x systems; FC071200040;
2) FC070400034;
3) FC070600046;
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated January 20 and 21, 2010. Firm initiated recall is ongoing.
REASON
Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cardinal Health EnVe Ventilator Cat # 19250-001. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Recall # Z-0857-2010
CODE
Serial number # 33600, 33604, 33619, 35063, 35068, 35071, 35072, 35073, 35074
RECALLING FIRM/MANUFACTURER
CareFusion 203, Inc., Minneapolis, MN, by letter dated January 7, 2010. Firm initiated recall is ongoing.
REASON
CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MN
___________________________________
PRODUCT
1) Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901NY, Sterile EO, Assembled In Mexico. Safety IV administration set used to access surgically implanted vascular ports. Recall # Z-0861-2010;

2) Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Assembled In Mexico. Safety IV administration set used to access surgically implanted vascular ports. Recall # Z-0862-2010
CODE
1) Lot Numbers: RETK0229, RETJ0655;
2) Lot Number: RETJ0656
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bard Access Systems, Salt Lake City, UT, by visit beginning January 2010.
Manufacturer: Bard Healthcare, Reynosa, Mexico. Firm initiated recall is ongoing.
REASON
After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury.
VOLUME OF PRODUCT IN COMMERCE
5,750 units
DISTRIBUTION
VA, KY, MA, NJ, TN and Belgium
___________________________________
PRODUCT
CareSuite" - Critical Care Manager, PACU Manager and Anesthesia Manager Software. Recall # Z-1252-2010
CODE
Software version CareSuite 5.1 and later
RECALLING FIRM/MANUFACTURER
Picis, Inc., Wakefield, MA, by letter beginning on March 8, 2010. Firm initiated recall is ongoing.
REASON
Under specific timing of conditions and in configuration with 3rd party infusion pumps, an error within the clinical application causes the manual documentation of clinical orders to be changed to an automatic update status.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
NJ, Canada, Australia, Austria, Denmark, Finland, Germany Norway, Portugal, Sweden, France, Netherlands, Spain
___________________________________
PRODUCT
1) Qwix 4.3mm Stabilization Screws - 32mm. Part Number: 111432SND. Recall # Z-1253-2010;

2) Qwix 4.3mm Stabilization Screws - 34mm, Part Number: 111434SND. Recall # Z-1254-2010
CODE
1) Lot number: E6CZ;
2) Lot number: E6DO
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Cincinnati, OH, by telephone or letter on February 12, 2010.
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.
REASON
The screws were etched incorrectly as 32mm instead of the correct 34mm length.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
AL, AZ, CO, CT, MD, MI, NE, NJ, NC, OH, SC, UT, New England
___________________________________
PRODUCT
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019. Recall # Z-1255-2010
 CODE
Lot number 53944551
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by e-mail on February 22, 2010. Firm initiated recall is ongoing.
REASON
One lot of product was incorrectly manufactured. Pegs are larger than specification.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, ID
___________________________________
PRODUCT
Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392. Intended use: Angiographic x-ray system. Recall # Z-1312-2010
CODE
Model number 5917054 - Serial numbers: 49004, 49006, and 49008; Model number 7008605 - Serial numbers: 55164, 55167, 55171, 55175, 55177, 55181, 55183, 55184, 55186, 55187, 55188, 55191, 55196, 55199, 55200, 55202, 55204, 55206, 55210, 55211, 55212, 55213, 55215, 55216, 55217, 55218, 55219, 55220, 55222, 55223, 55224, 55227, 55228, 55230, 55231, 55232, 55233, 55234, 55238, 55241, 55242, 55243, 55244, 55246, 55249, 55254, 55256, 55258, 55259, 55260, 55261, 55262, 55263, 55269, 55270, 55272, 55273, 55274, 55275, 55276, 55277, 55279, 55282, 55284, 55285, 55286, 55287, 55288, 55289, 55292, 55294, 55298, 55299, 55304, 55305, 55306, 55307, 55308, 55310, 55312, 55313, 55314, 55316, 55318, 55320, 55322, 55324, 55325, 55326, 55329, 55335, 55337, 55338, 55342, 55343, 55347, 55349, 55350, 55353, 55354, 55355, 55356, 55358, 55359, 55362, 55365, 55368, 55369, 55374, 55375, 55376, 55377, 55378, 55381, 55382, 55384, 55385, 55386, 55387, 55388, 55392, 55394, 55395, 55396, 55399, 55400, 55401, 55404, 55405, 55407, 55408, 55409, 55410, 55411, 55412, 55414, 55415, 55416, 55423, 55425, 55426, 55434, 55435, 55436, 55438, 55439, 55441, 55443, 55455, 55461, 55462, 55466, 55468, 55469, 55470, 55473, 55477, 55483, 55503, 55513, 55518, 55526, 55531, 55545, 55548, 55550, 55553, 55567, 55569, 55574, 55575, 55576, 55708, 55713, and 55715; Model number 7412807 - Serial numbers: 35427, 35431, 35432, 35438, 35439, 35441, 35442, 35451, 35452, 35456, 35465, 35466, 35467, 35469, 35471, 35472, 35486, 35490, 35499, 35501, 35502, 35504, 35508, 35511, 35512, 35516, 35518, 35522, 35525, 35528, 35529, 35535, 35536, 35538, 35540, 35545, 35547, 35550, 35553, 35556, 35560, 35561, 35562, 35566, 35567, 35571, 35577, 35580, 35581, 35599, 35600, 35601, 35603, 35604, 35610, 35613, 35614, 35615, 35623, 35626, 35627, 35629, 35634, 35635, 35649, 35651, 35652, 35655, 35659, 35660, 35663, 35664, 35665, 35666, 35668, 35669, 35670, 35672, 35678, 35683, 35684, 35690, 35695, 35698, 35704, 35707, 35709, 35710, 35712, 35714, 35727, 35728, 35730, 35732, 35734, 35736, 35739, 35741, 35743, 35744, 35745, 35750, 35762, 35764, 35768, 35776, 35778, 35782, 35783, 35784, 35787, 35788, 35789, 35793, 35802, 35810, 35815, 35821, 35828, 35831, 35834, 35836, 35893, 35908, 35909, 35916, 35918, 35921, 35937, 35945, 35968, 35971, 37705, 37706, 37708, 37709, 37710, 37711, 37713, 37715, and 37716; Model number 7413078 - Serial numbers: 46077, 46079, 46080, 46082, 46085, 46086, 46087, 46091, 46097, 46098, 46099, 46100, 46101, 46103, 46105, 46106, 46107, 46108, 46111, 46112, 46113, 46114, 46115, 46117, 46118, 46120, 46121, 46122, 46124, 46125, 46126, 46127, 46128, 46129, 46130, 46133, 46134, 46137, 46138, 46139, 46140, 46141, 46142, 46143, 46144, 46145, 46146, 46147, 46150, 46152, 46153, 46154, 46156, 46157, 46158, 46160, 46162, 46163, 46164, 46166, 46167, 46168, 46169, 46170, 46171, 46172, 46174, 46176, 46178, 46179, 46180, 46182, 46186, 46189, 46190, 46192, 46193, 46194, 46196, 46198, 46201, 46202, 46203, 46204, 46205, 46208, 46209, 46210, 46213, 46215, 46216, 46218, 46219, 46220, 46221, 46223, 46224, 46225, 46226, 46229, 46231, 46232, 46233, 46235, 46236, 46239, 46241, 46245, 46251, 46256, 46262, 46263, 46269, 46270, 46271, and 46272; Model number 7555357 - Serial numbers: 53058, 53065, 53066, 53067, 53070, 53074, 53075, 53076, 53078, 53082, 53083, 53084, 53085, 53086, 53090, 53093, 53094, 53096, 53098, 53102, 53103, 53104, 53109, 53111, 53113, 53114, 53115, 53116, 53117, 53122, 53124, 53125, 53128, 53131, 53133, 53135, 53140, 53141, 53142, 53146, 53147, 53149, 53152, 53159, 53160, 53161, 53162, 53165, 53166, 53167, 53170, 53175, 53176, 53178, 53180, 53181, 53182, 53185, 53187, 53188, 53189, 53190, 53191, 53194, 53195, 53196, 53201, 53202, 53209, 53215, 53219, 53222, 53223, 53225, 53227, 53253, 53256, 53260, 53261, 53263, 53264, 53706, and 53710; Model number 7555365 - Serial numbers: 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57113, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204; Model number 7555373 - Serial numbers: 50046, 50048, 50050, 50057, 50059, 50062, 50063, 50064, 50065, 50074, 50079, 50081, 50084, 50087, 50093, 50096, 50101, 50105, 50120, 50132, 50133, 50139, 50142, 50161, 50167, 50176, 50187, 50189, 50191, 51706, and 51707; and Model number 7728392 - Serial numbers: 44118, 44122, 44125, 44134, 44135, 44136, 44144, 44145, 44151, 44152, 44155, 44157, 44163, 44165, 44168, 44169, 44171, 44174, 44184, 44185, 44189, 44190, 44193, 44195, 44198, 44199, 44201, 44206, 44210, 44211, 44215, 44218, 44223, 44224, 44227, 44229, 44242, 44243, 44244, 44246, 44251, 44254, 44255, 44259, 44260, 44262, 44263, 44264, 44265, 44267, 44268, 44271, 44275, 44277, 44278, 44279, 44280, 44282, 44286, 44289, 44290, 44292, 44304, and 44316
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated February 16, 2010.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Communication problems can occur which may result in unavailability of Bypass Fluoro.
VOLUME OF PRODUCT IN COMMERCE
640 units
DISTRIBUTION
Nationwide
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PRODUCT
Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas. The AS3000 is intended for use in operating rooms. It is used with O2, N2O and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. Product numbers 0998-00-3024-01. Recall # Z-1313-2010
CODE
Product code only
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah, NJ, by letter dated March 5, 2010. Firm initiated recall is ongoing.
REASON
An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
VOLUME OF PRODUCT IN COMMERCE
479 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
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PRODUCT
Gluten/soyhulls blends sold in ton lots bulk commodity. Recall # V-069-2010
CODE
All products manufactured between 12/15/2009 - 12/28/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southern States Seed & Farm, Richmond, VA, by telephone on December 28, 2009. Firm initiated recall is ongoing. 
Manufacturer: Southern States Cooperative Inc., Campbellsville, KY. Firm initiated recall is ongoing.
REASON
The firm discovered that the product, gluten and soyhull blends, are contaminated with fertilizer-grade urea.
VOLUME OF PRODUCT IN COMMERCE
97.18 tons
DISTRIBUTION
KY

END OF ENFORCEMENT REPORT FOR APRIL 14, 2010

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