Recall Z-1264-2009 ยท OEX Cardiovascular Catheter Sheath Introducer Kit
Spectranetics Corporation
Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
| Date | Jun 1, 2009 (initiated Mar 16, 2009) |
| Status | Terminated |
| Reason | Catheter outer jacket may split during use. |
| Root cause | Process control |
| Action | Spectranetics notified the 8 recipients of the catheters by letter on 3/17/2009. They were told that a Spectranetics sales rep would contact them to coordinate the return of the suspect devices. Questions were referred to 719-447-2462 or 719-447-2539. |
| Quantity | 17 units |
| Distribution | Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.