[Recalled] Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for u
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-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 |
|---|---|
| Brand / manufacturer | Leoni Fiber Optics GmbH |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0578-2019 |
| Country of notice | Germany |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 October 2018 |
| EAN / barcode | 00816901020272 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Leoni Fiber Optics GmbH
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.