Recall Z-0709-03 ยท FRN Pump, Infusion
I-Flow Corporation
Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936
| Date | Apr 3, 2003 (initiated Mar 5, 2003) |
| Status | Terminated |
| Reason | Wrong component may result in over infusion of medications. |
| Root cause | Other |
| Action | Recall was initiated by fax on March 5, 2003 and follow-up email on March 6, 2003. Firm is requesting returns of any unused product. |
| Quantity | 5,808 units |
| Distribution | States of NY and MA, and internationally to England, Spain, Mexico, Canada, Italy, Austrailia, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923875 | SIDEKICK 50 PLUS AND SIDEKICK 100 PLUS I-Flow Corp., May 13, 1993 |