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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 8, 2011

 

 
June 8, 2011                                                                                        11-23
 
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Grape Tomatoes sold under the following labels, a) Aldi "From the Vine" in 1 pint clamshell packages, UPC 0 33383 65585 7; Sunset Grape Tomatoes sold in 1 pint, UPC 0 57836 65585 0; and c) 2 lb clamshell packages, UPC 0 57836 65586 7; d) Trader Joe's Splendido Little Tomatoes sold in 12 oz clamshell packages, UPC 0080 8606. Recall # F-1352-2011
CODE
a) Lot numbers: 41141, 41144, and 41149; b) Lot numbers: 40665, 40667, 40673, 40883, 40955, 40986, 40989, 40990, 40991, 41148, 41154, 41155, and 41160; c) Lot number 40680; d) Lot numbers: 40675, 40676 and 41142
RECALLING FIRM/MANUFACTURER
Recalling Firm:Mastronardi Produce-USA, Inc. - Midwest Division, Livonia, MI, by telephone on April 30, 2011, and by press release on May 4, 2011. 
Manufacturer: Six L's Packing Company, Inc., Immokalee, FL. Michigan initiated recall is ongoing.
REASON
The recalled tomatoes are associated with the recall initiated by Six L's Packing Company of Immokalee, FL because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3584 1 lb packages 1200 2 lb packages
DISTRIBUTION
IL, MI, WI, FL, MA, MD, NJ, NY, OH, PA, and TX and Canada
___________________________________
PRODUCT
1) RAW Organic Food Bar Chocolatey Chocolate Chip; a) UPC: 87352100022 0; b) UPC: 87352100021 3; c) UPC: 87352100521 8. Recall # F-1353-2011;
 
2) RAW Organic Food Bar Cinnamon Raisin; a) UPC: 8 7352100011 4; b) UPC: 8 7352100511 9. Recall # F-1354-2011;
 
3) RAW Organic Food Bar Chocolate Coconut; a) UPC: 8 7352100031 2; b) UPC: 8 7352100531 7. Recall # F-1355-2011;
 
4) RAW Organic Food Bar Oooatmeal Apple Pie; UPC: 8 7352100111 1. Recall # F-1356-2011;
 
5) RAW Organic Food Bar Fiber Chocolate Delite; a) b) UPC: 8 7352100041 1; UPC: 8 7352100541 6. Recall # F-1357-2011;
 
6) RAW Organic Food Bar Keerunch Crunchy Chocolate Chip; UPC: 8 7352100121 0. Recall # F-1358-2011;
 
7) RAW Organic Food Bar Oohmega Cherry Pie; UPC: 8 7352100101 2. Recall # F-1359-2011
CODE
1) a) Lot Numbers: 3071210 exp. 12-Jul-2011, 2071210 12-Jul-2011, 02081610 08/11, 01081610, 08/11, 04092710 27 Sep 2011; b) Lot Numbers: 2062810 exp. 28-Jun-11, 4062810 28-Jun-11, 3071210 12-Jul-11, 2072810 28-Jul-11, 2081610 16-Aug-11, 4092810 28-Sep-11, 2102010 20-0ct-11; c) Lot Numbers: 1062810 exp. 28-Jun-11, 3062810 28-Jun-11, 2071210 12-Jul-11 1072810 28-Jul-11, 1081610 16-Aug-11, 4092710 27-Sep-11, 1102010 20-0ct-11;
 
2) a) Lot Numbers 3070910 exp. 09-Jul-11, 3072110 21-Jul-11, 3083110 31-Aug-11, 2092710 27-Sep-11, 3100410 04-0ct-11; b) Lot Numbers: 2062410 exp. 24-Jun-11, 2070910 09-Jul-11, 2083110 31-Aug-11;
 
3) a) Lot Numbers: 6071210 exp. 12-Jul-11, 6072810 28-Jul-11, 4081710 17-Aug-11, 3082710 27-Aug-11, 5102010 20-0ct-11; b) Lot Numbers 5071210 exp. 12-Jun-11, 4072810 28-Jul-11, 3081710 17-Aug-11, 2092010 20-Sep-11, 4102010 20-0ct-11;
 
4) Lot Numbers: 2071610 exp. 16-Jul-11, 1083010 30-Aug-11, 3090710 07-Sep-11;
 
5) a) Lot Numbers: 6062810 exp. 28-Jun-11, 7072110 21-Jul-11, 1082710 27-Aug-11; b) Lot Numbers 5062810 exp. 28-Jun-11, 6072110 21-Jul-11, 1092010 20-Sep-11;
 
6) Lot Number: 3070710 exp. 07-Jul-11, 2101410 14-Oct-11;
 
7) Lot Number: 3072910 exp. 29-Jul-11
RECALLING FIRM/MANUFACTURER
Organic Food Bar, Inc., Corona, CA, by press release on April 15, 2011 and April 28, 2011 and by letters beginning on April 15, 2011 and April 29, 2011. FDA initiated recall is ongoing.
REASON
Product may contain undeclared peanut proteins.
VOLUME OF PRODUCT IN COMMERCE
358,986 bars
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Unlabeled plastic mesh sacks containing 50 pounds of IQF Wild Caught Gulf Shrimp of various sizes not limited to U15, 16-20s, 20-25s and 25-30s. Recall # F-1360-2011;
 
2) Bulk boxes of shrimp labeled LA BLUE CRAB I.Q.F. WILD CAUGHT PRODUCT OF USA or TEXAS PREMIUM I.Q.F. WILD CAUGHT PRODUCT OF USA. 16/20's Frozen IQF Shrimp; U/15's Frozen IQF Shrimp. Recall F # - 1361-2011
CODE
1) All products shipped between January 1, 2009 - February 18, 2011;
2) a) Lot Codes: M260, D080, I079, N020, M280, N140; b) Lot Codes: D279, U159, N020, M280, Z010, N140, and N100
RECALLING FIRM/MANUFACTURER
Texas Gulf Seafood, Inc., Galveston, TX, by letter and telephone beginning February 18, 2011. FDA initiated recall is ongoing.
REASON
The shrimp contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
20,456 cases
DISTRIBUTION
MD, TX
___________________________________
PRODUCT
1) Tuna Saku CO Treated AAA, 22 lbs.; Tuna Saku Cube CO Treated AA, 10 lbs.; Tuna Saku CO Treated Meat 10 lbs. Recall # F-1362-2011;
 
2) 1) Tuna Loin CO Treated size 5/8, 44 lbs.; 2) Tuna Loin CO Treated (Size 8/12) 44 lbs. Recall # F-1363-2011;
 
3) Tuna Steak CO Treated, 10 lbs each: 1) size 4; 2) size 8; 3) bulk; 4) meat. Recall # F-1364-2011
CODE
1) Lot # A-06489; Lot # A-06490; Lot # A-06493;
2) 1) Lot # 06494; 2) Lot # 06494;
3) 1) Lot # 06496; 2) Lot # 06498; 3) Lot # 06500; 4) Lot # 06501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mercantile Harmony Food Corp., El Monte, CA, by letter on March 24, 2011.
Manufacturer: PT Usaha Centraljaya Sakti, Makassar, Indonesia. Firm initiated recall is ongoing.
REAESON
The CO treated Tuna Saku, cube, loin, steak, chunk, and strip have the potential to be contaminated by Salmonella.
VOLUME OF PRODUCT IN COMMERCE
861 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
Market Pantry Cookies Snickerdoodles, Net Wt 15 oz. (425 g); packaged 12 cookies per plastic clam shell, 12 packages per shipping case; UPC 0 85239 44207 4. Recall # F-1365-2011
CODE
Lot numbers: 110592W03, 110933W03, 110941W03, 111152W03 and 111232W03
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ralcorp Frozen Bakery Products, Downers Grove, IL, by telephone and email on May 4, 2011, letters on May 5, 2011 and press release on May 6, 2011.  
Manufacturer: Ralcorp Frozen Bakery Products - Ogden Facility, Ogden, UT. Firm initiated recall is ongoing.
REASON
The cookies contain whey protein, which is not declared in the ingredient statement on the label. The label does have an allergen statement that states "May contain milk, peanut and tree nuts."
VOLUME OF PRODUCT IN COMMERCE
1,989 cases
DISTRIBUTION
AZ, CA, FL, IA, MD, MA, TX
___________________________________
PRODUCT
Jelly Roll (Ninos in Spanish), 2.5 oz. (71g), UPC code: "7 5318245022 3". Recall # F-1368-2011
CODE
None
RECALLING FIRM/MANUFACTURER
San Antonio Bakery, Compton, CA, by visits beginning May 8, 2011. Firm initiated recall is ongoing.
REASON
The product was found to contain undeclared milk in finished product.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Thai Kitchen� Noodle Cart, Sweet Citrus Ginger, item # 900301795, packaged in 9.70 oz. single serve bowls, UPC Code: 37628-01024. Recall # F-1369-2011;
 
2) Thai Kitchen� Rice Noodle Cart, Thai Peanut, item # 900303477, packaged in 9.77 oz. single serve bowls and as part of a 4 bowl multi-pack containing Pad Thai and Thai Peanut varieties, Single Serve Bowl UPC Code: 37628-01027; Multi-Pack UPC: 37628-01038. Recall # F-1370-2011;
 
3) Thai Kitchen� Rice Noodle Cart, Spicy Thai Basil, item # 900375335, packaged in 9.70 oz. single serve bowls; UPC Code: 37628-01023. Recall # F-1371-2011;
 
4) Simply Asia� Noodle Bowl, Roasted Peanut, Item Number: SA00087, packaged in 8.5 oz. single serve bowls, 6 bowls per shipping case; additionally packed as item # 900206693, part of a multi-flavor 54-count pre-pack shipping case; UPC Code: 54285-00087. Recall # F-1372-2011
CODE
1), 2), 3) All Best By dates through BEST BY OCT 18 12;
4) BEST BY JAN 10 12 through BEST BY OCT 18 12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Simply Asia Foods LLC, Hunt Valley, MD, by press release and letter on April 29, 2011. 
Manufacturer: Beijing JTM International Food Co., LTD., Beijing, China. Firm initiated recall is ongoing.
REASON
Food product contains an undeclared milk ingredient.
VOLUME OF PRODUCT IN COMMERCE
309,482 cases
DISTRIBUTION
Nationwide, Aruba, Bahamas, and Costa Rica
___________________________________
PRODUCT
1) Sassy Cow Creamery, Premium Ice cream, 1 Quart (945 ml), Butter Pecan. Ingredients: Ice cream mix (cream, milk, sugar) Natural butter pecan (brown sugar, water, corn syrup, natural flavor, milk, sodium benzoate and potassium sorbate as preservatives, citric acid annatto extract) Toasted pecans (pecans, coconut oil, butter, salt). UPC 8 93597 00236 2 Plant #55-192. Recall # F-1375-2011;
 
2) Sassy Cow Creamery, Premium Ice cream, 1 Quart (945 ml), Blueberry Cheesecake. Ingredients: Ice cream mix (cream, milk, sugar) Cheesecake base(corn syrup, water, cheese powder, nonfat milk solids, lactic acid, and cultures, buttermilk powder, natural flavor, and sugar) Cheesecake pieces ( cream cheese, sugar, graham meal, high fructose corn syrup, whole wheat flour) Blubbery Swirl (blueberries, sugar, modified food starch, natural flavor and sodium benzoate) UPC 8 93597 00251 5 Plant #55-192. Recall # F-1374-2011;
CODE
1), 2) Best by dates on or before Sept 17th 2011
RECALLING FIRM/MANUFACTURER
Sassy Cow Creamery, Columbus, WI, by letters on March 21, 2011 and by press release on March 23, 2011. FDA initiated recall is ongoing.
REASON
Sassy Cow Creamery, LLC is recalling two ice cream products because of undeclared allergens which may include peanuts, eggs, or soy.
VOLUME OF PRODUCT IN COMMERCE
1) 763 cases (6 quarts/case); 2) 57 cases (6 quarts/case)
DISTRIBUTION
WI, IL
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Vita-Spelt, Grain for Life, Spelt Products; The Baking Quality Spelt, Whole Spelt Flour, Product of U.S.A., Net Weight 50 lbs. 22.68 Kg. Recall # F-1350-2011
CODE
Lot #: 7916
RECALLING FIRM/MANUFACTURER
Purity Foods, Inc., Okemos, MI, by telephone on February 10, 2011 and by letter dated February 14, 2011. Firm initiated recall is ongoing.  
REASON
Firm testing found Vomitoxin (DON) levels at 3 ppm, above the established limit of 1 ppm for human consumption.
VOLUME OF PRODUCT IN COMMERCE
150 – 50 lb bags
DISTRIBUTION
TX, CO, NY, PA
___________________________________
PRODUCT
365 Everyday Value Organic Unsweetened Green Tea, 64 Fl oz (2 qt). Recall # F-1351-2011
CODE
Best by 12/13/11, Lot Code 40L001073 1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Brand 365, LLC, Austin, TX, by e-mail on March 28, 2011.
Manufacturer: Clement Pappas & Company Inc., Carneys Point, NJ. Firm initiated recall is complete.
REASON
Supplier of affected product reported test results indicating potential for elevated pH levels.
VOLUME OF PRODUCT IN COMMERCE
198 cases
DISTRIBUTION
CO, CA
___________________________________
PRODUCT
Sassy Cow Creamery, Premium Ice cream, 1 Quart (945 ml), Birthday Cake. Ingredients: Ice cream mix (cream, milk, sugar) Yellow cake mix (sugar, wheat flour, palm oil with mono and diglycerides, and soy lecithin, leavening agents, sodium bicarbonate, monocalcium phosphate, sodium acid pyrophosphate, corn starch, dextrose, salt natural and artificial flavors, xanthan gum, soybean oil, oleoresin tumeric for color) Semi-sweet chocolate chips ( sugar chocolate liquor, butter, oil/cocoa butter, dextrose, soy lecithin, vanilla, corn starch, titanium dioxide, gum arabic, confectioner's glaze, artifical color, camuba wax). UPC 8 93597 00250 Plant #55-192. Recall # F-1373-2011
CODE
1), 2), 3) Best by dates on or before Sept 17th 2011
RECALLING FIRM/MANUFACTURER
Sassy Cow Creamery, Columbus, WI, by letters on March 21, 2011 and by press release on March 23, 2011. FDA initiated recall is ongoing.
REASON
Sassy Cow Creamery, LLC is recalling this ice cream product because of undeclared Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
113 cases (6 quarts/case)
DISTRIBUTION
WI, IL
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Povidone Iodine Prep Pads (Povidone Iodine, USP, 10%), Antiseptic/Germicide, For Hospital and Professional Use Only, Uses: First aid to help prevent infection in minor cuts, scrapes, and burns. Healthcare antiseptic for preparation of the skin prior to surgery. Labeled under the following names: a) Povidone Iodine Prep Pads (10% Povidone Iodine, USP), 1 pad per foil packet, 100-count pads per box, 12 boxes per case, TRIAD, Cat. No. # 10-3201, NDC 50730-3201-1; b) Povidone Iodine Prep Pads (Povidone Iodine 10%), 1 pad per foil packet, 100-count pads per box, 12 boxes per case, VERSA Pro, UPC 5 07 30113 42201 1; c) Povidone Iodine Prep Pad (10% Povidone Iodine, USP), 1 pad per foil packet, 100-count pads per box, 12 boxes per case, AmeriNet Choice, Reorder # AC-3201, NDC 50730-3201-7. Recall # D-533-2011
CODE
All lots beginning with the digits 8, 9, 0 or 1
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by press release on March 15, 2011 and letters, dated March 16, 2011, and March 28, 2011. FDA initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The recall of all lots of Povidine Iodine Prep Pads was initiated due to results of analytical testing showing the presence of objectionable organisms, namely showing the presence of objectionable organisms, namely Staphylococcus warneri, Stenotrophomas maltophilia, and Elizabethkingia meningoseptica
VOLUME OF PRODUCT IN COMMERCE
338,400 boxes (28,200 cases)
DISTRIBUTION
Nationwide, Puerto Rico, Australia, Canada, Israel, Malaysia, Philippines, Singapore, and Turkey
___________________________________
PRODUCT
MAN UP Now, Dietary Supplement capsule, 450 mg, 1 Capsule Blister Pack UPC 753182057552, 2 Capsule Blister Pack UPC 753182111032, 3 Capsule Blister Pack UPC 753182057569, Bottle 6 count UPC 753182111001, Bottle 12 count UPC 753182057590, Bottle 30 count UPC 753182057583, OTC, Recall # D-535-2011
CODE
All Lots w/the following UPC numbers: 753182111018, 753182057552, 753182111056, 753182111032, 753182111025, 753182057569, 753182111001, 753182057590, 753182057583
RECALLING FIRM/MANUFACTURER
Body Action, Land O Lakes, FL, by letter beginning on December 10, 2010. Firm initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of Sildenafil, a prescription drug used for treatment of male Erectile Dysfunction.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS -   CLASS II
___________________________________
PRODUCT
Povidone Iodine Prep Pads, (Povidone Iodine, USP 10%), Use: First aid to help prevent infection in minor cuts, scrapes, and burns. Labeled under the following names: a) Povidone Iodine Prep Pad (10% Povidone Iodine, USP), 1 pad per foil packet, sold in Bulk, TRIAD, Cat. No. 10-3201, NDC 50730-3201-1. b) Povidone Iodine Prep Pad (10% Povidone Iodine, USP w/v), 1 pad per foil packet, sold in Bulk, TRIAD PLUS, Made in USA, Cat. No. 11-PP32, NDC 50730-3201-8. c) Allegiance Povidone-Iodine Prep Pad (Povidone Iodine, USP, 10% w/v), 1 pad per foil packet UPC (01) 0 0380470 04715 7; 100-count pads per box, UPC (01) 2 0630140 06394 4, Cat. 40000-020, NDC 63517-320-11. d) Povidone-Iodine Prep Pads (10% Povidone-Iodine solution), 1 prep pad per foil packet; 100-count pads per box, UPC 3 50730 32019 1, NOVAPLUS, Cat. No. V9120, NDC 50730-3201-9; e) PVP Iodine Wipe (Povidone-iodine, 10%), 1 Single Use wipe per foil packet, sold in Bulk, Item # PL-3534 f) Povidone Iodine Prep Pad (Povidone Iodine USP, 10% w/v), 1 pad per foil packet, sold in Bulk, Be Smart * Get Prepared. Recall # D-534-2011
CODE
All lots beginning with the digits 8, 9, 0 or 1
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by press release on March 15, 2011 and letters, dated March 16, 2011, and March 28, 2011. FDA initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: The recall of all lots of Povidine Iodine Prep Pads was initiated due to results of analytical testing showing the presence of objectionable organisms, namely showing the presence of objectionable organisms, namely Staphylococcus warneri, Stenotrophomas maltophilia, and Elizabethkingia meningoseptica
VOLUME OF PRODUCT IN COMMERCE
338,400 boxes (28,200 cases)
DISTRIBUTION
Nationwide, Puerto Rico, Australia, Canada, Israel, Malaysia, Philippines, Singapore, and Turkey
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Percocet (oxycodone and acetaminophen tablets, USP) 10 mg/325 mg, 100-count bottles, Rx only; NDC 63481-629-70. Recall # D-532-2011
CODE
Lot 402243NV, Exp 09/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo Pharmaceuticals, Inc., Chadds Ford, PA, letter dated May 12, 2011.
Manufacturer: Novartis Consumer Health, Lincoln, NE. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: An Endocet 10/325 mg tablet was found in a 100-count bottle of Percocet 10/325 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
22,366 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1357-11
CODE
Units: 032KW05814 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Madison, WI, by facsimile on August 30, 2007.
Manufacturer: American Red Cross Blood Services Badger-Hawkeye Region, Madison, WI. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1366-11;
2) Recovered Plasma. Recall # B-1367-11
CODE
1) and 2) Unit: LV46153
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by internet on November 28, 2006, by fax on January 17, 2007, March 5, 2007 and April 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not respond to a question regarding increased risk for vCJD, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Switzerland
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-1368-11
CODE
Unit: 019LK64661
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by fax on April 2, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1371-11
CODE
Unit: KR58038
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by fax on November 15, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who travelled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1372-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1373-11;
3) Cryoprecipitated AHF. Recall # B-1374-11
CODE
1), 2), and 3) Unit KR77047
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by fax on January 21, 2008.  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
3 units
DISTRIBUTION
CA and Switzerland
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1375-11
CODE
Unit: 1661289
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter dated July 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1377-11
CODE:
Unit: W036811078830
RECALLING FIRM/MANUFACTURER
by telephone on April 1, 2011 and letter dated April 4, 2011. Firm initiated recall is complete..
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1388-11
CODE
Unit: 3325662
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on April 30, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1389-11
CODE
Unit: 84KM64941
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated July 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1391-11
CODE
Unit: 084FT93430
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated September 21, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1395-11
CODE
Unit: V75620
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on May 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1397-11
CODE
Units: FM58127
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on August 16, 2005. Firm initiated recall is complete.
REASON
Blood products, for which the platelet yield did not support storage in three bags,were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1398-11
CODE
Unit: FM47917 (2 units)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on April 29, 2005. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1412-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1413-11
CODE
1) and 2) Unit: W037911556797
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by fax on March 31, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NE
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1365-11
CODE
Unit: 2915840
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on September 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsutable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1369-11
CODE
Unit: 21LN13770
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by the LOGIC computer system and letter dated March 29, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1378-11
CODE:
Unit: W036811078830
RECALLING FIRM/MANUFACTURER
by telephone on April 1, 2011 and letter dated April 4, 2011. Firm initiated recall is complete..
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL, Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1390-11
CODE
Unit: 84KM64941
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by letter dated July 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1396-11
CODE
Unit: V75620
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on May 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Austria
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall # Z-2049-2011;
 
2) VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The cards are intended for use with the Vitek 2 systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic/anaerobic gram-negative bacilli to antimicrobial agents. Recall # Z-2050-2011
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Biomerieux Inc., Hazelwood, MO, by letter dated March 30, 2011 and April 4, 2011 and by press release on April 8, 2011. Firm initiated recall is ongoing.  
REASON
The piperacillin/tazobactam drug on the antimicrobial susceptibility cards is providing false susceptible and false resistant results for E. coli, as well as an additional 7 organisms; and the same drug is providing false resistant results for K. pneumoniae.
VOLUME OF PRODUCT IN COMMERCE
3,493 boxes as of 3/31/11
DISTRIBUTION
Canada and Sweden
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1973-2011
 
2) Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1974-2011;
 
3) Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Used in clinical and hospital settings by trained radiologists. Recall # Z-1975-2011
CODE
1) Units: 598959, 599042, 599084, 599091, 599144, 599189, 599225, 599278, 599539, 599593, 599616, 599704, 599706, 599708, 599744, 599847, 599862, 599937, 600018, 600032, 600046, 600106, 600107, 600343, 600428, and 600667 located on the side of the table;
 
2) Units: 599236, 599457, 599764, 599780,599802, 599845, 599898, 600012, 600047, 600249, 600290, 600304, and 600809 located on the side of the table;
 
3) Units: 598972, 599406, 599650, 599707, 599710, 599721, 599771, 599870, 599871, 599964, 600024, 600115, 600333, 600550,
600551, 600655, and 600790 located on the side of the table
RECALLING FIRM/MANUFACTURER
Medical Positioning Inc., Kansas City, MO, by letter on February 1, 2010. Firm initiated recall is complete.
REASON
The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic. Recall # Z-1976-2011
CODE
PID (8 digits unique ID), Master Lot (9 digits), Exp Date (mo-year) 41932700 110179713 Jul-2010 41932708 110179713 Jul-2010 41932970 110179713 Jul-2010 41720764 110196095 Nov-2009 41896447 110196264 Jun-2010 41896457 110196265 Jun-2010 41720784 110196489 Nov-2009 41720775 110196491 Nov-2009 41720776 110196494 Nov-2009 41720773 110196495 Nov-2009 41728794 110196536 Nov-2009 41728814 110196539 Nov-2009 41728804 110196542 Nov-2009 41728816 110196548 Nov-2009 41728793 110196549 Nov-2009 41728811 110196551 Nov-2009 41739045 110196553 Nov-2009 41720758 110196555 Nov-2009 41728828 110196580 Nov-2009 41728864 110196582 Nov-2009 41726667 110196583 Nov-2009 41728830 110196597 Nov-2009 41755766 110196965 Apr-2009 41759209 110196966 Dec-2009 41758554 110196967 Apr-2009 41758549 110196968 Apr-2009 41759213 110196969 Dec-2009 41758558 110196984 Dec-2009 41758544 110196985 Apr-2009 41759219 110196987 Apr-2009 41755734 110196988 Dec-2009 41758553 110196989 Dec-2009 41759214 110196991 Dec-2009 41758557 110196992 Dec-2009 41755762 110196993 Apr-2009 41758550 110196994 Apr-2009 41757969 110196996 Dec-2009 41755737 110196997 Dec-2009 41757981 110196998 Dec-2009 41757980 110196999 Apr-2009 41757983 110197000 Apr-2009 41760706 110197001 Dec-2009 41759210 110197007 Dec-2009 41755780 110197010 Apr-2009 41755756 110197011 Dec-2009 41759206 110197012 Dec-2009 41759226 110197013 Dec-2009 41755761 110197014 Dec-2009 41755721 110197015 Dec-2009 41757975 110197017 Dec-2009 41758623 110197020 Apr-2009 41758551 110197022 Dec-2009 41757984 110197023 Apr-2009 41757976 110197024 Dec-2009 41759205 110197025 Dec-2009 41762149 110197026 Apr-2009 41759208 110197027 Apr-2009 41751033 110197028 Dec-2009 41757977 110197029 Apr-2009 41755745 110197030 Apr-2009 41757978 110197032 Apr-2009 41755735 110197037 Apr-2009 41755736 110197059 Apr-2009 41755758 110197073 Dec-2009 41755759 110197075 Dec-2009 41751034 110197076 Dec-2009 41755779 110197078 Dec-2009 41742361 110197091 Apr-2009 41755722 110197092 Dec-2009 41758624 110197093 Apr-2009 41757979 110197094 Apr-2009 41758545 110197095 Apr-2009 41757974 110197097 Dec-2009 41758559 110197100 Dec-2009 41758556 110197101 Apr-2009 41735282 110197117 Jan-2010 41755757 110197118 Jan-2010 41757972 110197120 Jan-2010 41758547 110197121 May-2009 41757973 110197123 May-2009 41740215 110197124 Jan-2010 41762213 110197126 May-2009 41762122 110197127 May-2009 41762170 110197128 May-2009 41762167 110197129 May-2009 41762211 110197130 May-2009 41762165 110197131 May-2009 41762180 110197132 May-2009 41742366 110197134 Jan-2010 41737285 110197135 Jan-2010 41757982 110197136 May-2009 41762207 110197138 Jan-2010 41762176 110197139 Jan-2010 41762129 110197140 Jan-2010 41762193 110197146 Jan-2010 41735274 110197147 Jan-2010 41762217 110197153 Jan-2010 41762206 110197154 Jan-2010 41762173 110197155 Jan-2010 41740229 110197156 Jan-2010 41759218 110197157 May-2009 41743545 110197158 Jan-2010 41762186 110197165 Jan-2010 41748755 110197166 Jan-2010 41740269 110197167 Jan-2010 41762192 110197168 Jan-2010 41757971 110197169 Jan-2010 41762178 110197170 Jan-2010 41760700 110197171 Jan-2010 41764722 110197178 May-2009 41764726 110197179 Jan-2010 41764725 110197180 Jan-2010 41767079 110197182 May-2009 41767107 110197184 May-2009 41767110 110197185 May-2009 41767258 110197186 May-2009 41767088 110197187 Jan-2010 41764724 110197192 May-2009 41764713 110197193 May-2009 41767327 110197194 Jan-2010 41764716 110197197 Jan-2010 41764718 110197198 May-2009 41764715 110197199 May-2009 41767318 110197200 Jan-2010 41764714 110197201 May-2009 41767189 110197202 May-2009 41767228 110197206 May-2009 41764711 110197207 Jan-2010 41764712 110197210 May-2009 41764706 110197212 May-2009 41767096 110197213 May-2009 41767185 110197214 Jan-2010 41767260 110197215 Jan-2010 41767084 110197218 Jan-2010 41767284 110197219 Jan-2010 41767217 110197220 Jan-2010 41767289 110197221 Jan-2010 41767323 110197222 Jan-2010 41767092 110197223 Jan-2010 41764717 110197224 Jan-2010 41767259 110197225 Jan-2010 41764705 110197226 Jan-2010 41767099 110197268 Jan-2010 41767223 110197269 Jan-2010 41767212 110197270 Jan-2010 41764708 110197271 Jan-2010 41767276 110197272 Jan-2010 41764709 110197273 Jan-2010 41764719 110197275 Jan-2010 41764707 110197276 Jan-2010 41767188 110197278 Jan-2010 41767150 110197280 Jan-2010 41764704 110197289 Jan-2010 41767314 110197290 Jan-2010 41767248 110197297 Jan-2010 41767194 110197298 Jan-2010 41767186 110197299 Jan-2010 41767160 110197302 Jan-2010 41767251 110197303 Jan-2010 41767257 110197305 Jan-2010 41767179 110197308 Jan-2010 41767144 110197309 May-2009 41767177 110197310 May-2009 41767299 110197312 Jul-2009 41767204 110197313 Jan-2010 41767265 110197314 Jan-2010 41767294 110197315 May-2009 41767333 110197317 May-2009 41767255 110197318 Jan-2010 41767199 110197319 May-2009 41767303 110197320 Jan-2010 41767246 110197321 Jul-2009 41767280 110197322 Jan-2010 41771647 110197329 May-2009 41771522 110197330 Jan-2010 41771610 110197331 Jan-2010 41771541 110197332 Jul-2009 41771575 110197334 May-2009 41771587 110197336 Jan-2010 41768036 110197338 May-2009 41771559 110197341 Jul-2009 41767308 110197342 Jan-2010 41771537 110197343 Jan-2010 41767250 110197344 Jan-2010 41771432 110197345 May-2009 41767232 110197346 May-2009 41767237 110197347 Jan-2010 41771562 110197348 Jan-2010 41771633 110197350 May-2009 41771621 110197351 May-2009 41771555 110197352 Jan-2010 41773547 110197353 Jan-2010 41771546 110197354 May-2009 41771584 110197355 May-2009 41771569 110197356 Jan-2010 41771366 110197357 May-2009 41771518 110197359 Jan-2010 41771635 110197360 Jan-2010 41771626 110197361 May-2009 41771640 110197362 May-2009 41771580 110197363 Jan-2010 41771549 110197364 May-2009 41771354 110197367 May-2009 41771630 110197368 May-2009 41771370 110197370 May-2009 41771577 110197371 Jan-2010 41773558 110197373 May-2009 41773552 110197374 Jan-2010 41773553 110197375 Jan-2010 41771606 110197376 Jan-2010 41773557 110197377 Jan-2010 41773544 110197379 Jan-2010 41773542 110197381 Jan-2010 41773543 110197382 Jul-2009 41773561 110197383 Jul-2009 41773534 110197384 Jan-2010 41773546 110197386 Jan-2010 41773536 110197388 Jan-2010 41773538 110197402 Jan-2010 41773539 110197412 Jan-2010 41773571 110197414 Jan-2010 41773559 110197415 Jan-2010 41773532 110197417 Jan-2010 41773574 110197445 Jan-2010 41773564 110197446 May-2009 41773566 110197447 May-2009 41773545 110197449 Jan-2010 41771405 110197451 Jan-2010 41773541 110197452 Jan-2010 41773555 110197453 Jan-2010 41773540 110197455 Jan-2010 41773560 110197459 May-2009 41773567 110197460 May-2009 41775504 110197466 Jan-2010 41776523 110197467 May-2009 41775499 110197468 May-2009 41776404 110197471 May-2009 41775485 110197472 May-2009 41776539 110197472 May-2009 41775506 110197474 May-2009 41776538 110197475 May-2009 41775501 110197476 May-2009 41776510 110197477 May-2009 41776546 110197478 May-2009 41771431 110197480 Jan-2010 41771436 110197482 Jan-2010 41771365 110197482 May-2009 41775508 110197482 May-2009 41773549 110197487 Jan-2010 41775488 110197488 May-2009 41771363 110197490 Jan-2010 41771413 110197490 May-2009 41771425 110197490 May-2009 41776561 110197492 May-2009 41776530 110197493 May-2009 41776500 110197498 Jan-2010 41775505 110197498 May-2009 41776494 110197498 May-2009 41776554 110197499 May-2009 41771565 110197500 May-2009 41775494 110197503 May-2009 41773568 110197517 Jan-2010 41775497 110197518 May-2009 41771397 110197519 May-2009 41775500 110197520 Jan-2010 41775484 110197520 May-2009 41775496 110197521 Jan-2010 41771416 110197522 May-2009 41771422 110197523 May-2009 41771372 110197524 May-2009 41771438 110197525 May-2009 41776559 110197526 May-2009 41776563 110197526 May-2009 41775489 110197527 May-2009 41773565 110197528 May-2009 41775503 110197529 Jan-2010 41775493 110197530 Jan-2010 41773573 110197531 Jan-2010 41775491 110197532 Jan-2010 41775498 110197533 Jan-2010 41771420 110197533 May-2009 41775481 110197533 May-2009 41776465 110197536 Jan-2010 41771386 110197536 May-2009 41776391 110197536 May-2009 41771379 110197537 Jan-2010 41775495 110197537 Jan-2010 41776485 110197537 Jan-2010 41775482 110197538 May-2009 41776418 110197538 May-2009 41776505 110197538 May-2009 41771392 110197539 May-2009 41771428 110197539 May-2009 41773575 110197540 May-2009 41775483 110197541 May-2009 41775486 110197541 May-2009 41775502 110197541 May-2009 41775492 110197543 May-2009 41771355 110197544 Jan-2010 41780105 110197555 May-2009 41780087 110197556 May-2009 41780089 110197557 May-2009 41780088 110197561 May-2009 41780090 110197563 Jan-2010 41780091 110197570 Jan-2010 41780094 110197571 Jan-2010 41780103 110197572 May-2009 41780074 110197574 May-2009 41780092 110197575 Jan-2010 41780082 110197577 May-2009 41780075 110197578 May-2009 41780104 110197579 May-2009 41780077 110197580 May-2009 41780079 110197581 Jan-2010 41780102 110197582 May-2009 41780078 110197583 May-2009 41780083 110197584 May-2009 41780101 110197621 May-2009 41780081 110197622 Jan-2010 41780106 110197623 Jan-2010 41786789 110197627 May-2009 41786795 110197628 Jan-2010 41786791 110197630 Jan-2010 41783927 110197631 Jan-2010 41780100 110197632 May-2009 41780071 110197633 Jan-2010 41780097 110197634 Jan-2010 41780096 110197635 May-2009 41780076 110197636 May-2009 41780070 110197638 May-2009 41780072 110197639 Jan-2010 41780073 110197640 Jan-2010 41780069 110197642 May-2009 41783911 110197645 Jan-2010 41780086 110197647 May-2009 41780107 110197648 May-2009 41783933 110197649 Jan-2010 41783914 110197650 Jan-2010 41783926 110197651 Jan-2010 41783924 110197652 May-2009 41780080 110197656 May-2009 41783936 110197659 May-2009 41780098 110197660 Jan-2010 41783929 110197661 Jan-2010 41780085 110197662 May-2009 41780099 110197663 May-2009 41780084 110197664 Jan-2010 41783938 110197665 Jan-2010 41786796 110197678 Jan-2010 41786788 110197679 Jul-2009 41783923 110197680 Jan-2010 41786792 110197682 Jan-2010 41783912 110197683 Jan-2010 41786793 110197690 Jan-2010 41787053 110197691 Jan-2010 41783940 110197721 Feb-2010 41787061 110197722 Feb-2010 41783920 110197724 Aug-2009 41787069 110197726 Feb-2010 41786797 110197727 Feb-2010 41783918 110197728 Feb-2010 41787060 110197730 Feb-2010 41783919 110197731 Feb-2010 41783934 110197732 Feb-2010 41783916 110197743 Feb-2010 41787067 110197751 Feb-2010 41787058 110197757 Jun-2009 41787055 110197758 Feb-2010 41787068 110197759 Feb-2010 41787057 110197760 Feb-2010 41783925 110197761 Feb-2010 41787056 110197762 Jun-2009 41787070 110197763 Feb-2010 41783932 110197768 Feb-2010 41783939 110197793 Jun-2009 41787066 110197795 Feb-2010 41783915 110197797 Feb-2010 41787062 110197798 Feb-2010 41790585 110197799 Feb-2010 41787054 110197802 Jun-2009 41790617 110197803 Jun-2009 41787063 110197804 Feb-2010 41787059 110197805 Feb-2010 41790586 110197807 Jun-2009 41787064 110197810 Aug-2009 41790593 110197811 Jun-2009 41787065 110197813 Jun-2009 41790584 110197814 Aug-2009 41790621 110197815 Feb-2010 41790578 110197821 Feb-2010 41790626 110197823 Feb-2010 41790582 110197824 Feb-2010 41790590 110197825 Feb-2010 41790620 110197826 Feb-2010 41790580 110197828 Jun-2009 41790627 110197829 Feb-2010 41790624 110197830 Feb-2010 41790599 110197850 Feb-2010 41792586 110197866 Feb-2010 41792598 110197878 Feb-2010 41790579 110197880 Jun-2009 41790583 110197884 Jun-2009 41790600 110197885 Feb-2010 41792601 110197886 Feb-2010 41792602 110197887 Feb-2010 41792578 110197888 Feb-2010 41792564 110197889 Feb-2010 41792596 110197891 Jun-2009 41790615 110197893 Feb-2010 41792590 110197894 Jun-2009 41792583 110197896 Feb-2010 41792572 110197897 Feb-2010 41790622 110197898 Feb-2010 41792567 110197899 Feb-2010 41792611 110197900 Feb-2010 41790625 110197901 Jun-2009 41792569 110197902 Jun-2009 41790592 110197903 Feb-2010 41787071 110197904 Jun-2009 41792562 110197905 Feb-2010 41792585 110197906 Jun-2009 41790623 110197907 Feb-2010 41790616 110197908 Feb-2010 41792568 110197908 Feb-2010 41792595 110197908 Feb-2010 41792603 110197909 Feb-2010 41790597 110197910 Jun-2009 41790589 110197911 Feb-2010 41792584 110197912 Feb-2010 41790618 110197914 Feb-2010 41790598 110197915 Feb-2010 41792594 110197939 Feb-2010 41792597 110197939 Feb-2010 41792605 110197939 Feb-2010 41790596 110197941 Feb-2010 41792592 110197941 Feb-2010 41792599 110197941 Feb-2010 41792607 110197944 Feb-2010 41792608 110197944 Feb-2010 41792570 110197946 Jun-2009 41792582 110197947 Feb-2010 41792563 110197949 Feb-2010 41792571 110197950 Jun-2009 41790595 110197951 Feb-2010 41787072 110197953 Jun-2009 41792574 110197954 Jun-2009 41792566 110197956 Feb-2010 41790587 110197957 Feb-2010 41790588 110197957 Jun-2009 41799025 110197996 Jun-2009 41798781 110198015 Jun-2009 41798786 110198015 Jun-2009 41792609 110198018 Feb-2010 41790581 110198018 Jun-2009 41792606 110198019 Feb-2010 41798799 110198020 Jun-2009 41800105 110198022 Aug-2009 41799020 110198023 Feb-2010 41799021 110198025 Feb-2010 41798776 110198026 Feb-2010 41799016 110198029 Feb-2010 41802252 110198046 Feb-2010 41802250 110198046 Feb-2010 41802270 110198047 Feb-2010 41802273 110198047 Feb-2010 41802275 110198047 Feb-2010 41798804 110198049 Feb-2010 41800104 110198049 Feb-2010 41800108 110198049 Feb-2010 41800111 110198051 Aug-2009 41798794 110198052 Aug-2009 41798789 110198055 Aug-2009 41799018 110198055 Aug-2009 41799019 110198055 Aug-2009 41802271 110198059 Feb-2010 41802272 110198059 Feb-2010 41802274 110198059 Feb-2010 41802287 110198072 Jun-2009 41802256 110198079 Aug-2009 41802259 110198080 Feb-2010 41802266 110198081 Aug-2009 41802283 110198082 Feb-2010 41802268 110198084 Aug-2009 41802267 110198085 Feb-2010 41802269 110198085 Feb-2010 41802281 110198090 Feb-2010 41802284 110198090 Feb-2010 41802286 110198090 Feb-2010 41802255 110198092 Feb-2010 41802257 110198092 Feb-2010 41802258 110198092 Feb-2010 41800109 110198094 Feb-2010 41800103 110198096 Feb-2010 41800113 110198097 Feb-2010 41802260 110198102 Jun-2009 41802262 110198102 Jun-2009 41799023 110198103 Feb-2010 41799022 110198104 Feb-2010 41802239 110198111 Feb-2010 41802240 110198111 Feb-2010 41802248 110198111 Feb-2010 41802285 110198112 Feb-2010 41802288 110198112 Feb-2010 41802289 110198112 Feb-2010 41802278 110198113 Feb-2010 41802279 110198113 Feb-2010 41802263 110198114 Feb-2010 41802264 110198114 Feb-2010 41802265 110198114 Feb-2010 41802242 110198115 Feb-2010 41802243 110198115 Feb-2010 41802247 110198115 Feb-2010 41802261 110198116 Feb-2010 41802291 110198121 Feb-2010 41802254 110198122 Feb-2010 41802276 110198123 Feb-2010 41802277 110198123 Feb-2010 41802302 110198132 Jun-2009 41802293 110198135 Feb-2010 41802294 110198135 Feb-2010 41802297 110198135 Feb-2010 41802246 110198137 Jun-2009 41802296 110198139 Feb-2010 41802299 110198145 Feb-2010 41802298 110198161 Feb-2010 41802244 110198173 Jun-2009 41802245 110198173 Jun-2009 41806537 110198177 Feb-2010 41802292 110198178 Feb-2010 41806529 110198180 Feb-2010 41802300 110198191 Jun-2009 41806522 110198192 Jun-2009 41802301 110198193 Feb-2010 41806510 110198193 Feb-2010 41806505 110198194 Feb-2010 41806519 110198194 Feb-2010 41806514 110198202 Feb-2010 41806524 110198203 Feb-2010 41810757 110198204 Feb-2010 41810768 110198206 Feb-2010 41812159 110198206 Feb-2010 41806490 110198207 Feb-2010 41806533 110198207 Feb-2010 41806494 110198210 Feb-2010 41806530 110198211 Feb-2010 41812198 110198211 Feb-2010 41806523 110198216 Feb-2010 41810766 110198216 Feb-2010 41810767 110198216 Feb-2010 41810755 110198217 Feb-2010 41810759 110198217 Feb-2010 41810760 110198217 Feb-2010 41806527 110198218 Jun-2009 41812190 110198219 Feb-2010 41810758 110198220 Jun-2009 41810756 110198221 Feb-2010 41822345 110198531 Sep-2009 41820876 110198534 Mar-2010 41831416 110198549 Sep-2009 41815675 110198550 Sep-2009 41820873 110198551 Sep-2009 41820891 110198562 Mar-2010 41820884 110198585 Sep-2009 41833368 110198586 Mar-2010 41820882 110198587 Sep-2009 41833374 110198588 Sep-2009 41816551 110198589 Sep-2009 41833370 110198590 Sep-2009 41820868 110198591 Sep-2009 41820877 110198592 Mar-2010 41820878 110198603 Mar-2010 41833371 110198604 Sep-2009 41816708 110198605 Sep-2009 41833366 110198606 Apr-2010 41833372 110198607 Sep-2009 41833369 110198609 Mar-2010 41833367 110198610 Sep-2009 41833373 110198645 Sep-2009 41815669 110198646 Sep-2009 41820879 110198647 Sep-2009 41822349 110198648 Sep-2009 41820691 110198649 Sep-2009 41820875 110198650 Sep-2009 41815662 110198651 Apr-2010 41822380 110198653 Apr-2010 41837268 110198656 Sep-2010 41837200 110198657 Sep-2009 41837183 110198659 Apr-2010 41837269 110198660 Sep-2009 41815671 110198662 Apr-2010 41820894 110198664 Sep-2009 41833365 110198665 Sep-2009 41822351 110198666 Sep-2009 41820896 110198668 Sep-2009 41820901 110198669 Sep-2009 41837196 110198681 Sep-2009 41822348 110198683 Sep-2009 41838375 110198684 Sep-2009 41831427 110198685 Sep-2009 41820869 110198686 Sep-2009 41828808 110198687 Sep-2009 41820895 110198689 Sep-2009 41816705 110198709 Sep-2009 41822372 110198710 Sep-2009 41815666 110198711 Apr-2010 41822366 110198712 Sep-2009 41831426 110198713 Sep-2009 41828810 110198714 Sep-2009 41820898 110198715 Sep-2009 41822362 110198716 Sep-2009 41820872 110198717 Sep-2009 41820690 110198718 Sep-2009 41822347 110198720 Sep-2009 41828807 110198721 Sep-2009 41822363 110198722 Sep-2009 41820692 110198723 Oct-2009 41822367 110198724 Sep-2009 41838371 110198742 Sep-2009 41838389 110198744 Sep-2009 41820886 110198745 Sep-2009 41828809 110198746 Sep-2009 41815680 110198747 Sep-2009 41837284 110198748 Apr-2010 41831417 110198751 Sep-2009 41838390 110198752 Sep-2009 41838369 110198753 Sep-2009 41838388 110198754 Sep-2009 41838368 110198755 Sep-2009 41838376 110198756 Sep-2009 41838391 110198757 Apr-2010 41838378 110198758 Sep-2009 41838380 110198759 Sep-2009 41837230 110198760 Apr-2010 41838384 110198761 Sep-2009 41838381 110198762 Sep-2009 41838386 110198763 Apr-2010 41837252 110198764 Sep-2009 41838394 110198765 Apr-2010 41838377 110198766 Apr-2010 41838393 110198767 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Jul-2011 42052195 110204272 Jul-2011 42049666 110204273 Jul-2011 42052167 110204274 Jul-2011 42050435 110204276 Jul-2011 42049695 110204279 Jul-2011 42049706 110204282 Jul-2011 42050434 110204286 Jul-2011 42050438 110204288 Jul-2011 42049665 110204289 Jul-2011 42052139 110204291 Jul-2011 42049708 110204293 Jul-2011 42041446 110204294 Jul-2011 42049696 110204295 Jul-2011 42049678 110204296 Jul-2011 42051347 110204297 Jul-2011 42052184 110204298 Jul-2011 42049671 110204299 Jul-2011 42050437 110204300 Jul-2011 42049702 110204301 Jul-2011 42049693 110204302 Jul-2011 42050440 110204303 Jul-2011 42052196 110204304 Jul-2011 42049701 110204312 Jul-2011 42032460 110204313 Jul-2011 42049699 110204314 Jul-2011 42028670 110204315 Jul-2011 42052187 110204317 Jul-2011 42052848 110204318 Jul-2011 42049692 110204320 Jul-2011 42049687 110204321 Jul-2011 42052870 110204323 Jul-2011 42049709 110204324 Jul-2011 42052868 110204325 Jul-2011 42052843 110204326 Jul-2011 42049697 110204327 Jul-2011 42041443 110204328 Jul-2011 42052847 110204329 Jul-2011 42050436 110204330 Jul-2011 42052841 110204331 Jul-2011 42052861 110204332 Jul-2011 42052857 110204333 Jul-2011 42052837 110204334 Jul-2011 42052859 110204335 Jul-2011 42052864 110204336 Jul-2011 42052831 110204337 Jul-2011 42052833 110204338 Jul-2011 42052842 110204340 Jul-2011 42052869 110204341 Jul-2011 42052845 110204357 Jul-2011 42052873 110204359 Jul-2011 42052838 110204360 Jul-2011 42052858 110204362 Jul-2011 42052839 110204363 Jul-2011 42052856 110204365 Jul-2011 42052871 110204366 Jul-2011 42052853 110204367 Jul-2011 42052876 110204368 Jul-2011 42052874 110204369 Jul-2011 42052835 110204370 Jul-2011 42052830 110204371 Jul-2011 42054743 110204401 Jul-2011 42052855 110204403 Jul-2011 42057450 110204404 Jul-2011 42055798 110204406 Jul-2011 42057482 110204407 Jul-2011 42057499 110204408 Jul-2011 42052846 110204409 Jul-2011 42052834 110204410 Jul-2011 42057442 110204412 Jul-2011 42056753 110204413 Jul-2011 42057468 110204415 Jul-2011 42057474 110204416 Jul-2011 42057461 110204417 Jul-2011 42057496 110204418 Jul-2011 42052875 110204419 Jul-2011 42057473 110204420 Jul-2011 42057494 110204420 Jul-2011 42057498 110204420 Jul-2011 42057505 110204421 Jul-2011 42044656 110204423 Jul-2011 42054742 110204424 Jul-2011 42056755 110204425 Jul-2011 42057445 110204425 Jul-2011 42057457 110204425 Jul-2011 42057483 110204428 Jul-2011 42057503 110204428 Jul-2011 42057507 110204428 Jul-2011 42057454 110204432 Jul-2011 42057475 110204434 Jul-2011 42058841 110204434 Jul-2011 42052863 110204436 Jul-2011 42057490 110204439 Jul-2011 42059646 110204479 Jul-2011 42059654 110204479 Jul-2011 42059655 110204479 Jul-2011 42055802 110204483 Jul-2011 42057486 110204483 Jul-2011 42052836 110204484 Jul-2011 42055799 110204484 Jul-2011 42054739 110204486 Jul-2011 42058842 110204486 Jul-2011 42052832 110204488 Jul-2011 42057479 110204488 Jul-2011 42058840 110204490 Jul-2011 42059656 110204490 Jul-2011 42055801 110204493 Jul-2011 42059639 110204495 Jul-2011 42052854 110204500 Jul-2011 42054741 110204500 Jul-2011 42059630 110204500 Jul-2011 42055800 110204501 Jul-2011 42057480 110204501 Jul-2011 42059653 110204501 Jul-2011 42054744 110204503 Jul-2011 42059643 110204503 Jul-2011 42059645 110204503 Jul-2011 42059633 110204504 Jul-2011 42059637 110204504 Jul-2011 42052872 110204507 Jul-2011 42056748 110204507 Jul-2011 42056752 110204509 Jul-2011 42057491 110204510 Jul-2011 42057504 110204510 Jul-2011 42057488 110204513 Jul-2011 42057495 110204513 Jul-2011 42059644 110204515 Jul-2011 42059651 110204515 Jul-2011 42057444 110204518 Jul-2011 42061574 110204519 Jul-2011 42054746 110204520 Jul-2011 42057500 110204521 Jul-2011 42056747 110204522 Jul-2011 42059649 110204536 Jul-2011 42057446 110204537 Jul-2011 42057467 110204537 Jul-2011 42054745 110204538 Jul-2011 42060752 110204538 Jul-2011 42059640 110204539 Jul-2011 42059647 110204539 Jul-2011 42059636 110204541 Jul-2011 42060753 110204541 Jul-2011 42060756 110204542 Jul-2011 42060759 110204542 Jul-2011 42057481 110204545 Jul-2011 42060757 110204545 Jul-2011 42056751 110204547 Jul-2011 42056745 110204548 Jul-2011 42056750 110204548 Jul-2011 42059650 110204549 Jul-2011 42061571 110204549 Jul-2011 42059604 110204549 Jul-2011 42057471 110204551 Jul-2011 42059642 110204552 Jul-2011 42059638 110204553 Jul-2011 42059648 110204553 Jul-2011 42052849 110204554 Jul-2011 42057493 110204555 Jul-2011 42059631 110204555 Jul-2011 42060754 110204556 Jul-2011 42061572 110204556 Jul-2011 42059632 110204557 Jul-2011 42056749 110204558 Jul-2011 42059652 110204560 Jul-2011 42052851 110204583 Jul-2011 42052866 110204583 Jul-2011 42054740 110204583 Jul-2011 42059582 110204584 Jul-2011 42059629 110204584 Jul-2011 42059634 110204584 Jul-2011 42061569 110204586 Jul-2011 42062113 110204586 Jul-2011 42062114 110204586 Jul-2011 42054747 110204589 Jul-2011 42059603 110204589 Jul-2011 42059576 110204598 Jul-2011 42059657 110204598 Jul-2011 42052850 110204599 Jul-2011 42060755 110204602 Jul-2011 42060761 110204602 Jul-2011 42052852 110204603 Jul-2011 42052878 110204603 Jul-2011 42057470 110204604 Jul-2011 42054738 110204605 Jul-2011 42056746 110204605 Jul-2011 42060785 110204605 Jul-2011 42057485 110204606 Jul-2011 42059593 110204607 Jul-2011 42061573 110204607 Jul-2011 42062112 110204630 Jul-2011 42063400 110204630 Jul-2011 42057476 110204632 Jul-2011 42057489 110204632 Jul-2011 42059571 110204634 Jul-2011 42060751 110204634 Jul-2011 42052879 110204635 Jul-2011 42062993 110204637 Jul-2011 42061570 110204638 Jul-2011 42061567 110204639 Jul-2011 42062991 110204644 Jul-2011 42063076 110204644 Jul-2011 42066633 110204644 Jul-2011 42063845 110204645 Jul-2011 42065927 110204645 Jul-2011 42065931 110204645 Jul-2011 42065892 110204646 Jul-2011 42065893 110204646 Jul-2011 42065925 110204646 Jul-2011 42060760 110204647 Jul-2011 42066637 110204648 Jul-2011 42066643 110204648 Jul-2011 42062984 110204650 Jul-2011 42062988 110204650 Jul-2011 42065923 110204650 Jul-2011 42063840 110204651 Jul-2011 42062111 110204652 Jul-2011 42065889 110204653 Jul-2011 42065919 110204653 Jul-2011 42066642 110204654 Jul-2011 42057443 110204655 Jul-2011 42063842 110204655 Jul-2011 42062116 110204656 Jul-2011 42057441 110204657 Jul-2011 42059597 110204657 Jul-2011 42062995 110204658 Jul-2011 42066634 110204659 Jul-2011 42065890 110204660 Jul-2011 42065894 110204660 Jul-2011 42061568 110204661 Jul-2011 42059641 110204662 Jul-2011 42062997 110204663 Jul-2011 42066636 110204663 Jul-2011 42064917 110204664 Jul-2011 42057497 110204665 Jul-2011 42057508 110204666 Jul-2011 42062996 110204666 Jul-2011 42062985 110204667 Jul-2011 42065891 110204667 Jul-2011 42066635 110204667 Jul-2011 42067072 110204668 Jul-2011 42067082 110204668 Jul-2011 42063403 110204669 Jul-2011 42066638 110204671 Jul-2011 42067070 110204671 Jul-2011 42067068 110204672 Jul-2011 42066641 110204673 Jul-2011 42067079 110204674 Jul-2011 42066639 110204675 Jul-2011 42063077 110204676 Jul-2011 42063401 110204708 Jul-2011 42067081 110204708 Jul-2011 42062994 110204710 Jul-2011 42067074 110204711 Jul-2011 42067076 110204711 Jul-2011 42067080 110204711 Jul-2011 42067071 110204715 Jul-2011 42067073 110204715 Jul-2011 42067554 110204715 Jul-2011 42067066 110204716 Jul-2011 42062989 110204717 Jul-2011 42064916 110204717 Jul-2011 42067078 110204719 Jul-2011 42062998 110204720 Jul-2011 42062986 110204729 Jul-2011 42067069 110204729 Jul-2011 42067561 110204729 Jul-2011 42063843 110204731 Jul-2011 42052862 110204732 Jul-2011 42056754 110204732 Jul-2011 42057502 110204732 Jul-2011 42062115 110204733 Jul-2011 42067077 110204733 Jul-2011 42052840 110204735 Jul-2011 42057487 110204735 Jul-2011 42057477 110204738 Jul-2011 42057484 110204738 Jul-2011 42064988 110204738 Jul-2011 42064989 110204739 Jul-2011 42067566 110204740 Jul-2011 42063404 110204741 Jul-2011 42062401 110204742 Jul-2011 42062110 110204743 Jul-2011 42068079 110204763 Jul-2011 42068088 110204763 Jul-2011 42068090 110204763 Jul-2011 42062992 110204766 Jul-2011 42068082 110204766 Jul-2011 42068076 110204768 Jul-2011 42068081 110204769 Jul-2011 42068091 110204769 Jul-2011 42068080 110204771 Jul-2011 42067075 110204773 Jul-2011 42068085 110204773 Jul-2011 42057501 110204775 Jul-2011 42057509 110204775 Jul-2011 42068078 110204776 Jul-2011 42068084 110204776 Jul-2011 42068086 110204779 Jul-2011 42068089 110204779 Jul-2011 42067067 110204780 Jul-2011 42057472 110204781 Jul-2011 42065888 110204781 Jul-2011 42062982 110204783 Jul-2011 42068074 110204796 Aug-2011 42069393 110204796 Aug-2011 42063836 110204797 Aug-2011 42068075 110204798 Aug-2011 42068654 110204798 Aug-2011 42057465 110204799 Aug-2011 42068083 110204799 Aug-2011 42068653 110204799 Aug-2011 42068077 110204800 Aug-2011 42068655 110204800 Aug-2011 42062983 110204801 Aug-2011 42067083 110204802 Aug-2011 42068087 110204803 Aug-2011 42068652 110204824 Aug-2011 42070129 110204824 Aug-2011 42070265 110204824 Aug-2011 42068812 110204827 Aug-2011 42069401 110204827 Aug-2011 42070145 110204827 Aug-2011 42069400 110204828 Aug-2011 42069394 110204830 Aug-2011 42069395 110204831 Aug-2011 42068810 110204832 Aug-2011 42069992 110204833 Aug-2011 42070152 110204834 Aug-2011 42070149 110204841 Aug-2011 42070261 110204841 Aug-2011 42070761 110204841 Aug-2011 42069931 110204842 Aug-2011 42069935 110204842 Aug-2011 42070756 110204842 Aug-2011 42070136 110204844 Aug-2011 42070137 110204844 Aug-2011 42070177 110204844 Aug-2011 42070117 110204846 Aug-2011 42070254 110204846 Aug-2011 42070120 110204846 Aug-2011 42069402 110204847 Aug-2011 42070755 110204847 Aug-2011 42068811 110204848 Aug-2011 42069927 110204848 Aug-2011 42070124 110204848 Aug-2011 42070267 110204850 Aug-2011 42069396 110204851 Aug-2011 42070134 110204851 Aug-2011 42070174 110204851 Aug-2011 42069988 110204852 Aug-2011 42070258 110204852 Aug-2011 42070128 110204853 Aug-2011 42070206 110204853 Aug-2011 42070157 110204854 Aug-2011 42070764 110204855 Aug-2011 42070108 110204860 Aug-2011 42070110 110204860 Aug-2011 42070111 110204860 Aug-2011 42070146 110204864 Aug-2011 42070245 110204864 Aug-2011 42070252 110204864 Aug-2011 42069397 110204867 Aug-2011 42070135 110204867 Aug-2011 42070176 110204867 Aug-2011 42070131 110204869 Aug-2011 42070132 110204869 Aug-2011 42070175 110204870 Aug-2011 42070178 110204870 Aug-2011 42070249 110204872 Aug-2011 42070251 110204872 Aug-2011 42070164 110204873 Aug-2011 42070165 110204873 Aug-2011 42070237 110204874 Aug-2011 42069398 110204875 Aug-2011 42070759 110204876 Aug-2011 42070130 110204877 Aug-2011 42070166 110204877 Aug-2011 42070167 110204877 Aug-2011 42069936 110204879 Aug-2011 42070127 110204879 Aug-2011 42070189 110204879 Aug-2011 42070142 110204881 Aug-2011 42070192 110204881 Aug-2011 42070199 110204881 Aug-2011 42069938 110204884 Aug-2011 42070113 110204884 Aug-2011 42070758 110204884 Aug-2011 42070196 110204885 Aug-2011 42070109 110204885 Aug-2011 42070221 110204885 Aug-2011 42070139 110204887 Aug-2011 42070181 110204887 Aug-2011 42070183 110204887 Aug-2011 42070754 110204888 Aug-2011 42070760 110204888 Aug-2011 42070762 110204888 Aug-2011 42070169 110204890 Aug-2011 42070170 110204890 Aug-2011 42070171 110204890 Aug-2011 42062990 110204891 Aug-2011 42070172 110204892 Aug-2011 42070126 110204893 Aug-2011 42070179 110204893 Aug-2011 42070180 110204893 Aug-2011 42070168 110204894 Aug-2011 42070250 110204896 Aug-2011 42070140 110204897 Aug-2011 42070133 110204898 Aug-2011 42070173 110204898 Aug-2011 42070138 110204899 Aug-2011 42052844 110204909 Aug-2011 42062987 110204909 Aug-2011 42070241 110204909 Aug-2011 42072550 110204910 Aug-2011 42073314 110204910 Aug-2011 42073315 110204910 Aug-2011 42070202 110204912 Aug-2011 42070226 110204912 Aug-2011 42072543 110204912 Aug-2011 42070230 110204915 Aug-2011 42070233 110204915 Aug-2011 42071934 110204915 Aug-2011 42057492 110204918 Aug-2011 42072553 110204918 Aug-2011 42071954 110204920 Aug-2011 42057506 110204921 Aug-2011 42071950 110204932 Aug-2011 42072551 110204932 Aug-2011 42072558 110204932 Aug-2011 42071943 110204933 Aug-2011 42072539 110204933 Aug-2011 42073312 110204933 Aug-2011 42071937 110204935 Aug-2011 42072556 110204935 Aug-2011 42073316 110204935 Aug-2011 42072541 110204938 Aug-2011 42072542 110204938 Aug-2011 42072549 110204938 Aug-2011 42071932 110204939 Aug-2011 42071944 110204939 Aug-2011 42073311 110204939 Aug-2011 42072540 110204949 Aug-2011 42072544 110204949 Aug-2011 42072555 110204949 Aug-2011 42071935 110204950 Aug-2011 42073299 110204950 Aug-2011 42073853 110204950 Aug-2011 42069983 110204952 Aug-2011 42069995 110204952 Aug-2011 42072547 110204952 Aug-2011 42071938 110204954 Aug-2011 42071939 110204954 Aug-2011 42072024 110204954 Aug-2011 42052867 110204956 Aug-2011 42069989 110204956 Aug-2011 42069991 110204956 Aug-2011 42073293 110204961 Aug-2011 42073294 110204961 Aug-2011 42073298 110204961 Aug-2011 42072023 110204963 Aug-2011 42073307 110204963 Aug-2011 42073308 110204963 Aug-2011 42069990 110204965 Aug-2011 42069993 110204965 Aug-2011 42073855 110204965 Aug-2011 42071933 110204967 Aug-2011 42071946 110204967 Aug-2011 42073305 110204967 Aug-2011 42069399 110204968 Aug-2011 42072536 110204968 Aug-2011 42071948 110204969 Aug-2011 42071958 110204969 Aug-2011 42072538 110204969 Aug-2011 42072022 110204971 Aug-2011 42073317 110204971 Aug-2011 42071936 110204974 Aug-2011 42072546 110204974 Aug-2011 42073354 110204976 Aug-2011 42073380 110204976 Aug-2011 42071947 110204978 Aug-2011 42072548 110204978 Aug-2011 42071949 110204979 Aug-2011 42073381 110204980 Aug-2011 42069996 110204981 Aug-2011 42073303 110204981 Aug-2011 42073313 110204982 Aug-2011 42071941 110204983 Aug-2011 42073306 110204983 Aug-2011 42071953 110204984 Aug-2011 42071956 110204984 Aug-2011 42072554 110204985 Aug-2011 42070186 110204986 Aug-2011 42072552 110204987 Aug-2011 42071945 110204988 Aug-2011 42073355 110204989 Aug-2011 42073302 110204996 Aug-2011 42073856 110204996 Aug-2011 42078134 110204996 Aug-2011 42073292 110204997 Aug-2011 42073295 110204997 Aug-2011 42073297 110204997 Aug-2011 42036992 110204999 Aug-2011 42041491 110204999 Aug-2011 42073287 110204999 Aug-2011 42073301 110205002 Aug-2011 42074341 110205002 Aug-2011 42078133 110205002 Aug-2011 42079442 110205003 Aug-2011 42078141 110205004 Aug-2011 42073296 110205005 Aug-2011 42052865 110205006 Aug-2011 42074946 110205006 Aug-2011 42073289 110205007 Aug-2011 42073352 110205007 Aug-2011 42074945 110205007 Aug-2011 42052877 110205008 Aug-2011 42072545 110205009 Aug-2011 42078138 110205010 Aug-2011 42078710 110205010 Aug-2011 42071940 110205011 Aug-2011 42069994 110205012 Aug-2011 42073304 110205013 Aug-2011 42073353 110205013 Aug-2011 42046364 110205014 Aug-2011 42071952 110205015 Aug-2011 42073286 110205016 Aug-2011 42078140 110205017 Aug-2011 42073854 110205018 Aug-2011 42078135 110205018 Aug-2011 42078139 110205019 Aug-2011 42073300 110205020 Aug-2011 41945654 110201589 Aug-2010 41952764 112021753 Aug-2010 41984042 112023013 Sep-2010 42049667 112024215 Jul-2011 42041445 112024224 Jul-2011 42059604 112024549 Jul-2011
RECALLING FIRM/MANUFACTURER
CIBA Vision Puerto Rico, Inc., Cidra, PR, by letters dated June 2010 and February 1, 2011. Firm initiated recall is ongoing,
REASON
Out of specification values were obtained for sterility testing. The pH of the saline solution may be higher than the spec (up to pH 8.6 compared to a spec limit of pH 7.8). The osmolarity of the saline solution may be lower than specification (263 mOsm/kg compared to a spec limit of 270)
VOLUME OF PRODUCT IN COMMERCE
28,124 units
DISTRIBUTION
Nationwide, and Australia, Austria, Argentina, Bahrain, Belgium, Canada, Colombia, Czech Republic, Denmark, Dubai (United Arab Emirates), Finland, France, Great Britain, Greece, Hungary, Iceland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Netherlands, Oman, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and Venezuela
___________________________________
PRODUCT
1) Sarns Flexible Weighted Sucker, Sterile, catalog 804113. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2001-2011;
 
2) Sarns Flexible Weighted Sucker in K9 Pack (custom pack), catalog number 63635-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2002-2011;
 
3) Sarns Flexible Weighted Sucker in WI CARDIOVASCULAR PUMP & TABLE PACK (custom pack), catalog number 64789-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2003-2011;
 
4) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2004-2011;
 
5) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-03, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall# Z-2005-2011;
 
6) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK (custom pack), catalog number 70295-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2006-2011;
 
7) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-04, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2007-2011;
 
8) Sarns Flexible Weighted Sucker in PUMP & TABLE PACK with PALL (custom pack), catalog number 70579-05, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2008-2011;
 
9) Sarns Flexible Weighted Sucker in X-COATED CUSTOM TUBING PACK, catalog number 70932-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Sarns weighted sucker is indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2009-2011;
 
10) Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2010-2011;
 
11) Sarns Flexible Weighted Sucker in CUSTOM X-COATED PERFUSION PACK, catalog number 73013-02, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2011-2011;
 
12) Sarns Flexible Weighted Sucker in X-COATED PUMP & TABLE PACK, catalog number 73067-01, Sterile and Non-pyrogenic. Sterilized by ethylene oxide. The Flexible Intracardiac Sucker and Weighted Flexible Sucker are indicated for stationary use to remove excess fluid from the surgical field. Recall # Z-2012-2011
CODE
1) Lot numbers: 0629293, 0626551, 0618233, 0612412, 0608207, 0605124, 0600214, 0585956, 0582479, 0576835, 0572250, 0565377, 0557560, 0551549, 0541635, 0540864, 0537157, 0533487, 0528683, 0524211, 0519856, 0516938, 0512528, 0510871, 0509707, 0506130, 0502530, 0502218, 0501931 and 0500756;   
 
2) 2) Lot number LK17;
 
3) Lot numbers: KC04, KD24, KE07, KH07, KK04, KN03, KP01, LA05, LC02, LC23, LD09, LG22, and LG22A;
 
4) Lot numbers: KC11, KD24, KE14, and KF27;
 
5) Lot numbers: KG30, KK11, KN17, LA12, LC02, LD23, LF04, LG15, LG29, LK03, LL28, and MG01;
 
6) Lot numbers: MK23, MN29, and NC07;
 
7) Lot numbers: HM08R, HM08RT, and KE28;
 
8) Lot numbers: KM13 and KL24;
 
9) Lot numbers: KA14R, KC25, KD31, KE28, KF19, KG23, KK11, KK25, KM20, KN10, KP15, LA19, LC02, LC23, LD23, LE13, LF18, LG15, LH20, LK31, LL28, LL28T, LN02, LP21, MA18, MC15, MA18R, MD15, ME19, MF10, MH19, MK09, MK30, MM04, MN15, and NA03;
 
10) Lot number MA04;
 
11) Lot numbers: MD22, MK09, MK23, and NA03;
 
12) Lot numbers: ME26, MG07, MH19, MK23, ML13, MM18, MN15, MP13, and NA24
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on
REASON
The firm has received two reports of the Terumo Weighted Flexible Sucker becoming ensnared in cardiac tissue after it was inserted into a ventricle through a valve. The firm has determined that the product’s instructions for use are inadequate; the product should not be used to drain a cardiac chamber or inserted through a valve. However this is not stated in the IFU. The firm is conducting this recall to inform users of the hazards associated with using the weighted sucker to drain a cardiac chamber or placing it through a valve.
VOLUME OF PRODUCT IN COMMERCE
11,690 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO;  (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Lubricating body orifices.  Recall # Z-2013-2011
CODE
Units: 31-702: 18040107, 18125741, 18150322, 18368014, 18605067, 18605067, 19032694, 19032694, 19136741, 19557491, 20023453, 20102637, 20190729, 20190729, 20023453, 20190729, 20510139, 20023453, 20190729, 21049840, 21049840, 21517201, 21780683, 21780683, 21517201, 21780683, 22025604, 22147169, 21517201, 21517201, 22269799, 22952133, 23474014, 23474014, 23474014, 24194532, 24194532, 24406620, 17950117, 19136741, 21517201, 21780683, 22147169, 22025604, 22595121, 23918771, 24406620, 20190729, 18040107, 18605067, 19032694, 19136741, 20190729, 18150322, 19032694, 20102637, 20190729, 20190729, 21517201, 22269799, 22269799, 24406620, 24406620, 17296856, 17950117, 18368014, 18368014, 18368014, 18605067, 19557491, 19557491, 20510139, 20634166, 21168988, 22952133, 22595121, 22898042, 22952133, 22269799, 24194532, 24194532, 24406620, 19557491, 19032694, 19032694, 20023453, 20023453, 20190729, 20510139, 20634166, 21517201, 21517201, 21517201, 22898042, 21517201, 23918771, 18040107, 18605067, 20023453, 20634166, 21049840, 21168988, 21517201, 22595121, 17950117, 17296856, 19136741, 19032694, 20190729, 20190729, 20190729, 20190729, 20190729, 20023453, 20634166, 21517201, 22025604, 21517201, 21517201, 23918771, 17950117, 18040107, 18368014, 18605067, 18605067, 19032694, 19218034, 19136741, 19557491, 20190729, 20190729, 20190729, 20510139, 21049840, 21049840, 21517201, 21780683, 22025604, 21517201, 21517201, 21517201, 21517201, 22952133, 22595121, 21517201, 23918771, 23474014, 24194532, 23474014, 24892314, 24194532, 22025604, 18040107, 18125741, 18368014, 18605067, 19032694, 19136741, 19218034, 20023453, 20102637, 20190729, 20190729, 20510139, 20634166, 21168988, 21517201, 21588464, 21517201, 20634166, 21517201, 21780683, 22025604, 22595121, 21517201, 22269799, 23474014, 24194532, 24194532, 20023453, 20190729, 20634166, 22595121, 22898042, 21517201, 23474014, 24641355 31-704: 17407430, 18395135, 18605075, 18605075, 19476391, 19476391, 19557520, 20510155, 20914037, 21049866, 21238801, 1397561, 21588481, 21746987, 22269810, 23474022, 23474022, 23750736, 23750736, 24406638, 24406638, 24406638, 17407430, 17407430, 17407430, 17950133, 18234024, 18395143, 18368031, 18368031, 18368031, 18605075, 18962021, 18962021, 18605075, 18962021, 18605075, 18962021, 18605075, 19089121, 19089121, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 19557520, 19792802, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20510155, 20656576, 20914037, 21049866, 20656576, 21049866, 21049866, 21238801, 21238801, 21397561, 21588481, 21588481, 21588481, 21746987, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22758218, 22269810, 23192682, 23192682, 23474022, 23474022, 23750736, 23474022, 23750736, 24175892, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 17950133, 18234024, 18368031, 18368031, 18368031, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 19476391, 19792802, 19557520, 19557520, 20510155, 20656576, 20656576, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21588481, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22758218, 22269810, 23474022, 23750736, 23750736, 23750736, 24175892, 23750736, 24175892, 24175892, 24175892, 24175892, 24406638, 24175892, 24175892, 24406638, 24406638, 24764187, 22269810, 18962021, 17407430, 18234024, 18234024, 18368031, 18395135, 18605075, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 17407430, 18234024, 19089121, 18605075, 19476391, 20510155, 20656576, 21397561, 21588481, 21588481, 21746987, 22531646, 22758218, 22269810, 22269810, 23192682, 23474022, 23192682, 23474022, 24406638, 24764187, 18605075, 19089121, 19476391, 19557520, 19792802, 20510155, 20914037, 21049866, 21049866, 21049866, 21238801, 23750736, 24406638, 24406638, 24406638, 23192682, 18962021, 21049866, 21588481, 23750736, 17407430, 17950133, 18234024, 18234024, 20510155, 21049866, 21238801, 21746987, 22037111, 20914037, 18605075, 23474022, 22758218, 17407430, 17407430, 17407430, 17950133, 17950133, 18234024, 18368031, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 18962021, 18605075, 18962021, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 20510155, 20510155, 19557520, 20510155, 20656576, 20656576, 20914037, 20914037, 20656576, 20656576, 21049866, 21049866, 21506318, 21746987, 21746987, 22037111, 22037111, 22269810, 22758218, 22758218, 22758218, 22269810, 22269810, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23474022, 23474022, 23474022, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 24406638, 21397561, 22269810, 23474022, 23750736, 24175892, 24764187, 19792802, 17407430, 17950133, 18234024, 18395143, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19792802, 19557520, 19557520, 19792802, 20510155, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20656576, 21238801, 21506318, 21397561, 21397561, 21588481, 21397561, 22037111, 22531646, 22531646, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23474022, 23750736, 23750736, 24175892, 24175892, 23750736, 24406638, 24406638, 24406638, 24406638, 24764187, 23192682, 17407430, 18605075, 18605075, 18605075, 19476391, 19476391, 20510155, 20914037, 21506318, 21588481, 22037111, 22758218, 22269810, 23474022, 23750736, 24175892, 24764187, 17950133, 18234024, 18368031, 18234024, 18605075, 19089121, 19089121, 18605075, 19476391, 1792802, 19557520, 20510155, 20510155, 20510155, 20914037, 21238801, 21238801, 21506318, 21397561, 21588481, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22758218, 22269810, 22758218, 22269810, 22531646, 23192682, 23192682, 23750736, 23750736, 24175892, 24175892, 24764187, 18605075, 17950133, 17950133, 18395143, 18368031, 18962021, 18605075, 19089121, 18605075, 19476391, 18605075, 19557520, 19557520, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21588481, 21746987, 22269810, 22531646, 22758218, 22269810, 23192682, 23474022, 23750736, 24406638, 24406638, 24406638, 24764187, 19476391, 21049866, 22037111, 17950133, 18395143, 18368031, 18605075, 17950133, 18368031, 18605075, 19089121, 19476391, 19557520, 20510155, 20656576, 21238801, 21397561, 21588481, 21746987, 22037111, 22758218, 22758218, 23192682, 23750736, 24175892, 24406638, 18605075, 20510155, 20510155, 20656576, 21049866, 21049866, 21746987, 21746987, 22269810, 23192682, 23192682, 24406638, 17950133, 18368031, 18605075, 19792802, 20510155, 20914037, 21049866, 21397561, 21588481, 21588481, 21588481, 22269810, 23192682, 23192682, 23192682, 23474022, 23750736, 24175892, 24175892, 24406638, 24764187, 24764187, 18234024, 18234024, 18234024, 18234024, 18962021, 19089121, 19476391, 19476391, 19557520, 19557520, 20510155, 20510155, 20510155, 22758218, 23750736, 19476391, 19089121, 19476391, 19089121, 19476391, 20510155, 20510155, 20656576, 21238801, 18605075, 22531646, 22758218, 20656576, 22037111, 17407430, 17950133, 18395143, 18234024, 18368031, 18368031, 18605075, 18605075, 18605075, 18605075, 18605075, 18962021, 19089121, 18962021, 18605075, 18605075, 19476391, 19476391, 19089121, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20510155, 20914037, 20914037, 18234024, 20656576, 20914037, 21049866, 21049866, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21397561, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23750736, 23750736, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24406638, 24764187, 17407430, 23192682, 23474022, 24175892, 24175892, 21397561, 21588481, 21746987, 22037111, 22037111, 22269810, 22269810, 22269810, 22531646, 22269810, 23474022, 24406638, 24764187, 24406638, 24764187, 17407430, 18234024, 18368031, 18395135, 18395135, 18605075, 18605075, 18962021, 18962021, 18962021, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21506318, 17950133, 17950133, 17950133, 18234024, 18368031, 18605075, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20656576, 20914037, 20914037, 24406638, 24764187, 18962021, 19476391, 19792802, 19792802, 20510155, 20656576, 21588481, 21746987, 22037111, 22531646, 23192682, 23474022, 23750736, 18234024, 19476391, 21238801, 22037111, 23192682, 24175892, 21397561, 21746987, 22531646, 22269810, 23474022, 24175892, 21049866 31-938: 18368057, 17070224, 17407448, 17407448, 18368057, 20656584, 21588499, 22147193, 20510180, 21747007, 24194559, 18500214, 20656584, 22269836, 23750744, 21747007, 24046927, 24194559, 24406646, 20069646, 21672797, 21672797, 18368057, 24406646, 17407448, 17407448, 18368057, 18500214, 18500214, 18500214, 19089148, 19089148, 19089148, 19089148, 19089148, 18500214, 20069646, 19940879, 20069646, 20510180, 20656584, 20656584, 20656584, 20069646, 20510180, 21672797, 21747007, 21747007, 21907509, 22147193, 22269836, 21907509, 22269836, 22853565, 21747007, 21907509, 23382419, 23750744, 24046927, 24194559, 24406646, 24194559, 17407448, 18500214, 18500214, 19089148, 20069646, 19940879, 20656584, 21672797, 22269836, 23750744, 19089148, 20656584, and 22269836
RECALLING FIRM/MANUFACTURER
Recalling Firm: DeRoyal Processing Center, New Tazewell, TN, by letter dated March 18, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI, Firm initiated recall is ongoing.
REASON
Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
323,400 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 02H30-01; b) Refurbished list number: 02H030-03. Recall # Z-2014-2011;
 
2) CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a)List Number 02H31-01; b) Refurbished list number: 02H31-03. Recall # Z-2015-2011;
 
3) CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 91350-01; b) Refurbished list number: 91350-03. Recall # Z-2016-2011;
 
4) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories; a) List Number 04H59-01; b) Refurbished list number: 04H59-03. Recall # Z-2017-2011;
 
5) CELL-DYN Shear Valve Assembly used on CELL-DYN 3200SL Analyzer and CELL-DYN 3200SL Analyzer (refurb). Designed for in vitro diagnostic use in clinical laboratories. a) List Number 04H60-01; b) Refurbished list number: 04H60-03. Recall # Z-2018-2011;
 
6) CELL-DYN Shear Valve Assembly used on CELL-DYN Ruby Analyzer. List Number 08H67-01. Recall # Z-2019-2011;
 
7) CELL-DYN Sheer Valve Assembly Driver. a) List Number 8921204902, Pallet ID 48312339; Date Code 08-Feb-2011 Pallet ID 95795162. List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet 81-GKZ. Recall # Z-2020-2011
CODE
1) a) lot number 20071AN; b) Lot numbers 20478AN96, 20390AN96, and 20421AN96;
 
2) a) Lot numbers: 23444AK, 23445AK, 23446AK, 23448AK to 23456AK, 23461AK, 20576AK, 21408AK, 21426AK, 21515AK, 21651AK, 21694AK, 271726AK, 21955AK, 22145AK, 22229AK, 22458AK, 22732AK, 22760AK, 23198AK, 23209AK, 23210AK, 23236AK, 22881AK, 19966AK, 20880AK, 20924AK, 21051AK, 21522AK, and 22650AK; b) number: 02H31-03; lot numbers: 20074AK96, 20334AK96, 20416AK96, 20751AK96, 20985AK96, 21167AK96, 21368AK96, 21610AK96, 21753AK96, 21842AK96, 21885AK96, 21934AK96, 22142AK96. 22340AK96, 22346AK96, 22380AK96, 22501AK96, 23056AK96, 23145AK96, 23457AK96, 23458AK96, 23459AK96, 23460AK96, and 23462AK96;
 
3) a) Lot numbers: 31222P, 32091P; b) Lot number: 32159P96;
 
4) a) Lot number: 30406AH; b) Lot numbers: 30687AH96, 30688AH96, 30689AH96, 30690AH96, and 30448AH96;
 
5) a) Lot numbers: 61401AF, 61686AF, 61705AF, 62201AF, 62634AF, and 62469AF; b) Lot numbers: 62418AF96, and 60311AF96;
 
6) Lot numbers: 35678BG, 35682BG to 35759BG, 35761BG to 35768BG, 35771BG, 34163BG, 34283BG, 34090BG, and 34862BG;
 
7) Date Code 20-Jan-2011; Date Code 08-Feb-2011; Date Code 13-Dec-2010; Date Code 15-Dec-2010; Date Code 16-Dec-2010; Date Code 18-Jan-2011; and Date Code 20-Jan-2011
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, byletters on March 15, 2011. Firm initiated recall is ongoing.
REASON
The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
VOLUME OF PRODUCT IN COMMERCE
170 instruments, FRU's
DISTRIBUTION
AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile
___________________________________
PRODUCT
Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation. Recall # Z-2067-2011
CODE
Lots Y703 through Y707 and Y709 though Y726 Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015
RECALLING FIRM/MANUFACTURER
Therakos Inc., Raritan, NJ, by letter dated February 1, 2011. Firm initiated recall is ongoing.
REASON
Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125).
VOLUME OF PRODUCT IN COMMERCE
4,323 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ACUSON S2000 ultrasound system. Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications. Model Number 10041461-ACUSON S2000. Recall # Z-2051-2011
CODE
Serial numbers to follow.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on March 15, 2011. Firm initiated recall is ongoing.
REASON
The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report.
VOLUME OF PRODUCT IN COMMERCE
1,533 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer. The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer. Recall # Z-2062-2011
CODE
Serial Numbers: 02KHRT, 02L66Z, 02LJ0G, 02LJKW, 02R6K9, 02R8HK, 02R8JJ, 02RB69, 02RBRM, 02RBVK, 02RDQJ, 02RDTX, 02RPDG, 02RPT9, 02X3KY, 02X3RG, 02X3WD, 02X3WD, 02X434, 02X43J, 02X43Y, 02X4JH, 02XDNH, 02XF24, 02XF6J, 02XJXG, 02XK9H, 02XKBF, 02XKCH, 02XKCQ, 02XKCQ, 02XKCY, 02XL54, 02XRN8, 02XT0Z, 02XTHZ, 034JBN, 034K6R, 034KC0, 034L0J, 034L34, 034L4W, 034L5X, 034LDN, 034V9K, 034VL2, 034VMJ, 034VP2, 034VTC, 034VZ0, 034W05, 034W20, 0353HK, 039VGF, 039VPZ, 039VWY, 039VZL, 039W1G, 039W66, 039W86, 039W9X, 039WB4, 039WB8, 039WBY, 039WX8, 039WY1, 039WY2, 039X41, 039X49, 039X99, 039XC1, 039XHG, 039XHG, 03B48J, 03B49T, 03B4GG, 03B4H4, 03B4HC, 03B4JQ, 03B4QR, 03B4V6, 03B4ZX, 03B51R, 03B521, 03B524, 03B566, 03B57R, 03B597, 03B8QB, 03B8RR, 03B8TX, 03B8TZ, 03B8V3, 03B8X1, 03B8X6, 03B8ZY, 03B905, 03B906, 03B90L, 03B912, 03B92H, 03B92H, B008YN, B008YY, B00905, B00919, B009BW, B009FG, B009FY, B009JX, B009MY, B009VM, B009ZW, B009ZW, B00D88, B00DBN, B00DF1, B00DL4, B00DLC, B00DQG, B00DR7, B00DXP, B00DZX, B00F05, B00F11, B00F14, B00F20, B00F3C, B00F5M, B00F5V, B00F61, B00F7J, B00F89, B00HRV, B00J3X, B00J73, B00JCD, B00JG5, B00JK0, B00JKG, B00JMC, B00P7K, B00P7R, B00P9C, B00PB0, B00PDV, B00PFB, B00PGV, B00PKG, B00PM0, B00PMP, B00PPW, B00PQ5, B00PT5, and B00PW4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems Nederlands, Best, Netherlands, by letter on March 28, 2011.
Manufacturer: Philips Medical Systems North America Co. Phillips, Bothell, WA. Firm initiated recall is ongoing.
REASON
Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.
VOLUME OF PRODUCT IN COMMERCE
155 units total (76 units distributed in US and 79 units distributed to foreign consignees)
DISTRIBUTION
AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MN, MS, NC, ND, NH, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea Rep, Netherlands, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, and United Kingdom
___________________________________
PRODUCT
Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and InterX Personal Sport packaged with Triad alcohol wipes. The alcohol wipes manufactured by the Triad Group were labeled under brand names Triad, Select, Select Medical Products, PSS Select or PSS World Medical Inc. Alcohol wipe is provided as a cleaning convenience for device electrodes. Recall # Z-2105-2011
CODE
All lots of the alcohol wipes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Neuro Resource Group Inc., Plano, TX, by press release on February 7, 2011 and by e-mail on March 2, 2011.
Manufacturer: H & P Industries, Inc., Hartland, WI. Firm initiated recall is ongoing.
REASON
Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
VOLUME OF PRODUCT IN COMMERCE
57,252 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps. Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008. Recall # Z-2386-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Medela Inc., McHenry, IL, by letter dated April 4, 2011. FDA initiated recall is ongoing.
REASON
The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled.
VOLUME OF PRODUCT IN COMMERCE
17,681 units alone, 461,142 units with product
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Xpert Infinity Software, V 4.1a. System software for GeneXpert Infinity 48. Recall # Z-2401-2011
CODE
V 4.1a
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letter dated April 13, 2011. Firm initiated recall is ongoing.
REASON
A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia ___________________________________
PRODUCT
XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Recall # Z-2408-2011
CODE
XiO Release 1.0.2 and above
RECALLING FIRM/MANUFACTURER
Computerized Medical Systems Inc., Maryland Heights, MO, by letters beginning September 2010.  Firm initiated recall is ongoing.
REASON
XiO Software is not transferring the correct information regarding coordinates for the radiation beam. The coordinates may not be accurate. If all the information is transferred at once, the information appears to be correct. If something is changed, edited, or the information is transmitted in parts, the coordinate information may not be accurate. Two patients were mistreated.
VOLUME OF PRODUCT IN COMMERCE
1,377 units
DISTRIBUTION
Nationwide, and Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, .Netherlands, New Zealand, Nicaragua, North Korea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, Venezuela, Yemen, and Zimbabwe
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Drainage Bag, Model 600D, 600 mL, Single use, Ethylene Oxide sterilized. The Biliary Drainage Bag is used to aid with fluid drainage involving abscess, biliary and nephrostomy. Mechanical failure of this device would result in patient discomfort. This device is not life sustaining no life supporting. The medical device is not intended to be implanted. This medical device has surface contact with the patient. Improper use of this device could cause fluid back-up and result in invasive contact through the catheter. The drainage bag will be used in conjunction with a nephrostomy/biliary drainage catheter. Recall # Z-2405-2011
CODE
Lot numbers: 082943, 083375, 083302, 083232 and 100904
RECALLING FIRM/MANUFACTURER
Remington Medical Inc., Alpharetta, GA, by letter dated January 12, 2011. Firm initiated recall is ongoing.
REASON
There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
VOLUME OF PRODUCT IN COMMERCE
89,294 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Jones Natural Chews Pig Ears Dog Chews; the pig ears were packaged under the following labels and configurations: a) Jones Natural Chews label i) item #00104: 2 pack bag with header card, UPC 7 41956 00104 7, and Pig Outs 2 pk,12 bags per case, UPC 7 41956 00104 4; ii) bulk 100 count box, UPC 7 41956 00113 9; iii) bulk 50 count box, UPC 7 41956 00150 4; iv) bulk 25 count box, UPC 7 41956 00146 7; v) item #00114: 1 pack shrink wrap, UPC 7 41956 00114 6, and Pig Ears 100 per case, UPC 7 41956 00114 3; vi) item # 00140, 10 pack printed bag, UPC 7 41956 00140 5, 12 per case, UPC 7 41956 10140 2, and Mills Pig Ears 10 Pk, 12 per case UPC 7 41956 00140 5; b) Country Butcher Dog Chews label i) item # 00151, 1 pk shrink wrap, 50 per case, UPC 7 41956 00151 1; ii) item # 00114, 1 pk shrink wrap, 30 per case, UPC 7 41956 00114 6; iii) item # 00124, 12 pk bag, 12 bags per case, UPC 7 41956 00124 5; c) Blain's Farm & Fleet Pig Ears label, 10 pack bag, UPC 7 41956 00140 5, 12 bags per case, UPC 7 41956 00140 2. Recall # V-150-2011
CODE
Lots 2420, 2490, 2560, 2630, 2700, 2840, 2910 and 2980
RECALLING FIRM/MANUFACTURER
Jones Natural Chews, Inc., Rockford, IL, by press release on March 8, 2011. Washington initiated recall is ongoing.
REASON
The pig ear dog chews were found to be contaminated with Salmonella bacteria.
VOLUME OF PRODUCT IN COMMERCE
2,705 boxes
DISTRIBUTION
CT, IA, IL, MA, ME, MN, MO, MT, NJ, NM, NY, NC, PA, VA, WA, WI
___________________________________
PRODUCT
1) Iams Proactive Health Filets with Chicken in Gravy, Filets, 3 oz, UPC, 19014024933, Brand Code, 84831291, P&G Formula Code, 674; 5.5 oz, UPC, 19014025978, Brand Code, 84831450, P&G Formula Code, 674. Recall # V-151-2011;
 
2) Iams Proactive Health Filets with Salmon in Sauce, Filets, 3 oz, UPC, 19014024926, Brand Code, 84831301, P&G Formula Code, 676; 5.5 oz, UPC, 19014025947, Brand Code, 84831336, P&G Formula Code, 676. Recall # V-152-2011;
 
3) Iams Proactive Health Filets with Skipjack Tuna in Sauce, Filets, 3 oz, UPC, 19014024919, Brand Code, 84831297, P&G Formula Code, 675; 5.5 oz, UPC, 19014025954, Brand Code, 84831447, P&G Formula Code, 675. Recall # V-153-2011;
 
4) Iams Proactive Health Pate with Chicken & Liver, Pate, 3 oz, UPC, 19014025022, Brand Code, 84831070, P&G Formula Code, 667. Recall # V-154-2011;
 
5) Iams Proactive Health Pate with Country Style Turkey & Giblets , Pate, 3 oz, UPC, 19014296538, Brand Code, 84831333, P&G Formula Code, 664; 5.5 oz, UPC, 19014025084, Brand Code, 84831448, P&G Formula Code, 664. Recall # V-155-2011;
 
6) Iams Proactive Health Pate with Gourmet Chicken, Pate, 3 oz, UPC, 19014296330, Brand Code, 84831320, P&G Formula Code, 661;5.5 oz, UPC, 19014025053, Brand Code, 84831319, P&G Formula Code, 661; Iams Proactive Health Pate with Gourmet Chicken (Kitten), Pate, 3 oz, UPC, 019014 297337, Brand Code, 84831058, P&G Formula Code, 665. Recall # V-156-2011;
 
7) Iams Proactive Health Pate with Lamb & Rice, Pate, 3 oz, UPC, 19014296736, Brand Code, 84831075, P&G Formula Code, 662; 5.5 oz, UPC, 19014025060, Brand Code, 84831332, P&G Formula Code, 662. Recall # V-157-2011;
 
8) Diagnostic testing indicated that the product may contain insufficient levels of thiamine (Vitamin B1), which is essential for cats. Cats that were fed these canned products as their only food are at greater risk for developing signs of thiamine deficiency. Recall # V-158-2011;
 
9) Iams Proactive Health Pate with Seafood Sampler, Pate, 3 oz, UPC, 19014025015, Brand Code, 84831065, P&G Formula Code, 666. Recall # V-159-2011;
 
10) Iams Proactive Health Pate with Select Oceanfish, Pate, 3 oz, UPC, 19014296132, Brand Code, 84831329, P&G Formula Code, 663; 5.5 oz, UPC, 19014025077, Brand Code, 84831337, P&G Formula Code, 663. Recall # V-160-2011;
 
11) Iams Proactive Health Pate with Tender Beef, Pate, 3 oz, UPC, 19014296231, Brand Code, 84831304, P&G Formula Code, 660; 5.5 oz, UPC, 19014025046, Brand Code, 84831338, P&G Formula Code, 660. Recall # V-161-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH, by letters on June 9, 2011.
Manufacturer: Simmons Pet Food, Inc., Siloam Springs, AZ. Firm initiated recall is ongoing.
REASON
Diagnostic testing indicated that the product may contain insufficient levels of thiamine (Vitamin B1), which is essential for cats. Cats that were fed these canned products as their only food are at greater risk for developing signs of thiamine deficiency.
VOLUME OF PRODUCT IN COMMERCE
980,277 cases
DISTRIBUTION
AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and Canada
 
END OF ENFORCEMENT REPORT FOR JUNE 8, 2011
 
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