CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling,

FDA device recall Z-0089-2012 · posted 2011-10-25 · Terminated

Recall details

Recalling firm

CORPAK MedSystems

Reason for recall

Corpak is removing the Corflo 300 Enteral Pump from the market due to the possibility that with fluid ingress or other damage, the keypad may not function, and the possibility of motor mount failure.

Action taken

Corpak MedSystems sent Recall Notification letters dated September 19, 2011 to all CorFlo 300 Enteral Pump customers on the same date. The customers were informed that there is a possibility that with fluid ingress the keypad may become inoperable, and that there is a possibility of motor mount failure. Either event could possibly affect the rate at which formula is delivered to the patient, and fluid ingress could cause a potential of audible alarm failure. Corpak determined that the removal of the pumps from the market was the best option for their customers, and requested the return of all CorFlo 300 pumps to Corpak by no later than December 1, 2011. The customers were requested to contact Corpak at 1-800-323-6305 to arrange for the return of the pumps, and to complete and return the enclosed acknowledgement form, indicating the number of pumps on hand, via fax at 847-541-9526 or e-mail to questions@corpak.com. Dealers/distributors were requested to notify their customers of the recall.

Root cause

Process control

Status

Terminated

Product code

LZH

Quantity affected

13,000 pumps

Distribution

Nationwide Distribution

Date initiated

2011-09-19

Date posted

2011-10-25

Date terminated

2017-12-27

Location

Wheeling, IL

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