Z-0005-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2013
- Initiation Date
- January 4, 2013
- Termination Date
- April 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 549
Product Description
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Reason for Recall
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Distribution Pattern
Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
Code Information
Lot number 226201