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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Class I Devices Event

Event ID61835
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmNatus Medical Incorporated
CitySeattle
StateWA
CountryUS
Distribution PatternWorldwide 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 DescriptionThe 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 Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***"
Code Info1008; 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.
ClassificationClass I
Reason for RecallThe 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 Quantity324 units
Recall NumberZ-0447-2013

Class I Food Event

Event ID63421
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBreedlove Foods, Inc.
CityLubbock
StateTX
CountryUS
Distribution PatternProduct was exported to Columbia.
 

Associated Products

Product DescriptionVitanut Pro IC, 50 g
Code InfoLot Code 2236
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. The product was manufactured using peanut paste supplied by Sunland, Inc.
Product Quantity1,469 cases (240 sachets/case)
Recall NumberF-0795-2013

Class I Food Event

Event ID63648
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmOmya Inc
CitySuperior
StateAZ
CountryUS
Distribution PatternNationwide in the US: TX, MN, CA, LA, IL, AZ and Worldwide to Mexico.
 

Associated Products

Product DescriptionGround 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 InfoLot numbers Z227510511 Z227500511 Z227500511 Z227510409 Z230310409 Z228400712 Z228200712
ClassificationClass I
Reason for RecallOmya 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 Quantity922,250 lbs
Recall NumberF-0741-2013

Class I Food Event

Event ID63721
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKennys Farmhouse Cheese
CityAustin
StateKY
CountryUS
Distribution PatternKY, AL, IN, NC, TN, and VA
 

Associated Products

Product DescriptionColby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info120724
ClassificationClass I
Reason for RecallListeria monocytogenes contamination in product
Product Quantity358.65lbs
Recall NumberF-0743-2013
Product DescriptionChipotle Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info120711
ClassificationClass I
Reason for RecallListeria monocytogenes contamination in product
Product Quantity144.07lbs
Recall NumberF-0744-2013
Product DescriptionMonterey Jack , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info120719
ClassificationClass I
Reason for RecallListeria monocytogenes contamination in product
Product Quantity361.03lbs
Recall NumberF-0745-2013
Product DescriptionMild Cheddar , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed
Code Info120625
ClassificationClass I
Reason for RecallListeria monocytogenes contamination in product
Product Quantity238.83lbs
Recall NumberF-0746-2013

Class I Food Event

Event ID63726
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBoulder Ice Cream
CityBoulder
StateCO
CountryUS
Distribution PatternUnited 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 DescriptionOrganic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO.
Code InfoAll products with a "Best Buy" date of 10/3/13 or earlier.
ClassificationClass I
Reason for RecallProducts manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity144 x 5 liter containers.
Recall NumberF-0799-2013
Product DescriptionSerano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO.
Code InfoAll products with a "Best Buy" date of 08/10/13 or earlier.
ClassificationClass I
Reason for RecallProducts manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity16,928 pints
Recall NumberF-0800-2013
Product DescriptionElvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO.
Code InfoAll products with a "Best Buy" date of 06/02/13 or earlier.
ClassificationClass I
Reason for RecallProducts manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity28 x 2.5 gallon
Recall NumberF-0801-2013
Product DescriptionAll 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 Info2.5 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.
ClassificationClass I
Reason for RecallProducts manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity329 x 2.5 gallon; 18,436 pints
Recall NumberF-0802-3013
Product DescriptionYoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO.
Code InfoAll 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.
ClassificationClass I
Reason for RecallProducts manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination.
Product Quantity6,988 x 1 gallon
Recall NumberF-0803-2013

Class I Food Event

Event ID63736
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHillshire Brands Company
CityDowners Grove
StateIL
CountryUS
Distribution PatternAlabama, 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 DescriptionSara 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 InfoUPC: 032100023429; Best By Date of 10/16/2013
ClassificationClass I
Reason for RecallThe 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 Quantity588 cases
Recall NumberF-0796-2013

Class I Food Event

Event ID63766
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLegendary Baking
CityChaska
StateMN
CountryUS
Distribution PatternDistributed to Quality Food Centers (QFC) in Washington State and Oregon by common carrier.
 

Associated Products

Product DescriptionApple 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 InfoLot code CH12296
ClassificationClass I
Reason for RecallLegendary 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 Quantity726 pies
Recall NumberF-0805-2013

Class I Food Event

Event ID63770
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmJagpreet Enterprises Inc.
CityHayward
StateCA
CountryUS
Distribution PatternIN, CA, TX, MN, GA, CO, WA
 

Associated Products

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

Class II Biologics Event

Event ID41641
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternOK, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LH71740
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0123-13
Product DescriptionRecovered Plasma
Code Info02LH71740
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Product Quantity1 unit
Recall NumberB-0124-13

Class II Biologics Event

Event ID48841
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08OUTB0022, 08OUTA7668, 08OUTA3003, 08OUTA0406, 07OUTF5925, 07OUTF5433, 07OUTF4393, 07OUTF4091, 07OUTF3071, 07OUTF1724, 07OUTF0389, 07OUTE9920
ClassificationClass II
Reason for RecallBlood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity12 units
Recall NumberB-0070-13

Class II Biologics Event

Event ID48843
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityOgden
StateUT
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info08OUTB4879, 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
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity108
Recall NumberB-0069-13

Class II Biologics Event

Event ID50658
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Nov-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info366075510, 366075578, 366081734, 366083633, 366084506, 366085118, 366085884, 366087228, 366087696, 366088653, 366089152, 366093041, 366096304, 366099383, 366100646, 366101126, 366102595
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a tattoo within one year of donation, were distributed.
Product Quantity17 units
Recall NumberB-0042-13

Class II Biologics Event

Event ID50667
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info366060584, 366062394, 366062738, 366063408, 366063980, 366068895, 366070142, 366070611
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may have received a tattoo within one year of donation, were distributed.
Product Quantity8 units
Recall NumberB-0043-13

Class II Veterinary Event

Event ID62133
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLloyd Inc
CityShenandoah
StateIA
CountryUS
Distribution PatternDistribution was made nationwide. There was no foreign, military, or government distribution.
 

Associated Products

Product DescriptionPrednisTab (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 InfoLot 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.
ClassificationClass II
Reason for RecallSome of the bottles may contain broken tablets
Product Quantity18.074/1,000-tablet bottles
Recall NumberV-117-2013

Class II Drugs Event

Event ID62511
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLloyd Inc. of Iowa
CityShenandoah
StateIA
CountryUS
Distribution PatternDistribution was nationwide, including Puerto Rico. There was no foreign, military, or government distribution.
 

Associated Products

Product DescriptionThyro-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 InfoLot #HB01212
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity1,923,887 tablets
Recall NumberD-074-2013
Product DescriptionLevothroid (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 InfoLot #1097830 exp. 1/31/2013
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity13,692/100-tablet bottles
Recall NumberD-075-2013
Product DescriptionThyro-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 InfoLot #HA31411 and #HE17811
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity3,826,269 tablets
Recall NumberD-076-2013
Product DescriptionLevothroid (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 InfoLot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity31,252/100-tablet bottles
Recall NumberD-077-2013
Product DescriptionThyro-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 InfoLot #HC31411 and #HE18711
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity3,813,645 tablets
Recall NumberD-078-2013
Product DescriptionLevothroid (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 InfoLot #1096371, exp. 5/312013; and #1092299, exp. 1/31/2013
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity37,827/100-tablet bottles
Recall NumberD-079-2013
Product DescriptionThyro-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 InfoLot #HB27811
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity1,924,174 tablets
Recall NumberD-080-2013
Product DescriptionLevothroid (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 InfoLot #1095210, exp. 4/30/2013
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity19,162/100-tablet bottles
Recall NumberD-081-2013
Product DescriptionThyro-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 InfoLot #HA27911 and #HA12511
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity3,774,541 tablets
Recall NumberD-082-2013
Product DescriptionLevothroid (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 InfoLot #1095212 exp. 4/30/2013; and #1088877, exp. 11/30/2012
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity36,978/100-tablet bottles
Recall NumberD-083-2013
Product DescriptionThyro-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 InfoLot #HE35311
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity1,902,957 tablets
Recall NumberD-084-2013
Product DescriptionLevothroid (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 InfoLot #1097178 exp. 7/31/2013
ClassificationClass II
Reason for RecallcGMP Deviations; does not meet in process specification requirements
Product Quantity1,443/100-tablet bottles
Recall NumberD-085-2013

Class II Biologics Event

Event ID62610
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeNet Health
CityVirginia Beach
StateVA
CountryUS
Distribution PatternThe tissues were shipped nationwide and to Canada and Korea.
 

Associated Products

Product DescriptionDecellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251
Code InfoSerial numbers: 1012784D190, 1012784D191, 1012784D192, 1012784D193, 1012784D194, 1012784D195, 1012784D196, 1012784D197, 1012784D198, 1012784D199, 1012784D200, 1012784D201, 1012784D202, 1012784D212, 1012784D213, 1012784D214, 1012784D218
ClassificationClass II
Reason for RecallHuman tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity17 tissues
Recall NumberB-0350-13
Product DescriptionFascia, human tissue for transplantation, product code FL M
Code InfoSerial number: 1012784045
ClassificationClass II
Reason for RecallHuman tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity1 tissue
Recall NumberB-0351-13
Product DescriptionBone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP.
Code InfoSerial 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
ClassificationClass II
Reason for RecallHuman tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity42 tissues
Recall NumberB-0352-13
Product DescriptionTendon, human tissue for transplantation,
Code InfoSerial numbers: 1012784001, 1012784002, 1012784003, 1012784004, 1012784005, 1012784006, 1012784007, 1012784008, 1012784009, 1012784010
ClassificationClass II
Reason for RecallHuman tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed.
Product Quantity10 tissues
Recall NumberB-0353-13

Class II Devices Event

Event ID62749
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMerit Medical Systems, Inc.
CityChester
StateVA
CountryUS
Distribution PatternNationwide distribution: US including states of: NE and SD.
 

Associated Products

Product DescriptionCustom 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 InfoMerit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
ClassificationClass II
Reason for RecallCustom 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 Quantity83 packs
Recall NumberZ-0464-2013

Class II Biologics Event

Event ID63131
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038612825235;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
Product Quantity1
Recall NumberB-0056-13
Product DescriptionFresh Frozen Plasma
Code InfoW038612825235;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-0057-13

Class II Biologics Event

Event ID63132
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMichigan Blood
CityGrand Rapids
StateMI
CountryUS
Distribution PatternMichigan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW120611007684;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-0058-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW120611181662;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-0059-13

Class II Biologics Event

Event ID63133
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW051512087394 Part 1; W051512087394 Part 2;
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Product Quantity2
Recall NumberB-0060-13

Class II Biologics Event

Event ID63190
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCaridianBCT, Inc.
CityLakewood
StateCO
CountryUS
Distribution PatternUS distribution only: VA, MS, SC, AZ, TN, MI, TX, PN, CA, NY, CA, UT.
 

Associated Products

Product DescriptionVista 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 InfoVista 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).
ClassificationClass II
Reason for RecallTerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed.
Product Quantity2
Recall NumberB-0387-13

Class II Drugs Event

Event ID63243
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGenentech Inc
CitySouth San Francisco
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionNutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01
Code InfoLot# 936674 Exp. 09/30/13
ClassificationClass II
Reason for RecallMiscalibrated 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 Quantity10,306 syringes
Recall NumberD-087-2013
Product DescriptionNutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01
Code InfoLot # 936670 Exp. 09/30/13
ClassificationClass II
Reason for RecallMiscalibrated 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 Quantity12,791 syringes
Recall NumberD-088-2013

Class II Biologics Event

Event ID63401
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBloodCenter of Wisconsin, Inc
CityMilwaukee
StateWI
CountryUS
Distribution PatternWisconsin
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW036311158586
ClassificationClass II
Reason for RecallBlood product, which was incorrectly labeled as negative for the C red cell antigen, was distributed.
Product Quantity1 unit
Recall NumberB-0158-13

Class II Biologics Event

Event ID63402
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112283072F
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-0157-13

Class II Biologics Event

Event ID63403
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112218788D
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-0156-13

Class II Biologics Event

Event ID63404
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112272578B
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-0155-13

Class II Devices Event

Event ID63407
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide 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 Description24 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 Infocatalog number: 5841 and 5845 and lot number: 0581536 and 0581138.
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total
Recall NumberZ-0456-2013
Product Description24 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 Infocatalog number: 5843 and lot number: 0584961
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total
Recall NumberZ-0457-2013
Product Description24 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 Infocatalog number: 5847 and lot number: 0582251 and 0586068
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total
Recall NumberZ-0458-2013
Product Description18 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 Infocatalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810.
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total
Recall NumberZ-0459-2013
Product Description18 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 Infocatalog number: 7072 and lot number: 0602542, 0614871, and 0620810.
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total
Recall NumberZ-0460-2013
Product Description24 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 Infocatalog number: 5762 and lot number: 0570466 and 0589212
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total products
Recall NumberZ-0461-2013
Product Description24 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 Infocatalog number: 5774 and lot number: 0595116.
ClassificationClass II
Reason for RecallBased 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 Quantity5760 total units
Recall NumberZ-0462-2013

Class II Biologics Event

Event ID63427
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeNet Health
CityVirginia Beach
StateVA
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionCardiac Tissue, Non-valved
Code Info11112910004
ClassificationClass II
Reason for RecallCardiac Tissue Allograft, processed in a manner that did not prevent the introduction, transmission, or spread of communicable disease, was distributed.
Product Quantity1
Recall NumberB-0386-13

Class II Devices Event

Event ID63429
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternWorldwide 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 DescriptionDimension 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 InfoLot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD.
ClassificationClass II
Reason for RecallSiemens 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 Quantity19,310
Recall NumberZ-0452-2013

Class II Biologics Event

Event ID63434
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNorthern Illinois Blood Bank dba Rock River Valley BC
CityRockford
StateIL
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW044412202215
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1 unit
Recall NumberB-0159-13

Class II Biologics Event

Event ID63436
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOur Lady Of The Lake Hospital Inc
CityBaton Rouge
StateLA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW1657120214005
ClassificationClass II
Reason for RecallBlood product, with a platelet count that exceeded the maximum specification, was distributed.
Product Quantity1 unit
Recall NumberB-0161-13

Class II Devices Event

Event ID63442
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide Distribution.
 

Associated Products

Product DescriptionStryker 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 InfoClass I, 510(k) exempt Catalog Number: 6543-1-600 Lot Number; NE1WR1
ClassificationClass II
Reason for RecallOffset 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 Quantity7 units
Recall NumberZ-0469-2013
Product DescriptionStryker 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 InfoClass I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31
ClassificationClass II
Reason for RecallOffset 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 Quantity8
Recall NumberZ-0470-2013

Class II Devices Event

Event ID63495
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide distribution: USA including states of: GA, ID, IL, IA, NE, NC, OH, SD, TX, and WI.
 

Associated Products

Product DescriptionSiemens Mobilette Mira, intended use as Mobile x-ray system.
Code InfoModel Number 10273100
ClassificationClass II
Reason for RecallThere is a risk of lost images during examination.
Product Quantity21
Recall NumberZ-0480-2013

Class II Devices Event

Event ID63521
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
 

Associated Products

Product DescriptionSiemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Code InfoModel number 10 592 457
ClassificationClass II
Reason for RecallFirm 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 Quantity15
Recall NumberZ-0465-2013

Class II Devices Event

Event ID63553
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips And Neusoft Medical Systems Co., Ltd.
CityShenyang, Liaoning
State
CountryCN
Distribution PatternNationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
 

Associated Products

Product DescriptionNeuViz 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 InfoNeuViz 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.
ClassificationClass II
Reason for RecallThe 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 Quantity20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Recall NumberZ-0466-2013

Class II Devices Event

Event ID63577
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Diagnostics Operations, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide 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 DescriptionCobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis.
Code InfoCatalog 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.
ClassificationClass II
Reason for RecallOn 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 Quantity78 analyzers
Recall NumberZ-0473-2013

Class II Devices Event

Event ID63615
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSekisui Diagnostics Llc
CityStamford
StateCT
CountryUS
Distribution PatternNationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.
 

Associated Products

Product DescriptionSekisui 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 InfoLot # 120827, exp 11/27/2012
ClassificationClass II
Reason for RecallSpectrolyse 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 Quantity63 kits
Recall NumberZ-0463-2013

Class II Devices Event

Event ID63619
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide 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 DescriptionPhilips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
Code InfoAll Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
ClassificationClass II
Reason for RecallWith 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 Quantity623 units
Recall NumberZ-0475-2013

Class II Drugs Event

Event ID63628
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCaraco Pharmaceutical Laboratories, Ltd.
CityDetroit
StateMI
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptiontraMADOL 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 InfoLot # GKK1373, Exp 09/13
ClassificationClass II
Reason for RecallAdulterated 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 Quantity2,264 bottles
Recall NumberD-089-2013

Class II Devices Event

Event ID63634
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-11
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmStryker Instruments Div. of Stryker Corporation
CityPortage
StateMI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and Pacific countries, and the countries of EEMEA, Canada, Latin America, and Japan.
 

Associated Products

Product DescriptionNeptune® 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 InfoPart 0702-001-000 (120v) Lot 0733700353 through 1036100423
ClassificationClass II
Reason for RecallBeginning 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 Quantity5865
Recall NumberZ-0454-2013
Product DescriptionNeptune® 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 InfoPart 0702-002-000 (230v) Lot 0733700353 through 1036100423
ClassificationClass II
Reason for RecallBeginning 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 Quantity154
Recall NumberZ-0455-2013

Class II Food Event

Event ID63640
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZingerman's Bakehouse, Inc.
CityAnn Arbor
StateMI
CountryUS
Distribution PatternMichigan and Ohio
 

Associated Products

Product DescriptionZingerman's Bakehouse Gingerbread Cake Net wt. 3 LB; 1.25 LB
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3LB and 1.25 LB (Total Quantity: 180)
Recall NumberF-0747-2013
Product DescriptionZingerman's Bakehouse Sourcream Coffeecake Net wt. 3 LB; 1.25 LB
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3lbs: 1.25lb (Total Quantity: 1,039)
Recall NumberF-0748-2013
Product DescriptionZingerman's Bakehouse Hot Cocoa Cake Net wt. 3 LB; 1.25 LB
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3lbs; 1.5lb (Total Quantity: 325)
Recall NumberF-0749-2013
Product DescriptionZingerman's Bakehouse Lemon Poppy Seed Coffeecake Net wt. 2.5 LB; 1.25 LB
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity2.5lbs.; 1.25lb (Total Quantity: 84)
Recall NumberF-0750-2013
Product DescriptionZingerman's Bakehouse Funky Chunky Chocolate Cookies Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces (Total Quantity: 875)
Recall NumberF-0751-2013
Product DescriptionZingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity6 ounces (Total Quantity: 217)
Recall NumberF-0752-2013
Product DescriptionZingerman's Bakehouse Big O Cookie Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0753-2013
Product DescriptionZingerman's Bakehouse Big O Cookie Jrs. Net wt. 1/2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/2 lb (Total Quantity: 148)
Recall NumberF-0754-2013
Product DescriptionZingerman's Bakehouse Ginger Jump-up Cookies Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces (Total Quantity: 804)
Recall NumberF-0755-2013
Product DescriptionZingerman's Bakehouse Jr. Ginger Jump-up Cookies Net wt. 6 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity6 ounces (Total Quantity: 202)
Recall NumberF-0756-2013
Product DescriptionZingerman's Bakehouse Triple Trouble Chocolate Cookie Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces
Recall NumberF-0757-2013
Product DescriptionZingerman's Bakehouse Junior Triple Trouble Chocolate Cookies Net wt. 6 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity6 ounces (Total Quantity: 78)
Recall NumberF-0758-2013
Product DescriptionZingerman's Bakehouse Mandelbread Net wt. 8 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity8 ounces (Total Quantity: 101)
Recall NumberF-0759-2013
Product DescriptionZingerman's Bakehouse Bumble Honey Cake Net wt. 1.25 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.25 ounces
Recall NumberF-0760-2013
Product DescriptionZingerman's Bakehouse Banana Bread Net wt. 20 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity20 ounces (Total Quantity: 216)
Recall NumberF-0761-2013
Product DescriptionZingerman's Bakehouse Genuine Ginger Brownies Net wt. 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 48)
Recall NumberF-0762-2013
Product DescriptionZingerman's Bakehouse Country Scone Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces
Recall NumberF-0763-2013
Product DescriptionZingerman's Bakehouse Ginger Scone Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces
Recall NumberF-0764-2013
Product DescriptionZingerman's Bakehouse Northern Corn Bread Net wt. 18 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity18 ounces (Total Quantity: 64)
Recall NumberF-0765-2013
Product DescriptionZingerman's Bakehouse Currant Scone Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces
Recall NumberF-0766-2013
Product DescriptionZingerman's Bakehouse Townie Brownies Net wt. 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 398)
Recall NumberF-0767-2013
Product DescriptionZingerman's Bakehouse Chocolate Banana Bread Net wt. 20 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity20 ounces (Total Quantity: 202)
Recall NumberF-0768-2013
Product DescriptionZingerman's Bakehouse Buenos Aires Brownies Net wt. 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 1,566)
Recall NumberF-0769-2013
Product DescriptionZingerman's Bakehouse Almond Pound Cake Net wt. 1.25 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.25 lb
Recall NumberF-0770-2013
Product DescriptionZingerman's Bakehouse Rugelach Net wt. 1/2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/2 lb (Total Quantity: 191)
Recall NumberF-0771-2013
Product DescriptionZingerman's Bakehouse Cinful Cinnamon Rolls Net wt. 1 1/2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1 1/2 lb (Total Quantity: 105)
Recall NumberF-0772-2013
Product DescriptionZingerman's Bakehouse Brownie Party Net wt. 1.2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.2 lb (Total Quantity: 282)
Recall NumberF-0773-2013
Product DescriptionZingerman's Bakehouse Palmiers Net wt. 4 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity4 ounces (Total Quantity: 282)
Recall NumberF-0774-2013
Product DescriptionZingerman's Bakehouse Summer Fling Coffeecake Net wt. 3 lbs
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 lbs
Recall NumberF-0775-2013
Product DescriptionZingerman's Bakehouse ZBPB's Peanut Butter Cookie Net wt. 3 ounces
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity3 ounces (Total Quantity: 299)
Recall NumberF-0776-2013
Product DescriptionZingerman's Bakehouse Cape Cod Cranberry Walnut Pie
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0777-2013
Product DescriptionZingerman's Bakehouse Stollen
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0778-2013
Product DescriptionZingerman's Bakehouse Chocolate Chess Pie
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0779-2013
Product DescriptionZingerman's Bakehouse Perky Pecan Pie
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0780-2013
Product DescriptionZingerman's Bakehouse Olive Oil Cake Net wt. 1.25 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.25 lb
Recall NumberF-0781-2013
Product DescriptionZingerman's Bakehouse Jumbleberry Pie
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 NumberF-0782-2013
Product DescriptionZingerman's Bakehouse Pound Cake 1 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman's BAKEHOUSE pastry labels were found not identifying the source of flour as wheat.
Product Quantity1 lb (Total Quantity: 39)
Recall NumberF-0783-2013
Product DescriptionZingerman's Bakehouse Graham Crackers 1 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1 lb (Total Quantity: 230)
Recall NumberF-0784-2013
Product DescriptionZingerman's Bakehouse Orange-Almond Magic Brownies 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity:16)
Recall NumberF-0785-2013
Product DescriptionZingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk.
Product Quantity1 lb
Recall NumberF-0786-2013
Product DescriptionZingerman's Bakehouse Pecan Blondies 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 794)
Recall NumberF-0787-2013
Product DescriptionZingerman's Bakehouse Sweet Butter Teacake 1.25 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.25 lb (Total Quantity: 12)
Recall NumberF-0788-2013
Product DescriptionZingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.25 lb
Recall NumberF-0789-2013
Product DescriptionZingerman's Bakehouse Apricot Rugelach Net wt. 1/2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/2 lb (Total Quantity: 168)
Recall NumberF-0790-2013
Product DescriptionZingerman's Bakehouse Black Magic Brownies Net wt. 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 1,742)
Recall NumberF-0791-2013
Product DescriptionZingerman's Bakehouse Magic Brownies Net wt. 1/4 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1/4 lb (Total Quantity: 2,323)
Recall NumberF-0792-2013
Product DescriptionZingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb
Code Infonone
ClassificationClass II
Reason for RecallZingerman'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 Quantity1.2 lb (Total Quantity: 79)
Recall NumberF-0793-2013

Class II Devices Event

Event ID63642
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOmniGuide, Inc.
CityCambridge
StateMA
CountryUS
Distribution PatternNationwide Distribution including AZ, FL, MA, NY, OH, and OR.
 

Associated Products

Product DescriptionOmniGuide 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 InfoLot 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 :
ClassificationClass II
Reason for RecallFailure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient
Product Quantity45 units
Recall NumberZ-0453-2013

Class II Devices Event

Event ID63643
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInvivo Corporation
CityOrlando
StateFL
CountryUS
Distribution PatternWorldwide 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 DescriptionInvivo 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 InfoModel 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
ClassificationClass II
Reason for RecallInvivo 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 Quantity543 units
Recall NumberZ-0468-2013

Class II Devices Event

Event ID63646
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling Firmiwalk inc
CityBedford
StateMA
CountryUS
Distribution PatternNationwide Distribution including OH, NC, and NY.
 

Associated Products

Product DescriptionBiOM 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 InfoProduct Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973
ClassificationClass II
Reason for RecallBattery may over-heat during charging and smoke
Product Quantity21 Batteries; 9 Chargers
Recall NumberZ-0467-2013

Class II Drugs Event

Event ID63685
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTaro Pharmaceuticals U.S.A., Inc.
CityHawthorne
StateNY
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionFluorouracil 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 InfoLot #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.
ClassificationClass II
Reason for RecallProduct Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Product Quantity39,982 Tubes
Recall NumberD-086-2013

Class II Devices Event

Event ID63708
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternUSA Nationwide Distribution in the state of WI.
 

Associated Products

Product DescriptionBio-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 InfoCatalog Number: 113740 and Lot Number Identification: 779270
ClassificationClass II
Reason for RecallThe 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 Quantity4
Recall NumberZ-0474-2013

Class II Food Event

Event ID63762
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeachside Produce Llc
CityGuadalupe
StateCA
CountryUS
Distribution PatternCA and NJ
 

Associated Products

Product DescriptionIced Broccoli crown, 20lbs.
Code InfoHighway One Label: 040112A3-01810182 140312C3-10110182 031912A7-07010182 031812A7-01910182 031812A7-01810182 020112A1-12310182 031512A7-06910182 Beachside Label: 140312C3-10110182
ClassificationClass II
Reason for RecallBeachside Produce is recalling iced broccoli crownds due to the potential of having hydraulic fluid onto the ice that cooled the product.
Product Quantity946 units
Recall NumberF-0794-2013

Class III Biologics Event

Event ID48855
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas; Austria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW045007075233
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0067-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045007075233
ClassificationClass III
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 Unit
Recall NumberB-0068-13

Class III Veterinary Event

Event ID62550
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLloyd Inc. of Iowa
CityShenandoah
StateIA
CountryUS
Distribution PatternDistribution was nationwide. There was no foreign, military, or government distribution.
 

Associated Products

Product DescriptionLLOYD 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 InfoKA16611, exp. SEP 2012
ClassificationClass III
Reason for RecallProduct lot KA16611 did not meet finished product release specifications
Product Quantity2,535/120-ct. and 648/1,000-ct. bottles
Recall NumberV-112-2013
Product DescriptionLevothyroxine 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 InfoThyro-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.
ClassificationClass III
Reason for RecallProduct did not meet in-process specification
Product Quantity1,210/120-ct., 1,941/180-ct., and 3,176/1,000-ct. bottles
Recall NumberV-113-2013
Product DescriptionLevothyroxine 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 InfoThyro-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.
ClassificationClass III
Reason for RecallProduct did not meet in-process specification
Product Quantity2,300/120-ct., 1,517/180-ct., and 1,286/1,000-ct. bottles
Recall NumberV-114-2013
Product DescriptionLevothyroxine 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 InfoThyroxine L - KD11711, exp. AUG 2012; and Thyrosyn - KD11711 and KD11711A, exp. AUG 2012.
ClassificationClass III
Reason for RecallProduct did not meet in-process specification
Product Quantity1,891/1,000-ct. bottles
Recall NumberV-115-2013
Product DescriptionLLOYD 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 InfoLot KB17311, exp. OCT 2012
ClassificationClass III
Reason for RecallProduct did not meet in-process specification
Product Quantity4,232/120-ct. and 811/1,000-ct. bottles
Recall NumberV-116-2013

Class III Biologics Event

Event ID63113
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Natl Red Cross Mid Atlantic Region
CityNorfolk
StateVA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info029KH65246;
ClassificationClass III
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0054-13

Class III Biologics Event

Event ID63114
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmAmerican Red Cross Blood Services
CityFarmington
StateCT
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRecovered Plasma
Code Info033FM41980;
ClassificationClass III
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0055-13

Class III Biologics Event

Event ID63170
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternSwitzerland; Iowa
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW044112108023;
ClassificationClass III
Reason for RecallBlood product, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity
Recall NumberB-0061-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW044112108023;
ClassificationClass III
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity2
Recall NumberB-0062-13

Class III Biologics Event

Event ID63435
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKnoxville Plasma Corporation
CityKnoxville
StateTN
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code InfoTQ192038
ClassificationClass III
Reason for RecallBlood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-0160-13

Class III Drugs Event

Event ID63538
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFerring Pharmaceuticals Inc
CityParsippany
StateNJ
CountryUS
Distribution Patternnationwide
 

Associated Products

Product DescriptionNovarel® (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 InfoLot 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
ClassificationClass III
Reason for RecallLabeling; 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 Quantity146,867 Vials
Recall NumberD-073-2013

Class III Biologics Event

Event ID63562
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTransplant Services Center UT Southwestern Medical Center
CityDallas
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionCornea
Code Info20111263; 20111264
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-0378-13
Product DescriptionSkin
Code Info20111263BL16; 20111263BL26; 20111263BL36; 20111263BL46; 20111263BL56; 20111263BL66; 20111263FL15; 20111263FL25; 20111263FL35; 20111263FL45; 20111263FL55
ClassificationClass III
Reason for RecallHuman allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity11
Recall NumberB-0379-13

Class III Food Event

Event ID63647
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHP Hood LLC
CityLynnfield
StateMA
CountryUS
Distribution PatternConnecticut, Georgia, Florida, Massachusetts, New Jersey, New York, Rhode Island and Wisconsin
 

Associated Products

Product DescriptionBlue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618
Code InfoBest by: 12/05/2012 plt# 51-4109
ClassificationClass III
Reason for RecallProduct labeled as Unsweetened Vanilla Blue Diamond Almond Breeze Almond milk may contain chocolate flavored Almondmilk ( undeclared ingredients: cocoa and evaporated cane juice).
Product Quantity4,320/Half Gallon
Recall NumberF-0742-2013

Class III Biologics Event

Event ID63678
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmEast Tennessee Lions Eye Bank
CityKnoxville
StateTN
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionCornea
Code Info120349100; 120349200
ClassificationClass III
Reason for RecallHuman corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity2
Recall NumberB-0388-13

Mixed Classification Food Event

Event ID62710
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTomales Bay Foods, Inc.
CityPetaluma
StateCA
CountryUS
Distribution PatternPart 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 DescriptionTumulo 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 InfoPack Dated of 6/28 and after
ClassificationClass I
Reason for RecallState of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese. .
Product Quantity101.1 pounds
Recall NumberF-0797-2013
Product DescriptionShepherd'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 InfoPack Dates of 6/28 and after; Make date of 7/19/11 to 7/27/11
ClassificationClass I
Reason for RecallState of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese.
Product Quantity31.9 pounds
Recall NumberF-0798-2013
Product DescriptionTomales 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 InfoAll product cut and wrapped on July 24 and 25, 2012.
ClassificationClass II
Reason for RecallFirm received a positive environmental for Listeria Monocytogenes from their internal testing samples.
Product Quantity562.74 pounds original recall, 101.1 pounds of Pondhopper and 31.41 pounds of Big Woods Blue
Recall NumberF-1985-2012

Mixed Classification Biologics Event

Event ID63171
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida; Kentucky
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812381616;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity1
Recall NumberB-0063-13
Product DescriptionRed Blood Cells
Code InfoW036812381616;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed
Product Quantity1
Recall NumberB-0064-13

Mixed Classification Biologics Event

Event ID63172
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida; New Zealand
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810167666; W036812336104;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0065-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036810167666; W036812336104;
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0066-13
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