Recall Z-2609-2010 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Convatec Inc.
Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy
| Date | Sep 28, 2010 (initiated Jul 9, 2010) |
| Status | Terminated |
| Reason | Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity. |
| Root cause | Device Design |
| Action | Recall notification letters were sent to 46 customers, acute care facilities and durable medical device distributors on July 9, 2010, by Federal Express. |
| Quantity | 1190 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061788 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories, Jul 11, 2006 |