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U.S. Department of Health and Human Services

Class 2 Device Recall CORFLO 300 Enteral Pump

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 Class 2 Recall
CORFLO 300 Enteral Pump
see related information
Date Posted October 25, 2011
Recall Status1 Open
Recall Number Z-0089-2012
Recall Event ID 59969
Premarket Notification
510(K) Number
K944750 
Product Classification Pump, Infusion, Enteral - Product Code LZH
Product 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.
Code Information catalog 20-0500, all serial numbers
Recalling Firm/
Manufacturer
CORPAK MedSystems
100 Chaddick Dr
Wheeling, Illinois 60090
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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 questions@corpak.com. Dealers/distributors were requested to notify their customers of the recall.
Quantity in Commerce 13,000 pumps
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZH and Original Applicant = CORPAK, INC.
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