Z-0005-2014 Class II Terminated
FDA device recall Z-0005-2014 was initiated by PhotoMedex, Inc. on January 4, 2013 and is designated Class II. Reason for recall: Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier. The recall status is terminated (terminated April 16, 2014). Affected quantity: 549.
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