FDA Recall Terminated

CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. Intended to deliver formula to patients requiring tube feedings.

Recall: Z-0089-2012 · Initiated September 19, 2011

Recall

Recall Number
Z-0089-2012
Event Number
59969
Firm
CORPAK MedSystems
FEI Number
3011270181
Product Code
LZH
Status
Terminated
Root Cause
Process control
Initiated
September 19, 2011
Posted
October 25, 2011
Terminated
December 27, 2017
Address
100 Chaddick Dr, Wheeling, IL, 60090

Description

CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding pump; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #20-0500. Intended to deliver formula to patients requiring tube feedings.

Reason

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

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 [email protected]. Dealers/distributors were requested to notify their customers of the recall.

Distribution

Nationwide Distribution

Quantity

13,000 pumps