ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation,
FDA device recall Z-0870-06 · posted 2006-05-17 · Terminated
Recall details
- Recalling firm
- Excelsior Medical Corp
- Reason for recall
- 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.
- Action taken
- An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 3911 units
- Distribution
- Nationwide and Quebec, Canada
- Date initiated
- 2006-03-21
- Date posted
- 2006-05-17
- Date terminated
- 2006-12-07
- Location
- Neptune, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 500 INFUSER (K914988) | Excel Medical, Inc. | 1992-04-06 |