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.
FDA Recall Z-2252-2009 · Posted 2009-09-21
Recalling FirmAbbott Nutrition, Abbott Laboratories
Recall StatusTerminated
Product CodeLZH
Date Initiated2009-09-04
Date Terminated2012-09-19
Product Quantity5,173 pumps
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.
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.
Root Cause
Device Design
Distribution Pattern
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).
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.