Recall Z-0687-03 ยท MEB Pump, Infusion, Elastomeric
I-Flow Corporation
Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500 Part No. 5001065
| Date | Mar 27, 2003 (initiated Mar 4, 2003) |
| Status | Terminated |
| Reason | Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up. |
| Root cause | Other |
| Action | Recall was initiated by Fax on March 4, 2003 and phone calls on March 5, 2003. |
| Quantity | 2,832 units |
| Distribution | CA, OH, WA, TX, UT, SC, MI, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932740 | HOMEPUMP NSF Block Medical, Inc., Oct 6, 1993 |