Events

Retiro De Equipo (Recall) de Device Recall ExactaMix 2400 Compounder (EM 2400)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxa Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    52174
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1371-2012
  • Fecha de inicio del evento
    2008-06-03
  • Fecha de publicación del evento
    2012-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82410
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System/device, pharmacy compounding - Product Code NEP
  • Causa
    Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the em 2400.
  • Acción
    The firm, Baxa, sent a "Exacta-Mix 2400 Compounder Safety Alert" dated June 3, 2008 to all customers. The alert describes the product, problem and actions to be taken. The customers were instructed to not use the main module if any of the 24 valve actuators are damaged; do not infuse any bags if damage is noticed after they have been pumped; do not try to repair or adjust a damaged or bent valve actuator; immediately alert all compounder users of this issue to ensure that when the device is used, the valve actuators are always inspected for damage;" inspect all valve acutators before setup and after tear-down to ensure they are not damaged or bent. Do not use the compounder if the valve actuators are damaged or bent."; and if a damaged or bent valve is noticed after using the EM2400, immediately hold all pumped bags and contact Baxa Technical Support. If you need additional assistance, please contact Baxa Technical Support (800-678-2292). Technical Support is available 24 hours a day, 7 days a week.

Device

Device Recall ExactaMix 2400 Compounder (EM 2400)
  • Modelo / Serial
    30248; 30304; 30577; 30578; 30600; 30321; 30264; 30507; 30256; 30120; 30587; 30778; 30779; 30512; 30218; 30136; 30260; 30549; 30612; 30940; 30268; 30415; 30949; 30300; 30435; 30162; 30269; 30356; 30291;30464; 30915; 30916; 30235; 30136; 30150; 30394; 30704; 30705; 30180; 30134; 30207; 30208; 30376; 30419; 30420; 30510; 30534; 30547; 30548; 30583; 30589; 30590; 30591; 30629; 30630; 30644; 30645; 30654; 30661; 30674; 30686; 30687; 30698; 30699; 30702; 30703; 30707; 30708; 30739; 30752; 30756; 30759; 30765; 30772; 30791; 30793; 30800; 30801; 30816; 30830; 30831; 30836; 30842; 30843; 30869; 30870; 30886; 30899; 30900; 30932; 30935; 30936; 30937; 30938; 30950; 30961; 30962; 30963; 30970; 30981; 30984; 30985; 30997; 31003; 30004; 31027; 31028; 31035; 31036; 31055; 31056; 31074; 31077; 31080; 31081; 31084; 31085; 31097; 31118; 31119; 31120; 31129; 31134; 31142; 31161; 31162; 31163; 31169; 31170; 31171; 31172; 31173; 31174; 31181; 31182; 31194; 31201; 31211; 31212; 31213; 31214; 31215; 31216; 31216; 31217; 31224; 31237; 31238; 31262; 31263;  31264; 31265; 31267; 31268; 31269; 31270; 30918; 30706; 31266; 30943; 30527; 30138; 30323; 30651; 30241; 30515; 30805; 31061; 30440; 30441; 31240; 31006; 30818; 30297; 30798; 30331; 30677; 30579; 30105; 30362; 30287; 30194; 30384; 30489; 30544; 30863; 30203; 30148; 30332; 30978; 30993; 30994; 30360; 30697; 31053; 31054; 31141; 30934; 30137; 31001; 31002; 31029; 31030; 30769; 30770; 30771; 30237; 31104; 31105; 30809; 30810; 31271; 31272; 30727; 31123; 30299; 30341; 30274; 30316; 30141; 30142; 30678; 30679; 30855; 30856; 30490; 30382; 30982; 30983; 30201; 30202; 31179; 31180; 30977; 30799; 30389; 30397; 30465; 30478; 30624; 30443; 30234; 30422; 30242; 30551; 30251; 30781; 30296; 30225; 30638; 30976; 31071; 30722; 30367; 30611; 30819; 30820; 30483; 30484; 30192; 30258; 30974; 30885; 30214; 30290; 30572; 30712; 30787; 30461; 30313; 30523; 30754; 30767; 30682; 30393; 30184; 30343; 30398; 30400; 30616; 30617; 30500; 30574; 30554; 30161; 30567; 30609; 30975; 30280; 31050; 30245; 30806; 30302; 30724; 30294; 30675; 31019; 31020; 30528; 30576; 30462; 30713; 30479; 30480; 30850; 30851; 31015; 31016; 30432; 30780; 30757; 30758; 30584; 30733; 30734; 30605; 30995; 30844; 30231; 30450; 30874; 31116; 31117; 30680; 30117; 30355; 31115; 30346; 30841; 31127; 30627; 30882; 30187; 30349; 30325; 30447; 30580; 30785; 30449; 30491; 30506; 30348; 30598; 30354; 30681; 30919; 31076; 30966; 30967; 30498; 30511; 30466; 30471; 31064; 30575; 30164; 30205; 30838; 31110; 30672; 30725; 30620; 30621; 30613; 30570; 30639; 30944; 30945; 30658; 30660; 31033; 31044; 31057; 30571; 30236; 30906; 30179; 31195; 31196; 30539; 30540; 30334; 30335; 30659; 30939; 30175; 30240; 31051; 30210; 31258; 31259; 30545; 30550; 30320; 30615; 30927; 30928; 30387; 30417; 30959; 30960; 30951; 30952; 30531; 30532; 30622; 30130; 30160; 30255; 30503; 30504; 30846; 30636; 30603; 31025; 31034; 30730; 30633; 30738; 30115; 30156; 30372; 30433; 30606; 30783; 30177; 30493; 31075; 30488; 31017; 30773; 30775; 30525; 30533; 30804; 30135; 30267; 30340; 30463; 30894; 30941; 30889; 30481; 30494; 30709; 30796; 30872; 30381; 30890; 30876; 30198; 30157; 30229; 30526; 30111; 30273; 31072; 31073; 30634; 30723; 30221; 30296; 30676; 31018; 30835; 30803; 30811; 30924; 30905; 30641; 30642; 30149; 30216; 30595; 30128; 30188; 30185; 30524; 30563; 30152; 30270; 30306; 30505; 31207; 31208; 30369; 30254; 30406; 30497; 30784; 31111; 30469; 30826; 30519; 30520; 30541; 30625; 30688; 31151; 30535; 30536; 30986; 30987; 30197; 30247; 30486; 30592; 31112; 31012; 30305; 30475; 30379; 30812; 31239; 30619; 30343; 30223; 30288; 30366; 30217; 30700; 30174; 30263; 30314; 30685; 30308; 30209; 30204; 30412; 30315; 30378; 30345; 30789; 30508; 30653; 31159; 31160; 30908; 30499; 30683; 31065; 30448; 30477; 30807; 30808; 30742; 30139; 30902; 30903; 31274; 31275; 30664; 30648; 31234; 30485; 30743; 30762; 30763; 30439; 31176; 31177; 30423; 31008; 30565; 30250; 30988; 30989; 30607; 30696; 30509; 30181; 30999; 31000; 30113; 30392; 30404; 30582; 30953; 30414; 30614; 30802; 30892; 30893; 30646; 30259; 30338; 30361; 30405; 30409; 30650; 30145; 30119; 30319; 30109; 31125; 31247; 31248; 30454; 30455; 30719; 30168; 31197; 31198; 30102; 30118; 30887; 30888; 30166; 30167; 30942; 30170; 30626; 30839; 31070; 30468; 30735; 30879; 30881; 30410; 30649; 30909; 30425; 60456; 31078; 31079; 31158; 30750; 30751; 30790; 30200; 31058; 30555; 60556; 30792; 30721; 30618; 30640; 30213; 30310; 30979; 30980; 30964; 30965; 30690; 30647; 30637; 30797; 30521; 30522; 30923; 30322; 30327; 30155; 30232; 30363; 30413; 30849; 30744; 30760; 30821; 30822; 31164; 31249; 31250; 30729; 30858; 30513; 30514; 30529; 30530; 30666; 30667; 30823; 30827; 31100; 30276; 30643; 30342; 30428; 30749; 30153; 30178; 30632; 30635; 30837; 30838; 30560; 30561; 30452; 30453; 30552; 30710; 30401; 30459; 31218; 31219; 30593; 30776; 30176; 30817; 30238; 30239; 30399; 30282; 30782; 30910; 30917; 30265; 30954; 31143; 31144; 30222; 30446; 30657; 30460; 31095; 31031; 31191; 31192; 31149; 30476; 30546; 30227; 30228; 30921; 30922; 30968; 30969; 30144; 30581; 31220; 31221; 31222; 31223; 30226; 30227; 31228; 31230; 31251; 31252; 31253; 31254; 31037; 31038; 31039; 31040; 31041; 31042; 31043; 31045; 31046; 31047; 30693; 30764; 31204; 31205; 31206; 30599; 31145; 31146; 31147; 31148; 31150; 31152; 31153; 31154; 30277; 30492; 30873; 31114; 31005; 31007; 31009; 30114; 30129; 30189; 30328; 30768; 30336; 30585; 31260; 31261; 31087; 31088; 31089; 31090; 31091; 31092; 31093; 31094; 31052; 30601; 30602; 30753; 30122; 30233; 30261; 30788; 30487; 30257; 30861; 30815; 30946; 30226; 30411; 30445; 31010; 30929; 30930; 30430; 30692; 30777; 30230l 31165; 31175; 30329; 30652; 30897; 30898; 30196; 30373; 30182; 30673; 30467; 30597; 30746; 30761; 30472; 31026; 30337; 31062; 31063; 30691; 31121; 30852; 30853; 30374; 30990; 30991; 30971; 30972; 31059; 31060; 30326; 30845; 30813; 31032; 30731; 30732; 30121; 30402; 30668; 30669; 30867; 30868; 30913; 30914; 30370; 30371; 30586; 30588; 30252; 30496; 30594; 30711; 30907; 30391; 30665; 30948; 30748; 30862; 30863; 30127; 31094; 30840; 30243; 30364; 30365; 30235; 30755; 30891; 30517; 30518; 31255; 31256; 30542; 30568; 30281; 30747; 30786; 30537; 30538; 30539; 30726; 30718; 30143; 30824; 30825; 30303; 30694; 30631; 30165; 30737; 30925; 30926; 30333; 30429; 30474; 30794; 30795; 31048; 31848; 30470; 30124; 30864; 30357; 30442; 30623; 30295; 30857; 30878; 30716; 30717; 31103; 30502; 30911; 30912; 31183; 31184; 31186; 31187; 31188; 31225; 30955; 30956; 30318; 30957; 30958; 30834; 30847; 31021; 30559; 30286; 30662; 30663; 31209; 31210; 30740; 30741; 30173; 30195; 31123; 30159; 30163; 30655; 30656; 30358; 30684; 30875; 30877; 30998; 30901; 30436; 31199; 31200; 30407; 30610; 30278; 30418; 30896; 30458; 30101; 30317; 30720; 31229; 31231; 31139; 31140; 30116; 30151; 30173; 30865; 30271; 30895; 30828; 30829; 31022; 31023; 30124; 30344; 30421; 31126; 30132; 30133; 30112; 30253; 31067; 31068; 31185; 30206; 30564; 30880; 30569; 31156; 31157; 31113; 30147; 30171; 30301; 30244; 30285; 30604; 30832; 30833; 30883; 30396; 31108; 31166; 31167; 31168; 30390; 30566; 30158; 30884; 30339; 30292; 31106; 31107; 31189; 31190; 31109; 31135; 31136; 31137; 31138; 30562; 30933; 30596; 30211; 30854; 30860; 31241; 31242; 31243; 31244; 31245; 31246; 30871; 30131; 30859; 31130; 31131; 30293; 30243; 30244; 30110; 30191; 30219; 30714; 30996; 31124; 30154; 31013; 31014; 30108; 31132; 31133; 31098; 31099; 30557; 31066; 31122; 31178; 31257; 31233; 30543; 30106; 31102; 30330; 30424; 31082; 31083
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom.
  • Descripción del producto
    The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. || Pharmacy compounding system for mixing ingredients for intravascular administration.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Dirección del fabricante
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA