ClearanceBrief
Recall Z-0741-03 ยท

I-Flow Corporation

Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)

DateApr 18, 2003 (initiated Mar 18, 2003)
StatusTerminated
ReasonOverinfusion due to misassembly.
Root causeOther
ActionRecall letter was sent to sole distributor, B Braun FRance by email on 3/18/2003. Return of stock and subrecall was requested. Consignee has acknowledged implementing subrecall.
Quantity2638 units
DistributionOnly in France to distributor B. Braun Medical, France
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K991513HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
I-Flow Corp., Jun 21, 1999