Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-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 s
Check against the official notice below — it lists the full affected range.
Leoni Fiber Optics GmbH is recalling Laser Fiber Assy-Single Use products sold under the SmartScope brand name in Ohio. Some of these products, which are used in medical procedures, were shipped in packaging with broken seals that compromised their sterility. Two cases of compromised sterility have been reported, and all products in SmartScope single-box packaging are considered at risk. If used, these non-sterile fibers could increase the risk of infection.
The affected products have lot code 096876 00816901020289. The source document does not specify what action 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: 096876 00816901020289
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.