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Enforcement Report - Week of December 12, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Devices Event

Event ID	61835
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Natus Medical Incorporated
City	Seattle
State	WA
Country	US
Distribution Pattern	Worldwide distribution: USA (nationwide) including states of: AK, AR, AZ, CA, CO, DE, FL, GA, HI, ID, IL, IN, KY, MA, MI, MN, MS, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, WA, Puerto Rico, and countries of: Argentina, Australia, Austria, Bahrain, Canada, Chile, China, Colombia, Ecuador, Egypt, Germany, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Kuwait, Latvia, Malaysia, Mexico, Morocco, Panama, Puerto Rico, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.

Associated Products

Product Description	The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "*OLYMPIC COOL-CAP Cooling UnitNatus Medical Incorporated 5900 First Avenue South Made in USAControl Unit Model No. 60010Software in this product isTechnical Service**"
Code Info	1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1029; 1030; 1031; 1032; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1079; 1080; 1081; 1082; 1083; 1084; 1085; 1086; 1087; 1088; 1089; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1098; 1101; 1116; 1117; 1118; 1119; 1120; 1121; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1134; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7012; 7013; 7014; 7015; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7029; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7050; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7254; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7266; 7268; 7269; 7274; 7276; 7277; 7281; 7286; 7287; 7289; 7293; 7305; 7306; 7307; 7308; 7310; 7311; 7327; 7330; 7348; 7351; 7356; 7358; 7360; 7363; 7364; 7365; 7366; 7367; 7368; 7369; 7370; 7371; 7372; 7374; 7375; 7376; 7377; 7378; 7380; 7381; 7383; 7384; 7385; 7386; 7387; 7388; 7389; 7394; 7400; 7401; 7402; 7405; 7406; 7407; 7409; 7410; 7411; 7412; 7413; 7414; 7416; 7418; 7420; 7421; 7424; 7431; 7433; 7434; 7435; 7436; 7437; 7438; 7440; 7441; 7265; 7267; 7270; 7271; 7272; 7273; 7275; 7278; 7279; 7280; 7282; 7283; 7284; 7285; 7288; 7290; 7291; 7292; 7294; 7295; 7296; 7297; 7298; 7299; 7300; 7301; 7302; 7303; 7304; 7309; 7312; 7313; 7314; 7315; 7316; 7317; 7318; 7319; 7320; 7321; 7322; 7323; 7324; 7325; 7326; 7328; 7329; 7331; 7332; 7333; 7334; 7335; 7336; 7337; 7338; 7339; 7340; 7341; 7342; 7343; 7344; 7345; 7346; 7347; 7349; 7350; 7352; 7353; 7354; 7355; 7357; 7359; 7361; 7362; 7379; 7382; 7391; 7392; 7393; 7395; 7397; 7398; 7399; 7403; 7404; 7408; 7422; 7423; 7429; 7432.
Classification	Class I
Reason for Recall	The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing.
Product Quantity	324 units
Recall Number	Z-0447-2013

Class I Food/Cosmetics Event

Event ID	63421
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Breedlove Foods, Inc.
City	Lubbock
State	TX
Country	US
Distribution Pattern	Product was exported to Columbia.

Associated Products

Product Description	Vitanut Pro IC, 50 g
Code Info	Lot Code 2236
Classification	Class I
Reason for Recall	The product has the potential to be contaminated with Salmonella. The product was manufactured using peanut paste supplied by Sunland, Inc.
Product Quantity	1,469 cases (240 sachets/case)
Recall Number	F-0795-2013

Class I Food/Cosmetics Event

Event ID	63648
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Omya Inc
City	Superior
State	AZ
Country	US
Distribution Pattern	Nationwide in the US: TX, MN, CA, LA, IL, AZ and Worldwide to Mexico.

Associated Products

Product Description	Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling. Product Container Size Omya-Cal FG-10 AZ 50 lb. bags 2500 lb. bulk bags 2000 lb. bulk bags Omya-Cal FG-4 AZ 50 lb. bags Omya-Cal FG-15 AZ 2500 lb. bulk bags
Code Info	Lot numbers Z227510511 Z227500511 Z227500511 Z227510409 Z230310409 Z228400712 Z228200712
Classification	Class I
Reason for Recall	Omya Inc. is voluntarily recalling certain lots of food grade ground limestone products processed at its Superior, Arizona plant because of the possible presence of Salmonella.
Product Quantity	922,250 lbs
Recall Number	F-0741-2013

Class I Food/Cosmetics Event

Event ID	63721
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Kennys Farmhouse Cheese
City	Austin
State	KY
Country	US
Distribution Pattern	KY, AL, IN, NC, TN, and VA

Associated Products

Product Description	Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info	120724
Classification	Class I
Reason for Recall	Listeria monocytogenes contamination in product
Product Quantity	358.65lbs
Recall Number	F-0743-2013

Product Description	Chipotle Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info	120711
Classification	Class I
Reason for Recall	Listeria monocytogenes contamination in product
Product Quantity	144.07lbs
Recall Number	F-0744-2013

Product Description	Monterey Jack , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info	120719
Classification	Class I
Reason for Recall	Listeria monocytogenes contamination in product
Product Quantity	361.03lbs
Recall Number	F-0745-2013

Product Description	Mild Cheddar , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info	120625
Classification	Class I
Reason for Recall	Listeria monocytogenes contamination in product
Product Quantity	238.83lbs
Recall Number	F-0746-2013

Class I Food/Cosmetics Event

Event ID	63726
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Boulder Ice Cream
City	Boulder
State	CO
Country	US
Distribution Pattern	United States distribution including CT, NJ, NY, GA, NC, SC, AL, TN, ME, MA, RI, LA, TX, AK, OK, CA, AZ, NV, HI, OR, WA, CO, KS, NM, UT.

Associated Products

Product Description	Organic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO.
Code Info	All products with a "Best Buy" date of 10/3/13 or earlier.
Classification	Class I
Reason for Recall	Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity	144 x 5 liter containers.
Recall Number	F-0799-2013

Product Description	Serano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO.
Code Info	All products with a "Best Buy" date of 08/10/13 or earlier.
Classification	Class I
Reason for Recall	Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity	16,928 pints
Recall Number	F-0800-2013

Product Description	Elvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO.
Code Info	All products with a "Best Buy" date of 06/02/13 or earlier.
Classification	Class I
Reason for Recall	Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity	28 x 2.5 gallon
Recall Number	F-0801-2013

Product Description	All Natural Boulder Ice Cream Peanut Butter Cup, 2.5 gallon, packed in plastic packaging, manufactured by Fresca Foods, CO. All Natural Boulder Ice Cream Peanut Butter Cup, 1 pint, packed in semi flexible paper packaging, manufactured by Fresca Foods, CO.
Code Info	2.5 gallon with a "Best Buy" date of 07/24/13 or earlier; 1 pint with a "Best Buy" date of 08/16/13 or earlier.
Classification	Class I
Reason for Recall	Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity	329 x 2.5 gallon; 18,436 pints
Recall Number	F-0802-3013

Product Description	Yoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO.
Code Info	All products with a lot date of 4/1/2010, 5/5/2010, 6/10/2010, 7/14/2010, 12/29/2010, 2/17/2011, 4/1/2011, 4/23/2011, 5/26/2011, 6/3/2011, 7/2/2011, 7/7/2011, 8/14/2011, 9/18/2011, 11/26/2011, 39755, 38780.
Classification	Class I
Reason for Recall	Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity	6,988 x 1 gallon
Recall Number	F-0803-2013

Class I Food/Cosmetics Event

Event ID	63736
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Hillshire Brands Company
City	Downers Grove
State	IL
Country	US
Distribution Pattern	Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia and Wisconsin.

Associated Products

Product Description	Sara Lee Butter Streusel Coffee Cake, Net Wt. 11.5 oz ; 8 cakes per 5.75 lb case; Distributed by Sara Lee Corp., Downers Grove, IL 60515 U.S.A.; UPC: 032100023429
Code Info	UPC: 032100023429; Best By Date of 10/16/2013
Classification	Class I
Reason for Recall	The retail packages of Sara Lee Butter Streusel Coffee Cake with UPC #3210002342 and a Best By Date of 10/16/2013 actually contain Sara Lee Pecan Coffee Cake, resulting in the undeclared allergen - pecans.
Product Quantity	588 cases
Recall Number	F-0796-2013

Class I Food/Cosmetics Event

Event ID	63766
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Legendary Baking
City	Chaska
State	MN
Country	US
Distribution Pattern	Distributed to Quality Food Centers (QFC) in Washington State and Oregon by common carrier.

Associated Products

Product Description	Apple Lattice Pie (9-inch, 36oz). Pies are sealed in a brown cardboard box with a see-through plastic label and sold as a fresh item at the consumer level.
Code Info	Lot code CH12296
Classification	Class I
Reason for Recall	Legendary Baking of Denver, CO is recalling 726 Private Selection 9-inch pies labeled as "Apple Lattice" with a UPC of 1111060195 and Lot Code 12296 (located on side of aluminum pie tie) because the pies may contain undeclared EGGS. People who have an allergy or severe sensitivity to EGGS may run the risk of serious or life-threatening allergic reaction if they consume these products.
Product Quantity	726 pies
Recall Number	F-0805-2013

Class I Food/Cosmetics Event

Event ID	63770
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Jagpreet Enterprises Inc.
City	Hayward
State	CA
Country	US
Distribution Pattern	IN, CA, TX, MN, GA, CO, WA

Associated Products

Product Description	Sukhi's Gourmet Indian Food; Red Curry Vegetables; 9 oz. package. Manufactured by Jagpreet Enterprises dba Sukhi's Gourmet Indian Foods; Hayward, CA 94545
Code Info	Lot code: 3390113612; Use by Date: 05/14/2013; UPC 7-76226-02901-6
Classification	Class I
Reason for Recall	A consumer complaint determined that some boxes of Red Curry and Vegetables were inadvertently packaged with Yellow Curry with Shrimp.
Product Quantity
Recall Number	F-0804-2013

Class II Biologics Event

Event ID	41641
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jan-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American Red Cross Blood Services
City	Wichita
State	KS
Country	US
Distribution Pattern	OK, CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	02LH71740
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-0123-13

Product Description	Recovered Plasma
Code Info	02LH71740
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity	1 unit
Recall Number	B-0124-13

Class II Biologics Event

Event ID	48841
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-May-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Ogden
State	UT
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	08OUTB0022, 08OUTA7668, 08OUTA3003, 08OUTA0406, 07OUTF5925, 07OUTF5433, 07OUTF4393, 07OUTF4091, 07OUTF3071, 07OUTF1724, 07OUTF0389, 07OUTE9920
Classification	Class II
Reason for Recall	Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	12 units
Recall Number	B-0070-13

Class II Biologics Event

Event ID	48843
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jun-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	BioLife Plasma Services L.P.
City	Ogden
State	UT
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Source Plasma
Code Info	08OUTB4879, 08OUTB2635, 08OUTB1306, 08OUTA8922, 08OUTA7100, 08OUTA6681, 08OUTA5922, 08OUTA5562, 08OUTA4418, 08OUTA4386, 08OUTA3642, 08OUTA3242, 08OUTA2979, 08OUTA2077, 08OUTA0915, 07OUTF4985, 07OUTF4353, 07OUTF3686, 07OUTA4758, 07OUTA5615, 07OUTB0037, 07OUTB0803, 07OUTB1486, 07OUTB2556, 07OUTB3213, 07OUTB3834, 07OUTB6136, 07OUTB6376, 07OUTB7237, 07OUTB9597, 07OUTC0475, 07OUTC1012, 07OUTC2225, 07OUTC2842, 07OUTC4143, 07OUTC4456, 07OUTC5199, 07OUTC6632, 07OUTC8560, 07OUTD1005, 07OUTD3596, 07OUTD5143, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTD4266, 07OUTC9724, 07OUTD0460, 07OUTD2498, 07OUTD8237, 07OUTE0989, 07OUTE1522, 07OUTE6623, 07OUTE7686, 07OUTF0829, 07OUTF1519, 07OUTF4353, 07OUTF4985, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTS0487 08OUTA2979, 08OUTB2635, 08OUTA2077, 08OUTA4386, 08OUTB6603, 08OUTB7200, 08OUTA0915, 08OUTB5655, 07OUTS0551, 07OUTS0998, 07OUTS0940, 07OUTS0991, 07OUTS1070, 07OUTS1118, 07OUTS1162, 07OUTS1334, 07OUTS1350, 07OUTS1415, 07OUTS1589, 07OUTS1654, 07OUTS1692, 07OUTS1778, 07OUTS1828, 07OUTS1923, 07OUTS1946, 07OUTS1999, 07OUTS2108, 07OUTS2247, 07OUTS2428, 07OUTS2617, 07OUTS0273, 07OUTS0551
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	108
Recall Number	B-0069-13

Class II Biologics Event

Event ID	50658
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Nov-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Talecris Plasma Resources, Inc.
City	Research Triangle Park
State	NC
Country	US
Distribution Pattern	North Carolina

Associated Products

Product Description	Source Plasma
Code Info	366075510, 366075578, 366081734, 366083633, 366084506, 366085118, 366085884, 366087228, 366087696, 366088653, 366089152, 366093041, 366096304, 366099383, 366100646, 366101126, 366102595
Classification	Class II
Reason for Recall	Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity	17 units
Recall Number	B-0042-13

Class II Biologics Event

Event ID	50667
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Talecris Plasma Resources, Inc.
City	Research Triangle Park
State	NC
Country	US
Distribution Pattern	North Carolina

Associated Products

Product Description	Source Plasma
Code Info	366060584, 366062394, 366062738, 366063408, 366063980, 366068895, 366070142, 366070611
Classification	Class II
Reason for Recall	Blood products, collected from a donor who may have received a tattoo within one year of donation, were distributed.
Product Quantity	8 units
Recall Number	B-0043-13

Class II Veterinary Event

Event ID	62133
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Lloyd Inc
City	Shenandoah
State	IA
Country	US
Distribution Pattern	Distribution was made nationwide. There was no foreign, military, or government distribution.

Associated Products

Product Description	PrednisTab (Prednisolone, USP) 5 mg, packaged in 1,000-tablet bottles, For Oral Use in Dogs Only, RX, NADA #140-921, packaged under the following labels: (1) Lloyd, Inc., Shenandoah, IA; (2) Butler Schein Animal Health, Dublin, OH; and (3) Phoenix, Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO.
Code Info	Lot numbers KM01310, exp. Jan-13; KN01310, exp. Jan-13; KG07010, exp. Mar-13; KG20710, exp. Aug-13; KH20710, exp. Aug-13; KA26410, exp. Sep-13; KB26410, exp. Sep-13; KC26410, exp. Sep-13; KC29910, exp. Nov-13; KD33710, Exp. Dec-13; KE33710, exp. Dec-13; KF33710, exp. Dec-13; and KJ33710, exp. Dec-13.
Classification	Class II
Reason for Recall	Some of the bottles may contain broken tablets
Product Quantity	18.074/1,000-tablet bottles
Recall Number	V-117-2013

Class II Drugs Event

Event ID	62511
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Lloyd Inc. of Iowa
City	Shenandoah
State	IA
Country	US
Distribution Pattern	Distribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.

Associated Products

Product Description	Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HB01212
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	1,923,887 tablets
Recall Number	D-074-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1097830 exp. 1/31/2013
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	13,692/100-tablet bottles
Recall Number	D-075-2013

Product Description	Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HA31411 and #HE17811
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	3,826,269 tablets
Recall Number	D-076-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	31,252/100-tablet bottles
Recall Number	D-077-2013

Product Description	Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HC31411 and #HE18711
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	3,813,645 tablets
Recall Number	D-078-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1096371, exp. 5/312013; and #1092299, exp. 1/31/2013
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	37,827/100-tablet bottles
Recall Number	D-079-2013

Product Description	Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HB27811
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	1,924,174 tablets
Recall Number	D-080-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1095210, exp. 4/30/2013
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	19,162/100-tablet bottles
Recall Number	D-081-2013

Product Description	Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HA27911 and #HA12511
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	3,774,541 tablets
Recall Number	D-082-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1095212 exp. 4/30/2013; and #1088877, exp. 11/30/2012
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	36,978/100-tablet bottles
Recall Number	D-083-2013

Product Description	Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #HE35311
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	1,902,957 tablets
Recall Number	D-084-2013

Product Description	Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Code Info	Lot #1097178 exp. 7/31/2013
Classification	Class II
Reason for Recall	cGMP Deviations; does not meet in process specification requirements
Product Quantity	1,443/100-tablet bottles
Recall Number	D-085-2013

Class II Biologics Event

Event ID	62610
Status	Completed
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	LifeNet Health
City	Virginia Beach
State	VA
Country	US
Distribution Pattern	The tissues were shipped nationwide and to Canada and Korea.

Associated Products

Product Description	Decellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251
Code Info	Serial numbers: 1012784D190, 1012784D191, 1012784D192, 1012784D193, 1012784D194, 1012784D195, 1012784D196, 1012784D197, 1012784D198, 1012784D199, 1012784D200, 1012784D201, 1012784D202, 1012784D212, 1012784D213, 1012784D214, 1012784D218
Classification	Class II
Reason for Recall	Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity	17 tissues
Recall Number	B-0350-13

Product Description	Fascia, human tissue for transplantation, product code FL M
Code Info	Serial number: 1012784045
Classification	Class II
Reason for Recall	Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity	1 tissue
Recall Number	B-0351-13

Product Description	Bone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP.
Code Info	Serial numbers: 1012784011, 1012784012, 1012784013, 1012784014, 1012784015, 1012784016, 1012784017, 1012784018, 1012784019, 1012784020, 1012784021, 1012784022, 1012784023, 1012784024, 1012784025, 1012784026, 1012784027, 1012784028, 1012784029, 1012784030, 1012784031, 1012784032, 1012784033, 1012784034, 1012784035, 1012784036, 1012784037, 1012784038, 1012784039, 1012784040, 1012784041, 1012784042, 1012784043, 1012784044, 1012784047, 1012784048, 1012784049, 1012784050, 1012784051, 1012784052, 1012784053, 1012784054
Classification	Class II
Reason for Recall	Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity	42 tissues
Recall Number	B-0352-13

Product Description	Tendon, human tissue for transplantation,
Code Info	Serial numbers: 1012784001, 1012784002, 1012784003, 1012784004, 1012784005, 1012784006, 1012784007, 1012784008, 1012784009, 1012784010
Classification	Class II
Reason for Recall	Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity	10 tissues
Recall Number	B-0353-13

Class II Devices Event

Event ID	62749
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Merit Medical Systems, Inc.
City	Chester
State	VA
Country	US
Distribution Pattern	Nationwide distribution: US including states of: NE and SD.

Associated Products

Product Description	Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Code Info	Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
Classification	Class II
Reason for Recall	Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
Product Quantity	83 packs
Recall Number	Z-0464-2013

Class II Biologics Event

Event ID	63131
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Suncoast Communities Blood Bank, Inc.
City	Sarasota
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W038612825235;
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity	1
Recall Number	B-0056-13

Product Description	Fresh Frozen Plasma
Code Info	W038612825235;
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1
Recall Number	B-0057-13

Class II Biologics Event

Event ID	63132
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Michigan Blood
City	Grand Rapids
State	MI
Country	US
Distribution Pattern	Michigan

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W120611007684;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-0058-13

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	W120611181662;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-0059-13

Class II Biologics Event

Event ID	63133
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W051512087394 Part 1; W051512087394 Part 2;
Classification	Class II
Reason for Recall	Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Product Quantity	2
Recall Number	B-0060-13

Class II Biologics Event

Event ID	63190
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	CaridianBCT, Inc.
City	Lakewood
State	CO
Country	US
Distribution Pattern	US distribution only: VA, MS, SC, AZ, TN, MI, TX, PN, CA, NY, CA, UT.

Associated Products

Product Description	Vista System Version 3.2 service pack 3 used on Trima Accel Automated Collection System version 5.1 or User Defined Machines. The software is used for determining donor eligibility based on annual Red Blood Cell Volume Loss Limits.
Code Info	Vista Version 3.2 Service Pack 3 (stand alone Service Pack) part number 923000-326 and Vista V3.2 with Vista 3.2 Service Pack 3 (part number 923000-327B).
Classification	Class II
Reason for Recall	TerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed.
Product Quantity	2
Recall Number	B-0387-13

Class II Drugs Event

Event ID	63243
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Genentech Inc
City	South San Francisco
State	CA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Code Info	Lot# 936674 Exp. 09/30/13
Classification	Class II
Reason for Recall	Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Product Quantity	10,306 syringes
Recall Number	D-087-2013

Product Description	Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Code Info	Lot # 936670 Exp. 09/30/13
Classification	Class II
Reason for Recall	Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Product Quantity	12,791 syringes
Recall Number	D-088-2013

Class II Biologics Event

Event ID	63401
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	BloodCenter of Wisconsin, Inc
City	Milwaukee
State	WI
Country	US
Distribution Pattern	Wisconsin

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036311158586
Classification	Class II
Reason for Recall	Blood product, which was incorrectly labeled as negative for the C red cell antigen, was distributed.
Product Quantity	1 unit
Recall Number	B-0158-13

Class II Biologics Event

Event ID	63402
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112283072F
Classification	Class II
Reason for Recall	Blood product, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-0157-13

Class II Biologics Event

Event ID	63403
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112218788D
Classification	Class II
Reason for Recall	Blood product, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-0156-13

Class II Biologics Event

Event ID	63404
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112272578B
Classification	Class II
Reason for Recall	Blood product, with a low platelet count, was distributed.
Product Quantity	1 unit
Recall Number	B-0155-13

Class II Devices Event

Event ID	63407
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia,United Arab Emirates (UAE), Singapore, USA, Malaysia, BELGIUM, Japan, and CANADA.

Associated Products

Product Description	24 Fr 8mm Sft Flow Str Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 5841 and 5845 and lot number: 0581536 and 0581138.
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total
Recall Number	Z-0456-2013

Product Description	24 Fr 8mm Sft Flow Straight Wir The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use
Code Info	catalog number: 5843 and lot number: 0584961
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total
Recall Number	Z-0457-2013

Product Description	24 Fr 8mm Sft Flow Straight The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 5847 and lot number: 0582251 and 0586068
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total
Recall Number	Z-0458-2013

Product Description	18 Fr 6mm Sft Flow Angled Wire The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810.
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total
Recall Number	Z-0459-2013

Product Description	18 Fr 6mm Sft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 7072 and lot number: 0602542, 0614871, and 0620810.
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total
Recall Number	Z-0460-2013

Product Description	24 Fr 8mm Soft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 5762 and lot number: 0570466 and 0589212
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total products
Recall Number	Z-0461-2013

Product Description	24 Fr 8mm Soft Flow Ang W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Code Info	catalog number: 5774 and lot number: 0595116.
Classification	Class II
Reason for Recall	Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact.
Product Quantity	5760 total units
Recall Number	Z-0462-2013

Class II Biologics Event

Event ID	63427
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	LifeNet Health
City	Virginia Beach
State	VA
Country	US
Distribution Pattern	New York

Associated Products

Product Description	Cardiac Tissue, Non-valved
Code Info	11112910004
Classification	Class II
Reason for Recall	Cardiac Tissue Allograft, processed in a manner that did not prevent the introduction, transmission, or spread of communicable disease, was distributed.
Product Quantity	1
Recall Number	B-0386-13

Class II Devices Event

Event ID	63429
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Internationally to Canada, AU, NZ, JP, DE, SA, and MY

Associated Products

Product Description	Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.
Code Info	Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.
Classification	Class II
Reason for Recall	Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the magnitude of the elevation is consistent for all 15 tests in that well set. The observed magnitude of the elevation ranges from approximately 20-800 ug/dL and the estimated rate is approximately 1 out of 2,500 wells.
Product Quantity	19,310
Recall Number	Z-0452-2013

Class II Biologics Event

Event ID	63434
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Northern Illinois Blood Bank dba Rock River Valley BC
City	Rockford
State	IL
Country	US
Distribution Pattern	Illinois

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W044412202215
Classification	Class II
Reason for Recall	Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity	1 unit
Recall Number	B-0159-13

Class II Biologics Event

Event ID	63436
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Oct-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Our Lady Of The Lake Hospital Inc
City	Baton Rouge
State	LA
Country	US
Distribution Pattern	Louisiana

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W1657120214005
Classification	Class II
Reason for Recall	Blood product, with a platelet count that exceeded the maximum specification, was distributed.
Product Quantity	1 unit
Recall Number	B-0161-13

Class II Devices Event

Event ID	63442
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Stryker Howmedica Osteonics Corp.
City	Mahwah
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. Made in USA
Code Info	Class I, 510(k) exempt Catalog Number: 6543-1-600 Lot Number; NE1WR1
Classification	Class II
Reason for Recall	Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.
Product Quantity	7 units
Recall Number	Z-0469-2013

Product Description	Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
Code Info	Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31
Classification	Class II
Reason for Recall	Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings.
Product Quantity	8
Recall Number	Z-0470-2013

Class II Devices Event

Event ID	63495
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions USA, Inc
City	Malvern
State	PA
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.

Associated Products

Product Description	Siemens Mobilette Mira, intended use as Mobile x-ray system.
Code Info	Model Number 10273100
Classification	Class II
Reason for Recall	There is a risk of lost images during examination.
Product Quantity	21
Recall Number	Z-0480-2013

Class II Devices Event

Event ID	63521
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions USA, Inc
City	Malvern
State	PA
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

Associated Products

Product Description	Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Code Info	Model number 10 592 457
Classification	Class II
Reason for Recall	Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could remain unprotected and not archived leading to a potential data loss. - System crashes when user tries to delete a self created spine labeling step. - For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user. - Within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing. - Viewer crashes during load of next patient. Error is related to 'Next Patient' from RIS.
Product Quantity	15
Recall Number	Z-0465-2013

Class II Devices Event

Event ID	63553
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips And Neusoft Medical Systems Co., Ltd.
City	Shenyang, Liaoning
State
Country	CN
Distribution Pattern	Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.

Associated Products

Product Description	NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Code Info	NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
Classification	Class II
Reason for Recall	The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Product Quantity	20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Recall Number	Z-0466-2013

Class II Devices Event

Event ID	63577
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Roche Diagnostics Operations, Inc.
City	Indianapolis
State	IN
Country	US
Distribution Pattern	Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.

Associated Products

Product Description	Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Code Info	Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190; Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190; Bicarbonate Liquid 05446376190; Creatinine Jaffé Gen.2 05168597190; C-Reactive Protein Gen.3 05172373190; and Urea/BUN 05171873190. Serial Number(s): 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05, 1031-09, 1032-09, 1032-10, 1033-04, 1033-05, 1107-06, 1109-02, 1109-03, 1111-07, 1111-08, 1112-02, 1112-04, 1115-06, 1115-07, 1115-08, 1115-10, 1117-04, 1117-07, 1118-02, 1126-02, 1126-03, 1126-04, 1127-01, 1127-02, 1127-06, 1127-07, 1138-03, 1138-04, 1139-04, 1139-05, 1139-06, 1140-02, 1140-03, 1140-04, 1140-05, 1140-10, 1141-08, 1141-09, 1142-02, 1142-03, 1142-04, 1143-01, 1143-02, 1143-03, 1143-04, 1143-05, 1143-06, 1144-05, 1146-04, 1146-05, 1146-06, 1146-07, and 1146-08.
Classification	Class II
Reason for Recall	On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (CREJ2), Urea (UREAL), C Reactive Protein (CRPL3).
Product Quantity	78 analyzers
Recall Number	Z-0473-2013

Class II Devices Event

Event ID	63615
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sekisui Diagnostics Llc
City	Stamford
State	CT
Country	US
Distribution Pattern	Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.

Associated Products

Product Description	Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
Code Info	Lot # 120827, exp 11/27/2012
Classification	Class II
Reason for Recall	Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values with "0" standard reducing the slope of the standard curve requiring more frequent sample dilutions.
Product Quantity	63 kits
Recall Number	Z-0463-2013

Class II Devices Event

Event ID	63619
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Philips Healthcare Inc.
City	Andover
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Eastonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Lybia, Malta, Mexico, Netherlands, New Zealnd, Norway, Oman, Polnad, Protugual, Quatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Soth Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.

Associated Products

Product Description	Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Code Info	All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
Classification	Class II
Reason for Recall	With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
Product Quantity	623 units
Recall Number	Z-0475-2013

Class II Drugs Event

Event ID	63628
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Caraco Pharmaceutical Laboratories, Ltd.
City	Detroit
State	MI
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.
Code Info	Lot # GKK1373, Exp 09/13
Classification	Class II
Reason for Recall	Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Product Quantity	2,264 bottles
Recall Number	D-089-2013

Class II Devices Event

Event ID	63634
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-May-11
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Stryker Instruments Div. of Stryker Corporation
City	Portage
State	MI
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.

Associated Products

Product Description	Neptune® 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Code Info	Part 0702-001-000 (120v) Lot 0733700353 through 1036100423
Classification	Class II
Reason for Recall	Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Product Quantity	5865
Recall Number	Z-0454-2013

Product Description	Neptune® 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices.
Code Info	Part 0702-002-000 (230v) Lot 0733700353 through 1036100423
Classification	Class II
Reason for Recall	Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain.
Product Quantity	154
Recall Number	Z-0455-2013

Class II Food/Cosmetics Event

Event ID	63640
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Nov-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Zingerman's Bakehouse, Inc.
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Michigan and Ohio

Associated Products

Product Description	Zingerman's Bakehouse Gingerbread Cake Net wt. 3 LB; 1.25 LB
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	3LB and 1.25 LB (Total Quantity: 180)
Recall Number	F-0747-2013

Product Description	Zingerman's Bakehouse Sourcream Coffeecake Net wt. 3 LB; 1.25 LB
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	3lbs: 1.25lb (Total Quantity: 1,039)
Recall Number	F-0748-2013

Product Description	Zingerman's Bakehouse Hot Cocoa Cake Net wt. 3 LB; 1.25 LB
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	3lbs; 1.5lb (Total Quantity: 325)
Recall Number	F-0749-2013

Product Description	Zingerman's Bakehouse Lemon Poppy Seed Coffeecake Net wt. 2.5 LB; 1.25 LB
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	2.5lbs.; 1.25lb (Total Quantity: 84)
Recall Number	F-0750-2013

Product Description	Zingerman's Bakehouse Funky Chunky Chocolate Cookies Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces (Total Quantity: 875)
Recall Number	F-0751-2013

Product Description	Zingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	6 ounces (Total Quantity: 217)
Recall Number	F-0752-2013

Product Description	Zingerman's Bakehouse Big O Cookie Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	(Total Quantity: 607)
Recall Number	F-0753-2013

Product Description	Zingerman's Bakehouse Big O Cookie Jrs. Net wt. 1/2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1/2 lb (Total Quantity: 148)
Recall Number	F-0754-2013

Product Description	Zingerman's Bakehouse Ginger Jump-up Cookies Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces (Total Quantity: 804)
Recall Number	F-0755-2013

Product Description	Zingerman's Bakehouse Jr. Ginger Jump-up Cookies Net wt. 6 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	6 ounces (Total Quantity: 202)
Recall Number	F-0756-2013

Product Description	Zingerman's Bakehouse Triple Trouble Chocolate Cookie Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces
Recall Number	F-0757-2013

Product Description	Zingerman's Bakehouse Junior Triple Trouble Chocolate Cookies Net wt. 6 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	6 ounces (Total Quantity: 78)
Recall Number	F-0758-2013

Product Description	Zingerman's Bakehouse Mandelbread Net wt. 8 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	8 ounces (Total Quantity: 101)
Recall Number	F-0759-2013

Product Description	Zingerman's Bakehouse Bumble Honey Cake Net wt. 1.25 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source may contain butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1.25 ounces
Recall Number	F-0760-2013

Product Description	Zingerman's Bakehouse Banana Bread Net wt. 20 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	20 ounces (Total Quantity: 216)
Recall Number	F-0761-2013

Product Description	Zingerman's Bakehouse Genuine Ginger Brownies Net wt. 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 48)
Recall Number	F-0762-2013

Product Description	Zingerman's Bakehouse Country Scone Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces
Recall Number	F-0763-2013

Product Description	Zingerman's Bakehouse Ginger Scone Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces
Recall Number	F-0764-2013

Product Description	Zingerman's Bakehouse Northern Corn Bread Net wt. 18 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	18 ounces (Total Quantity: 64)
Recall Number	F-0765-2013

Product Description	Zingerman's Bakehouse Currant Scone Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces
Recall Number	F-0766-2013

Product Description	Zingerman's Bakehouse Townie Brownies Net wt. 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 398)
Recall Number	F-0767-2013

Product Description	Zingerman's Bakehouse Chocolate Banana Bread Net wt. 20 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	20 ounces (Total Quantity: 202)
Recall Number	F-0768-2013

Product Description	Zingerman's Bakehouse Buenos Aires Brownies Net wt. 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 1,566)
Recall Number	F-0769-2013

Product Description	Zingerman's Bakehouse Almond Pound Cake Net wt. 1.25 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1.25 lb
Recall Number	F-0770-2013

Product Description	Zingerman's Bakehouse Rugelach Net wt. 1/2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1/2 lb (Total Quantity: 191)
Recall Number	F-0771-2013

Product Description	Zingerman's Bakehouse Cinful Cinnamon Rolls Net wt. 1 1/2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1 1/2 lb (Total Quantity: 105)
Recall Number	F-0772-2013

Product Description	Zingerman's Bakehouse Brownie Party Net wt. 1.2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1.2 lb (Total Quantity: 282)
Recall Number	F-0773-2013

Product Description	Zingerman's Bakehouse Palmiers Net wt. 4 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	4 ounces (Total Quantity: 282)
Recall Number	F-0774-2013

Product Description	Zingerman's Bakehouse Summer Fling Coffeecake Net wt. 3 lbs
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	3 lbs
Recall Number	F-0775-2013

Product Description	Zingerman's Bakehouse ZBPB's Peanut Butter Cookie Net wt. 3 ounces
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	3 ounces (Total Quantity: 299)
Recall Number	F-0776-2013

Product Description	Zingerman's Bakehouse Cape Cod Cranberry Walnut Pie
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	(Total Quantity: 43)
Recall Number	F-0777-2013

Product Description	Zingerman's Bakehouse Stollen
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity
Recall Number	F-0778-2013

Product Description	Zingerman's Bakehouse Chocolate Chess Pie
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	(Total Quantity: 191)
Recall Number	F-0779-2013

Product Description	Zingerman's Bakehouse Perky Pecan Pie
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	(Total Quantity: 278)
Recall Number	F-0780-2013

Product Description	Zingerman's Bakehouse Olive Oil Cake Net wt. 1.25 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1.25 lb
Recall Number	F-0781-2013

Product Description	Zingerman's Bakehouse Jumbleberry Pie
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	(Total Quantity: 194)
Recall Number	F-0782-2013

Product Description	Zingerman's Bakehouse Pound Cake 1 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of flour as wheat.
Product Quantity	1 lb (Total Quantity: 39)
Recall Number	F-0783-2013

Product Description	Zingerman's Bakehouse Graham Crackers 1 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1 lb (Total Quantity: 230)
Recall Number	F-0784-2013

Product Description	Zingerman's Bakehouse Orange-Almond Magic Brownies 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity:16)
Recall Number	F-0785-2013

Product Description	Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk.
Product Quantity	1 lb
Recall Number	F-0786-2013

Product Description	Zingerman's Bakehouse Pecan Blondies 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 794)
Recall Number	F-0787-2013

Product Description	Zingerman's Bakehouse Sweet Butter Teacake 1.25 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1.25 lb (Total Quantity: 12)
Recall Number	F-0788-2013

Product Description	Zingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1.25 lb
Recall Number	F-0789-2013

Product Description	Zingerman's Bakehouse Apricot Rugelach Net wt. 1/2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat.
Product Quantity	1/2 lb (Total Quantity: 168)
Recall Number	F-0790-2013

Product Description	Zingerman's Bakehouse Black Magic Brownies Net wt. 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 1,742)
Recall Number	F-0791-2013

Product Description	Zingerman's Bakehouse Magic Brownies Net wt. 1/4 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1/4 lb (Total Quantity: 2,323)
Recall Number	F-0792-2013

Product Description	Zingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb
Code Info	none
Classification	Class II
Reason for Recall	Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products.
Product Quantity	1.2 lb (Total Quantity: 79)
Recall Number	F-0793-2013

Class II Devices Event

Event ID	63642
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Nov-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	OmniGuide, Inc.
City	Cambridge
State	MA
Country	US
Distribution Pattern	Nationwide Distribution including AZ, FL, MA, NY, OH, and OR.

Associated Products

Product Description	OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy
Code Info	Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 :
Classification	Class II
Reason for Recall	Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Product Quantity	45 units
Recall Number	Z-0453-2013

Class II Devices Event

Event ID	63643
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Invivo Corporation
City	Orlando
State	FL
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) including the states of MO; MS; MA; IL; OH; NY; KS; PA; WI; VA; SD; AZ; FL; OR; TX; MA; MO; FL; MA; MI; CT; CA; NJ; NC; ME; IL; MA; MA; WV; MA; MN; CA; AL; AL; WI; DC; OH; WV; CA; NC; NY; MT; NJ; CA; WA; IN; MI; PA; TX; NC; TN; TX; ID; NM; IL; PA; IN; IL; WA; CO; MN; CA; IN; MD; MI; DC; GA; DE; CO; CT; WA; NJ; MD; TX; TN; MN; WA; CA; FL; OH; PA; NY; IN; OK; ID; IA; NY; WI; VA; CA; HI; MS; TX; HI; CT; TN; OR; WA; PA; NH; CA; MA; LA; IN; PA; AZ; GA; UT; ND; GA; TX; TX; IN; CA; MI; CT; CA; NC; MS; VA; IN; MI; NE; NV; MI; WA; IL; KY; LA; OR; OK; LA; TN; KY; TX; CA; PA; NM; NC; CO; DC; AL; MI; TX; SD; PA; OR; ID; NM; SD; CO; MN; NJ; MI; ND; MN; MT; LA; CT; WA; TX; IA; NJ; WI; SD; and UT, and the countries of Canada, Italy, Thailand, Russian Federation, Saudi Arabia, Slovenia, Singapore, Republic of Korea, Uzbekistan, Iceland, Israel, Austria, United Kingdom, Afganhistan, Japan, South Africa, Germany, Qatar, Netherlands, Switzerland, Denmark, and Sweden.

Associated Products

Product Description	Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner.
Code Info	Model number 865214: (Service Numbers 453564180091, 453564181201). Lot numbers: US00201487, US00201488, US00201489, US00201490, US00201493, US11401510, US11401511, US11401513, US11401514, US11401515, US11401516, US11401531, US11401532, US11401533, US11401546, US11401562, US11401563, US11401564, US11401565, US11401566, US11401567, US11401568, US11401569, US11401570, US11401571, US11401572, US11401573, US11401574, US11401575, US11401576, US11401577, US11401578, US11401579, US11401611, US11401617, US11401618, US11401631, US11401633, US11401634, US11401645, US11401646, US11401647, US11401648, US11401649, US11401651, US11401652, US11401672, US11401673, US11401674, US11401675, US11401712, US11401713, US11401714, US11401715, US11401716, US11401717, US11401718, US11401719, US11401720, US11401721, US11401722, US11401723, US11401724, US11401737, US11401738, US11401739, US11401740, US11401741, US11401742, US11401743, US11401744, US11401745, US11401746, US11401747, US11401775, US11401776, US11401777, US11401778, US11401779, US11401780, US11401781, US11401782, US11401783, US11401784, US11401785, US11401786, US11401799, US11401843, US11401844, US11401845, US11401846, US11401851, US11401871, US11401872, US11401882, US11401883, US11401884, US11401885, US11401886, US11401892, US11401893, US11401903, US11401904, US11401905, US11401916, US11401917, US11401918, US11401969, US11401970, US11401971, US11401972, US11401973, US11401974, US11401975, US13301988, US13301989, US13301990, US13301991, US13301992, US13301993, US13301994, US13301995, US13301996, US13301997, US13301998, US13302000, US13302001, US13302034, US13302035, US13302036, US13302037, US13302039, US13302040, US13302041, US13302042, US13302043, US13302044, US13302050, US13302051, US13302052, US13302054, US13302055, US13302094, US13302095, US13302096, US13302097, US13302098, US13302099, US13302107, US13302108, US13302109, US13302111, US13302112, US13302113, US13302114, US13302115, US13302117, US13302118, US13302119, US13302141, US13302148, US13302175, US13302176, US13302177, US13302178, US13302179, US13302180, US13302182, US13302192, US13302193, US13302194, US13302195, US13302196, US13302197, US13302198, US13302209, US13302210, US13302211, US13302212, US13302247, US13302248, US13302249, US13302250, US13302251, US13302252, US13302254, US13302265, US13302266, US13302267, US13302291, US13302292, US13302293, US13302294, US13302295, US13302296, US13302297, US13302298, US13302300, US13302302, US13302304, US13302346, US13302347, US13302348, US13302349, US13302350, US13302362, US13302363, US13302364, US13302365, US13302366, US13302367, US13302373, US13302378, US13302421, US13302422, US13302423, US13302424, US13302425, US13302427, US13302430, US13302431, US13302432, US13302434, US13302437, US13302438, US13302439, US13302441, US13302445, US13302446, US13302447, US13302449, US13302450, US13302478, US13302485, US13302488, US13302498, US13302501, US13302503, US13302504, US13302505, US13302507, US13302508, US13302509, US13302510, US13302511, US13302512, US13302513, US13302514, US13302515, US13302516, US13302517, US13302519, US13302520, US13302521, US13302522, US13302523, US13302524, US13302525, US13302526, US13302527, US13302528, US13302529, US13302609, US13302610, US13302612, US13302613, US13302614, US13302617, US13302618, US13302619, US13302620, US13302621, US13302622, US13302623, US13302624, US13302625, US13302631, US13302641, US13302642, US13302644, US13302645, US13302646, US13302647, US13302648, US13302649, US13302650, US13302651, US13302652, US13302653, US13302654, US13302656, US13302657, US13302658, US13302701, US13302702, US13302703, US13302704, US13302705, US13302706, US13302708, US13302709, US13302710, US13302713, US13302714, US13302715, US13302716, US13302717, US13302782, US13302783, US13302784, US13302785, US13302786, US13302787, US13302788, US13302789, US13302790, US13302804, US13302805, US13302806, US13302807, US13302808, US13302809, US13302810, US13302811, US13302812, US13302837, US13302852, US13302853, US13302854, US13302855, US13302856, US13302864, US13302865, US13302866, US13302871, US13302872, US13302873, US13302874, US13302875, US13302878, US13302879, US13302880, US13302881, US13302882, US13302883, US13302887, US13302888, US13302914, US13302915, US13302937, US13302938, US13302939, US13302940, US13302941, US13302942, US13302943, US13302944, US13302954, US13302955, US13302956, US13302957, US13302958, US13302959, US13302960, US13302982, US13302983, US13302985, US13302986, US13302987, US13302988, US13302989, US13302990, US13302991, US13302992, US13302993, US13302998, US13302999, US13303000, US13303001, US13303002, US13303048, US13303049, US13303050, US13303051, US13303052, US13303053, US13303054, US13303055, US13303056, US13303057, US13303080, US13303084, US13303085, US13303086, US13303126, US13303127, US13303128, US13303129, US13303130, US13303158, US13303159, US13303160, US13303161, US13303162, US13303163, US13303178, US13303179, US13303180, US13303187, US13303188, US13303203, US13303214, US13303216, US13303217, US13303219, US13303221, US13303222, US13303223, US13303224, US13303238, US13303239, US13303240, US13303241, US13303243, US13303244, US13303245, US13303270, US13303271, US13303272, US13303273, US13303288, US13303298, US13303306, US13303325, US13303326, US13303327, US13303328, US13303329, US13303330, US13303331, US13303332, US13303333, US13303334, US13303347, US13303348, US13303349, US13303350, US13303351, US13303352, US13303380, US13303381, US13303382, US13303383, US13303384, US13303387, US13303388, US13303409, US13303413, US13303414, US13303416, US13303417, US13303418, US13303419, US13303420, US13303421, US13303422, US13303436, US13303462, US13303463, US13303464, US13303465, US13303466, US13303467, US13303468, US13303482, US13303488, US13303489, US13303490, US13303499, US13303500, US13303501, US13303502, US13303503, US13303504, US13303505, US13303506, US13303507, US13303508, US13303509, US13303510, US13303511, US13303512, US13303543, US13303544, US13303573, US13303574, US13303575, US13303576, US13303577, US13303578, US13303579, US13303580, US13303584, US13303585, US13303586, US13303587, US13303588, US13303589, US13303590, US13303591, US13303597, US13303598, US13303601, US13303625, US13303626, US13303627, US13303628, US13303630, US13303631, US13303662, US13303665, US13303666, US13303667, US13303668, US13303671, US13303672, US13303721, US13303722, US13303723, US13303724, US13303725, US13303726, US13303727, US13303733, US13303734, US13303735, US13303738, US13303739, US13303748, US13303749, US13303750, US13303780, US13303781
Classification	Class II
Reason for Recall	Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall.
Product Quantity	543 units
Recall Number	Z-0468-2013

Class II Devices Event

Event ID	63646
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	iwalk inc
City	Bedford
State	MA
Country	US
Distribution Pattern	Nationwide Distribution including OH, NC, and NY.

Associated Products

Product Description	BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger
Code Info	Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
Classification	Class II
Reason for Recall	Battery may over-heat during charging and smoke
Product Quantity	21 Batteries; 9 Chargers
Recall Number	Z-0467-2013

Class II Drugs Event

Event ID	63685
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Taro Pharmaceuticals U.S.A., Inc.
City	Hawthorne
State	NY
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Code Info	Lot #s: 118903, Exp. 03/2013; 119477, 119483,119743, 119748, Exp. 05/2013, 110440, Exp. 07/2013; 110951, Exp 08/2013; 110599, Exp. 09/2013; 110602, 110606, 110607, 110949, 110953, 110954, 110956, 110958, 110963, Exp. 10/2013; 110962, 110965, 111659, 111844, 111845, 111846, Exp. 11/2013; 112227, 112228, Exp. 12/2013.
Classification	Class II
Reason for Recall	Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Product Quantity	39,982 Tubes
Recall Number	D-086-2013

Class II Devices Event

Event ID	63708
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Nov-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomet, Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	USA Nationwide Distribution in the state of WI.

Associated Products

Product Description	Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Code Info	Catalog Number: 113740 and Lot Number Identification: 779270
Classification	Class II
Reason for Recall	The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
Product Quantity	4
Recall Number	Z-0474-2013

Class II Food/Cosmetics Event

Event ID	63762
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beachside Produce Llc
City	Guadalupe
State	CA
Country	US
Distribution Pattern	CA and NJ

Associated Products

Product Description	Iced Broccoli crown, 20lbs.
Code Info	Highway One Label: 040112A3-01810182 140312C3-10110182 031912A7-07010182 031812A7-01910182 031812A7-01810182 020112A1-12310182 031512A7-06910182 Beachside Label: 140312C3-10110182
Classification	Class II
Reason for Recall	Beachside Produce is recalling iced broccoli crownds due to the potential of having hydraulic fluid onto the ice that cooled the product.
Product Quantity	946 units
Recall Number	F-0794-2013

Class III Biologics Event

Event ID	48855
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-May-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Community Blood Center Of Gtr KC
City	Kansas City
State	MO
Country	US
Distribution Pattern	Kansas; Austria

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W045007075233
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0067-13

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W045007075233
Classification	Class III
Reason for Recall	Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity	1 Unit
Recall Number	B-0068-13

Class III Veterinary Event

Event ID	62550
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Lloyd Inc. of Iowa
City	Shenandoah
State	IA
Country	US
Distribution Pattern	Distribution was nationwide. There was no foreign, military, or government distribution.

Associated Products

Product Description	LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 0.2 mg., packaged in 120-ct. (NDC 11789-252-10) and 1,000-ct. bottles (NDC 11789-252-20), RX, LLOYD, Inc., Shenandoah, IA..
Code Info	KA16611, exp. SEP 2012
Classification	Class III
Reason for Recall	Product lot KA16611 did not meet finished product release specifications
Product Quantity	2,535/120-ct. and 648/1,000-ct. bottles
Recall Number	V-112-2013

Product Description	Levothyroxine sodium tablets, USP, 0.3 mg., RX, packaged under the following labels: (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-253-10) and 1,000-ct. bottles (NDC 11789-253-20), LLOYD, Inc., Shenandoah, IA; (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2), Distributed Exclusively by Butler Schein Animal Health, Dublin, OH; (3) Phoenix Thyrozine 0.3 mg., packaged in 180-ct. (NDC 57319-333-31) and 1,000-ct. bottles (NDC 57319-333-16), Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO; (4) VEDCO Thyrosyn .3 mg Tablets, packaged in 180-ct. (NDC 50989-201-86) and 1,000-ct. bottles (NDC 50989-201-53), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed by VEDCO, INC., St. Joseph, MO.
Code Info	Thyro-Tabs - KB15711, exp. SEP 2012; Thyroxine L - KB13611 and KB13611A, exp. AUG 2012; and KB15711 and KB15711A, exp. SEP 2012; Thyrozine - KB15711 and KB15711F, exp. SEP 2012; and KB13611 and KB13611A, Exp. AUG 2012; and Thyrosyn - KB13611 and KB13611A, exp. AUG 2012.
Classification	Class III
Reason for Recall	Product did not meet in-process specification
Product Quantity	1,210/120-ct., 1,941/180-ct., and 3,176/1,000-ct. bottles
Recall Number	V-113-2013

Product Description	Levothyroxine sodium tablets, USP, 0.7 mg.,RX, packaged under the following labels: (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-257-10), and 1,000-ct. bottles (NDC 11789-257-20), LLOYD, Inc., Shenandoah, IA; (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2) , Distributed Exclusively by Butler Schein Animal Health, Dublin, OH; (3) Phoenix Thyrozine 0.7 mg, packaged in 180-ct. (NDC 57319-337-31) and 1,000-ct. bottles (NDC 57319-337-16), Manufactured for Clipper distributing Company, LLC, St. Joseph, MO; (4) VEDCO Thyrosyn .7 mg Tablets, packaged in 180-ct. bottles (NDC 50989-283-86), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed By VEDCO, INC., St. Joseph, MO.
Code Info	Thyro-Tabs - Lot KB18011, exp. OCT 2012; Thyroxine L - Lot KB18011 and KB18011A, exp. OCT 2012; Thyrozine - Lot KB18011, KB18011F, and KB18011FA, exp. OCT 2012; and Thyrosyn - Lot KB18011 and KB18011A, exp. OCT 2012.
Classification	Class III
Reason for Recall	Product did not meet in-process specification
Product Quantity	2,300/120-ct., 1,517/180-ct., and 1,286/1,000-ct. bottles
Recall Number	V-114-2013

Product Description	Levothyroxine sodium tablets, USP, 0.8 mg., packaged in 1,000-ct. bottles, RX, under the following private labels: (1) Butler Schein Animal Health Thyroxine L, NDC 11695-4468-2, Distributed Exclusively by Butler Schein Animal Health, Dublin. OH; and (2) VEDCO Thyrosyn .8 mg Tablets, NDC 50989-204-53, Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed by VEDCO, INC., St. Joseph, MO.
Code Info	Thyroxine L - KD11711, exp. AUG 2012; and Thyrosyn - KD11711 and KD11711A, exp. AUG 2012.
Classification	Class III
Reason for Recall	Product did not meet in-process specification
Product Quantity	1,891/1,000-ct. bottles
Recall Number	V-115-2013

Product Description	LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 1.0 mg., packaged in 120-ct. (NDC 11789-268-10) and 1,000-ct. bottles (NDC 11789-268-20), RX. The firm name on the label is LLOYD, Inc., Shenandoah, IA.
Code Info	Lot KB17311, exp. OCT 2012
Classification	Class III
Reason for Recall	Product did not meet in-process specification
Product Quantity	4,232/120-ct. and 811/1,000-ct. bottles
Recall Number	V-116-2013

Class III Biologics Event

Event ID	63113
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American Natl Red Cross Mid Atlantic Region
City	Norfolk
State	VA
Country	US
Distribution Pattern	California

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	029KH65246;
Classification	Class III
Reason for Recall	Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0054-13

Class III Biologics Event

Event ID	63114
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jun-12
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	American Red Cross Blood Services
City	Farmington
State	CT
Country	US
Distribution Pattern	California

Associated Products

Product Description	Recovered Plasma
Code Info	033FM41980;
Classification	Class III
Reason for Recall	Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-0055-13

Class III Biologics Event

Event ID	63170
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Aug-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeServe Blood Center
City	Des Moines
State	IA
Country	US
Distribution Pattern	Switzerland; Iowa

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W044112108023;
Classification	Class III
Reason for Recall	Blood product, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity
Recall Number	B-0061-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W044112108023;
Classification	Class III
Reason for Recall	Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity	2
Recall Number	B-0062-13

Class III Biologics Event

Event ID	63435
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Sep-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Knoxville Plasma Corporation
City	Knoxville
State	TN
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	TQ192038
Classification	Class III
Reason for Recall	Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity	1 unit
Recall Number	B-0160-13

Class III Drugs Event

Event ID	63538
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Ferring Pharmaceuticals Inc
City	Parsippany
State	NJ
Country	US
Distribution Pattern	nationwide

Associated Products

Product Description	Novarel® (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall.
Code Info	Lot Number Expiration Date 1C264A 09/12 1H047A 12/12 1H047B 12/12 1H052A 12/12 1H052B 04/13 1H052C 04/13 1M417A 04/13 1M417B 09/13 2A012A 09/13 2A012B 11/13 2C278A 09/13 2C278B 09/13 2C278C 11/13 2C278D 11/13 2C278E 11/13
Classification	Class III
Reason for Recall	Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.
Product Quantity	146,867 Vials
Recall Number	D-073-2013

Class III Biologics Event

Event ID	63562
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Transplant Services Center UT Southwestern Medical Center
City	Dallas
State	TX
Country	US
Distribution Pattern	Texas

Associated Products

Product Description	Cornea
Code Info	20111263; 20111264
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-0378-13

Product Description	Skin
Code Info	20111263BL16; 20111263BL26; 20111263BL36; 20111263BL46; 20111263BL56; 20111263BL66; 20111263FL15; 20111263FL25; 20111263FL35; 20111263FL45; 20111263FL55
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	11
Recall Number	B-0379-13

Class III Food/Cosmetics Event

Event ID	63647
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Oct-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	HP Hood LLC
City	Lynnfield
State	MA
Country	US
Distribution Pattern	Connecticut, Georgia, Florida, Massachusetts, New Jersey, New York, Rhode Island and Wisconsin

Associated Products

Product Description	Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618
Code Info	Best by: 12/05/2012 plt# 51-4109
Classification	Class III
Reason for Recall	Product labeled as Unsweetened Vanilla Blue Diamond Almond Breeze Almond milk may contain chocolate flavored Almondmilk ( undeclared ingredients: cocoa and evaporated cane juice).
Product Quantity	4,320/Half Gallon
Recall Number	F-0742-2013

Class III Biologics Event

Event ID	63678
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	East Tennessee Lions Eye Bank
City	Knoxville
State	TN
Country	US
Distribution Pattern	Tennessee

Associated Products

Product Description	Cornea
Code Info	120349100; 120349200
Classification	Class III
Reason for Recall	Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-0388-13

Mixed Classification Food/Cosmetics Event

Event ID	62710
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Tomales Bay Foods, Inc.
City	Petaluma
State	CA
Country	US
Distribution Pattern	Part One: CA, VA, VT, WI, OR, UT and Italy, Spain, Switzerland, France, Holland, Greece. Part Two: Dates of Distribution: 6/2512 - 7/27/12 Pattern: CA, NC, FL

Associated Products

Product Description	Tumulo Farms, Pondhopper Cheese; any cut or partial wheels, wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
Code Info	Pack Dated of 6/28 and after
Classification	Class I
Reason for Recall	State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese. .
Product Quantity	101.1 pounds
Recall Number	F-0797-2013

Product Description	Shepherd's Way Big Woods Blue cut wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA
Code Info	Pack Dates of 6/28 and after; Make date of 7/19/11 to 7/27/11
Classification	Class I
Reason for Recall	State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese.
Product Quantity	31.9 pounds
Recall Number	F-0798-2013

Product Description	Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda, Holey Cow, Big Woods Blue, Fiore Sardo,, Valdeon, Pecorino Romano, Sottocenere, Capriago, Capricious, Cave Aged Gruyere, Cave Aged Marisa, Fenacho, Pondhopper, Comte, L'Amuse Signature Gouda, Dante Waxed Rind, Dry Jack Special Reserve, Mezzo Secco, Extra Mature Bandage Cheddar, San Joaquin Gold, Flagship Reserve Truckle, Fontina Vallet Pietro, Grana Padano, Parmigiano Reggiano Organic, Taleggio Organic, Comte Reserve Ete, Loma Alta, Mt. Viko Barrel Aged Feta, Pepato, San Andreas Bellwether Farms, Reading, Tarentaise, Seahive, St. George, Toma and Wagon Wheel. Cheese is cut per order and wrapped in cheese paper and marked with a magic marker indicating the type of cheese, poundage and pack date as well as a Tomales Bay Foods label. There are no code numbers or expiration dates marked on the product.
Code Info	All product cut and wrapped on July 24 and 25, 2012.
Classification	Class II
Reason for Recall	Firm received a positive environmental for Listeria Monocytogenes from their internal testing samples.
Product Quantity	562.74 pounds original recall, 101.1 pounds of Pondhopper and 31.41 pounds of Big Woods Blue
Recall Number	F-1985-2012

Mixed Classification Biologics Event

Event ID	63171
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Community Blood Centers of Florida, Inc.
City	Miami
State	FL
Country	US
Distribution Pattern	Florida; Kentucky

Associated Products

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036812381616;
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity	1
Recall Number	B-0063-13

Product Description	Red Blood Cells
Code Info	W036812381616;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity	1
Recall Number	B-0064-13

Mixed Classification Biologics Event

Event ID	63172
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Aug-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Centers of South Florida, Inc.
City	Lake Worth
State	FL
Country	US
Distribution Pattern	Florida; New Zealand

Associated Products

Product Description	Red Blood Cells
Code Info	W036810167666; W036812336104;
Classification	Class II
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0065-13

Product Description	Blood and Blood Products for Reprocessing
Code Info	W036810167666; W036812336104;
Classification	Class III
Reason for Recall	Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-0066-13

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