Class 2 Device Recall FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP

• Date Initiated by Firm: September 04, 2009
• Date Posted: September 21, 2009
• Recall Status: Terminated on September 19, 2012
• Recall Number: Z-2252-2009
• Recall Event ID: 53207
• 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; 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• Recalling Firm/ Manufacturer: Abbott Nutrition, Abbott Laboratories; 625 Cleveland Ave; Columbus OH 43215-1754
• 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: Device Design
• 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 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.

• 510(K) Database: 510(K)s with Product Code = LZH and Original Applicant = ABBOTT LABORATORIES