Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0313-04

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

Halyard Health / initiated 2003-08-23 / Terminated

I-Flow Corporation began a recall of Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120 on . The reason FDA records is "Some pumps run at 2 ml/hr instead of 0.5 ml/hr". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0313-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Halyard Health
Product
Easypump LT 100-200 Elastomeric Infusion Pump (100 ml x 0.5 ml/hr) Part number: 5001120
Product code
MEB Pump, Infusion, Elastomeric
Reason for recall
Some pumps run at 2 ml/hr instead of 0.5 ml/hr.
FDA root cause
Other
Action
Firm sent recall letter to thier only customer in France on August 23, 2002.
Quantity in commerce
950
Distribution
Only to France, and one customer.
Product codes and lots
Lot number 132185.