Abbott Nutrition, Abbott Laboratories: 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.

Recall number

Z-2252-2009

Recalling firm

Abbott Nutrition, Abbott Laboratories

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.

Status

Terminated

Initiated

2009-09-04

Posted

2009-09-21

Terminated

2012-09-19

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.

Root 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

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).

Lot, serial or model codes

Model # 50596, 50598 and 59322. 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1061199; 1061265; 1061348; 1061418; 1061421; 1061611; 1061673; 1061768; 1062095; 1062219; 1062399; 1062405; 1062454 and 1063000-1067802.

510(k) numbers

["K913958"]

PMA numbers

not on file

Product code

LZH

Firm FEI

1000136098

Firm city

Columbus

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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