Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Recall
- Recall Number
- Z-0577-2019
- Event Number
- 81519
- Firm
- Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany
- FEI Number
- 3005128587
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- October 17, 2018
- Terminated
- April 10, 2020
Description
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.
The firm, LEONI, notified its distributor of the product issue on 10/16/18 via phone call and a subsequent "URGENT: MEDICAL DEVICE RECALL" letter. The distributor was informed of the product issue, and asked to disseminate recall information to customers. Actions to be taken by the Customer/User: End users should discontinue usage of the product. Product should be immediately quarantined. The Distributor should complete the acknowledgement of receipt form, to arrange for replacement and or credit to their account. A Leoni Customer Service Representative shall contact you with a Return material Authorization. If a replacement order is needed please inform customer service at the time of RMA issuance. - Discontinue usage if packaging irregularities exist - Return RMA units to Leoni Fiber Optics Inc. - Inform Customer Service if replacement product is required. - Complete acknowledge form and return back to Leoni Fiber Optics Inc. Attention Roger West, LFOI Quality Manager, [email protected] If you have any questions, please contact Quality Manager at 757-258-4805 or Email: [email protected].
US Distribution to the state of: Ohio.