Leoni Fiber Optics recalls SmartScope laser fiber assemblies with potential broken seals that could compromise sterility and increase infection risk during surgery.
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.
Leoni Fiber Optics recalls SmartScope laser fiber assemblies that may have broken seals, risking infection during surgical procedures. This affects products sold in Smartscope single-box packaging.
Broken seals in the packaging can compromise sterility, allowing contaminants to enter the device. This increases the risk of infection during surgical procedures if the device is used without a properly sealed package.
Surgical professionals using SmartScope laser fiber assemblies for procedures like cutting or coagulating tissue. Patients undergoing surgery with these devices face infection risks if the seal is compromised.
Check for Smartscope single-box packaging with the product name 'Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT'. Products were sold with the SmartScope packaging.
Inspect the packaging for a broken seal; if broken, do not use the device.
The recall is due to potential broken seals in the packaging that could compromise sterility, increasing infection risk during surgery.
Look for Smartscope single-box packaging labeled 'Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT'.
Do not use the device if the seal is broken; contact the manufacturer for guidance.
We’ve drafted a message you can send Leoni Fiber Opt: SmartScope to request your refund or repair — edit it as you like.
Subject: Recall Z-0580-2019 — Leoni Fiber Opt: SmartScope Leoni Fiber Opt: SmartScope Hello, I own a Leoni Fiber Opt: SmartScope that is covered by recall Z-0580-2019 from Leoni Fiber Opt: SmartScope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
