12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in pa
FDA device recall Z-1395-2012 · posted 2012-04-11 · Terminated
Recall details
- Recalling firm
- Spectranetics Corp.
- Reason for recall
- Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
- Action taken
- 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).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPC
- Quantity affected
- 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 Ve
- Date initiated
- 2012-03-13
- Date posted
- 2012-04-11
- Date terminated
- 2012-05-02
- Location
- Colorado Springs, CO
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