Leoni recalls laser fiber sleeves with potential broken seals that could compromise sterility and increase infection risk during surgery. Affected items were sold in Smartscope single-box packaging.
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 is recalling laser fiber sleeves that may have broken seals, which could lead to infection if used. This risk applies to products sold in Smartscope single-box packaging.
Broken seals in the packaging can compromise sterility, meaning the sleeves might not be sterile when used. This could increase infection risk during surgical procedures if the sleeves are used without proper sterility.
Surgical staff using these laser fiber sleeves for procedures like cutting or coagulating tissue are most at risk. Patients undergoing surgery with compromised sterility could face infection.
Check for the product name 'Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO' in Smartscope single-box packaging. The product was sold with the private label 'SU-200-RT' and has specific serial numbers.
Inspect the packaging for a broken seal pouch, which may indicate compromised sterility.
Yes, all products packaged in Smartscope single-box packaging are at risk of a broken seal.
A broken seal pouch compromises sterility, meaning the sleeves might not be sterile when used, potentially increasing infection risk during surgery.
If you find a broken seal, do not use the product and contact Leoni for guidance.
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-0577-2019 — Leoni Fiber Optics Leoni Fiber Optics Hello, I own a Leoni Fiber Optics that is covered by recall Z-0577-2019 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.
