Recall Z-0089-2012 ยท LZH Pump, Infusion, Enteral
CORPAK MedSystems
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.
| Date | Oct 25, 2011 (initiated Sep 19, 2011) |
| Status | Terminated |
| 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. |
| Root cause | 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 al |
| Quantity | 13,000 pumps |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944750 | CORFLO 300 PUMP Corpak, Inc., Jun 19, 1995 |