Recall Z-1021-2010 ยท MEB Pump, Infusion, Elastomeric
Hsmg, Inc. D/b/a Smartinfuser Usa
SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234.
| Date | Mar 8, 2010 (initiated Jan 8, 2009) |
| Status | Terminated |
| Reason | Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature. |
| Root cause | Process control |
| Action | SmartInfuser USA sent letters to consignees on 1/8/2009 and 1/22/2009. |
| Quantity | 6,393 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061409 | SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET Precise Medical Products, Ltd., Jun 16, 2006 |