• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for March 17, 2010

March 17, 2010                                                                                        10-10

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
1) Corrado's -- Roasted - Salted Mixed Nuts -- Net Wt. 14 oz. (397g) --- UPC  021005008792. Recall # F-0979-2010;

2) Corrado's --- Shelled Pistachios Roasted - Salted -- Net Wt. 10 oz. (284g). UPC 021005010894. Recall # F-0980-2010;

3) Corrado's --- Shelled Pistachios Roasted - Unsalted -- Net Wt. 10 oz. (284g) -- UPC  021005010900. Recall # F-0981-2010;

4) Setton Farms -- Certified Delicious -- Dark Chocolate Pistachios -- Net Wt: 12 oz. (340g) -- UPC 034325028609. Recall # F-0982-2010;

5) Setton Farms -- Kosher For Passover -- Dark Chocolate Pistachios. Available in 12 oz. (340g) packages, UPC 034325076723; and 15 lb. bulk cases. Recall # F-0983-2010;

6) Setton Farms -- Super Fancy -- Roasted - Salted Mixed Nut. Available in a 16 oz. (454g) package, UPC 034325009233; and a 9 oz. (255g) package, UPC 034325009172. Recall # F-0984-2010;

7) Setton Farms -- Super Fancy -- Roasted - Unsalted Mixed Nuts. Available in a 16 oz. (454g) package, UPC 034325009240; and a 9 oz. (255g) package, UPC 034325009202. Recall # F-0985-2010;

8) Setton Farms -- Roasted - Salted Mixed Nuts. Available in 16 oz. (454g) package, UPC 034325078628; and 20 lb. bulk case. Recall # F-0986-2010;

9) Setton Farms -- Shelled -- Roasted - Salted Pistachios. Available in a 9 oz. (255g) package, UPC 034325036055; 10 oz. (284g) package - UPC 034325010994. Recall # F-0987-2010;

10) Setton Farms -- Dark Chocolate Pistachios -- Net Wt. 15 lbs. Recall # F-0988-2010;

11) Setton Farms -- Roasted - Unsalted Mixed Nuts -- Net Wt. 20 lbs. -- Recall # F-0989-2010;

12) Setton Farms -- Roasted - Salted Mixed Nuts -- With Peanuts -- Net Wt. 20 lbs. Recall # F-0990-2010
CODE
1) Lot code T139773; Exp. Dates 11/19/09 thru 11/20/09. NOTE: Lot code is not on retail packaging;

2) Lot code OR39843; Exp. Dates 1/21/10 thru 1/29/10. NOTE: Lot code is not on retail packaging;

3) Lot code OR39843; Exp. Dates 1/21/10 thru 1/29/10. NOTE: Lot code is not on retail packaging;

4) Lot codes OR39778 thru OR39870, & T239785; Exp. Dates 11/25/09 thru 2/24/10. NOTE: Lot code is not on retail packaging;

5) Lot codes T139847 thru T239891; Exp. Dates 1/2/10 thru 3/18/10. NOTE: Lot code is not on retail packaging. Lot codes PA39847 thru PA39892;

6) Lot codes OR39756 thru OR39766, & T139800; Exp. Dates 10/8/09 thru 12/17/09. NOTE: Lot code is not on retail packaging; Lot codes T139773 & T239806; Exp. Dates 11/21/09 thru 12/24/09. NOTE: Lot code is not on retail packaging;

7) Lot codes T139777 thru T239804 & SA39764; Exp. Dates 11/12/09 thru 12/22/09. NOTE: Lot code is not on retail packaging. Lot codes T139786 & T139806; Exp. Dates 12/04/09 thru 12/24/09. NOTE: Lot code is not on retail packaging.

8) Lot codes T339758 & T239771; Exp. Dates 11/3/09 thru 11/19/09. NOTE: Lot code is not on retail packaging. Lot codes BK39757 thru BK39809;

9) Lot codes OR39766 thru OR39840, & T339857, & T239872; Exp. Dates 11/3/09 thru 2/26/10. NOTE: Lot code is not on retail packaging. Lot codes T139794 & T139874; Exp. Dates 12/11/09 thru 2/23/10. NOTE: Lot code is not on retail packaging;

10) Lot codes PA39768 thru PA39841;

11) Lot codes BK39763 thru BK39812;

12) Lot codes BK39755 thru BK39772
RECALLING FIRM/MANUFACTURER
Recalling Firm: Setton International Foods, Inc., Commack, NY, by fax, e-mail and press release on April 3, 2009.
Manufacturer: Setton Pistachio Co., Inc., Terra Bella, CA. FDA initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Canada, Panama

___________________________________
PRODUCT
1) ZonePerfect Chocolate Peanut Butter All Natural Nutrition Bar 0.72 oz (20.5g) bars and 1.76 oz (50 g) packaged in a metalized plastic wrap. Recall # F-1352-2010;

2) ZonePerfect Peanut Toffee All Natural Nutrition Bar 1.76 oz (50 g) packaged in a metalized plastic wrap. Single Unit UPC 638102589118. Stock # 58509; Stock # 58912.  Recall # F-1353-2010;

3) Pediasure NutriPals Peanut Butter Chocolate Balanced Nutrition Bar 0.78 oz (22 g) packaged in a metalized plastic wrap. Single Unit UPC 070074533940. Stock # 53392.
Recall # F-1354-2010;

4) ZonePerfect Chocolate Caramel Cluster bars: 0.72 oz (20.5g) bars and 1.76 oz (50 g) bars packaged in a metalized plastic wrap. Recall # F-1355-2010;

5) Champions Chocolate Peanut Butter bars: 1.41 oz (40 g) bars packaged in a metalized plastic wrap.  Recall # F-1356-2010;

6) Glucerna Chocolate Peanut bars: 2.04 oz (58 g) bars and 0.70 oz (20g) bars packaged in a metalized plastic wrap. Recall # F-1357-2010;
CODE
1) Stock # 50395, Lot # 60653B800, 60653B810, 60653B820, 60653B830, 60700B800, 61700B810, 61700B811, 61700B812, 61758B800, 61758B801, 61778B800, 61778B801, 61778B810, 61778B811, 61778B812, 61778B813, 62806B800, 62806B801, 62806B810, 62806B811, 62806B820, 62825B800, 62825B810, 62825B811, 62825B820, 63848B800, 63848B810, 63848B820, 63874B800, 63874B800, 63874B810, 63874B820, 64920B800, 64920B801, 64920B810, 64959B800, 64959B810, 64959B820, 64959B830, 64959B840, 64959B850, 65019B800, 65019B810, 65065B800, 65065B801, 65065B810, 65065B811, 65065B820, 65065B830, 66113B800, 66113B810, 66113B811, 66113B812, 66113B820, 66127B800, 66127B801, 66127B810, 66127B820, 67149B800, 67149B810, 67149B811, 67149B820, 67149B830, 67209B800, 67209B801, 67209B802, 67209B803, 67209B810, 67209B811, 67209B812, 67209B820, 67209B830, 68251B800, 68251B810, 69332B800, 69332B810, 69332B820, 69332B830, 69332B840, 69332B850, 69339B800, 69339B810, 69339B820, 69339B830, 69339B840, 70421B800, 70421B810, 70421B820, 71434B800, 71434B810, 72584B800, 72584B810, 72584B830, 72584B830, 72584B840, 72584B840, 72584B840, 72584B840, 72584B840, 72584B840, 72584B850, 73588B800, 73588B810, & 73588B820; Stock # 53251, Lot # 61680B800, 61695B800, 66042B800, 66042B810, & 66043B800; Stock # 53308, Lot # 63071LM00, 68104LM00, & 72117LM00; Stock # 53330, Lot # 65973B800, 68219B800, 70338B800, 70355B800, 70382B800, 71413B800, & 72500B800; Stock # 53449, Lot # 62824B800, 62824B801, 62824B810, 62824B820, 63866B800, 63866B801, 63866B810, 63866B820, 63866B821, 63872B821, 64905B800, 64905B810, 65039B800, 65039B801, 65039B802, 65039B810, 65039B820, 65039B821, 65039B830, 6126B800, 66126B801, 66126B810, 66126B811, 66126B820, 67184B800, 67184B810, 67184B811, 67184B820, 67184B830, 68225B800, 68225B810, 68237B800, 68237B810, 68237B811, 69291B800, 69291B801, 69291B810, 69291B811, 69291B820, 69291B830, 70372B800, 70372B801, 70372B802, 70372B810, 70372B820, & 70372B830; Stock # 53776, Lot # 72473B800; Stock # 57975, Lot # 60584B800, 60588B800, 60589B800, 60607B800, 60612B800, 61678B800, 61697B800, 62748B800, 62749B800, 62809B800, 62810B800, 62811B800, 63879B800, 63879B810, 64929B800, 65715RV00, 65718RV00, 65962B800, 65962B810, 65981B800, 65981B810, 66723RV00, 66724RV00, 66729RV00, 66730RV00, 67745RV00, 67746RV00, 68752RV00, 68763RV00, 68764RV00, 69307B800, 69307B810, 70356B800, 70357B800, 71414B800, 71415B800, 71443B800, 72498B800, 72499B800, 72555B800, & 73575B800; Stock # 57977, Lot # 60555B800; Stock # 58086, Lot # 60829RL00, 61029W700, 61865RL00, 63050W700, 63061W700, 63066W700, 64078W700, 65089W700, 66105W700, 68156W700, 69168W700, 70196W700, & 72215W700; Stock # 58106, Lot # 60830RL00,, 61039W700, 61858RL00, 63074W700, 68159W700, & 72220W700; Stock # 58132, Lot # 60834RL00, 61026W700, 61859RL00, 61866RL00, 61868RL00, 63055W700, 63055W701, 63067W700, 63072W700, 63075W700, 65094W700, 65095W700, 65098W700, 66117W700, 67129W700, 68151W700, 71214W700, & 73003W700; Stock # 58134, Lot # 61042W700, 66116W700, 67133W700, 69177W700, & 73005W700; Stock # 58171, Lot # 60575B800, 60576B800, 60680RV00, 61682RV00, 61753B800, 62696RV01, 62764B800, 66116B800, 66729RV01, 66730RV01, 67129B800, 67151B800, 67156B800, 67745RV01, 67746RV01, 68751RV01, 68752RV01, 69296B800, 69296B810, 70308B800, 70309B800, 71412B800, 71452B800, 72501B800, 72501B800, 72557B800, 73556B800, 73556B800, 73591B800, & 73592B800; Stock # 58596, Lot # 60573B800, 60631B800, 61742B800, 62813B800, 65012B800, 65887B800, 66022B800, 66022B810, 66102B800, 66731RV00, 68759RV00, 70310B800, & 71458B800; Stock # 59345, Lot # 62044W700, 63073W700, 67132W700, 67136W700, 68153W700, 71212W700, & 72221W700; Stock # 59690, Lot # 66085B800, 66110B800, 68199B800, & 73576B800; Stock # 59766, Lot # 60652B821, 60652B830, 60652B831, 60698B800, 60698B810, 60698B814, 60698B820, 60698B821, 60698B830, 60698B832, 60698B833, 60698B840, 60698B850, 61702B800, 61702B810, 61702B811, 61702B820, 61702B830, 61705B800, 61705B801, 61705B802, 61705B810, 61705B811, 61705B820, 61705B830, 61739B800, 61739B810, 61739B811, 61739B820, 61739B821, 61739B830, 61757B800, 61757B801, 61757B810, 61757B820, 61757B821, 61757B830, 62693RV00, 62781B811, 62781B820, 62800B800, 62800B801, 62800B810, 62800B811, 62800B820, 62800B830, 63898B800, 63898B801, 63898B810, 63898B820, 63898B830, 63898B831, 63898B840, 63904B800, 63904B801, 64946B800, 64946B810, 64946B820, 64946B821, 64946B830, 64946B831, 64946B840, 64972B800, 64972B810, 65020B800, 65020B801, 65020B810, 65020B820, 65020B830, 65020B840, 65020B841, 65067B800, 65067B810, 65719RV00, 65983B822, 65983B830, 65983B840, 66080B800, 66080B810, 66080B811, 66080B812, 66080B820, 66080B821, 66080B830, 66114B800, 66114B801, 66114B810, 66114B811, 66114B820, 66114B821, 66114B830, 66114B840, 66114B850, 66148B800, 66148B801, 66148B810, 66148B820, 66148B821, 66148B822, 66726RV00, 67169B800, 67169B801, 67169B802, 67169B803, 67169B804, 67169B810, 67169B820, 67169B821, 67169B830, 67185B800, 67185B810, 67210B800, 67210B810, 67210B811, 68226B800, 68226B810, 68226B811, 68226B812, 68226B820, 68226B830, 68252B800, 68252B810, 68252B811, 68252B820, 68277B800, 68277B801, 68277B810, 68277B811, 68277B820, 68277B830, 68277B840, 68753RV00, 68765RV00, 69330B800, 69330B810, 69330B820, 69330B830, 69330B831, 70340B800, 70373B800, 70373B810, 70399B800, 70399B810, 70399B820, 70399B830, 70399B840, 70399B850, 71431B800, 71431B810, 71431B820, 71431B830, 71431B840, 71462B800, 71462B810, 71462B820, 71462B830, 71462B840, 71482B800, 71482B810, 71482B820, 71482B830, 71482B840, 71482B850, 71482B860, 71482B870, 72510B800, 72510B810, 72532B810, 72532B820, 72532B830, 72532B840, 72532B850, 72532B860, 72532B870, 72565B800, 72565B810, 72565B820, 72565B830, 72565B840, 72567B800, 72567B810, 72567B820, 72584B820, 73585B800, 73585B810, 73585B820, 73585B830, 73585B840, 73589B800, 73589B810, 73589B810, 73589B820, 73589B830, 73589B840, 73589B840, 73589B850, 73625B800, 73625B810, 73625B810, 73625B820, 73625B830, 73625B840, 73625B850, 73625B860, 73625B870, 73625B880, 73625B890, & 73625B891; Stock # 59795, Lot # 63851B800, 64947B800, 65021B800, 65985B800, 69292B800, 70393B800, & 71432B800; Stock # 59864, Lot # 61743B800; Stock # 5817178, Lot # 63832B800, 63833B800, 63859B800, 63859B810, 63859B820, 64891B800, 64891B810, 64922B800, 65963B800, 65982B800, 65986B800, & 66098B800;

2) Lot # 61684B800, 65961B800, 66142B800, & 69284B800; Lot # 63856B800, 65960B800, 66073B800, 68203B800, 69285B800, & 70365B800;

3) Lot # 67088B800, 67088B810, 68246B800, 69265B800, & 69337B800;

4) Lot codes: #61778B814, #72502B800, 60578B800, 60586B800, 61674B800, 62765800, 6385B800, 63858B810, 64908B800, 64908B810, 64930B800, 66045B800, 66047B800, 66048B800, 66048B810, 68202B800, 68215B800, 69255B800, 69255B810, 70313B800, 70313B810, 71417B800, 71454B800, 71454B810, 72511B800, 73594B800, 73594B810, 73634B800, 60552B800, 60552B810, 60585B800, 60672B800, 61670B800, 61671B800, 61752B800, 62788B800, 66097B800, 67130B800, 69201B800, 69201B810, 69239B800, 69293B800, 70360B800, 70379B800, 71425B800, 72477B800, 72477B810, 72516B800, 72516B810, 73558B800, 73593B800, 73645B800, 73650B800, 63841B800, 63842B800, 64890B800, 64890B810, 64890B820, 64931B800, 65979B800, 65979B810, 66059B800, 62782B800, 67119B800, 70370B800, 60614B800, 61726B800, 65011B800, 69240B800, 70311B800, 70400B800, 72517B800, 73628B800, 62812B800, 63886B800, 66026B800, 67175B800, 65990B800, 65991B800, 65992B800, 66096B800, 69200B800, 70380B800;

5) Lot #s 60599B800, 63835B800;

6) Lot #s 60450S00, 61452PS00, 61453PS00, 61456PS00, 6145PS00, 6240PS00, 62473PS00, 62480PS00, 62484PS00, 63489PS00, 63492PS00, 63493PS00, 67091LM00, 62823B800, 62823B810, 67168B800, 71428B800, 60639B800, 60640B800, 61645B800, 61648B800, 62780B800, 62799B800, 6384B800, 64901B800, 64902B800, 64919B800, 64944B800, 65004B800, 65953B800, 65953B810, 66064B800, 67155B800, 67165B800, 67165B810, 67166B800, 67182B800, 70396B800, 71429B800, 71429B810, 71480B800, 72488B800, 72562b800, 73623B800, 736B810, 61650B800, 66084B800, 69323B800, 60638B800, 60642B800, 60643B800, 61649B800, 61777B800, 6279B800, 62798B800, 63870B800, 63870B810, 63882B800, 64899B800, 64900B800, 64040B800, 64948B800, 64949B800, 65003B800, 65037B800, 65038B800, 65954B800, 95854B810, 65955B800, 65955B810, 66060B800, 66082B800, 66083B800, 66124B800, 66125B800, 6716B800, 6718B800, 67206B800, 6823B800, 68233B800, 6827B800, 68274B810, 68275B800, 68275B810, 69290B800, 69323B810, 69331B800, 70361B800, 70397B800, 70398B800, 70404B800, 71426B800, 71427B800, 71481B800, 72489B800, 72490B800, 72560B800, 72561B800, 72582B800, 72583B800, 74686B800, 74687b800
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Columbus, OH, by press release on January 19, 2009 and by letter on January 21, 2009.
Manufacturer: Ross Products Division, Abbott Laboratories, Fairfield, CA. Firm initiated recall is ongoing.
REASON
The product is being recalled because it was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
552,757 cases
DISTRIBUTION
Nationwide, Mexico, New Zealand, Singapore and Italy
___________________________________
PRODUCT
Rico Queso", duro blanco (white hard cheese), 16 ounce, clear plastic package. Imported from Hunduras; Due to the distributor's coding procedure, we have no way of determining specific lots of product that may be affected. Recall # F-1372-2010
CODE
All lots and all codes
RECALLING FIRM/MANUFACTURER
Alimeno Llc, West Palm Beach, FL, by telephone on December 21, 2009 and by press release and visit on December 23, 2009. Firm initiated recall is complete.
REASON
"Rico Queso", duro blando (White hard Cheese), may have become contaminated with salmonella and E. coli bacteria.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
FL
___________________________________
PRODUCT
Artisana Organic Raw Tahini; sold in bulk 17 lb white plastic pails, 8 lb. plastic pails, and 16 oz. jars. Recall # F-1373-2010
CODE
Lot # 90708
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Premier Organics – Oakland, Oakland, CA, by telephone on August 7, 2009.
Manufacturer: Premier Organics – Oakland, Oakland, CA. Firm initiated recall is complete.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
42/17 lb pails
DISTRIBUTION
CA, TX, WA, OR

___________________________________
PRODUCT
1) Case label reads in part: "Queen Victoria... SPINACH...IPPOLITO INTERNATIONAL". Twist ties around bunches of spinach read: "SPINACH 4090 Queen Victoria PRODUCE OF USA 0 33383 65200 9". The product is tied in bunches of 12 or 24 per case. Recall # F-1374-2010;

2) Case label reads in part: "Tubby Fresh Vegetables". Twist ties around bunches of spinach read: "SPINACH PRODUCE OF USA 4090, UPC number 0 33383 65200 9". The product is tied in bunches of 12 or 24 per case. Recall # F-1375-2010
CODE
1) Recalled product cartons have an orange sticker applied to the outer side of the carton. The sticker has one of 3 harvest identification numbers: 105 22441 5 205, 105 22451 5 205 or 105 22461 5 205. Twist ties around bunches of spinach are identified with PLU number 4090;

2) Recalled product cartons have an orange sticker applied to the outer side of the carton. The sticker has harvest identification number: 105 22451 5 205. Twist ties around bunches of spinach are identified with PLU number 4090.
RECALLING FIRM/MANUFACTURER
Ippolito International, Salinas, CA, by press release and letters on September 18, 2009. Firm initiated recall is ongoing.
REASON
Spinach collected by the Michigan Department of Agriculture under the USDA Microbiological Data Program (MDP) tested positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,645 cases contain 24 bunches of spinach; 70 cases contain 12 bunches of spinach
DISTRIBUTION
AL, AZ, CA, FL, GA, IL, IN, KY, MI, MN, NJ, NY, British Columbia, Ontario and Manitoba, Canada
___________________________________
PRODUCT
Brooklyn's BEST brand Smoked Salmon, Sliced Smoked Nova Salmon. The Smoked Nova Salmon was vacuum-packed in clear, plastic bags of various size packages including 3 oz., 4 oz., 8 oz., 12 oz., 16 oz. and random weight sides. The product was also air-packed in bulk boxes. Air-packed product has a 7-10 day shelf-life. Vacuum-packed products have a 30 day shelf-life. Recall # F-1376-2010
CODE
Vacuum-packed "Use-By" dates: 12/03/09 through 12/19/09; Air-packed lot numbers: 060 through 043 (060, 059, 058, 057, 056, 053, 052, 051, 050, 049, 047, 046, 045, 044, 043)
RECALLING FIRM/MANUFACTURER
Service Smoked Fish Corp., Brooklyn, NY, by press release and letter dated November 19, 2009. Firm initiated recall is complete.
REASON
The smoked salmon has the potential to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Air packed: approx. 10,220 lbs distributed, Vacuum-packed: approx. 2918 lbs
DISTRIBUTION
NY, NJ, CT, MD, CA, OR
___________________________________
PRODUCT
Specialty Commodities, Indian Hulled sesame Seeds, mechanically dried, in brown paper 50 lb bags. Recall # F-1377-2010
CODE
C#34626 (Specialty Commodities' lot #'s: 27631, SD22607, AD42390 & AD43053)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by telephone beginning January 20, 2010 and by letter on February 12, 2010.
Manufacturer: Shri Chakra Udyog Pvt Ltd., Mumbai, India. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
819 – 50 lb. bags (total of 40,800 lbs)
DISTRIBUTION
AZ, CA, FL, HI, NY, WA
___________________________________
PRODUCT
1) Red Darla Cheese, in 3/4 lb. wheel, packed in waxy paper, labeled Estrella Family Creamery Red Darla. Recall # F-1378-2010;

2) Dominoes Cheese, 1 lb. natural rind wheel with label stating Dominoes Estrella Family Creamery. Recall # F-1379-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Estrella Family Creamery, Montesano, WA, by telephone and/or e-mail beginning February 10, 2010, and by press release, telephone and/or e-mail on February 11, 2010 and February 15, 2010. Firm initiated recall is complete.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
WA, OR, CA, NJ
___________________________________
PRODUCT
Turkey Hill Chocolate Marshmallow Premium Ice Cream in 1.5 qt (48 oz) containers. Recall # F-1380-2010
CODE
01/18/2011 56/L1 with four digit number indicating production time between 02:25 and 02:35
RECALLING FIRM/MANUFACTURER
Turkey Hill Dairy, Inc., Conestoga, PA, by telephone on February 5, 2010 and by press release. Firm initiated recall is complete.
REASON
Product contains undeclared almonds.
VOLUME OF PRODUCT IN COMMERCE
150 containers
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Snacks on Racks Garlic Club Mix, packaged in 3.0 oz. clear plastic clamshell containers. Recall # F-1381-2010;

2) Snacks on Racks Spicy Club Mix, net weight not declared, packaged in clear plastic clamshell containers. The product was also labeled under the Wolfgang Puck label, net wt. 3.0 oz. Recall # F-1382-201;

3) Snacks on Racks Peanut Caramel Clusters, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1383-2010;

4) Snacks on Racks Chewy Sprees, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1385-2010;
CODE
None
RECALLING FIRM/MANUFACTURER
Snacks on Racks, Inc., Parkville, MO, by visit on November 11, 2009, by press release, telephone and e-mailed letter on November 17, 2009 and by 2-mail on November 19, 2009. Firm initiated recall is ongoing.
REASON
Some of the repackaged products contain undeclared allergens, have FALCPA violations and/or NLEA violations. Undeclared soy and wheat, no firm name.
VOLUME OF PRODUCT IN COMMERCE
804 3 oz. clamshell containers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Snacks on Racks Sesame Sensation, packaged in 3.0-oz. clear plastic clamshell containers. Recall # F-1384-2010;

2) Snacks on Racks Select Peanut Mix, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1386-2010;

3) Snacks on Racks Energy Mix, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1387-2010;

4) Snacks on Racks Pea-Nut Colada Mix, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1388-2010;

5) Snacks on Racks Dark Chocolate Maltballs, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1389-2010;

6) Snacks on Racks Chocolate Bridge Mix, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1390-2010;

7) Snacks on Racks Cinnaberry Breakfast Blend, packaged in 3.0-oz. clear plastic clamshell containers. Recall # F-1391-2010;

8) Snacks on Racks Caramel Apple Pie Mix, packaged in 4-oz. clear plastic clamshell containers. Recall # F-1392-2010;

9) Snacks on Racks Honey Cheddar Mix, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1393-2010;
10) Snacks on Racks Holiday Pretzel Balls, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1394-2010;

11) Snacks on Racks Autumn Mellocreme Mix, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1395-2010;

12) Snacks on Racks Confetti Trail Mix, packaged in 4.0-oz. clear plastic clamshell containers. The product was also labeled under the Wolfgang Puck label, no net weight declared. Recall # F-1396-2010;

13) Snacks on Racks Sugar Free Chocolate Peanuts, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1397-2010;

14) Snacks on Racks Chocolate Coffee Beans, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1398-2010;

15) Snacks and Racks No Sugar Added Chocolate Peanuts, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1399-2010;

16) Snacks on Racks Dark Chocolate Coffee Beans, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1400-2010;

17) Snacks on Racks Chocolate Almonds, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1401-2010;

18) Snacks on Racks Sour Patch Kids, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1402-2010;

19) Snacks on Racks Gummi Bears, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1403-2010;

20) Snacks on Racks Gummi Peach O's, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1404-2010;

21) Snacks on Racks Gummi Sour Worms, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1405-2010;

22) Snacks on Racks Gummi Worms, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1406-2010;

23) Snacks on Racks Gummi Apple O's, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1407-2010;

24) Snacks on Racks Super Sour Bears, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1417-2010;

25) Snacks on Racks Butter Toffee Mixed Nuts, packaged in 4.0-oz. clear plastic clamshell containers. The product was also packaged under the Wolfgang Puck label, net wt. 4.0 oz. Recall # F-1418-2010;

26) Snacks on Racks Boston Baked Beans, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1425-2010;

27) Snacks on Racks Lemon Drops, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1426-2010;  

28) Snacks on Racks Mike & Ike, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1427-2010;

29) Snacks on Racks Milk Chocolate Peanut Clusters, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1428-2010;

30) Snacks on Racks Milk Chocolate Pretzels, packaged in 2.5-oz. clear plastic clamshell containers. Recall # F-1429-2010;

31) Snacks on Racks Autumn Peanut Mix, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1441-2010;
CODE
None
RECALLING FIRM/MANUFACTURER
Snacks on Racks, Inc., Parkville, MO, by visit on November 11, 2009, by press release, telephone and e-mailed letter on November 17, 2009 and by 2-mail on November 19, 2009. Firm initiated recall is ongoing.
REASON
Some of the repackaged products contain undeclared allergens, have FALCPA violations and/or NLEA violations. Undeclared soy and wheat, no firm name.
VOLUME OF PRODUCT IN COMMERCE
8.051 clamshell containers
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) Tuna salad sandwich packaged in plastic open-faced containers. The label reads Grandma’s Tuna Sandwich. Recall # F-1452-2010;

2) Chicken salad sandwich packaged in plastic open-faced containers. The label reads Grandma’s Chicken Sandwich. Recall # F-1453-2010
CODE
Date: January 29, 2010
RECALLING FIRM/MANUFACTURER
Dolce LLC, Louisville, KY, by telephone on January 27, 2010. Firm initiated recall is ongoing.
REASON
Failure to declare allergens. Sandwiches contain wheat, which is not listed on the finished product label.
VOLUME OF PRODUCT IN COMMERCE
1) 12 sandwiches; 2) 9 sandwiches
DISTRIBUTION
KY
___________________________________
PRODUCT
Yogurt coated raisins, packaged in a 12 oz. clear plastic bag, Albanese Gold Label Creamy Yogurt Raisins, UPC 3441872087. Recall # F-1454-2010
CODE
Lot # 9261
RECALLING FIRM/MANUFACTURER
Albanese Confectionery Group, Inc., Merrillville, IN, by letters dated February 15, 2010 and telephone by February 28, 2010. Firm initiated recall is ongoing.
REASON
Product label fails to declare milk as the source ingredient for yogurt.
VOLUME OF PRODUCT IN COMMERCE
84 bags 12 oz per bag
DISTRIBUTION
IN, IL
___________________________________
PRODUCT
Winter Gardens Naturally Fresh Foods Red Beet Eggs. The product is packaged in a) 6 count - Item number #0200, and b) 12 count - Item number #0212, plastic containers. Recall # F-1455-2010
CODE
a) Lot numbers: 318-3 exp 2/12/10, 320-13 exp 2/12/10, 323-13 exp 2/12/10, 325-13 exp 2/12/10, 326-13 exp 2/12/10, 327-13 exp 2/12/10, 359-3 exp 2/19/10, 341-3 exp 2/19/10, 360-3 exp 2/26/10, 361-3 exp 2/26/10, 366-16 exp 2/26/10, 376-5 exp 2/26/10, 377-9 exp 2/26/10, 388-11 exp 2/26/10, 389-16 exp 2/26/10, 394-17 exp 2/26/10, 431-34 exp 3/5/10, and 433-28 exp 3/5/10; b) Lot numbers: 275-16 exp 2/5/10, 284-16 exp 2/5/10, 285-13 exp 2/5/10, 287-13 exp 2/5/10, 293-13 exp 2/5/10, 294-13 exp 2/5/10, 295-13 exp 2/5/10, 296-13 exp 2/5/10, 336-13 exp 2/12/10, 337-13 exp 2/12/10, 338-13 exp 2/12/10, 339-13 exp 2/12/10, 341-3 exp 2/19/10, 342-13 exp 2/12/10, 345-13 exp 2/12/10, 346-13 exp 2/12/10, 348-16 exp 2/12/10, 349-16 exp 2/19/10, 352-16 exp 2/19/10, 354-16 exp 2/19/10, 355-3 exp 2/19/10, 380-9 exp 2/26/10, 381-9 exp 2/26/10, 382-10 exp 2/26/10, 383-10 exp 2/26/10, 385-10 exp 2/26/10, 395-17 exp 2/26/10, 396-17 exp 2/26/10, 402-18 exp 2/26/10, 409-19 exp 2/26/10, 416-15 exp 3/5/10, 412-15 exp 3/5/10, 414-15 exp 3/5/10, 423-32 exp 3/5/10, 424-32 exp 3/5/10, 425-32 exp 3/5/10, 426-33 exp 3/5/10, and 416-15 exp 3/5/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Winter Gardens Quality Foods, Inc., New Oxford, PA, by fax and e-mail on January 27, 2010.
Manufacturer: Lehman’s Egg Service, Inc., Chambersburg, PA. Firm initiated recall is complete.
REASON
Labels do not state keep refrigerated.
VOLUME OF PRODUCT IN COMMERCE
2,338 containers
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Sauerkraut and Mushroom pierogi frozen in 16 oz. bag, SM 10M02, UPC 3523690103. Recall # F-1456-2010;

2) Farmer cheese and potato pierogi frozen in 16 oz. bag, FP 10E05, UPC 3523690105. Recall # F-1457-2010;

3) Mushrooms pierogi frozen in 16 oz. bag, MR 9M52, UPC 3523690104. Recall # F-1458-2010;

4) Potato pierogi frozen in 16 oz. bag, PT 10A06, UPC 3523690111. Recall # F-1459-2010;

5) Sour cherry pierogi froze in 16 oz. bag, SC 9M49, UPC 3523690115. Recall # F-1460-2010;

6) Sauerkraut pierogi froze in 16 oz. bag, SK 10D05, UPC 3523690102. Recall # F-1461-2010;

7) Plum pierogi froze in 16 oz. bag, PL 9M36, UPC 3523690108. Recall # F-1462-2010;

8) Cottage cheese pierogi frozen in 16 oz. bag, CC 10M03, UPC 3523690114. Recall # F-1463-2010;

9) Farmer cheese pierogi frozen in 16 oz. bag, FC 10B05, UPC 3523690112. Recall # F-1464-2010;

10) Blueberry pierogi, frozen in 16 oz. bag, BB 9M49, UPC 3523690107. Recall # F-1465-2010;

11) Placki Ziermniaczane Potato Pancakes, frozen in 16 oz. bag, PP 9D43, UPC 3523690130. Recall # F-1466-2010
CODE
No codes
RECALLING FIRM/MANUFACTURER
Polish Harvest Food Products, Inc., Hamtramck, MI, by letters via e-mail and fax beginning January 20, 2010. Firm initiated recall is complete.
REASON
Product contains wheat which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
16,000
DISTRIBUTION
MI, IL

___________________________________
PRODUCT
1) All Star Dairies brand Fudge Nut Sundae Cone, Vanilla Flavored Ice Cream, 3 fl oz. The product is packed in a brown box with brown tape. The product name and expiration date is printed on the tape. Recall # F1473-2010;

2) MR. Big brand Reduced Fat Vanilla Ice Cream Cone (40% Less Fat Than Our Regular Ice Cream), 3 fl oz (88mL). The product is packed in a brown box with brown tape. The product name and the expiration date are printed on the tape. Recall # F-1474-2010;

3) Mr. Big brand Reduced Fat Chocolate Ice Cream Cone (40% Less Fat Than Our Regular Ice Cream), 3 fl oz (88mL). The product is packed in a brown box with brown tape. The product name and the expiration date are printed on the tape. Recall # F-1475-2010
CODE
1) Expiration Dates 11/9/10 and 12/17/10;
2) Expiration Date 12/7/10;
3) Expiration Date 12/17/10;
RECALLING FIRM/MANUFACTURER
Washburns Dairy, Inc., Gloversville, NY, by letters dated January 29, 2010. Firm initiated recall is ongoing.
REASON
The ice cream products contain undeclared wheat. This was discovered during an FDA inspection.
VOLUME OF PRODUCT IN COMMERCE
4,537 boxes
DISTRIBUTION
NY, NJ, PA, MA
___________________________________
PRODUCT
1) Just Be Natural Whey Superior Protein Plus Strawberry Banana in 2.2 lb containers. Recall # F-1476-2010;

2) Just Be Natural Whey Superior Protein Plus Strawberry in 2.2 lb containers. Recall # F-1477-2010;

3) Just Be Natural Whey Superior Protein Plus French Vanilla in 2.2 lb containers. Recall # F-1478-2010;

4) Just Be Natural Whey Superior Protein Plus Tropical Vanilla in 2.2 lb containers. Recall # F-1479-2010;

5) Just Be Natural Whey Superior Protein Plus Oatmeal Cookie in 2.2 lb containers. Recall # F-1480-2010;

6) Just Be Natural Whey Superior Protein Plus Chocolate in 2.2 lb containers. Recall # F-1481-2010;

7) Just Be Natural Whey Superior Protein Plus Chocolate Mocha in 2.2 lb containers. Recall # F-1482-2010;

8) Just Be Natural Whey Superior Protein Plus Caribbean Cooler in 2.2 lb containers. Recall # F-1483-2010;

9) Just Be Natural Whey Superior Protein Plus Caramel in 2.2 lb containers. Recall # F-1484-2010;

10) Just Be Natural Whey Superior Protein Plus Unflavored in 2.2 lb containers. Recall # F-1485-2010
CODE
1) Codes 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

2) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

3) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

4) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

5) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

6) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

7) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

8) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

9) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12;

10) Codes: 1061009 - 06-10-11, 2061009-06-10-11, 3061009-06-10-11, 4061009-06-10-11, 5071009-09-15-11, 6071009-09-15-11, 7071009-09-15-11, 8071009-09-15-11, and 9071009-01-08-12
RECALLING FIRM/MANUFACTURER
Nutrition Resource Services, Inc., Bethlehem, PA, by e-mail beginning February 1, 2010. Firm initiated recall is ongoing.
REASON
The product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
500 containers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Snacks on Racks Nature's Harvest, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1408-2010;  

2) Snacks on Racks Chocolate Raisins, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1409-2010;

3) Snacks on Racks Roasted Almonds, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1410-2010;

4) Snacks on Racks Roasted Salted Almonds, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1411-2010;

5) Snacks on Racks Honey Roasted Peanuts, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1412-2010;

6) Snacks on Racks Sunflower Seeds, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1413-2010;

7) Snacks on Racks Virginia Roasted Salted Peanuts, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1414-2010;

8) Snacks on Racks Sour Patch Cherries, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1415-2010;

9) Snacks on Racks Sour Patch Watermelon, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1416-2010;

10) Snacks on Racks Orange Slices, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1419-2010;  

11) Snacks on Racks Mini Swedish Fish, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1420-2010;

12) Snacks on Racks Assorted Mini Swedish Fish, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1421-2010;

13) Snacks on Racks Asst. Sour Balls, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1422-2010;

14) Snacks on Racks Cherry Sour Balls, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1423-2010;

15) Snacks on Racks Cinnamon Bears, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1424-2010;

16) Snacks on Racks Yogurt Almonds, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1430-2010;

17) Snacks on Racks Yogurt Pretzels, packaged in 2.5-oz. clear plastic clamshell containers. Recall # F-1431-2010;

18) Snacks on Racks Yogurt Raisins, packaged in 5.0-oz. clear plastic clamshells. Recall # F-1432-2010;

19) Snacks on Racks Chocolate Malt Balls, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1433-2010;

20) Snacks on Racks Chocolate Banana Chips, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1434-2010;

21) Snacks on Racks Hot Tamales, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1435-2010;

22) Snacks on Racks Nik Nak Mix, net weight not declared, packaged in clear plastic clamshell containers. Recall # F-1436-2010;

23) Snacks on Racks Salted Cashews, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1437-2010;

24) Snacks on Racks Soy Energy Mix, packaged in 2.5-oz. clear plastic clamshell containers. Recall # F-1438-2010;

25) Snacks on Racks Lemonheads, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1439-2010;

26) Snacks on Racks Double Dipped Peanuts, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1440-2010;

27) Snacks on Racks Grape Sour Balls, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1442-2010;

28) Snacks on Racks Strawberry Field Trail Mix, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1443-2010;  

29) Snacks on Racks Candy Corn, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1444-2010;  

30) Snacks on Racks Holiday Sour Balls, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1445-2010;

31) Snacks on Racks Select Mixed Nuts, packaged in 4.0-oz. clear plastic clamshell containers. The product was also labeled under the Wolfgang Puck label, no net weight declared. Recall # F-1446-2010;

32) Snacks on Racks Orange Cranberry Trail Mix, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1447-2010;

33) Snacks on Racks Gummi Strawberries, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1448-2010;

34) Snacks on Racks Butter Toffee Pecans, packaged in 4.0-oz. clear plastic clamshell containers. Recall # F-1449-2010;

35) Snacks on Racks Yogurt Cranberries, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1450-2010;

36) Snacks on Racks Juju Pumpkins, packaged in 5.0-oz. clear plastic clamshell containers. Recall # F-1451-2010;
CODE
None
RECALLING FIRM/MANUFACTURER
Snacks on Racks, Inc., Parkville, MO, by visit on November 11, 2009, by press release, telephone and e-mailed letter on November 17, 2009 and by 2-mail on November 19, 2009. Firm initiated recall is ongoing.
REASON
Some of the repackaged products contain undeclared allergens, have FALCPA violations and/or NLEA violations. Undeclared soy and wheat, no firm name.
VOLUME OF PRODUCT IN COMMERCE
10,008 clamshell containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Smoke and Fire Sauce (LMC09-0450) packed in 5 gallon (18.9L) white pails. The recalled product is intended for beef injection into finished meat products. Recall # F-1470-2010
CODE
Lot #09246
RECALLING FIRM/MANUFACTURER
JES Foods Celina, Inc., Celina, OH, by letter and e-mail on January 20, 2010. Firm initiated recall is ongoing.
REASON
Smoke flavored sauce was distributed which was found to contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
2,500 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
Imperial Sugar, Pure Cane, Specialty Granulated, Net Wt. 50 lbs (22.8 kg). Recall # F-1471-2010
CODE
C291K, C292K, C294K, C298K, C304K, C305K, C313K, C327K, C337K, and C341K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Imperial Sugar Co., Sugar Land, TX, by letters on December 23, 2009, December 24, 2009, and January 19, 2010.
Manufacturer: Imperial Sugar Co., Gramercy, LA. Firm initiated recall is ongoing.
REASON
The product may contain plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
5,900/ 50 lb bags
DISTRIBUTION
IN, TN, IA, IL

___________________________________
PRODUCT
Lil Dutch Maid cookies, Old Fashioned Ginger Snaps, Net Wt. 12 oz, 14 oz, and 16 oz brand ginger snaps, 16 oz package. Recall # F-1472-2010
CODE
12 oz - Lot number 061510; 14 oz - Lot numbers 060310, 060210, and 061610; 16 oz - Lot numbers 060110, 061410, and 060210
RECALLING FIRM/MANUFACTURER
Fehr Foods, Inc., Abilene, TX, by e-mail and telephone on December 23, 2009. Firm initiated recall is complete.
REASON
Sugar on the top of ginger snaps may contain plastic pieces.
VOLUME OF PRODUCT IN COMMERCE
9,147 units
DISTRIBUTION
TN, NC
___________________________________
PRODUCT
Birds Eye McKenzie's Corn with Butter Sauce, Net Wt. 20 oz. UPC 38897-48957. Ingredients: Corn, water, contains 2% or less of high fructose corn syrup, food starch-modified, salt, butter (cream), natural and artificial flavor (including soy lecithin as a processing aid), partially hydrogenated soybean oil, annatto (color). Contains Milk and Soy. Recall $ F-1486-2010
CODE
Codes beginning with the characters 918NB
RECALLING FIRM/MANUFACTURER
Recalling Firm: Birds Eye Foods, Inc., Rochester, NY, by letter dated November 18, 2009 and updated November 19, 2009.
Manufacturer: Birds Eye Foods, Inc., Waseca, MN. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat, a food allergen.
VOLUME OF PRODUCT IN COMMERCE
147 cases (12//20 oz chub packs per case)
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Sucralfate, USP; CAS#54182-58-0, NDC: 055642-0011; Non-Sterile Bulk; Net Weight: 25 KG, Gross Weight: 27.4 KG; For Manufacturing, Processing or Repacking; Rx Only. Recall # D-354-2010 
CODE
Batch Numbers: 20041002, 20041003, 20041004, 20071001, 20071002, 20071003, 20071004, 20071005, 20071006, 20071007, 20071008, 20071009, 20071010; 20071011, 20071012, 20071013, 20071014, 20071015, 20071026, 20071027, 20081001, 20081002, 20081004, 20081005, 20081006, 20081007, 20081008, 20081009, 20081010, 20081011, 20081012, 20081013, 20081014, 20081015, 20081016, 20081017, 20081018, 20081019, 20081020, 20081021, 20081022, 20081023, 20081024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flavine North America Inc., Closter, NJ, by telephone, e-mail and letters on January 19 and 20, 2009.
Manufacturer: Nanjing Pharmaceutical Factory Co., Ltd., Nanjing, China. Firm initiated recall is ongoing.
REASON
cGMP Deviations: An FDA inspection conducted September 21-25,2009 observed numerous violations in record keeping practices that are not in accordance with the manufacturer's related SOPs and cGMP requirements, which may cause the final product to be adulterated.
VOLUME OF PRODUCT IN COMMERCE
39068.8 KG
DISTRIBUTION
FL, MN, MO, NJ, NY, PA, Croatia and Poland
___________________________________
PRODUCT
BiCNU (carmustine) for injection, 100 mg vial (NDC 0015-3012-18) and diluent, packaged in a kit (NDC 0015-3012-60), BMS Item number 301260; Rx only. Recall # D-361-2010
CODE
Lot 8K4219A, Lot 1486494B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ, by letters dated December 23, 2009. 
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Lack of assurance of sterility of one lot of carmustine during retesting after importation through the European Union, to Argentina.
VOLUME OF PRODUCT IN COMMERCE
2,570 kits in the United States; International Unknown
DISTRIBUTION
Nationwide, Argentina, Australia, Austria, Bulgaria, Canada (packaged and sent from Indiana Technical Operations), Chile, Columbia, Czech Rep, Ecuador, Finland, Hungary, Netherlands, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, United Kingdom and Venezuela
___________________________________
PRODUCT
Prednisone Tablets, USP, 1 mg, Rx Only, 100 count (NDC 51991 458 01); 1000 count (NDC 51991 458 10) plastic bottles, Recall # D-362-2010
CODE
Lot 8A064, Exp 2/10
RECALLING FIRM/MANUFACTURER
Cadista Pharmaceuticals, Inc., Salisbury, MD, by letter on December 22, 2009. Firm initiated recall is ongoing.
REASON
Pharmaceutical failed to meet specification at 18 month stability station.
VOLUME OF PRODUCT IN COMMERCE
4,668 bottles
DISTRIBUTION
FL
___________________________________
PRODUCT
Children's Nasal Decongestant Liquid (Pseudoephedrine HCl), 30 mg, 4 FL oz (118 mL), bottle; OTC; UPC Number N3 0536-1850-97 5. Recall # D-364-2010
CODE
Lots 7D04, 7H04, 8C11 and 8F04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rugby Laboratories, Inc., Duluth, GA, by letter on/about February 24, 2010. 
Manufacturer: Bio-Pharm, Inc., Levittown, PA. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or defective delivery system. The dosage cup provided with the product is not consistent with the dosing instructions.
VOLUME OF PRODUCT IN COMMERCE
35,329 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ranitidine Tablets, USP, 150 mg, 500-count bottle, Rx only, NDC 53746-253-05. Recall # D-365-2010
CODE
Lot HE14509, Exp. Date 6/2011
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Hauppauge, NY, by letters dated November 30, 2009. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient) Drug: This product is being recalled because of two reports of oversized Ranitidine Tablets. Analysis of a tablet showed 149% of label claim.
VOLUME OF PRODUCT IN COMMERCE
1965 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Our Family Ibuprofen Caplets, Ibuprofen Tablets USP (NSAID) 200 mg, 24 Caplets, 200 mg Each, NDC 70253-292-08, OTC. Item Number 1308-292-08, Product Code L-292. Recall # D-353-2010
CODE
Lots P56629 (exp. 4/30/2012), P57769 (exp. 6/30/2012), P53094 (exp. 9/30/2010), P55188 (exp. 1/31/2011), P55779 (exp. 3/31/2011), P56537 (exp. 4/30/2012), P56539 (exp. 4/30/2012), P59645 (exp. 9/30/2012) & P51376 (exp. 5/31/2010)
RECALLING FIRM/MANUFACTURER
LNK International, Inc., Hauppauge, NY, by letter dated December 31, 2009. Firm initiated recall is ongoing.
REASON
Mislabeling: the directions on the outer box are wrong and lack the word "not", thereby incorrectly reading "Do exceed 6 caplets in 24 hours unless directed by a doctor".
VOLUME OF PRODUCT IN COMMERCE
32,144 bottles
DISTRIBUTION
OH, SD
___________________________________
PRODUCT
Claravis (isotretinoin) USP, capsules, USP, 40 mg, 3 Prescription Blister Packs of 10 Capsules Each (30 capsules), Rx only; NDC 0555-1057-86. Recall # D-363-2010
CODE
Lot number 312733 exp 7/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 5, 2010.  
Manufacturer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Some capsules do not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
5,770 boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0487-10
CODE
Unit: 72H95739-X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on October 13, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0492-10
CODE
Unit: 55R75265
RECALLING FIRM/MANUFACTURER
American National Red Cross, Little Rock, AR, by telephone and electronic notification on April 25, 2008 and by facsimile on April 28, 2008.
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR 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
AR
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0493-10;
2) Fresh Frozen Plasma. Recall # B-0494-10;
3) Platelets. Recall # B-0495-10
CODE
1) Units: LV84211, LV84218, LV84219, LV84222, LV84236, LV84238;
2) Units: LV84211, LV84218, LV84236;
3) Unit: LV84236
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile or electronic notification on October 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
PA, FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0503-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0504-10;
3) Plasma Frozen. Recall # B-0505-10
CODE
1) Unit: 003KF34108;
2) and 3) Unit: 003S43365
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone, letter and electronic (LOGIC) on March 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0506-10
CODE
Units: 384070392 and 384069982
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Phenix City, AL, by fax on December 10, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0508-10
CODE
Units: 003LR99165, 003LR99172 and 003KX29116
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile on September 5, 2008 and by letter on October 14, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, which was not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0515-10
CODE
Unit: 026KJ52776
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on August 12, 2008 and by letter on August 28, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, which may have had an inadequate volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0521-10
CODE
Units: 003LF39354, 003LF39367
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by telephone on May 11, 2007 and by letter dated May 16, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Irradiated. Recall # B-0524-10
CODE
Unit: 9953890
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on March 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0525-10
CODE
Unit: 9917413
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 28, 2008. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0526-10
CODE
Unit: 5391172
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by email on April 2, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0527-10
CODE
Unit: 9896718
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter dated April 17, 2008 and by email on April 28, 2008, May 7, 12 and 14, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0531-10
CODE
Unit: 03KH40513
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red, Douglasville, GA, by telephone on January 23, 2008.
Manufacture: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Platelets. Recall # B-0532-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0533-10;
3) Plasma Frozen. Recall # B-0534-10
CODE
1), 2), and 3) Units: 028FL04785, 028FL06551 and 028FY03633
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by letter on December 5, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, MI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0581-10
CODE
Unit: W287709000318
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifesource, Glenview, IL, y telephone and fax on April 27, 2009.  
Manufacturer: Lifesource Mundelein, Mundelein, IL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with unacceptably low hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

___________________________________
PRODUCT
1) Cornea. Recall # B-0582-10;
2) Sclera. Recall # B-0583-10
CODE
1) Units: 20080297 (2); 20080423 (2); 20080457 (2); 20080517 (2); 20080549 (2); 20080553 (2); 20080601 (2); 20080805 (2); 20080835 (2); 20080899 (2); 20080921 (2); 20080925 (2);

2) Units: 20080457 (8 pieces); 20080601 (2 pieces); 20080805 (8 pieces)
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT Southwestern Medical Center, Dallas, TX, by telephone on August 19, 2008. Firm initiated recall is complete.
REASON
1) Tissue products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 corneas and 18 pieces of sclera
DISTRIBUTION
TX, Venezuela
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0584-10
CODE
Units: W087608043352; W087608043403
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by letter dated September 6. 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced, which had not undergone leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0586-10
CODE
Unit: 35V91549
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone and letter dated May 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0588-10
CODE
Unit: 27S95141
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on August 25, 2009. Firm initiated recall is complete.
REASON
Blood product, phenotypically mislabeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0590-10
CODE
Unit: 9864575
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA, by telephone on July 29, 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
LA
___________________________________
PRODUCT
Cornea. Recall # B-0596-10
CODE
Corneas: IN2007040861, IN2007040862
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by letter dated June 28, 2007. Firm initiated recall is complete.
REASON
Tissue, tested for viral markers using a sample that was possible diluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM, SC
___________________________________
PRODUCT
Cornea. Recall # B-0597-10
CODE
Corneas: 09343OSCN, 090343ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN, by e-mail on June 2, 2009. Firm initiated recall is complete.
REASON
Tissue, tested for viral markers using a sample that was possible diluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0615-10
CODE
Unit: 21KT52445
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on February 12, 2009 and February 13, 2009.
Firm initiated recall is complete.
REASON
Blood product, for which there was incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

___________________________________
PRODUCT
Red Blood Cells. Recall # B-0622-10;
Plasma Frozen. Recall # B-0623-10
CODE
1) and 2) Unit: 35FX29611
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone and letter dated April 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, D.C.
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0628-10
CODE
Unit: 53GQ50455
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone and letter dated May 2, 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
MD
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0651-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0652-10
CODE
1) Unit: W047009065340;
2) Unit: W047009054586; W047009054707; W047009065340
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY, by letter dated September 10, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0653-10
CODE
Unit: W126909242270
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter dated October 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0654-10
CODE
Unit: 2542471
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated October 16, 2009. 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
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0655-10
CODE
Unit: 2533178
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated October 16, 2009. 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
KY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0656-10
CODE
Units: W087908654400; W087909651903; W087909652963; W087909654017; W087909650769
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by fax on October 8, 2009.
Manufacturer: Community Blood Bank of Lancaster County, Lincoln, NB. 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
5 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0657-10;
2) Fresh Frozen Plasma. Recall # B-0658-10
CODE
1) and 2) Unit: W221609603461
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by telephone and fax on September 8, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0659-10
CODE
Unit: W036509108156
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on September 10, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled “leukoreduced”, but which had not undergone leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0661-10;
2) Recovered Plasma. Recall # B-0662-10
CODE
1) and 2) Units: GC48895; GC27593
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by e-mails on June 1, 2009 and June 2, 2009 and letter dated June 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in a HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0694-10
CODE
Unit: 003KY45445
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on February 18, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0702-10
CODE
Unit: NG0226370
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX, by fax on August 5, 2009 and August 6, 2009, Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received ear piercings within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
___________________________________
PRODUCT
Source Plasma. Recall # B-0704-10
CODE
Unit: WN0177327
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington, Inc., Wilmington, NC, by fax on August 19, 2009 and August 21, 2009, Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

___________________________________
PRODUCT
Source Plasma. Recall # B-0734-10
CODE
Units: HS0204796; HS0205007; HS0205666
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc., Hot Springs, AR, by fax on September 4, 2009 and September 8, 2009, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported non-sexual exposure to Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
UK
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0735-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0736-10
CODE
1) and 2) Unit: 2326023
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on September 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0738-10
CODE
Units: 0354165, 0354135, 0354138
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL, by email on June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0739-10
CODE
Units: 0569297, 0569616, 0569922
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL, by letter dated April 11, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0740-10
CODE
Unit: 0136077
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL by telephone on April 24, 2006. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0741-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0742-10
CODE
1) and 2) Unit: 1818783
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by letter dated August 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0744-10
CODE
Units: 9954025 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on November 7, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis 7-d Leukocytes Reduced. Recall # Recall # B-0745-10
CODE
Unit: 9956590 ( part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on February 2, 2008.  Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 untis
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis-7 d Leukocytes Reduced. Recall # B-0746-10
CODE
Unit: 9954034 (part 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on November 23, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis-7 d Leukocytes Reduced. Recall # B-0747-10
CODE
Units: 9955180 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on November 24, 2007. Firm initiated recall is complete. 
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis 7d Leukocytes Reduced. Recall # B-0748-10
CODE
Unit: 9912799
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on January 3, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0749-10
CODE
Units: 8994037(part 1 and 2) 1946346(part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by letter on July 21, 2005. Firm initiated recall is complete. 
REASON
Blood products, with unacceptable qc results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0750-10;
2) Cryoprecipitated AHF. Recall # B-0751-10;
3) Fresh Frozen Plasma. Recall # B-0752-10
CODE
1) Units: 3234138, 3224073;
2) Unit: 3234138;
3) Unit: 3224073
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by fax on April 21, 2008 and by letter on April 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a therapeutic donor and not labeled to indicate the type of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0754-10
CODE
Units: 18FV8399, 18GW20186, 18FV85432, 18FG30990, 18FY66419, 18GR35712, 18GR36237, 18FF24878, 18FY60491, 18FY60240, 18FG31008, 18GR35290, 18FJ95274, 18GW18849, 18GT33406, 18GF69440, 18FG30985, 18FG30053, 18FY60233, 18GR35251, 18GW19433, 18FG27582, 18GR35270, 18FY66454, 18FY60497, 18GC62586, 18GW20097, 18GR35566, 18FG29985, 18FY61277 and 18FG28705
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 15, 2008 and facsimile on November 22, 2008 and by follow-up letter dated December 12, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
AZ, MD, MI, NJ, PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0755-10
CODE
Units 18FJ93535, 18FJ93552, 18GD58657, 18GC58988, 18GR33983, 18GR32659, 18GC58751, 18GC58610, 18GW18105, 18GR38950, 18GW20234, 18FG26685, 18GW18136, 18FY66025, 18FG29271 and 18FG23249
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on November 13, 2008 and facsimile on November 21, 2008 and by follow-up letter dated December 12, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
AZ, MI, NJ, NY, PA
___________________________________
PRODUCT
Source Plasma. Recall # B-0756-10
CODE
Units: 08BINA6632, 08BINA6272, 08BINA5693, 08BINA5363, 08BINA2801, 08BINA2194, 08BINA1611, 08BINA1231, 08BINA0740, 08BINA0371, 07BINE2632, 07BINE2000, 07BINE1705, 07BINE1128, 07BINE0364, 07BIND9904, 07BIND9112, 07BIND8528, 07BIND8381, 07BIND7827, 07BIND7469, 07BIND6735, 07BIND6397, 07BIND5813, 07BIND5492 and 07BIND4515
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P, Bloomington, IN, by facsimile on February 13, 2009. Firm initiated recall is complete.
REASON
Blood products, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-0760-10
CODE
Unit: 09MMTB3720
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT, by facsimile on August 4, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in deferral status, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0761-10
CODE
Unit: 003LM31567
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone and electronic (LOGIC) on October 8, 2008 and a follow-up letter on November 12, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA  
___________________________________
PRODUCT
Source Plasma. Recall # B-0764-10
CODE
Unit: LC0603366
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, via email on June 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have received a tattoo within twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0490-10
CODE
Units: 266822741 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by telephone and facsimile on April 22, 2008. 
Manufacturer: United Blood Services - Hot Springs, Hot Springs, AR. Firm initiated recall is complete.
REASON
Blood products, for which the documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0491-10;
CODE
Unit: 55R75265
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Little Rock, AR, by telephone and electronic notification on April 25, 2008 and by facsimile on April 28, 2008.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR. 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-0496-10
CODE
Units: LV84219, LV84222, LV84238
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile or electronic notification on October 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0502-10
CODE
Unit: 003KF34108
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone, letter and electronic (LOGIC) on March 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA    
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0512-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0513-10;
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0514-10
CODE
1) Unit: 003KR16641;
2) Unit: 003KY31572;
3) Unit: 003S33443 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by fax and telephone on October 6, 2005 and by  letter on October 12, 2005. Firm initiated recall is complete.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for Leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0516-10
CODE
Unit: 08FIND6543
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile on December 11, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0517-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0518-10
CODE
1) Units: 003F25635, 003F25636, 003F25639, 003F25634, 003F25637;

2) Units: 003F25634, 003F25635, 003F25636, 003F25637, 003F25638 (Parts 1 & 2), 003F25639
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone or facsimile on February 28, 2008 and by letter dated March 5, 2008. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0519-10
CODE
Units: 041GM68991 (3 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on August 7, 2007 and by letter dated August 13, 2007. Firm initiated recall is complete.
REASON
Blood products, for which a platelet count was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL, GA
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0520-10
CODE
Units: 1881980, 1881993, 1882008, 1882963, 1882980, 1886244, 1886268, 1886272, 1886274, 1886278, 1886284, 1886304, 1886349, 1886614, 1886618, 1886622, 1886629
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Army, Augusta, GA, by telephone on February 14, 2005.
Manufacturer: D. D. Eisenhower Army Med. Ctr. - Blood Bank, Fort Gordon, GA. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NJ

___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0528-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0529-10
CODE
1) and 2) Unit: 003KF33846
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone and electronic (LOGIC) on October 19, 2007 and by letter on October 26, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, GA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0535-10
CODE
Unit: 028FY00831
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by letter on December 5, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0585-10
CODE
Unit: 35V91549
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone and letter dated May 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0640-10;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0641-10
CODE
1) Units: W03940941524300, W03940941524500, W03940941524900,
2) Units: W03940941525200 (2 units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by facsimile on August 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using equipment for which the quality control testing was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0660-10
CODE
Units: 038GP42314; 038GP42324; 038GP42328; 038LJ06630; 038LJ06631 (split product)
RECALLING FIRM/MANUFACTURER
American National Red Cross – Indiana-Ohio Region, Fort Wayne, IN, by fax on July 7, 2009 and November 10, 2009. Firm initiated recall is complete.
REASON
Blood products, in transit for more than 24 hours and without continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0663-10;
2) Fresh Frozen Plasma. Recall # B-0664-10;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-0665-10;
4) Granulocytes. Recall # B-0666-10;
5) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0667-10;
6) Plasma Frozen. Recall # B-0668-10;
7) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0669-10
CODE
1) Units: 55C36777, 55C36782, 55C36785, 55C36786, 55C36788, 55C36805, 55E59641, 55E59642, 55E59648, 55E59652, 55E59657, 55E59660, 55FK60213, 55FK60215, 55FK60216, 55FK60217, 55FK60219, 55FK60222, 55FK60224, 55FK60226, 55FK60227, 55FK60228, 55FK60233, 55FK60234, 55FR67578, 55FR67579, 55FR67580, 55FR67583, 55FR67585, 55FR67592, 55FR67593, 55FR67596, 55FR67598, 55FR67604, 55FR67605, 55FR67610, 55FR67611, 55FR67614, 55FR67616, 55FR67617, 55FR67619, 55FR67620, 55FR67622, 55FR67624, 55FR67626, 55FR67627, 55FR67628, 55FR67629, 55FS35415, 55FS35417, 55FS35418, 55FS35420, 55FS35421, 55FS35426, 55FS35430, 55FS35431, 55FS35434, 55FS35438, 55FS35439, 55FS35441, 55FS35444, 55FS35446, 55FS35451, 55FS35454, 55FS35455, 55FS35457, 55FS35458, 55FS35463, 55FS35464, 55FS35465, 55FS35467, 55FS35471, 55FS35485, 55FS35487, 55H15750, 55H15751, 55H15766, 55H15769, 55H15773, 55H15774, 55H15779, 55H15780, 55H15784, 55H15787, 55H15789, 55H15794, 55H15795, 55H15797, 55H15798, 55K63476, 55K63477, 55K63479, 55K63486, 55K63488, 55K63495, 55K63496, 55K63497, 55K63498, 55K63501, 55K63502, 55K63503, 55K63504, 55K63506, 55K63507, 55K63508, 55L71155, 55L71158, 55L71161, 55L71162, 55L71164, 55L71165, 55L71169, 55L71171, 55L71174, 55R73547, 55R73548, 55R73549, 55R73550, 55S62860, 55S62862, 55S62864, 55S62865, 55S62866, 55S62869, 55S62870, 55S62873, 55S62874, 55S62875, 55S62876, 55S62878, 55S62879, 55S62884, 55S62886, 55S62887, 55S62891, 55Y36405, 55Y36406, 55Y36407, 55Y36425, 55Y36426, 55Y36427, 55Y36430, 55Y36431, 55Y36433, 55Y36435, 55Y36437, 55Y36441, 55Y36445, 55Y36447, 55Y36449, 55Y36450, 55Y36451, 55Y36453, 55Y36454, 55Y36465, 55Y36466, 55Y36468, 55Y36469, 55Y36471, 55Y36472, 55Y36477, 55Y36478, 55Y36480, 55Y36482, 55Y36483, 55Y36485, 55Y36487, 55Y36488, 55Y36491, 55Y36492, 55Y36494, 55Y36496, 55Y36498, 55Z69781;

2) Units: 55C36787, 55C36788, 55C36791, 55C36794, 55C36797, 55C36799, 55C36802, 55C36807, 55E59640, 55E59641, 55E59648, 55E59649, 55E59653, 55E59654, 55E59655, 55E59656, 55E59660, 55FK60221, 55FK60224, 55FK60233, 55FR67600, 55FR67603, 55FR67605, 55FR67614, 55FR67618, 55FR67619, 55FR67620, 55FR67622, 55FR67626, 55FR67629, 55FS35434, 55FS35455, 55FS35465, 55FS35478, 55FS35487, 55K63487, 55K63492, 55K63495, 55K63497, 55K63498, 55K63501, 55L71170, 55R73550, 55S62875, 55S62876, 55S62884, 55S62888, 55Y36458, 55Y36466, 55Y36468, 55Y36469, 55Y36475, 55Y36477, 55Y36481, 55Y36482, 55Y36483, 55Y36489, 55Y36491, 55Y36492, 55Y36498;

3) Units: 55FT09890 (Parts 1 & 2), 55FT09891 (Parts 1 & 2), 55FT09892 (Parts 1 & 2), 55FT09893 (Parts 1 & 2), 55FT09894 (Parts 1 & 2), 55P54494 (Part 1), 55P54495 (Parts 1 & 2), 55P54499 (Parts 1 & 2), 55P54500 (Parts 1 & 2), 55P54501 (Parts 1 & 2), 55P54502 (Parts 1 & 2), 55Q29248 (Parts 1, 2, & 3), 55Q29249 (Part 1), 55Q29252 (Part 1), 55Q29253 (Part 1), 55Q29254 (Part 1);

4) Unit: 55C36806;

5) Unit: 55C36808 (Part 1);

6) Units: 55FK60216, 55FR67579, 55FR67580, 55FR67592; 55H15762, 55H15768, 55H15770, 55H15780, 55K63480, 55S62863, 55Y36411, 55Y36416, 55Y36434, 55Y36444;

7) Units: 55FS35422 (Bags 1 & 2), 55FS35423 (Bags 1 & 2), 55FS35424 (Bags 1 & 2), 55FS35425 (Bag 2), 55FS35436 (Bags 1 & 2), 55FS35442 (Bags 1 & 2), 55FS35448 (Bags 1 & 2), 55Y36408 (Bags 1 & 2), 55Y36417 (Bags 1 & 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Little Rock, AR, by facsimile on November 21, 2007. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for West Nile virus (WNV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
295 units
DISTRIBUTION
AR, TN, TX, MD, MO, CA, OK

___________________________________
PRODUCT
Source Plasma. Recall # B-0690-10
CODE
Units: 377051574, 377051655, 377051658, 377051664, 377051693, 377051696, 377051703, 377051706, 377051710, 377051725, 377051746, 377051754, 377051763, 377051797, 377051798, 377051807, 377051830, 377051842, 377051843, 377051844, 377051845, 377051848, 377051849, 377051852, 377051855, 377051858, 377051863, 377051864, 377051865, 377051867, 377051895, 377051896, 377051900, 377051909, 377051911, 377051914, 377051916, 377051993, 377052034, 377052376, 377052380, 377052384, 377052386, 377052592, 377052594, 377052596, 377052603, 377052617, 377052619, 377052621, 377052625, 377052655, 377052686, 377052842, 377052857, 377052871, 377052872, 377052879, 377052887, 377052889, 377052890, 377052896, 377052898, 377052900, 377052907, 377052914, 377052927, 377052933, 377052946, 377052950, 377053016, 377053066, 377053089, 377053104, 377053113, 377053121, 377053144, 377053145, 377053150, 377053163, 377053173, 377053185, 377053187, 377053208, 377053215, 377053218, 377053225, 377053235, 377053239, 377053242, 377053245, 377053271, 377053280, 377053298, 377053326, 377053343, 377053349, 377053362, 377053420, 377053422, 377053426, 377053429, 377053452, 377053454, 377053459, 377053467, 377053470, 377053475, 377053492, 377053500, 377053518, 377053524, 377053525, 377053552, 377053563, 377053577, 377053590, 377053599, 377053623, 377053628, 377053630, 377053632, 377053644, 377053649, 377053690, 377053714, 377053716, 377063747, 377053759, 377053760, 377053766, 377053780, 377053789, 377053803, 377053806, 377053863, 377053878, 377053923, 377053938, 377053957, 377053958, 377053962, 377053968, 377053973, 377054632, 377054642, 377054648, 377054665, 377054669, 377054672, 377054677, 377054690, 377054696, 377054697, 377054704, 377054713, 377054723, 377054742, 377054743, 377054768, 377054773, 377054776, 377054780, 377054781, 377054783, 377054784, 377054814, 377054816, 377054829, 377054839, 377054847, 377054849, 377054878, 377054888, 377054898, 377054901, 377054909, 377054914, 377054919, 377054937, 377054952, 377054954, 377054955, 377054957, 377054960, 377054981, 377054983, 377054987, 377054994, 377054997, 377055003, 377055019, 377055045, 377055273, 377055288, 377055290, 377055305, 377055310, 377055318, 377055331, 377055339, 377055355, 377055356, 377055360, 377055403, 377055407, 377055408, 377055410, 377055413, 377055423, 377055427, 377055436, 377055443, 377055457, 377055460, 377055461, 377055477, 377055497, 377056237, 377056276, 377056288, 377056295, 377056305, 377056318, 377056359, 377056372, 377506405, 377056424, 377056431, 377056440, 377056441, 377056445, 377056489, 377056497, 377056501, 377056507, 377056518, 377056525, 377056527, 377056541, 377056547, 377056612, 377056613, 377056616, 377056625, 377056631, 377056632, 377056641, 377056642, 377056645, 377056678, 377056750, 377056762, 377056787, 377056834, 377057006, 377057002, 377057022, 377057028, 377057034, 377057048, 377057050, 377057056, 377057060, 377057067, 377057075, 377057086, 377057089, 377057287, 377057290, 377057327, 377057345, 377057349, 377057366, 377057372, 377057386, 377057397, 377057403, 377057527, 377057722, 377057744, 377057749, 377057753, 377057761, 377057773, 377057780, 377057784, 377057796, 377057812, 377057816, 377057853, 377057854, 377057864, 377057895, 377057904, 377057905, 377057911, 377057928, 377057945, 377057975, 377057992, 377058017, 377058020, 377058053, 377058070, 377058075, 377058117, 377058120, 377058123, 377058140, 377058145, 377058148, 377058161, 377058163, 377058166, 377058170, 377058175, 377058206, 377058209, 377058221, 377058233, 377058242, 377058246, 377058258, 377058417, 377058420, 377058422, 377058428, 377058438, 377058439, 377058452, 377058472, 377058475, 377058491, 377058497, 377058519, 377058524, 377058544, 377058549, 377058551, 377058553, 377058555, 377058561, 377058563, 377058572, 377058574, 377058579, 377058599, 377058615, 377058619, 377058621, 377058832, 377058872, 377058873, 377058887, 377058940, 377058952, 377058956, 377058959, 377058976, 377058981, 377058982, 377058985, 377060003, 377060011, 377060020, 377060022, 377060031, 377060045, 377060054, 377060057, 377060066, 377060069, 377060077, 377060106, 377060124, 377060127, 377060128, 377060131, 377060139, 377060140, 377060158, 377060167, 377060172, 377060180, 377060182, 377060208, 377060227, 377060240, 377060241, 377060243, 377060249, 377060255, 377060257, 377060259, 377060266, 377060283, 377060294, 377060297, 377060312, 377060313, 377060316, 377060325, 377060371, 377060437, 377060471, 377060473, 377060487, 377060490, 377060497, 377060500, 377060507, 377060513, 377060516, 377060526, 377060534, 377060544, 377060547, 377060573, 377060608, 377060613, 377060615, 377060626, 377060631, 377060635, 377060641, 377060646, 377060657, 377060666, 377060681, 377060685, 377060686, 377060726, 377061195, 377061198, 377061207, 377061209, 377061230, 377061234, 377061241, 377061245, 377061444, 377061458, 377061470, 377061475, 377061477, 377061487, 377061528, 377061529, 377061566, 377061576, 377061607, 377061608, 377061610, 377061611, 377061620, 377061622, 377061623, 377061625, 377061645, 377061651, 377061654, 377061689, 377061690, 377061707, 377061714, 377061740, 377061744, 377061764, 377061777, 377061789, 377061769, 377061805, 377061807, 377061813, 377061814, 377061823, 377061884, 377061899, 377061913, 377061916, 377061931, 377061973, 377061981, 377061984, 377062008, 377062022, 377062034, 377062039, 377062062, 377062092, 377062105, 377062110, 377062122, 377062126, 377062134, 377062140, 377062146, 377062153, 377062155, 377062162, 377062171, 377062179, 377061828, 377062180, 377062212, 377062232, 377062253, 377062261, 377062282, 377062297, 377062302, 377062303, 377062310, 377062313, 377062317, 377062328, 377062331, 377062334, 377062375, 377062379, 377062381, 377062383, 377062409, 377062420, 377062438, 377062439, 377062446, 377062492, 377062497, 377062514, 377062516, 377062521, 377062537, 377062538, 377062545, 377062554, 377062556, 377062557, 377062559, 377062567, 377062569, 377062571, 377062771, 377062787, 377062805, 377062820, 377062825, 377062826, 377062831, 377062870, 377062885, 377062984, 377062911, 377062986, 377062996, 377062997, 377063034, 377063030, 377063045, 377063047, 377063049, 377063064, 377063069, 377063071, 377063075, 377063081, 377063083, 377063088, 377063103, 377063108, 377063132, 377063134, 377063136, 377063137, 377063156, 377063158, 377063160, 377063179, 377063191, 377063206, 377063207, 377063211, 377063217, 377063220, 377063244, 377063246, 377063255, 377063256, 377063260, 377063264, 377063273, 377063278, 377063279, 377063283, 377063284, 377063286, 377063291, 377063293, 377063294, 377063300, 377063306, 377063308, 377063310, 377063315, 377063319, 377063321, 377063323, 377063329, 377063330, 377063335, 377063336, 377063337, 377063350, 377063375, 377063387, 377063404, 377063422, 377063449, 377063474, 377063479, 377063485, 377063524, 377063533, 377063541, 377063544, 377063454, 377063547, 377063550, 377063552, 377063560, 377063562, 377063567, 377063571, 377063578, 377063601, 377063620, 377063622, 377063791, 377063808, 377063812, 377063841, 377063852, 377063865, 377063867, 377063894, 377063907, 377063913, 377063937, 377063967, 377063978, 377063979, 377063986, 377063993, 377063998, 377064002, 377064006, 377064007, 377064009, 377064038, 377064041, 377064049, 377064055, 377064059, 377064080, 377064099, 377064102, 377064123, 377064132, 377064119, 377064134, 377064135, 377064136, 377064186, 377064209, 377064215, 377064217, 377064223, 377064230, 377064231, 377064234, 377064252, 377064258, 377064265, 377064276, 377064257, 377064287, 377064347, 377064350, 377064365, 377064372, 377064402, 377064421, 377064354, 377064371, 377064443, 377064758, 377064764, 377064772, 377064775, 377064782, 377064790, 377064845, 377064855, 377064891, 377064905, 377064917, 377064919, 377064928, 377064932, 377064945, 377064949, 377064952, 377064970, 377065026, 377065049, 377065053, 377065060, 377065074, 377065093, 377065150, 377065159, 377065193, 377065205, 377065209, 377065211, 377065251, 377065253, 377065260, 377065266, 377065294, 377065322, 377065323, 377065343, 377065355, 377065365, 377065366, 377065378, 377065541, 377065560, 377065578, 377065588, 377065593, 377065603, 377065615, 377065618, 377065640, 377065651, 377065655, 377065656, 377065658, 377065662, 377065667, 377065687, 377065706, 377065761, 377065786, 377065841, 377065846, 377065854, 377065863, 337065877, 377065930, 377065900, 377066586, 377066587, 377066589, 377066592, 377066784, 377066793, 377066796, 377066800, 377066813, 377066819, 377066837, 377066852, 377066859, 377066868, 377066869, 377066874, 377066878, 377066884, 377066888, 377066889, 377066890, 377066891, 377066896, 377067003, 377067018, 377067213, 377067224, 377067235, 377067241, 377067250, 377067278, 377067322, 377067362, 377067366, 377067421, 377067425, 377067504, 377067532, 377067557, 377067558, 377067562, 377067568, 377067614, 377067628, 377067633, 377067697, 377067699, 377067717, 377067720, 377067743, 377067808, 377067837, 377067839, 377067921, 377067922, 377067970, 377068002, 377068004, 377068029, 377068031, 377068036, 377068041, 377068064, 377068110, 377068113, 377068128, 377068540, 377068553, 377068560, 377068568, 377068573, 377068587, 377068623, 377068637, 377068638, 377068641, 377068676, 377068677, 377068681, 377068698, 377068713, 377068719, 377068749, 377068755, 377068764, 377068813, 377068814, 377068815, 377068877, 377068889, 377068915, 377068950, 377068954, 377068960, 377068968, 377069049, 377069212, 377069294, 377069117, 377069328, 377069580, 377069603, 377069606, 377069608, 377069789, 377069806, 377069884, 377069897, 377069916, 377069958, 377069960 and 377069967
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by letter on January 18, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
876 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Recall # B-0743-10
CODE
Unit: 5359563
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by fax on June 15, 2005. Manufacturer: The Blood Alliance, Inc., Jacksonville, FL. Firm initiated recall is complete.
REASON
Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0762-10
CODE
Unit: 003LM31567
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone and electronic (LOGIC) on October 8, 2008 and a follow-up letter on November 12, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0753-10
CODE
Unit: 4770795
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by telephone on July 15, 2007. Firm initiated recall is complete.
REASON
Blood product, found to be contaminated with Propionbacterium acnes using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. Recall # Z-0799-2010;

2) HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has a PRO card, a small electronic data card, which stores information from the nurse or doctor and automatically sets up the system for the patient. Recall # Z-0800-2010
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated January 8, 2010 and January 12, 2010.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
94,076 units
DISTRIBUTION
Nationwide, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom and Venezuela

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
i-STAT 1 Analyzer, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels. Catalog number 06F16-10. Recall # Z-0812-2010
CODE
No lot or serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Inc., Princeton, NJ, by letter during September 2009. Firm initiated recall is ongoing.
REASON
The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
VOLUME OF PRODUCT IN COMMERCE
3,918 analyzers
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker XIA 3 Polyaxial Screw, 8.5mm x 65 mm. Catalog Number: 482318565. Not Sterile; Intended for use in the non-cervical spine. Recall # Z-0823-2010
CODE
Lot number: A91109
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated January 15, 2010.
Manufacturer: Stryker Spine, Aquitane, France. Firm initiated recall is ongoing.
REASON
The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. Recall # Z-0825-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letter dated January 8, 2010. Firm initiated recall is ongoing.
REASON
There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
VOLUME OF PRODUCT IN COMMERCE
187 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; Catalog number 18181030S; Sterile, TI Alloy; Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0841-2010;

2) Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Catalog Number: 18181130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0842-2010;

3) Stryker T2 Ankle Arthrodesis Nail, left; 012 x 300 mm; Catalog number: 18181230S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0843-2010;

4) Stryker T2 Ankle Arthrodesis Nail, right; 010 x 300 mm; Catalog number: 18191030S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0844-2010;

5) Stryker T2 Ankle Arthrodesis Nail, right; 011 x 300 mm; Catalog number: 18191130S; Sterile, TI Alloy. Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0845-2010

6) Stryker T2 Ankle Arthrodesis Nail, right; 012 x 300 mm; Catalog number: 18191230S; Sterile, TI Alloy; Intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Recall # Z-0846-2010
CODE
1) Lot codes: K152966, K177319, K208221, K230272, K254574, K735537, K779942, K841062, K842726, K868798, K868816, K883947, and K892961;

2) Lot codes: K152966, K177319, K208221, K230272, K254574, K735537, K779942, K841062, K842726, K868798, K868816, K883947, and K892961;

3) Lot codes: K163646, K192333, K236971, K472870, K733121, K776754, K785625, K842732, K868822, K875207, K893039, and K977374;

4) Lot codes: K101051, K157119, K185536, K210257, K549634, K735538, K769105, K779949, K837690, K868843, and K893064;

5) Lot codes: K125357, K158792, K185537, K199852, K227392, K452805, K455652, K461353, K624000, K732800, K769107, K782950, K785627, K820525, K858019, K863219, K868858, K893086, K951620, K963944, and K983458;

6) Lot codes: K108843, K152964, K171685, K180561, K194187, K227390, K253168, K733141, K776745, K785626, K785652, K802766, K831465, K837694, K868868, and K999298
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, letters on December 29, 2009 and January 11, 2009. 
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
REASON
Stryker Orthopedics became aware that there is the potential for damage to the sterile packaging of the product during transport.
VOLUME OF PRODUCT IN COMMERCE
702 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Coulter LH SlideMaker, LH Barcode Specification, LH SM Intended Use, LH Slide and Sample Flow, Part Number 6605633, P/N 4277248, 4277299, and 277299. Intended for use as an optional peripheral to the Beckman Coulter LH 700 Series System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the LH 700 Series. Recall # Z-0850-2010;

2) GEN*S SlideMaker, Barcode Label Specifications, GEN*S SM Intended Use, GEN*S Slide and Sample, Part Numbers 6605360, P/N 4237221, 4237212, and 4277299. Intended for use as an optional peripheral to the COULTER GEN*S System. Creates a blood smear on a clean microscope slide using a segment of the blood sample aspirated by the GEN*S System. Recall # Z-0851-2010
CODE
All Software Versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated June 9, 2008.
Manufacturer: Beckman Coulter Inc., Fullerton, CA. Firm initiated recall is ongoing.
REASON
The Sample ID information embedded in the barcode affixed to a slide made by the Coulter GEN*S and LH SlideMaker does not match the text.
VOLUME OF PRODUCT IN COMMERCE
847 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Liquid HDL (PEG) Cholesterol Reagent Set. Pointe Scientific HDL Cholesterol Reagent Set; Catalog # H7511-60 and Catalog # H7511-SAM. HDL Cholesterol Reagent Set, (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum. Recall # Z-0859-2010;

2) Liquid HDL (PEG) Cholesterol Reagent; Catalog # 7-H7511-30, 8-H7511-30, 3-H-7511-L. (Clinical chemistry). For the quantitative determination of high density lipoprotein (HDL) in cholesterol in serum. Recall # Z-0860-2010
CODE
All lots containing the numbers 815701 in the lot number.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated November 10, 2009. Firm initiated recall is ongoing.
REASON
The firm initiated the recall due to the presence of visible contamination of the product.
VOLUME OF PRODUCT IN COMMERCE
616 sets plus 9 L
DISTRIBUTION
Nationwide, Bolivia, Ghana, Jamaica, Kenya, Korea, Malaysia, Mexico, Nicaragua, Nigeria, Philippines, Poland, Sri Lanka and Trinidad
___________________________________
PRODUCT
Variant II Turbo Hemoglobin A1c Program, model number 270 2417. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Recall # Z-0867-2010
CODE
Lot Number: 70291520
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by telephone and fax on October 12, 2009 and by letter dated October 13, 2009. Firm initiated recall is ongoing.
REASON
Product update kit CD rom will not upload. As a result, the device cannot be run.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
Nationwide, Hong Kong, New Zealand
___________________________________
PRODUCT
PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood. Recall # Z-0871-2010
CODE
Lot Number: C908
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN., by letter dated April 2, 2009. Firm initiated recall is ongoing.
REASON
The memory chip was coded with incorrect product information.
VOLUME OF PRODUCT IN COMMERCE
486 vials
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes. Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip. Recall # Z-0909-2010

2) Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes. Intended to be used with femoral components in primary or revision total knee arthroplasty. Recall # Z-0910-2010;

3) Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes. Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty. Recall # Z-0911-2010
CODE
1) Lot Numbers: 36481101; 36491201; 36514901; 36609101; 36517801; 36526201; 36602201; 36422401; 36631201; 36643801; 36425501; 36448901; 36647201; 36737701; 36742301; 36772901; 36775301; 36547101; 36563001; 36473901; 36738101; 36609001; 36466401; 36642601; 36481401 and 36428401;

2) Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101;

3) Lot Numbers: 35458101; 36121101; 36121401; 36209601; 36209701; 35904301; 35904501; 35904701; 36294401; 36297801; 36605701; 36297902; 36605801; 35904901; 36298101; 35905001; 36298201; 35905101; 35905301; 36295101; 35905501; 36298801; 36298902; 36299301; 35906001; 36007001; 36301001; 36007101; 36301301; 36862701; 36011001; 36606201; 36606401; 36011801; 36301501; 36012201; 36012301; 36301901; 36012901; 36302001; 36013001; 36013401; 36302101; 36302301; 36014501; 36014701A 36014801; V145; V146; V148; V161; V162; V163; V165; V166; V024C and V026C
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter dated February 17, 2007. Firm initiated recall is complete.
REASON
A potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
VOLUME OF PRODUCT IN COMMERCE
594 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Pointe Scientific Uric Acid (Liquid) Reagent Set; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only. Recall # Z-0912-2010;

2) Pointe Scientific Liquid Uric Acid (R1) Reagent Set; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only. Recall # Z-0913-2010
CODE
All lot numbers containing the numbers 918301; exp. 2011-01.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated December 1, 2009. Firm initiated recall is ongoing.
REASON
A process deviation occurred during the production of the R1 component which may affect its performance.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA, FL, KY, MI, OH, OK, VA, Chili and Malaysia
___________________________________
PRODUCT
Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems. Intended to be used with the Access Immunoassay System to remove waste from the system. Pump Part Numbers A62712, A62839, A62840, A62841, and A63124; Instrument Part Numbers: 973100, A30260, and A59102. Recall # Z-0914-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, letter dated October 16, 2008. 
Manufacturer: Beckman Coulter Inc., Fullerton, CA. Firm initiated recall is ongoing.
REASON
A new premature failure of the upper aspirate peristaltic pump in the systems listed above. Premature failure of the pump may negatively affect precision. The failure is limited to those UniCel DXI 800, DXI 600, and DxC 880i systems which have a pump identified with one of the new pump manufacturing numbers (Mfg. Nos.) listed above. The upper peristaltic pump assembly may not maintain a proper flow rate.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Sealapex Express, Part Number: 33639, root canal filling material. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points. Recall # Z-0917-2010
CODE
Lot Numbers: 6-1314, 7-1221 and 7-1258
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letter dated February 19, 2009.
Manufacturer: Sybron Dental Specialties Inc., Glendora, CA. Firm initiated recall is complete.
REASON
Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.
VOLUME OF PRODUCT IN COMMERCE
1,309
DISTRIBUTION
Nationwide, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan
___________________________________
PRODUCT
OvuChek Saliva Ovulation Disposable Test Strips; 5 disposable test strips per pouch, packaged in a box with a specimen cup and instructions for use, 12 boxes per case; a rapid colorimetric indicator for the qualitative changes (ferning) of salt content in saliva to aid in the prediction of ovulation; Manufacturer: A rapid saliva indicator for the qualitative prediction of favorable and unfavorable fertile days in women's menstrual cycles. UPC 8 50877 00055 5. Recall # Z-0968-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quest Products, Libertyville, IL, by telephone and e-mail on November 7, 2008.
Manufacturer: Integrated Biomedical Technology, Inc., Elkhart, IN.  Firm initiated recall is complete.
REASON
The ovulation test strips were shipped without 510(k) premarket notification clearance from the FDA.
VOLUME OF PRODUCT IN COMMERCE
3,930 cases
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
"K-ASSAY CRP (3) Calibrator E". This product is an IVD calibrator for use on automated clinical chemistry analyzers by laboratories. It is used for the calibration of the K-ASSAY CRP (3) immunoturbidimetric assay for quantifying C-Reactive Protein (CRP) in serum and plasma (sodium EDTA or lithium heparin) samples. It is for in vitro diagnostic use. Catalog number: "KAI-084C". Recall # Z-0973-2010
CODE
Lot # 559011
RECALLING FIRM/MANUFACTURER
Kamiya Biomedical Co., LLC, Tukwila, WA, by telephone on May 1, 2009, e-mail on May 4, 2009 and letter dated May 13, 2009. Firm initiated recall is complete.
REASON
The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
VOLUME OF PRODUCT IN COMMERCE
3 kits
DISTRIBUTION
NY, NJ, NC
___________________________________
PRODUCT
1) Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 100- and 500-ml. bottles and a 6x100-ml. bottle package. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null lymphocytes. Recall # Z-0976-2010;

2) Sigma-Aldrich Histopaque-1119, Ref. 11191, packaged in 100- ml. bottles and 6x100-ml. bottle packages. The product is for use in separating mononuclear cells and granulocytes when used with Histopaque-1077. Recall # Z-0977-2010
CODE
1) Lot numbers: 037K6141, 037K6300, 047K6015, 069K6086, 087K6015, 088K6035, and 107K6201;
2) Lot numbers: 038K6030, 126K6002, and 079K6047
RECALLING FIRM/MANUFACTURER
Sigma-Aldrich Mfg LLC, Saint Louis, MO, by letter dated December 7, 2009. Firm initiated recall is ongoing.
REASON
Instructions for Use (IFU) was revised to recommend sterile filtering of the product under certain circumstances.
VOLUME OF PRODUCT IN COMMERCE
1077 - 11,015/100-ml bottles, 5,745/6/100-ml bottle packages, and 14,872/500-ml bottles; 1119 - 8,640/100-ml bottles and 3,138/6/100-ml. bottle packages
DISTRIBUTION
Nationwide, Canada, Mexico, United Arab Emirate, Australia, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Ecuador, France, Great Britain, Hong Kong, Israel, India, Italy, Jamaica, Japan, Korea, Panama, Peru, Paraguay, Saudi Arabia, Singapore, Thailand, West Indies, Taiwan, Venezuela, and South Africa

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
Herculite Ultra (Part Number 34333), dental composite resorative material. Recall # Z-0916-2010
CODE
Lot Number: 3161098
RECALLING FIRM/MANUFACTURER
Sybron Dental Specialties, Orange, CA, by letter dated February 23, 2009. Firm initiated recall is complete.
REASON
Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.
VOLUME OF PRODUCT IN COMMERCE
442 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
___________________________________
PRODUCT
Nanjing Pharmaceutical Factory Co., Ltd; Praziquantel, NDC: 05564200312. USP; Net Weight: 25 kg; Gross Weight: 29.1 kg For further manufacturing, processing or repacking. Recall # V-045-2010
CODE
Batch numbers: 20061006, 20061007, 20061008, 20061009, 200610010, 200610011, 200610012, 200610013, 200610014, 200610015, 200810001, 200810002, 200810003, 200810004, 200810005, 200810006, 200810007, 200810008, 200810009, 200810010, 200810011, 200810012, 200810013, 200810014, 200810015, 200810016, 200810017, 200810018, 200810019, 200810020, 200820021, 200810022, 200810023, 200810024, 200810026, 200810027, 200810028, 200810029, 200810030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flavine North America Inc., Closter, NJ, by letters on January 20, 2010 and January 27, 2010, and e-mails on October 1, 2009.  
Manufacturer: Nanjing Pharmaceutical Factory Co., Ltd., Nanjing, China. Firm initiated recall is ongoing.
REASON
An FDA inspection conducted September 21-25, 2009 observed numerous violation in record keeping practices that are not in accordance with the manufacturer's factory related SOPs and cGMP requirements which may cause the final product to be considered adulterated.
VOLUME OF PRODUCT IN COMMERCE
4300 kg. 1000 kg currently being quarantined by FDA
DISTRIBUTION
MO, IA

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS III
___________________________________
PRODUCT
REN O DAIRY 2000 222ORG Mineral Supplement for Lactating Dairy Cattle in 50 lb bags. Recall # V-044-2010
CODE
Lot number: 01110H
RECALLING FIRM/MANUFACTURER
Renaissance Nutrition, Inc., Roaring Spring, PA, by telephone and e-mail on February 24, 2010.Firm initiated recall is ongoing.
REASON
Cross contaminated with drugs.
VOLUME OF PRODUCT IN COMMERCE
20 bags
DISTRIBUTION
OH

END OF ENFORCEMENT REPORT FOR MARCH 17, 2010

#