ThromCat Thrombectomy Catheter System. Catalog number 63000-01
FDA device recall Z-1115-2007 · posted 2007-07-23 · Terminated
Recall details
- Recalling firm
- Kensey Nash Corp
- Reason for recall
- Defective component (power supply)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 11 units
- Distribution
- Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.
- Date initiated
- 2007-05-21
- Date posted
- 2007-07-23
- Date terminated
- 2007-08-29
- Location
- Exton, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THROMCAT THROMBECTOMY CATHETER SYSTEM (K060016) | Kensey Nash Corp. | 2006-04-25 |