SmartInfuser PainPump, Part numbers: P49220-S, P49230-S, P49230-SD, P49234-S, and P49234-SD.
FDA device recall Z-1982-2011 · posted 2011-04-14 · Terminated
Recall details
- Recalling firm
- Hsmg, Inc. D/b/a Smartinfuser Usa
- Reason for recall
- Elastomeric tube in product's compression unit has the potential to burst following filling.
- Action taken
- Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 1,483 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-03-17
- Date posted
- 2011-04-14
- 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 |
| SMARTINFUSER PAINPUMP (K042122) | Precise Medical Products | 2004-09-22 |