Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
FDA device recall Z-1264-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- Reason for recall
- Catheter outer jacket may split during use.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OEX
- Quantity affected
- 17 units
- Distribution
- Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
- Date initiated
- 2009-03-16
- Date posted
- 2009-06-01
- Date terminated
- 2011-11-28
- Location
- Colorado Springs, CO
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