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 soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Publicado el 19 de diciembre de 2018 · Inicio del retiro: 17 de octubre de 2018
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Leoni Fiber Optics GmbH
- Distribuidor
- US Distribution to the state of: Ohio.
- Lote
- 096877 00816901020296
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Germany
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