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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 19, 2010

May 19, 2010                                                                                        10-19

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
1) N Steak Seasoning Type Fl FAEG319, 50 lb plastic bag inside cardboard box. Recall # F-2052-2010;

2) BBQ Flavor FAGA641, 50 lb plastic bag inside cardboard box. Recall # F-2053-2010;

3) Onion Flavors System FAGD882, 50 lb plastic bag inside cardboard box. Recall # F-2054-2010;

4) Cajun Flavor System FAIB534, 50 lb plastic bag inside cardboard box. Recall # F-2055-2010
CODE
1) Lot F09121584C;
2) Lot F10021532C;
3) Lot F10020136C; lot F10020137C; lot F10020138C; lot F09120139C & lot F09120141C;
4) Lot F10020235C & lot F10012588C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wild Flavors Inc., Erlanger, KY, by letter on March 3, 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
14, 450 lbs
DISTRIBUTION
IL, SC, TX
___________________________________
PRODUCT 
1) Butter Oatmeal Cookies, packaged six cookies and cellophane wrap, net wt. 1.25 lbs. Recall # F-2056-2010;

2) Chocolate Chip Cookies, packaged six cookies and cellophane wrap, net wt. 1.25 lbs. Recall # F-2057-2010;

3) Peanut Butter Cookies, packaged six cookies and cellophane wrap, net wt. 1.25 lbs. Recall # F-2058-2010;

4) Ginger Snaps, packaged six cookies and cellophane wrap, net wt. 1.25 lbs. Recall # F-2059-2010;

5) Cinnamon Roll, packaged each cinnamon roll in cellophane wrap, net wt. 8 oz. Recall # F-2060-2010;

6) Raisin & Walnut Cinnamon Roll packaged each cinnamon roll in cellophane wrap, net wt. 8 oz. Recall # F-2061-2010;

7) Toe-Curling Brownie packaged each brownie in cellophane wrap, net wt. 4.7 oz (133 g). Recall # F-2062-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Great Harvest Bread, Great Falls, MT, by telephone on April 7, 2010. Firm initiated recall is completed.
REASON
Products do not contain an ingredient statement and contain undeclared allergens: Wheat, Milk and Eggs.
VOLUME OF PRODUCT IN COMMERCE
Cookies: 15 packages; Cinnamon Rolls: 16 packages; Brownies:: 14 packages
DISTRIBUTION
MT

___________________________________
PRODUCT 
Gaveteco S.A. I.C.F.I., Shark Cartilage Powder, Bulk. Recall # F-2063-2010
CODE
Lot 03112009
RECALLING FIRM/MANUFACTURER
SRB Trading, Inc., Estero, FL, by telephone on January 15, 2010.
Gaveteco S.A. Ind. Com., Buenos Aires, Argentina. Firm initiated recall is ongoing.
REASON
Possible microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
1,360 kilos
DISTRIBUTION
CA, NY, AZ

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT 
1) Propofol Injectable Emulsion 1%, 10 mg/mL, a) 5 Units x 20 mL vials per box NDC 0409-4699-30; b) 5 Units x 20 mL vials per box (Amerinet Choice) NDC 0409-4699-61;  c) 20 Units x 50 mL vials per box NDC 0409-4699-33; d) 10 Units x 100 mL vials per box NDC 0409-4699-24; e) 10 Units x 100 mL vials per box (Amerinet Choice) NDC 0409-4699-63; Rx only. Recall # D-530-2010;

2) Liposyn II Intravenous Fat Emulsion, 10%, 500 mL bottle, Rx only, NDC 0409-9786-03.
Recall # D-531-2010;

3) Liposyn II Intravenous Fat Emulsion, 20%, 500 mL bottle, Rx only, NDC 0409-9789-03. Recall # D-532-2010;

4) Liposyn III Intravenous Fat Emulsion, 10%, a) 250 mL bottle, NDC 0409-9790-02; b) 500 mL bottle, NDC 0409-9790-03; Rx only. Recall # D-533-2010;

5) Liposyn III Intravenous Fat Emulsion, 20%, a) 250 mL bottle, NDC 0409-9791-02; b) 500 mL bottle, NDC 0409-9791-03; Rx only. Recall # D-534-2010;

6) Liposyn III Intravenous Fat Emulsion, 30%, 500 mL bottle, Rx only, NDC 0409-6892-03. Recall # D-535-2010
CODE
1) a) Lot #: 79-814-DJ, 79-816-DJ, 79-817-DJ, 79-818-DJ, 79-820-DJ, 79-821-DJ, 79-823-DJ, 79-824-DJ, 79-825-DJ, 79-827-DJ, and 79-872-DJ, Exp 07/01/11; Lot #: 80-006-DJ, 80-009-DJ, 80-011-DJ, 80-012-DJ, 80-016-DJ, 80-017-DJ, 80-020-DJ, 80-021-DJ, 80-022-DJ, 80-025-DJ, 80-026-DJ, 80-028-DJ, 80-103-DJ and 80-104-DJ and 80-108-DJ, Exp 08/01/11; b) Lot #: 80-055-DJ, Exp 08/01/11; c) Lot #: 79-884-DJ, 79-885-DJ, 79-886-DJ, 79-892-DJ, 79-894-DJ, 79-896-DJ, 79-898-DJ, 79-899-DJ, 79-901-DJ, 79-902-DJ, 79-903-DJ, 79-904-DJ and 79-906-DJ, Exp 07/01/11; d) Lot #: 79-842-DJ, 79-843-DJ, 79-844-DJ, 79-873-DJ, 79-874-DJ, 79-847-DJ, 79-848-DJ, 79-849-DJ, 79-850-DJ, 79-851-DJ, 79-854-DJ, 79-855-DJ, 79-856-DJ, 79-861-DJ, 79-863-DJ, 79-864-DJ, 79-865-DJ, 79-867-DJ, 79-868-DJ, 79-869-DJ, 79-870-DJ, 79-871-DJ, 79-910-DJ, and 79-911-DJ, Exp 07/01/11; Lot #: 80-118-DJ, 80-119-DJ, 80-120-DJ and 80-121-DJ, Exp 08/01/11; e) Lot #: 79-840-DJ and 79-841-DJ, Exp 07/01/11; Lot #: 80-111-DJ, 80-112-DJ and 80-113-DJ, Exp 08/01/11;

2) Lot #: 79-772-DW, 79-773-DW, 79-774-DW, 79-775-DW, 79-776-DW, 79-777-DW, and 79-778-DW, Exp 01/01/11; Lot #: 80-981-DW, 80-982-DW, 80-983-DW, 80-984-DW, 80-986-DW, 80-989-DW, 80-990-DW, 80-991-DW, 80-992-DW and 80-993-DW, Exp 02/01/11;

3) Lot #: 79-787-DW, 79-788-DW, 79-789-DW, 79-790-DW, 79-791-DW, 79-792-DW, and 79-793-DW, Exp 01/01/11; Lot #: 80-995-DW, 80-996-DW, 80-997-DW and 80-998-DW, Exp 02/01/11;

4) a) Lot #: 79-733-DW, Exp 01/01/11; Lot #: 80-912-DW, and 80-913-DW, Exp 02/01/11; b) Lot #80-925-DW, 80-926-DW, 80-928-DW, 80-929-DW, 80-930-DW, 80-931-DW, 80-932-DW and 80-933-DW, Exp 02/01/11;

5) a) Lot #: 79-736-DW, 79-737-DW, 79-738-DW, 79-739-DW, 79-740-DW, 79-741-DW, 79-742-DW, and 79-743-DW, Exp 01/01/11; Lot #: 80-916-DW, 80-917-DW, 80-918-DW, and 80-919-DW, Exp 02/01/11; b) Lot #: 79-746-DW, 79-747-DW, 79-748-DW, 79-749-DW, 79-750-DW, 79-751-DW, 79-752-DW, 79-753-DW, 79-754-DW, 79-755-DW, and 79-756-DW, Exp 01/01/11; Lot #: 80-940-DW, 80-941-DW, 80-942-DW, 80-943-DW, 80-944-DW, 80-945-DW, 80-946-DW, 80-947-DW, 80-948-DW, 80-949-DW, 80-950-DW, 80-951-DW and 80-952-DW, Exp 02/01/11;

6) Lot #: 79-761-DW, and 79-762-DW, Exp 01/01/11; Lot #: 80-970-DW, 80-972-DW, 80-973-DW, 80-974-DW, 80-975-DW, 80-976-DW, 80-977-DW and 80-978-DW, Exp 02/01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters on October 16, 2009 and October 22, 2009, and by e-mail on October 20, 2009.
Manufacturer: Hospira, Inc., Clayton, NC. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Particle substance observed in the bottom of filled product retains samples.
VOLUME OF PRODUCT IN COMMERCE
1,322,403 vials/bottles
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Hyaluronidase PF, 150 units/mL Injection solution, 10 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID #15859: Drug ID#16102; Drug ID#15927. Recall # D-536-2010;

2) Hyaluronidase PF, 160 units/mL Injection solution, 10 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, Compounded for Physician/Hospital used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID#15824. Recall # D-537-2010;

3) Hyaluronidase PF, 1500 units/mL Injection solution, 1 mL clear glass vial with red cap, No Preservatives, Single use vial, Rx only, used for ophthalmic surgeries. Affected product was dispensed beginning 07/25/2009. Product was distributed domestically to hospital pharmacies and ophthalmic surgical clinics. Drug ID# 16032. Recall # D-538-2010
CODE
1) Lot #s (Rx #s) - 2306460, 2306462, 2306463, 2306464, 2306465, 2307026, 2303427, 2301103, 2300720, 2306206, 2307529, 2305815, 2304707, 2308456, 2308458, 2309625, 2301008, 2304412, 2306431, 2306644; Lot #s (Rx #s)- 2302326, 2302015, 2303424, 2301305, 2301308, 2301592, 2302657, 2301804, 2303437; Lot# (Rx#)- 2305638;

2) Lot #s (Rx #s) - 2297000, 2297002, 2296999, 2296998, 2296996, 2298500, 2298378, 2298894;

3) Lot #s (Rx #s) - 2306632, 2306209
RECALLING FIRM/MANUFACTURER
AnazaoHealth Corp., Tampa, FL, by telephone on September 14, 2009 and by letters dated September 30, 2009 and December 8, 2009. Firm initiated recall is complete.
REASON
Product is being recalled due to reports of adverse events such as lid swelling, periorbital cellulitis and chemosis.
VOLUME OF PRODUCT IN COMMERCE
1242 mL (126 vials)
DISTRIBUTION
AL, CO, FL, IL, OH, TX, VA
___________________________________
PRODUCT 
1) Ketorolac Tromethamine Injection, USP, 30 mg/mL, 25-count 1 mL Single Dose Vials per carton, Rx Only, NDC 0517-0801-25. Recall # D-539-2010;

2) Ketorolac Tromethamine Injection, USP, 15 mg/mL, 25-count 1 mL Single Dose Vials per carton, Rx Only, NDC 0517-0601-25. Recall # D-540-2010;

3) Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 25-count 2 mL Single Dose Vials per carton, Rx only; NDC 0517-0902-25. Recall # D-541-2010
CODE
1) Lots 8512 (exp. 1/31/2010), 8534 (exp. 2/28/2010), 8538 (exp. 2/28/2010), 8626 (exp. 3/31/2010), 8708 (exp. 4/30/2010), 8721 (exp. 4/30/2010), 9017 (exp. 11/30/2009), 9025 (exp. 11/30/2009), 9045 (exp. 11/30/2009), 9054 (exp. 11/30/2009), 9161 (exp. 1/31/2010), 9192 (exp. 1/31/2010), 9221 (exp. 2/28/2010), 9235 (exp. 2/28/2010), 9261 (exp. 2/28/2010), 9314 (exp. 3/31/2010), 9341 (exp. 3/31/2010), 9395 (exp. 4/30/2010), 9463 (exp. 5/31/2010), 9484 (exp. 5/31/2010);

2) Lots 8513 (exp. 1/31/2010); 8725 (exp. 4/30/2010), and 9279 (exp. 10/31/2010);

3) Lots 8514 (exp. 1/31/2010), 9021 (exp. (11/30/2009), 9079 (exp. 12/09/2009), 9102 (exp. 12/31/2009), 9238 (exp. 2/28/2010), 9466 (exp. 5/31/2010)
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letters dated October 16, 2009, October 26, 2009, and November 3, 2009 and by press release on October 21, 2009. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Firm observed particles in some retain vials of Ketorolac Tromethamine Injection, USP, 30 mg/mL & 15mg/mL.
VOLUME OF PRODUCT IN COMMERCE
5,029,650 vials
DISTRIBUTION
Nationwide and Abu Dhabi

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT 
1) Firmagon (degarelix) for injection; 80 mg, 1 vial of 80 mg per carton; Rx only; NDC 55566-8301-1. Recall # D-522-2010;

2) Firmagon (degarelix) for injection; 240 mg (NDC 5566-8401-1), 2 vials of 120 mg (NDC 55566-8401-0) per carton; Rx only. Recall # D-523-2010
CODE
1) Lot: CC0417A, CC0417C, CC0417D, CC0417H, CC0417I, Exp 08/11; CC0032A, CD0032F, CD0032I, Exp 12/11; CD0173A, CD0173B, Exp 03/12;

2) Lot: CC0558A, CC0558B, CC0559B, CC0559C, Exp 10/11; CD0172B, CD0172D, Exp 03/12; CD0255A, CD0355D, Exp 04/12; CD0342E, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals Inc., Parsippany, NJ, by e-mail on March 2, 2010 and by letters on March 2, 2010, May 4, 2010, May 5, 2010 and May 6, 2010.
Manufacturer: Rentschler Biotechnologie Gmbh & Co. KG, Laupheim, Germany. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: A small number of defective containers (reject vials) were introduced into commercial distribution.
VOLUME OF PRODUCT IN COMMERCE
15,689 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) GlipiZIDE and Metformin HCL Tablets 2. 5 mg/250 mg; 100 count bottle, Rx only; NDC # 0781-5304-01. Recall # D-524-2010;

2) GlipiZIDE and Metformin HCL Tablets 2. 5 mg/500 mg; 100 count bottle, Rx only, NDC # 0781-5305-01. Recall # D-525-2010;

3) GlipiZIDE and Metformin HCL Tablets 5 mg/500 mg, 100 count bottle, Rx only. NDC # 0781-5306-01. Recall # D-526-2010
CODE
1) Lot/ Exp date, 100606 4/11, 102466 10/11;

2) Lot / Exp date, CPI870 8/10, CPB931 1/11, 100387 3/11, 100824 5/11, 101101 5/11, 101651 7/11, 102482 10/11, 102483 10/11;

3) Lot/ Exp date, CPK825 10/10, CPB914 1/11, CPB915 1/11, 100353, 3/11 100354 3/11, 100573 3/11, 100602 3/11, 100939 5/11, 101096 5/11, 101097 5/11, 101652 7/11, 101653 7/11, 102484 10/11, 102486 10/11 102485 10/11
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by telephone on January 22, 2010. This was letter on February 8, 2010. Firm initiated recall is ongoing.
REASON
Tablets have the potential to contain metal particulates.
VOLUME OF PRODUCT IN COMMERCE
163,255 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Glyburide (micronized) and Metformin HCl tablets, 1.25 mg/250 mg, 100-count bottle NDC 0781-5170-01; 500-count bottle NDC 0781-5170-05; Rx only. Recall # D-527-2010;

2) Glyburide(micronized) and Metformin HCL Tablets; 2.5 mg/500 mg,100 count bottle NDC 0781-5171-01, 2.5 mg/500 mg, 500 count bottle NDC 0781-5171-05, Rx only. Recall # D-528-2010;

3) Glyburide(micronized) and Metformin HCL Tablets; 5 mg/500 mg, 100 count bottle, NDC 0781-5172-01, 5 mg/500 mg, 500 count bottle NDC 0781-5172-05, Rx only. Recall # D-529-2010
CODE
1) Lot /Exp. Date, CPI869 8/10, CPK819A 10/10, CPB968A 2/11, 100980 5/11 101423B 6/11, CPK819B 10/10, CPB968B 1/11, 101423A 6/11;

2) Lot /Exp. Date, CPI812 8/10, CPK818 10/10, CPK829 10/10, CPA961 12/10, CPA962 12/10, CPB939 1/11, CPB940 1/11, CPB941 1/11, CPB955 2/11, CPB956 2/11, 100278 2/11, 100279 2/11, 100280 2/11, 100657 4/11, 100658 4/11, 100925 5/11, 100926 5/11, 101098 5/11, 101099 5/11, 101100 5/11, 101419 6/11, 101420 6/11, 101931 9/11, CPK816 10/10 CPK817 10/10, CPK830 10/10, CPL801 11/10, CPB942 1/11;

3) Lot / Exp. Date, CPK821C 10/10, 100281 2/11, 101564 7/11, CPK832B 10/10 CPL802B 11/10. NDC# 0781-5172-05 (500 count), Lot / Exp. CPK822 10/10 CPK823 10/10, CPK832 10/10, CPL802 11/10, CPL803 11/10, CPL804 11/10
RECALLING FIRM/MANUFACTURER
Corepharma Llc, Middlesex, NJ, by telephone on January 22, 2010 and letters on February 8, 2010. Firm initiated recall is ongoing.
REASON
Tablets have the potential to contain metal particulates.
VOLUME OF PRODUCT IN COMMERCE
223,111 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
1) Plasma Frozen within 24 hours (FP24). Recall # B-1155-10;
2) Recovered Plasma. Recall # B-1156-10
CODE
1) Unit: W044609220826;
2) Units: W044608211648, W044608322459, W044609340801
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on August 31, 2009 and September 6, 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
TX, NJ

___________________________________
PRODUCT 
Source Plasma. Recall # B-1157-10
CODE
Unit: 08MMIA5304
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Inc., Marquette, MI, by facsimile and e-mail on October 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1160-10 
CODE
Unit: 9651196, 9715661, 5812088
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 16, 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
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Source Plasma. Recall # B-1190-10
CODE
Unit: TA2106889
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax, email and letter on July 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
England
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1191-10
CODE
Unit: W288009006328
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by fax 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
IL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1193-10
CODE
Units: 3310013708, 3310014004, 3310014141, 3310014430, 3310014561
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Shreveport, LA, by fax on May 13, 14, and 18, 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
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1195-10
CODE
Units: 380085874, 380087593, 380086873, 380091988, 380091589, 380009159, 380008418
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Monroe, LA, by fax on July 30, 2008. 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
7 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Plasma Frozen within 24 hours (FP24). Recall # B-1201-10
CODE
Unit: 003LM38428
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,  by email, fax and letter on October 20, 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
AL, GA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1202-10;
2) Liquid Plasma. Recall # B-1203-10;
3) Platelets. Recall # B-1204-10;
4) Source Leukocytes. Recall # B-1205-10
CODE
1) Unit: W046609273704;
2), 3) and 4) Unit: W044609273704
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on August 18 and 21, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1207-10;
2) Fresh Frozen Plasma. Recall # B-1208-10
CODE
1) and 2) Units: R41826, R33828, R32312
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by e-mail on December 1, 2009 and by letter dated December 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1209-10
CODE
Unit: 01LF56321
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by fax and the LOGIC system on November 9, 2009.
Manufacture: American Red Cross Blood Service, Buffalo, 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-1211-10
CODE
Units: TA2042271; TA2042828; TA2042986; TA2044018; TA2044442; TA2044797; TA2075409; TA2075612; TA2076125; TA2076453; TA2077018; TA2078350; TA2108541; TA2111792; TA2112354; TA2112667; TA2077110
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax on November 14, 2009 and e-mail on January 22, 2010 and January 25, 2010. Firm initiated recall was complete.
REASON
Blood products, collected from a donor who failed to disclose application of a new tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC, UK
___________________________________
PRODUCT 
Source Plasma. Recall # B-1212-10
CODE
Units: LC0631410; LC0620604; LC0620990; LC0621338; LC0621872; LC0622663; LC0623526; LC0624001
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, New Mexico, by fax on September 11, 2009 and e-mail on January 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a new body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, UK
___________________________________
PRODUCT 
Source Plasma. Recall # B-1213-10
CODE
Units: FD0342566; FD0343054; FD0344060; FD0344402; FD0344961; FD0345166; FD0346347; FD0346552; FD0347255; FD0347453; FD0352165; FD0352489; FD0398556; FD0398769; FD0399291; FD0399542
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, New Mexico,by fax on August 29, 2009 and September 17, 2009 and e-mail on January 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who failed to disclose application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC, UK
___________________________________
PRODUCT 
Source Plasma. Recall # B-1214-10
CODE
Units: SS0016801; SS0017094; SS0017873; SS0018201; SS0018653; SS0018896; SS0021917
RECALLING FIRM/MANUFACTURER
DCI Biologicals San Marcos, LLC, San Marcos, TX, by fax on September 15, 2009 and e-mail on January 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with high risk behavior, were distributed
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1215-10 
CODE
Units: 3530044658; 3530044151; 3530043192; 3530042689; 3530041785
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Flint, MI, by fax on April 20, 2009 and May 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1216-10
CODE
Units: 3940024640; 3940024806
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Lansing, MI, by fax on April 9, 2009. Firm initiated recall is complete.   
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1220-10;
2) Fresh Frozen Plasma. Recall # B-1221-10
CODE
1) and 2) Unit: W001306014125
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, Lackland AFB, TX, by fax on April 27, 2007.
Manufacturer: Department of Air Force - BB/HT, Lackland AFB, TX. 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
TX, NJ
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1224-10;
2) Platelets Leukocytes Reduced, Recall # B-1225-10
CODE
1) Units: 16GR41674, 16KS09109;
2) Unit: 16GR41674
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on June 3, 2008 and by follow-up letter on June 6, 2008.
Manufacturer: American Red Cross Blood Services, Central Ohio Region, Columbus, OH. 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
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1227-10;
2) Platelets. Recall # B-1228-10
CODE
1) and 2) Unit: 4734706
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on January 4, 2010 and January 6, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis). Recall # B-1229-10
CODE
Unit: 5425269
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 8, 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
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1231-10 
CODE
Unit: 03LC47771
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on October 6, 2009 and by letter dated October 6, 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
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1233-10
CODE
Unit: 003K45761
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile July 16, 2009 and July 17, 2009 and by letters dated July 16, 2009 and July 17, 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
AL, GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1234-10
CODE
Unit: 004GK99276
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on January 3, 2008 and April 2, 2008. Firm initiated recall is complete.
REASON
Blood product, which tested positive for syphilis on an invalidated test run, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1236-10
CODE
Unit: 17KW89860
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated December 9, 2005 or by electronic notification on December 9, 2005. 
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.   
REASON
Blood product, collected from a donor who received an accidental needle stick, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA, IL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1238-10
CODE
Unit: 7127372
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on July 4, 2007.  Firm initiated recall is complete.  
REASON
Blood product, which was contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1240-10;
2) Recovered Plasma. Recall # B-1241-10
CODE
1) and 2) Unit: 1186066
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on August 28, 2008 and September 10, 2008. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
Source Plasma. Recall # B-1192-10
CODE
Unit: 386040203
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Waukegan, IL, by fax on March 13, 2009. Firm initiated recall is complete.
REASON
Blood product, stored at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Fresh Frozen Plasma. Recall # B-1194-10
CODE
Unit: W042209010004F
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by email on March 05, 2009. Firm initiated recall is complete.
REASON
Blood component, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT 
Source Plasma. Recall # B-1196-10
CODE
Units: 368104648, 368103237, 368102784, 368100746, 368096348
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc dba International BioResources. Glendale, AZ, by fax on April 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred due to receiving a piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1197-10
CODE
Units: 3600009626, 3600000488, 3600000057, 3600028843, 3600011893, 3600000370, 3600033900, 3600038873, 3600048974, 3600043274, 3600042938, 3600038356, 3600032026, 3600003587, 3600003128, 3600031025, 3600027214
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Canton, OH, by fax on April 16, 2009. 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
17 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1198-10
CODE
Units: 3990013152, 3990020951, 3990022567, 3990022929, 3990023228, 3990023965, 3990024345, 3990024809, 3990025212, 3990025668, 3990026864, 3990027216, 3990027527, 3990028198, 3990028545, 3990028726
RECALLING FIRM/MANUFACTURER
International BioResources LLC, Columbus, OH, by fax on May 29, 2009 and June 1, 2009. 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
16 units
DISTRIBUTION
NC

___________________________________
PRODUCT 
Source Plasma. Recall # B-1199-10
CODE
Unit: 3850065160
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Oklahoma City, OK, by fax on May 26, 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
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1200-10
CODE
Unit: 003LM38428
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,  by email, fax and letter on October 20, 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
AL, GA
___________________________________
PRODUCT 
Fresh Frozen Plasma. Recall # B-1206-10
CODE
Units: W067109060257, W067109060231, W067109060236, W067109060256, W067109058002, W067109061443
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 16, 2009 and by letter dated December 17, 2009. Firm initiated recall is complete.  
REASON
Blood products, which were not frozen within eight hours after Whole Blood collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1210-10
CODE
Unit: 01LF56321
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by fax and the LOGIC system on November 9, 2009.
Manufacture: American Red Cross Blood Service, Buffalo, 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
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1217-10
CODE
Unit: 3500022259; 3500022659
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Montgomery, AL, by fax on April 23, 2009 and April 24, 2009.  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
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1218-10
CODE
Units: 3530005424; 3530007465; 3530015675; 3530016246; 3530017301
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Flint, MI, by fax on April 21, 2009 and April 22, 2009. 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
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1219-10
CODE
Units: 3600044651; 3600045532; 3600050624
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Canton, OH, by fax on April 9, 2009. 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
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1222-10;
2) Source Leukocytes. Recall # B-1223-10
CODE
1) and 2) Unit: W044608434899
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on August 18, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, NJ
___________________________________
PRODUCT 
Source Plasma. Recall # B-1226-10
CODE
Units: ST1011282; ST1011801
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center, LLC, Stillwater, OK, by fax on November 24, 2009 and e-mail on February 4, 2010. 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
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1230-10
CODE
Unit: 03LC47771
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on October 6, 2009 and by letter dated October 6, 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
GA

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1232-10
CODE
Unit: 003K45761
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile July 16, 2009 and July 17, 2009 and by letters dated July 16, 2009 and July 17, 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
AL, GA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1235-10
CODE
Units: 3920008149, 3920009137, 3920009990, 3920010735, 3920011176, 3920011523, 3920010140, 3920010705, 3920010220, 3920010899, 3920008314, 3920008587, 3920008978, 3920009154, 3920011115, 3920008818, 3920010372, 3920011170, 3920007632, 3920007925, 3920008127, 3920009107, 3920007203, 3920008363, 3920007721, 3920007853, 3920008318, 3920008996, 3920011129, 3920009101, 3920010150, 3920010673, 3920011570, 3920011110, 3920007923, 3920008224, 3920009556, 3920009796, 3920010802, 3920007292, 3920007178, 3920007655, 3920007929, 3920007584, 3920010078, 3920010422, 3920011531, 3920007208, 3920008178, 3920010176, 3920011284, 3920008670, 3920008815, 3920009146, 3920008004, 3920007518, 3920007125, 3920007586, 3920007750, 3920009979, 3920010328, 3920010960, 3920011496, 3920007955, 3920008444, 3920009149, 3920009953, 3920007625, 3920007902, 3920009447, 3920010712, 3920008182, 3920008159, 3920009170, 3920009425, 3920009640, 3920009151, 3920009481, 3920008295, 3920008769, 3920010332, 3920011577, 3920008999, 3920010189, 3920010927, 3920007106, 3920007278, 3920009891, 3920009233, 3920010107, 3920011185, 3920007022, 3920008312, 3920007607, 3920008247, 3920008758, 3920010415, 3920010720, 3920011149, 3920010191, 3920010473, 3920007663, 3920007086, 3920008827, 3920009800, 3920008568, 3920008949, 3920009812, 3920010129, 3920010378, 3920010901, 3920011155, 3920008442, 3920010425, 3920011272, 3920010097, 3920007855, 3920008523, 3920010267, 3920008345, 3920008536, 3920010747, 3920007273, 3920007770, 3920008503, 3920008851, 3920009029, 3920010426, 3920007163, 3920007524, 3920008814, 3920009726, 3920009856, 3920010933, 3920011485, 3920009191, 3920010418, 3920010764, 3920009999, 3920010201, 3920007716, 3920008231, 3920008386, 3920008805, 3920009835, 3920010364, 3920011169, 3920007542, 3920008269, 3920009519, 3920010036, 3920010261, 3920008782, 3920009580, 3920010446, 3920010968, 3920008398, 3920007778, 3920008725, 3920008834, 3920008963, 3920010375, 3920010895, 3920008430, 3920010386, 3920007952, 3920009034, 3920008802, 3920008158, 3920007089, 3920008678, 3920009074, 3920010387, 3920011270, 3920010293, 3920007680, 3920009291, 3920006972, 3920008797, 3920008984, 3920009500, 3920010026, 3920010402, 3920011112, 3920009526, 3920010346, 3920007836, 3920010224, 3920008505, 3920008730, 3920008982, 3920009166, 3920010352, 3920008453, 3920008844, 3920010132, 3920011188, 3920010965, 3920007120, 3920008772, 3920009562, 3920009799, 3920010797, 3920009616, 3920009929, 3920010055, 3920010995, 3920010102, 3920008125, 3920008392, 3920009104, 3920010684, 3920011240, 3920007098, 3920008500, 3920007912, 3920008123, 3920009505, 3920010067, 3920010384, 3920010748, 3920007032, 3920007303, 3920008238, 3920008989, 3920007059, 3920007943, 3920007961, 3920010853, 3920006939, 3920007522, 3920007775, 3920008010, 3920008753, 3920009095, 3920010196, 3920007673, 3920008190, 3920008639, 3920009142, 3920009439, 3920007920, 3920008625, 3920009122, 3920009944, 3920007000, 3920008355, 3920008602, 3920010158, 3920010946, 3920011494, 3920011163, 3920010270, 3920011131, 3920009512, 3920008565, 3920009065, 3920010350, 3920011187, 3920007063, 3920008494, 3920008986, 3920009941, 3920010766, 3920007555, 3920010399, 3920010778, 3920008510, 3920009207 and 3920010769
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources Inc, Research Triangle Park, NC, by facsimile and letter between February 17, 2009 and February 27, 2009.
Manufacturer: Talecris Plasma Resources Inc., Rockford, IL. 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
270 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1237-10
CODE
Unit: 17KW89860
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated December 9, 2005 or by electronic notification on December 9, 2005. 
Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm initiated recall is complete.   
REASON
Blood product, collected from a donor who received an accidental needle stick, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA, IL

___________________________________
PRODUCT 
Source Plasma. Recall # B-1242-10
CODE
Units: 355034328, 355038068, 355037506, 355034047, 355035400, 355036992, 355034748, 355037509, 355036344, 355034660, 355034049, 355035378, 355035987, 355036600, 355036869, 355038264, 355033763, 355034152, 355035424, 355034420, 355034011, 355034290, 355035689, 355036221, 355037951, 355034066, 355033877, 355036700, 355034213, 355034078, 355034104, 355034436, 355037817, 355038021, 355035933, 355034056, 355034261, 355036710, 355037648, 355034482, 355038011, 355033838, 355033888, 355034315, 355034429, 355035362, 355036110, 355034931, 355034338, 355035465, 355035786, 355036335, 355037644, 355034597, 355035712, 355034729, 355033863, 355036362, 355036072, 355038632, 355034050, 355033835, 355035945, 355034806, 355038194, 355036840, 355035357, 355036402, 355034440, 355034340, 355034662, 355038186, 355034741, 355035947, 355038074, 355037975, 355036071, 355035562, 355035708, 355036321, 355036487, 355035755, 355034718, 355037996, 355038210, 355036532, 355036557, 355034477, 355035590, 355036049, 355036632, 355037735, 355034027, 355034273, 355036235, 355036834, 355035989, 355035549, 355034025, 355034588, 355036964, 355038160, 355034802, 355035365, 355034836, 355036005, 355036431, 355036931, 355036387, 355037596, 355035484, 355034989, 355035545, 355035859, 355035489, 355035734, 355035917, 355035149, 355038071, 355034180, 355033419, 355035701, 355035888, 355034592, 355035004, 355035564, 355035960, 355034371, 355037656, 355034785, 355035963, 355038183, 355036680, 355036281, 355036922, 355038229, 355034678, 355036928, 355035892, 355037550, 355035577, 355037763, 355034271, 355036694, 355034307, 355037586, 355033800, 355035407, 355033884, 355036461, 355037815, 355035984, 355035823, 355035482, 355036035, 355036613, 355036541, 355037675, 355038052, 355038624, 355037652, 355034022, 355038215, 355035986, 355035569, 355033844, 355029700, 355027624, 355023355, 355023897, 355024461, 355024932, 355025431, 355025642, 355026640, 355027187, 355027308, 355028462, 355027767, 355029605, 355024720, 355025378, 355025077, 355025333, 355029640, 355029616, 355021312, 355021396, 355025415, 355025617, 355025909, 355026906, 355027411, 355028682, 355029001, 355026422, 355028987, 355029224, 355023771, 355025029, 355026720, 355027217, 355028783, 355029595, 355025323, 355027132, 355028444, 355023770, 355025169, 355027851, 355025446, 355026897, 355028670, 355028842, 355029293, 355027947, 355027574, 355026480, 355026985, 355026657, 355023375, 355027888, 355027824, 355026913, 355028219, 355028944, 355029317, 355030033, 355023265, 355023840, 355025350, 355026153, 355026646, 355029250, 355024359, 355026326, 355026509, 355027029, 355023340, 355026678, 355027228, 355028227, 355027599, 355025917, 355027892, 355029735, 355023212, 355023669, 355024412, 355025276, 355027446, 355028661, 355025014, 355028033, 355027536, 355023419, 355023835, 355025000, 355023698, 355025355, 355025659, 355026361, 355026629, 355028812, 355023956, 355024676, 355024986, 355026240, 355028875, 355024236, 355023851, 355024838, 355025334, 355023131, 355023742, 355024700, 355025505, 355028006, 355028291, 355029074, 355029411, 355027815, 355027849, 355027674, 355027453, 355026462, 355028903, 355025318, 355029002, 355021438, 355027956, 355027435, 355028461, 355028821, 355029079, 355027680, 355026632, 355029378, 355027808, 355027826, 355026948, 355027311, 355028549, 355029706, 355023394, 355024767, 355025416, 355025929, 355028018, 355028466, 355029472, 355027843, 355023301, 355028179, 355024453, 355027854, 355023256, 355023426, 355024372, 355024911, 355023600, 355024018, 355024524, 355027317, 355029593, 355027544, 355021462, 355024806, 355025104, 355026506, 355028248, 355027946, 355023094, 355023096, 355023114, 355023342, 355027405, 355023527, 355024296, 355024460, 355024943, 355026344, 355027358, 355027419, 355029478, 355030124, 355023693, 355024382, 355024769, 355021349, 355024325, 355024418, 355029326, 355030065, 355023480, 355024483, 355024647, 355029569, 355026231, 355026731, 355028257, 355027575, 355024238, 355024709, 355024304, 355028020, 355028395, 355025398, 355030099, 355021435, 355025140, 355027006, 355028354, 355025002, 355029708, 355029731, 355024284, 355025087, 355026915, 355028210, 355026269, 355027834, 355026991, 355027461, 355028281, 355028808, 355027972, 355023105, 355023874, 355024935, 355025887, 355030097, 355023740, 355024528, 355026983, 355027270, 355028883, 355023556, 355023690, 355024746, 355025042, 355026260, 355028140, 355026625, 355028131, 355021310, 355021481, 355024518, 355025358, 355025405, 355025908, 355026155, 355026283, 355024021, 355024793, 355025079, 355025465, 355026137, 355029707, 355027847, 355023893, 355025427, 355027363, 355027466, 355028907, 355029613, 355030044, 355021493, 355025968, 355028455, 355027918, 355027352, 355023553, 355025675, 355025993, 355021460, 355027920, 355027991, 355025484, 355026117, 355021282, 355024803, 355023328, 355028379, 355029314, 355029730, 355023550, 355024476, 355026907, 355023088, 355024496, 355024975, 355025943, 355026245, 355028266, 355028489, 355028796, 355029046, 355023345, 355023784, 355024473, 355023320, 355027412, 355029010, 355029008, 355027541, 355025013, 355025338, 355025991, 355026345, 355029499, 355027535, 355027871, 355024744, 355025291, 355023838, 355024799, 355025407, 355027840, 355027464, 355023545, 355023875, 355023818, 355023531, 355021385, 355026616, 355023767, 355023349, 355027115, 355029743, 355030122, 355025947, 355026753, 355026988, 355028497, 355029064, 355029383, 355023990, 355024290, 355024762, 355026740, 355027643, 355027688, 355023318, 355023810, 355023919, 355024433, 355026215, 355027211, 355028234, 355027831, 355027244, 355028008, 355028274, 355029257, 355027576, 355027609, 355026439, 355027168, 355028373, 355021371, 355023772, 355024022, 355024293, 355024779, 355029559, 355030084, 355021498, 355026677, 355027654, 355027709, 355027593, 355027612, 355027154, 355023262, 355024407, 355025332, 355028003, 355028518, 355028825, 355029068, 355027868, 355023800, 355023982, 355028523, 355028814, 355029060, 355029379, 355027229, 355029698, 355027836, 355027258, 355028742, 355028918, 355027027, 355029421, 355027711, 355027484, 355024745, 355025041, 355028236, 355029015, 355030078, 355027965, 355027988, 355028994, 355028970, 355027925, 355024914, 355026729, 355027224, 355026770, 355027994, 355027844, 355028127, 355023107, 355029713, 355025187, 355026308, 355026715, 355028196, 355028377, 355028747, 355029354, 355023115, 355023734, 355024832, 355025679, 355026171, 355028371, 355030029, 355030127, 355029555, 355025182, 355024834, 355026612, 355029298, 355030100, 355023424, 355023476, 355023958, 355024517, 355025513, 355025686, 355023409, 355027855, 355021360, 355029738, 355028334, 355028858, 355025460, 355025976, 355026273, 355027480, 355028214, 355030121, 355024265, 355024442, 355024650, 355029403, 355025940, 355026467, 355023995, 355024851, 355023117, 355023599, 355026213, 355028778, 355024738, 355021362, 355029543, 355029037, 355023980, 355027530, 355025108, 355025290, 355023541, 355026445, 355028343, 355030086, 355023587, 355023884, 355025980, 355026109, 355027232, 355023352, 355029302, 355026778, 355023985, 355028822, 355027648, 355027583, 355025690, 355027204, 355023108, 355023347, 355027265, 355028479, 355029005, 355023686, 355024363, 355026256, 355028160, 355023244, 355027415, 355029056, 355023386, 355026672, 355027297, 355025693, 355029460, 355028719, 355028878, 355029267, 355024853, 355026411, 355026622, 355029364, 355027802, 355024394, 355024498, 355025977, 355026468, 355026947, 355028468, 355028313, 355026290, 355027023, 355028270, 355028847, 355023327, 355023764, 355026233, 355024952, 355024489, 355024640, 355025923, 355027350, 355023815, 355024395, 355025084, 355026275, 355027371, 355028393, 355023216, 355023412, 355024811, 355025115, 355025651, 355026097, 355024500, 355025625, 355026758, 355028284, 355027685, 355026263, 355026767, 355027159, 355027483, 355027454, 355027633, 355024670, 355023338, 355024318, 355024942, 355021466, 355024440, 355024921, 355025129, 355023307, 355022592, 355023890, 355024025, 355024404, 355023312, 355023464, 355023855, 355024365, 355024680, 355025317, 355026685, 355024447, 355026324, 355026696, 355023123, 355023728, 355023865, 355024996, 355025315, 355025489, 355026166, 355026315, 355026680, 355027143, 355028200, 355028715, 355023099, 355025293, 355023360, 355027032, 355027129, 355028517, 355023944, 355023752, 355027476, 355028442, 355028743, 355028993, 355030119, 355029241, 355027772, 355027683, 355027180, 355028387, 355030118, 355029629, 355029601, 355027919, 355029349, 355025184, 355024288, 355021404, 355028431, 355029218, 355030088, 355023474, 355025981, 355028030, 355025075, 355028132, 355028973, 355029365, 355024652, 355024883, 355025145, 355030019, 355027316, 355028158, 355024491, 355026168, 355025311, 355021444, 355027838, 355028978, 355027246, 355027845, 355027996, 355029030, 355030135, 355028687, 355028198, 355026320, 355024980, 355023533, 355023401, 355023087, 355023368, 355023579, 355023802, 355023983, 355024509, 355024843, 355024977, 355025480, 355025983, 355026331, 355027041, 355028526, 355029115, 355030040, 355025353, 355026761, 355023581, 355024397, 355024885, 355025105, 355026182, 355026369, 355027197, 355028416, 355028949, 355021314, 355021350, 355024003, 355025438, 355027376, 355028324, 355026338, 355028829, 355029408, 355027644, 355026252, 355028293, 355029373, 355024299, 355025492, 355026247, 355028561, 355023290, 355023125, 355023814, 355024292, 355029385, 355023364, 355029621, 355029652, 355030104, 355023809, 355025386, 355025875, 355021477, 355021476, 355025424, 355029078 and 355029259
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Bloomington, IL, facsimile and letter between February 25, 2008 and March 18, 2008. Firm initiated recall is complete.
REASON
Blood products collected donors whose suitability determination were inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
875 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
1) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit (Orange) Pack NAV, Abbott Item Number 70684-01. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-0820-2010;

2) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Packaging Orange, Abbott Item Number 70684-02. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-0821-2010;

3) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Packaging, Abbott Item Number 70684-03. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1444-2010;

4) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1445-2010;

5) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Replacement Kit, Transmitter, Abbott Item Number 70791-02. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1446-2010;

6) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, Reorder/Warranty Kit EMEA, Abbott Item Number 70791-20. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1447-2010;

7) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB System Kit MG, EMEA, DE. Abbott Item Number 70965-01, Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1448-2010;

8) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG, (E). Abbott Item Number 70965-02. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1449-2010;

9) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG, and System Kit MG (EMEA) FR, Pack. Abbott Item Number 70965-03. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1450-2010;

10) Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1451-2010;

11) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL. Abbott Item Number 70966-02. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1452-2010;

12) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System, Business 1, MMOL (EMEA) UK. Abbott Item Number 70966-03. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1453-2010;

13) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL (EMEA) SV. Abbott Item Number 70966-04. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1454-2010;

14) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MMOL EMEA. Abbott Item Number 71036-01. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1455-2010;

15) Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit MG EMEA and System Kit MMOL, EMEA. Abbott Item Number 71036-02. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1456-2010;

16) Freestyle Navigator Continuous Glucose Monitor System, System Kit, Business 1, (Orange). Abbott Item Number: PRT 03415-001. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1457-2010;

17) Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1458-2010;

18) Freestyle Navigator Continuous Glucose Monitor System, ABB Transmitter Navigator. Abbott Item Number: PRT 03831-001. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1459-2010;

19) Freestyle Navigator Continuous Glucose Monitor System, Assy, Transmitter Poly Contac, Abbott Item Number: PRT 03831-002. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1460-2010;

20) Freestyle Navigator Continuous Glucose Monitor System, Clinical Transmitter, Abbott Item Number: PRT 03831-091. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care. Recall # Z-1461-2010
CODE
1) Lot No. 01M0248; Kit Serial numbers BAAH220-80089, BAAH220-81000, Tx Serial Numbers AAAH187-80187, AAAH187-80845;

2) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers: 01M1018 or 01M1028 or 01M1038 or 01M1148 or 01M1178 or 01M1218 or 01M1288 or 01M1368 or 01M1488 or 01M1618 or 01M1708 or 01M1898 or 01M1918 or 01M2108 or 01M2198 or 02M1038 or 02M1048 or 03M1058. Kit Serial numbers beginning with: BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 186 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 299 or BAAH 341 or BAAH 353 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 283 or AAAH 296 or AAAH 354, and followed by a five (5) digit number;

3) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M2328 or 01M2388 or 01M2408 or 01M2478 or 01M2528 or 01M2558 or 01M2608 or 01M3518, or 01N0208 or 01N0488 or 02N0068. Kit Serial numbers beginning with: BAAH 067, BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 186 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 275 or BAAH 299 or BAAH 341 or BAAH 353 and followed by a five (5)digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 158 or AAAH 195 or AAAH or AAAH 268 or AAAH 296 and followed by a five (5) digit number;

4) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1928, 01M1978, 01M2038, 01M2178, 01M2528, and 01M3258. Kit Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH283 and followed by a five (5)digit number. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH 283 and followed by a five (5) digit number;

5) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M2068, 01M2548, and 01M3238. Kit Serial numbers beginning with: AAAH 187 or AAAH 195 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 195 or AAAH 283 and followed by a five (5) digit number;

6) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01N0578, 02N0418 and 04N0418 Kit Serial numbers beginning with: AAAH 187 or AAAH 195 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 195 or AAAH 283 and followed by a five (5) digit number;

7) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01K2578, 01K2638, 01K2698, 01K3238, 01K3328, 01K3338, 01K3488, 01M0108, 01M0238, 01M0368, 01M0798, 01M0848, 01M1768, 01M2048, 01M2138 AND 02M0238. Kit Serial numbers beginning with: BAAH 156 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261or BAAH 299 or BAAH 341 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 268 or AAAH 283 or AAAH 296 and followed by a five (5) digit number;

8) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1268, 01M1728, 01M1998, 01M2068 and 01M2468. Kit Serial numbers beginning with: BAAH 156 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261or BAAH 299 or BAAH 341 and followed by a five (5) digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 354 and followed by a five (5) digit number;

9) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1408 or 01M1838. Kit Serial numbers beginning with: BAAH 156 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 299 and followed by a five (5) digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 and followed by a five (5) digit number;

10) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0028 or 01M0168 or 01K 2768 or 01K 2898 or 01K 3238 or 01K3328 or 01K3478 or 01M0028 or 01M0298 or or 01M1438 or 01M1638 or 01M2808. Kit Serial numbers beginning with BAAH 186 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 290 or BAAH 299 or BAAH 341and followed by a 5 digit number. TX Serial number beginning with AAAH 008 or AAAH 90 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 268 or AAAH 296 or AAAH 354 and followed by a 5 digit number;

11) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M0748 or 01M0858 or 01M1548 or 01M2628 or 01M2188. Kit Serial numbers beginning with: BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 275 or BAAH 290 or BAAH 299 or BAAH 341 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH187 or AAAH 212 or AAAH 221 or AAAH 239 or AAAH 296 and followed by a five (5) digit number;

12) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1268 or 01M1728 or 01M1918 or 01M 2058 or 01M2178, or 01M 2678 or 01M3228. Kit Serial numbers beginning with: BAAH 186 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 341 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 268 or AAAH 296 and followed by a five (5) digit number;

13) Multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1658 or 01M1968 or 01M2548 or 01M2828. Kit Serial numbers beginning with: BAAH 186 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 275 or BAAH 290 or BAAH 299 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH139 or AAAH 158 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 239 or AAAH 268 or AAAH 296 and followed by a five (5) digit number;

14) Lot numbers: 01N0158 or 01N0278 or 01N0348 or 01N0568 or 02N0128. Kit Serial numbers beginning with: BAAH 156 BAAH 162 or BAAH 200 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 275 or BAAH 290 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 207 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 268 or AAAH 283 or AAAH 296, and AAAK 008 and followed by a five (5) digit number;

15) Lot numbers: 01N0228 or 01N0478 or 01N0588 or 02N0338 or 05N0418. Kit Serial numbers beginning with: BAAH 186 or BAAH 207 or BAAH 243 or BAAH 261 or BAAH 341 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 195 or AAAH 221 or AAAH 228 or AAAH 268 or AAAH 283, or AAAK 008 and followed by a five (5) digit number;

16) Lot numbers are these: 01M0168 or AB000003 or AB000004 or AB000005 or AB000006 or AB000007 or AB000008 or AB000009 or AB000010 or AB000011 or AB000012 or AB000013 or AB000014 or AB000015 or AB000016 or BAAH186 or BAAH 223 or BAAH 243 or THPK 018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 162 or BAAH 180 or BAAH 181 or BAAH 186 or BAAH 188 or BAAH 207 or BAAH 220 or BAAH 223 or BAAH 243 or BAAH 261 or BAAH 299 or BAAH 312 or BAAH 341 or BAAG 299 or BAAG 312 and followed by a five (5)digit number. Tx Serial numbers beginning with: AAAH 055 or AAAH 090 or AAAH 139 or AAAH 158 or AAAH 179 or AAAH 181 or AAAH 187 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 268 or AAAH 283 or AAAH 296 or AAAH 354 or AAAK 307 and followed by a five (5) digit number;

17) Lot numbers: 01M0878 or 01M3018. Kit Serial numbers beginning with: BAAH 067 BAAH 093 or BAAH 107 or BAAH 156 or BAAH 200 or BAAH 207 or BAAH 275 or BAAH 290 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 139 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 288 and followed by a five (5) digit number;

18) Lot numbers: AB000020 or AB000022 or AB000023 or AB000026 or AB000027 or AB000031 or AB000033 or AB000037 or AB000038 or AB000041 or AB000042 or AB000044 or AB000045 or AB000047 or AB000048 or AB000049 or AB000050 or WST001887 WST002245 WST002402 WST003842 or WST004811. Kit Serial numbers: NA. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 268 or AAAH 283 or AAAH 296 or AAAH 354 and followed by a five (5) digit number. Tx Serial numbers AAAK 008 followed by a 5 digit number is for Lot numbers AB000047, AB000048, AB000049 and AB000050 only;

19) Lot numbers: AB000020 or AB000021 or AB000021.2 or AB000023 or AB000024 or AB000025 or AB000026 or AB000027 or AB000029 or AB000030 or AB000031 or AB000032 or AB000033 or AB000034 or AB000035 or AB000036 or AB000037 or AB000040 or AB000041 or AB000042 or AB000044 or AB000046 or AB000047 or AB000048. Kit Serial numbers: NA. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 248 or AAAH 268 or AAAH 283 or AAAH 296 or AAAH 354 and followed by a five (5) digit number. Tx Serial numbers AAAK 008 followed by a 5 digit number for Lot numbers AB000047 and AB000048 only;

20) Lot numbers: AB000005, AB000020 or AB000021 or AB000022.2 or AB000024 or AB000025 or AB000026 or AB000030 or AB000032 or AB000033 or AB000034 or AB000037. Kit Serial number: AAAH 283 is for Lot Number: AB000005 only. Kit Numbers for other Lot numbers: NA Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 212 or AAAH 221 or AAAH 228 or AAAH 239 or AAAH 283 and followed by a five (5) digit number
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by letters on April 14, 2009.
Manufacturer: Benchmark Electronics, Rochester, MN. Firm initiated recall is ongoing.
REASON
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
VOLUME OF PRODUCT IN COMMERCE
5,449 units
DISTRIBUTION
OH, FL, NJ, CA, MS, MN, MA, NY, France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany

___________________________________
PRODUCT 
Precise Treatment Table Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. Recall # Z-1432-2010
CODE
Lot numbers: 103101, 105136, 105183, 105223, 105271, 105281, 105292, 105330, 105343, 105370, 105446, 105473, 105511, 105518, 105528, 105532, 105542, 105550, 105568, 151416, 151417, 151420, 151421, 151422, 151423, 151424, 151425, 151426, 151427, 151428, 151429, 151430, 151432, 151433, 151434, 151435, 151436, 151437, 151439, 151440, 151441, 151443, 151444, 151445, 151446, 151447, 151448, 151449, 151450, 151451, 151452, 151453, 151454, 151455, 151456, 151457, 151458, 151459, 151460, 151461, 151462, 151463, 151464, 151466, 151467, 151468, 151469, 151470, 151472, 151473, 151474, 151475, 151476, 151477, 151478, 151479, 151480, 151481, 151483, 151484, 151485, 151486, 151487, 151488, 151489, 151490, 151491, 151492, 151493, 151494, 151495, 151496, 151497, 151499, 151500, 151501, 151502, 151503, 151504, 151505, 151506, 151507, 151508, 151509, 151510, 151511, 151513, 151514, 151515, 151516, 151517, 151518, 151519, 151520, 151522, 151523, 151524, 151525, 151526, 151527, 151528, 151529, 151530, 151531, 151532, 151533, 151534, 151535, 151536, 151537, 151538, 151539, 151540, 151541, 151542, 151543, 151544, 151546, 151547, 151549, 151550, 151551, 151552, 151553, 151554, 151555, 151557, 151558, 151559, 151561, 151565, 151566, 151567, 151568, 151569, 151572, 151573, 151578, 151574, 151575, 151579, 151580, 151581, 151583, 151584, 151585, 151587, 151588, 151589, 151590, 151595, 151596, 151597, 151599, 151600, 151601, 151602, 151603, 151608, 151614, 151618, 151622, 151626, 151627, and 151628
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, by a Mandatory Field Change Order (FCO) 528 053, dated January 11, 2007.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps, Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON
In some instances, the bolts which are supplied with the table have sheared off, resulting in inability to operate the powered table.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Nationwide, Puerto Rico, Argentina, Australia, Austria, Bangladesh, Belgium, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Poland, Russia, Serbia, Spain, Sudan, Sweden, Taiwan, Thailand, Turkey & United Kingdom
___________________________________
PRODUCT 
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. Catalog Number: 392-11-604. Recall # Z-1433-2010
CODE
Lot Number: 59600085
RECALLING FIRM/MANUFACTURER
Encore Medical, LP. Austin, TX, by e-mail dated March 19, 2010. Firm initiated recall is ongoing.
REASON
Affected product had incorrect color label which is a secondary visual indicator for sizing.
VOLUME OF PRODUCT IN COMMERCE
7 (US-3, OUS-4)
DISTRIBUTION
UT, IA, and Germany
___________________________________
PRODUCT 
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P, 30P and 40P. Intended as an accessory to the Ascension PyroCarbon PIP Total Joint used in finger joint implant procedures where the joint has become painful, stiff or cannot move because of arthritis. Recall # Z-1524-2010
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Ascension Orthopedics, Inc., Austin, TX, by e-mail beginning June 2009. Firm initiated recall is ongoing.
REASON
Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
VOLUME OF PRODUCT IN COMMERCE
129 units (64 US, 65 OUS)
DISTRIBUTION
Nationwide, United Kingdom and France
___________________________________
PRODUCT 
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals. REF#1806061. Recall # Z-1525-2010
CODE
2 lots: Lot # RETE0854 and RETG1016
RECALLING FIRM/MANUFACTURER
Bard Access Systems, Salt Lake City, UT, letter dated March 18, 2010. Firm initiated recall is ongoing.
REASON
8F PowerPort stems were mixed with 6F PowerPorts and packaged.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC
___________________________________
PRODUCT 
Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia (AMON), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) on the Dimension Vista System. Catalog number KC130. Recall # Z-1535-2010
CODE
Lot number: 9ED058 exp 5/1/10
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated October 2009. Firm initiated recall is ongoing.
REASON
Patient results are depressed.
VOLUME OF PRODUCT IN COMMERCE
1,753 cartons
DISTRIBUTION
Nationwide, Australia, Canada, Japan, New Zealand, South Korea, and Switzerland
___________________________________
PRODUCT 
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Product Code: 0010211. The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. Recall # Z-1536-2010
CODE
Lot number: DATB0015
RECALLING FIRM/MANUFACTURER
Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated April 8, 2010. Firm initiated recall is ongoing.
REASON
Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0").
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1539-2010;

2) AEM Disposable Electrode, Spatula, 45cm, REF ES0301-45, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1540-2010;

3) AEM Disposable Electrode, Flat J-Hook, 35cm, REF ES0309, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1541-2010;

4) AEM Disposable Electrode, J-Hook, 35cm, REF ES0310, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1542-2010;

5) AEM Disposable Electrode, J-Hook, 45cm, REF ES0310-45. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1543-2010;

6) AEM Disposable Electrode, L-Diamond, 35cm, REF ES0311, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1544-2010;

7) AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1545-2010;

8) AEM Disposable Electrode, L-Wedge, 45cm, REF ES0312-45, Qty 10 each Sterile R. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. Recall # Z-1546-2010
CODE
1) Lot No.: PH;
2) Lot No.: PK;
3) Lot No.: PK
4) Lot No.: QA;
5) Lot No.: PK;
6) Lot No.: QAA;
7) Lot No: PK;
8) Lot No: PJ
RECALLING FIRM/MANUFACTURER
Encision, Inc., Boulder, CO, by letter dated April 5, 2010. Firm initiated recall is ongoing.
REASON
Electrosurgical electrode tip insulation may crack and break off during use.
VOLUME OF PRODUCT IN COMMERCE
1,140 units
DISTRIBUTION
CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, New Zealand and The Netherlands

___________________________________
PRODUCT 
ZOLL E Series Defibrillator/Pacemaker/Monitors, BLS Model, with software versions 4.XX, 6.XX and 7.0X. Intended for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall # Z-1547-2010
CODE
Software versions 4.XX, 6.XX and 7.0X in the E Series BLS Model.
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corp., World Wide Headquarters, Chelmsford, MA, by letter dated March 26, 2010. Firm initiated Recall is ongoing.
REASON
Device issued Shock Advised message but failed to auto-charge the defibrillator.
VOLUME OF PRODUCT IN COMMERCE
1383 units (957 US, 426 OUS)
DISTRIBUTION
Nationwide, Australia, Germany, Libyan Arab Jamahiriya, Malaysia, Singapore, United Arab Emirates and the United Kingdom
___________________________________
PRODUCT
1) 7.5mm Ti Solid Humeral Nail 230 mm Sterile Catalog number 462.723S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures. Recall # Z-1548-2010;

2) 7.5mm Ti Solid Humeral Nail 250 mm Sterile Catalog number 462.725S Synthes Titanium Solid Humeral Nail System is intended for intramedullary fixation of a variety of humeral fractures using either an antegrade or retrograde approach. The indications for the Titanium Solid Humeral Nail System includes: diaphyseal fractures of the humeral shaft, fractures of the proximal humerus, proximal humeral fractures with diaphyseal extension, and impending pathological fractures. Recall # Z-1549-2010
CODE
1) Lot number 6303874 exp 12/2018;
2) Lot number 6209477 exp 7/2018
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letter dated February 25, 2010. Firm initiated recall is ongoing.
REASON
Potential compatibility issue.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
LA, MA, ME, NC, PA and VA
___________________________________
PRODUCT 
Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack. The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a craniomaxillofacial plating system intended to maintain accurate alignment of bone fractures and osteotomies in the cranium and mid-face. Recall # Z-1550-2010
CODE
Lot numbers 0808009 and 0809069
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Craniomaxillofacial Division, Portage, MI, letters, dated March 5, 2010 and March 19, 2010.
Manufacturer: <amifactirer” Inion Ltd. Laakarinkatu 2, Tampere, Finland. Firm initiated recall is ongoing.
REASON
During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.
VOLUME OF PRODUCT IN COMMERCE
184 packs (5/pack)
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS I
___________________________________
PRODUCT 
Merrick Beef Filet Squares Dog Treats, 10 oz. bags. Recall # V-057-2010
CODE
Best By 111911
RECALLING FIRM/MANUFACTURER
Tejas Industries Inc., Hereford, TX, by letter dated January 11, 2010. Firm initiated recall is ongoing.
REASON
Product has the potential to contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
84 cases of 12 units each
DISTRIBUTION
RI, WA, MN, CA, TX, and MD

END OF ENFORCEMENT REPORT FOR MAY 19, 2010

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