Leoni Fiber Optics recalls laser fiber assemblies with potential broken seals that could compromise sterility and increase infection risk during surgery. Affected products shipped in Smartscope single-box packaging may need replacement.
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 certain laser fiber assemblies used in surgical procedures because some packages may have broken seals, which could lead to infection if used. This risk applies to products sold in Smartscope single-box packaging.
The products may have broken seals that compromise sterility. If the seal is broken, the assembly could become contaminated and increase the risk of infection during surgery.
Surgical staff and hospitals using the recalled laser fiber assemblies for procedures like cutting or coagulating soft tissue. Those handling the products in Smartscope single-box packaging are most at risk.
Check for the product name 'Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO' with the private label 'SU-550-RT' in Smartscope single-box packaging.
Inspect the packaging for a broken seal; if broken, do not use the product.
Reach out to Leoni Fiber Optics for guidance on next steps if the seal appears compromised.
The recall is due to a potential broken seal in some packages that could compromise sterility and increase infection risk during surgery.
Look for the product name 'Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO' with the private label 'SU-550-RT' in Smartscope single-box packaging.
Do not use the product if the seal is broken; contact Leoni Fiber Optics for further instructions.
We’ve drafted a message you can send Leoni Fiber Optics to request your refund or repair — edit it as you like.
Subject: Recall Z-0579-2019 — Leoni Fiber Optics Leoni Fiber Optics Hello, I own a Leoni Fiber Optics that is covered by recall Z-0579-2019 from Leoni Fiber Optics. 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.
