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 i
Check against the official notice below — it lists the full affected range.
Leoni Fiber Optics GmbH has recalled Laser Fiber Assy devices (model SU-200-RT SmartScope) distributed in Ohio due to a potential safety issue with the product packaging. Some units shipped in Smartscope single-box packaging may have broken package seals, which compromises the sterility of the product. Although only two cases of compromised sterility have been reported, all products in this packaging type are considered at risk.
If a sterile medical device's seal is broken, it could allow contamination and increase the risk of infection if the product is used. The recalled devices have lot/code number 096874 00816901020265. 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: 096874 00816901020265
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.