Device product
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.
Z-0005-2014
Product summary
- Firm
- PhotoMedex, Inc.
- Event
- Event 64454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 549
- Official record key
device-enforcement:Z-0005-2014
Official wording
Reason: Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.
Code information: Lot number 226201
Distribution pattern: Worldwide Distribution-USA including the states of AR, KS and OH, and the countries of Germany, South Africa and the United Kingdom.
Derived failure modes
-
Unknown
Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.