Reported Dec 19, 2018 · Terminated
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label:…
Leoni Fiber Optics GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Leoni Fiber Optics GmbH · Muhldamm 6 · Neuhaus-Schierschnitz, N/A · N/A
Is this the product you have?
- Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve
- Silver-Sterile ETO- Private labelSU-200-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 NdYAG
- HoYAG, KTP and Diode lasers have been cleared
- Lot codes and dates
- 096874 00816901020265
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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 product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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