Recall Z-0578-2019— Leoni Fiber Optics GmbH

Name: FDA recall Z-0578-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-17

Class II · Terminated

Class II FDA medical device recall by Leoni Fiber Optics GmbH, initiated 2018-10-17, terminated 2020-04-10. It names one FDA 510(k) clearance: K050738. Product: Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-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: 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..

Recalling firm: Leoni Fiber Optics GmbH
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Terminated: 2020-04-10
Firm location: Neuhaus-Schierschnitz, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K050738 — FT FIBER OPTIC DELIVERY SYSTEMSFibertech GmbH·cleared 2005-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.