FDAFDA · Food and drugs·Recall number Z-0580-2019
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.
Published December 19, 2018 · Recall initiated: October 17, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Leoni Fiber Optics GmbH
- Distributor
- US Distribution to the state of: Ohio.
- Lot
- 096877 00816901020296
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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