Recall Z-1981-2011 ยท MEB Pump, Infusion, Elastomeric
Hsmg, Inc. D/b/a Smartinfuser Usa
SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.
| Date | Apr 14, 2011 (initiated Mar 17, 2010) |
| Status | Terminated |
| Reason | Elastomeric tube in product's compression unit has the potential to burst following filling. |
| Root cause | Other |
| Action | 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. |
| Quantity | 368 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072053 | SMARTBLOCK PAIN PUMP Medical Flow Systems, Ltd., Nov 6, 2007 |