SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
FDA device recall Z-1021-2010 · posted 2010-03-08 · Terminated
Recall details
- Recalling firm
- Hsmg, Inc. D/b/a Smartinfuser Usa
- Reason for recall
- Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
- Action taken
- SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 6,393 units
- Distribution
- Nationwide.
- Date initiated
- 2009-01-08
- Date posted
- 2010-03-08
- Date terminated
- 2011-04-25
- Location
- Houston, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET (K061409) | Precise Medical Products, Ltd. | 2006-06-16 |