Recall Z-1115-2007 ยท MCW Catheter, Peripheral, Atherectomy
Kensey Nash Corp
ThromCat Thrombectomy Catheter System. Catalog number 63000-01
| Date | Jul 23, 2007 (initiated May 21, 2007) |
| Status | Terminated |
| Reason | Defective component (power supply) |
| Root cause | Other |
| Action | New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately. |
| Quantity | 11 units |
| Distribution | Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM Kensey Nash Corp., Apr 25, 2006 |