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U.S. Department of Health and Human Services

Enforcement Report - Week of December 12, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 02LH71740 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. American Red Cross Blood Services
Biologics Recovered Plasma 02LH71740 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. American Red Cross Blood Services
Biologics Source Plasma 08OUTB0022, 08OUTA7668, 08OUTA3003, 08OUTA0406, 07OUTF5925, 07OUTF5433, 07OUTF4393, 07OUTF4091, 07OUTF3071, 07OUTF1724, 07OUTF0389, 07OUTE9920 Class II Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 08OUTB4879, 08OUTB2635, 08OUTB1306, 08OUTA8922, 08OUTA7100, 08OUTA6681, 08OUTA5922, 08OUTA5562, 08OUTA4418, 08OUTA4386, 08OUTA3642, 08OUTA3242, 08OUTA2979, 08OUTA2077, 08OUTA0915, 07OUTF4985, 07OUTF4353, 07OUTF3686, 07OUTA4758, 07OUTA5615, 07OUTB0037, 07OUTB0803, 07OUTB1486, 07OUTB2556, 07OUTB3213, 07OUTB3834, 07OUTB6136, 07OUTB6376, 07OUTB7237, 07OUTB9597, 07OUTC0475, 07OUTC1012, 07OUTC2225, 07OUTC2842, 07OUTC4143, 07OUTC4456, 07OUTC5199, 07OUTC6632, 07OUTC8560, 07OUTD1005, 07OUTD3596, 07OUTD5143, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTD4266, 07OUTC9724, 07OUTD0460, 07OUTD2498, 07OUTD8237, 07OUTE0989, 07OUTE1522, 07OUTE6623, 07OUTE7686, 07OUTF0829, 07OUTF1519, 07OUTF4353, 07OUTF4985, 07OUTD5720, 07OUTD6487, 07OUTD7609, 07OUTD9191, 07OUTE0341, 07OUTE3864, 07OUTE8341, 07OUTE9470, 07OUTF2162, 07OUTF3686, 07OUTS0487 08OUTA2979, 08OUTB2635, 08OUTA2077, 08OUTA4386, 08OUTB6603, 08OUTB7200, 08OUTA0915, 08OUTB5655, 07OUTS0551, 07OUTS0998, 07OUTS0940, 07OUTS0991, 07OUTS1070, 07OUTS1118, 07OUTS1162, 07OUTS1334, 07OUTS1350, 07OUTS1415, 07OUTS1589, 07OUTS1654, 07OUTS1692, 07OUTS1778, 07OUTS1828, 07OUTS1923, 07OUTS1946, 07OUTS1999, 07OUTS2108, 07OUTS2247, 07OUTS2428, 07OUTS2617, 07OUTS0273, 07OUTS0551 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. BioLife Plasma Services L.P.
Biologics Blood and Blood Products for Reprocessing W045007075233 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced W045007075233 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Center Of Gtr KC
Biologics Source Plasma 366075510, 366075578, 366081734, 366083633, 366084506, 366085118, 366085884, 366087228, 366087696, 366088653, 366089152, 366093041, 366096304, 366099383, 366100646, 366101126, 366102595 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366060584, 366062394, 366062738, 366063408, 366063980, 366068895, 366070142, 366070611 Class II Blood products, collected from a donor who may have received a tattoo within one year of donation, were distributed. Talecris Plasma Resources, Inc.
Devices The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***" 1008; 1009; 1011; 1012; 1014; 1016; 1017; 1018; 1020; 1021; 1022; 1023; 1024; 1025; 1027; 1028; 1029; 1030; 1031; 1032; 1034; 1035; 1036; 1038; 1044; 1045; 1048; 1050; 1051; 1052; 1053; 1054; 1055; 1056; 1059; 1060; 1062; 1063; 1064; 1065; 1066; 1070; 1071; 1072; 1073; 1074; 1075; 1076; 1077; 1079; 1080; 1081; 1082; 1083; 1084; 1085; 1086; 1087; 1088; 1089; 1090; 1091; 1092; 1093; 1094; 1095; 1096; 1097; 1098; 1101; 1116; 1117; 1118; 1119; 1120; 1121; 1122; 1124; 1125; 1126; 1127; 1128; 1129; 1130; 1131; 1132; 1134; 1136; 1137; 1138; 1139; 1141; 7002; 7003; 7004; 7005; 7007; 7008; 7009; 7010; 7011; 7012; 7013; 7014; 7015; 7016; 7017; 7018; 7019; 7020; 7021; 7022; 7023; 7024; 7025; 7026; 7027; 7028; 7029; 7030; 7031; 7032; 7033; 7034; 7036; 7037; 7038; 7039; 7040; 7041; 7042; 7043; 7044; 7045; 7046; 7047; 7048; 7049; 7050; 7051; 7052; 7053; 7054; 7055; 7250; 7251; 7252; 7253; 7254; 7255; 7256; 7257; 7258; 7259; 7260; 7261; 7262; 7263; 7264; 7266; 7268; 7269; 7274; 7276; 7277; 7281; 7286; 7287; 7289; 7293; 7305; 7306; 7307; 7308; 7310; 7311; 7327; 7330; 7348; 7351; 7356; 7358; 7360; 7363; 7364; 7365; 7366; 7367; 7368; 7369; 7370; 7371; 7372; 7374; 7375; 7376; 7377; 7378; 7380; 7381; 7383; 7384; 7385; 7386; 7387; 7388; 7389; 7394; 7400; 7401; 7402; 7405; 7406; 7407; 7409; 7410; 7411; 7412; 7413; 7414; 7416; 7418; 7420; 7421; 7424; 7431; 7433; 7434; 7435; 7436; 7437; 7438; 7440; 7441; 7265; 7267; 7270; 7271; 7272; 7273; 7275; 7278; 7279; 7280; 7282; 7283; 7284; 7285; 7288; 7290; 7291; 7292; 7294; 7295; 7296; 7297; 7298; 7299; 7300; 7301; 7302; 7303; 7304; 7309; 7312; 7313; 7314; 7315; 7316; 7317; 7318; 7319; 7320; 7321; 7322; 7323; 7324; 7325; 7326; 7328; 7329; 7331; 7332; 7333; 7334; 7335; 7336; 7337; 7338; 7339; 7340; 7341; 7342; 7343; 7344; 7345; 7346; 7347; 7349; 7350; 7352; 7353; 7354; 7355; 7357; 7359; 7361; 7362; 7379; 7382; 7391; 7392; 7393; 7395; 7397; 7398; 7399; 7403; 7404; 7408; 7422; 7423; 7429; 7432. Class I The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occurs, the on-screen information remains on display, but the system is no longer providing cooling treatment to the infants. The visible clock displayed at the upper right hand corner of the screen stops advancing. Natus Medical Incorporated
Veterinary PrednisTab (Prednisolone, USP) 5 mg, packaged in 1,000-tablet bottles, For Oral Use in Dogs Only, RX, NADA #140-921, packaged under the following labels: (1) Lloyd, Inc., Shenandoah, IA; (2) Butler Schein Animal Health, Dublin, OH; and (3) Phoenix, Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO. Lot numbers KM01310, exp. Jan-13; KN01310, exp. Jan-13; KG07010, exp. Mar-13; KG20710, exp. Aug-13; KH20710, exp. Aug-13; KA26410, exp. Sep-13; KB26410, exp. Sep-13; KC26410, exp. Sep-13; KC29910, exp. Nov-13; KD33710, Exp. Dec-13; KE33710, exp. Dec-13; KF33710, exp. Dec-13; and KJ33710, exp. Dec-13. Class II Some of the bottles may contain broken tablets Lloyd Inc
Drugs Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HB01212 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1097830 exp. 1/31/2013 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HA31411 and #HE17811 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1096369, exp. 11/30/2012; and #1092046, exp. 7/31/2012 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HC31411 and #HE18711 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1096371, exp. 5/312013; and #1092299, exp. 1/31/2013 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HB27811 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1095210, exp. 4/30/2013 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HA27911 and #HA12511 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1095212 exp. 4/30/2013; and #1088877, exp. 11/30/2012 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot #HE35311 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot #1097178 exp. 7/31/2013 Class II cGMP Deviations; does not meet in process specification requirements Lloyd Inc. of Iowa
Veterinary LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 0.2 mg., packaged in 120-ct. (NDC 11789-252-10) and 1,000-ct. bottles (NDC 11789-252-20), RX, LLOYD, Inc., Shenandoah, IA.. KA16611, exp. SEP 2012 Class III Product lot KA16611 did not meet finished product release specifications Lloyd Inc. of Iowa
Veterinary Levothyroxine sodium tablets, USP, 0.3 mg., RX, packaged under the following labels: (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-253-10) and 1,000-ct. bottles (NDC 11789-253-20), LLOYD, Inc., Shenandoah, IA; (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2), Distributed Exclusively by Butler Schein Animal Health, Dublin, OH; (3) Phoenix Thyrozine 0.3 mg., packaged in 180-ct. (NDC 57319-333-31) and 1,000-ct. bottles (NDC 57319-333-16), Manufactured for Clipper Distributing Company, LLC, St. Joseph, MO; (4) VEDCO Thyrosyn .3 mg Tablets, packaged in 180-ct. (NDC 50989-201-86) and 1,000-ct. bottles (NDC 50989-201-53), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed by VEDCO, INC., St. Joseph, MO. Thyro-Tabs - KB15711, exp. SEP 2012; Thyroxine L - KB13611 and KB13611A, exp. AUG 2012; and KB15711 and KB15711A, exp. SEP 2012; Thyrozine - KB15711 and KB15711F, exp. SEP 2012; and KB13611 and KB13611A, Exp. AUG 2012; and Thyrosyn - KB13611 and KB13611A, exp. AUG 2012. Class III Product did not meet in-process specification Lloyd Inc. of Iowa
Veterinary Levothyroxine sodium tablets, USP, 0.7 mg.,RX, packaged under the following labels: (1) LLOYD Thyro-Tabs, packaged in 120-ct. (NDC 11789-257-10), and 1,000-ct. bottles (NDC 11789-257-20), LLOYD, Inc., Shenandoah, IA; (2) Butler Schein Animal Health Thyroxine L, packaged in 180-ct. (NDC 11695-4463-1) and 1,000-ct. bottles (NDC 11695-4463-2) , Distributed Exclusively by Butler Schein Animal Health, Dublin, OH; (3) Phoenix Thyrozine 0.7 mg, packaged in 180-ct. (NDC 57319-337-31) and 1,000-ct. bottles (NDC 57319-337-16), Manufactured for Clipper distributing Company, LLC, St. Joseph, MO; (4) VEDCO Thyrosyn .7 mg Tablets, packaged in 180-ct. bottles (NDC 50989-283-86), Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed By VEDCO, INC., St. Joseph, MO. Thyro-Tabs - Lot KB18011, exp. OCT 2012; Thyroxine L - Lot KB18011 and KB18011A, exp. OCT 2012; Thyrozine - Lot KB18011, KB18011F, and KB18011FA, exp. OCT 2012; and Thyrosyn - Lot KB18011 and KB18011A, exp. OCT 2012. Class III Product did not meet in-process specification Lloyd Inc. of Iowa
Veterinary Levothyroxine sodium tablets, USP, 0.8 mg., packaged in 1,000-ct. bottles, RX, under the following private labels: (1) Butler Schein Animal Health Thyroxine L, NDC 11695-4468-2, Distributed Exclusively by Butler Schein Animal Health, Dublin. OH; and (2) VEDCO Thyrosyn .8 mg Tablets, NDC 50989-204-53, Manufactured by LLOYD, Inc., Shenandoah, IA, Distributed by VEDCO, INC., St. Joseph, MO. Thyroxine L - KD11711, exp. AUG 2012; and Thyrosyn - KD11711 and KD11711A, exp. AUG 2012. Class III Product did not meet in-process specification Lloyd Inc. of Iowa
Veterinary LLOYD Thyro-Tabs (Levothyroxine sodium tablets, USP), 1.0 mg., packaged in 120-ct. (NDC 11789-268-10) and 1,000-ct. bottles (NDC 11789-268-20), RX. The firm name on the label is LLOYD, Inc., Shenandoah, IA. Lot KB17311, exp. OCT 2012 Class III Product did not meet in-process specification Lloyd Inc. of Iowa
Biologics Decellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251 Serial numbers: 1012784D190, 1012784D191, 1012784D192, 1012784D193, 1012784D194, 1012784D195, 1012784D196, 1012784D197, 1012784D198, 1012784D199, 1012784D200, 1012784D201, 1012784D202, 1012784D212, 1012784D213, 1012784D214, 1012784D218 Class II Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. LifeNet Health
Biologics Fascia, human tissue for transplantation, product code FL M Serial number: 1012784045 Class II Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. LifeNet Health
Biologics Bone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP. Serial numbers: 1012784011, 1012784012, 1012784013, 1012784014, 1012784015, 1012784016, 1012784017, 1012784018, 1012784019, 1012784020, 1012784021, 1012784022, 1012784023, 1012784024, 1012784025, 1012784026, 1012784027, 1012784028, 1012784029, 1012784030, 1012784031, 1012784032, 1012784033, 1012784034, 1012784035, 1012784036, 1012784037, 1012784038, 1012784039, 1012784040, 1012784041, 1012784042, 1012784043, 1012784044, 1012784047, 1012784048, 1012784049, 1012784050, 1012784051, 1012784052, 1012784053, 1012784054 Class II Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. LifeNet Health
Biologics Tendon, human tissue for transplantation, Serial numbers: 1012784001, 1012784002, 1012784003, 1012784004, 1012784005, 1012784006, 1012784007, 1012784008, 1012784009, 1012784010 Class II Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. LifeNet Health
Food Tumulo Farms, Pondhopper Cheese; any cut or partial wheels, wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA Pack Dated of 6/28 and after Class I State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese. . Tomales Bay Foods, Inc.
Food Shepherd's Way Big Woods Blue cut wrapped in cheese paper with with type of cheese marked with magic marker and a Tomales Bay Foods sticker applied. Product is cut and packaged by Tomales Bay Foods, Petaluma, CA Pack Dates of 6/28 and after; Make date of 7/19/11 to 7/27/11 Class I State of CA Department of Agriculture sampled finished product and found Listeria monocytogenes in Pondhopper cheese. Tomales Bay Foods, Inc.
Food Tomales Bay Foods brand Artisan Cheese in PARTIAL WHEELS of Cheese, from cheese makers in US (VA, VT, Ca, WI, OR, WA and UT) and Ireland, Italy, Switzerland, France, Holland and Greece. Varieties include Appalachian, Coolea, Cabot clothbound Cheddar, Big Rock Blue, Goat Gouda, Holey Cow, Big Woods Blue, Fiore Sardo,, Valdeon, Pecorino Romano, Sottocenere, Capriago, Capricious, Cave Aged Gruyere, Cave Aged Marisa, Fenacho, Pondhopper, Comte, L'Amuse Signature Gouda, Dante Waxed Rind, Dry Jack Special Reserve, Mezzo Secco, Extra Mature Bandage Cheddar, San Joaquin Gold, Flagship Reserve Truckle, Fontina Vallet Pietro, Grana Padano, Parmigiano Reggiano Organic, Taleggio Organic, Comte Reserve Ete, Loma Alta, Mt. Viko Barrel Aged Feta, Pepato, San Andreas Bellwether Farms, Reading, Tarentaise, Seahive, St. George, Toma and Wagon Wheel. Cheese is cut per order and wrapped in cheese paper and marked with a magic marker indicating the type of cheese, poundage and pack date as well as a Tomales Bay Foods label. There are no code numbers or expiration dates marked on the product. All product cut and wrapped on July 24 and 25, 2012. Class II Firm received a positive environmental for Listeria Monocytogenes from their internal testing samples. Tomales Bay Foods, Inc.
Devices Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092 Class II Custom Procedural trays contain Stryker Hytrel Togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Merit Medical Systems, Inc.
Biologics Blood and Blood Products for Reprocessing 029KH65246; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American Natl Red Cross Mid Atlantic Region
Biologics Recovered Plasma 033FM41980; Class III Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced W038612825235; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed Suncoast Communities Blood Bank, Inc.
Biologics Fresh Frozen Plasma W038612825235; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Suncoast Communities Blood Bank, Inc.
Biologics Red Blood Cells Leukocytes Reduced W120611007684; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Michigan Blood
Biologics Platelets Pooled Leukocytes Reduced W120611181662; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Michigan Blood
Biologics Platelets Pheresis Leukocytes Reduced W051512087394 Part 1; W051512087394 Part 2; Class II Blood products, which were labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W044112108023; Class III Blood product, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing W044112108023; Class III Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing W036812381616; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036812381616; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells W036810167666; W036812336104; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036810167666; W036812336104; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Vista System Version 3.2 service pack 3 used on Trima Accel Automated Collection System version 5.1 or User Defined Machines. The software is used for determining donor eligibility based on annual Red Blood Cell Volume Loss Limits. Vista Version 3.2 Service Pack 3 (stand alone Service Pack) part number 923000-326 and Vista V3.2 with Vista 3.2 Service Pack 3 (part number 923000-327B). Class II TerumoBCT Vista version 3.2 software, with a defect or glitch causing donors to be incorrectly deemed eligible, was distributed. CaridianBCT, Inc.
Drugs Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01 Lot# 936674 Exp. 09/30/13 Class II Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). Genentech Inc
Drugs Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01 Lot # 936670 Exp. 09/30/13 Class II Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery). Genentech Inc
Biologics Red Blood Cells Leukocytes Reduced W036311158586 Class II Blood product, which was incorrectly labeled as negative for the C red cell antigen, was distributed. BloodCenter of Wisconsin, Inc
Biologics Platelets Pheresis Leukocytes Reduced W115112283072F Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112218788D Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Biologics Platelets Pheresis Leukocytes Reduced W115112272578B Class II Blood product, with a low platelet count, was distributed. LifeSouth Community Blood Centers Inc - Birmingham Region
Devices 24 Fr 8mm Sft Flow Str Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5841 and 5845 and lot number: 0581536 and 0581138. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 24 Fr 8mm Sft Flow Straight Wir The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use catalog number: 5843 and lot number: 0584961 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 24 Fr 8mm Sft Flow Straight The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5847 and lot number: 0582251 and 0586068 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 18 Fr 6mm Sft Flow Angled Wire The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 7072 and lot number: 0602542, 0614871, and 0620810. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5762 and lot number: 0570466 and 0589212 Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Devices 24 Fr 8mm Soft Flow Ang W/L The Sarns" Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. catalog number: 5774 and lot number: 0595116. Class II Based on a review retrospective review of quality data, the presence of plastic flash was identified at the tip of certain lots of Sarns" Soft-Flow" Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptable clinical impact. Terumo Cardiovascular Systems Corporation
Food Vitanut Pro IC, 50 g Lot Code 2236 Class I The product has the potential to be contaminated with Salmonella. The product was manufactured using peanut paste supplied by Sunland, Inc. Breedlove Foods, Inc.
Biologics Cardiac Tissue, Non-valved 11112910004 Class II Cardiac Tissue Allograft, processed in a manner that did not prevent the introduction, transmission, or spread of communicable disease, was distributed. LifeNet Health
Devices Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism. Lot numbers 11286BA, 11319BB, 12004BB, 12044BC, 12073BB, 12073BC, 12101BC, 12101BD, 12130BB, 12130BC and 12188BD. Class II Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a well set contaminated with iron from environmental sources. All lots of IRON Flex(R) reagent cartridges have the potential for this issue. If a well set is contaminated with trace amounts of iron, the entire well set is impacted, and the magnitude of the elevation is consistent for all 15 tests in that well set. The observed magnitude of the elevation ranges from approximately 20-800 ug/dL and the estimated rate is approximately 1 out of 2,500 wells. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells Leukocytes Reduced W044412202215 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Northern Illinois Blood Bank dba Rock River Valley BC
Biologics Source Plasma TQ192038 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Knoxville Plasma Corporation
Biologics Platelets Pheresis Leukocytes Reduced W1657120214005 Class II Blood product, with a platelet count that exceeded the maximum specification, was distributed. Our Lady Of The Lake Hospital Inc
Devices Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. Made in USA Class I, 510(k) exempt Catalog Number: 6543-1-600 Lot Number; NE1WR1 Class II Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings. Stryker Howmedica Osteonics Corp.
Devices Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. Class I, 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43, P2A31 Class II Offset Bushings associated with the lots identified were mismarked: the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise; the Femoral Offset Bushing did not include rotational markings. Stryker Howmedica Osteonics Corp.
Devices Siemens Mobilette Mira, intended use as Mobile x-ray system. Model Number 10273100 Class II There is a risk of lost images during examination. Siemens Medical Solutions USA, Inc
Devices Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System Model number 10 592 457 Class II Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could remain unprotected and not archived leading to a potential data loss. - System crashes when user tries to delete a self created spine labeling step. - For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user. - Within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing. - Viewer crashes during load of next patient. Error is related to 'Next Patient' from RIS. Siemens Medical Solutions USA, Inc
Drugs Novarel® (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUSCULAR USE ONLY Rx Only NDC 55566-1501-0 Manufactured for : Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 Manufactured by: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada. NDC # 55566-1501-0 is assigned to the vial of NOVAREL and is displayed on the vial label. NDC # 55566-1501-1 is assigned to the unit of sale, which is a carton containing 1 vial of NOVAREL and 1 vial of diluent along with the insert. NDC # 55566-1501-1 is displayed on the unit of sale and is the item subject to recall. Lot Number Expiration Date 1C264A 09/12 1H047A 12/12 1H047B 12/12 1H052A 12/12 1H052B 04/13 1H052C 04/13 1M417A 04/13 1M417B 09/13 2A012A 09/13 2A012B 11/13 2C278A 09/13 2C278B 09/13 2C278C 11/13 2C278D 11/13 2C278E 11/13 Class III Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products. Ferring Pharmaceuticals Inc
Devices NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013. Class II The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners. Philips And Neusoft Medical Systems Co., Ltd.
Biologics Cornea 20111263; 20111264 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Transplant Services Center UT Southwestern Medical Center
Biologics Skin 20111263BL16; 20111263BL26; 20111263BL36; 20111263BL46; 20111263BL56; 20111263BL66; 20111263FL15; 20111263FL25; 20111263FL35; 20111263FL45; 20111263FL55 Class III Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Transplant Services Center UT Southwestern Medical Center
Devices Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system for clinical chemistry analysis. Catalog numbers affected: Alkaline Phosphatase acc. to IFCC Gen.2 05166888190; Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate (P5P) activation 05850797190; Bicarbonate Liquid 05446376190; Creatinine Jaffé Gen.2 05168597190; C-Reactive Protein Gen.3 05172373190; and Urea/BUN 05171873190. Serial Number(s): 0917-10, 1020-04, 1020-05, 1021-03, 1021-04, 1021-07, 1021-08, 1023-06, 1023-09, 1023-10, 1024-03, 1024-04, 1024-05, 1024-09, 1025-02, 1025-05, 1025-07, 1025-09, 1026-01, 1026-02, 1027-09, 1028-01, 1028-07, 1030-09, 1031-05, 1031-09, 1032-09, 1032-10, 1033-04, 1033-05, 1107-06, 1109-02, 1109-03, 1111-07, 1111-08, 1112-02, 1112-04, 1115-06, 1115-07, 1115-08, 1115-10, 1117-04, 1117-07, 1118-02, 1126-02, 1126-03, 1126-04, 1127-01, 1127-02, 1127-06, 1127-07, 1138-03, 1138-04, 1139-04, 1139-05, 1139-06, 1140-02, 1140-03, 1140-04, 1140-05, 1140-10, 1141-08, 1141-09, 1142-02, 1142-03, 1142-04, 1143-01, 1143-02, 1143-03, 1143-04, 1143-05, 1143-06, 1144-05, 1146-04, 1146-05, 1146-06, 1146-07, and 1146-08. Class II On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (CREJ2), Urea (UREAL), C Reactive Protein (CRPL3). Roche Diagnostics Operations, Inc.
Devices Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use. Lot # 120827, exp 11/27/2012 Class II Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values with "0" standard reducing the slope of the standard curve requiring more frequent sample dilutions. Sekisui Diagnostics Llc
Devices Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022 Class II With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side. Philips Healthcare Inc.
Drugs traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18. Lot # GKK1373, Exp 09/13 Class II Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg. Caraco Pharmaceutical Laboratories, Ltd.
Devices Neptune® 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices. Part 0702-001-000 (120v) Lot 0733700353 through 1036100423 Class II Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain. Stryker Instruments Div. of Stryker Corporation
Devices Neptune® 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, consult accompanying documents Consult instructions for use, Max Vacuum; 21.0 in-Hg, 530 mm-Hg, The Neptune Waste Management System consists of a mobile rover unit used to suction and collect fluid waste, small debris and electrocautery smoke from a surgical site. Mobility allows the rover unit to be relocated to a waste disposal area where the rovers collection canisters can be emptied, via the docking station. Intended to be used in the Operating Room, Surgical Centers and Doctors Offices to collect and dispose of surgical fluid waste as well as collect smoke from electrocautery or laser devices. Part 0702-002-000 (230v) Lot 0733700353 through 1036100423 Class II Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with a new castor design because investigation found the old design had the potential for the casters to bind compromising the Rover's ability to roll. This can result in additional strain on the operator, due to multiple exposures resulting in back pain. Stryker Instruments Div. of Stryker Corporation
Food Zingerman's Bakehouse Gingerbread Cake Net wt. 3 LB; 1.25 LB none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Sourcream Coffeecake Net wt. 3 LB; 1.25 LB none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Hot Cocoa Cake Net wt. 3 LB; 1.25 LB none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Lemon Poppy Seed Coffeecake Net wt. 2.5 LB; 1.25 LB none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Funky Chunky Chocolate Cookies Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Funky Chunky Chocolate Cookie Jrs. Net wt. 6 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Big O Cookie Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Big O Cookie Jrs. Net wt. 1/2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Ginger Jump-up Cookies Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Jr. Ginger Jump-up Cookies Net wt. 6 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Triple Trouble Chocolate Cookie Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Junior Triple Trouble Chocolate Cookies Net wt. 6 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Mandelbread Net wt. 8 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Bumble Honey Cake Net wt. 1.25 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source may contain butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Banana Bread Net wt. 20 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Genuine Ginger Brownies Net wt. 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Country Scone Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Ginger Scone Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Northern Corn Bread Net wt. 18 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Currant Scone Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Townie Brownies Net wt. 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Chocolate Banana Bread Net wt. 20 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Buenos Aires Brownies Net wt. 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Almond Pound Cake Net wt. 1.25 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Rugelach Net wt. 1/2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Cinful Cinnamon Rolls Net wt. 1 1/2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Brownie Party Net wt. 1.2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Palmiers Net wt. 4 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Summer Fling Coffeecake Net wt. 3 lbs none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse ZBPB's Peanut Butter Cookie Net wt. 3 ounces none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Cape Cod Cranberry Walnut Pie none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Stollen none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Chocolate Chess Pie none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Perky Pecan Pie none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Olive Oil Cake Net wt. 1.25 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Jumbleberry Pie none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Pound Cake 1 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Graham Crackers 1 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Orange-Almond Magic Brownies 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Mary's Wild Oats Cranberry Almond Granola 1 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Pecan Blondies 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Sweet Butter Teacake 1.25 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Nueske's Bacon Apple Coffeecake Net wt. 1.25 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Apricot Rugelach Net wt. 1/2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk and the source of flour as wheat. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Black Magic Brownies Net wt. 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Magic Brownies Net wt. 1/4 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Food Zingerman's Bakehouse Brownies -Magic & Black Magic (variety pack) Net wt. 1.2 lb none Class II Zingerman's BAKEHOUSE pastry labels were found not identifying the source of butter and cream ingredients as milk; the source of flour as wheat, and lacking identity of soy allergen found in products. Zingerman's Bakehouse, Inc.
Devices OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy Lot Numbers: LA121003AO-P1 LA121003AQ-P1 LA121001CB-P1 LA121003AL-P1 LA121002AC-P1 LA121001CC-P1 LA121001BZ-P1 LA121001BZ-P1 LA121001AR-P1 LA121001AQ-P1 LA121001CA-P1 LA120926BA-P1 LA120926AS-P1 LA120919BG-P1 LA120920AF-P1 LA120924AG-P1 : Class II Failure of glue joint, allowed a portion of the single use device to shift inside, may separate and fall into the patient OmniGuide, Inc.
Devices Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI Patient Monitoring System is intended for use by healthcare professionals to monitor vital signs for patients undergoing MRI procedures. The Patient Monitoring System also provides signals for synchronization to the MR scanner. Model number 865214: (Service Numbers 453564180091, 453564181201). Lot numbers: US00201487, US00201488, US00201489, US00201490, US00201493, US11401510, US11401511, US11401513, US11401514, US11401515, US11401516, US11401531, US11401532, US11401533, US11401546, US11401562, US11401563, US11401564, US11401565, US11401566, US11401567, US11401568, US11401569, US11401570, US11401571, US11401572, US11401573, US11401574, US11401575, US11401576, US11401577, US11401578, US11401579, US11401611, US11401617, US11401618, US11401631, US11401633, US11401634, US11401645, US11401646, US11401647, US11401648, US11401649, US11401651, US11401652, US11401672, US11401673, US11401674, US11401675, US11401712, US11401713, US11401714, US11401715, US11401716, US11401717, US11401718, US11401719, US11401720, US11401721, US11401722, US11401723, US11401724, US11401737, US11401738, US11401739, US11401740, US11401741, US11401742, US11401743, US11401744, US11401745, US11401746, US11401747, US11401775, US11401776, US11401777, US11401778, US11401779, US11401780, US11401781, US11401782, US11401783, US11401784, US11401785, US11401786, US11401799, US11401843, US11401844, US11401845, US11401846, US11401851, US11401871, US11401872, US11401882, US11401883, US11401884, US11401885, US11401886, US11401892, US11401893, US11401903, US11401904, US11401905, US11401916, US11401917, US11401918, US11401969, US11401970, US11401971, US11401972, US11401973, US11401974, US11401975, US13301988, US13301989, US13301990, US13301991, US13301992, US13301993, US13301994, US13301995, US13301996, US13301997, US13301998, US13302000, US13302001, US13302034, US13302035, US13302036, US13302037, US13302039, US13302040, US13302041, US13302042, US13302043, US13302044, US13302050, US13302051, US13302052, US13302054, US13302055, US13302094, US13302095, US13302096, US13302097, US13302098, US13302099, US13302107, US13302108, US13302109, US13302111, US13302112, US13302113, US13302114, US13302115, US13302117, US13302118, US13302119, US13302141, US13302148, US13302175, US13302176, US13302177, US13302178, US13302179, US13302180, US13302182, US13302192, US13302193, US13302194, US13302195, US13302196, US13302197, US13302198, US13302209, US13302210, US13302211, US13302212, US13302247, US13302248, US13302249, US13302250, US13302251, US13302252, US13302254, US13302265, US13302266, US13302267, US13302291, US13302292, US13302293, US13302294, US13302295, US13302296, US13302297, US13302298, US13302300, US13302302, US13302304, US13302346, US13302347, US13302348, US13302349, US13302350, US13302362, US13302363, US13302364, US13302365, US13302366, US13302367, US13302373, US13302378, US13302421, US13302422, US13302423, US13302424, US13302425, US13302427, US13302430, US13302431, US13302432, US13302434, US13302437, US13302438, US13302439, US13302441, US13302445, US13302446, US13302447, US13302449, US13302450, US13302478, US13302485, US13302488, US13302498, US13302501, US13302503, US13302504, US13302505, US13302507, US13302508, US13302509, US13302510, US13302511, US13302512, US13302513, US13302514, US13302515, US13302516, US13302517, US13302519, US13302520, US13302521, US13302522, US13302523, US13302524, US13302525, US13302526, US13302527, US13302528, US13302529, US13302609, US13302610, US13302612, US13302613, US13302614, US13302617, US13302618, US13302619, US13302620, US13302621, US13302622, US13302623, US13302624, US13302625, US13302631, US13302641, US13302642, US13302644, US13302645, US13302646, US13302647, US13302648, US13302649, US13302650, US13302651, US13302652, US13302653, US13302654, US13302656, US13302657, US13302658, US13302701, US13302702, US13302703, US13302704, US13302705, US13302706, US13302708, US13302709, US13302710, US13302713, US13302714, US13302715, US13302716, US13302717, US13302782, US13302783, US13302784, US13302785, US13302786, US13302787, US13302788, US13302789, US13302790, US13302804, US13302805, US13302806, US13302807, US13302808, US13302809, US13302810, US13302811, US13302812, US13302837, US13302852, US13302853, US13302854, US13302855, US13302856, US13302864, US13302865, US13302866, US13302871, US13302872, US13302873, US13302874, US13302875, US13302878, US13302879, US13302880, US13302881, US13302882, US13302883, US13302887, US13302888, US13302914, US13302915, US13302937, US13302938, US13302939, US13302940, US13302941, US13302942, US13302943, US13302944, US13302954, US13302955, US13302956, US13302957, US13302958, US13302959, US13302960, US13302982, US13302983, US13302985, US13302986, US13302987, US13302988, US13302989, US13302990, US13302991, US13302992, US13302993, US13302998, US13302999, US13303000, US13303001, US13303002, US13303048, US13303049, US13303050, US13303051, US13303052, US13303053, US13303054, US13303055, US13303056, US13303057, US13303080, US13303084, US13303085, US13303086, US13303126, US13303127, US13303128, US13303129, US13303130, US13303158, US13303159, US13303160, US13303161, US13303162, US13303163, US13303178, US13303179, US13303180, US13303187, US13303188, US13303203, US13303214, US13303216, US13303217, US13303219, US13303221, US13303222, US13303223, US13303224, US13303238, US13303239, US13303240, US13303241, US13303243, US13303244, US13303245, US13303270, US13303271, US13303272, US13303273, US13303288, US13303298, US13303306, US13303325, US13303326, US13303327, US13303328, US13303329, US13303330, US13303331, US13303332, US13303333, US13303334, US13303347, US13303348, US13303349, US13303350, US13303351, US13303352, US13303380, US13303381, US13303382, US13303383, US13303384, US13303387, US13303388, US13303409, US13303413, US13303414, US13303416, US13303417, US13303418, US13303419, US13303420, US13303421, US13303422, US13303436, US13303462, US13303463, US13303464, US13303465, US13303466, US13303467, US13303468, US13303482, US13303488, US13303489, US13303490, US13303499, US13303500, US13303501, US13303502, US13303503, US13303504, US13303505, US13303506, US13303507, US13303508, US13303509, US13303510, US13303511, US13303512, US13303543, US13303544, US13303573, US13303574, US13303575, US13303576, US13303577, US13303578, US13303579, US13303580, US13303584, US13303585, US13303586, US13303587, US13303588, US13303589, US13303590, US13303591, US13303597, US13303598, US13303601, US13303625, US13303626, US13303627, US13303628, US13303630, US13303631, US13303662, US13303665, US13303666, US13303667, US13303668, US13303671, US13303672, US13303721, US13303722, US13303723, US13303724, US13303725, US13303726, US13303727, US13303733, US13303734, US13303735, US13303738, US13303739, US13303748, US13303749, US13303750, US13303780, US13303781 Class II Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expression MRI Patient Monitoring System because during transport of the systems cart with a docked Display Controller Unit (DCU), a caster (wheel) may become detached. If this occurs, the cart can become unbalanced and may fall. Invivo Corporation
Devices BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system: Product Number: 2001249 BiOM Battery Product Number: 2001240 BiOM Charger Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973 Class II Battery may over-heat during charging and smoke iwalk inc
Food Blue Diamond Almond Breeze Almond milk Half Gallon (1.89 L) Paper Carton UPC: 4157005618 Best by: 12/05/2012 plt# 51-4109 Class III Product labeled as Unsweetened Vanilla Blue Diamond Almond Breeze Almond milk may contain chocolate flavored Almondmilk ( undeclared ingredients: cocoa and evaporated cane juice). HP Hood LLC
Food Ground limestone also known as calcium carbonate. Omya's food grade ground limestone products. All bulk with no product labeling. Product Container Size Omya-Cal FG-10 AZ 50 lb. bags 2500 lb. bulk bags 2000 lb. bulk bags Omya-Cal FG-4 AZ 50 lb. bags Omya-Cal FG-15 AZ 2500 lb. bulk bags Lot numbers Z227510511 Z227500511 Z227500511 Z227510409 Z230310409 Z228400712 Z228200712 Class I Omya Inc. is voluntarily recalling certain lots of food grade ground limestone products processed at its Superior, Arizona plant because of the possible presence of Salmonella. Omya Inc
Biologics Cornea 120349100; 120349200 Class III Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. East Tennessee Lions Eye Bank
Drugs Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6. Lot #s: 118903, Exp. 03/2013; 119477, 119483,119743, 119748, Exp. 05/2013, 110440, Exp. 07/2013; 110951, Exp 08/2013; 110599, Exp. 09/2013; 110602, 110606, 110607, 110949, 110953, 110954, 110956, 110958, 110963, Exp. 10/2013; 110962, 110965, 111659, 111844, 111845, 111846, Exp. 11/2013; 112227, 112228, Exp. 12/2013. Class II Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. Taro Pharmaceuticals U.S.A., Inc.
Devices Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable. Catalog Number: 113740 and Lot Number Identification: 779270 Class II The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life. Biomet, Inc.
Food Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed 120724 Class I Listeria monocytogenes contamination in product Kennys Farmhouse Cheese
Food Chipotle Colby , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed 120711 Class I Listeria monocytogenes contamination in product Kennys Farmhouse Cheese
Food Monterey Jack , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed 120719 Class I Listeria monocytogenes contamination in product Kennys Farmhouse Cheese
Food Mild Cheddar , Sizes could be 8 oz, 5lbs, 10lb, or 25lbs- vacuum packed 120625 Class I Listeria monocytogenes contamination in product Kennys Farmhouse Cheese
Food Organic Gelato Chocolate Peanut Butter, 5 liter, contained in plastic packaging, manufactured by Fresca Foods, CO. All products with a "Best Buy" date of 10/3/13 or earlier. Class I Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination. Boulder Ice Cream
Food Serano Gelato Chocolate Peanut Butter, 16 oz, contained in a semiflexible paper container, manufactured by Fresca Foods, CO. All products with a "Best Buy" date of 08/10/13 or earlier. Class I Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination. Boulder Ice Cream
Food Elvis Ice Cream, 2.5 gallon, packed in a plastic container, manufactured by Fresca Foods, CO. All products with a "Best Buy" date of 06/02/13 or earlier. Class I Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination. Boulder Ice Cream
Food All Natural Boulder Ice Cream Peanut Butter Cup, 2.5 gallon, packed in plastic packaging, manufactured by Fresca Foods, CO. All Natural Boulder Ice Cream Peanut Butter Cup, 1 pint, packed in semi flexible paper packaging, manufactured by Fresca Foods, CO. 2.5 gallon with a "Best Buy" date of 07/24/13 or earlier; 1 pint with a "Best Buy" date of 08/16/13 or earlier. Class I Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination. Boulder Ice Cream
Food Yoki Bliss Peanut Butter frozen yogurt, 1 gallon, packaged in plastic containers, manufactured by Fresca Foods, CO. All products with a lot date of 4/1/2010, 5/5/2010, 6/10/2010, 7/14/2010, 12/29/2010, 2/17/2011, 4/1/2011, 4/23/2011, 5/26/2011, 6/3/2011, 7/2/2011, 7/7/2011, 8/14/2011, 9/18/2011, 11/26/2011, 39755, 38780. Class I Products manufactured using peanut ingredients recall by Sunland due to potential Salmonella contamination. Boulder Ice Cream
Food Sara Lee Butter Streusel Coffee Cake, Net Wt. 11.5 oz ; 8 cakes per 5.75 lb case; Distributed by Sara Lee Corp., Downers Grove, IL 60515 U.S.A.; UPC: 032100023429 UPC: 032100023429; Best By Date of 10/16/2013 Class I The retail packages of Sara Lee Butter Streusel Coffee Cake with UPC #3210002342 and a Best By Date of 10/16/2013 actually contain Sara Lee Pecan Coffee Cake, resulting in the undeclared allergen - pecans. Hillshire Brands Company
Food Iced Broccoli crown, 20lbs. Highway One Label: 040112A3-01810182 140312C3-10110182 031912A7-07010182 031812A7-01910182 031812A7-01810182 020112A1-12310182 031512A7-06910182 Beachside Label: 140312C3-10110182 Class II Beachside Produce is recalling iced broccoli crownds due to the potential of having hydraulic fluid onto the ice that cooled the product. Beachside Produce Llc
Food Apple Lattice Pie (9-inch, 36oz). Pies are sealed in a brown cardboard box with a see-through plastic label and sold as a fresh item at the consumer level. Lot code CH12296 Class I Legendary Baking of Denver, CO is recalling 726 Private Selection 9-inch pies labeled as "Apple Lattice" with a UPC of 1111060195 and Lot Code 12296 (located on side of aluminum pie tie) because the pies may contain undeclared EGGS. People who have an allergy or severe sensitivity to EGGS may run the risk of serious or life-threatening allergic reaction if they consume these products. Legendary Baking
Food Sukhi's Gourmet Indian Food; Red Curry Vegetables; 9 oz. package. Manufactured by Jagpreet Enterprises dba Sukhi's Gourmet Indian Foods; Hayward, CA 94545 Lot code: 3390113612; Use by Date: 05/14/2013; UPC 7-76226-02901-6 Class I A consumer complaint determined that some boxes of Red Curry and Vegetables were inadvertently packaged with Yellow Curry with Shrimp. Jagpreet Enterprises Inc.
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