Events

Recall of FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Nutrition, Abbott Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53207
  • Event Risk Class
    Class 2
  • Event Number
    Z-2252-2009
  • Event Initiated Date
    2009-09-04
  • Event Date Posted
    2009-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84938
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, infusion, enteral - Product Code LZH
  • Reason
    The firm initiated this voluntary recall because some of its flexiflo quantum enteral pumps, have a 110-volt ac power cord plug that may crack or fail. this potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.
  • Action
    An "Urgent Device Recall" letter dated September 4, 2009 was issued via FedEx overnight delivery to all direct consignees. The letter described the affected product, issue and immediate actions for customers. Direct consignees were further instructed to immediately contact affected customers and notify them about the Urgent Device Recall. Abbott Nutrition (AN) Device Call Center (DCC) will telephone those customers who do not responded promptly to the "Urgent Device Recall" letter with the completed AN Account Summary of the Flexiflo Quantum Enteral Pump Shipments. AN Device Call Center will make arrangements for the service or replacement of the recalled pumps. Please contact the AN Device Call Center at 1-877-457-0249, Monday through Friday between the hours of 8:30 am and 5:00 pm Eastern Standard Time (EST). An AN representative will work with you to arrange service or replacement of the recalled enteral pumps.

Device

FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
  • Model / Serial
    Model # 50596, 50598 and 59322. Pump Serial Numbers: 1000016; 1000026; 1000030; 1000031; 1000048; 1000152; 1000154; 1000350; 1000384; 1000429; 1000506; 1000523; 1000528; 1000548; 1000569; 1000609; 1000635; 1000679; 1000751; 1000870; 1000889; 1001007; 1001102; 1001107; 1001167; 1001306; 1001329; 1001372; 1001391; 1001442; 1001654; 1001693; 1001743; 1001851; 1001865; 1001893; 1001916; 1001918; 1002027; 1002028; 1002074; 1002095; 1002110; 1002117; 1002125; 1002136; 1002142; 1002143; 1002193; 1002209; 1002227; 1002292; 1002294; 1002297; 1002313; 1002315; 1002342; 1002352; 1002376; 1002420; 1002463; 1002487; 1002489; 1002641; 1002674; 1002734; 1002790; 1002823; 1002841; 1002864; 1002898; 1002951; 1002959; 1003016; 1003018; 1003059; 1003109; 1003127; 1003128; 1003176; 1003212; 1003220; 1003263; 1003317; 1003366; 1003415; 1003422; 1003465; 1003524; 1003562; 1003585; 1003617; 1003663; 1003668; 1003682; 1003701; 1003715; 1003719; 1003747; 1003759; 1003772; 1003823; 1003917; 1003935; 1003952; 1003968; 1003971; 1004140; 1004143; 1004185; 1004188; 1004231; 1004329; 1004339; 1004340; 1004388; 1004529; 1004539; 1004615; 1004624; 1004703; 1004726; 1004739; 1004785; 1004816; 1004840; 1004852; 1004862; 1004874; 1004909; 1004927; 1004966; 1004975; 1004995; 1005165; 1005190; 1005262; 1005268; 1005278; 1005315; 1005353; 1005378; 1005437; 1005456; 1005488; 1005519; 1005581; 1005595; 1005639; 1005648; 1005678; 1005719; 1005732; 1005746; 1005799; 1005849; 1005850; 1005861; 1005909; 1005929; 1005972; 1005992; 1006056; 1006135; 1006163; 1006174; 1006191; 1006221; 1006247; 1006260; 1006284; 1006290; 1006324; 1006331; 1006388; 1006451; 1006470; 1006504; 1006511; 1006541; 1006606; 1006608; 1006639; 1006643; 1006678; 1006680; 1006713; 1006740; 1006744; 1006760; 1006796; 1006860; 1006958; 1006973; 1006985; 1006997; 1007077; 1007079; 1007176; 1007241; 1007245; 1007303; 1007328; 1007342; 1007394; 1007417; 1007420; 1007448; 1007449; 1007456; 1007460; 1007492; 1007517; 1007531; 1007615; 1007676; 1007678; 1007695; 1007721; 1007768; 1007796; 1007801; 1007814; 1007827; 1007842; 1007871; 1007902; 1007953; 1007957; 1007958; 1007960; 1007966; 1008058; 1008111; 1008120; 1008137; 1008192; 1008199; 1008242; 1008245; 1008321; 1008323; 1008324; 1008336; 1008397; 1008419; 1008442; 1008448; 1008469; 1008483; 1008503; 1008541; 1008545; 1008661; 1008703; 1008745; 1008746; 1008755; 1008761; 1008763; 1008775; 1008790; 1008793; 1008808; 1008810; 1008858; 1008938; 1008952; 1009014; 1009015; 1009065; 1009094; 1009118; 1009185; 1009201; 1009221; 1009228; 1009234; 1009235; 1009269; 1009281; 1009297; 1009318; 1009379; 1009405; 1009442; 1009470; 1009499; 1009523; 1009629; 1009653; 1009668; 1009705; 1009709; 1009758; 1009759; 1009766; 1009791; 1009837; 1009871; 1009957; 1010031; 1010038; 1010077; 1010102; 1010146; 1010162; 1010197; 1010215; 1010238; 1010243; 1010261; 1010276; 1010359; 1010361; 1010395; 1010398; 1010449; 1010478; 1010484; 1010492; 1010503; 1010504; 1010538; 1010547; 1010549; 1010608; 1010610; 1010624; 1010718; 1010722; 1010739; 1010763; 1010803; 1010820; 1010843; 1010867; 1010906; 1010915; 1010927; 1010943; 1010973; 1010999; 1011050; 1011076; 1011103; 1011125; 1011130; 1011225; 1011254; 1011262; 1011313; 1011450; 1011500; 1011520; 1011528; 1011606; 1011642; 1011698; 1011721; 1011733; 1011738; 1011880; 1011942; 1011980; 1012030; 1012032; 1012048; 1012129; 1012247; 1012316; 1012335; 1012377; 1012438; 1012442; 1012540; 1012574; 1012622; 1012623; 1012661; 1012667; 1012673; 1012681; 1012731; 1012770; 1012802; 1012808; 1012853; 1012911; 1012938; 1012941; 1012947; 1013018; 1013029; 1013087; 1013089; 1013117; 1013143; 1013218; 1013279; 1013308; 1013358; 1013381; 1013382; 1013391; 1013413; 1013426; 1013478; 1013490; 1013563; 1013591; 1013603; 1013617; 1013648; 1013656; 1013672; 1013685; 1013734; 1013784; 1013802; 1013803; 1013806; 1013821; 1013847; 1013865; 1013896; 1014047; 1014053; 1014055; 1014147; 1014173; 1014185; 1014230; 1014231; 1014235; 1014269; 1014281; 1014287; 1014322; 1014361; 1014363; 1014368; 1014373; 1014377; 1014439; 1014523; 1014538; 1014558; 1014564; 1014589; 1014605; 1014614; 1014700; 1014734; 1014747; 1014748; 1014813; 1014883; 1014894; 1014954; 1014973; 1015010; 1015022; 1015025; 1015027; 1015052; 1015090; 1015103; 1015120; 1015128; 1015142; 1015149; 1015172; 1015191; 1015224; 1015238; 1015244; 1015250; 1015288; 1015401; 1015411; 1015457; 1015470; 1015472; 1015530; 1015582; 1015592; 1015593; 1015607; 1015681; 1015703; 1015711; 1015727; 1015737; 1015740; 1015759; 1015827; 1015840; 1015863; 1015868; 1015873; 1015880; 1015899; 1015925; 1015932; 1015990; 1016033; 1016046; 1016136; 1016153; 1016195; 1016232; 1016276; 1016296; 1016313; 1016328; 1016370; 1016415; 1016416; 1016419; 1016437; 1016524; 1016544; 1016552; 1016577; 1016582; 1016664; 1016736; 1016762; 1016790; 1016863; 1016880; 1016900; 1016916; 1016917; 1016929; 1016954; 1017025; 1017067; 1017097; 1017104; 1017139; 1017179; 1017182; 1017303; 1017306; 1017332; 1017349; 1017367; 1017383; 1017447; 1017494; 1017587; 1017693; 1017771; 1017781; 1017880; 1017919; 1017925; 1017929; 1017935; 1017957; 1017978; 1018040; 1018082; 1018088; 1018104; 1018109; 1018171; 1018243; 1018276; 1018298; 1018322; 1018325; 1018358; 1018370; 1018380; 1018388; 1018445; 1018465; 1018475; 1018519; 1018520; 1018545; 1018547; 1018557; 1018558; 1018563; 1018614; 1018661; 1018680; 1018690; 1018708; 1018744; 1018753; 1018765; 1018794; 1018796; 1018843; 1018851; 1018854; 1018930; 1018945; 1018965; 1018981; 1019014; 1019023; 1019062; 1019085; 1019101; 1019121; 1019147; 1019157; 1019191; 1019201; 1019205; 1019232; 1019234; 1019250; 1019259; 1019261; 1019281; 1019291; 1019298; 1019339; 1019341; 1019348; 1019359; 1019363; 1019369; 1019407; 1019424; 1019485; 1019506; 1019539; 1019565; 1019611; 1019620; 1019672; 1019710; 1019728; 1019757; 1019776; 1019787; 1019821; 1019867; 1019903; 1020025; 1020032; 1020047; 1020102; 1020107; 1020149; 1020157; 1020177; 1020208; 1020238; 1020252; 1020285; 1020295; 1020359; 1020374; 1020558; 1020592; 1020631; 1020666; 1020668; 1020676; 1020760; 1020771; 1020775; 1020788; 1020864; 1020883; 1020895; 1020897; 1020910; 1020928; 1020967; 1020992; 1021062; 1021063; 1021084; 1021158; 1021161; 1021207; 1021245; 1021409; 1021477; 1021530; 1021573; 1021575; 1021580; 1021624; 1021656; 1021720; 1021809; 1021813; 1021839; 1021929; 1021958; 1021994; 1021995; 1022020; 1022069; 1022072; 1022073; 1022095; 1022114; 1022132; 1022163; 1022245; 1022381; 1022387; 1022437; 1022440; 1022444; 1022450; 1022467; 1022469; 1022495; 1022535; 1022540; 1022570; 1022596; 1022604; 1022639; 1022640; 1022654; 1022661; 1022668; 1022678; 1022699; 1022718; 1022792; 1022816; 1022835; 1022838; 1022863; 1022886; 1022937; 1023162; 1023164; 1023180; 1023312; 1023358; 1023436; 1023469; 1023518; 1023522; 1023584; 1023593; 1023621; 1023686; 1023701; 1023762; 1023802; 1023822; 1023841; 1023932; 1023951; 1023964; 1024024; 1024040; 1024098; 1024145; 1024155; 1024187; 1024193; 1024233; 1024247; 1024254; 1024258; 1024275; 1024306; 1024311; 1024359; 1024406; 1024435; 1024509; 1024559; 1024612; 1024643; 1024693; 1024718; 1024754; 1024763; 1024803; 1024860; 1024878; 1024890; 1024899; 1024970; 1024979; 1024992; 1025031; 1025048; 1025059; 1025079; 1025082; 1025084; 1025086; 1025160; 1025173; 1025225; 1025230; 1025264; 1025378; 1025410; 1025413; 1025414; 1025451; 1025457; 1025502; 1025535; 1025544; 1025586; 1025635; 1025656; 1025660; 1025683; 1025709; 1025757; 1025822; 1025852; 1025970; 1026001; 1026035; 1026037; 1026063; 1026068; 1026072; 1026201; 1026204; 1026207; 1026211; 1026222; 1026261; 1026325; 1026351; 1026389; 1026411; 1026481; 1026526; 1026576; 1026582; 1026588; 1026643; 1026698; 1026742; 1026775; 1026782; 1026791; 1026793; 1026870; 1026895; 1026920; 1026991; 1027023; 1027081; 1027113; 1027138; 1027151; 1027173; 1027174; 1027185; 1027208; 1027246; 1027283; 1027350; 1027389; 1027418; 1027434; 1027441; 1027453; 1027484; 1027491; 1027532; 1027644; 1027710; 1027726; 1027728; 1027750; 1027763; 1027835; 1027837; 1027862; 1027880; 1027882; 1027940; 1027955; 1027981; 1027997; 1028025; 1028041; 1028059; 1028070; 1028104; 1028130; 1028146; 1028182; 1028193; 1028201; 1028208; 1028249; 1028290; 1028399; 1028410; 1028438; 1028443; 1028484; 1028504; 1028511; 1028700; 1028722; 1028729; 1028780; 1028924; 1028956; 1028979; 1028985; 1029014; 1029084; 1029102; 1029105; 1029110; 1029139; 1029323; 1029380; 1029468; 1029514; 1029573; 1029588; 1029605; 1029647; 1029653; 1029663; 1029700; 1029729; 1029743; 1029803; 1029841; 1029856; 1029862; 1029892; 1029982; 1029994; 1030093; 1030102; 1030183; 1030191; 1030193; 1030204; 1030255; 1030318; 1030324; 1030363; 1030374; 1030421; 1030451; 1030469; 1030538; 1030575; 1030612; 1030709; 1030711; 1030730; 1030754; 1030759; 1030773; 1030803; 1030831; 1030851; 1030930; 1030942; 1030956; 1030972; 1031029; 1031042; 1031090; 1031098; 1031138; 1031204; 1031439; 1031464; 1031503; 1031546; 1031590; 1031596; 1031600; 1031676; 1031696; 1031717; 1031729; 1031748; 1031752; 1031753; 1031760; 1031796; 1031807; 1031835; 1031857; 1031942; 1031963; 1032019; 1032076; 1032077; 1032079; 1032085; 1032187; 1032191; 1032193; 1032195; 1032207; 1032275; 1032304; 1032354; 1032395; 1032409; 1032433; 1032448; 1032467; 1032480; 1032507; 1032581; 1032596; 1032624; 1032631; 1032643; 1032645; 1032666; 1032703; 1032740; 1032762; 1032775; 1032812; 1032815; 1032864; 1032867; 1032888; 1032943; 1033018; 1033020; 1033031; 1033032; 1033039; 1033110; 1033125; 1033193; 1033231; 1033268; 1033358; 1033374; 1033382; 1033388; 1033408; 1033423; 1033459; 1033515; 1033520; 1033529; 1033542; 1033551; 1033562; 1033597; 1033607; 1033610; 1033681; 1033712; 1033731; 1033738; 1033752; 1033764; 1033774; 1033822; 1033900; 1033927; 1033944; 1033962; 1033970; 1033976; 1033988; 1034074; 1034093; 1034109; 1034111; 1034217; 1034239; 1034263; 1034283; 1034351; 1034419; 1034464; 1034512; 1034513; 1034519; 1034564; 1034582; 1034601; 1034609; 1034652; 1034660; 1034673; 1034790; 1034811; 1034822; 1034830; 1034870; 1034900; 1034923; 1034943; 1034981; 1035004; 1035062; 1035075; 1035076; 1035109; 1035157; 1035229; 1035241; 1035246; 1035263; 1035272; 1035391; 1035432; 1035451; 1035610; 1035614; 1035681; 1035683; 1035729; 1035744; 1035756; 1035757; 1035769; 1035845; 1035854; 1035872; 1035877; 1035878; 1035884; 1035916; 1035938; 1035946; 1036039; 1036041; 1036043; 1036088; 1036123; 1036146; 1036170; 1036238; 1036313; 1036375; 1036437; 1036440; 1036453; 1036464; 1036469; 1036488; 1036502; 1036546; 1036566; 1036618; 1036667; 1036669; 1036687; 1036704; 1036723; 1036759; 1036801; 1036811; 1036872; 1036879; 1036883; 1036898; 1036951; 1036960; 1036963; 1036971; 1036979; 1036988; 1037012; 1037076; 1037108; 1037139; 1037174; 1037188; 1037229; 1037283; 1037363; 1037447; 1037451; 1037468; 1037502; 1037525; 1037570; 1037586; 1037589; 1037598; 1037602; 1037603; 1037612; 1037614; 1037652; 1037678; 1037699; 1037712; 1037760; 1037763; 1037818; 1037843; 1037857; 1037899; 1037927; 1037932; 1037950; 1037989; 1038011; 1038075; 1038081; 1038103; 1038282; 1038332; 1038341; 1038367; 1038424; 1038453; 1038456; 1038498; 1038510; 1038532; 1038632; 1038664; 1038678; 1038825; 1038852; 1038897; 1038907; 1038927; 1038938; 1038944; 1038950; 1038987; 1039007; 1039018; 1039036; 1039038; 1039077; 1039090; 1039173; 1039184; 1039194; 1039234; 1039244; 1039267; 1039268; 1039277; 1039332; 1039355; 1039368; 1039431; 1039434; 1039466; 1039515; 1039520; 1039525; 1039581; 1039595; 1039688; 1039697; 1039812; 1039814; 1039901; 1039912; 1039926; 1039927; 1039947; 1039958; 1039965; 1040010; 1040021; 1040079; 1040229; 1040236; 1040248; 1040280; 1040351; 1040371; 1040390; 1040433; 1040447; 1040523; 1040612; 1040622; 1040686; 1040774; 1040801; 1040817; 1040840; 1040898; 1040911; 1040927; 1040952; 1040962; 1040967; 1040993; 1041004; 1041017; 1041066; 1041082; 1041149; 1041160; 1041188; 1041223; 1041232; 1041264; 1041301; 1041305; 1041318; 1041328; 1041357; 1041390; 1041460; 1041466; 1041497; 1041539; 1041543; 1041574; 1041599; 1041679; 1041687; 1041708; 1041753; 1041766; 1041794; 1041839; 1041867; 1041900; 1041904; 1041963; 1041984; 1042027; 1042028; 1042119; 1042129; 1042137; 1042169; 1042175; 1042225; 1042238; 1042274; 1042298; 1042307; 1042375; 1042382; 1042387; 1042410; 1042434; 1042438; 1042500; 1042542; 1042627; 1042628; 1042648; 1042690; 1042695; 1042698; 1042773; 1042856; 1042931; 1042984; 1043004; 1043037; 1043046; 1043120; 1043190; 1043192; 1043234; 1043326; 1043390; 1043397; 1043422; 1043433; 1043476; 1043486; 1043591; 1043612; 1043613; 1043653; 1043661; 1043727; 1043762; 1043780; 1043791; 1043793; 1043826; 1043840; 1043913; 1043921; 1043943; 1043955; 1043966; 1043974; 1044020; 1044058; 1044106; 1044114; 1044141; 1044182; 1044296; 1044369; 1044411; 1044435; 1044458; 1044459; 1044467; 1044477; 1044497; 1044523; 1044544; 1044560; 1044569; 1044602; 1044628; 1044666; 1044681; 1044705; 1044711; 1044735; 1044788; 1044799; 1044886; 1044915; 1044990; 1045004; 1045158; 1045163; 1045181; 1045193; 1045213; 1045265; 1045277; 1045305; 1045350; 1045363; 1045380; 1045408; 1045412; 1045417; 1045436; 1045467; 1045482; 1045487; 1045510; 1045552; 1045574; 1045595; 1045653; 1045683; 1045699; 1045716; 1045768; 1045870; 1045881; 1045897; 1045960; 1045968; 1045975; 1046032; 1046147; 1046152; 1046197; 1046260; 1046261; 1046270; 1046296; 1046346; 1046390; 1046457; 1046510; 1046546; 1046611; 1046625; 1046640; 1046877; 1046931; 1046947; 1047015; 1047017; 1047033; 1047037; 1047193; 1047202; 1047245; 1047295; 1047315; 1047331; 1047348; 1047410; 1047414; 1047416; 1047474; 1047539; 1047600; 1047638; 1047646; 1047669; 1047711; 1047797; 1047830; 1047844; 1047896; 1047922; 1047993; 1048001; 1048041; 1048068; 1048072; 1048134; 1048155; 1048163; 1048166; 1048191; 1048242; 1048339; 1048507; 1048508; 1048618; 1048627; 1048679; 1048703; 1048710; 1048723; 1048738; 1048745; 1048771; 1048851; 1048922; 1048939; 1048945; 1049023; 1049074; 1049107; 1049160; 1049185; 1049201; 1049227; 1049241; 1049308; 1049309; 1049333; 1049390; 1049395; 1049401; 1049408; 1049417; 1049422; 1049442; 1049453; 1049455; 1049467; 1049474; 1049507; 1049511; 1049521; 1049602; 1049624; 1049646; 1049666; 1049669; 1049698; 1049721; 1049889; 1049926; 1049927; 1049932; 1049962; 1049971; 1049983; 1050000; 1050055; 1050085; 1050086; 1050099; 1050111; 1050116; 1050155; 1050220; 1050223; 1050230; 1050233; 1050302; 1050335; 1050378; 1050384; 1050436; 1050438; 1050500; 1050534; 1050555; 1050563; 1050600; 1050604; 1050621; 1050656; 1050705; 1050722; 1050743; 1050805; 1050956; 1050975; 1050977; 1051004; 1051150; 1051161; 1051220; 1051222; 1051232; 1051233; 1051244; 1051285; 1051297; 1051312; 1051320; 1051333; 1051337; 1051347; 1051389; 1051392; 1051397; 1051496; 1051589; 1051627; 1051655; 1051732; 1051777; 1051802; 1051846; 1051899; 1051913; 1051940; 1051945; 1051951; 1051988; 1051990; 1052001; 1052004; 1052006; 1052028; 1052051; 1052085; 1052086; 1052389; 1052435; 1052448; 1052458; 1052486; 1052492; 1052500; 1052511; 1052540; 1052578; 1052582; 1052628; 1052722; 1052726; 1052793; 1052798; 1052802; 1052813; 1052851; 1052859; 1052908; 1052919; 1052928; 1052987; 1053081; 1053087; 1053106; 1053119; ; 053128; 1053143; 1053150; 1053212; 1053241; 1053290; 1053297; 1053310; 1053377; 1053378; 1053420; 1053431; 1053432; 1053440; 1053489; 1053499; 1053508; 1053515; 1053516; 1053520; 1053537; 1053539; 1053581; 1053588; 1053596; 1053679; 1053699; 1053728; 1053738; 1053749; 1053750; 1053759; 1053760; 1053822; 1053861; 1053894; 1053897; 1054008; 1054014; 1054025; 1054032; 1054059; 1054063; 1054081; 1054086; 1054094; 1054115; 1054178; 1054205; 1054223; 1054237; 1054252; 1054271; 1054277; 1054278; 1054330; 1054335; 1054354; 1054363; 1054379; 1054387; 1054438; 1054447; 1054464; 1054474; 1054498; 1054508; 1055015; 1055017; 1055027; 1055032; 1055035; 1055043; 1055048; 1055052; 1055078; 1055090; 1055093; 1055132; 1055144; 1055159; 1055175; 1055193; 1055202; 1055210; 1055229; 1055243; 1055254; 1055264; 1055266; 1055287; 1055303; 1055315; 1055328; 1055353; 1055366; 1055395; 1055397; 1055413; 1055417; 1055422; 1055428; 1055439; 1055474; 1055491; 1055518; 1055519; 1055523; 1055530; 1055579; 1055640; 1055694; 1055719; 1055742; 1055748; 1055750; 1055774; 1055775; 1055779; 1055835; 1055867; 1055906; 1055916; 1055943; 1055949; 1055960; 1055964; 1056145; 1056153; 1056164; 1056181; 1056222; 1056244; 1056253; 1056272; 1056349; 1056363; 1056369; 1056374; 1056375; 1056453; 1056485; 1056503; 1056536; 1056573; 1056584; 1056609; 1056610; 1056620; 1056642; 1056653; 1056688; 1056742; 1056765; 1056772; 1056784; 1056848; 1056849; 1056853; 1056876; 1056880; 1056883; 1056888; 1056921; 1056927; 1056951; 1056975; 1057008; 1057048; 1057158; 1057192; 1057215; 1057221; 1057235; 1057257; 1057260; 1057262; 1057270; 1057279; 1057295; 1057296; 1057314; 1057395; 1057423; 1057425; 1057429; 1057430; 1057432; 1057434; 1057453; 1057459; 1057492; 1057501; 1057518; 1057542; 1057544; 1057564; 1057569; 1057617; 1057628; 1057632; 1057653; 1057654; 1057699; 1057705; 1057711; 1057728; 1057745; 1057755; 1057761; 1057765; 1057770; 1057794; 1057808; 1057851; 1057852; 1057893; 1057933; 1057955; 1057991; 1058007; 1058024; 1058043; 1058060; 1058071; 1058076; 1058133; 1058135; 1058165; 1058179; 1058180; 1058186; 1058214; 1058238; 1058272; 1058286; 1058293; 1058296; 1058301; 1058308; 1058321; 1058324; 1058337; 1058382; 1058386; 1058427; 1058508; 1058533; 1058578; 1058597; 1058609; 1058616; 1058664; 1058670; 1058672; 1058678; 1058692; 1058729; 1058786; 1058808; 1058809; 1058821; 1058839; 1058846; 1058871; 1058888; 1058911; 1058918; 1058968; 1058975; 1059002; 1059003; 1059004; 1059008; 1059034; 1059100; 1059112; 1059140; 1059150; 1059153; 1059154; 1059184; 1059234; 1059237; 1059244; 1059248; 1059276; 1059278; 1059289; 1059314; 1059322; 1059330; 1059369; 1059380; 1059388; 1059399; 1059428; 1059446; 1059447; 1059465; 1059478; 1059491; 1059504; 1059520; 1059522; 1059523; 1059550; 1059593; 1059607; 1059614; 1059651; 1059667; 1059671; 1059675; 1059709; 1059832; 1060235; 1060319; 1060366; 1060472; 1060494; 1060496; 1060632; 1060649; 1060866; 1060877; 1060892; 1060898; 1060944; 1061011; 1061104; 1061199; 1061265; 1061348; 1061418; 1061421; 1061611; 1061673; 1061768; 1062095; 1062219; 1062399; 1062405; 1062454 and 1063000-1067802.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY).
  • Product Description
    Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. || The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care.
  • Manufacturer
    Abbott Nutrition, Abbott Laboratories

Manufacturer

Abbott Nutrition, Abbott Laboratories
  • Manufacturer Address
    Abbott Nutrition, Abbott Laboratories, 625 Cleveland Ave, Columbus OH 43215-1754
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA