Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0687-03

Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part...

Halyard Health / initiated 2003-03-04 / Terminated

I-Flow Corporation began a recall of Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065 on . The reason FDA records is "Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0687-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Halyard Health
Product
Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065
Product code
MEB Pump, Infusion, Elastomeric
Reason for recall
Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
FDA root cause
Other
Action
Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003.
Quantity in commerce
2,832 units
Distribution
CA, OH, WA, TX, UT, SC, MI, IL.
Product codes and lots
Lot 262074