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U.S. Department of Health and Human Services

Enforcement Report - Week of August 27, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 Lot # 27-352-DK; Exp 03/15 Class I Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. Hospira Inc.
Food XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; HOT; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252 Lot Code FA2046252 Class II Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Renfro Foods, Inc.
Food XOCHITL(so cheel) Chipotle Queso Dip; ALL NATURAL NO TRANS FAT; Mild; NET WT. 11.5 OZ (326g); DIST BY: XOCHITL (so cheel), INC. (214)800-351 DALLAS, TEXAS 75252 Lot Code FA2045253 Class II Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Renfro Foods, Inc.
Food Chile Con Queso; AN ALL NATURAL SPICY CHEESE DIP;Net Weight 16 oz. (454g); DISTRIBUTED BY STONEWALL KITCHEN; STONEWALL LANE, YORK MAINE 03909 USA 800-207-JAMS; STONEWALLKITCHEN.COM Lot Code FJ2236225, Exp date 10/22/2015; Lot Code FK253C225, Exp Date 11/25/2015 Class II Undeclared wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese pre-mix for the recalling firm. Renfro Foods, Inc.
Devices All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013. All brochures and online literature printed before November 20, 2013. Class II Brochures and web site information for the Hyper blue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. Specifically, the web site and brochures misbranded the product with claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, as well as a claim that the product could be used with a 15 mm hand piece. Hyperion Medical
Drugs Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 Lot #s: 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, 29-630-DJ, Exp 05/01/2015 Class I Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution. Hospira Inc.
Devices DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) Part nos. 04.315.003, 04.315.004, 04.315.005, 04.315.006 04.315.023 04.315.024 04.315.025 04.315.026 04.315.027 04.315.028 04.315.053 04.315.054 04.315.055 04.315.056 04.315.063 04.315.064 04.315.065 04.315.066 04.315.067 04.315.068, with lot nos.: 6245205, 7129328, IS10400 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148 6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818 6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179,  ...
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Class I DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively. Synthes, Inc.
Drugs 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL 60015 Lot C931923, exp 8/31/2015 Class I Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes Baxter Healthcare Corp.
Drugs ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588 Lot# 20142104@30 USE BY: 10/18/2014 Class II Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL. US Compounding Inc
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1193901309 1193981309 1194001309 1194021309 1194041309 1194061309 1194081309 1194101309 1194121309 1194141309 1194161309 1194181309 1194191309 1194201309 1194221309 1194231309 1194251309 1194321309 1194351309 1194371309 1194411309 1194541309 1194551309 1194591309 1194611309 1194631309 1194651309 1194801309 1301391308 1301411308 1301471308 1301491308 1301511308 1301531308 1301551308 1301571308 1301591308 1301611308 1301631308 1301671308 1301751308 1301981308 1039461309 1039481309 1039521309 1039541309 1039561309 1039581309 1039601309 1039621309  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 10.0 and 10.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1003871311 1042751309 1166801309 1003911311 1042761309 1166811309 1003931311 1042771309 1166821309 1003951311 1042781309 1166831309 1003971311 1042801309 1166841309 1003991311 1042821309 1166851309 1004011311 1042841309 1166861309 1004501311 1042861309 1166871309 1004521311 1042881309 1166881309 1004561311 1042901309 1166891309 1004581311 1042941309 1166901309 1004601311 1042961309 1166911309 1004621311 1043061309 1166921309 1004631311 1043081309 1166941309 1004641311 1043121309 1166961309 1004661311 1043141309 1166971309 1004671311 1043161309 1166981309 1004681311 1166391309 1166991309 1042091309 1166431309 1167001309 1042111309 1166441309 1167021309 1042191309 1166451309 1167041309 1042271309 1166471309 1167051309 1042291309 1166481309 1167061309 1042311309 1166511309 1167081309 1042331309 1166531309 1167101309 1042351309 1166561309 1167111309 1042391309 1166581309 1167131309 1042481309 1166601309 1167141309 1042571309 1166621309 1167151309 1042581309 1166631309 1167161309 1042591309 1166641309 1167171309 1042601309 1166661309 1167181309 1042611309 1166671309 1167201309 1042621309 1166681309 1167221309 1042631309 1166691309 1167241309 1042641309 1166701309 1167251309 1042651309 1166711309 1167261309 1042671309 1166721309 1167271309 1042681309 1166731309 1167281309 1042691309 1166741309 1167291309 1042701309 1166751309 1167301309 1042711309 1166761309 1167311309 1042721309 1166771309 1167321309 1042731309 1166781309 1167331309 1042741309 1166791309 1167351309 1167371309 1167391309 1167411309 1167431309 1167441309 1167451309 1167461309 1013301309 1014161309 1013311309 1014171309 1013331309 1014191309 1013351309 1014231309 1013391309 1014251309 1013411309 1014261309 1013431309 1014281309 1013451309 1014301309 1013511309 1014321309 1013531309 1014341309 1013551309 1014351309 1013561309 1083721309 1013571309 1083731309 1013581309 1083751309 1013601309 1083851309 1013611309 1083871309 1013621309 1083881309 1013641309 1083891309 1013661309 1083901309 1013701309 1083911309 1013721309 1083921309 1013741309 1083931309 1013761309 1083991309 1013771309 1084021309 1013791309 1084061309 1013811309 1084081309 1013821309 1084091309 1013831309 1084111309 1013841309 1084121309 1013851309 1084131309 1013861309 1084141309 1013871309 1084151309 1013891309 1084161309 1013921309 1084171309 1013941309 1084181309 1013961309 1084191309 1013981309 1084201309 1014021309 1084211309 1014051309 1084221309 1014071309 1084231309 1014091309 1084241309 1014121309 1084251309 1014131309 1084261309 1014141309 1084271309 1014151309 1084281309 1084291309 1084301309 1084311309 1084321309 1084341309 1084361309 1084381309 1084391309 1084401309 1084411309 1084421309 1084441309 1084461309 1084481309 1084491309 1217341310 1217391310 1217421310 1217441310 1217461310 1217481310 1217521310 1217541310 1217561310 1217581310 1217601310 1217621310 1217801310 1217811310 1004031311 1004051311 1042501309 1042521309 1042531309 1042551309 1042811309 1166521309 1166571309 1166611309 1013491309 1083711309 1083771309 1216881310 Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1177211309 1228981309 1177341309 1229001309 1177361309 1229021309 1177381309 1229041309 1177391309 1229061309 1177401309 1229111309 1177411309 1229191309 1177421309 1229211309 1177431309 1229221309 1177451309 1229241309 1177601309 1229261309 1177621309 1229271309 1177681309 1229281309 1177751309 1229291309 1177771309 1229301309 1177791309 1229311309 1177811309 1229321309 1177821309 1229331309 1177831309 1229341309 1177841309 1229351309 1177861309 1229381309 1177881309 1229401309 1177901309 1229501309 1177921309 1229521309 1178041309 1229541309 1178061309 1229551309 1178081309 1229561309 1178101309 1229571309 1178121309 1229581309 1178141309 1229591309 1178151309 1229601309 1178161309 1229611309 1178181309 1229621309 1178201309 1229631309 1178211309 1229651309 1178221309 1229671309 1228801309 1229681309 1228821309 1229691309 1228851309 1229701309 1228861309 1229721309 1228881309 1229741309 1228901309 1229761309 1228921309 1229771309 1228941309 1229781309 1228961309 1229811309 1229831309 1229841309 1229871309 1229881309 1177291309 1228871309 1228891309 1228911309 1229451309 1229511309 1107621309 1107721309 1107741309 1107801309 1108041309 1215161310 1224661309 1225081309 1293581308 1293621308 1294031308 1294091308 1294111308 1294251308 1107431309 1108051309 1215071310 1224861309 1293691308 1107441309 1108061309 1215091310 1224871309 1293751308 1107451309 1108071309 1215111310 1224881309 1293761308 1107471309 1108081309 1215131310 1224891309 1293771308 1107481309 1108091309 1215151310 1224911309 1293781308 1107491309 1108101309 1215171310 1224921309 1293791308 1107511309 1108111309 1215191310 1224931309 1293801308 1107521309 1108131309 1215211310 1224941309 1293811308 1107531309 1108151309 1215221310 1224951309 1293821308 1107551309 1108161309 1215241310 1224961309 1293831308 1107561309 1108171309 1215251310 1224971309 1293841308 1107571309 1108181309 1215261310 1224981309 1293851308 1107591309 1108201309 1215271310 1225001309 1293871308 1107601309 1108211309 1215281310 1225021309 1293891308 1107611309 1108221309 1215291310 1225041309 1293901308 1107631309 1108241309 1215301310 1225071309 1293911308 1107641309 1108261309 1215311310 1225091309 1293921308 1107651309 1108281309 1215331310 1225111309 1293931308 1107661309 1108301309 1215351310 1225121309 1293951308 1107671309 1108311309 1215551310 1225131309 1293971308 1107681309 1108321309 1215581310 1225141309 1293991308 1107691309 1108341309 1215601310 1225151309 1294011308 1107701309 1108361309 1215621310 1225161309 1294051308 1107711309 1108381309 1215631310 1225171309 1294071308 1107731309 1108391309 1215641310 1225191309 1294151308 1107751309 1108401309 1215651310 1225211309 1294171308 1107761309 1214701310 1215681310 1225231309 1294191308 1107771309 1214721310 1215691310 1225251309 1294211308 1107781309 1214741310 1215711310 1225271309 1294231308 1107791309 1214801310 1215731310 1225291309 1294291308 1107811309 1214821310 1224381309 1225311309 1294311308 1107821309 1214841310 1224401309 1225331309 1294331308 1107841309 1214861310 1224611309 1225351309 1294341308 1107861309 1214881310 1224631309 1225371309 1294351308 1107901309 1214901310 1224651309 1225391309 1294361308 1107911309 1214921310 1224671309 1225411309 1294371308 1107921309 1214931310 1224691309 1225431309 1294381308 1107941309 1214941310 1224711309 1293501308 1294391308 1107971309 1214951310 1224731309 1293511308 1294401308 1107981309 1214961310 1224751309 1293521308 1294411308 1107991309 1214971310 1224771309 1293531308 1294421308 1108001309 1214991310 1224791309 1293541308 1294431308 1108011309 1215011310 1224811309 1293551308 1294441308 1108021309 1215031310 1224831309 1293571308 1294451308 1108031309 1215051310 1224851309 1293671308 1294461308 1294471308 1294481308 1294491308 Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 12.0 and 12.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1016841311 1036331309 1190471309 1191411309 1221461309 1016851311 1036341309 1190481309 1191421309 1221471309 1016871311 1036351309 1190491309 1191431309 1221481309 1016891311 1036371309 1190501309 1191441309 1221491309 1016911311 1036381309 1190511309 1191461309 1221501309 1016931311 1036401309 1190521309 1191471309 1221521309 1016951311 1036421309 1190531309 1191481309 1221531309 1016971311 1036431309 1190541309 1220991309 1221541309 1016991311 1036451309 1190551309 1221011309 1221551309 1017011311 1036461309 1190561309 1221021309 1221561309  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1030801310 1031311310 1112971309 1113531309 1213831310 1214371310 1262641310 1290511308 1030811310 1031321310 1112991309 1113541309 1213861310 1214381310 1262661310 1290521308 1030821310 1031331310 1113011309 1113551309 1213881310 1214401310 1262721310 1290531308 1030831310 1031351310 1113031309 1113561309 1213891310 1214421310 1262731310 1290541308 1030841310 1031361310 1113051309 1113571309 1213911310 1214441310 1262751310 1290551308 1030861310 1031371310 1113071309 1113581309 1213921310 1214461310 1262771310 1290561308 1030871310 1031381310  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 14.5, 15.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1019721311 1020201311 1025121309 1025571309 1028501309 1039911310 1040361310 1093801310 1019731311 1020211311 1025131309 1025581309 1028511309 1039921310 1040371310 1093811310 1019741311 1020221311 1025141309 1025591309 1028521309 1039931310 1040381310 1093821310 1019751311 1020231311 1025151309 1025601309 1028531309 1039941310 1040391310 1093831310 1019761311 1020241311 1025161309 1025611309 1028541309 1039951310 1040401310 1093841310 1019771311 1020251311 1025171309 1025621309 1028551309 1039961310 1040411310 1093851310 1019781311 1020261311  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 15.5, 16.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1014361309 1014851309 1022981309 1023501309 1023971309 1097131310 1124801310 1125311310 1014371309 1014861309 1023001309 1023511309 1023981309 1097141310 1124811310 1125331310 1014381309 1014871309 1023011309 1023521309 1023991309 1097161310 1124821310 1125351310 1014391309 1014881309 1023021309 1023531309 1024011309 1097181310 1124831310 1125361310 1014401309 1014891309 1023031309 1023541309 1024031309 1097201310 1124841310 1125371310 1014411309 1014901309 1023041309 1023551309 1096541310 1097221310 1124851310 1125381310 1014421309 1014911309  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 16.5, 17.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1006311309 1006881309 1031811311 1032341311 1041171312 1041681312 1042161312 1048341311 1006321309 1006891309 1031821311 1032361311 1041181312 1041701312 1042171312 1048351311 1006331309 1006901309 1031841311 1032381311 1041191312 1041711312 1042181312 1048361311 1006341309 1006911309 1031851311 1032401311 1041201312 1041721312 1042191312 1048371311 1006351309 1006921309 1031861311 1032421311 1041211312 1041741312 1042201312 1048381311 1006361309 1006931309 1031871311 1032431311 1041221312 1041761312 1042211312 1048401311 1006371309 1006941309  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5, 18.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1004271312 1004831312 1012421311 1013091311 1027651310 1028131310 1031861309 1032381309 1004281312 1004841312 1012521311 1013101311 1027661310 1028141310 1031871309 1032401309 1004291312 1004851312 1012541311 1013121311 1027671310 1028151310 1031881309 1032411309 1004301312 1004861312 1012601311 1013141311 1027691310 1028161310 1031891309 1032421309 1004311312 1004871312 1012621311 1013161311 1027701310 1028171310 1031901309 1032431309 1004321312 1004881312 1012641311 1013181311 1027711310 1028181310 1031921309 1032441309 1004331312 1004891312  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. 1001141312 1001151312 1001161312 1001171312 1001181312 1001191312 1001201312 1001211312 1001221312 1001231312 1001241312 1001251312 1001261312 1001271312 1001291312 1001301312 1001311312 1001321312 1001331312 1001341312 1001351312 1001361312 1001371312 1001381312 1001391312 1001401312 1001411312 1001421312 1001431312 1001441312 1001451312 1001461312 1001471312 1001481312 1001491312 1001501312 1001511312 1001521312 1001531312 1001541312 1001551312 1001571312 1001591312 1001611312 1001631312 1001651312 1001671312 1001691312 1001711312 1001731312  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 19.5-20 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1014621311 1014631311 1014641311 1014651311 1014661311 1014671311 1014681311 1014691311 1014701311 1014711311 1014721311 1014731311 1014741311 1014751311 1014761311 1014771311 1014781311 1014791311 1014801311 1014811311 1014821311 1014831311 1014841311 1014851311 1014861311 1014871311 1014881311 1014891311 1014901311 1014911311 1014921311 1014931311 1014941311 1014951311 1014961311 1014971311 1014981311 1014991311 1015001311 1015011311 1015021311 1015031311 1015041311 1015051311 1015061311 1015071311 1015081311 1015091311  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 20.5-21 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1000541311 1000561311 1000581311 1000601311 1000621311 1000641311 1000661311 1000681311 1000701311 1000721311 1000741311 1000761311 1000781311 1000801311 1000821311 1000841311 1000861311 1000881311 1000891311 1000901311 1000911311 1000921311 1000931311 1000941311 1000951311 1000961311 1000971311 1000981311 1000991311 1001001311 1001011311 1001021311 1001031311 1001041311 1001051311 1001061311 1001071311 1001081311 1001091311 1001101311 1001111311 1001121311 1001131311 1001141311 1001151311 1001161311 1001171311 1001181311  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 21.5-22.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1001951310 1001961310 1001971310 1001981310 1001991310 1002001310 1002011310 1002021310 1002031310 1002041310 1002051310 1002061310 1002071310 1002081310 1002091310 1002101310 1002111310 1002121310 1002131310 1002141310 1002151310 1002161310 1002171310 1002181310 1002191310 1002201310 1002221310 1002241310 1002281310 1002301310 1002321310 1002341310 1002361310 1002381310 1002391310 1002411310 1002431310 1002451310 1002471310 1002491310 1002511310 1002531310 1002551310 1002571310 1002591310 1002611310 1002621310 1002631310  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1006151310 1006191310 1006211310 1006231310 1006251310 1006271310 1006291310 1006311310 1006331310 1006351310 1006371310 1006371312 1006391310 1006391312 1006411310 1006411312 1006431310 1006431312 1006451310 1006451312 1006471310 1006471312 1006481310 1006491310 1006491312 1006501310 1006511310 1006511312 1006521310 1006531310 1006531312 1006541310 1006551310 1006561310 1006571310 1006591310 1006601310 1006611310 1006621310 1006631310 1006641310 1006651310 1006661310 1006671310 1006681310 1006691310 1006701310 1006711310  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 24.5, 25, 25.5 & 26. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1004711311 1004721311 1004731311 1004741311 1004751311 1004761311 1004771311 1004781311 1004791311 1004801311 1004821311 1004841311 1004861311 1004881311 1004901311 1004921311 1004941311 1004961311 1004971311 1004981311 1004991311 1005001311 1005021311 1005041311 1005061311 1005071311 1005091311 1005111311 1005121311 1005151311 1005161311 1005171311 1005181311 1005191311 1005201311 1005211311 1005221311 1005231311 1005241311 1005251311 1005291311 1005331311 1005351311 1005521311 1005531311 1005541311 1005551311 1005561311  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 26.5, 27, 27.5 & 28.5. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1007351309 1007361309 1007371309 1007381309 1007391309 1007411309 1007431309 1007441309 1007451309 1007461309 1007471309 1007481309 1007491309 1007501309 1007511309 1007521309 1007531309 1007541309 1007551309 1007561309 1007571309 1007581309 1007591309 1007601309 1007611309 1007621309 1007631309 1007641309 1007651309 1007661309 1007671309 1007681309 1007691309 1007701309 1007711309 1007721309 1007731309 1007741309 1007751309 1007761309 1007771309 1007791309 1007801309 1007811309 1007821309 1007831309 1007841309 1007851309  ...
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Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 29, 29.5 & 30. Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag. Serial Num 1101821309 1101831309 1101841309 1101861309 1101881309 1101901309 1101921309 1101941309 1101981309 1101991309 1102001309 1102011309 1102031309 1102051309 1102071309 1102091309 1102111309 1102131309 1102201309 1102211309 1102221309 1102231309 1102241309 1102261309 1102271309 1102291309 1102301309 1102311309 1102321309 1102331309 1102351309 1102371309 1102381309 1102391309 1102401309 1102411309 1102431309 1102461309 1102481309 1102501309 1102551309 1102621309 1102641309 1102651309 1102661309 1102681309 1102811309 1102831309 1102851309 1102871309 1102911309 1102941309 1289831308 1289841308 1289851308 1289861308 1289871308 1289881308 1289891308 1289901308 1289911308 1289921308 1289931308 1289941308 1289961308 1290001308 1290021308 1290041308 1290061308 1290071308 1290081308 1290091308 1290101308 1290111308 1290121308 1290141308 1290161308 1290171308 1290181308 1290191308 1290201308 1290211308 1290231308 1290251308 1290271308 1290281308 1290291308 1290311308 1290321308 1290331308 1290341308 1290351308 1290361308 1290371308 1290381308 1039861309 1039881309 1039901309 1039961309 1039981309 1040011309 1040021309 1040041309 1040121309 1040151309 1040161309 1040171309 1040181309 1040191309 1040201309 1040211309 1040231309 1040251309 1040271309 1040291309 1040311309 1040331309 1040351309 1040371309 1040391309 1040471309 1040501309 1040551309 1040571309 1040591309 1040671309 1040711309 1040771309 1048531309 1048541309 1048551309 1048561309 1048571309 1048591309 1048601309 1048611309 1048621309 1048631309 1048641309 1048661309 1048671309 1048681309 1048691309 1048701309 1048711309 1048721309 1048731309 1048741309 1048751309 1048761309 1048771309 1048781309 1048801309 1048811309 1048841309 1048911309 1048921309 1048931309 1048941309 1048951309 1048971309 1048981309 1048991309 1049001309 1049021309 1049031309 1049041309 1049051309 1049071309 1049101309 1049121309 1049141309 1049161309 1049181309 1049201309 1049211309 1049221309 1049251309 1049271309 1049291309 1049321309 1049331309 1049341309 1049361309 1049371309 1049391309 1049401309 1049411309 1049421309 1049431309 1049441309 1049451309 1049461309 1049471309 1049481309 1049491309 1049501309 1049511309 1066121309 1066131309 1066161309 1066181309 1066211309 1066221309 1066231309 1066251309 1066261309 1066321309 1066361309 1066401309 1066441309 1066481309 1066521309 1066561309 1066571309 1066591309 1066601309 1066641309 1066661309 1066761309 1066951309 1066971309 1067041309 1067061309 1067081309 1067101309 1067121309 1067141309 1067151309 Class II Units may be labeled with the incorrect diopter power. AMO Puerto Rico Manufacturing, Inc.
Devices Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated. All lots of models: 92025-A, 92025-B, 92025-C, 91033-2 Class I The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds. Childrens Medical Ventures
Biologics Red Blood Cells Leukocytes Reduced W270114502680; Class II Blood product, collected from a donor who reported travel to an area possibly endemic for malaria, was distributed. Central Pennsylvania Blood Bank
Devices Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA Lot: 17284 Class II Staining on hip implant. Omnilife Science Inc.
Food FISH FAMILY FARM INC. & & Shadow Valley Farm brand CHOCOLATE MILK GRADE A PASTEURIZED HOMOGENIZED in a glass half-gallon container Sell by 6/23/14 Class II Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio). Fish Family Farm
Food FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A 2% Reduced Fat Milk Pasteurized and Homogenized in a glass half-gallon container Sell by 6/23/14 Class II Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio). Fish Family Farm
Food FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A FAT FREE SKIM MILK Pasteurized and Homogenized in a glass half-gallon container Sell by 6/23/14 Class II Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio). Fish Family Farm
Food FISH FAMILY FARM INC. & Shadow Valley Farm brand GRADE A WHOLE MILK Pasteurized and Homogenized in a glass half-gallon container Sell by 6/23/14 Class II Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio). Fish Family Farm
Food FISH FAMILY FARM INC. GRADE A PASTEURIZED HEAVY CREAM in glass pints, quarts, half-gallons Sell by 6/23/14 Class II Milk products and cream products may be contaminated with peanuts and tree nuts (pistachio). Fish Family Farm
Drugs Doctor's Best Red Yeast Rice 1200, 600 mg Capsules, 120-count bottle. UPC 753950001183, Manufactured for Doctor's Best San Clemente, CA 92673 Lot # 3121005; Exp 02/17 Class II Marketed Without an Approved NDA/ANDA: FDA analysis discovered undeclared lovastatin, making this an unapproved new drug. Doctor's Best, Inc.
Drugs Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91. Lot # 2004069, Expiry: 09/2014; Lot #: 2004070, Expiry: 09/2014. Class III Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities. Mylan Pharmaceuticals Inc.
Devices Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581 Catalog Number: DNPDG, Lot Number: NB0311 and NB0611 Class II The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck. Biomet, Inc.
Devices PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. Item Number 00-5907-015-00, Lot Numbers: 56518863 & 56518862 Class II The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide. Zimmer, Inc.
Devices PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel. Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861 Class II The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide. Zimmer, Inc.
Devices Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement. Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot  ...
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Class II Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached either the inner or outer package tray. Zimmer has not received any complaints of damaged package trays for these 20 lots. Zimmer, Inc.
Devices Double Offset Rasp Handle, Left Hand Nonsterile Item Number 82016757821 Lot Number 97005188, 97005789 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Left Hand Nonsterile Item Number 82016757830 Lot Number 97009559 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Left Hand Nonsterile Item Number 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices VI DBL OFFST W/ LRG STPL, LT Nonsterile Item Number 82016757841 Lot Number 97009219, 97009254 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Right Hand Nonsterile Item Number 82016757922 Lot Number 97005189, 97005833 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Left Hand Nonsterile Item Number 82016757931 Lot Number 97009560 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Right Hand Nonsterile Item Number 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Vl DBL OFFST WI LRG STPL, RT Nonsterile Item Number 82016757942 Lot Number 97009220, 97009255, 97009256, 97009585 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices VER2 DBL OFFSET RASP HANDLE, LT Nonsterile Item Number 82016761201 Lot Number 97009494, 97009561, 97009569 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices VER2 D8L OFFSET RASP HANDLE, RT Nonsterile Item Number 82016761302 Lot Number 97009564, 97009565, 97009570 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left) Item Number 00780803521 Lot Number 56474891, 56474892, 56474893, 56474894 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices VER2 HANDLE, PIN REWORK, LT Nonsterile Item Number 82-0167-612-31, Lot Number 97009753, 97010150 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices VER2 HANDLE, PIN REWORK, RT Nonsterile Item Number 82-0167-613-32 Lot Number 97010151 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices 23.5 Deg Rasp Handle Assy- LEFT Nonsterile Item Number 82-0167-636-00 Lot Number 97009530, 97009782 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Devices 23.5 Deg Rasp Handle Assy- RIGHT Nonsterile Item Number 82-0167-636-20 Lot Number 97009531, 97009781 Class II The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Zimmer, Inc.
Drugs Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869. Lot: 06062014@8, Do Not Use Beyond 12/03/2014 Class I Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination. Pharmacy Creations
Drugs Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2. Lot #: 505024006, 505024007, Exp 03/15; 505024008; 505024009, Exp 06/15; 505024010, Exp 08/15; 505024011, Exp 09/15; and 505024012, Exp 10/15 Class III Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12. Trigen Laboratories, Inc.
Biologics Red Blood Cells Leukocytes Reduced W035212077434N; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare, Inc.
Biologics Cryoprecipitated AHF W035212077434N; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare, Inc.
Biologics Blood and Blood Products for Reprocessing W035212077434N; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare, Inc.
Biologics Fresh Frozen Plasma W035214005157X; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Red Blood Cells Leukocytes Reduced W035213029024M; W035214005157X; W0352133025163; W035214030021C; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Platelets W035213029024M; W0352133025163; W035214030021C; Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Blood and Blood Products for Reprocessing W035213029024M; W0352133025163; W035214030021C; Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Carter BloodCare
Biologics Source Plasma 2820721948; 2820722336; 2820723770; 2820724285; 2820725965; 2820726577; 2820727839; 2820728883; 2820730483; 2820730836; 2820780433; 2820780969; 2820781929; 2820782356; 2820783397; 2820789414; Class III Blood products, collected from a donor who disclosed history that warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed. Grifols PlasmaCare, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W047014011451; Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. New York Blood Center, Inc.
Biologics Red Blood Cells Leukocytes Reduced W333414009307; Class III Blood product, which was also tested as part of a clinical trial, but was not handled according to protocol, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W333613092147; Class II Blood product, collected from a donor who emigrated from a malarial endemic country, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W0415130095307; W041513013459G; W041513013459G; W0415130131841; W0415130131841; W0415130178544; W041513021982F; W0415130095307; W041513021982F; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Platelets Pheresis Leukocytes Reduced W050914015360; W050914015360; Class II Blood products,that did not undergo quality control testing for pH or platelet count, were distributed. HCSC-Blood Center
Devices IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources. software versions 3-8-1 to 4-9-1 Class II In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated. Intelerad Medical Systems
Devices blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of a number of components. The components are the following: 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral Frequency Signal Processor). The different monitor components that can be used in the system are one of the following per system are as follows: Patient Physiological Monitors used: CJPS Vital Pro, Zoe Medical Nightingale Monitoring system, Ivy Biomedical model 405P, Software components: Ansar ANS C 3000. The device is also referred to as the ANS-C3000. ANX 3.0 unit numbers: 193 through 1203. Class II Ansar Group, Inc. recalled the blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system because of complaints that it occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured. Ansar Group, Inc. Dba Ansar Medical Technologies, Inc
Devices Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set Part Number: 145.17E Lot Number: EV01609, individual part numbers contained within 145.17E: 304.49 309.501 310.221 310.804 311.43 312.151 312.153 313.969 314.463 314.464 314.465 319.291 319.292 319.702 319.97 398.408 398.409 402.608-402.640 402.714-402.740 419.89 419.972 292.622, and 292.623. Class II A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. Synthes, Inc.
Devices PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve Model No. OF-B130 OF-B194 Class II The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health. Pentax Medical Company
Food Jody's, Funfetti, Net Wt 7.5 oz (213 g) and 4 oz in clear cellophane bag. 7.5 oz bags: 9/24/14, 9/28/14, 10/1/14, 10/9/14, 10/14/14, 10/18/14, 10/24/14, 11/1/14, 11/10/14, 11/22/14, 11/30/14, 12/7/14. 4 oz bags: 9/7/14. Class II Undeclared colors Blue #1, Red #3 and Yellow #5. Jody's Inc.
Food Jody's, Freedom Funfetti; Net Wt 7.5 oz (213 g) in clear cellophane bag. 8/13/14, 10/9/14, 11/1/14, 11/12/14, and 11/22/14. Class III Undeclared colors Blue #1, Blue #2 and Red #40. Jody's Inc.
Food Jody's, Breast Cancer Awareness Kettle Corn; Net Wt 3oz in clear cellophane bag. 3/15/14, 6/12/14 Class III Undeclared color Red #3 . Jody's Inc.
Devices Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations. Serial number--802971, 803106, 803356, 803588, 803616, 803854, 802781, 802783, 802780, 802784, 802421, 802861, 802939, 802949, 802924, 803867, 803926, 802809 and 804118. Class II Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. Medical Positioning Inc
Devices Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations. Serial number--803942 Class II Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. Medical Positioning Inc
Devices Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations. Serial number--802722, 802368, 803147, 804007, 804132, 803195, 802286, 802303, 802782, 803112, 803200, 803274, 803455, 803468, 803883, 803961 and 803960. Class II Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. Medical Positioning Inc
Devices Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations. Serial number--803976 Class II Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction. Medical Positioning Inc
Devices Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands. catalog No.: 000878-4, not lot controlled. Class II Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator. Gyrus Medical, Inc
Devices Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017. Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015. Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016. Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015. Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 Model Number MARS Treatment Kit Type 1116/1 X-MARS US, Batch Number 0000020229, Expiry Date 02/2017 Class II Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. Gambro Renal Products, Incorporated
Devices TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, LEFT, REF 71676575, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 34 CM NAIL, 130o, RIGHT, REF 71676576, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, LEFT, REF 71676577, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 36 CM NAIL, 130o, RIGHT, REF 71676578, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, LEFT, REF 71676579, QTY (1), STERILE R, Smith & Nephew, Memphis, Inc., TN 38116 TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 38 CM NAIL, 130o, RIGHT, REF 71676580, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, LEFT, REF 71676581, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 40 CM NAIL, 130o, RIGHT, REF 71676582, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, LEFT, REF 71676583, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 42 CM NAIL, 130o, RIGHT, REF 71676584, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 11.5MM X 44 CM NAIL, 130o, LEFT, REF 71676585, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, LEFT, REF 71676597, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 125o, RIGHT, REF 71676598, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 38 CM NAIL, 125o, RIGHT, REF 71676602, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 40 CM NAIL, 125o, LEFT, REF 71676603, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 42 CM NAIL, 125o, RIGHT, REF 71676606, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 44 CM NAIL, 125o, RIGHT, REF 71676608, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 32 CM NAIL, 130o, RIGHT, REF 71676618, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 34 CM NAIL, 130o, RIGHT, REF 71676620, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 1.5 13MM X 36 CM NAIL, 130o, RIGHT, REF 71676622, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 10MM X 24 CM NAIL, 125o, REF 71934479, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 10MM X 24 CM NAIL, 130o, REF 71934480, QTY (1), STERILE R, TRIGEN(R) INTERTAN(TM) 11.5MM X 24 CM NAIL, 130o, REF 71934482, QTY (1), STERILE R, TRIGEN INTERTAN 10MM X 18 CM NAIL, 125o, REF 71675201, Lot Numbers: 14CM05726, 14DM08712, 14CM12004, 14DM08713, 14CM12005, 14DM08714, 14CM12006, 14DM08715, 14CM12008, 14DM09828, 14CM12009, 14DM09829, 14CM15434, 14DM09830, 14CM15435, 14DM11951, 14CM15438, 14DM11952, 14CM15488, 14DM16264, 14CM15490, 14DM19617, 71675201 14CM17964, 14CM17965, 14CM17966, 14CM17966, 14DM01455, 14DM01456, 14DM04231, 14DM04232, 14DM04233, 14DM04234, 14DM04235, 14DM05411, 14DM05412, 71675201 14DM05413,  ...
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Class II There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS. Smith & Nephew, Inc.
Drugs CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC 55390-808-01 Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14 Class II Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. Ben Venue Laboratories Inc
Devices Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. Model # 10007101; Lot # 14A0041IN Class II Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system. Nellcor Puritan Bennett Inc. (dba Covidien LP)
Devices CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. 100573, 100575, 100674, 100676, 100678, 100680. Class I CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use. Cardiovascular Systems, Inc.
Devices Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional Top Nonsterile TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 3-5 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 6-9 CD TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 3-5 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 6-9 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 10-11 EF TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 6-9 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 GH TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP TASP PS L 10-12 J TOP Item Numbers: 42517400410 42517400510 42517400610 42517400710 42517400810 42517400910 42517401010 Lot Numbers: 62043556 62110045 62121489 62125589 62147235 62168383 62177247 62165546 62311021 62314722 62386421 62442838 62525491 62558585 62605208 62627292 62683432 62696865 62717343 62022344 62041351 62073566 62104372 62117744 62121488 62149175 62187324 62187325 62247351 62311022 62314723 62364961 62391117 62436468 62474903 62538403 62564311 62611089 62669905 62690895 62720225 62020946 62028233 62073570 62110047 62130976 62187327 62187329 62189325 62290822 62305407 62314724 62386424 62420258 62469459 62531662 62565041 62551356 62584447 62612266 62687089 62690049 62690909 62702763 62724739 62022345 62024978 62104374 62124040 62134006 62200223 62200224 62233921 62294595 62314725 62385328 62436479 62511942 62544381 62565042 62597795 62669933 62696869 62710618 62043559 62104415 62121530 62203396 62203397 62314728 62314730 62356529 62390841 62442847 62511926 62565057 62551396 62595859 62654933 62656069 62720226 62034569 62055683 62113088 62130978 62149714 62165547 62168384 62177253 62184260 62256285 62256284 62397161 62420223 62511956 62565108 62551402 62601570 62696376 62043561 62055684 62116593 62152728 62145793 62166196 62166195 62168385 62184261 62239294 62319851 62320878 62356546 62390865 62474905 62538415 62565044 62581863 62622558 62632819 62740693 62398035 62440437 62515479 62515499 62563803 62581853 62675491 Class II Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Zimmer, Inc.
Devices Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile TASP L CD BOTTOM, +0MM TASP L CD BOTTOM, +6MM TASP L EF BOTTOM, +0MM TASP L EF BOTTOM, +6MM TASP L GH BOTTOM, +0MM TASP L GH BOTTOM, +6MM TASP L J BOTTOM, +0MM TASP L J BOTTOM, +6MM TASP R CD BOTTOM, +0MM TASP R CD BOTTOM, +6MM TASP R EF BOTTOM, +0MM TASP R EF BOTTOM, +6MM TASP R GH BOTTOM, +0MM TASP R GH BOTTOM, +6MM TASP R J BOTTOM, +0MM TASP R J BOTTOM, +6MM Item Numbers: 42517000303 42517000313 42517000505 42517000515 42517000707 42517000717 42517000909 42517000919 42527000303 42527000313 42527000505 42527000515 42527000707 42527000717 42527000909 42527000919 Lot Numbers: 62022340 62024973 62062232 62104367 62187314 62187315 62190367 62190370 62265725 62301862 62314675 62385126 62385132 62355857 62403987 62414017 62420244 62456269 62506026 62506044 62531664 62558106 62564325 62596552 62600208 62614790 62683419 62691385 62698730 62716777 62024974 62032099 62075271 62144791 62171682 62171684 62184223 62187317 62239237 62256256 62248153 62386757 62391108 62414001 62391109 62414002 62456271 62474902 62544384 62565107 62565106 62601564 62612269 62627270 62678888 62684675 62695301 62710627 62745014 62019862 62091183 62177238 62177239 62177240 62268818 62282708 62305406 62314683 62351287 62356123 62385455 62401419 62405946 62419059 62429198 62456279 62504887 62531665 62559945 62565049 62595861 62621822 62627202 62663169 62690886 62696853 62698724 62716769 62710616 62030854 62050136 62125572 62154284 62165540 62168382 62177242 62190375 62247344 62247345 62256257 62364951 62391110 62413998 62391111 62427064 62413999 62469454 62525495 62538399 62565110 62565111 62565109 62595858 62630285 62632817 62680122 62680123 62691389 62696886 62710624 62717356 62022342 62024977 62087042 62091198 62165542 62189343 62187321 62233919 62239239 62256279 62247347 62386756 62391114 62391115 62403989 62419057 62429191 62461234 62525494 62544359 62564327 62587605 62601573 62601574 62668825 62696851 62717321 62744886 62747704 62030862 62029578 62125573 62165544 62189323 62189322 62189324 62201539 62239240 62256280 62247349 62372408 62386777 62391226 62403995 62420263 62456272 62506051 62544380 62565113 62565114 62595867 62663132 62668575 62691387 62689234 62717344 62338672 62338673 62338674 62338675 62504658 62511928 62564328 62619534 62383954 62427416 62443506 62495522 62498723 62669167 62710621 62055685 62075277 62149177 62192902 62192903 62198204 62233922 62305408 62356554 62385133 62385134 62404280 62420241 62449201 62515528 62529691 62551363 62564308 62604993 62614838 62616391 62683416 62715142 62715143 62724729 62732162 62043562 62104420 62166222 62196582 62196583 62196584 62233923 62305409 62356575 62356576 62386778 62404281 62427063 62419055 62449190 62497269 62544355 62565097 62565098 62600182 62595870 62608888 62677155 62678897 62696859 62710617 62730175 62043563 62091814 62177255 62188407 62188408 62188409 62233924 62305410 62356580 62356582 62386427 62429080 62429081 62442784 62479530 62480204 62480205 62544357 62544358 62568264 62569954 62592280 62595862 62611084 62641326 62654924 62695307 62710625 62740696 62036671 62125597 62144797 62203401 62203402 62209047 62229714 62239297 62248169 62315063 62356591 62364962 62386780 62391235 62419058 62442845 62469460 62531658 62551097 62568294 62654893 62654894 62663171 62683434 62702755 62055687 62089764 62189328 62209048 62229720 62239303 62290779 62311023 62351301 62315137 62356596 62386781 62391238 62404283 62420245 62449209 62504870 62544366 62565096 62581866 62597790 62608891 62612281 62683418 62686270 62724731 62724732 62046410 62125598 62149716 62187330 62187331 62239305 62239306 62248170 62320808 62356601 62385135 62385136 62404284 62420257 62449213 62504874 62529692 62558587 62581868 62600187 62608890 62627268 62684651 62689233 62690894 62702304 62702306 62710622 62394886 62400296 62428415 62443507 62500932 62500933 62551242 62597759 62660204 62646280 62380844 62399812 62428395 62443504 62493131 62536079 62564309 62632816 62695868 Class II Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Zimmer, Inc.
Devices Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional Top Nonsterile TASP CR L 3-9 CD TOP Item Numbers: 42517000410 Lot Numbers: 62024975 62043546 62144792 62152725 62165538 62187318 62337961 62372407 62386776 62397159 62405917 62456263 62499170 62551386 62568272 62572572 62565051 62663168 62691384 62707494 62717346 Class II Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Zimmer, Inc.
Devices Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP Item Numbers: 42517200410 42517200510 42517200610 42517200710 Lot Numbers: 62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418 Class II Zimmer, Inc.
Devices Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM +6MM PSN A/S PROV L J BOTTOM +0MM PSN A/S PROV L J BOTTOM +6MM PSN A/S PROV R CD BOTTOM +0MM PSN A/S PROV R CD BOTTOM +6MM PSN A/S PROV R EF BOTTOM +0MM PSN A/S PROV R EF BOTTOM +6MM PSN A/S PROV R GH BOTTOM +0MM PSN A/S PROV R GH BOTTOM +6MM PSN A/S PROV R J BOTTOM +0MM PSN A/S PROV R J BOTTOM +6MM Item Numbers: 42517600303, 42517600313, 42517600505, 42517600515, 42517600707, 42517600717, 42517600909, 42517600919, 42527600303, 42527600313, 42527600505, 42527600515, 42527600707, 42527600717, 42527600909, 42527600919 Lot Numbers: 62345370 62402721 62423922 62424796 62494665 62563912 62590524 62696878 62717331 62347233 62399612 62428432 62505575 62563917 62592279 62692687 62352330 62416376 62432157 62490790 62563913 62590525 62696881 62357329 62374803 62412999 62432797 62490792 62563911 62654931 62717334 62357328 62372411 62407772 62432794 62463961 62525489 62563914 62575756 62702758 62724743 62358632 62373739 62405896 62432154 62463962 62563916 62656074 62710626 62432790 62462267 62572574 62443455 62456923 62568289 62357865 62410790 62423921 62424804 62500930 62573363 62695299 62347240 62399870 62430403 62504858 62572571 62692683 62732165 62357866 62406970 62432150 62479624 62573364 62695293 62351310 62410788 62435708 62507548 62569955 62698727 62358633 62373740 62410789 62432796 62465722 62517280 62581856 62695873 62363685 62364505 62407568 62432152 62463963 62505999 62572570 62695889 62710608 62432792 62499171 62704629 62445747 62497257 Class II Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs. Zimmer, Inc.
Devices Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6-9 CD TOP TASP MLC L 3-5 EF TOP TASP MLC L 6-9 EF TOP TASP MLC L 10-11 EF TOP TASP MLC L 6-9 GH TOP Item Numbers: 42517600410 42517600510 42517600610 42517600710 42517600810 42517600910 Lot Numbers: 62342526 62423918 62423919 62423920 62427414 62482212 62563745 62612225 62656072 62740698 62342527 62405895 62430401 62504179 62511925 62563784 62638665 62695870 62343066 62406967 62432146 62515486 62564324 62691390 62717335 62351291 62374838 62415307 62430397 62518138 62622527 62696875 62357867 62374796 62427836 62441229 62511924 62565948 62563908 62590523 62695295 62361315 62376662 62420192 62434748 62518137 62540059 62563778 62627131 62698733 Class II Zimmer, Inc.
Devices Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 00-1146-030,035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, -99 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 00-1146-040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-32 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4865-020, 025, 030-00 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-01 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4865-045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-02 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-00 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 4.5 mm Malleolar Screw Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4845-025, 030, 035, 040, 050, 055, 060, 065, 070, -08 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices 4.0 mm Cancellous Screw, Partially Threaded Sterile zimmer, WARSAW, IN 46580, U.S.A. Item Number 47-4840-010, 012, 014, 016, 018, 020, 022, 024, 026, 028, 030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 095, 100-01 Class II Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. Zimmer, Inc.
Devices Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. Model/Catalog Number: 19061-03 Class II Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called "table-zero-position" is sent from the CT scanner to the Brainlab navigation software in a special format. Due to a change in the corresponding Siemens data output, the information from the CT scanner cannot be correctly processed in the navigation software, when using: 1) Automatic Registration of iCT Data, in combination with 2) Siemens SOMATOM Definition AS CT scanner with Software Somaris SOM 7 (or higher), and 3) Automatic Gantry Communication (available for Spine & Trauma 3D 2.0 and 2.1 only). As a result, in the navigation software the CT image data set appears shifted in the scanner movement direction (patient head-feet direction). The scale of the shift can differ in each scan, varying from sub-millimeters to meters. Brainlab AG
Devices Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement. lot RD41041, exp. 10/13/2014 Class II Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal investigation has confirmed bacterial contamination in ChemistryWash lot RD41041. A positive bias will be observed on CTNI, LTNI, TSH, PBNP and LPBN and a negative bias will be seen on FT4 when this lot is first placed on the instrument without recalibration of methods. Recalibration of these assays when using this lot will not correct the problem and may cause falsely high or low results. Siemens Healthcare Diagnostics, Inc.
Biologics Blood and Blood Products for Reprocessing W036513019029; Class II Blood product, collected from a donor considered to be at risk for variant Creutzfeldt- Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Food Ciranda Organic Carob Powder Light, Product Code 20030. Net Wt. 55.11 lbs / 25 kg. Ingredients: Organic Carob Powder. Manufactured in Italy. Lot 395-13 Class I Ciranda is recalling one lot of Organic Carob Powder Light after learning that a customer received a positive test for Salmonella. Ciranda, Inc.
Biologics Red Blood Cells W039714865009N; Class II Blood products, collected from an ineligible donor, were distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Red Blood Cells Frozen Leukocytes Reduced W0397148945288; Class II Blood products, collected from an ineligible donor, were distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced W044114555810; Class II Blood product for which some quality control procedures were not performed, was distributed. LifeServe Blood Center
Devices WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. Serial No. 72110047 72111060 72110077 72110128 72110263 72110281 72110286 72110343 72110469 72110836 72110940 72110983 72130260 72130263 72140014 72140033 72140034 72140036 72140037 72140038 72140041 72140042 72140045 72140046 72140047 72140048 72140052 72140054 72140057 72140058 72140059 72140060 72140061 72140063 72140064 72140066 72140068 72140070 72140072 72140078 72140110 72140111 72140083 72140114 72140165 72140176 72140126 72140129 72140129 72140130 72140136 72140139 72140140 72140141 72140144 72140145 72140152 72140153 72120052 72140039 72140077 72140079 72140090 72140127 72140131 72140133 72140148 72140177 72140051 72140053 72140055 72140056 72140073 72140074 72140075 72140085 72140076 72140154 72120057 72130195 72130540 72130631 72140132 72140112 72140067 72140128 72140071 72140087 72140089 72140086 72140084 72140088 72140123 72140106 72140107 72140146 72140108 72140137 72140122 72140134 72140124 72140115 72140116 72140117 72140118 72140119 72140120 72140121 72140091 72140092 72140095 72140096 72140097 72140098 72140099 72140125 Class II Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting will change to 1% and OFF. Biolase Technology Inc
Food American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Total package size (e.g. 12 packages per case): 12 jars per case Catalog #: MARM-CH, Lots:408400040001 - 408400040431, Best flavor date: 03/2016 and Lots: 408400050001 - 408400050459, Best flavor date: 03/2016 Class II Product may have mold in jar. American Spoon Foods, Inc.
Food Organic Carob Powder, Net Wt. 55lbs (25kg), Product Code: CAROB-100 Lot Code: AN-395-13 Class I BrandStorm is recalling Organic Carob Powder because it may be contaminated with Salmonella. BrandStorm Inc
Food Sesame Ginger Dressing sold under the Whole Foods Market brand in plastic jars, 14 oz. per jar. This product is labeled to keep refrigerated. Batch Numbers and Expiration Dates: 1) Batch 14196, Expires 7/26/14; 2) Batch 14198, Expires 7/28/14; 3) Batch 14200, Expires 7/30/14; 4) Batch 14203, Expires 8/2/14 Class II Brett Anthony Foods is recalling Sesame Ginger Dressing because the allergen almonds (a tree nut) is not listed in the "Contains" allergen warning statement although almonds are listed in the list of ingredients. D.A. Stein Culinary Group, LLC dba Brett Anthony Foods
Devices Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum Pivot Bipolar Cup 22x42mm,Part 133-2242,Lot A136254,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136256,Pivot Bipolar Cup 22x43mm,Part 133-2243,Lot A136255,Pivot Bipolar Cup 22x44mm,Part 133-2244,Lot A136257,Pivot Bipolar Cup 22x45mm,Part 133-2245,Lot A136258,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136259,Pivot Bipolar Cup 22x46mm,Part 133-2246,Lot A136260,Pivot Bipolar Cup 22x47mm,Part 133-2247,Lot A136261,Pivot Bipolar Cup 22x48mm,Part 133-2248,Lot A136262,Pivot Bipolar Cup 22x49mm,Part 133-2249,Lot  ...
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Class II Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Ortho Development Corporation
Devices Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component Patella 38mm Part 164-0038, Lot A135844 Class II Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Ortho Development Corporation
Devices PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component PS Tibial Insert Size 3 8mm,Part 163-1308,Lot A135943,PS Tibial Insert Size 3 9mm,Part 163-1309,Lot A136492,PS Tibial Insert Size 3 12mm,Part 163-1312,Lot A136453,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A135945,PS Tibial Insert Size 4 7mm,Part 163-1407,Lot A136454,PS Tibial Insert Size 5 9mm,Part 163-1509,Lot A135827, Class II Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Ortho Development Corporation
Devices Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component UC Tibial Insert Sz 3 10mm,Part 163-3310,Lot A136109,UC Tibial Insert Sz 4 8mm,Part 163-3408,Lot A135948,UC Tibial Insert Sz 4 14mm,Part 163-3414,Lot A136110,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136113,UC Tibial Insert Sz 6 7mm,Part 163-3607,Lot A136746, Class II Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Ortho Development Corporation
Devices Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed CK Tibial Insert Sz 6 12mm Part 563-1612, Lot A135666 Class II Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation. Ortho Development Corporation
Food Product is in a 160 gram, light green tin container, labeled in part: "ecoato Sweet Paprika Powder Product of Spain" Lot# 8147 Class I Salmonella The TJX Companies, Inc.
Food Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA Sell by APR 09 2015; Product code 55557. Class II Consumer complaint alerted firm that one date code of Butternut Squash Ravioli, may actually contain Spinach Florentine Ravioli that contains milk, egg and soy ingredients that are not listed as ingredients of the package. Carmel Food Group, Inc.
Drugs PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01 Lot 6007698, Exp. 03/16 Class II CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection. Fresenius Kabi USA, LLC
Food CaCoCo Superfood Drinking Chocolate; Global Warrior - Flavor Melody: Dark, Bitter-sweet, Medicinal, Energizing Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Beans, Cacao Butter, Maca, Carob, coconut Crystal Sugar, Mesquite, Wildcrafted Shilajit, Vanilla Bean, Turmeric, Cardamon, Orange Peel, Himalayan Salt, Whole Leaf Stevia. Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA UPC 091131352076 Lot # GW99, Exp 10/19/2014; GW100, Exp 11/28/2014; GW101, Exp 6/18/2015. Class I Firm used organic powder that is now under recall by supplier for potential contamination with Salmonella. CaCoCo, Inc.
Food CaCoCo Superfood Drinking Chocolate; Original - Flavor Melody: Sweet, Playful, Perfectly Spiced Raw Chocolate. Gluten-free/Vegan/Raw Sold in 8 .14 oz (231 g). o and 2 lb. bags. Ingredients: Cacao Butter, Maca, Coconut Crystal Sugar,Carob, Cacao Bean, Cacao Powder, Lucuma, Himalayan Salt, Vanilla Bean, Cinnamon, Nutmeg, Cayenne. Manufactured at 13425 Snow Mt. Camp Road, Nevada, CA UPC 09113152113 Lot # OG99, Exp 10/19/2014; OG100, Exp 11/28/2014; OG101, Exp 6/18/2015. Class I Firm used organic powder that is now under recall by supplier for potential contamination with Salmonella. CaCoCo, Inc.
Devices Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950 Class II The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component. Biomet, Inc.
Devices Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa® PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain. Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H. Class II Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. Medtronic Neuromodulation
Food Natural Grocers Organic Chunks of Energy Carob Supergreens, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600 "Packed On" dates: 155-14, 167-14, 175-14 Class I Natural Grocers by Vitamin Cottage is recalling Chunks of Energy Carob Greens and Chunks of Energy Date Flax/Tumeric due to the potential presence of Salmonella. Natural Grocers by Vitamin Cottage
Food Natural Grocers Organic Chunks of Energy Date Flax Turmeric, 0.70 lb. random weight, Packaged in Plastic Bags, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600 "Packed On" dates: 125-14, 133-14, 147-14, 155-14 Class I Natural Grocers by Vitamin Cottage is recalling Chunks of Energy Carob Greens and Chunks of Energy Date Flax/Tumeric due to the potential presence of Salmonella. Natural Grocers by Vitamin Cottage
Drugs Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA Lot # a) LN11005, Exp 04/15; LN11006; Exp 04/15; b) LN10979; Exp. 04/15, LN10980; Exp. 04/15 Class II Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point. Wockhardt Usa Inc.
Devices TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art® 4.2.0, 4.2.1 and 4.2.2). . Serial # 110403 110366 110319 110352 110034 110083 110140 110336 110126 110009 110129 110014 110332 110333 110212 110287 110130 110417 110133 110450 110416 110365 110389 110340 110341 110372 110279 110370 110345 110167 110292 110061 110142 110334 110306 110342 110143 110351 110374 110208 110356 110430 110315 110447 110431 110444 110124 110263 110123 110151 110294 110435 110111 110422 110353 110364 110384 110261 110297 110157 110300 110267 110428 110405 110299 110246 110429 110071 110200 110171 110305 110330 110407 110359 110361 110136 110371 110211 110304 110075 110063 110437 110183 110199 110184 110337 110049 110172 110076 110036 110426 110107 110113 110326 110093 110400 110393 110085 110229 110412 110425 110052 110182 110391 110178 110159 110291 110302 110350 110265 110288 110237 110150 110289 110301 110449 110293 110278 110442 110436 110148 110068 110233 110376 110236 110153 110181 110439 110411 110241 110295 110064 110303 110249 110058 110114 110296 110414 110110 110240 110313 110079 110191 110156 110128 110069 110362 110310 110207 110423 110443 110433 110382 110421 110375 110460 110335 110404 110307 110324 110325 110432 110321 110245 110440 110194 110317 110418 110051 110177 110108 110206 110120 110257 110329 110179 110311 110125 110115 110040 110074 110406 110283 110165 110195 110225 110161 110210 110160 110204 110175 110006 110098 110144 110187 110217 110262 110214 110067 110047 110222 110097 110119 110048 110149 110221 110198 110193 110239 110203 110318 110215 110258 110244 110256 110312 110023 110378 110132 110201 110016 110322 110343 110145 110282 110190 110039 110026 110250 110056 110216 110066 110320 110401 110035 110209 110091 110281 110346 110380 110379 110284 110099 110094 110273 110105 110054 110168 110186 110185 110122 110272 110331 110234 110020 110243 110059 110271 110390 110188 110041 110251 110224 110116 110255 110252 110042 110238 110247 110309 110134 110135 110073 110101 110024 110218 110219 110045 110316 110220 110154 110138 110152 110087 110276 110176 110092 110057 110086 110269 110166 110213 110127 110005 110030 110003 110139 110323 110022 110104 110399 110339 110354 110344 110112 110118 110141 110223 110192 110044 110121 110226 110270 110338 110274 110046 110358 110253 110103 110235 Class II Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art® 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions. TomoTherapy Incorporated
Devices Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company 731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032,  ...
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Class II The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively). Vascutek, Ltd.
Devices Philips IP5 Information Portal The Expression Information Portal (Model IP5), a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professionals to remotely monitor the vital signs of patients undergoing MRI procedures. Product: 865471 Number 453564251511 Serial Numbers: US23200121, US23200122, US23200123, US23200124, US23200125, US23200126, US23200127, US23200128, US23200129, US23200130, US23200131, US23200132, US23200133, US23200134, US23200135, US23200136, US23200137, US23200138, US23200139, US23200140, US23200141, US23200142, US23200143, US23200144, US23200145, US23200146, US23200147, US23200148, US23200149, US23200150, US23200151, US23200152, US23200153, US23200154, US23200155, US23200156, US23200157, US23200158, US23200159, US23200160, US23200161, US23200162, US23200163, US23200164,  ...
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Class II The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system. Invivo Corporation
Devices TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art® 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan. Serial # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 110065 110077 110078 110081 110082 110084 110088 110090 110095 110096 110100 110102 110106 110109 110117 110121 110131 110137 110146 110147 110155 110158 110162 110163 110164 110169 110170 110174 110180 110189 110196 110197 110202 110205 110226 110227 110228 110231 110232 110248 110254 110259 110260 110264 110266 110268 110270 110275 110285 110286 110290 110298 110308 110314 110327 110328 110338 110347 110348 110349 110352 110355 110360 110363 110367 110368 110369 110373 110377 110381 110383 110385 110386 110387 110388 110392 110394 110395 110396 110397 110402 110408 110409 110410 110411 110413 110415 110419 110420 110424 110427 110434 110438 110441 110445 110446 110448 110451 110452 110453 110454 110455 110456 110457 110458 110459 110460 110461 110462 110463 110464 110465 110466 110467 110468 110469 110470 110471 110472 110473 110474 110475 110476 110477 110478 110479 110480 110481 110482 110483 110484 110485 110486 110487 110488 110489 110490 110491 110492 110493 110494 110495 110496 110497 110498 110499 110500 110501 110502 110503 110505 110507 110508 110504 110509 Class II Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art® 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions. TomoTherapy Incorporated
Drugs ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container bag, Rx only, Baxter Healthcare Corporation, Clinitec Nutrition Division, Deerfield, IL 60015 USA, Product Code 2B6186, NDC 0338-0499-06. Lot #: P306225, Exp 08/14 Class II Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine). Baxter Healthcare Corp
Devices GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages. Mfg Lot or Serial # System ID 00000098016HL9 419291DR1 00000098927HL7 954MCHM656 00000099011HL9 513MWDR2 00000099012HL7 419PERRYDR 00000099013HL5 252962ED1 00000099016HL8 419435DR 00000099440HL0 417347DPORT1 00000099441HL8 708684RAD3 00000099443HL4 708684RAD2 00000099444HL2 732840ER1 00000099445HL9 504349R8 00000099447HL5 608775XR6561 00000099448HL3 408259RMCED1 00000099846HL8 239424XR656 00000099848HL4 HSSE3D656 00000099850HL0 732840ER2 00000099851HL8 7737021555 00000100228HL6 802775RAD5 00000100230HL2 440816D656 00000100231HL0 910WAROBINSON2 00000100366HL4 334793SXR656 00000100368HL0  ...
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Class II GE Healthcare has become aware of a potential safety issue involving the nylon hooks which support the FlashPad" detector on the Discovery XR656 wall stand systems. There have been reported incidents of detector falls, but no injuries have been reported. GE Healthcare, LLC
Devices CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. Lot No. 2704633, 2705206 Class II ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility. ICU Medical, Inc.
Devices Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. Lot No. 2705219 Class II ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility. ICU Medical, Inc.
Devices Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch. Lot No. 2705203 Class II ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility. ICU Medical, Inc.
Devices Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. IntelliSpace 4.4 Class II A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data. Philips Healthcare Informatics, Inc.
Devices Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 Lot 4731639 (exp. date 31-Mar-17) Class II AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). Angiodynamics, Inc.
Devices Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 Lot 4731641 (exp. date 31-Mar-17) Class II AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). Angiodynamics, Inc.
Devices Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 Lot 4762513 (exp. date 31-May-17) Class II AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). Angiodynamics, Inc.
Devices Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426 Model No. 860426 Serial Numbers: US11400027, US31400041, US31400042, US31400044, US31400045, US31400046, US41400051, US51300008, US51400056, US81300016, USN1300020 Class II Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy. Philips Medical Systems, Inc.
Biologics Ligament 126370107; Class II Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed. AlloSource, Inc.
Drugs fentaNYL 1500 mcg/30 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-90 Lot 7088-0 Exp. 07/14 Class II Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Healix Infusion Therapy, Inc.
Drugs fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8002-04 Lots 7230-0, 7269-0 Exp. 08/14 Class II Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Healix Infusion Therapy, Inc.
Drugs fentaNYL 200 mcg/100 mL (2 mcg/mL) and Ropivacaine 0.2% in 0.9% Sodium Chloride 100mL, in flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc., at 866-299-4826, 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8007-02 Lot 7250-0 Exp. 08/14 Class II Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Healix Infusion Therapy, Inc.
Drugs fentaNYL 2750 mcg/55 mL (50 mcg/mL) in prefilled syringe, COMPOUNDED DRUG, For Institutional or Office Use Only--Not for Resale Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478 NDC 75901-8008-33 Lots 7083-0, 7202-0, 7222-0 Exp. 08/14 Class II Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Healix Infusion Therapy, Inc.
Drugs fentaNYL 5000 mcg/250 mL (20 mcg/mL) in 0.9% Sodium Chloride in a flexable bag, COMPOUNDED DRUG For Institutional or Office Use Only--Not for Resale, Federal Law Prohibits Dispensing without Prescription Healix Infusion Therapy, Inc. (866) 298-4826 1075 West Park One Drive, Suite 200, Sugar Land, Texas, 77478, NDC 75901-8015-04 Lot 7257-0 Exp. 08/14 Class II Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing. Healix Infusion Therapy, Inc.
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