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
Check against the official notice below — it lists the full affected range.
Leoni Fiber Optics GmbH has recalled laser fiber assemblies sold under the Smartscope brand name due to potential broken package seals that compromise sterility. Some units shipped in Smartscope single-box packaging may have damaged seals, and two cases of compromised sterility have been reported. Using these products with broken seals could increase the risk of infection.
The recalled products were distributed in Ohio. The affected lot/code is 096875 00816901020272. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US Distribution to the state of: Ohio. Quantity: N/A Lot/code info: 096875 00816901020272
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.