Recall Z-0035-2007 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
Haemonetics Corporation
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
| Date | Oct 12, 2006 (initiated Jul 28, 2006) |
| Status | Terminated |
| Reason | Faulty circuit board may short circuit and cause electric shock to operator |
| Root cause | Other |
| Action | Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement. |
| Quantity | 15 units |
| Distribution | AZ, CT, GA, NE, MS Austria, France, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052626 | SMARTSUCTION HARMONY DEVICE Haemonetics Corp., Oct 5, 2005 |