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U.S. Department of Health and Human Services

Enforcement Report - Week of March 12, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 36FM54379 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. The American National Red Cross South Carolina Region
Biologics Platelets Pheresis Leukocytes Reduced 36FM54379 (2 units) Class II Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells Leukocytes Reduced 106657699 Class III Blood product, not prepared in accordance with specifications was distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 107228886(A) ;107228886(B) Class II Blood products, which did not meet acceptable product specifications, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 107198792 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 104192654 Class III Blood product, collected from an ineligible donor, was distributed. Blood Systems, Inc.
Drugs B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 Lot numbers: C02R and F03Q Class I Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug Mira Health Products Ltd.
Drugs Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433. lot numbers: 1) M55Q (A) Exp 04/2016, 2) M55Q (2) Exp 05/16, 3)E07Q Exp unknown Class I Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug Mira Health Products Ltd.
Drugs METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL lot number: L54Q Class I Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug Mira Health Products Ltd.
Devices GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2 00000171121GE7 00000171120GE9 00000186991GE6 00000186695GE7 00000171129GE0 00000207772GE5 00000211999GE8 00000194705GE0 00000175339GE1 00000171944GE2 00000198439GE2 00000187430GE4 00000183133HP8 00000171643GE0 00000L10106002 00000N10127001 00000V10334001 000000Z9309005 000000Z9309002 00000F10090001 00000H10153001 00000K10130001 000000G9337003 000000G9337002 00000W10230001 00000W10230002 00000H11083001 00000Y10245001 00000G10161002 00000M10162001 000000G9337001 00000180602GE5 00000187436GE1 00000171943GE4 00000194704GE3 00000194703GE5 00000194702GE7 00000175342GE5 00000187435GE3 00000172680GE1 00000171127GE4 00002UAO430KJL 00002UA04307KD 0000CZC9450FKS 0000CZC944B57J 0000CZC9385MCH 0000CZC94602P9 0000CZC94583RB 0000CZC1128HGN 0000CZC1128HGR 0000CZC1100YF8 0000CZC1128HGJ 00002UA04307L2 00002UA0430KL4 00002UA04307KV 00002UA04211JK 00002UA04307K5 0000CZC942647P 0000CZC9441VF1 00000V10245007 00000D10252002 0000CZC94602PY 0000CZC94602PC 00000185759HP8 0000CZC9406S71 0000CZC9412L3G 00000185734HP1 00000018579HP0 0000AB10235005 0000CZC9445HLZ 0000CZC9425PPQ 00000E10011004 00000E10011005 00000S11019009 00000S11019010 00000H11027003 00000Q11060006 000000G9337004 0000AB10126002 00000T10123004 00000E10336009 00000E10336005 00000E10336006 00000E10336008 00000E10011001 00000E10011002 00000T10123002 00000T10123001 00000H10028003 00000J10208004 00000M10189002 00000M10189003 00000F10229001 000000G9337012 00000S11019008 00000S11019007 00000N10337001 000000G9337015 000000G9337020 00000T10071001 00000ZA9324001 000000L9343005 00000E10336001 00000E10336002 00000S11019005 00000N10337005 00000N10337006 00000N10337015 00000N10337016 00000N10337017 00000S11019004 00000S11019006 00000S11019003 00000R11020006 00000R11020004 00000R11020003 00000C10256001 00000C10256002 00000C10256003 00000S11019001 000000G9337013 00000M10146001 000000L9343004 00000U10258003 00000U10259002 00000L10286003 00000U10258002 00000N10337008 00000N10337009 00000N10337010 00000Q11075001 0000CZC7435R7N 0000CZC743632K 00000V10334002 00000V10334003 000000G9337008 00000J10215003 00000J10215002 000000G9337017 00000H10131002 000000G9337018 00000G10161001 000000Z9356001 00000W10125001 00000T10109001 00000H10028002 00000L10106001 00000W10250001 000000M9322001 00000N10337007 00000A10194001 000000G9337009 000000G9337010 0000AD10244001 0000CZC9180HH9 000000L9343002 00000J10293001 00000T10294001 00000R10105001 00000L10333003 00000L10333002 000000L9343008 00000P10008001 00000H10028001 00000F10173001 00000J10113001 000000L9343006 000000G9337014 00000N10337011 00000U10061002 00000G10161003 00000M10162002 000000G9337005 000000L9343007 00000J10208003 000000L9343009 00000F10229003 00000F10229004 00000A10299001 000000L9343003 000000G9337019 000000G9337006 00000U10258001 00000U10251001 00000F10229005 00000E10083001 00000E10083002 00000E10083003 00000U10042001 00000T10123003 00000P10159001 00000400402179 00000G10271002 00000F10281001 00000G10271001 00000H10098001 000000Z9350001 00000A10194003 00000A10194002 00000L10286001 00000L10286002 00000N10337018 000000Z9309003 00000D10232002 00000E10336003 000000W9351002 0000AB10126001 00000G10312002 00000C11087001 00000X11076003 00000G10271003 000000L9343010 00000H10085001 00000D10232001 00000V10243002 00000V10243001 00000Q10188001 00000N10337004 00000N10337013 00000Q11060001 00000N10337012 00000400400243 00000400400244 0000AD10244002 00000F10229008 00000U10251002 00000AE9295001 00000D10308001 00000D10308002 00000G10312001 00000G10312003 00000G10312004 000000Z9309001 00000U10246001 000000W9351001 00000Q11070001 000000L9343001 00000D11066001 Class II When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate. GE Healthcare, LLC
Devices McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment. The system provides clinical decision support by communicating potential Adverse Drug Event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care. MAC 14.3.1/MAC 14.3.1.1 Class I There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. MCKESSON TECHNOLOGIES INC.
Devices TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238, JDA1162239, JDA1182240, JDA1182241, JDA1182242, JDA1182243, JDA1182244, JDA11X2245, JDA11X2246, JDA11X2247, JDA11Z2249, JDA11Z2250, JDA11Z2252, JDA11Z2253, JDA11Z2254, JDA11Z2255, JDA1222257, JDA1222258, JDA1222259, JDA1222260, JDA1222261, JDA1242264, JDA1252265, JDA1252266, JDA1252267, JDA12Z2271, JDA1312272, JGA1062178, JGA1062181, JGA1062182, JGA1112220, JGA1112228, JGA11Z2256, JGA1222262, JGA12X2269, JLA1062179, JLA1062180, JLA1072185, JLA10Z2208, JLA1122232, JLA1122233, JLA1132235, JLA11Y2248, JLA11Z2251, JLA1232263, JLA1262268, JLA12Y2270, KDA1062080, KDA1072081, KDA1072082, KDA1072083, KDA1072085, KDA1072086, KDA1072088, KDA1082090, KDA1082091, KDA1082092, KDA1092093, KDA10X2094, KDA10X2095, KDA10X2096, KDA10X2097, KDA10X2098, KDA10X2099, KDA10Y2100, KDA10Y2101, KDA10Y2102, KDA10Z2104, KDA1112107, KDA1122110, KDA1122111, KDA1132113, KDA1142114, KDA1152115, KDA1152116, KDA1152117, KDA1152118, KDA1162119, KDA1162120, KDA1162121, KDA1162122, KDA1162123, KDA1162124, KDA1172125, KDA1182126, KDA1182127, KDA1182128, KDA1182129, KDA1192130, KDA1192131, KDA11X2132, KDA11X2133, KDA11Y2134, KDA11Z2136, KDA11Z2137, KDA11Z2138, KDA11Z2139, KDA11Z2140, KDA1222141, KDA1222142, KDA1222143, KDA1232144, KDA1242145, KDA1242146, KDA1252147, KDA1272148, KDA1282149, KDA1292151, KDA12X2152, KDA12Y2153, KDA12Z2154, KDA1322155, KGA1082089, KGA10Z2103, KGA10Z2105, KGA1112106, KGA1112108, KGA1122109, KGA1122112, KGA11Z2135, KLA1072084, KLA1072087, KLA1292150, RDA1292019, RDA12X2023, RDA12X2024, RDB12Y2029, RDB12Z2032, RDB1312037, RDB1312038, RGA12X2025, RGB12Y2028, RGB1312034, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, 2DA0962116, 2DA0972123, 2DA0982131, 2DA0982133, 2DA09X2139, 2DA09X2143, 2DA09Y2148, 2DA09Y2151, 2DA09Z2158, 2DA09Z2161, 2DA09Z2162, 2DA1012165, 2DA1012167, 2DA1012168, 2DA1012169, 2DA1012170, 2DA1012174, 2DA1062208, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222, 2DB10X2241, 2DB10Y2253, 2DB10Y2257, 2DB10Z2265, 2DB1112275, 2DB1112283, 2DB1122284, 2DB1122291, 2DB1122294, 2DC1142308, 2DC1142311, 2DC1152316, 2DC1162324, 2DC1172328, 2DC1172332, 2DC1172333, 2DC11X2352, 2DC11Y2365, 2DC11Y2367, 2DC11Z2372, 2DC11Z2374, 2DC1212377, 2DC1212383, 2DC1232392, 2DC1232393, 2DC1232396, 2DC1232397, 2DC1232398, 2DC1242407, 2DC1242409, 2DC1252410, 2DC1262412, 2DC1272417, 2DC1272421, 2DC1282423, 2DC12X2427, 2DC12Y2430, 2DC12Y2431, 2DC12Z2433, 2DC1312435, 2DC1312436, 2DC1322437, 1DA0962006, 1DA0972007, 1DA0972008, 1DA0992011, 1DA09Y2014, 1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019, 1DB10Y2020, 1DB10Y2021, 1DB10Y2022, 1DB1112025, 1DB1122027, 1DC1142030, 1DC1152031, 1DC1162032, 1DC1162033, 1DC1172035, 1DC11Y2037, 1DC11Y2038, 1DC11Z2040, 1DC1222042, 1DC1232043, 1DC1232044, 1DC1252045, 1DC1252046, 1DC1262048, 1DC1272050, 1DC1282051, 1DC1292052, 1DC12X2053, 1DC12Y2054, 1DC12Y2055, 1DC12Z2056, 1DC1312057, 1DC1312058, 1DC1342059, 1GC1262047, 1GC1272049, 1DA1222096, 1DA1222097, 1DA1232099, 1DA1232100, 1DA1232103, 1DA1252124, 1DA1252131, 2DA1252001, 2DA1262003, 2DA1272004, 2DA1272005, 2DA1272006, 2DA1282007, 2DA1292008, 2DA12X2009, 2DA12X2010, 2DA12X2012, 2DA12X2013, 2DA12Y2014, 2DA12Y2015, 2DA12Y2016, 2DA12Z2017, 2DA12Z2018, 2DA1312019, 2DA1312020, 2DA1312021, 2DA1312022, 2GA1262002, 2GA12X2011, 2DA1072211, 2DA08X2063, 2DC11Y2368.SERIAL NUMBER JDA1062176, JDA1062177, JDA1072183, JDA1072184, JDA1072186, JDA1072187, JDA1082188, JDA1082189, JDA1082190, JDA10X2191, JDA10X2192, JDA10X2193, JDA10X2194, JDA10X2195, JDA10X2196, JDA10X2197, JDA10X2198, JDA10Y2199, JDA10Y2200, JDA10Y2201, JDA10Y2202, JDA10Y2203, JDA10Y2204, JDA10Y2205, JDA10Z2206, JDA10Z2207, JDA10Z2209, JDA10Z2210, JDA10Z2211, JDA10Z2212, JDA10Z2213, JDA10Z2214, JDA10Z2215, JDA1112216, JDA1112217, JDA1112218, JDA1112219, JDA1112221, JDA1112222, JDA1112224, JDA1112225, JDA1112226, JDA1112227, JDA1122231, JDA1122234, JDA1142236, JDA1162237, JDA1162238, JDA1162239, JDA1182240, JDA1182241, JDA1182242, JDA1182243, JDA1182244, JDA11X2245, JDA11X2246, JDA11X2247, JDA11Z2249, JDA11Z2250, JDA11Z2252, JDA11Z2253, JDA11Z2254, JDA11Z2255, JDA1222257, JDA1222258, JDA1222259, JDA1222260, JDA1222261, JDA1242264, JDA1252265, JDA1252266, JDA1252267, JDA12Z2271, JDA1312272, JGA1062178, JGA1062181, JGA1062182, JGA1112220, JGA1112228, JGA11Z2256, JGA1222262, JGA12X2269, JLA1062179, JLA1062180, JLA1072185, JLA10Z2208, JLA1122232, JLA1122233, JLA1132235, JLA11Y2248, JLA11Z2251, JLA1232263, JLA1262268, JLA12Y2270, KDA1062080, KDA1072081, KDA1072082, KDA1072083, KDA1072085, KDA1072086, KDA1072088, KDA1082090, KDA1082091, KDA1082092, KDA1092093, KDA10X2094, KDA10X2095, KDA10X2096, KDA10X2097, KDA10X2098, KDA10X2099, KDA10Y2100, KDA10Y2101, KDA10Y2102, KDA10Z2104, KDA1112107, KDA1122110, KDA1122111, KDA1132113, KDA1142114, KDA1152115, KDA1152116, KDA1152117, KDA1152118, KDA1162119, KDA1162120, KDA1162121, KDA1162122, KDA1162123, KDA1162124, KDA1172125, KDA1182126, KDA1182127, KDA1182128, KDA1182129, KDA1192130, KDA1192131, KDA11X2132, KDA11X2133, KDA11Y2134, KDA11Z2136, KDA11Z2137, KDA11Z2138, KDA11Z2139, KDA11Z2140, KDA1222141, KDA1222142, KDA1222143, KDA1232144, KDA1242145, KDA1242146, KDA1252147, KDA1272148, KDA1282149, KDA1292151, KDA12X2152, KDA12Y2153, KDA12Z2154, KDA1322155, KGA1082089, KGA10Z2103, KGA10Z2105, KGA1112106, KGA1112108, KGA1122109, KGA1122112, KGA11Z2135, KLA1072084, KLA1072087, KLA1292150, RDA1292019, RDA12X2023, RDA12X2024, RDB12Y2029, RDB12Z2032, RDB1312037, RDB1312038, RGA12X2025, RGB12Y2028, RGB1312034, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, 2DA0962116, 2DA0972123, 2DA0982131, 2DA0982133, 2DA09X2139, 2DA09X2143, 2DA09Y2148, 2DA09Y2151, 2DA09Z2158, 2DA09Z2161, 2DA09Z2162, 2DA1012165, 2DA1012167, 2DA1012168, 2DA1012169, 2DA1012170, 2DA1012174, 2DA1062208, 2DA1072212, 2DB1082219, 2DB1082220, 2DB1082222, 2DB10X2241, 2DB10Y2253, 2DB10Y2257, 2DB10Z2265, 2DB1112275, 2DB1112283, 2DB1122284, 2DB1122291, 2DB1122294, 2DC1142308, 2DC1142311, 2DC1152316, 2DC1162324, 2DC1172328, 2DC1172332, 2DC1172333, 2DC11X2352, 2DC11Y2365, 2DC11Y2367, 2DC11Z2372, 2DC11Z2374, 2DC1212377, 2DC1212383, 2DC1232392, 2DC1232393, 2DC1232396, 2DC1232397, 2DC1232398, 2DC1242407, 2DC1242409, 2DC1252410, 2DC1262412, 2DC1272417, 2DC1272421, 2DC1282423, 2DC12X2427, 2DC12Y2430, 2DC12Y2431, 2DC12Z2433, 2DC1312435, 2DC1312436, 2DC1322437, 1DA0962006, 1DA0972007, 1DA0972008, 1DA0992011, 1DA09Y2014, 1DA1062015, 1DB1072016, 1DB1082017, 1DB1082018, 1DB1082019, 1DB10Y2020, 1DB10Y2021, 1DB10Y2022, 1DB1112025, 1DB1122027, 1DC1142030, 1DC1152031, 1DC1162032, 1DC1162033, 1DC1172035, 1DC11Y2037, 1DC11Y2038, 1DC11Z2040, 1DC1222042, 1DC1232043, 1DC1232044, 1DC1252045, 1DC1252046, 1DC1262048, 1DC1272050, 1DC1282051, 1DC1292052, 1DC12X2053, 1DC12Y2054, 1DC12Y2055, 1DC12Z2056, 1DC1312057, 1DC1312058, 1DC1342059, 1GC1262047, 1GC1272049, 1DA1222096, 1DA1222097, 1DA1232099, 1DA1232100, 1DA1232103, 1DA1252124, 1DA1252131, 2DA1252001, 2DA1262003, 2DA1272004, 2DA1272005, 2DA1272006, 2DA1282007, 2DA1292008, 2DA12X2009, 2DA12X2010, 2DA12X2012, 2DA12X2013, 2DA12Y2014, 2DA12Y2015, 2DA12Y2016, 2DA12Z2017, 2DA12Z2018, 2DA1312019, 2DA1312020, 2DA1312021, 2DA1312022, 2GA1262002, 2GA12X2011, 2DA1072211, 2DA08X2063, 2DC11Y2368. Class II Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may not be set correctly. As a result, X-ray exposure under the scan conditions used for contrast study may not start. Toshiba American Medical Systems Inc
Biologics Cryoprecipitated AHF, Pooled 021L48171, 021L48172, 021L48173, 021L48174, 021L48175, 021L48176, 021L48177, 021L48178, 021L48179, 021L48180, 021L48181, 021L48182, 021L48183, 021L48201, 021L48202, 021L48203, 021L48204, 021L48205, 021L48206, 021L48207, 021L48208, 021L48209, 021L48210, 021L48211, 021L48212, 021L48213, 021L48214, 021L48215, 021L48216, 021L48221, 021L48222, 021L48223, 021L48224, 021L48225, 021L48226, 021L48227, 021L48228, 021L48232, 021L48233, 021L48234, 021L48235, 021L48236, 021L48237, 021L48238, 021L48239, 021L48240, 021L48251, 021L48252, 021L48253, 021L48254, 021L48255, 021L48256, 021L48257, 021L48258, 021L48259, 021L48260, 021L48261, 021L48263, 021L48279, 021L48280, 021L48285, 021L48287, 021L48288, 021L48289, 021L48290, 021L48291, 021L48292, 021L48293, 021L48294, 021L48295, 021L48296, 021L48317, 021L48318, 021L48319, 021L48320, 021L48321, 021L48322, 021L48323, 021L48324, 021L48325, 021L48326, 021L48327, 021L48328, 021L48347, 021L48348, 021L48349, 021L48350, 021L48352, 021L48358, 021L48359, 021L48360, 021L48361, 021L48362, 021L48363, 021L48396, 021L48397, 021L48398, 021L48399, 021L48400, 021L48401, 021L48402, 021L48403, 021L48404, 021L48405, 021L48406, 021L48407, 021L48409, 021L48410, 021L48411, 021L48412, 021L48438, 021L48439, 021L48440, 021L48444, 021L48446, 021L48462, 021L48463, 021L48464, 021L48465, 021L48466, 021L48467, 021L48468, 021L48469, 021L48470, 021L48471, 021L48472, 021L48473, 021L48474, 021L48475, 021L48477, 021L48479 Class II Blood products, which failed the monthly quality control testing for Factor VIII level, were distributed. American National Red Cross (The)
Drugs Lidocaine 4% Urethral Gel Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14 Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Acetylcysteine 10% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs AMP/M-B12/Pyridox/Methionine Inositol All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bladder Instillation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Bleomycin Sulfate 1unit/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyanocobalamin 100mcg/ml injection All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 p-f 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Cyano B-12 (Cmpd) 1000mcg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone (pf) 0.05 % opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Dexamethasone phosphate 24mg/ml inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Ethanol 20% ophthal. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs EDTA 3% ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil pf in methocel 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs 5-Fluorouracil 1% ophthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Folic acid (pf) 10mg/cc inj All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Gentamycin 80mg/1000cc 0.9% NS All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs L-Glutathione inhalation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 6%/ascorbic 1%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25% All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Glutathione Inhalation 200mg/5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxocobalamin inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Hydroxyprogesterone Caproate All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Idoxuridine 0.1% Ophthalmic All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methotrexate Intraocular 400mcg 0.1cc All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Methylcobalamin All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Novarel (IM) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 1nj 30mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Papaverine 12mg/phent 1mg/Pros 9mcq/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Prostaglandin all combinations All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Pyridoxine (p-f) 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Renacidin Irrigation All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Sodium Bicarbonate 8.4% inj. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Scopolamine 0.25 opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tetracaine 0.5% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus (H20-based) 0.03% ophth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Tacrolimus 0.02% opth. (H20-based) All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Terbutaline/Ipratropium 0.5mg/2.5ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 100mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Testosterone Cypionate 200mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Triamcinolone Acetonide 3mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vancomycin (fortified) 25mg/ml opth All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vit A (olive oil) 0.1% opth. All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Vitamin D (Ergocalciferol) 800 u/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 1% opthal All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Drugs Voriconazole 0.5mg/ml All lot numbers within expiry. Class II Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Natures Pharmacy & Compounding Center
Devices *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 2) List Number 127200465 labeled in part: 12720-65 LifeShield LATEX-FREE HEMA; BLOOD SET, Nonvented, 81 Inch with 170 Micron Filter, Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest, IL 60045 USA; *** 3) List Number 046419701 labeled in part: Hospira VENISYSTEMS Blood Bottle Pump Set with CAIR Clamp Hospira infusion blood sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system. *** 1) List number 126970465; Lot Numbers: 281145H, 180015H, 040115H, 8804085H, 782245H, 680585H; *** 2) List Number 127200465; Lot Numbers: 161475H, 153405H, 031595H; *** 3) List Number 046419701: Lot Numbers: 040945G, 131335G Class II Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. Hospira Inc.
Devices Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. Model 1.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Model 3.0 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Model 3.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Food Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand. NONE Class I Sampler Bag of Biscotti is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz. NONE Class I Lemon Biscotti dipped in White Chocolate Bag is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Cranberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Almond dipped in Dark Chocolate Biscotti-individually wrapped- is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Blueberry dipped in White Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Traditional Toasted Almond-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. Alaskan Birch Brittle Drizzled in dark chocolate-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Alaska Birch with Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Hazelnut Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Hazelnut Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Food Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. NONE Class I Mandarin Orange Tozzetti Biscotti - individually wrapped is recalled due to undeclared wheat, soy, and milk. Yukon Concessions Alaska LLC
Devices RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. R4.2, R5.0, R5.1, R6.0, R6.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. Identifier - 6.0, 6.1.0, 7.0.1 Class II During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Elekta, Inc.
Devices TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. SERIAL NO.: 1CB1262006, 1DB1312033, 1DC1352070, 1DB1342060, 1DB1332049, 1DC1382081, 1DB1312027, 1DB1332045, 1DC1362073, 1CB12X2018. Class II Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. Toshiba American Medical Systems Inc
Biologics Cryoprecipitated AHF, Pooled W087613902271 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W087613553381 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W038113264435 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W038113264435 Class II Blood products, collected from a donor who received a tattoo within one year of donation, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037712017691 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W036813171414 Class II Blood product, which was incorrectly labeled as leukoreduced, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813132985 Class II Blood product, which was incorrectly labeled as leukoreduced, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W037713042561 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Hoxworth Blood Center
Biologics Red Blood Cells Leukocytes Reduced W137513107352 Class II Blood product, collected from a donor who was taking the medication Avodart, was distributed. Lane Memorial Blood Bank
Food Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) COATING: Dextrose, cornstarch, partially hydrogenated vegetable oil, titanium dioxide, rice flour, hydrogenated cottonseed oil, artificial flavor, silicon dioxide. Contains wheat, soy and milk no code, produced 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Chocolate Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, butter (milk), chocolate drops (sugar, cocoa butter, chocolate liquor), cocoa powder, flavor salt. Contains wheat, soy and milk no code, produced 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Bavarian Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: High fructose corn syrup, sugar, food starch modified, palm oil, salt, titanium dioxide, agar sorbic acid, sodium benzoate, potassium sorbate, artificial flavor, modified cellulose, propylene glyocol, glycerin, corn starch, dextrose, polysorbate 80 & 60, sorbitan monostearate, sodium citrate, xanthangum, annatto, caramel color, yellow 5, yellow 6. Contains wheat, soy and milk no code, manufactured 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Apple Fritter, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Apple Fritter Enriched wheat flour, apples, soybean oil, dextrose, cinnamon, salt, leavening, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, conrnstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk no code, manufactured 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and found in 6 count (436 g)UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Caramel Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), salt Contains wheat, soy and milk no codes, producte 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code 6 26570 61743 3. Cinnamon Caramel Donuts, donut holes Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) TOPPING: Powdered sugar, brown sugar, butter (milk), dextrose, cornstarch, cinnamon, palm and soy oil, salt and flavor. Contains wheat, soy and milk no codes, manuactured 1/13/2014 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Glazed Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) GLAZE: Powdered sugar, cornstarch, modified foodstarch (corn) and milk. Contains wheat, soy and milk no codes, produced 1/13/14 or before Class I Undeclared egg ingredient Rise'n Roll Bakery, LLC
Food Rise n Roll Bakery & Deli, Raspberry Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Raspberry Creme Donuts Enriched wheat flour, soybean oil, dextrose, salt, leaving, soy flour, dry whey, mono and diglycerides with BHT, sodium stearoyl, latylate, guar gum wheat starch, ascorbic acid, corn oil, beta carotene, citric acid, silicon dioxide, alpha tocopherols, tricalcium phosphate, soy shortening (palm oil, soybean oil, vitamin E) FILLING: Black raspberries, granulated sugar, permaflo, lemon juice and natural flavor. Contains wheat, soy and milk No codes, manufactured 1/13/2014 or before Class I Undeclared egg ingredient and undeclared Yellow # 6 and Yellow #5 Rise'n Roll Bakery, LLC
Food A. Rise n Roll Specialties, Homemade, Nutty Crunch, ..., boiled to perfection, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 3 B Simply Amish, Crunch N Nutter, Mixed Nut,... No Preservatives, ...NT. WT 4 oz. Ingredients: cashews, pecans, almonds, butter (milk) sugar. Contains Nuts, Milk, and Soy, Merrell Food Group, Inc., Dalton, WI 53926 UPC#861522000042. Rise N Roll, Nutty Crunch Best by date June 13th, 2014 or earlier Simply Amish, Crunch N Nutter, Best by date of June 1, 2014 or earlier; Class I Undeclared peanuts Rise'n Roll Bakery, LLC
Food Amish Wedding, Nutty Crunch, ... boiled to perfection, Distributed by Troyer Cheese, Inc. ... Millersburg, OH 44654, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 Best by date June 13th, 2014 or earlier Class II Undeclared peanuts Rise'n Roll Bakery, LLC
Drugs a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 Lot #: a) 79305114A, b) 79305114B, c) 79305114C, d) 79305114D, e) 79305114E, f) 79305114F, Exp 05/2015 Class II Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules. Dr. Reddy's Laboratories, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W1151132824302 Class II Blood products, for which the testing for pH was invalid, were distributed. LifeSouth Community Blood Centers Inc
Biologics Platelets Pheresis Leukocytes Reduced W1151132824302 Class II Blood products, for which the testing for pH was invalid, were distributed. LifeSouth Community Blood Centers Inc
Biologics Source Plasma TT0294494, TT0295547, TT0296098 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Platelets Pheresis Leukocytes Reduced W229813800598 Class II Blood product, with a low platelet yield, was distributed. Blood Center of Northcentral Wisconsin, Inc.
Drugs Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11. Lot Number: 6004137, Expiration date: 06/2014 Class II Subpotent; 18 month time point Fresenius Kabi USA, LLC
Biologics Lambda Cell Tray" Cell Panels, Article Number: LCT-TRAY-PI, Rev 14. BK840013. Catalog Identification: LCT1W30 (Lots 26, 27); LCT1W60 (Lots 26, 27); and LCT1W72 (Lots 3, 4). Article Number: LCT-TRAY-PI, Rev 14. Class II One Lambda, Inc., part of Thermo Fisher Scientific, is conducting a correction of Lambda Cell Tray", because the product insert for Lambda Cell Tray products (document identification LCT-TRAY-PI-EN-00, Rev 14), contains a documentation error. In the product insert, line 2 in the Directions For Use section is mistakenly repeated. The documentation error in the protocol may cause an end user to incorrectly perform a second incubation and wash off the product. This duplication may result in additional cell loss during the washing procedure. One Lambda Inc
Devices ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml. Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601. Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14. Class II HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers or other analyte values are affected. Horiba Instruments, Inc dba Horiba Medical
Devices Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD Class II Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Carestream Health Inc.
Devices Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major components: x-ray tube, x-ray generator, collimator and image receptor. These systems are permanently installed diagnostic dental x-ray systems for generation of x-rays for examination of the teeth, jaw and oral structures. Serial Numbers starting with WE, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD Class II Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Carestream Health Inc.
Devices Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems. Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769 Class II Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h) Medtronic Navigation, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients. 1000001310 1000601310 1230911309 1231211309 1231511309 1231811309 1000011310 1000311310 1000611310 1230921309 1231221309 1231521309 1231821309 1000021310 1000321310 1000621310 1230931309 1231231309 1231531309 1231831309 1000031310 1000331310 1000631310 1230941309 1231241309 1231541309 1231841309 1000041310 1000341310 1000641310 1230951309 1231251309 1231551309 1000051310 1000351310 1000651310 1230961309 1231261309 1231561309 1000061310 1000361310 1000661310 1230971309 1231271309 1231571309 1000071310 1000371310 1000671310 1230981309 1231281309 1231581309 1000081310 1000381310 1000681310 1230991309 1231291309 1231591309 1000091310 1000391310 1000691310 1231001309 1231601309 1000101310 1000401310 1000701310 1231011309 1231311309 1231611309 1000111310 1000411310 1000711310 1231021309 1231321309 1231621309 1000121310 1000421310 1000721310 1231031309 1231331309 1231631309 1000131310 1000431310 1000731310 1231641309 1000141310 1000441310 1000741310 1231051309 1231351309 1231651309 1000151310 1000451310 1000751310 1231061309 1231361309 1231661309 1000161310 1000461310 1000761310 1231071309 1231371309 1000171310 1000471310 1000771310 1231081309 1231381309 1231681309 1000181310 1000481310 1000781310 1231091309 1231391309 1000191310 1000491310 1000791310 1231101309 1231401309 1231701309 1000201310 1000501310 1000801310 1231111309 1231411309 1231711309 1000211310 1000811310 1231121309 1231421309 1231721309 1000221310 1000521310 1000821310 1231131309 1231431309 1000231310 1000531310 1000831310 1231141309 1231441309 1231741309 1000241310 1000541310 1231151309 1231451309 1231751309 1000251310 1000551310 1231161309 1231461309 1231761309 1000261310 1000561310 1231171309 1231471309 1231771309 1000271310 1000571310 1231181309 1231481309 1231781309 1000281310 1000581310 1231191309 1231491309 1231791309 1000291310 1000591310 1231501309 1231801309 Class II Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices Greatbatch Medical, Offset Cup Impactor. The Standard Offset Cup Impactor is a reusable instrument used during acetabular replacement surgery to implant an acetabular cup. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. The Standard Offset Cup Impactor is used to implant cups during many minimally invasive surgical approaches to Total Hip Arthroplasty ( ri-IA). all lots Class I Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current Instructions For Use (IFU) provided with the device. The Standard Offset Cup Impactor is provided non-sterile and must be sterilized prior to use in a surgery. Greatbatch has not received any reports of deaths, illnesses, injuries, or other adverse effects associated with this issue. Greatbatch Medical
Drugs Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02. Lot # 34013698A, Exp. 01/16. Lot # 34013699A, Exp. 01/16. Lot # 34013700A, Exp. 01/16. Lot # 34013756A, Exp. 01/16. Class II CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation. Teva Pharmaceuticals USA
Drugs Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02 Lot # 34017426A, Exp. 10/16. Class II CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. Teva Pharmaceuticals USA
Drugs Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0972-02. Lot # 34017575A, Exp. 10/16. Class II CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment. Teva Pharmaceuticals USA
Drugs Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02. Lot # 34016752A, Exp. 09/16. Lot # 34016753A, Exp. 09/16. Class II CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing. Teva Pharmaceuticals USA
Devices Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation. Serial numbers of units distributed from October 16, 2012 to December 18, 2013: 189,190,191,192,193,207,208,209,210,211,212,213,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,235,236,237,238,244,245,246,247,248,249,264,265,266,267,268,269,270,271,272,273,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299. Class II Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER. MEDICAMAT S.A.
Devices GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICUI, pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, C02 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, 02, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and/or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The Solar 8000i patient monitoring system also provides physiological data over the UNITY NETWORK TM. Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G D3G44977G D3G44983G D3G44984G D3G44985G D43T4071G D43T4072G D43T4073G D43T4074G D43T4075G D43T4076G D43T4077G E1RF5364G E1RF5479GR E1RF5480GR E1RF5599G E3RF5317G E3RF5318G F0RF0134G F0RF0135G F0RF0136G F0RF0140G F0RF0141G F1RF4827GR F1RF5952G F1RF6042GR F1RF6075GR F1RF6079GR F1RF6084GR F1RF6085GR F1RF6086GR F1RF6088GR F1RF6092GR F1RF6097GR F1RF6100GR 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SJ813051259GA SJ813051260GA SJ813051261GA SJ813051262GA SJ813051263GA SJ813051270GA SJ813051272GA SJ813051273GA SJ813051274GA SJ813051275GA SJ813051277GA SJ813051278GA SJ813051280GA SJ813051281GA SJ813051282GA SJ813051283GA SJ813051286GA SJ813061290GA SJ813061292GA SJ813061293GA SJ813061294GA SJ813081334GA SJ813081336GA SJ813081337GA SJ813081338GA SJ813081339GA SJ813081340GA SJ813081341GA SJ813081342GA SJ813081343GA SJ813081344GA SJ813081345GA SJ813081346GA SJ813091355GA SJ813091356GA SJ813091358GA SJ813091359GA SJ813091360GA SJ813091361GA SJ813091365GA SJ813091368GA SJ813091371GA SJ813091374GA SJ813091375GA SJ813091376GA SJ813091378GA SJ813091379GA SJ813091380GA SJ813091391GA SJ813091392GA SJ813091393GA SJ813091394GA SJ813091395GA SJ813091396GA SJ813091397GA SJ813091398GA SJ813091399GA SJ813091400GA SJ813091405GA SJ813091406GA SJ813091407GA SJ813101411GA SJ813101412GA SJ813101423GA SJ813101424GA SJ813101427GA SJ813101428GA SJ813101429GA SJ813101430GA SJ813101431GA SJ813101432GA SJ813101433GA SJ813101435GA SJ813101439GA SJ813101440GA SJ813101441GA SJ813101442GA SJ813111445GA SJ813111449GA SJ813111452GA SJ813131454GA SJ813131455GA SJ813131456GA SJ813131457GA SJ813131458GA SJ813131459GA SJ813131460GA SJ813131461GA SJ813131462GA SJ813131463GA SJ813131465GA SJ813131466GA SJ813131467GA SJ813131468GA SJ813131469GA SJ813131470GA SJ813131472GA SJ813141484GA SJ813141485GA SJ813141486GA SJ813141487GA SJ813141488GA SJ813141489GA SJ813141490GA SJ813141491GA SJ813141492GA SJ813141493GA SJ813141494GA SJ813141495GA SJ813141496GA SJ813141498GA SJ813141499GA SJ813141500GA SJ813141501GA SJ813141502GA SJ813141503GA SJ813141505GA SJ813141506GA SJ813141507GA SJ813141508GA SJ813141509GA SJ813141510GA SJ813141512GA SJ813141513GA SJ813141514GA SJ813141517GA SJ813141518GA SJ813151519GA SJ813151520GA SJ813161539GA SJ813161540GA SJ813161541GA SJ813161542GA SJ813161543GA SJ813161544GA SJ813161545GA SJ813161546GA SJ813161547GA SJ813161548GA SJ813161549GA SJ813161550GA SJ813161552GA SJ813161553GA SJ813161555GA SJ813161556GA SJ813161558GA SJ813161559GA SJ813161563GA SJ813161564GA SJ813161565GA SJ813161566GA SJ813171569GA SJ813171570GA SJ813171571GA SJ813171576GA SJ813201587GA SJ813201591GA SJ813201592GA SJ813201594GA SJ813201597GA SJ813201599GA SJ813201600GA SJ813201602GA SJ813201604GA SJ813201605GA SJ813201606GA SJ813201607GA SJ813201610GA SJ813201611GA SJ813201612GA SJ813201613GA SJ813201614GA SJ813201615GA SJ813201617GA SJ813201620GA SJ813201623GA SJ813201625GA SJ813201626GA SJ813201627GA SJ813201628GA SJ813201641GA SJ813201642GA SJ813201643GA SJ813201644GA SJ813201646GA SJ813201647GA SJ813201648GA SJ813201649GA SJ813201650GA SJ813201651GA SJ813201653GA SJ813201654GA SJ813201655GA SJ813221666GA SJ813221667GA SJ813221668GA SJ813221669GA SJ813221670GA SJ813231671GA SJ813231672GA SJ813231673GA SJ813231676GA SJ813231677GA SJ813231678GA SJ813231679GA SJ813261726GA SJ813261727GA SJ813261728GA SJ813261729GA SJ813261730GA SJ813261731GA SJ813261732GA SJ813261733GA SJ813261734GA SJ813261735GA SJ813261736GA SJ813271754GA SJ813331846GA SJ813331847GA SJ813331848GA SJ813341851GA SJ813341852GA SJ813341853GA SJ813341854GA SJ813341855GA SJ813341856GA SJ813341857GA SJ813341858GA SJ813341859GA SJ813341861GA SJ813341862GA SJ813341863GA SJ813341864GA SJ813341865GA SJ813341866GA SJ813341867GA D1RF5130G D1RF5164G M1RF9796G PA2312626 SBH05440960GA SBH05450980GA SBM06261082GA SE410125060GA SE410175359GA SE410427727GA SE410427736GA SE411120829GA SE411120834GA SE411373361GA SE411373424GA SE411373430GA SE411373450GA PA1787323 PA1990529 PA1990530 PA1990531 PA1990532 PA1990533 PA1990534 PA1990535 PA1990536 PA1990537 PA1990902 PA2007151 R3T04490894GA R3T04490895GA R3T04490902GA R3T04490904GA R3T04490905GA R3T04490906GA R3T04490907GA R3T04490908GA R3T04490909GA R3T04490910GA R3T04490911GA R3T04490912GA R3T04490937GA R3T04490941GA R3T04490942GA R3T04490945GA R3T04490946GA R3T04490947GA R3T04490948GA R3T04490949GA R3T04490952GA R3T04490953GA R3T04490954GA R3T04490955GA R3T04490956GA SE410518952GA SE410034381GA A3G44075G SE410296397GA SE410306446GA SE410306448GA SE410084705GA SE410084821GA SE411171508GA SE411171514GA A43T2648G A43T2827G A43T2828G A43T2829G G2RF3761G G2RF3769G J2G42141G J2G42142G J2G42144G J2G42146G J2G42149G J2G42150G L33T1515G L33T1516G L33T1519G L33T1520G L33T1521G L33T1522G L33T1523G L33T1524G L33T1525G L33T1526G L33T1527G L33T1529G L33T1530G L33T1531G L33T1532G L33T1533G L33T1535G L33T1536G L33T1537G PA1786866 PA1787409 PA1787410 PA1787411 PA1787412 PA1787413 PA1787414 PA1787415 PA1787416 PA1787417 PA1787418 PA1787419 PA1787420 PA1787421 PA1787422 PA1787423 PA1787424 PA1787425 PA1787426 PA1787427 PA1787428 PA1787429 PA1787430 PA1787431 PA1787432 PA1787433 PA1853043 PA1853044 PA1853045 PA1853046 PA1853047 PA1853048 PA1853049 PA1853050 PA1853051 PA1853052 PA1853053 PA1853054 PA1853055 PA1853056 PA1853057 PA1853058 PA1853059 PA1853060 PA1853061 PA1853062 PA1853063 PA1853064 PA1853065 PA1853066 PA1853067 PA1853068 PA1853069 PA1853070 PA1853071 PA1853072 PA2138233 PA2138290 PA2139685 PA2139686 PA2139687 PA2139688 PA2139689 PA2139690 PA2139691 PA2139692 PA2139693 PA2139694 R3T04490969GA R3T04490970GA SE409452977GA SE409473201GA SE409473202GA SE409473203GA SE409473204GA SE409473205GA SE409473206GA SE409473207GA SE409473208GA SE409473215GA SE409473216GA SE409473217GA SE409473221GA SE409473237GA SE409473238GA SE409473250GA SE409473257GA SE409473258GA SE409483260GA SE409483261GA SE409483262GA SE409483263GA SE409483265GA SE409493348GA SE409493356GA SE409493361GA SE409493375GA SE409493379GA SE409493382GA SE409493385GA SE409493394GA SE409493401GA SE409493405GA SE409493406GA SE409493411GA SE409503428GA SE409503443GA SE409503446GA SE409503447GA SE409503449GA SE409503456GA SE409503458GA SE409503460GA SE409503482GA SE409503484GA SE410034386GA SE410064659GA SE410064661GA SE410064662GA SE410064663GA SE410064664GA SE410064665GA SE410064666GA SE410064667GA SE410064668GA SE410064669GA SE410074670GA SE410074671GA SE410074672GA SE410074673GA SE410074674GA SE410074675GA SE410074682GA SE410074683GA SE410074686GA SE410084749GA SE410155177GA SE410468097GA SE410468099GA SE410468105GA SE410488599GA SE410488602GA SE411191642GA SE411302542GA SE411302544GA SE411302550GA SE411302564GA SE411302573GA SE411312693GA SE411322865GA SE411322872GA SE411332985GA SE411332992GA SE411332994GA SE411332999GA SE411343032GA SE411373350GA SE411373354GA SE411373363GA SE411373365GA SE411373366GA SE411373377GA SE411373379GA SE411373380GA SE411373384GA SE411373385GA SE411373419GA SE411373423GA SE411373428GA SE411373438GA SE411383486GA SE411383497GA SE411383502GA SE411383534GA SE411383535GA SE411383537GA SE411383538GA SE411383544GA SE411383545GA SE411383550GA SE411383557GA SE411383565GA SE411393687GA SE411393693GA SE411393695GA SE411393704GA SE411393705GA SE411393709GA D1RF4986G SE411141030GA SE409432600GA SE409442784GA SE409442790GA SE409452881GA SE409452883GA SE409452884GA SE409452904GA SE409452910GA SE409452912GA SE409493387GA SE409503502GA SE409503518GA SE409503526GA SE409503528GA SE409503529GA SE409503530GA SE409503532GA SE409503533GA SE409503534GA SE409503536GA SE409503537GA SE409503538GA SE409503541GA SE409503542GA SE409503543GA SE409503551GA SE409503552GA SE409503556GA SE409503572GA SE409503574GA SE409503578GA SE409503579GA SE409503588GA SE409503590GA SE409503591GA SE409503594GA SE409503595GA SE409503596GA SE409503597GA SE409503598GA SE409503599GA SE409503600GA SE409503602GA SE409503603GA SE409503606GA SE409503610GA SE409503613GA SE409503615GA SE409503621GA SE409503622GA SE409503629GA SE409503630GA SE409503631GA SE409503632GA SE409513647GA SE409513648GA SE409513649GA SE409513652GA SE409513660GA SE409513662GA SE409513663GA SE409513664GA SE409513666GA SE409513668GA SE409513669GA SE409513672GA SE409513673GA SE409513675GA SE409513676GA SE409513677GA SE409513723GA SE409523904GA SE409523909GA SE409523913GA SE409523924GA SE409523925GA SE409523926GA SE409523927GA SE409523928GA SE409523929GA SE409523930GA SE409523931GA SE409523936GA SE409523937GA SE409523940GA SE409523943GA SE409523944GA SE409523945GA SE409523946GA SE409523954GA SE409523956GA SE409523958GA SE409523977GA SE409523979GA SE409523980GA SE409523985GA SE409523986GA SE409523991GA SE409523993GA SE409523994GA SE409523995GA SE409534041GA SE409534048GA SE409534055GA SE409534065GA SE409534084GA SE410024201GA SE410024209GA SE410024214GA SE410024241GA SE410024246GA SE410024247GA SE410024248GA SE410024249GA SE410024250GA SE410024251GA SE410024252GA SE410024253GA SE410024254GA SE410024255GA SE410024256GA SE410024257GA SE410024258GA SE410024259GA SE410024260GA SE410024261GA SE410024262GA SE410024263GA SE410024264GA SE410024265GA SE410024266GA SE410024267GA SE410024268GA SE410024269GA SE410024270GA SE410024271GA SE410024274GA SE410024275GA SE410024276GA SE410024277GA SE410024278GA SE410024279GA SE410024280GA SE410024281GA SE410024282GA SE410024283GA SE410024284GA SE410024285GA SE410024286GA SE410024287GA SE410024288GA SE410024289GA 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SE410064589GA SE410064590GA SE410064591GA SE410064592GA SE410064593GA SE410064596GA SE410064599GA SE410064600GA SE410064601GA SE410064602GA SE410064603GA SE410084830GA SE410084833GA SE410084836GA SE410084838GA SE410084839GA SE410084840GA SE410084841GA SE410094893GA SE410235629GA SE410498816GA SE410508901GA SE410508905GA SE410508914GA SE410508915GA SE410518918GA SE410518921GA SE410518922GA SE410518923GA SE410518928GA SE410518929GA SE410518930GA SE410518932GA SE410518956GA SE410518968GA SE410518982GA SE410518984GA SE410519020GA SE410519136GA SE410519139GA SE410519145GA SE411484172GA G3G46740G Class II GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AVOA alarms will not automatically appear on the left side of the Solar display. In addition, the user interface menus on the discharged patient monitor will not function correctly. This may result in delayed treatment due to missed alarms that may be serious. GE Healthcare, LLC
Food Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206 Lot 1573, 1873, 1843 , 2073 (which was repackaged into 3253 and 3263), & 3273 Class I Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk. Deb-El Food Products, LLC.
Drugs Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3. Lot #: 151631, Exp 10/15 and 152767, Exp 11/15 Class III Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out. Aaron Industries Inc
Devices Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation. Product M320, Accessory Shorts with lot numbers XIN1212 and XIN0413. Class II Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. AlterG, Incorporated
Devices Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650. Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807. Class II Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. Focus Diagnostics Inc
Devices DeRoyal(R) ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries, 200 DeBusk Lane, Powell, TN 37849 lot numbers 33347799, 33444071, and 33423747 Class II Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. DeRoyal Industries Inc
Devices Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. Part Number #180704-1, Lot #12151013-1. Class II The product may be mislabeled and could result in the incorrect implant being used. Mako Surgical Corporation
Devices PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, 2421871 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2373868, 2397890, 2407867, 2410931, 2417878, 2417880 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2373869, 2375897, 2382870, 2397889, 2410932 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2383867, 2397883 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot # 2410919 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot #'s 2367883, 2383868, 2397882, 2410914 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy. Kit Lot # 2410918 Class II Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing KCI USA, INC.
Devices MEDITECH Microbiology - Calculator/data processing module, for clinical use. Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13. Class II Potential for patient results being removed from LAB/EMR. Medical Information Technology, Inc.
Food Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each. 1106 Class I Positive Salmonella finding BIG RED TOMATO PACKERS, LLC
Devices FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip. Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) were mistakenly packaged/labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa Class II Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932-36-252, Lot# 728F1089 on the inside (10 units)were not distributed. The units labeled as Model/Catalog Number 932-36-252, Lot# 728F1089 on the outside and containing Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the inside (10 units) were distributed. Djo Surgical
Devices BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement. Part #1010-451 Lot #13121434 Class II As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary Cement Remover". Heraeus Kulzer, LLC.
Food Dark Meat Fajita School Lunch #3 88835 Dark Meat Fajita School Lunch, lot #'s 020401, 020402, 020403, 020404, 020405, 020406, 020407, 020408, 020409, 020410, 020411, 020412 (611 bags, manufactured on 1/20/14), and lot #'s 022401, 022402, 022403 (152 bags, manufactured on 1/22/14) Class I An ingredient used to manufacture the product tested positive for Salmonella Pepper Source Limited
Food Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes No lot codes used Class III Parsnips were found to be above tolerance, maximum residue level, for the pesticide linuron. Ed Fields & Sons, Inc
Cosmetics Wet Nuru Massage Gel, Nuru Original, Net Wt. 8.8 oz and 38 oz. Lot No. 25562 and 25674. Class II Due to microbial contamination Trigg Laboratories, Inc
Cosmetics Wet Nuru Massage Gel, Nuru Concentrate, Net Wt. 8.8 oz and 38 oz. Lot No. 25563, 25659, and 25672. Class II Due to microbial contamination Trigg Laboratories, Inc
Food 18 lb box of Curly Parsley packaged in 3 wire wooden crates Lot AG01GN Class I Sample of Parsley was found positive with Salmonella. Roth Farms Inc
Devices Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft. part no. 02.231.240, lot no. 823111 Class II Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). Synthes, Inc.
Drugs Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2. Lot #: 57617531, Exp 03/14 Class II Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Actavis Elizabeth LLC
Food Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5. Best By Date: 01MAY14. Case Manufacturing Code: 09309210 05:00 through 09309210 10:30 05:00 and 10:30 represent 5:00 am-10:30 am - production time stamp. Class I Kettle Foods, Inc. is recalling Bakes Sea Salt Potato Chips, Kettle Brand, due to potential undeclared milk. Diamond Foods Inc
Food Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton. Best By: 06/14/2015. UPC: 0-71580-08103-1. Class I This voluntary recall has been initiated because Dairy Rich Chocolate Ice Cream may contain peanut butter, which contains a peanut allergen. Ice Cream Specialities
Food Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL** Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014 Class I Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. Falafel King Ent, Inc.
Food Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps Exp. Dates 2/14,2014, 2/16, 2/21, 2/23, 2/28, 2/30, 3/3, 3/5, 3/10, 3/12,2014 Class I Falafel King is recalling their Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria Monocytogenes. Falafel King Ent, Inc.
Devices Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments. PFA14001,PFA14002,PFA14003,PFA14004,PFA14005,PFA14006,PFA14007,PFA14008,PFA14009,PFA14010,PFA14011,PFA14012,PFA14013,PFA14014,PFA14015,PFA14016,PFA14017,PFA14018,PFA14019,PFA14020,PFA14021,PFA14022,PFA14023,PFA14024,PFA14025,PFA14026,PFA14027,PFA14028,PFA14029,PFA14030,PFA14031,PFA14032,PFA14033,PFA14034,PFA14035,PFA14036,PFA14037,PFA14038,PFA14039,PFA14040,PFA14041,PFA14042,PFA14043,PFA14044,PFA14045,PFA14046,PFA14047,PFA14048,PFA14049,PFA14050,PFA14051,PFA14052,PFA14053,PFA14054,PFA14055,PFA14056,PFA14057,PFA14058,PFA14059,PFA14060,PFK13106,PFK13107,PFK13108,PFK13109,PFK13110,PFK13111,PFK13112,PFK13113,PFK13114,PFK13115,PFK13116,PFK13117,PFK13118,PFK13119,PFK13120,PFK13121,PFK13122,PFK13123,PFK13124,PFK13125,PFK13126,PFK13127,PFK13128,PFK13129,PFK13130,PFK13131,PFK13132,PFK13133,PFK13134,PFK13135,PFK13136,PFK13137,PFK13138,PFK13139,PFK13140,PFK13141,PFK13142,PFK13143,PFK13144,PFK13145,PFL13001,PFL13002,PFL13003,PFL13004,PFL13005,PFL13006,PFL13007,PFL13008,PFL13009,PFL13010,PFL13011,PFL13012,PFL13013,PFL13014,PFL13015,PFL13016,PFL13017,PFL13018,PFL13019,PFL13020,PFL13021,PFL13022,PFL13023,PFL13024,PFL13025,PFL13026,PFL13027,PFL13028,PFL13029,PFL13030,PFL13031,PFL13032,PFL13033,PFL13034,PFL13035,PFL13036,PFL13037,PFL13038,PFL13039,PFL13040,PFL13041,PFL13042,PFL13043,PFL13044,PFL13045,PFL13046,PFL13047,PFL13048,PFL13049,PFL13050, Class II WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction. WalkMed Infusion, LLC
Devices Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Trilogy 200 Intended Use: The Respironics Trilogy 200 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 200 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. Trilogy 202 Intended Use: The Respironics Trilogy 202 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator. Model (s), Catelogue, or Code Numbers were identified as: 1040000 Trilogy 202 International, Number 1040005 Trilogy200 USA, 1054096 Trilogy 100 International, 1054260 Trilogy 100 USA, 1040004 Trilogy 02, and 1058180 Garbin. Multiple serial numbers also indicated: TV114011447; TV114011448; TV114011449 TV11401144A; TV11401144B; TV11401144C; TV11401144D; TV11401144E; TV114011450; TV114011451; TV11401145B; TV11401145C; TV11401145D; TV11401145F; TV114011460; TV114011461; TV114011462; TV114011464; TV114012326; TV114012364;TV1140120A9; TV114012323; TV11401212C; TV11401230F; TV11401235A; TV11401235C; TV114012370TV114012371 TV114012372; TV114012376; TV114012415; TV114012465; TV21401150C; TV214011510; TV11401153D; TV11401213E; TV21401150F;TV114012165; TV11401133A;TV114012318; TV114012433; TV11401223A; TV11401223E; TV114012170; TV114011722; TV1140120B2;TV114012416; TV114012235; TV114012148; TV114011550; TV1140120BB; TV114012469; TV114012459; TV114012732;TV21401150A; TV11401130C; TV11401236D; TV114011455 ; TV114011465; TV114012239;TV11401223B; TV11401224D;TV114011336 TV11401133B;TV21401150E;TV214011511;TV214011513;TV214011515; TV214011516;TV214011519;TV21401151B;TV21401151F;TV21401210B TV214012117;TV214012119;TV21401211A;TV21401211D;TV214012122; TV114011712;TV114011458; TV114012133;TV114012361; TV114012429 TV11401245B TV114011724 TV114011727 TV114011740 TV214011512 TV21401210C TV214012111 TV214012120 TV214012121 TV21401240D TV114012333 TV11401233E TV114012349 TV11401234C TV114012422 TV11401243B TV11401245F TV11401231C TV114012355 TV114012137 TV11401233C TV1140120DB TV114012453 TV114011635 TV114011752 TV11401134F TV114011741 TV114011757 TV114012095 TV1140120CD TV1140120E3 TV11401215B TV114012130 TV114012134 TV114012343 TV114012347 TV114012462 TV114012473 TV114011554 TV114011711 TV114011719 TV114011723 TV114011725 TV114012259 TV014011405 TV014011503 TV014011504 TV21401210D TV21401210F TV214012114 TV214012116 TV11401207D TV11401207F TV114012085 TV11401208C TV1140120A6 TV114011311 TV1140120C1 TV114012146 TV1140120E2 TV11401174E TV114011754 TV1140120DA TV11401233A TV114012342 TV11401234B TV11401241D TV114012441 TV114012456 TV114012458 TV11401245A TV11401245C TV11401245D TV014012302 TV014012404 TV014012204 TV014012206 TV014012207 TV014012208 TV014012402 TV014012405 TV014012406 TV014012407 TV014012408 TV014011601 TV014011607 TV21401151D TV214011522 TV114011335 TV114012313 TV11401236C TV114011744 TV114012090 TV11401209C TV11401209F TV114012098 TV11401230C TV114012377 TV11401213B TV11401214A TV114012154 TV11401245E TV11401230B TV114012414 TV114012417 TV014011401 TV014011406 TV11401214D TV11401246D TV114012418 TV11401241C TV11312282C TV11401130F TV11401146A TV11401146C TV11401146F TV114011523 TV114011524 TV11401152A TV11401152D TV114011530 TV114011536 TV114011538 TV11401155C TV11401170F TV114011717 TV11401172C TV1140120DC TV114012160 TV114012163 TV11401216A TV11401216B TV114012240 TV114012446 TV11401246E TV1140120D4 TV1140120D5 TV114012155 TV114012157 TV114012423 TV114012132 TV11401241E TV114012432 TV11401212E TV114012312 TV11401231D TV114012351 TV11401235D TV114012468 TV11401246F TV114012470 TV114012472 TV11401241A TV11401242A TV1140120D0 TV11401224E TV114012233 TV114012234 TV114012237 TV11401223F TV11401224C TV114012250 TV114012255 TV114012256 TV11401225B TV114011746 TV114012322 TV11401154F TV11401231A TV114012330 TV114011317 TV11401152C TV114011540 TV114011546 TV11401154A TV11401154E TV114011551 TV114011555 TV114011562 TV11401170D TV114011718 TV11401172B TV114011745 TV114011760 TV21401151A TV21401151C TV1140120D9 TV114012162 TV114012238 TV114012242 TV11401224B TV114012358 TV11401161A TV11401161F TV114011623 TV11401162E TV11401162F; Class I Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients. Phillips Respironics, Inc.
Devices Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe. Product Number: MIH-3333; NDC Number: 64253-333-33; Lot Numbers and Expiration Dates: Lot H114120N, Expires 12/15; Lot H113403N, Expires 11/15; Lot H113369N, Expires 10/15; Lot H113327N, Expires 8/15; Lot H113291N, Expires 7/15; Lot H113266N, Expires 6/15; Lot H113232N, Expires 5/15; Lot H113185N, Expires 3/15. Class III The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe). Medefil Incorporated
Drugs Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02 Lot 25-097-DK; Exp 01/01/2015 Class II Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial. Hospira Inc.
Biologics Tendon 2643580002008; 2643590002008; 2643600002008; 2643610002008; 2643620002008; 2643630002008; 2643640002008; 2643650002008; 2643660002008; 2643670002008; Class II Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P, were distributed. University Of Miami Miller School of Medicine Tissue Bank
Drugs 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09 Lot 34-609-FW; Exp 10/15 Class II Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection. Hospira Inc.
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