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U.S. Department of Health and Human Services

Class 2 Device Recall SLS II Laser sheath kit.

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  Class 2 Device Recall SLS II Laser sheath kit. see related information
Date Initiated by Firm March 16, 2009
Date Posted June 01, 2009
Recall Status1 Terminated 3 on November 28, 2011
Recall Number Z-1264-2009
Recall Event ID 51438
PMA Number P960042 
Product Classification laser catheter sheath - Product Code OEX
Product Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
Code Information Lot number CJJ09B18A
Recalling Firm/
Manufacturer		 Spectranetics Corporation
9965 Federal Dr
Colorado Springs CO 80921-3617
For Additional Information Contact
719-447-2318
Manufacturer Reason
for Recall		 Catheter outer jacket may split during use.
FDA Determined
Cause 2		 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 in Commerce 17 units
Distribution Nationwide distribution: AL, KY, LA, MI, NC, NY, and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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