ClearanceBrief
Recall Z-0313-04 ยท MEB Pump, Infusion, Elastomeric

I-Flow Corporation

Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120

DateJan 9, 2004 (initiated Aug 23, 2003)
StatusTerminated
ReasonSome pumps run at 2 ml/hr instead of 0.5 ml/hr.
Root causeOther
ActionFirm sent recall letter to thier only customer in France on August 23, 2002.
Quantity950
DistributionOnly to France, and one customer.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.