Recall Z-1264-2009
Spectranetics Corporation · initiated March 16, 2009
Product
Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
Codes / lots: Lot number CJJ09B18A
Reason for recall
Catheter outer jacket may split during use.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1264-2009
- Initiated
- March 16, 2009
- Posted by FDA
- June 1, 2009
- Terminated
- November 28, 2011
- Product code
- OEX – Cardiovascular Catheter Sheath Introducer Kit
- Quantity
- 17 units
- Distribution
- Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
- Recalling firm
- Spectranetics Corporation, Colorado Springs, CO