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U.S. Department of Health and Human Services

Class 2 Device Recall 12Fr SLS II Laser Sheath

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  Class 2 Device Recall 12Fr SLS II Laser Sheath see related information
Date Initiated by Firm March 13, 2012
Date Posted April 11, 2012
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-1395-2012
Recall Event ID 61408
PMA Number P960042 
Product Classification Device, angioplasty, laser, coronary - Product Code LPC
Product 12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
Code Information C11H25B C11H25C C11H25D C11H29E C11H29F C11H29G C11J06A C11J06B C11J06C C11J06D C11J12A C11J12B C11J21E C11J22F C11J29A C11J29B C11J29C C11K03E C11K06A C11K06B C11K06C F11J19A F11J29F F11K11D F11K25G F11L03A and F11L17A
Recalling Firm/
Manufacturer		 Spectranetics Corp.
9965 Federal Drive
Colorado Springs CO 80921-3617
For Additional Information Contact
800-231-0978
Manufacturer Reason
for Recall		 Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Spectranetics sent Recall Notices to all customers on March 14, 2012. The product issue was described and requested actions were included. Questions were directed to Customer Service at 1-800-231-0978 (US).
Quantity in Commerce 615
Distribution Worldwide Distribution -- USA , and the countries of Australia, Belgium, Canada, Czech Republic, France, Germany, Italy, Ireland, Japan, Netherlands, Russia, Sweden, Switzerland, United Kingdom and Venezuela.
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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