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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 18, 2010

August 18, 2010                                                                                        10-32

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS II
___________________________________
PRODUCT   
Osceola Perineal Solution with Aloe Vera 8 fl. oz. bottle. Recall # F-2650-2010
CODE
Lot # 45-11239C
RECALLING FIRM/MANUFACTURER
Canberra Corporation, Toledo, OH, by letter on June 7, 2010. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Pseudomonas putida. The firm tested retain samples of the product and the results was positive for gram negative Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
50/48/8 fl oz bottles
DISTRIBUTION
     FL

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Pepper Belly's Habanero Ranch Dressing, 12 oz. Recall # F-2624-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Pepper Belly's, Inc., Aubrey, TX, by telephone on February 5, 2010. FDA initiated recall is ongoing.
REASON
Product labeling incomplete with undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
21 12-oz jars
DISTRIBUTION
TX
_________________________________
PRODUCT
Tropical Candies***Almejas***Chepito***Peso Neto (Net Weight) 6 oz. Recall # F-2644-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Dulceria Chepito, Cabo Rojo, PR, by telephone and letter on July 2, 2010. Firm initiated recall is ongoing.
REASON
Undeclared eggs in ingredients label.
VOLUME OF PRODUCT IN COMMERCE
765
DISTRIBUTION
PR

PRODUCT
SuperMom's Premium Western Omelet Croissant 4.75 oz (135 g). UPC 63913 94112. Keep Refrigerated. Recall # F-2652-2010
CODE
Lot numbers: 164-10, 167-10, 168-0, 169-10 Sell by: 6/21/10, 6/24/10, 6/25/10, 6/26/10
RECALLING FIRM/MANUFACTURER
Super Mom’s Recipe LLC, St Paul Park, MN, by letters dated June 23, 2010. Firm initiated recall is ongoing.
REASON
Recent quality inspections from our Croissant supplier show that 2 croissant sandwiches may contain an undeclared allergen. People with a sensitivity to pecans, run the risk of a severe allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
3600 croissants
DISTRIBUTION
MN, WI
___________________________________
PRODUCT
Romaine Lettuce in bulk bins. Recall #F-2653-2010
CODE
Lot numbers 2-6E (Y267), 2-6M (Y266), 2-6W (Y264)1
RECALLING FIRM/MANUFACTURER
Andrew Smith Co., Salinas, CA, by e-mail and telephone on May 7, 2010. FDA initiated recall is ongoing.
REASON
Product may be contaminated with e.coli O145. Related to Freshway Foods Recall, linked to outbreak.
VOLUME OF PRODUCT IN COMMERCE
46,882 lb
DISTRIBUTION
OK, MA
RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Gluten-Free Green Quinoa Cracker, Net Wt 4 oz. Recall #F-2648-2010
CODE
Lot 131, Best Used By Date: SEP 6 2010
RECALLING FIRM/MANUFACTURER
2 Moms in the Raw, LLC, Lafayette, CO, by e-mail on July 30, 2010. FDA initiated recall is ongoing.
REASON
Crackers may contain high levels of non-pathogenic e.coli.
VOLUME OF PRODUCT IN COMMERCE
60 /12 ct cases
DISTRIBUTION
CA

___________________________________
PRODUCT
Chicken of the Sea brand 12-ounce solid white tuna in water. Recall # F-2649-2010
CODE
Product Codes: 7OA1E ASWAB, 7OA2E ASWAB, 7OA3E ASWAB, 7OA4E ASWAB, 7OA5E ASWAB, 7OAEE ASWAB, 7OAFE ASWAB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-Union Seafoods, LLC dba Chicken of the Sea, San Diego, CA, by telephone on June 29, 2010 and press release on June 30, 2010.
Manufacturer: COS Georgia Canning, Lyons, GA. Firm initiated recall is ongoing.
REASON
The recall was initiated due to a production error; the product does not meet the company's standards for seal tightness. Loose seals, or seams, could result in the product contamination by spoilage organisms or by pathogens and lead to illness if consumed.
VOLUME OF PRODUCT IN COMMERCE
1112 cases (12 cans per case)
DISTRIBUTION
WI, NE, UT, PA, NY, ME, CO, IN, CA, OR
___________________________________
PRODUCT
SuperMom's Ham, Egg & Cheese Croissant 4.0 oz (113 g). UPC 63913 94070. Keep Refrigerated. Recall # F-2651-2010;
CODE
Lot number: 164-10-2;
RECALLING FIRM/MANUFACTURER
Super Mom’s Recipe LLC, St Paul Park, MN, by letters dated June 23, 2010. Firm initiated recall is ongoing.
REASON
Recent quality inspections from our Croissant supplier show that 2 croissant sandwiches may contain an undeclared allergen. People with a sensitivity to pecans, run the risk of a severe allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
11,200 croissants
DISTRIBUTION
MN, WI
___________________________________
PRODUCT
1) Bakery mixes to include Pillowy Pancakes, in approximate 1 lb. kraft paper bags. Recall # F-2654-2010;
2) Maple and Spice Coffeecake mix, in approximate 1 lb. kraft paper bags. Recall # F-2655-2010;
3) Cornmeal Muffins mix, in approximate 1 lb. kraft paper bags. Recall # F-2656-2010;
4) Applesauce and Maple Muffins mix in approximate 1 lb. kraft paper bags. Recall # F-2657-2010;
5) Peanut Butter Chocolate Chip Brownies mix and Peanut Butter Chocolate Chip Cookie mix (same recipe), in approximate 1 lb. kraft paper bags. Recall # F-2658-201;
6) Double Chocolate Brownies mix and Double Chocolate Cookies mix in approximate 1 lb. kraft paper bags. Recall # F-2659-2010;
7) Chocolate Chip Cookies mix in approximate 1 lb. kraft paper bags. Recall # F-2660-2010;
8) Everything but your Momma Cookies mix in approximate 1 lb. kraft paper bags. Recall # F-2661-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Black Sheep Bakery, Portland, OR, by letter on September 22, 2008. Oregon initiated recall is completed.
REASON
Label declares spelt, however, does not declare wheat. Label also states "wheat-free".
VOLUME OF PRODUCT IN COMMERCE
Approximately 240/1 lb. Bags total (30 bags per item)
DISTRIBUTION
OR
___________________________________
PRODUCT
Goya, 10 discos, Con Color Par Empanadas, Net Wt. 14 oz, 397 g. Product Code 9061.
Recall #F-2662-2010
CODE
RECALLING FIRM/MANUFACTURER
Cubanita Frozen Foods Corp., Miami, FL, by telephone on April 13, 2010. FDA initiated recall is ongoing.
REASON
The product is mislabeled and misbranded due to lack of allergen ingredients in its labeling. The labeling does not declare Yellow # 6, Red # 40, and Wheat.
VOLUME OF PRODUCT IN COMMERCE
468 cases, 24 per case
DISTRIBUTION
CA, TX, NJ, FL, GA, TN, LA, CO and Canada. Please note that GOA of Florida distributes only in South Florida, and GOYA of Texas distributes only in TX.

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Clover Valley, Black Cherry, Flavored, Sparkling Water Beverage, With Other Natural Flavors, 33.8 fl oz (1 qt 1.8 fl oz) 1 Litter. UPC: 0 61500 11890 9. Recall # F-2647-2010
CODE
Lot number: 16571207, Best By 110510 CV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cott Beverages USA, Tampa, FL, by telephone and email on June 4, 2010.
Manufacturer: Cott Beverages - Concordville Mint Warehouse, Concordville, PA. Firm initiated recall is ongoing. 
REASON
The firm's product label did not declare aspartame as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
210 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Sandimmune CycloSporine Capsules USP 100mg capsules. Recall # D-761-2010
CODE
Lot No: 092326, Exp. Date 03/2011 & Lot No: 094101, Exp. Date, 04/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on June 2, 2010.  
Manufacturer: Apotex Corp., Weston, FL. Firm initiated recall is ongoing.
REASON
The Apotex Recall was conducted due to a potential GMP violations.
VOLUME OF PRODUCT IN COMMERCE
2080 units/100/100 mg capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Adagen (pegademase bovine) injection, 250 units per mL, Sterile for intramuscular injection only, four 1.5 mL single-dose vials, Rx Only; NDC 57665-001-01. Recall # D-766-2010
CODE
Lot # 9150
RECALLING FIRM/MANUFACTURER
Sigma-tau Pharmasource, Inc., Indianapolis, IN, by letters dated May 11, 2010. Firm initiated recall is ongoing.
REASON
Impurities/Degradation products found during routine stability testing. The impurity level was 2.1%, which is above the specification level of 2%.
VOLUME OF PRODUCT IN COMMERCE
282 4-vial packs
DISTRIBUTION
TN, France, Australia
___________________________________
PRODUCT
Losartan Potassium and Hydrochorothiazide tablets, 100mg/12.5 mg, Rx only 90 tablets, NDC 0781-5817-92. Recall # D-767-2010
CODE
Lot Number: Z1809, Exp. Date: 01-2013; Lot Number: Z1895, Exp. Date: 02-2013 and Lot Number: E004934, Exp. Date: 02-2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merck and Co., Inc., Wilson, NC, by letter on/about June 4, 2010.
Manufacturer: Merck Sharp & Dohme Ltd., Cramlington North D, UK. Firm initiated recall is ongoing.
REASON
Labeling error: The front portion of the bottle label correctly states the product strength as "100mg/12.5mg", while the text on the back portion of the bottle label incorrectly states "Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide."
VOLUME OF PRODUCT IN COMMERCE
16,690 unit packages
DISTRIBUTION
CO

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Loratadine Oral Solution, 5 mg per 5 mL, Antihistamine, Fruit Flavored Syrup, 120 mL (4 Fl oz) Bottle, OTC, NDC 54838-538-40. Recall # D-760-2010
CODE
Control Numbers (Batches): 5890A, Exp. 02/12; 5891A, Exp. 02/12; 5892A, Exp. 02/12; 5893A, Exp. 02/12; 5894A, Exp. 02/12; 5895A, Exp. 02/12; 5896A, Exp. 02/12; 5897A, Exp. 02/12; 5898A, Exp. 02/12; 5899A, Exp. 02/12
RECALLING FIRM/MANUFACTURER
Silarx Pharmaceuticals, Inc., Spring Valley, NY, by letters and response forms dated July 22, 2010. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: The manufacturer received one complaint of minute particulate in Loratadine Oral Solution, Control # 5890. The firm has decided to recall a total of ten lots as a precaution.
VOLUME OF PRODUCT IN COMMERCE
81,746 Bottles were shipped (24 were damaged/destroyed resulting in a total of 81,722 bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Acetaminophen Tablets, Acetaminophen 325 mg., 100 tablet bottles, OTC, sold under the following brand names: Good Neighbor Pharmacy Pain Relief, NDC 24385-403-78; Care One Pain Relief Care One, NDC 41520-403-78; H.E.B. Pain Relief, NDC 37808-403-78; HyVee Pain Relief, NDC 42507-403-78; Leader Pain Reliever, NDC 37205-031-78; CVS Pain Relief, NDC 59779-403-78; Sunmark Pain reliever, NDC 49348-009-10; Hannaford Pain Reliever, NDC 41268-403-78; Equaline pain relief, NDC 41163-403-78; TopCare Pain Relief, NDC 36800-0403-78; Goodsense Pain Relief, NDC 0113-0403-78. Recall # D-768-2010
CODE
Units: 0BE2230, 0CE1359, 0CE1623, 0CE2533, 0DE1161, 0DE1610 and 0EE1594
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter dated June 8, 2010. Firm initiated recall is ongoing.
REASON
The liver warning section of the product label warns that severe liver damage may occur if an adult takes more than 8 tablets in 24 hours. The warning should state that liver damage may occur if an adult takes more than 12 tablets in 24 hours.
VOLUME OF PRODUCT IN COMMERCE
60,594 bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
MiraLAX (Polyethylene Glycol 3350) Powder for Solution, Laxative, 17g/dose, 30 ONCE-DAILY DOSES, Net Wt 17.9 oz (510g), OTC; NDC 11523-7234-4. Product is packaged in a "Wave" bottle presentation as single, twin packs and bonus pack. 1) Single Pack: Item # 80628 and 80770; Item UPC 0-41100-82071-6 and 0-41100-80770-0; Case: UPC 000-41100-80628-4 and 100-41100-80770-7. 2) Twin Pack: Item # 80650; Item UPC 000-41100-80650-5; Case UPC 100-411000-80650-2. 3) Bonus Pack: Item # 80770, Item UPC: 0-41100-80770-0; Case: UPC 100-41100-80770-7. The Bonus Pack has a separate tertiary lot number which appears on the bottom of the unit that is different from the recalled lot number. The recalled lot number is not visible due to the tertiary packaging configuration of the Bonus Pack. 4) Canada Distribution Label: RestoraLAX. Product is packaged in a "Wave" bottle presentation as single pack, UPC 0-56219-82330-5. Recall # D-762-2010
CODE
Lot Number: E-MLX-42, E-MLX-43, E-MLX-44, E-MLX-45, E-MLX-46, E-MLX-51, E-MLX-59, E-MLX-60, E-MLX-61, E-MLX-65, E-MLX-78, E-MLX-79, E-MLX-80, E-MLX-81, E-MLX-82, E-MLX-83, E-MLX-84, E-MLX-86, E-MLX-97, E-MLX-98, E-MLX-99, E-MLX-113, E-MLX-114, E-MLX-115, E-MLX-116, F-MLX-2, F-MLX-3, F-MLX-19, F-MLX-20, F-MLX-21, F-MLX-22, F-MLX-24, F-MLX-31, F-MLX-32, F-MLX-54. Tertiary Lot Number on Bonus Pack: 000936NM, 001036NM, 001136NM, 001536NM, 001636NM, 002836NM, 002936NM, 003036NM, 003136NM, 003236NM, 017532NM, 923836NM, 923936NM, 924036NM, 924136NM, 924236NM, 930036ANM, 930036NM, 931336ANM, 931336NM, 933631ANM, 933631BNM, 933631NM, 933836ANM, 933836CNM, 933836NM, 935536NM, 936236NM. E-MLX-64 (Canada distribution only)
RECALLING FIRM/MANUFACTURER
Schering Corp., Miami Lakes, FL, by letter dated July 16, 2010. Firm initiated recall is ongoing.
REASON
Defective Container: products may contain defective (burnt) cap liners and the product may have an off odor and off taste.
VOLUME OF PRODUCT IN COMMERCE
4,698,069 bottles US/ 113,340 bottles Canada
DISTRIBUTION
Nationwide, Canada

___________________________________
PRODUCT
1) Cleocin Phosphate IV (clindamycin) injection, 300 mg/50 mL in 5% Dextrose, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3414, Rx only, a) NDC 0009-3381-01, (IV Bag), b) NDC 0009-3381-02 (Unit of Sale). Recall # D-763-2010;

2) Cleocin Phosphate IV (clindamycin) injection, 600 mg/50 mL in 5% DEXTROSE, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3415, Rx only, a) NDC 009-3375-01 (IV Bag), b) NDC 0009-3375-02 (Unit of Sale). Recall # D-764-2010;

3) Cleocin Phosphate IV (clindamycin) injection, 900 mg/50 mL in 5% Dextrose, Single Dose Container, For Intravenous Use, Galaxy, Code 2G3416, Rx only, a) NDC 009-3382-01 (IV Bag), b) NDC 0009-3382-02 (Unit of Sale). Recall # D-765-2010
CODE
1) Lot Numbers: NC049676, Exp. 08/10; NC050773, Exp. 10/10; NC052100, Exp. 12/10; NC052118, Exp. 12/10; NC052241, Exp. 01/11; NC052415, Exp. 01/11; NC052431, Exp. 01/11; NC052704, Exp. 02/11; NC053108, Exp. 03/11; NC054429, Exp. 05/11; NC056283, Exp. 09/11; NC056648, Exp. 10/11; NC057430, Exp. 11/11; NC058545, Exp. 01/12;

2) Lot Numbers: NC049825, Exp. 08/10; NC050591, Exp. 09/10; NC050674, Exp. 10/10; NC050823, Exp. 10/10; NC051029, Exp. 10/10; NC051425, Exp. 11/10; NC051458, Exp. 11/10; NC051524, Exp. 11/10; NC051599, Exp. 11/10; NC052134, Exp. 12/10; NC052159, Exp. 12/10; NC052175, Exp. 12/10; NC052217, Exp. 01/11; NC052274, Exp. 01/11; NC052308, Exp. 01/11; NC052324, Exp. 01/11; NC052365, Exp. 01/11; NC052373, Exp. 01/11; NC052407, Exp. 01/11; NC052548, Exp. 01/11; NC052589, Exp. 01/11; NC052605, Exp. 01/11; NC052621, Exp. 01/11; NC052662, Exp. 02/11; NC052688, Exp. 02/11; NC052720, Exp. 02/11; NC052761, Exp. 02/11; NC052787, Exp. 02/11; NC052902, Exp. 02/11; NC053009, Exp. 02/11; NC053025, Exp. 02/11; NC053041, Exp. 02/11; NC053181, Exp. 03/11; NC053207, Exp. 03/11; NC053223, Exp. 03/11; NC053249, Exp. 03/11; NC053470, Exp. 03/11; NC053496, Exp. 03/11; NC053512, Exp. 03/11; NC053538, Exp. 04/11; NC053553, Exp. 04/11; NC053835, Exp. 04/11; NC053934, Exp. 04/11; NC053959, Exp. 04/11; NC053975, Exp. 04/11; NC053991, Exp. 04/11; NC054015, Exp. 05/11; NC054064, Exp. 05/11; NC054072, Exp. 05/11; NC054205, Exp. 05/11; NC054221, Exp. 05/11; NC054445, Exp. 06/11; NC054460, Exp. 06/11; NC054692, Exp. 06/11; NC054718, Exp. 06/11; NC054734, Exp. 06/11; NC054874, Exp. 07/11; NC054908, Exp. 07/11; NC054916, Exp. 07/11; NC054957, Exp. 07/11; NC054973, Exp. 07/11; NC055020, Exp. 07/11; NC055046, Exp. 07/11; NC055087, Exp. 07/11; NC055111, Exp. 07/11; NC055160, Exp. 07/11; NC055277, Exp. 07/11; NC055509, Exp. 08/11; NC055582, Exp. 08/11; NC055616, Exp. 08/11; NC055632, Exp. 08/11; NC055657, Exp. 08/11; NC055905, Exp. 09/11; NC056069, Exp. 09/11; NC056085, Exp. 09/11; NC056135, Exp. 09/11; NC056200, Exp. 09/11; NC056234, Exp. 09/11; NC056317, Exp. 09/11; NC056440, Exp. 10/11; NC056499, Exp. 10/11; NC056523, Exp. 10/11; NC056598, Exp. 10/11; NC056721, Exp. 10/11; NC056861, Exp. 10/11; NC056986, Exp. 11/11; NC057133, Exp. 11/11; NC057182, Exp. 11/11; NC057273, Exp. 11/11; NC057315, Exp. 11/11; NC057406, Exp. 11/11; NC057414, Exp. 11/11; NC057604, Exp. 12/11; NC057653, Exp. 12/11; NC057661, Exp. 12/11; NC059410, Exp. 03/12;

3) Lot Numbers: NC049759, Exp. 08/10; NC050625, Exp. 09/10; NC050799, Exp. 10/10; NC050948, Exp. 10/10; NC050997, Exp. 10/10; NC051326, Exp. 11/10; NC051375, Exp. 11/10; NC051631, Exp. 11/10; NC051961, Exp. 12/10; NC051987, Exp. 12/10; NC052001, Exp. 12/10; NC052027, Exp. 12/10; NC052043, Exp. 12/10; NC052068, Exp. 12/10; NC052191, Exp. 12/10; NC052340, Exp. 01/11; NC052456, Exp. 01/11; NC052530, Exp. 01/11; NC052563, Exp. 01/11; NC052647, Exp. 01/11; NC052746, Exp. 02/11; NC053298, Exp. 03/11; NC053314, Exp. 03/11; NC053330, Exp. 03/11; NC053355, Exp. 03/11; NC053371, Exp. 03/11; NC053454, Exp. 03/11; NC053587, Exp. 04/11; NC053694, Exp. 04/11; NC053728, Exp. 04/11; NC053751, Exp. 04/11; NC053785, Exp. 04/11; NC053819, Exp. 04/11; NC054247, Exp. 05/11; NC054262, Exp. 05/11; NC054395, Exp. 05/11; NC054403, Exp. 05/11; NC054635, Exp. 06/11; NC054650, Exp. 06/11; NC054668, Exp. 06/11; NC054767, Exp. 06/11; NC055061, Exp. 07/11; NC055178, Exp. 07/11; NC055202, Exp. 07/11; NC055210, Exp. 07/11; NC055491, Exp. 08/11, NC055517, Exp. 08/11; NC055558, Exp. 08/11; NC055574, Exp. 08/11; NC055673, Exp. 08/11; NC055699, Exp. 08/11; NC055723, Exp. 08/11; NC056119, Exp. 09/11; NC056184, Exp. 09/11; NC056366, Exp. 09/11; NC056416, Exp. 10/11; NC056671, Exp. 10/11; NC056747, Exp. 10/11; NC056895, Exp. 10/11; NC056911, Exp. 10/11; NC056945, Exp. 10/11; NC057034, Exp. 11/11; NC057364, Exp. 11/11; NC057372, Exp. 11/11; NC057448, Exp. 11/11; NC057570, Exp. 12/11; NC057703, Exp. 12/11; NC057737, Exp. 12/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter on July 16, 2010. 
Manufacturer: Baxter Healthcare Corp., Round Lake, IL. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance(s): the active pharmaceutical ingredient (API) used in the affected lots may have been contaminated with paraffin wax.
VOLUME OF PRODUCT IN COMMERCE
6,141,216 bags
DISTRIBUTION
Nationwide, Puerto Rico, Aruba and Costa Rica

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I
___________________________________
PRODUCT
1) Cancellous Bone Graft, Frozen. Recall # B-2032-10;
2) Tendon, Posterior tibial. Recall # B-2033-10
CODE
1) Units: 072464008, 072464007;
2) Unit: 072464001
RECALLING FIRM/MANUFACTURER
LifeNet Health, Virginia Beach, VA, by telephone and letter on July 20, 2007, and August 15, 2007. Firm initiated recall is complete.
REASON
Human tissue for transplantation, with positive culture results, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues
DISTRIBUTION
PA, MA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-1560-10
CODE
Units: 2040036199, 2040034980, 2040034634, 2040032889, 2040032647, 2040032246, 2040031891, 2040031756, 2040031310, 2040030903, 2040028248, 2040027880, 2040027586, 2040027214, 2040026989, 2040026399, 2040025566, 2040025187, 2040024968, 2040024185, 2040023961, 2040018908, 2040018495, 2040018191, 2040015324, 2040013492, 2040012509, 2040011884, 2040011494, 2040011165, 2040010929, 2040010645, 2040010412, 2040009999, 2040009721, 2040009436, 2040007454, 2040007198, 2040006628, 2040006460, 2040006116, 2040005942, 2040005431
RECALLING FIRM/MANUFACTURER
PlasmaCare Inc., Columbus, OH, by fax on March 13, 2006. 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
43 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1834-10
CODE
Unit: 6120235088
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Columbia, SC, by letter dated February 19, 2010. 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
Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1836-10
CODE
Units: TA2159516; TA2159719
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by letter dated August 8, 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
2 units
DISTRIBUTION
England
___________________________________
PRODUCT
Source Plasma. Recall # B-1854-10
CODE
Units: 0290135538, 0290135150, 0290134607, 0290134364, 0290133664, 0290133359, 0290132728, 0290132347, 0290131726, 0290131420, 0290130859, 0290130546, 0290129942, 0290129544, 0290128974, 0290128683, 0290128026, 0290127771
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Los Angeles, CA, by letter dated January 23, 2009.
Manufacturer: Biomat USA, Inc., Reading, PA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
CA, Spain
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1856-10
CODE
Unit: 17GZ64215
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated May 28, 2007.
Manufacturer: The American National Red Cross, North Central Region, Saint Paul, MN. 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
NJ
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1915-10;
2) Cryoprecipitated AHF. Recall # B-1916-10
CODE
1) and 2) Unit: 16LQ44520
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on December 4, 2007 and letter dated December 7, 2007. 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
MA, OH, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1918-10
CODE
Unit: 026FS69104
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone, letter and e-mail starting on November 9, 2007.
Manufacturer: Mobile Fixed Site, Mobile, AL. 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
MO, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1920-10
CODE
Unit: 041LN20799
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and electronically starting November 28, 2007. 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, CA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1922-10;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1923-10
CODE
1) Unit: 0929773; and 2) unit: 1341974
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by fax and letter on March 17, 2008. 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
MN, VT, Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1925-10
CODE
Units: 1389521; 1128080; 0917855
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter and fax on April 18, 2008.
Manufacturer: Memorial Blood Centers Duluth, Duluth, MN. 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
MN, Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1927-10
CODE
Unit: 1567179
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax on May 13, 2008. 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
FL, Switzerland

___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1928-10;
2) Plasma Frozen. Recall # B-1929-10;
3) Platelets Leukocytes Reduced. Recall # B-1930-10 
CODE
1), 2), and 3) Unit: 16KJ45207
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Columbus, OH, by telephone on April 23, 2008 and follow up letter dated May 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 whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1964-10
CODE
Unit: 1513395
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 22, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled as antigen negative but collected from a donor who subsequently tested antigen positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1967-10;
2) Fresh Frozen Plasma. Recall # B-1968-10;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-1969-10; 
4) Plasma. Recall # B-1970-10;  
5) Plasma. Recall # B-1971-10
CODE
1) Units: WW227708014159, W227708012927;
2) Unit: W227708012927;
3) Unit: W227709011579;
4) Unit: W227709010439;
5) Units: W227708014159, W227709010439
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile transmission dated February 24, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested HBsAg repeatedly reactive, neutralization positive, HBV PCR Negative, Anti-HBcore negative, was distributed. Donor was not properly re-entered.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
FL, WI, TN, MD, and Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2005-10
CODE
Units: 0530355334; 0530354836
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Lexington, KY, by fax on September 19, 2007.
Manufacturer: CSL Plasma, Lexington, KY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2007-10
CODE
7134078; 7134078 (split product)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on April 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Lodine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Source Plasma. Recall # B-2043-10
CODE
Units: 07KWIB2119, 07KWIB1682, 07KWIB1240, 07KWIB0508
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank of Wisconsin, Kenosha, WI, by facsimile on February 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1914-10
CODE
Unit: 16LQ44520
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbus, OH, by telephone on December 4, 2007 and letter dated December 7, 2007. 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
MA, OH, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1917-10
CODE
Unit: 026FS69104
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone, letter and e-mail starting on November 9, 2007.
Manufacturer: Mobile Fixed Site, Mobile, AL. 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
MO, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1919-10
CODE
Unit: 041LN20799
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and electronically starting November 28, 2007. 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, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1921 -10
CODE
Units: 0929773; 0929773; 1341974
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by fax and letter on March 17, 2008. 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
MN, VT, Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1924-10
CODE
Units: 1389521
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter and fax on April 18, 2008.
Manufacturer: Memorial Blood Centers Duluth, Duluth, MN. 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
MN, Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1926-10
CODE
Unit: 1567179
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and fax on May 13, 2008. 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
FL, Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2002-10
CODE
Unit: FW30366
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by fax on April 13, 2007. Firm initiated recall is complete.
REASON
Blood product labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2003-10
CODE
Unit: 2879319662
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on May 11, 2007 and May 14, 2007 and follow up letters on June 13, 2007 and July 16, 2007.  
Manufacturer: Whole Blood-Mobile, Mobile, AL. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
Source Plasma. Recall # B-2044-10
CODE
Units: 07GWIA8372, 07GWIA7479, 07GWIA6226, 07GWIA4166, 07GWIA3326, 07GWIA1776, 07GWIA0204, 06GWIJ4253, 06GWIJ3493, 06GWIJ2275, 06GWIJ1508
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on April 25, 2007. 
Manufacturer: BioLife Plasma Services, LP, Green Bay, WI. 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
11 units
DISTRIBUTION
CA, Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air. Recall # Z-1634-2010
CODE
Lot numbers: 200910, 200911, 200913, 200914, 200916, 200919, 200920, 200921, 200927, 200928, 200929, 200930, 200940, 200941, 200942, 200943, 200945, 200948 and 200951
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by letter on March 22, 2010.
Manufacturer: Teleflex Medical, Perak, Malaysia. Firm initiated recall is ongoing.
REASON
The patient end of the 22 cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector and therefore disconnect from the endotracheal tube. A disconnect in ventilator dependent patients without prompt response to the alarm could lead to hypoxia, organ failure, or cardio-respiratory arrest.
VOLUME OF PRODUCT IN COMMERCE
48,078 units
DISTRIBUTION
CA, FL, GA, KY, KS, IL, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI and Japan
___________________________________
PRODUCT
Ikaria INOMAX DS Drug Delivery System, model 10003. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the aspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. Recall # Z-2176-2010
CODE
Serial numbers: DS20070005, DS20070008, DS20070009, DS20070010, DS20070011, DS20070012, DS20070014, DS20070015, DS20070016, DS20070017, DS20070019, DS20070020, DS20070021, DS20070022, DS20070023, DS20070024, DS20070028, DS20070030, DS20070031, DS20070032, DS20070033, DS20070034, DS20070035, DS20070037, DS20070041, DS20070045, DS20070046, DS20070048, DS20070049, DS20070050, DS20070051, DS20070053, DS20070057, DS20070058, DS20070059, DS20070061, DS20070062, DS20070063, DS20070064, DS20070068, DS20070069, DS20070070, DS20070072, DS20070073, DS20070075, DS20070076, DS20070077, DS20070078, DS20070079, DS20070080, DS20070081, DS20070082, DS20070083, DS20070084, DS20070085, DS20070086, DS20070087, DS20070092, DS20070093, DS20070095, DS20070096, DS20070097, DS20070100, DS20070103, DS20070104, DS20070106, DS20070107, DS20070109, DS20070114, DS20070115, DS20070116, DS20070117, DS20070118, DS20070119, DS20070121, DS20070122, DS20070123, DS20070125, DS20070127, DS20070128, DS20070129, DS20070130, DS20070132, DS20070134, DS20070135, DS20070138, DS20070139, DS20070140, DS20070141, DS20070142, DS20070145, DS20070146, DS20070147, DS20070148, DS20070149, DS20070150, DS20070153, DS20070154, DS20070156, DS20070157, DS20070158, DS20070160, DS20070161, DS20070163, DS20070164, DS20070166, DS20070167, DS20070168, DS20070170, DS20070171, DS20070172, DS20070173, DS20070174, DS20070179, DS20070181, DS20070182, DS20070183, DS20070184, DS20070185, DS20070186, DS20070187, DS20070188, DS20070191, DS20070192, DS20070194, DS20070195, DS20070196, DS20070197, DS20070198, DS20070201, DS20070202, DS20070203, DS20070204, DS20070207, DS20070208, DS20070210, DS20070212, DS20070213, DS20070215, DS20070216, DS20070217, DS20070219, DS20070220, DS20070221, DS20070223, DS20070224, DS20070225, DS20070226, DS20070227, DS20070229, DS20070230, DS20070231, DS20070232, DS20070233, DS20070236, DS20070237, DS20070239, DS20070240, DS20070243, DS20070244, DS20070245, DS20070247, DS20070249, DS20070251, DS20070252, DS20070253, DS20070254, DS20070255, DS20070256, DS20070257, DS20070258, DS20070259, DS20070260, DS20070261, DS20070262, DS20070265, DS20070267, DS20070268, DS20070272, DS20070274, DS20070275, DS20070276, DS20070278, DS20070279, DS20070280, DS20070281, DS20070283, DS20080001, DS20080004, DS20080005, DS20080006, DS20080009, DS20080011, DS20080016, DS20080019, DS20080020, DS20080021, DS20080022, DS20080023, DS20080025, DS20080026, DS20080027, DS20080028, DS20080029, DS20080030, DS20080033, DS20080034, DS20080035, DS20080036, DS20080038, DS20080040, DS20080041, DS20080043, DS20080045, DS20080046, DS20080047, DS20080048, DS20080049, DS20080050, DS20080051, DS20080052, DS20080053, DS20080054, DS20080055, DS20080056, DS20080057, DS20080058, DS20080061, DS20080063, DS20080064, DS20080067, DS20080068, DS20080069, DS20080072, DS20080073, DS20080074, DS20080076, DS20080077, DS20080079, DS20080080, DS20080081, DS20080082, DS20080084, DS20080086, DS20080087, DS20080088, DS20080089, DS20080090, DS20080092, DS20080095, DS20080097, DS20080098, DS20080099, DS20080100, DS20080102, DS20080103, DS20080104, DS20080105, DS20080106, DS20080107, DS20080109, DS20080111, DS20080112, DS20080113, DS20080114, DS20080115, DS20080116, DS20080117, DS20080118, DS20080119, DS20080120, DS20080121, DS20080122, DS20080123, DS20080124, DS20080125, DS20080127, DS20080128, DS20080129, DS20080130, DS20080132, DS20080133, DS20080134, DS20080135, DS20080136, DS20080137, DS20080138, DS20080141, DS20080142, DS20080143, DS20080144, DS20080145, DS20080146, DS20080147, DS20080148, DS20080149, DS20080150, DS20080152, DS20080153, DS20080155, DS20080158, DS20080159, DS20080160, DS20080161, DS20080163, DS20080164, DS20080165, DS20080166, DS20080167, DS20080168, DS20080170, DS20080171, DS20080172, DS20080174, DS20080176, DS20080180, DS20080181, DS20080182, DS20080183, DS20080184, DS20080185, DS20080186, DS20080187, DS20080188, DS20080189, DS20080191, DS20080192, DS20080194, DS20080195, DS20080196, DS20080198, DS20080201, DS20080202, DS20080203, DS20080204, DS20080205, DS20080206, DS20080207, DS20080209, DS20080210, DS20080211, DS20080212, DS20080214, DS20080215, DS20080216, DS20080217, DS20080218, DS20080219, DS20080220, DS20080221, DS20080222, DS20080223, DS20080224, DS20080225, DS20080227, DS20080228, DS20080229, DS20080230, DS20080231, DS20080232, DS20080233, DS20080234, DS20080236, DS20080237, DS20080239, DS20080241, DS20080242, DS20080243, DS20080244, DS20080245, DS20080246, DS20080249, DS20080250, DS20080252, DS20080253, DS20080254, DS20080255, DS20080256, DS20080258, DS20080259, DS20080260, DS20080261, DS20080262, DS20080263, DS20080264, DS20080265, DS20080266, DS20080268, DS20080269, DS20080270, DS20080271, DS20080273, DS20080275, DS20080276, DS20080278, DS20080279, DS20080280, DS20080281, DS20080282, DS20080283, DS20080284, DS20080285, DS20080286, DS20080287, DS20080289, DS20080291, DS20080292, DS20080298, DS20080299, DS20080300, DS20080303, DS20080304, DS20080306, DS20080307, DS20080308, DS20080309, DS20080310, DS20080312, DS20080313, DS20080318, DS20080320, DS20080321, DS20080322, DS20080323, DS20080325, DS20080326, DS20080327, DS20080328, DS20080330, DS20080331, DS20080333, DS20080334, DS20080335, DS20080336, DS20080337, DS20080338, DS20080341, DS20080342, DS20080343, DS20080346, DS20080348, DS20080349, DS20080356, DS20080357, DS20080358, DS20080361, DS20080362, DS20080363, DS20080364, DS20080365, DS20080368, DS20080370, DS20080373, DS20090001, DS20090002, DS20090003, DS20090004, DS20090005, DS20090006, DS20090007, DS20090008, DS20090009, DS20090011, DS20090013, DS20090014, DS20090015, DS20090016, DS20090017, DS20090020, DS20090021, DS20090024, DS20090026, DS20090027, DS20090029, DS20090031, DS20090032, DS20090033, DS20090034, DS20090035, DS20090037, DS20090039, DS20090042, DS20090043, DS20090045, DS20090046, DS20090048, DS20090051, DS20090052, DS20090054, DS20090057, DS20090058, DS20090059, DS20090063, DS20090064, DS20090065, DS20090066, DS20090068, DS20090069, DS20090071, DS20090072, DS20090073, DS20090074, DS20090076, DS20090077, DS20090080, DS20090082, DS20090084, DS20090085, DS20090086, DS20090088, DS20090089, DS20090090, DS20090091, DS20090092, DS20090093, DS20090094, DS20090095, DS20090096, DS20090097, DS20090098, DS20090099, DS20090100, DS20090101, DS20090102, DS20090103, DS20090104, DS20090105, DS20090106, DS20090107, DS20090108, DS20090110, DS20090112, DS20090113, DS20090114, DS20090116, DS20090118, DS20090119, DS20090121, DS20090122, DS20090123, DS20090124, DS20090125, DS20090127, DS20090128, DS20090129, DS20090130, DS20090132, DS20090133, DS20090134, DS20090135, DS20090136, DS20090137, DS20090138, DS20090139, DS20090141, DS20090142, DS20090144, DS20090145, DS20090146, DS20090147, DS20090149, DS20090150, DS20090151, DS20090152, DS20090153, DS20090156, DS20090157, DS20090158, DS20090159, DS20090160, DS20090161, DS20090162, DS20090164, DS20090165, DS20090166, DS20090168, DS20090169, DS20090170, DS20090171, DS20090172, DS20090173, DS20090174, DS20090175, DS20090176, DS20090177, DS20090178, DS20090179, DS20090180, DS20090181, DS20090182, DS20090183, DS20090185, DS20090189, DS20090190, DS20090191, DS20090192, DS20090193, DS20090196, DS20090197, DS20090198, DS20090200, DS20090201, DS20090202, DS20090203, DS20090204, DS20090205, DS20090206, DS20090207, DS20090208, DS20090209, DS20090210, DS20090211, DS20090212, DS20090213, DS20090214, DS20090215, DS20090216, DS20090218, DS20090219, DS20090220, DS20090221, DS20090222, DS20090223, DS20090224, DS20090225, DS20090226, DS20090227, DS20090230, DS20090231, DS20090232, DS20090233, DS20090235, DS20090236, DS20090238, DS20090239, DS20090240, DS20090242, DS20090243, DS20090244, DS20090245, DS20090247, DS20090248, DS20090249, DS20090250, DS20090251, DS20090252, DS20090253, DS20090256, DS20090257, DS20090259, DS20090260, DS20090261, DS20090262, DS20090263, DS20090265, DS20090266, DS20090267, DS20090268, DS20090269, DS20090270, DS20090271, DS20090273, DS20090274, DS20090275, DS20090277, DS20090278, DS20090279, DS20090280, DS20090281, DS20090282, DS20090283, DS20090284, DS20090288, DS20090289, DS20090290, DS20090291, DS20090292, DS20090293, DS20090294, DS20090295, DS20090297, DS20090299, DS20090300, DS20090301, DS20090302, DS20090303, DS20090304, DS20090305, DS20090306, DS20090307, DS20090308, DS20090309, DS20090311, DS20090313, DS20090314, DS20090315, DS20090316, DS20090318, DS20090319, DS20090320, DS20090321, DS20090322, DS20090323, DS20090324, DS20090326, DS20090327, DS20090332, DS20090333, DS20090334, DS20090335, DS20090336, DS20090338, DS20090341, DS20090343, DS20090344, DS20090345, DS20090346, DS20090347, DS20090348, DS20090349, DS20090351, DS20090353, DS20090354, DS20090356, DS20090357, DS20090358, DS20090359, DS20090360, DS20090361, DS20090362, DS20090365, DS20090367, DS20090369, DS20090371, DS20090372, DS20090373, DS20090375, DS20090380, DS20090381, DS20090383, DS20090386, DS20090387, DS20090388, DS20090390, DS20090392, DS20090393, DS20090394, DS20090396, DS20090397, DS20090401, DS20090402, DS20090404, DS20090405, DS20090407, DS20090408, DS20090409, DS20090410, DS20090411, DS20090414, DS20090417, DS20090418, DS20090420, DS20090422, DS20090428, DS20090430, DS20090431, DS20090432, DS20090434, DS20090435, DS20090436, DS20090437, DS20090438, DS20090439, DS20090444, DS20090445, DS20090448, DS20090453, DS20090455, DS20090459, DS20090461, DS20090462, DS20090465, DS20090466, DS20090468, DS20090469, DS20090470, DS20090472, DS20090474, DS20090479, DS20090480, DS20090483, DS20090484, DS20090487, DS20090488, DS20090492, DS20090493, DS20090495, DS20090496, DS20090498, DS20090499, DS20090500, DS20090501, DS20090502, DS20090504, DS20090505, DS20090506, DS20090507, DS20090508, DS20090509, DS20090511, DS20090512, DS20090513, DS20090516, DS20090517, DS20090518, DS20090520, DS20090523, DS20090524, DS20090525, DS20090526, DS20090527, DS20090531, DS20090532, DS20090533, DS20090534, DS20090536, DS20090538, DS20090539, DS20090540, DS20090541, DS20090542, DS20090543, DS20090544, DS20090545, DS20090546, DS20090549, DS20090550, DS20090553, DS20090554, DS20090555, DS20090556, DS20090557, DS20090558, DS20090560, DS20090561, DS20090562, DS20090563, DS20090564, DS20090565, DS20090566, DS20090567, DS20090569, DS20090570, DS20090571, DS20090573, DS20090574, DS20090575, DS20090576, DS20090578, DS20090580, DS20090582, DS20090583, DS20090584, DS20090585, DS20090586, DS20090587, DS20090588, DS20090589, DS20090590, DS20090591, DS20090592, DS20090593, DS20090594, DS20090595, DS20090596, DS20090597, DS20090598, DS20090600, DS20090601, DS20090602, DS20090603, DS20090604, DS20090605, DS20090606, DS20090607, DS20090608, DS20090609, DS20090610, DS20090611, DS20090612, DS20090614, DS20090615, DS20090616, DS20090617, DS20090618, DS20090619, DS20090620, DS20090622, DS20090623, DS20090624, DS20090625, DS20090626, DS20090627, DS20090629, DS20090630, DS20090631, DS20090632, DS20090633, DS20090634, DS20090635, DS20090636, DS20090637, DS20090639, DS20090640, DS20090641, DS20090642, DS20090643, DS20090644, DS20090645, DS20090646, DS20090647, DS20090648, DS20090649, DS20090650, DS20090651, DS20090653, DS20090654, DS20090655, DS20090656, DS20090658, DS20090659, DS20090660, DS20090661, DS20090662, DS20090664, DS20090665, DS20090666, DS20090667, DS20090668, DS20090669, DS20090670, DS20090671, DS20090672, DS20090673, DS20090674, DS20090675, DS20090676, DS20090678, DS20090679, DS20090680, DS20090681, DS20090682, DS20090683, DS20090684, DS20090685, DS20090686, DS20090687, DS20090689, DS20090690, DS20090691, DS20090692, DS20090693, DS20090694, DS20090695, DS20090696, DS20090697, DS20090698, DS20090699, DS20090700, DS20090701, DS20090702, DS20090703, DS20090704, DS20090705, DS20090706, DS20090707, DS20090708, DS20090709, DS20090710, DS20090711, DS20090712, DS20090713, DS20090714, DS20090715, DS20090716, DS20090717, DS20090718, DS20090719, DS20090720, DS20090721, DS20090722, DS20090723, DS20090724, DS20090725, DS20090726, DS20090727, DS20090729, DS20090730, DS20090731, DS20090732, DS20090733, DS20090734, DS20090735, DS20090736, DS20090737, DS20090739, DS20090740, DS20090741, DS20090742, DS20090744, DS20090745, DS20090746, DS20090747, DS20090748, DS20090749, DS20090750, DS20090751, DS20090752, DS20090753, DS20090754, DS20090755, DS20090756, DS20090757, DS20090758, DS20090759, DS20090760, DS20090761, DS20090762, DS20090763, DS20090764, DS20090765, DS20090766, DS20090767, DS20090768, DS20090769, DS20090770, DS20090771, DS20090772, DS20090773, DS20090774, DS20090775, DS20090776, DS20090777, DS20090778, DS20090779, DS20090780, DS20090781, DS20090783, DS20090784, DS20090785, DS20090786, DS20090787, DS20090788, DS20090789, DS20090790, DS20090792, DS20090795, DS20090796, DS20090798, DS20090799, DS20090800, DS20090801, DS20090802, DS20090804, DS20090805, DS20090807, DS20090808, DS20090809, DS20090810, DS20090811, DS20090812, DS20090814, DS20090816, DS20090817, DS20090818, DS20090819, DS20090820, DS20090821, DS20090824, DS20090825, DS20090827, DS20090828, DS20090829, DS20090832, DS20090833, DS20090834, DS20090835, DS20090836, DS20090837, DS20090838, DS20090839, DS20090840, DS20090843, DS20090844, DS20090845, DS20090846, DS20090847, DS20090848, DS20090849, DS20090850, DS20090851, DS20090852, DS20090854, DS20090855, DS20090857, DS20090858, DS20090859, DS20090860, DS20090861, DS20090862, DS20090863, DS20090864, DS20090865, DS20090866, DS20090867, DS20090868, DS20090869, DS20090870, DS20090871, DS20090872, DS20090873, DS20090874, DS20090875, DS20090876, DS20090877, DS20090878, DS20090879, DS20090880, DS20090881, DS20090882, DS20090883, DS20090885, DS20090886, DS20090887, DS20090888, DS20090890, DS20090891, DS20090892, DS20090893, DS20090894, DS20090896, DS20090897, DS20090898, DS20090899, DS20090900, DS20090901, DS20090902, DS20090903, DS20090904, DS20090905, DS20090906, DS20090907, DS20090908, DS20090909, DS20090910, DS20090911, DS20090912, DS20090913, DS20090914, DS20090915, DS20090916, DS20090917, DS20090918, DS20090919, DS20090920, DS20090921, DS20090922, DS20090924, DS20090925, DS20090926, DS20090927, DS20090928, DS20090929, DS20090931, DS20090932, DS20090933, DS20090934, DS20090935, DS20090936, DS20090937, DS20090938, DS20090939, DS20090940, DS20090941, DS20090942, DS20090943, DS20090944, DS20090945, DS20090946, DS20100001, DS20100002, DS20100003, DS20100004, DS20100005, DS20100006, DS20100007, DS20100008, DS20100009, DS20100010, DS20100011, DS20100013, DS20100014, DS20100015, DS20100016, DS20100017, DS20100019, DS20100020, DS20100021, DS20100022, DS20100023, DS20100024, DS20100025, DS20100026, DS20100027, DS20100028, DS20100029, DS20100030, DS20100031, DS20100032, DS20100033, DS20100034, DS20100035, DS20100036, DS20100037, DS20100038, DS20100039, DS20100040, DS20100041, DS20100042, DS20100043, DS20100044, DS20100046, DS20100048, DS20100049, DS20100050, DS20100051, DS20100055, DS20100056, DS20100057, DS20100058, DS20100059, DS20100060, DS20100061, DS20100062, DS20100063, DS20100065, DS20100066, DS20100068, DS20100069, DS20100070, DS20100072, DS20100073, DS20100074, DS20100075, DS20100076, DS20100077, DS20100078, DS20100079, DS20100080, DS20100081, DS20100082, DS20100083, DS20100084, DS20100085, DS20100086, DS20100087, DS20100089, DS20100090, DS20100091, DS20100092, DS20100094, DS20100095, DS20100097, DS20100098, DS20100099, DS20100100, DS20100102, DS20100104, DS20100105, DS20100106, DS20100107, DS20100108, DS20100109, DS20100112, DS20100114, DS20100115, DS20100116, DS20100117, DS20100118, DS20100119, DS20100120, DS20100122, DS20100123, DS20100125, DS20100126, DS20100127, DS20100128, DS20100129, DS20100130, DS20100131, DS20100132, DS20100134, DS20100135, DS20100136, DS20100137, DS20100138, DS20100140, DS20100141, DS20100142, DS20100143, DS20100144, DS20100146, DS20100147, DS20100148, DS20100150, DS20100151, DS20100153, DS20100154, DS20100155, DS20100156, DS20100158, DS20100159, DS20100160, DS20100161, DS20100162, DS20100163, DS20100164, DS20100165, DS20100166, DS20100167, DS20100168, DS20100169, DS20100170, DS20100171, DS20100172, DS20100174, DS20100176, DS20100177, DS20100178, DS20100180, DS20100181, DS20100182, DS20100183, DS20100184, DS20100185, DS20100186, DS20100187, DS20100188, DS20100191, DS20100193, DS20100194, DS20100195, DS20100196, DS20100197, DS20100198, DS20100199, DS20100200, DS20100201, DS20100204, DS20100206, DS20100207, DS20100208, DS20100209, DS20100210, DS20100211, DS20100212, DS20100213, DS20100214, DS20100216, DS20100217, DS20100218, DS20100221, DS20100223, DS20100224, DS20100225, DS20100226, DS20100227, DS20100228, DS20100229, DS20100230, DS20100231, DS20100232, DS20100233, DS20100234, DS20100235, DS20100236, DS20100237, DS20100238, DS20100239, DS20100240, DS20100241, DS20100242, DS20100243, DS20100244, DS20100245, DS20100246, DS20100248, DS20100249, DS20100250, DS20100251, DS20100252, DS20100253, DS20100254, DS20100255, DS20100256, DS20100257, DS20100258, DS20100259, DS20100260, DS20100262, DS20100263, DS20100264, DS20100265, DS20100266, DS20100267, DS20100268, DS20100269, DS20100270, DS20100271, DS20100272, DS20100273, DS20100274, DS20100275, DS20100276, DS20100278, DS20100279, DS20100280, DS20100281, DS20100282, DS20100283, DS20100284, DS20100285, DS20100286, DS20100287, DS20100288, DS20100289, DS20100290, DS20100291, DS20100292, DS20100293, DS20100294, DS20100295, DS20100297, DS20100298, DS20100299, DS20100300, DS20100301, DS20100302, DS20100303, DS20100304, DS20100305, DS20100306, DS20100307, DS20100308, DS20100309, DS20100311, DS20100312, DS20100314, DS20100316, DS20100317, DS20100318, DS20100319, DS20100322, DS20100323, DS20100324, DS20100326, DS20100327, DS20100328, DS20100329, DS20100331, DS20100332, DS20100333, DS20100335, DS20100336, DS20100337, DS20100339, DS20100340, DS20100341, DS20100342, DS20100343, DS20100344, DS20100345, DS20100346, DS20100347, DS20100349, DS20100350, DS20100351, DS20100352, DS20100355, DS20100358, DS20100359, DS20100360, DS20100362, DS20100363, DS20100365, DS20100366, DS20100368, DS20100370, DS20100372, DS20100374, DS20100375, DS20100376, DS20100377, DS20100378, DS20100379, DS20100380, DS20100381, DS20100382, DS20100383, DS20100384, DS20100385, DS20100386, DS20100387, DS20100389, DS20100390, DS20100391, DS20100392, DS20100393, DS20100394, DS20100396, DS20100397, DS20100398, DS20100399, DS20100400, DS20100401, DS20100405, DS20100406, DS20100407, DS20100408, DS20100409, DS20100411, DS20100412, DS20100413, DS20100414, DS20100415, DS20100416, DS20100417, DS20100418, DS20100419, DS20100420, DS20100421, DS20100424, DS20100425, DS20100427, DS20100429, DS20100430, DS20100432, DS20100433, DS20100434, DS20100435, DS20100436, DS20100437, DS20100438, DS20100439, DS20100440, DS20100441, DS20100442, DS20100443, DS20100444, DS20100445, DS20100446, DS20100448, DS20100449, DS20100451, DS20100452, DS20100453, DS20100455, DS20100456, DS20100457, DS20100458, DS20100459, DS20100460, DS20100461, DS20100462, DS20100463, DS20100464, DS20100465, DS20100466, DS20100467, DS20100468, DS20100470, DS20100471, DS20100472, DS20100475, DS20100476, DS20100478, DS20100479, DS20100480, DS20100481, DS20100482, DS20100483, DS20100485, DS20100486, DS20100487, DS20100488, DS20100490, DS20100491, DS20100492, DS20100494, DS20100496, DS20100497, DS20100498, DS20100499, DS20100500, DS20100501, DS20100502, DS20100503, DS20100504, DS20100505, DS20100506, DS20100507, DS20100511, DS20100515, DS20100516, DS20100517, DS20100518, DS20100519, DS20100520, DS20100521, DS20100523, DS20100524, DS20100525, DS20100526, DS20100527, DS20100528, DS20100529, DS20100530, DS20100531, DS20100532, DS20100533, DS20100534, DS20100535, DS20100536, DS20100537, DS20100538, DS20100539, DS20100540, DS20100541, DS20100542, DS20100543, DS20100544, DS20100545, DS20100547, DS20100549, DS20100550, DS20100551, DS20100553, DS20100556, DS20100557, DS20100560, DS20100561, DS20100562, DS20100563, DS20100564, DS20100565, DS20100566, DS20100567, DS20100568, DS20100570, DS20100571, DS20100572, DS20100573, DS20100574, DS20100575, DS20100581, DS20100582, DS20100584, DS20100585, DS20100586, DS20100587, DS20100589, DS20100590, DS20100592, DS20100593, DS20100594, DS20100595, DS20100596, DS20100597, DS20100598, DS20100600, DS20100603, DS20100605, DS20100606, DS20100610, DS20100616, DS20100617, DS20100622, DS20100624, DS20100626, DS20100629, DS20100630, DS20100632, DS20100633, DS20100636, DS20100637, DS20100638, DS20100639, DS20100641, DS20100642, DS20100643, DS20100644, DS20100645, DS20100646, DS20100648, DS20100649, DS20100650, DS20100651, DS20100652, DS20100653, DS20100654, DS20100655, DS20100656, DS20100657, DS20100658, DS20100660, DS20100661, DS20100662, DS20100663, DS20100664, DS20100666, DS20100669, DS20100673, DS20100674, DS20100676, DS20100678, DS20100679, DS20100680, DS20100681, DS20100685, DS20100687, DS20100688, DS20100689, DS20100690, DS20100691, DS20100692, DS20100696, DS20100699, DS20100700, DS20100701, DS20100703, DS20100704, DS20100705, DS20100706, DS20100707, DS20100708, DS20100709, DS20100710, DS20100711, DS20100713, DS20100715, DS20100717, DS20100718, DS20100720, DS20100722, DS20100723, DS20100724, DS20100725, DS20100728, DS20100730, DS20100734, DS20100735, DS20100736, DS20100737, DS20100738, DS20100739, DS20100740, DS20100741, DS20100742, DS20100743, DS20100744, DS20100745, DS20100751, DS20100752, DS20100753, DS20100756, DS20100759, DS20100768, DS20100771, DS20100773, DS20100774, DS20100776, DS20100777, DS20100780, DS20100782, DS20100783, DS20100784, DS20100793, DS20100798, DS20100800, DS20100803, DS20100806, DS20100807, DS20100816, DS20100830, DS20100837, and DS20100931
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ikaria Holdings, Clinton, NJ, by letter dated July 21, 2010.
Manufacturer: INO Therapeutics, Middleton, WI. Firm initiated recall is ongoing.
REASON
The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients.
VOLUME OF PRODUCT IN COMMERCE
2,507 units
DISTRIBUTION
Nationwide and Countries of Canada and Malaysia

___________________________________
PRODUCT
1) Engage" TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. Recall # Z-2178-2010;

2) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094. Recall # Z-2179-2010;

3) Engage" TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549. Recall # Z-2180-2010;

4) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543. Recall # Z-2181-2010;

5) Engage" TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564. Recall # Z-2182-2010
CODE
1) Batch: 3109782;

2) Batch: 3105838;

3) Batch in US and OUS: 310764;

4) Batches in US: 3103891, 3110889, 3110892, 3118794, 3123051. Batches OUS: 3110892, 3118797;

5) Batches: 3107789, 3107790
RECALLING FIRM/MANUFACTURER
St. Jude Medical Cardiovascular Division, Minnetonka, MN, by letter dated June 24, 2010. Firm initiated recall is ongoing.
REASON
St Jude Medical Cardiovascular Division is performing a voluntary recall of certain batches of the 6 Fr. Engage" Introducer produced during the time period of 27 April to 03 June 2010. They have identified that a very small percentage of devices in the affected batches have the potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief. To date, no adverse events related to this issue have been reported.
VOLUME OF PRODUCT IN COMMERCE
5,120 units
DISTRIBUTION
OK, MN, CA, AZ, IN, SC, ME, MS, AR, NY, WY, NH, NJ, IL, VA, TX, UT, CT, LA, NM, PA, HI, AR, MI, WA, MO, NV, TN, KS, KY, OH, CO, WI, FL, and Countries of Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.  Model/Catalog Numbers: 800-01-368/370; 800-02-343/345; Specials that are affected: S1028, S1046, S1130, S1135, S1305, S1366, S1373, S1374, S1375, S1403, S1468, S1469, S1470, S1511, S1512, S1513. Recall # Z-2164-2010
CODE
Model and Catalog numbers only,
RECALLING FIRM/MANUFACTURER
Encore Medical, LP, Austin, TX, by letter dated May 20, 2010. Firm initiated recall is ongoing.
REASON
A crack or complete fracture in the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks.
VOLUME OF PRODUCT IN COMMERCE
729 and 67 Specials
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
IMx Sirolimus Reagent Pack; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Micro particles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; list 5C91-21. The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy. Recall # Z-2171-2010
CODE
Lot number 802873106, Expiry Date May13, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated April 30, 2010,
Manufacturer: Axis-Shield Diagnostics, Ltd., Dundee, UK. Firm initiated recall is ongoing.
REASON
IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
VOLUME OF PRODUCT IN COMMERCE
466 (207 kits Nationwide; 259 kits internationally)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; list 01L76-25. The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy. Recall # Z-2172-2010
CODE
Lot 80162M100, Expiry Date May 03, 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated May 27, 2010.
Manufacturer: Fujirebio Diagnostics, Inc., Malvern, PA. Firm initiated recall is ongoing.
REASON
The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.
VOLUME OF PRODUCT IN COMMERCE
875 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. Recall # Z-2190-2010
CODE
Lot numbers FQT09K07A through FQT10F09A
RECALLING FIRM/MANUFACTURER
Spectranetics Corp., Colorado Springs, CO, by letter on July 1, 2010. Firm initiated recall is complete.
REASON
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
VOLUME OF PRODUCT IN COMMERCE
5,080 units
DISTRIBUTION
Nationwide and Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela
__________________________________
PRODUCT
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart. Part number P05813 and P06841. Recall # Z-2191-2010
CODE
Serial numbers: DOMESTIC: 03B3G4, 03B7BJ, 03BKK9, 03CWKJ, 037XL6, 034J4X, 034T2R, 038fdn, 03BKJH, 03B3FT, 039F3H, 03BC26, 03CJTD, 03CHVH, 039F3L, 034Z4M, 03CWKD, 0354HB, 039F3J, 039F3Q, 03B3G3, 0354HC, 03B7B3, 0354HD, 03BKJ0, 03BKJK, 0356LC, 0360X5, 03BC2B, 03CVVH, 03CCBT, 0377LT, 038WXY, 03BC25, 037MR9, 037XPX, 03B3FY, 037XQ1, 03B3FX, 0392RC, 03B3G0, 0356FB, 035G72, 035NT0, 038WTJ, 03BKJF, 038WY1, 038WY3, 038WY5, 03CHVG, 03B3FW, 03CJ7D, 0392R8, 03CHVM, 03B3FV, 03936X, 0361FF, 0354J0, 0377LQ, 03CWCX, 0379T3, 037F5D, 03BC2G, 037X7R, 035NT3, 0384GM, 0392LP, 0360X7, 0376PB, 03936W, and 03BKKC. INTERNATIONAL: 035G71, 038FDP, 039V7L, 0356C3, 037XQ5, 0384K6, 0392RH, 03CJ83, 0377LN, 0392RG, 039KD3, 039V7P, 039V7T, 03BC24, 03BC2D, 03BKJJ, 03BKKY, 038WRH, 03CCBQ, 0384FH, 039KD4, 03BC20, 034PGZ, 034PH0, 03CCBR, 03BC23, 03CWKL, 034T2T , 03B7B2, 0384FL, 0384GN, 0384K4, 0384K5, 038WRD, 0390MH, 039190, 03918Z, 03BKKW, 03CJ82, 03CJ7B, 03CJ81, 03CJ86, 03CJ87, 03CJ88, 037XL7, 0384BX, 038WY7, 034PGQ, 0392RL, 034PGV, 03BC2C, 0392R9 , 039196 ,03CHVF, 03CJTB, 03CJTC, 034T30, 03570P, 0354HF, 0377LP, 038FL4 , 03CCBP, 03CWKF, 037MR7, 037XPW, 037MR6, 0384FJ, 034TN9, 0356HM, 038WTM, 0356GL, 034T32 , 039198, 0360YT , 0384CZ, 0384D1, 0361G5, 03B7B2, 03BKJG, 03CHVD, 03CJ7C, 03CJ84, 03CJ8B, 03CVVJ, 034T2W , 0356BV , 0377LV, 037MRC, 038WRJ, 039F3R, 0361DN, 036GYG, 037LTV, 037MR8, 037XQ3, 034PGX 035TZK, 034P7Y, 034PGM, 034PGP, 0356BW, 035G9X, 035NT2, 0361G6, 036GYD, 037F1Y, 037LTQ, 037LTT, 037LTY, 037M8T, 037XPY, 038WY2, 039V7M, 03CWD1, 03CWKM, 038XKX, 034NMJ, 0356C2, 034T2V, 034T2X, 034TNW, 034TNZ, 0354H9, 0356LD, 0360YV, 037XL8, and 0390MC
RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA, by telephone and by letter on August 21, 2008. Firm initiated recall is complete.
REASON
The TEE transesophageal transducer, when connected to a Sonosite M-Turbo Ultrasound System, may exhibit erratic operation of the Scanplane Orientation Indicator on the system display. The indicator may move erratically and not accurately represent the orientation of the TEE transducer array.
VOLUME OF PRODUCT IN COMMERCE
357 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. Made in USA. The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy. Recall # Z-2192-2010
CODE
Lot 0904151 through 1005201
RECALLING FIRM/MANUFACTURER
Recalling Firm: Linvatec Corp., dba ConMed Linvatec, Largo, FL, by letter dated July 6, 2010.
Manufacturer: ConMed Corp., Utica, NY. Firm initiated recall is ongoing.
REASON
Product may have a breach in the seal that could potentially compromise the sterility of the contents.
VOLUME OF PRODUCT IN COMMERCE
97,830 sets
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Crossfire Console, model number 475-000-000, Manufactured by Stryker Endoscopy
Jose Medical device indicated for use in orthopedic and arthroscopic procedures for the knee, shoulder, ankle, elbow, wrist and hip. The system provides abrasion, resection, debridement, and removal of bone and soft tissue through its shaver blade and ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its electrosurgical probe. Examples of use include resection, ablation and coagulation of torn knee cartilage, subacromial decompression and resection of synovial tissue in other joints. The probe is contraindicated for use in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants. Recall # Z-2193-2010
CODE
Manufactured between June 2009 and April 2010. All serial numbers are affected.
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters dated June 28, 2010 and July 9, 2010. Firm initiated recall is ongoing.
REASON
RF energy or powered shaver handpieces may continue to operate when not intended when used with the iSwitch Wireless Foot switch.
VOLUME OF PRODUCT IN COMMERCE
989 units
DISTRIBUTION
Nationwide and Australia, France, Germany, Greece, South Africa, Iberia, Italy, New Zealand, Poland, UK, Switzerland, Canada, China, Japan and the EME
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PRODUCT
Dynasty A-Class Poly Liner, REF DLXP-LD36, 1 each, Rx only, Sterile EO, Group D, I.D. 36 mm, LIP 15o, Liner STD. Product is used in total hip arthroplasty. Recall # Z-2212-2010
CODE
Lot number: 0501136375
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by letter on June 28, 2010. Firm initiated recall is ongoing.
REASON
The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI, WV, IN, IA, GA

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PRODUCT
DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope. Recall # Z-2213-2010
CODE
A lot number listing is not applicable as this is a field correction of the labeling. The 0109 hookup itself is not defective and can still be used safely with other endoscopes.
RECALLING FIRM/MANUFACTURER
Minntech, Corp., Plymouth, MN, by letter dated June l7, 2010. Firm initiated recall is ongoing.
REASON
The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinted DSD hook up Application Guide (M04-0001 revision M).
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
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PRODUCT
Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems. Recall # -2208-2010
CODE
Lot Numbers: 911158, 911581, and 917631
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on the week of April 19, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established reference range, but are elevated and statistically different than results from an uncontaminated control lot. Elevated CV's may also be observed with the contaminated vials.
VOLUME OF PRODUCT IN COMMERCE
166 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS I
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PRODUCT
1) Pig ears in Bulk Packaging, Item Number 18100-P, under Brand names Doggie Delight, Pork Tasteez and Pet Carousel. Recall # V-046-2010;

2) Pig ears in Bulk Packaging, Item Number 18016-P, packed in 10-pack red mesh bag, under Brand names Doggie Delight, Pork Tasteez and Pet Carousel. Recall # V-047-2010;

3) Pig ears in Bulk Packaging, Item Number 18120-P, packed in 20-pack red mesh bag, under Brand names Doggie Delight, Pork Tasteez and Pet Carousel. Recall # V-048-2010;

4) Beef Hooves, packed in 5 lb.-bulk packaging, Item number 1506-K and 1405-S, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-049-2010;

5) Beef Hooves, packed in 10 lb.-bulk packaging, Item number 1507-K, 1410-S, and 12122-T manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-050-2010;

6) Beef Hooves, packed in 20 lb.-bulk packaging, Item number 1520-K and 1420-S, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-051-2010;

7) Beef Hooves, packed in 10-pack vinyl bag, Item number 12125-T, 12110-T, 12111-T, 1408-S and 1510-K, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-052-2010;

8) Beef Hooves, packed in 3-pack vinyl bag, Item number 1503-K, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-053-2010;

9) Cheese & Bacon Stuffed Hoof, bulk, Item Number 90058-H, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-054-2010;

10) Peanut Butter Stuffed Hoof, bulk, Item Number 90056-H, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-055-2010;

11) Rope Toy with Beef Hooves, Item Number 17005-R, manufactured under brand name Pet Carousel Choo-Hooves, Dentley's, Doggie Delight and Pet Carousel. Recall # V-056-2010
CODE
Item Number only
RECALLING FIRM/MANUFACTURER
Pet Carousel, Sanger, CA, by telephone on November 3, 2009 and by press release on November 5, 2009 and December 9, 2009. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
97,345 hooves
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR AUGUST 18, 2010

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