Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-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 Assembly products (model LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO, private label SU-1000-RT SmartScope) due to broken package seals that compromise sterility. Some products shipped in Smartscope single-box packaging may have damaged seals, and all products in this packaging type are considered at risk. Two cases of compromised sterility have been reported. If used, these products could increase the risk of infection because the sterility barrier has been compromised.
The affected products were distributed to Ohio. The recall involves lot/code 096877 00816901020296. The source document does not specify a remedy or recommended action for consumers who may have this product.
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: 096877 00816901020296
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.