Recall Z-1022-2010 ยท MEB Pump, Infusion, Elastomeric
Hsmg, Inc. D/b/a Smartinfuser Usa
SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.
| 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 | 444 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072053 | SMARTBLOCK PAIN PUMP Medical Flow Systems, Ltd., Nov 6, 2007 |