Recall Z-0597-2007 ยท MCW Catheter, Peripheral, Atherectomy
Kensey Nash Corp
ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.
| Date | Mar 8, 2007 (initiated Feb 7, 2007) |
| Status | Terminated |
| Reason | Face seal may wear excessively and cause particulate matter. |
| Root cause | Other |
| Action | On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product. |
| Quantity | 165 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM Kensey Nash Corp., Apr 25, 2006 |