Recall Z-0870-06 ยท FRN Pump, Infusion
Excelsior Medical Corp
ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.
| Date | May 17, 2006 (initiated Mar 21, 2006) |
| Status | Terminated |
| Reason | Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller. |
| Root cause | Other |
| Action | An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list. |
| Quantity | 3911 units |
| Distribution | Nationwide and Quebec, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914988 | 500 INFUSER Excel Medical, Inc., Apr 6, 1992 |