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U.S. Department of Health and Human Services

Enforcement Report - Week of March 27, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced V10279A; V10279B Class II Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed. Blood Center of Central Iowa (The)
Biologics Red Blood Cells Leukocytes Reduced LX63739 Class III Blood product, which was labeled with an incorrect expiration date, was distributed. Blood Center of Central Iowa (The)
Biologics Platelets Pheresis Leukocytes Reduced 20LR16622 Class II Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma (Apheresis) 20LR16622 Class II Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LN57617 , 020LN57588 , 020LN57632 , 020LN57626 , 020LN57591 , 020LN57638 , 020LN57584 , 020LY55252 , 020LC71725 , 020LC71693 , 020LY55273 , 020LY55260 , 020LY55275 , 020LY55254 , 020LN57623 , 020LY55256 , 020LZ26853 , 020LZ26857 , 020LZ26850 , 020LC71703 , 020LZ26855 , 020LY55263 , 020LY55258 , 020LY55257 , 020LY55255 , 020LZ26861 , 020LZ26864 , 020LZ26869 , 020LY55261 , 020LN57596. Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 020LY55252. Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 020LN57613, 020LN57641, 020LN57605. Class II Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LN57900 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LN52994 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 020LZ30286; 020LH19466. Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 2833695 Class II Blood product, collected from a donor who was taking the drug Prednisone, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced 021KY12152 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Plasma Frozen 021KY12152 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Platelets Pheresis Leukocytes Reduced W037908113997 Class II Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. LifeServe Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038308070193; W038308070195; W038308072208; W038308072210; W038308072212; W038308072213; W038308072214; W038308072216; W038308072217; W038308072219; W038308072220; W038308072221; W038308072222; W038308072226 Class III Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Platelets Pheresis Leukocytes Reduced W038308001621(part 1); W038308001622 (part 1); W038308001621(part 2); W038308001622 (part 2) Class III Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W038308023614 Class III Blood product, manufactured without the entire quantity of additive solution, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells W127808301997. Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Tacoma-Pierce County Blood Bank
Biologics Source Plasma 375045485; 375048882; 375049084; 375049221; 375055501; 375055797; 375056342; 375057428; 375057950; 375049063; 375053713; 375057572; 375049008; 375049023; 375050131; 375050997; 375051299; 375051912; 375052053; 375052633; 375052819; 375049119; 375049164; 375050974; 375051238; 375051638; 375051869; 375053244; 375049122; 375049150; 375043877; 375044054; 375044502; 375044681; 375050865; 375051086; 375051569; 375052169; 375052257; 375052818; 375052961; 375054020; 375054135; 375054609; 375054769; 375055355; 375055404; 375055951; 375056080; 375056776; 375057001; 375057405; 375040851; 375040813; 375049127; 375049158; 375052604; 375059107; 375035760; 375035899; 375036335; 375036553; 375037320; 375037507; 375039637; 375039900; 375040417; 375041246; 375041601; 375042557; 375051074; 375051650; 375052008; 375052340; 375052700; 375053091; 375057467; 375057728; 375058334; 375059064; 375059611; 375059941; 375061471; 3750000723; 3750002056; 3750003323; 375031933; 375031965; 375037842; 375038068; 375047491; 375050828; 375055626; 375055845; 375060823; 375061146; 375045293; 375049144; 375050588; 375052712; 375053363; 375054021; 375054478; 375054821; 375055318; 375055648; 375056084; 375056428; 375049054; 375050448; 375050659; 375051079; 375051317; 375052274; 375052496; 375054416; 375054683; 375055248; 375055555; 375057420; 375031648; 375031726; 375033811; 375034200; 375034581; 375034854; 375035201; 375035962; 375040880; 375040890; 375044436; 375045615; 375047839; 375045252; 375045315; 375031901; 375031964; 375031665; 375031694; 375033817; 375049082; 375049212; 375051184; 375052975; 375054548; 375054920; 375040857; 375040904; 375040635; 375040685; 375042335; 375042703; 375043013; 375043991; 375044242; 375031689; 375031737; 375034179; 375034371; 375040628; 375040658; 375047585; 375047772; 375049109; 375049162; 375051243; 375051360; 375052210; 375052425; 375052991; 375053181; 375054320; 375054794; 375055088; 375055427; 375055710; 375057030; 375057181; 375057656; 375058006; 375058373; 375040670; 375040716; 375042570; 375049004; 375049173; 375050943; 375051502; 375049137; 375049193; 375051596; 375052302; 375053494; 375054870; 375055483; 375058003; 375060900; 375061715; 375049040; 375049064; 375050368; 375050579; 375051007; 375051286; 375051673; 375051921; 375052386; 375045257; 375045359; 375048142; 375051002; 375051454; 375052001; 375053037; 375054373; 375054719; 375055348; 375056075; 375056404; 375056799; 375045308; 375045327; 375051084; 375051414; 375051778; 375052062; 375052504; 375052846; 375053179; 375054480; 375054813; 375055125; 375055437; 375055767; 375056209; 375045304; 375047544; 375047835; 375048895; 375050282; 375050471; 375051581; 375051808; 375052303; 375053093; 375053281; 375055091; 375045260; 375048690; 375050889; 375052577; 375054891; 375049010; 375051437; 375052416; 375054809; 375055217; 375057298; 375057479; 375059302; 375045487; 3750003856; 375045486; 375049053; 375050022; 375050582; 375051094; 375051283; 375051773; 375051996; 375052490; 375052723; 375053268; 375054012; 375054355; 375054815; 375055030; 375055770; 375056003; 375055464; 375056733; 375058115; 375058290; 375059469; 375059838; 375060178; 375060480; 3750000265; 3750003534; 375045777; 375046110; 375045459; 375046971; 375048593; 375049000; 375049929; 375050302; 375050732; 375051026; 375051408; 375051726; 375052137; 375052434; 375052889; 375053323; 375054047; 375054579; 375054805; 375055212; 375055407; 375048211; 375050223; 375051803; 375056805; 375056936; 375057487; 375057704; 375058244; 375059090; 375059706; 375059973; 375060677; 375060953; 375061434; 375061663; 375062078; 375062228; 3750000029; 3750000781; 3750001105; 3750001365; 3750001890; 3750002234; 3750002768; 3750002914; 375031698; 375033739; 375033916; 375034361; 375034538; 375034925; 375035189; 375035629; 375036587; 375036999; 375037224; 375037918; 375038172; 375038535; 375038735; 375039702; 375040412; 375041248; 375041570; 375041814; 375042069; 375042327; 375042734; 375042998; 375043638; 375044994; 375045598; 375045924; 375047509; 375047767; 375048059; 375048295; 375048814; 375049727; 375050005; 375050406; 375050618; 375051040; 375051338; 375051691; 375052269; 375052821; 375031660; 375036368; 375039949; 375043372; 375048516; 375048682; 375052190; 375054973; 375056355; 375031699; 375031846; 375034952; 375038870; 375039716; 375031916; 375031995; 375036571; 375036952; 375037338; 375037559; 375038802; 375040392; 375042287; 375042630; 375043931; 375047505; 375047770; 375049760; 375050200; 375050535; 375050749; 375051177; 375049076; 375058532; 375061324; 375061641; 375061918; 3750000795; 3750001374; 3750002070; 3750002284; 3750004760; 3750005085; 3750005544; 3750005900; 3750006351; 3750006737; 3750007247; 3750007777; 3750008576; 3750009068; 3750011226; 3750011623; 3750012835; 3750013341; 375031906; 375039219; 375040886; 375045089; 375031656; 375031753; 375033878; 375034402; 375034610; 375035021; 375035273; 375035766; 375035930; 375036344; 375036581; 375037022; 375037196; 375037690; 375037872; 375038246; 375038565; 375038835; 375040092; 375040470; 375042538; 375042988; 375043377; 375043900; 375031696; 375031722; 375035265; 375031922; 375031949; 375036322; 375049002; 375049025; 3750000354; 3750000701; 3750000929; 3750001522; 375047563; 375047786; 375048140; 375048317; 375049842; 375050030; 375050774; 375051000; 375051452; 375052000; 375052919; 375053245; 375054013; 375054727; 375055347; 375056077; 375056405; 375056803; 375057602; 375059589; 375059843; 375060560; 375060699; 375061292; 375062168; 375062540; 3750000299; 3750000734; 3750000972; 3750003836; 3750004063; 3750005303; 3750005495; 3750005985; 3750006338; 3750006944; 3750007189; 3750008074; 375040690; 375040726; 375044158; 375044460; 375045953; 375040622; 375040674; 375042583; 375042735; 375045939; 375046516; 375046739; 375047097; 375047427; 375047697; 375047989; 375048192; 375048466; 375048698; 375049642; 375049984; 375050279; 375052864; 375052931; 375053485; 375054099; 375054695; 375054835; 375055319; 375055556; 375055962; 375056187; 375056665; 375056972; 375057363; 375057732; 375058016; 375058388; 375059210; 375059610; 375060209; 375060345; 375060821; 375061034; 375049045; 375049128; 375050514; 375051049; 375051716; 375051963; 375052427; 375052682; 375053251; 375053439; 375054420; 375054855; 375055074; 375056529; 375040867; 375040891; 375040678; 375040648; 375042519; 375031657; 375031714; 375034065; 375034348; 375034864; 375035103; 375035613; 375036176; 375036398; 375031662; 375031717; 375034094; 375036087; 375041046; 375042657; 375042894; 375044972; 375045680; 375046626; 375031683; 375031723; 375034367; 375031872; 375035857; 375036013; 375036518; 375036682; 375037189; 375037337; 375037716; 375039961; 375040494; 375042173; 375042517; 375043922; 375044995; 375045872; 375046715; 375046905; 375047404; 375048611; 375049715; 375049945; 375050297; 375050748; 3750007454; 375056460; 3750000952; 3750001255; 3750001521; 3750001861; 3750002225; 3750002575; 3750002931; 3750003571; 3750003642; 3750004247; 3750004495; 3750004935; 3750005248; 3750005783; 3750005983; 3750006561; 3750006828; 3750007730; 3750008325; 3750008658; 3750009425; 3750009856; 3750010311; 3750010777; 3750011781; 3750012092; 3750013080; 375040671; 375040694; 375056745; 375057115; 375057464; 375057747; 375058072; 375058480; 375059325; 375059833; 375060061; 375060650; 375061012; 375061363; 375062046; 375062198; 375033145; 375033409; 375033804; 375034005; 375034409; 375034620; 375035062; 375035295; 375035837; 375036042; 375036462; 375036814; 375037382; 375037660; 375036083; 375041976; 375042026; 375042445; 375042677; 375043212; 375043669; 375044831; 375044971; 375045795; 375045964; 375046324; 375046623; 375047643; 375048044; 375048207; 375048540; 3750000490; 3750001092; 375049080; 375049108; 375051128; 375051386; 375051794; 375052068; 375052525; 375052847; 375053488; 375054380; 375054632; 375055057; 375055299; 375055735; 375055936; 375056440; 375056666; 375057062; 375057299; 375057743; 375057979; 375062253; 375062460; 3750000335; 375050237; 375050891; 375051127; 375052329; 375052534; 375053059; 375053279; 375054178; 375054379; 375054860; 375055316; 375055470; 375055949; 375056286; 375056755; 375056943; 375057470; 375057718; 375058132; 375059268; 375059590; 375060294; 3750008281; 3750008744; 3750009398; 3750011272; 3750011624; 3750012559; 3750012884; 3750013937; 375049105; 375049183; 375050902; 375051362; 375051602; 375052037; 375052798; 375053065; 375053457; 375054287; 375054989; 375055257; 375055914; 375056160; 375056626; 375056818; 375057261; 375057563; 375059137; 375059391; 375059887; 375060356; 375060647; 375061237; 375061362; 375061873; 375061985; 375062547; 3750000147; 3750000291; 3750000594; 3750000813; 3750001351; 3750001470; 3750002175; 3750002411; 3750002825; 3750003104; 3750003632; 3750003877; 3750004244; 3750004615; 3750005017; 3750005409; 3750005729; 3750006155; 3750006581; 3750007045; 3750010773; 3750011051; 3750011752; 3750012076; 3750013377; 375062506; 375062159; 375061819; 375061528; 375061212; 375060813; 375059570; 375059118; 375058320; 375051742; 375051540; 375051075; 375050855; 375050057; 375049576; 375048923; 375048521; 375048096; 375047951; 375047561; 375047420; 375047045; 375046901; 375046454; 375046403; 375045946; 375044626; 375044255; 375040915; 375040860; 375045755; 375059762; 375059387; 375059032; 375058168; 375057867; 375057516; 375056512; 375056120; 375055685; 375055358; 375055060; 375054750; 375052941; 375052402; 375051953; 375051685; 375051268; 375051018; 375049884; 375049656; 375046868; 375045785; 375045547; 375044354; 375042536; 375040085; 375039815; 375037623; 375037354; 375036749; 375031936; 375031899; 3750000894; 3750001082; 375057162; 375056815; 375054261; 375054066; 375050569; 375050372; 375044112; 375042737; 375031643; 375039432; 375039850; 375040307; 375041218; 375040819; 375040837; 375043933; 375050747; 375051295; 375051866; 375052091; 375052775; 375052953; 375054466; 375054678; 375056122; 375057407; 375057676; 375040818; 375040824; 375043887; 375044226; 375044957; 375045564; 375046017; 375046203; 375046498; 375046675; 375047069; 375047567; 375047736; 375048100; 375048256; 375048578; 375048773; 375049651; 375049866; 375050470; 375050890; 375051129; 375051574; 375051791; 375052287; 375052527; 375053057; 375053282; 375054789; 375054968; 375055482; 375055692; 375056118; 375049139; 375040624; 37504077373 Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. Talecris Plasma Resources, Inc.
Devices ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO® MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Lot # 635436; Part #73601-110 Class II The rods were incorrectly laser etched as ILLICO® Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length. Alphatec Spine, Inc.
Biologics Fresh Frozen Plasma 06FE30808; 06FE30810; 06FE30814; 06FE30820; 06FY91231; 06FY91236; 06FY91247; 06FY91313; 06FY91320; 06FY91342; 06FY91348; 06FY91351; 06FY91355; 06FY91356; 06FY91374; 06FY91391; 06FY91394; 06FY91405 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 Hours After Phlebotomy (FP24) 006fy93230; 006gv77545; 006ge03248; 006fc59791; 006fc59790; 003gx8824; 006gx88853; 006fe31590; 006fe31594; 006gx88583; 006fr07331; 006fr07309; 006fy91348; 006fy91374; 006gg04309; 006lt84124; 006gt77187; 006fc60206; 006gv77634; 006fy91381; 006fy91405; 006lh17613; 006lh17618; 006lt84157; 006fc61113; 006gw55907; 006fe32874; 006gp97396; 006fy92831; 006fc50784; 006fe33660; 006lh16752; 006gt76426; 006fy92836; 006fe31486; 006fy91545; 006fy91462; 006fy91430; 006fy91342; 006lt84151; 006gt77353; 006gt77080; 006gt77097; 006gt77085; 006fe32661; 006gv77524; 006gv77539; 006gv77529; 006lh16795; 006lh16791; 006lh16786; 006lt84133; 006ls18619; 006fc59802; 006fc59807; 006fy92261, 006lp43760; 006lp43758; 006lp43622; 006fy92095; 006gg04096; 006gp95751; 006ls18807; 006lt84139; 006lv50488; 008fe32991; 006fy91351; 006GT77321; 006FC60202; 006FC59927; 006FY91252; 006FC59932; 006LV50476; 006LP45404; 006LP45412; 006LP45423; 006LP45417; 006FE32979; 006FE32652; 006GX8832; 006GX88838; 006GX88834; 006FR07306; 006FY91320; 006FE3265; 006FC5339; 006GX8882; 006FY93198; 006FC59938; 006FY91356; 006LV50512; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY913; 006GW55916; 006LP45234; 006GE34230; 006FY93228; 006GT77327; 006FC60177; 006LT84391; 006FY92828; 006LT84147; 006LP43762; 006FR07279; 006FY91552; 006FY91461; 006FY91461; 006GY91322; 006FE30810; 006LV50513; 006GP95732; 006GL03281; 006LT84131; 006GT76443; 006GT77323; 006FY91484; 006FY91440; 006FY91236; 006GP95748; 006FY91394; 006FE30801; 006FE30814; 006FE30820; 006LV50504; 006LV50477; 006LH16787; 006FY92633; 006LT83833; 006FY92525; 006FR07294; 006GT76431; 006LV50490; 006LV50469; 006LV50506; 006GH30474; 006FY92074; 006FY91439; 006FE32858; 006FE32651; 006LH16799; 006GH30456; 006GH30427; 006FY91355; 006FY91247; 006GC72859; 006GP97371; 006FY91231; 006GX88558; 006FY91466; 006FY91511; 006FE32995; 006FH83893; 006GV77555; 006GV77637; 006GV77561; 006GV77548; 006GL03250; 006LT84387; 006GX88846; 006FY92069; 006GC72866; 006GX88671; 006GP95741; 006FY91560; 006FY91559; 006FY91550; 006FY91584; 006GL03267; 006FY91566; 006FY93209; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 006LH17884; 006GT77083; 006FE32665; 006GV77287; 006FY92834; 006GT76448; 006GX88821; 006FC59395; 006FC59400; 006FC59379; 006FC59396; 006FY93532; 006GE34211; 006LT85275; 006LP45417; 006FC61113; 006LP45394; 006LY83109; 006FE33850; 006LV50513; 006LV50490; 006LV50608; 006LQ04201; 006GX90106; 006GX90110; 006LT85283; 006FY93527; 006FY93530; 006FY93510; 006LY83107; 006LH17616; 006LV50512; 006lv50488; 006lv50506; 006FY93684; 006FY93514; 006LP45234; 006GE34215; 006GS40462; 006LY83121; 006LY83089; 006LY83117; 006FC60182; 006LY83118; 006GE34230; 006LQ04205; 006GQ64197; 006GT77323; 006LH17618; 006LH17613; 006LQ04192; 006GV79381; 006GV79390; 006GV79386; 006GV79380; 006GV79375; 006GV79378; 006GW55924; 006GW55916; 006FC61101; 006FC61109; 006FC61098; 006FC61114; 006FC61097; 006GW55822; 006GW55815; 006GW55826; 006LH17921; 006LH17890; 006LH17915; 006LH17909; 006LT85274; 006LV50499; 006LP45404; 006LP45423; 006FC61103; 006GW55931; 006LV50469; 006LP45246; 006FY93535; 006GS40395; 006GQ64213; 006LV50476; 006FE33000; 006LH17913; 006LY83125; 006LY88104; 006LQ04185; 006LP45285; 006LP45263; 006LP45421; 006LV50477; 006FE32997; 006FY93500; 006FY93507; 006FY93506 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF, Pooled 006L18545; 006L15866; 006L15054; 006L16546; 006L16578; 006L15055; 006L15867; 006L16869; 006L16558; 006L16863; 006L15843; 006L15842; 006L15092; 006L15039; 006L15071; 006L16707; 006L16551; 006L16589 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 006LP45217; 006LQ03498; 006LP45821; 006LS18807; 006GS40378; 006GQ64179; 006LP46627; 006LP46623; 006LP45625; 006GW55908; 006GS40379; 006GX900069; 006GW55918; 006GW55917; 006LQ03495; 006LQ03496; 006LP45623; 006LP45627; 006LP45625; 006GW55808; 006LT85266- PART 1; 006LT85266- PART 2; 006LP45217; 006GE34207- PART 1; 006GS40378; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Cryoprecipitated AHF 006GQ64197 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Irradiated 006LV5047; 006LV5050; 006FE3299; 006FE3297; 006FE32995; Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. American National Red Cross (The)
Food The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box. None. Class II There is no labeling on the product, and the product contains the allergen, wheat. Ron's Pizza Warehouse
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Lemonade 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895649 Lots 1244001, 1292001, 1021101, 1075102, and 1276102. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Fruit Punch 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895625. Lots 1244003, 1292006, 1340011, 1021107, 1075104, 1151111, and 1307105. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Blue Raspberry 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895601. Lots 1292004, 1244004, 1025102, 1075115, and 1153101. Class I The product label declares whey but does not declare milk. Dymatize Enterprises, LLC
Food Grilled Chicken Marinade, IFF Code 3559317, Net Weight 50 Lb, Batch 0004700696, 004705802, and 004722458, Production Date 04/20/2012 and 05/01/2012, For Manufacturing Use Only. IFF Code 3559317, Batch 0004700696, and Production Date 04/20/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Natural Chicken Flavor Seasoning, IFF Code: 3714201, Net Weight 50 lbs, Batch 0004706362, Production Date 04/25/2012, For Manufacturing Use Only. IFF Code: 3714201, Batch 0004706362, and Production Date 04/25/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Flavor Beef Marrow, IFF Code: ULL681883, Net Weight 50 lb, Batch 0004684926, Production Date 04/25/2012, For Manufacturing Use Only. IFF Code: ULL681883, Batch 0004684926, and Production Date 04/25/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Flv Beef FF, IFF Code 13580894, Net Weight 50 lb, Batch 0004702577, Production Date 04/23/2012, For Manufacturing Use Only. IFF Code 13580894, Batch 0004702577, and Production Date 04/23/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Beef, IFF code: SN418156, Net Weight 50 lb, Batch 0004714076, Production date 04/23/2012, For Manufacturing use only. IFF code: SN418156, Batch 0004714076, and Production date 04/23/2012. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Nat Beef FF, Iff Code ULL89721, Net Weight 50 Lb, Batch 0004696310, Production Date 04/23/2012, For Manufacturing Use Only. Iff Code ULL89721, Batch 0004696310 and Production Date 04/23/2012 Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Food Bean Sauce Seasoning, IFF Code: 76185, Net Weight 25 lb, Production date:04/26/2012, For Manufacturing use only. Batch: 0004711598, Production date 04/26/2012, Iff Code 76185. Class I Product has the potential to be contaminated with Salmonella. International Flavors & Fragrances, Inc
Biologics Fresh Frozen Plasma (Apheresis) W036511136444; Class III Blood product, collected from a donor whose donor records failed answers to follow-up questions regarding vaccinations, was distributed LifeShare Blood Centers
Food Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: THE DANNON COMPANY, INC. WHITE PLAINS, NY 10603 UPC 36632 02633 Expiration code of DEC 04 2012 MZ UPC 36632 02633 Expiration code of DEC 04 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Food Dannon Activia LIGHT Nonfat Yogurt Strawberry / Blueberry Flavor 12-4oz cups STRAWBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, STRAWBERRIES***BLUEBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, BLUEBERRY PUREE***DISTRIBUTED BY THE DANNON COMPANY, WHITE PLAINS, NY 10603***UPC 36632 03581 Expiration code of DEC 05 2012 MZ UPC 36632 03581 Expiration code of DEC 05 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Food Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups UPC 36632 00427 Expiration code of NOV 25 2012 MZ Class II The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part. The Dannon Company, Inc - Discovery & Innovation Center
Devices Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. Lot numbers FA3085, exp 2013-03-26; and FA3316, exp 2013-11-12 Class II Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values (e.g., less than 5 ng/mL [6.5 nmol/L]), may show a more appreciable difference due to the typical precision of each methodology. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells W036812573302; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812846256; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036812573302; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W089812451534-B Class II Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated units W0397126643919 - part 1, W0397126643919 - part 2 Class II Blood products, labeled leukoreduced but which did not meet the requirements for leukoreduced products, were distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Red Blood Cells W039708027666D Class II Blood product, incorrectly determined to be negative for the Fyb antigen, was distributed. Aurora Area Blood Bank Dba Heartland Blood Centers
Biologics Red Blood Cells Leukocytes Reduced W089812604806; Class III Blood product, collected from a donor whose hemoglobin was not recorded during donor screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Blood and Blood Products for Reprocessing W051512030854; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Memorial Blood Centers
Biologics Red Blood Cells W051512030854; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Memorial Blood Centers
Biologics Source Plasma 12MTNB8646; 12MTNB8318; 12MTNB8074; 12MTNB7755; 12MTNB7400; 12MTNB7164; 12MTNB6681; Class II Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed. Plasma Biological Services Inc
Biologics Source Plasma TT0297632; TT0302949; TT0305187; Class III Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed. DCI Biologicals Temple Terrace, LLC
Biologics Red Blood Cells W036811257066; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Cryoprecipitated AHF, Pooled W036811823806; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Blood and Blood Products for Reprocessing W036811257066; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515) and MTS A/B Monoclonal Grouping Cards (Catalog # MTS080017) 06061205703; 07031203730; 07031203732; 07031203734; 07031203735; 07031203736; 09131203702; 09131203706 Class II In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Biologics MTS Anti-IgG Cards (Catalog # MTS084024) 08071200124; 08071200125; 08071200126; 08071200127; 08071200128; 08071200129; 08071200130; 08071200131; 08071200132; 08071200133; 08071200136; 09061200101; 09061200103 Class III In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed. Micro Typing Systems, Inc.
Biologics Red Blood Cells W067112099190; Class II Blood products, collected from a donor whose suitability was not adequately determined, were distributed. Blood Center Hammond Laboratory (the)
Biologics Fresh Frozen Plasma W067112099190; Class II Blood products, collected from a donor whose suitability was not adequately determined, were distributed. Blood Center Hammond Laboratory (the)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W037912178437; Class II Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. LifeServe Blood Center
Biologics Fresh Frozen Plasma (Apheresis) W089812008471; Class III Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W089812008471; Class III Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed. Inova Health Care Services, Inova Blood Donor Services
Biologics Red Blood Cells Leukocytes Reduced W040712234087; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Indiana Blood Center
Biologics Red Blood Cells Leukocytes Reduced W038612360535; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Suncoast Communities Blood Bank, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W118812517147A; W118812517147B; Class II Blood products, which did not meet the acceptable product specifications, were distributed. The Blood Alliance, Inc.
Biologics Fresh Frozen Plasma W037712024689; Class II Blood product, collected from a donor whose health history was not adequately performed, was distributed. Hoxworth Blood Center UC Medical Center
Biologics Red Blood Cells Leukocytes Reduced W045012026100; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Community Blood Center Of Gtr KC
Biologics Cryoprecipitated AHF, Pooled W045012600486; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. Community Blood Center Of Gtr KC
Devices Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits. Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54 C4GCC4 C4GBT4 C52F74 H1108 C52GV4 H1208 C52GL4 C67N14 C98CS4 H0109 C98BF4 DE5P34 H0309 DE5RP4 DF4H44 DG9LK4 H0409 DG9L64 DJ5E34 DK3E34 H0509 DK3FE4 EB5FV4 H0210 D95AN4 EB5GH4 H0310 EC9JY4 EF4DJ4 EJ7AP4 H0410 ES2G64 H0510 EJ7A34 ES2HA4 H0610 ES2HY4 H0710 EX5L44 EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4 FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG Class II Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure. DePuy Orthopaedics, Inc.
Biologics Blood Grouping Reagent, Anti-e (Monoclonal) SEB382A Class III Blood Grouping Reagent Anti-e (Monoclonal) BioClone, with potential of false negative results, was distributed. Ortho Clinical Diagnostics Inc
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Devices DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. All lots Class II Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck DePuy Spine, Inc.
Biologics Cornea 0804057COD; 0804057COS; 0806022COS; 0806022COD; 0808025COD; 0808025COS; 0808052COD; 0808052COS; 0810073COD; 0810073COS; 0812022COS; 0812022COD; 0905018COD; 0905018COS; 1004080COD; 1004080COSG1; 1004080COSG2; 1005014COD; 1005014COS; 1006028COD; 1006028COS; 1006046CODG1; 1006046CODG2; 1006046COS; 1007046COD; 1007046COS Class II Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Biologics Cornea 1005010CODG1, 1005010CODG2, 1005010COSG1, 1005010COSG2, 1005010SODW, 1005010SOSW Class III Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Florida Lions Eye Bank, Inc.
Drugs Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01. Lot #: 69160A Class III Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline. West-ward Pharmaceutical Corp.
Food Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Food Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible plastic containers with a stick on label. Pascalite Clay Powder, Pascalite Inc, PO Box 104 Worland, WY 82401, 307-347-3872 with directions for use as a Poultice, skin cleanser and softener, deodorant an freshener, dentrifice and oral hygiene, and dietary supplement for adults and children over 6. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Cosmetics Pascalite tooth powder, contained in a semitransparent flexible 6 oz. bottle with a flip top for dispensing. Lot numbers imprinted or hand written include: 2010M; and D10 through 12 with a noted OT,U,V, or W. The code information is found on the bottom of the product. Class II Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead. Pascalite, Incorporated
Devices Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. All Class II The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. Beckman Coulter Inc.
Devices Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion. Lot number 7965181 Class II It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree). Synthes USA HQ, Inc.
Food Cold-smoked salmon in plastic containers. An example of the labeling follows, however, the "SELL BY:" and "PACK DATE" changes. "0297629 015885 SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE. CONTAINS: FISH***SELL BY: 02.06.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" PLU: 97629, UPC: 0297629 015885 Product sold before 1/29/13. Class I The repacked cold-smoked salmon trim was processed on the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Food Cream cheese/cold smoked salmon (Gravlox) spread in plastic containers. A sample of product label (SELL BY and PACK DATES may differ): "0295307 014144 LOX & CREAM CHEESE WHOLE FOODS MARKET CCOLD SMOKED SALMON (SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE). CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURE, SALT.***SELL BY 02.06.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" PLU: 95307, UPC: 0295307 014144 Product sold before 1/29/13. Class I Cold-smoked salmon trim, used to manufacture this cream cheese spread, was processed the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Food Whole bagels and half bagels w/ cream cheese/cold smoked salmon spread wrapped in plastic. An example of the whole bagel label (in part): "0298437 003996 BAGEL FULL LOX CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH***SELL BY: 02.02.13***PACK DATE: 01.30.13***Whole Foods Market Inc., Bellevue, WA 98005***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" An example of the half bagel label (in part): "0292811 001998 HALF BAGEL WITH LOX CAPERS AND CREAM CHEESE CAPERS BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH OELIC SUNFLOWER OIL, ORGANIC RAISIN JUICE CONCENTRATE, ORGANIC BARLEY FLOUR, ORGANIC GUAR GUM, ORGANIC CULTURED WHEAT***SELL BY: 02.02.13***PACK DATE: 01.30.13***" There is a light blue water mark behind the ingredient statement that reads: "WHOLE FOODS MARKET" Half Bagel: PLU 92811, UPC: "0292811 001998 Whole Bagel: PLU: 98437, UPC 0298437 003996 All products sold before 1/29/13. Class I Cold-smoked salmon trim, used to manufacture these bagels, processed the same day as a surveillance sample was processed that was found positive for Listeria monocytogenes. Whole Foods Market Pacific NW Distribution Center (PDC)
Devices ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. Engraved Lot Number/ Label Lot Number J0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/ 000003583 In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/ NB12656 NB23480/ NB23480 NB23481/ NB23481 NB3584 / In Kit # 2975-50-025 NB3586 / NB3586 NB3587 / NB3587 NB3588 / In Kit # 2975-50-025 NB3590 / NB3590 NB3591 / In Kit # 2975-50-025 NB5955 / NB5955 NB7894 / NB7894 In Kit # 2975-50-025 NB8016 / In Kit # 2975-50-025 NB8017 / NB8017 NB8018 / NB8018 In Kit # 2975-50-025 NB8019 / In Kit # 2975-50-025 NB8020 / NB8020 NB8021 / NB8021 NB8022 / NB8022 NB8023 /NB8023 Class II DePuy has received 9 complaints where the tabs on the reamer extension device were broken. It was determined to notify surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient while DePuy investigates the root cause. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices. DePuy Orthopaedics, Inc.
Drugs Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01 386585A, Exp. 02/13; 429104A, Exp. 06/13; 474487A, Exp. 11/13; 491671A, Exp.01/14. Class II Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . Watson Laboratories Inc
Drugs Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01 387879A, Exp. 02/13; 429105A, Exp. 06/13; 474488A, Exp. 11/13; 491672A, Exp. 01/14; 529095A, Exp. 04/14 Class II Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone . Watson Laboratories Inc
Devices Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge. Catalog Number 101-00006; Lot Number 00921538. Class II The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended. Extremity Medical LLC
Drugs ZARAH® Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A Class II Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) . Watson Laboratories Inc
Devices 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. Product Code: V20LC; Lot/Serial Numbers: BB09213 & BB09205 Class III The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205). Volk Optical Inc
Food Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Arnold Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Arnold Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Stroehmann Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Aldi L'Oven Fresh Hearty 12 Grain Bread, NET WT 24 OZ (1 LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Healthfull Nutty Grain Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Brownberry Grains & More Double Protein Bread, 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Sara Lee 12 Grain Bread Hearty & Delicious, 24 OZ (1LB 8OZ) 680g Best by dates prior to and including Feb 17 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Earthgrains 12 Grain Natural Bread, NET WT 1 LB 8 OZ (680g) Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Farm Bread All Natural Multi-Grain, NET WT 24 OZ (1 LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread, NET WT 24 OZ (1LB 8 OZ) 680g Best by dates prior to and including Feb 20 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food Sara Lee Multi-Grain Thin Style Buns, NET WT 12 OZ (340g) Best by dates prior to and including Feb 17 Class II Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products. Bimbo Bakeries Usa
Food MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot 460259, exp. 10/31/2013; Lot 464764, exp. 12/31/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food MET-Rx EXTREME NOS PUMPED DOUBLE BERRY Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 35909 0, Label Revision 01C, Item Number 35909 (Bottle) Item Number 35910 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot # 470645, exp. 11/30/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food MET-Rx EXTREME NOS PUMPED NITRO-PUNCH Naturally Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC Code 7 49826 00512 6, Label Revision 05D, Item Number 48515 --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 Lot 469477, exp. 11/30/2013 Class III The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage. NBTY Inc.
Food Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 012314 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date:013013 and 020414 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value All Natural Medium Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 007874208640; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 013014 and 020614 Class II The products may contain plastic pieces. Conagra Inc
Food Great Value All Natural Hot Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 0078745208641; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR Code Date: 020514 and 020614 Class II The products may contain plastic pieces. Conagra Inc
Devices INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment. INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual Class II INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use. Intio Inc
Devices Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1. Class II Increased risk of failure at the driver tip during screw insertion or removal. Ebi, Llc
Devices Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right). Lot Codes: AP5W52 and AP7H19. Class II The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and that the "R" and "L" markings on the Right Sizer are reversed. Stryker Howmedica Osteonics Corp.
Devices Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. Catalog # 02-012-42-3508 All lot numbers Class II A dimensional mismatch was identified which can potentially allow for interference between devices. Exactech, Inc.
Devices Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. Lot numbers: 80106 and 80106b Class II The recalled product leaks at the connection site. Molded Products Inc
Drugs METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) Lot code 12-074-JT Exp 12/13 Class II Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal. Hospira Inc.
Food NuGo Free Trail Mix Bars, UPC 6 91535 45301 2 B12233A, best by 20 No 13 Class I NuGo became aware of the possible inadvertent presence of milk in the NuGo Free Trail Mix Bar. NuGo Nutrition HQ
Food Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 Best if used by dates: 20130326 (March 26, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387 Best if used by dates: 20130325 (March 25, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Trio shipper which includes two of the recalled products: Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 and Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387 Best if used by dates: UPC 024300090394: 20130326 (March 26, 2013) - 20130910 (September 10, 2013) and UPC 0240300090387: 20130325 (March 25, 2013) - 20130910 (September 10, 2013) Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Hannaford Autumn Spice Granola, UPC 041268186327, NET WT. 14 OZ (397g) codes: 20130806 11096071 and 20130813 11156072 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food #38605020 ORTH TRANSMART(TM) PRE-BAKED CRISP TOPPING, NET WEIGHT 30 LBS. (13.6 kg) codes: 20130706 07116051, 20130707 07126051, 20130801 08056052, 20130801 08056053, 20130801 08066051, 20130802 08066052, 20130810 08146053, 20130811 08166051, 20130812 08176051, 20130815 08196051, 20130830 09036052, 20130831 09046053, 20130901 09066051, 20130930 10046052, 20130930 10046053, 20130930 10056051, 20131003 10076052, 20131012 10166052, 20131012 10166052, 20131013 10176052, 20131014 10186052, 20131103 11086051, 20131109 11136052, 20131109 11146051, 20131208 12136051, 20131209 12136052, and 20140109 01136052 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food 10310 CRANBERRY ALMOND GRANOLA, 4/48 OZ. codes: 20130707 10106071, 20130720 10236071, 20131012 01146072, 20131012 01146072 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Food Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product) codes: 20121127 07306021, 20130212 10156021, 20130219 10226021, 20130313 11126023, 20130402 12036021, 20130403 12036022, 20130416 12166022, 20130426 12266022, 20130507 01066023, 20130515 01156021, 20130522 01216022, 20130528 01286021, 20130529 01286022, 20130110 10226021 Class II Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items. Blue Planet Foods, Inc.
Veterinary Sogeval Oxiderm +PS Shampoo (Benzoyl Peroxide 3%, Sulfur 2%, Salicylic Acid 2%, PhytoSphingosine 0.05%) Antiseborrheic and Antiseptic Shampoo in a Moisturizing and Soap-Free Cleaning Base 16oz. - For topical use in dogs, cats and horses. Lot # 10690B Product code # FSOXYPS1016 Class III Product contains approximately 12 ounces instead of 16 ounces. Sogeval Laboratories, Inc.
Devices Allen Traction Boot - Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. A260264, A253312, A260989, A260262, 418292, A260991, A260998, A253313, A260993, A260265, 418293, A253309, A260995, A253310, A260992, A253311, 418294, A253323, A260261, A253321, A260994, 418291, 418295, A253322 Class II Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall. Allen Medical Systems, Inc.
Devices Guardian II and Guardian II NC Hemostasis Valve, Model #'s: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited 209 Business Innovation Centre, NUI Galway, Newcastle Road, Galway, Ireland. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. Lot Number 29132 27295 27403 27660 27660 28050 28247 28247 28247 28247 28820 29133 29836 29836 30126 30579 30582 27658 28246 28246 29132 29132 29132 27658 27658 27658 28041 28041 28041 28048 28048 28245 28245 28245 28818 28818 28818 29131 30238 30580 27659 28049 29132 27294 27402 30582 31020 562784 27401 27658 27658 28041 28041 28245 28818 29131 29131 29453 29835 30238 27334 27397 27646 27646 27651 27779 28001 28006 28044 28051 28427 28817 29016 29016 29016 29137 29455 29455 29837 29837 30928 30930 30932 29454 28049 28246 28819 30581 27295 27403 27401 27658 28041 28245 28245 28245 28818 29453 29453 30580 28048 28001 28745 29016 29839 27403 31020 30579 27401 29131 30238 28048 28048 28050 30579 27295 27295 27295 27295 27295 27295 27295 27295 27403 27403 27403 27403 27660 27660 27660 27660 27660 28043 28043 28043 28043 28247 28247 28247 28247 28247 28247 28247 28247 28247 28820 28820 28820 28820 29133 29133 29133 29133 29836 29836 29836 29836 30126 30126 30126 30126 30579 30579 30579 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27658 28048 28245 28818 29131 29453 29835 30580 28246 28246 29132 30578 30578 27294 28246 28819 30578 27658 28042 28818 29132 29453 29454 29835 30238 27660 28247 27401 27401 28041 28245 28245 28818 29131 29453 29835 28048 27401 27658 28041 28048 28245 28818 29453 29453 30238 28041 28245 28818 29131 29131 30238 29132 27658 28245 30238 27294 28049 28246 31020 31020 29130 29138 29141 29459 29839 30035 30419 30419 30609 30611 30931 30126 30126 30579 30582 30126 30126 31020 31020 31020 27403 27660 27295 27295 27295 27295 27295 27403 27403 27660 27660 27660 27660 28043 28043 28050 28247 28247 28247 28247 28247 28247 28820 28820 29133 29133 29133 29836 29836 30126 30126 30126 30579 30579 30582 29836 31020 28041 28245 27295 27401 30579 30579 30579 30579 27401 27401 27401 27401 27401 27658 27658 27658 28041 28041 28041 28041 28048 28048 28245 28818 28818 29131 29131 29453 29453 29835 29835 30238 30580 30580 27401 27401 27401 29131 27660 28247 28820 29133 29836 30582 557884 27295 28050 30579 27402 28246 28246 29454 27294 28246 29454 28247 28247 29133 29453 28247 30126 27401 28245 29131 27390 27647 27651 27652 27654 28427 28428 28539 28816 29842 29844 27660 27660 28048 27295 27295 27403 27660 28043 28043 28050 28247 28247 28820 28820 29133 29836 30126 30579 30579 28043 29836 29836 28043 27295 27403 27660 27660 28247 27216 27217 28002 29649 29833 29839 29844 29131 30580 28818 29131 28818 28049 28246 29132 30578 27295 27403 27660 28247 29836 30579 29453 27401 27401 27658 28041 28041 28048 28245 28818 28818 29131 29131 29453 29453 30238 30580 27295 27403 28050 29133 31020 27403 27660 28048 28246 28247 28247 27401 27401 27658 27658 28041 28041 28048 28048 28245 28245 28245 28245 28818 28818 28818 29131 29131 29131 29453 29453 29835 29835 30238 30580 28050 27403 27403 28043 28043 28050 28247 28247 28820 28820 29133 29836 29836 29836 29836 30126 30126 30579 30582 27403 28048 30238 28245 29453 29835 27403 28247 30126 27294 31020 31020 28050 28247 28247 29836 27660 28043 28247 29133 29836 28245 28818 29131 29131 29453 27401 27658 27658 28041 28245 28245 28245 28818 29453 29453 30579 27401 27658 27658 27658 28041 28048 28048 28245 28245 29131 29453 29835 30238 30580 28247 29133 30582 27294 27294 27402 27659 28042 28246 28246 28246 28246 28819 29131 29131 29453 29835 30238 30238 27658 28245 28245 29836 28050 30126 28245 28818 28818 29454 28246 27646 29686 27646 27652 29016 29453 27658 28041 28048 28048 28245 28245 28818 29131 29453 30580 29131 27393 27655 28046 28051 28745 29141 29459 29844 27399 27646 28001 28005 29134 29455 29459 29837 30211 27393 27397 27399 27390 27394 28001 28745 29837 29842 29835 29455 29686 27294 27402 28042 28246 28246 28819 29132 30578 30578 30579 30238 31020 31020 28246 29132 30578 27658 28245 28245 27658 28247 27401 28048 28245 29131 29131 31020 28245 27295 28245 27295 27403 27660 27660 27660 28247 28247 28820 28820 29133 30580 29131 27660 28050 28247 28050 28050 28050 29835 28245 28041 28245 28818 29453 29835 27403 28050 28247 28048 28245 28245 28247 28820 29835 28041 29453 27295 27295 27403 27660 28247 28247 27401 28245 30238 28247 28049 28819 27660 30579 27295 27295 27295 27403 27403 27660 28043 28247 28247 28247 28820 28820 29836 30126 30126 30126 30579 30582 28041 28818 29453 30580 27660 30579 27660 28247 27295 27295 27660 28247 28247 28820 30126 30579 30238 29131 29835 27401 28048 29835 27216 27392 27396 27396 27399 27648 27648 27652 27653 28003 28004 28004 28044 28428 28745 29129 29134 29134 29135 29458 29538 29538 29649 29680 29686 29834 29841 29844 28245 28043 28041 27401 28245 28818 29131 557887 30580 28247 28041 28245 29131 27401 27658 28041 28041 28048 28245 28818 29131 29453 29453 30238 30238 28820 27401 27295 27403 27660 28043 28247 28820 29836 30582 28245 29835 28246 28246 28819 28246 27401 28048 28245 27401 27401 27401 27658 27658 27658 27658 27658 28041 28041 28041 28041 28048 28048 28048 28245 28245 28245 28245 28246 28246 28818 28818 28818 28818 28818 29131 29131 29131 29453 29453 29453 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Class I Vascular Solutions, Inc., is recalling certain lots of Guardian II and Guardian II NC Hemostasis Valves, due to the risk that air may be introduced into the device which may lead to an air embolism. Vascular Solutions, Inc.
Food Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. PN 135; Lot #'s: 090336 and 100340 Class II Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. Wynlife Healthcare, Inc.
Food All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130. PN 141; Lot #'s: 100521 and 110099 Class II Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents. Wynlife Healthcare, Inc.
Devices CR MD1.0 General Set, x-ray imager image plate. Product Usage: Usage: The product is an image plate, contained in an X-Ray cassette, and used to capture images from X-Ray exposures. The cassette with the image plate, once exposed is inserted int he Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing. Batch No. A2KQMW Class II The cassettes were shipped with the wrong IP (image plate) size bar code. AGFA Corp.
Drugs Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10086783, 10088745, 10088746, 10090537, 10093867, 10093868, 10098162, 10098541, 10098542, 10102311, 10109145, 10109146, 10120111, 10122759, and 10122760, Exp 3/13 to 9/14; b) 10086785, 10088747, 10088748, 10090538, 10093869, 10093870, 10098160, 10098161, 10098540, 10099841, 10104146, 10109143, 10109144, 10111501, 10115614, 10120112, 10121759, 10122698, 10122757, and 10122758, Exp 3/13 to 10/14. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10108375, 10108376, 10110025, 10110026, 10115487, 10115488, 10120594, 10120595, 10120596, 10120597, 10120753, 10120754, 10120755, 10127564, and 10127567, Exp 4/13 to 11/13, b) 10107916, 10108368, 10108369, 10108370, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: a) 10120598, Exp 7/13; 10127563, Exp 11/13; b) 10107920, 10108362, 10108363, 10108364, 10109881, 10110017, 10110018, 10110019, 10110020, 10120730, 10120731, 10120732, 10120733, 10120734, 10120735, 10120736, 10127556, 10127557, 10127558, and 10127559, Exp 3/13 to 10/13. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Drugs 4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054. Lot #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14. Class III Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Novartis Consumer Health
Devices Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation instaled with the CAS I/II Absorber. Product Usage: intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. serial numbers: ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087. Class I A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient. Del Mar Reynolds Medical, Ltd.
Devices Boston Scientific/Cameron SQ-RX® Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. SERIAL NUMBERS A002804 A003105 A001493 A001784 A001981 A003024 A003197 A001609 A001594 A001733 A002291 A002348 A002373 A002195 A002710 A004131 A001942 A002278 A002399 A002402 A001021 A001136 A001104 A001193 A001392 A002093 A002147 A001134 A001155 A001063 A001011 A001102 A001012 A001004 A001058 A001010 A001140 A001093 A001170 A001055 A001185 A001144 A001217 A001215 A001241 A001367 A001377 A001405 A001431 A001380 A001468 A001411 A001639 A001688 A001734 A001578 A001654 A001799 A001916 A001903 A002127 A002076 A002425 A002686 297-899 300-895 292-887 A001120 A001085 A001109 A001089 A001122 A001110 A001020 A001052 A001023 A001051 A001062 A001148 A001042 A001106 A001091 A001096 A001126 A001237 A001341 A001354 A001447 A001429 A001533 A001481 A001236 A001119 A001246 A001384 A001267 A001731 A001650 A001774 A001856 A001980 A001752 A002364 A002823 A002826 A002833 A002858 A002889 A002892 A002946 A002997 A002996 A002953 A003386 A003465 A003066 A003382 A003426 A003540 A003563 A001291 A001463 A002985 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A001863 A001867 A001887 A001588 A001808 A001953 A001859 A001690 A001729 A001692 A001872 A001871 A001908 A001822 A002013 A001550 A002083 A001932 A001952 A001923 A002095 A001832 A002134 A002135 A001824 A002003 A001875 A001987 A001853 A001850 A001817 A001975 A001739 A002082 A002111 A002017 A001896 A001843 A002165 A001920 A001990 A001695 A001962 A002102 A002339 A001801 A002113 A002136 A002084 A002235 A002105 A002150 A002143 A002118 A002022 A002204 A002211 A002069 A001963 A001970 A001861 A002210 A002397 A001847 A002101 A002131 A002157 A001960 A002232 A002098 A002103 A001985 A001629 A002175 A001792 A002160 A002249 A002250 A002199 A002188 A002289 A002318 A002400 A002110 A002242 A002254 A002213 A002312 A002223 A001921 A002224 A002393 A002077 A002075 A002315 A002361 A001993 A002251 A002226 A002420 A002156 A002245 A002125 A001876 A002177 A002370 A002241 A002230 A001865 A002427 A001597 A002416 A001753 A002338 A002369 A002454 A001727 A002349 A002423 A002326 A002203 A002434 A002458 A002461 A002382 A002407 A002336 A002575 A002323 A002537 A002499 A002139 A002356 A002367 A002438 A002383 A002448 A002457 A002647 A001787 A002311 A002408 A002661 A002529 A001880 A002255 A002554 A002299 A002595 A002366 A002006 A002675 A002462 A002325 A002592 A002653 A002507 A002616 A002472 A002107 A002428 A002117 A002603 A002715 A002572 A002587 A002417 A002586 A002598 A002582 A002535 A002629 A002617 A002518 A002599 A002649 A002638 A002679 A002631 A002431 A002774 A002779 A002551 A002716 A002557 A002628 A002640 A002687 A002803 A002677 A002761 A002786 A002784 A002674 A002696 A002639 A002741 A002789 A002814 A002727 A002048 A002820 A002708 A002765 A002806 A002464 A002702 A002526 A002749 A002422 A002513 A002790 A002319 A002651 A002565 A002759 A002530 A002656 A002775 A002746 A002704 A002813 A004236 A003020 A003030 A003019 A003023 A003628 A003635 A003918 A003921 A003791 A003835 A003922 A003937 A003923 A003725 A003931 A003942 A003934 A003945 A003927 A004067 A003968 A003939 A003935 A003833 A003960 A003977 A003965 A003936 A003943 A003980 A003970 A004076 A003933 A003938 A004021 A003975 A003920 A003917 A003689 A003712 A003841 A003944 A004051 A003852 A003951 A003949 A003947 A003974 A004055 A003900 A003950 A003954 A003948 A004061 A004089 A004080 A004127 A004073 A004039 A003930 A003667 A003696 A004033 A004099 A003877 A004143 A004163 A004164 A004063 A004072 A004139 A003849 A004040 A004098 A004225 A004074 A004235 A003953 A004119 A003928 A003957 A004011 A004133 A003956 A004065 A004151 A004204 A004100 A004038 A004050 A004031 A004138 A004181 A004199 A004215 A004239 A004060 A004107 A004226 A004105 A004137 A004128 A004150 A004249 A004256 A003871 A003631 A004064 A004140 A003978 A004198 A003630 A004185 A004222 A004233 A004224 A004266 A004268 A004290 A004345 A004296 A004308 A004190 A004221 A004261 A004269 A003926 A004208 A004142 A004246 A004267 A004350 A003962 A004159 A004192 A003633 A003959 A004071 A003952 A004217 A004218 A004030 A004244 A004253 A004289 A004053 A004242 A004118 A004191 A004045 A004240 A004348 A004329 A004044 A004149 A004264 A004288 A004262 A004212 A004303 A004025 A004077 A004561 A003982 A004213 A004356 A004435 A004447 A004464 A004508 A003961 A004101 A004171 A004366 A004295 A004361 A004369 A004452 A004518 A004086 A004515 A004391 A004405 A003916 A004183 A004272 A004453 A003964 A004404 A004514 A004306 A004327 A004384 A004487 A004512 A004546 A003958 A004507 A004534 A004559 A004382 A004419 A004494 A004501 A004506 A004548 A004624 A004588 A004284 A004682 A003643 A004450 A004479 A004172 A004461 A004444 A004451 A004531 A004618 A004738 A004374 A004357 A004161 A004394 A004488 A004389 A004406 A004554 A004547 A004596 A004616 A004093 A004344 A004544 A004549 A004569 A004049 A004573 A004545 A004539 A004586 A004611 A004625 A004711 A004397 A004455 A004509 A004731 A004407 A004591 A004697 A004517 A004576 A004395 A004587 A004562 A004583 A004600 A004277 A004568 A004420 A004552 A004619 A004707 A004694 A001131 A001216 A001414 A001440 A002054 A002975 A003053 A003147 A003260 A003189 A003362 A003451 A004176 A004462 A003618 A004387 A004684 A001022 A001160 A001015 A001014 A001154 A001142 A001159 A001124 A001107 A001181 A001175 A001196 A001199 A001212 A001370 A001315 A001345 A001312 A001356 A001228 A001203 A001289 A001307 A001285 A001223 A001230 A001278 A001264 A001218 A001245 A001311 A001330 A001358 A001424 A001420 A001526 A001305 A001382 A001508 A001525 A001406 A001316 A001352 A001419 A001438 A001509 A001395 A001379 A001510 A001462 A001490 A001499 A001506 A001310 A001648 A001210 A001340 A001664 A001821 A001642 A001775 A001686 A001704 A001726 A001780 A001707 A001744 A001794 A001904 A001879 A001559 A001716 A001624 A001699 A001894 A002037 A001891 A002078 A001870 A001912 A001211 A001866 A001925 A001396 A001665 A001836 A001840 A001926 A001846 A001893 A001979 A001746 A001546 A001873 A002018 A001616 A001622 A001592 A001598 A002001 A002010 A001693 A001645 A001657 A001700 A001806 A001599 A001791 A001796 A002038 A001549 A002002 A001927 A001991 A001583 A002043 A002073 A002106 A001760 A001988 A001897 A001918 A002094 A002128 A002166 A002067 A002186 A002191 A002154 A002169 A002104 A002028 A001842 A002332 A002116 A002317 A001408 A001679 A001934 A002146 A001826 A001900 A002341 A001884 A002057 A002350 A002189 A002347 A002026 A002109 A002033 A002132 A002065 A001881 A002298 A001885 A002011 A002279 A002284 A001869 A002096 A002253 A002259 A002120 A002307 A002173 A001999 A002044 A002088 A001997 A002263 A002152 A002246 A001839 A002159 A002222 A002378 A002138 A002379 A002392 A002035 A002281 A002217 A002353 A002398 A002396 A002309 A001989 A001855 A002357 A002360 A002368 A002227 A002024 A002371 A001977 A002268 A002460 A002488 A002389 A002452 A002233 A002409 A002421 A002385 A002258 A002446 A002456 A002273 A002490 A002229 A002351 A002007 A002432 A002257 A002477 A002142 A001759 A002270 A002486 A002576 A002346 A002129 A002377 A002437 A002481 A002294 A002288 A002355 A002509 A002282 A002264 A002494 A002549 A002697 A002614 A002495 A002633 A002637 A002491 A002666 A002429 A002471 A002506 A002144 A002426 A002504 A002384 A002706 A002489 A002345 A002521 A002654 A002545 A002600 A002062 A002673 A002728 A002755 A002605 A002601 A002680 A002632 A002285 A002671 A002731 A002650 A002660 A002752 A002602 A002711 A002590 A002754 A002683 A002777 A002238 A002581 A002713 A002644 A002768 A002668 A002730 A002469 A002501 A002729 A002736 A002670 A002463 A002795 A002475 A002483 A002498 A002643 A002776 A002484 A002520 A002522 A002555 A002531 A002735 A002620 A002534 A002624 A002750 A002556 A002547 A002550 A002564 A002800 A002515 A002798 A002692 A002567 A002560 A002542 A002331 A002517 A002301 A002511 A002703 A002740 A002748 A002607 A002724 A002802 A002505 A002540 A002588 A002619 A002766 A002597 A002527 A002676 A002589 A002825 A002433 A002751 A002866 A002479 A002778 A002830 A002583 A002594 A002856 A002883 A002745 A002758 A002613 A002859 A002837 A002718 A002634 A002838 A002714 A002695 A002611 A002627 A002404 A002641 A002871 A002842 A002839 A002851 A002652 A002760 A002805 A002788 A002688 A002684 A002852 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A003101 A003049 A003145 A003114 A003110 A003106 A003084 A003079 A003096 A003082 A003027 A003142 A003126 A003006 A003140 A003112 A003137 A003152 A003087 A003026 A003052 A002990 A003098 A003025 A003054 A002182 A003134 A003072 A003045 A003161 A003173 A003188 A003018 A003060 A003167 A003146 A002948 A003012 A003056 A003109 A003061 A003028 A003144 A003159 A003176 A003206 A003136 A003141 A003121 A003169 A003183 A003166 A003230 A003232 A003204 A002898 A003080 A003195 A003196 A003085 A003205 A003198 A002185 A003094 A003192 A003233 A003216 A002822 A002828 A003164 A003165 A002815 A003062 A003133 A003149 A003151 A002827 A003119 A003148 A003199 A002785 A003063 A003180 A003178 A003215 A003058 A002857 A002796 A003156 A003237 A003225 A003162 A003193 A003229 A003258 A003243 A003272 A002198 A003262 A003265 A003278 A003207 A003266 A003234 A003240 A003210 A002835 A003128 A003184 A003174 A003242 A003264 A003256 A003200 A003267 A003231 A003251 A003160 A003255 A003150 A003223 A003170 A003185 A003306 A003281 A003068 A003190 A003275 A003299 A003091 A003279 A003303 A003273 A003253 A003326 A003247 A003268 A003296 A003323 A003305 A003314 A003244 A003254 A003308 A003283 A003352 A003249 A003292 A003201 A003269 A003295 A003301 A003298 A003311 A003288 A003214 A003163 A003153 A003248 A003257 A003364 A003263 A003307 A003359 A003286 A003095 A003290 A003277 A003338 A003328 A003309 A003331 A003366 A003333 A003157 A003381 A003116 A003355 A003368 A003361 A003401 A003371 A003398 A003321 A003334 A002992 A003313 A003293 A003336 A003345 A003383 A003408 A003422 A003078 A003346 A003340 A003349 A003354 A003377 A003385 A003410 A003339 A003213 A003177 A003276 A003394 A003291 A003143 A003384 A003418 A003416 A003425 A003327 A003372 A003397 A003456 A003375 A003347 A003376 A003430 A003437 A003438 A003428 A003462 A003294 A003388 A003448 A003363 A003348 A003228 A003406 A003435 A003475 A003391 A003487 A003389 A003402 A003486 A003528 A003319 A003341 A003420 A003423 A003461 A003474 A003468 A003469 A003530 A003115 A003424 A003460 A003557 A003350 A003473 A003477 A003483 A003488 A003514 A003489 A003433 A003502 A003351 A003478 A003495 A003527 A003535 A003519 A003029 A003034 A003503 A003507 A003570 A003467 A003525 A003566 A003562 A003022 A003032 A003537 A003582 A002209 A003117 A003403 A003564 A003479 A003444 A003577 A003500 A003544 A003567 A003591 A003565 A003579 A003605 A003584 A003602 A003658 A003532 A003436 A003399 A003493 A003587 A003599 A003597 A003548 A003612 A003585 A003571 A003450 A003586 A003395 A003312 A003594 A003558 A003593 A003611 A003620 A003644 A003569 A003439 A003441 A003636 A003405 A003504 A003590 A003429 A003168 A003622 A003603 A003432 A003614 A003606 A003672 A003638 A003512 A003598 A003668 A003688 A003518 A003520 A003572 A003645 A003641 A003580 A003626 A003660 A003656 A003523 A003683 A003679 A003684 A003619 A003714 A003738 A003674 A003669 A003442 A003508 A003731 A003722 A003993 A003494 A003601 A003608 A003685 A003665 A003616 A003747 A003677 A003463 A003510 A003538 A003627 A003659 A003671 A003470 A004009 A003724 A003733 A004004 A004006 A003817 A003807 A003682 A003821 A003632 A003809 A003814 A003845 A003687 A003730 A003737 A004001 A003409 A003415 A003734 A003813 A003650 A003661 A003623 A003678 A003739 A004015 A003613 A003715 A004012 A003825 A003830 A003250 A003592 A003651 A003686 A004003 A003252 A003713 A004023 A003756 A003648 A003992 A004020 A003844 A003771 A003522 A003604 A003832 A003751 A003783 A003646 A003706 A003445 A003824 A003803 A003446 A003700 A003775 A003990 A003847 A003846 A003837 A003705 A003697 A003850 A004008 A003757 A003862 A003869 A003721 A003859 A003801 A003855 A003662 A003768 A003770 A003767 A003874 A003881 A003885 A003772 A003843 A004027 A003691 A003863 A003891 A004026 A003799 A003708 A003878 A003880 A003798 A003417 A004007 A003773 A003723 A003858 A003774 A003505 A003727 A003750 A003805 A003866 A003865 A003758 A003640 A003888 A003994 A003820 A003864 A003911 A004018 A003754 A003903 A003759 A004024 A003915 A003979 A004078 A004037 A003976 A003981 A003838 A003860 A004085 A004112 A004189 A004102 A004158 A004108 A004062 A003703 A004109 A004042 A003940 A004227 A003741 A003792 A004066 A004052 A004173 A003883 A003897 A003941 A004081 A004115 A004048 A004232 A004075 A004228 A004114 A004059 A003812 A003895 A003898 A004311 A003559 A004180 A004187 A004339 A004234 A003853 A003963 A004258 A004010 A003904 A004126 A004273 A003795 A004293 A004123 A004301 A004276 A004304 A004087 A004367 A004104 A004328 A004281 A004353 A004392 A003625 A003907 A004309 A004375 A003800 A004333 A003854 A004456 A003790 A004538 A003909 A004460 A004637 A003912 A003946 A004153 A004156 A004257 A004317 A004378 A004390 A004396 A004402 A004412 A004422 A004426 A004428 A004485 A004655 A004685 A004445 A004446 A004457 A004475 A004513 A004525 A004529 A004553 A004558 A004560 A004566 A004572 A004579 A004589 A004597 A004649 A004665 A004669 A004702 A004713 A004732 A004734 A004147 A004550 A004657 A004681 A004718 A004722 A004686 A002846 A002853 A004719 A004723 A004729 A004735 A004469 A004470 A003861 A003932 A004693 A004696 A004603 A004602 A004255 A004323 A004094 A004095 A004489 A004627 A004662 A002834 A002840 A003543 A003575 A003624 A003735 A003736 A004000 A003698 A003765 A003804 A003876 A004013 A003892 A003893 A003894 A003910 A003987 A004058 A004082 A004110 A004047 A004130 A003929 A004144 A004174 A004202 A004216 A004203 A004200 A004238 A004251 A004263 A004275 A004280 A004287 A004305 A004237 A004297 A004320 A004325 A004336 A004338 A004324 A004300 A004319 A004322 A004341 A004210 A004298 A004351 A004206 A004321 A004347 A004312 A004314 A004335 A004337 A004330 A004332 A004364 A004370 A004358 A004385 A004363 A004377 A004386 A004365 A004383 A004393 A004379 A004380 A004398 A004415 A004441 A004413 A004430 A004340 A004421 A004424 A004429 A004433 A004448 A004443 A004414 A004434 A004408 A004417 A004440 A004399 A004400 A004425 A004427 A004449 A004458 A004442 A004437 A004315 A004536 A004486 A004541 A004542 A004466 A004483 A004468 A004471 A004516 A004271 A004490 A004463 A004478 A004480 A004500 A004474 A004498 A004505 A003890 A004492 A003902 A004510 A004495 A004496 A004497 A004502 A004535 A004527 A004537 A004585 A004606 A004607 A004617 A004635 A004638 A004563 A004646 A004629 A004639 A004540 A004626 A004659 A004660 A004654 A004648 A004667 A004650 A004599 A004691 A004334 A004578 A004672 A004676 A004680 A004683 A004699 A004716 A004666 A004710 A004041 A004057 A004121 A004124 A004182 A004459 A004493 A004519 A004524 A004555 A004565 A004580 A004593 A004598 A004636 A004671 A004674 A004724 A004726 A004733 A004737 A004741 A004743 A004745 A004747 A004260 A004590 A004601 A004612 A004651 A004658 A004664 A004670 A004701 A004715 A004721 A004742 A004749 A004750 A004751 A004754 A004756 A004757 A004763 A004765 A004770 A004772 A004773 A004774 A004780 A004781 Class II Boston Scientific is conducting a recall on Cameron Health /Boston Scientific subcutaneous defibrillators (S-ICD® System). BS identified a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application. No patient deaths or injuries have been reported as a result of this behavior; affected devices were replaced without the need for emergency medical care. Boston Scientific CRM Corp
Food Rye bread with the following brands: Village Hearth , Rye Cottage Bread, NET WT 24 OZ ( 1 LB 8OZ) (680g) , East Coast Caraway Rye, NET WT 20 OZ (1 LB 4 OZ (567g) , PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Cub Foods, Deli Rye, NET WT 16 OZ (1 LB) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Essential Everyday, Deli Rye Bread, NET WT 16 OZ (1 LB) 454 g Distributed by Supervalu Inc., Eden Prairie, MN 55344, Flvorite, Deli Rye, NET WT 16 OZ (1 lb) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344. Family Choice, Northern Rye Bread, NET WT 16OZ (1 LB) (454G), Seeded Bye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), Unseeded Rye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Piggly Wiggly, Rye, Seeded Caraway Rye, NET WT 20 OZ (1LB 4 OZ) 568g., distributed by Piggly Wiggly LLC, Keene, NH 03431. Food Club, Rye, NET WT 16 OZ (1 LB) 454g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. Shurfresh, Rye, Seeded Rye, Unseeded Rye, NET WT 16 OZ (1LB) 454g & 20 OZ (1LB 4 OZ) 567g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077. Feb 12 P1..., Feb 12 P3..., Feb 13 P1..., Feb 13 P3..., Feb 14 P1..., Feb 14 P3..., Feb 15 P1..., Feb 15 P3...,Feb 16 P1..., Feb 16 P3...,Feb 17 P1..., Feb 17 P3..., Feb 18 P1..., Feb 18 P3..., Feb 19 P1...,Feb 19 P3... Class II A recall has been initiated by Pan-O-Gold Baking Co. after they were notified by Dakota Specialty Milling of a potential foreign material (stainless steel wire from disintegrated sifter screen) risk to the rye flour Pan O Gold uses as an ingredient in all of their rye breads. Pan -O- Gold Baking Co
Devices PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework. Lot Number: 12857 Class II Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled Keystone Dental Inc
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