Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury (infection) has not yet been reported, but the hazard is significant due to compromised sterility.
Plain-English summary
Leoni Fiber Optics GmbH is recalling single-use laser fiber assemblies (LFS-272-RT-0.22NA-SMA905) packaged in SmartScope single-box packaging. The recall is due to a potential broken package seal, which compromises the sterility of the device. These laser peripherals are intended for use in laser surgical procedures for cutting, coagulating, or vaporizing soft tissue.
The FDA has received two reports of compromised sterility. However, the agency notes that all products packaged in SmartScope single-box packaging are at risk of a compromised product seal. If a device with a broken seal is used, it could increase the risk of infection.
The affected products were distributed in the state of Ohio. Users should check their inventory for the specific product codes 096874 and 00816901020265. If the package seal is broken, the device should not be used.
The recalled product
- Product
- Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting…
- Manufacturer
- Leoni Fiber Optics GmbH
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 096874 00816901020265
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Leoni Fiber Optics GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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See all →- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
FDA (Devices) · 2018-12-19
- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
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- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
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- SevereLeoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
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