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U.S. Department of Health and Human Services

Class 2 Device Recall FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

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 Class 2 Recall
FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
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Date Posted September 21, 2009
Recall Status1 Open
Recall Number Z-2252-2009
Recall Event ID 53207
Premarket Notification
510(K) Number
K913958 
Product Classification Pump, Infusion, Enteral - Product Code LZH
Product 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.
Code Information 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; 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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.
Recalling Firm/
Manufacturer
Abbott Nutrition, Abbott Laboratories
625 Cleveland Ave
Columbus, Ohio 43215-1754
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Randal P. McKay
614-624-3688
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Quantity in Commerce 5,173 pumps
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).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = ABBOTT LABORATORIES
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