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Terminated

Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.

FDA Recall Z-1264-2009 · Posted 2009-06-01

Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeOEX
Date Initiated2009-03-16
Date Terminated2011-11-28
Product Quantity17 units

Reason for Recall

Catheter outer jacket may split during use.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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