FDA Recall
Terminated
Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)
Recall: Z-0741-03
·
Initiated March 18, 2003
Recall
- Recall Number
- Z-0741-03
- Event Number
- 25903
- Firm
- I-Flow Corporation
- FEI Number
- 3011270181
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 18, 2003
- Posted
- April 18, 2003
- Terminated
- November 20, 2003
- Address
- 20202 Windrow Dr, Lake Forest, CA, 92630
Description
Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr)
Reason
Overinfusion due to misassembly.
Action
Recall 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.
Distribution
Only in France to distributor B. Braun Medical, France
Quantity
2638 units