Recall Z-1115-2007
Kensey Nash Corp · initiated May 21, 2007
Product
ThromCat Thrombectomy Catheter System. Catalog number 63000-01
Codes / lots: Catalog number 63000-01, Lot number 57292 exp March 2008
Reason for recall
Defective component (power supply)
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1115-2007
- Initiated
- May 21, 2007
- Posted by FDA
- July 23, 2007
- Terminated
- August 29, 2007
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 11 units
- Distribution
- Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.
- Recalling firm
- Kensey Nash Corp, Exton, PA