Z-0577-2019 Class II Terminated
FDA device recall Z-0577-2019 was initiated by Leoni Fiber Optics GmbH on October 17, 2018 and is designated Class II. Reason for recall: 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; … The recall status is terminated (terminated April 10, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2018
- Initiation Date
- October 17, 2018
- Termination Date
- April 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product 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.
Reason for Recall
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.
Distribution Pattern
US Distribution to the state of: Ohio.
Code Information
096874 00816901020265