Date Initiated by Firm |
June 03, 2008 |
Date Posted |
April 05, 2012 |
Recall Status1 |
Terminated 3 on April 10, 2012 |
Recall Number |
Z-1371-2012 |
Recall Event ID |
52174 |
Product Classification |
System/device, pharmacy compounding - Product Code NEP
|
Product |
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Baxa Corporation 14445 Grasslands Dr Englewood CO 80112
|
For Additional Information Contact |
303-690-4204
|
Manufacturer Reason for Recall |
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
|
FDA Determined Cause 2 |
Device Design |
Action |
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. |
Quantity in Commerce |
1000 units (approximately) |
Distribution |
Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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