Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to potential broken seals that compromise sterility.
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 infection from compromised sterility in a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Leoni Fiber Optics GmbH is recalling single-use laser fiber assemblies (LFS-365-RT) packaged in SmartScope single-box packaging. The recall is due to a potential defect where a percentage of the products may exhibit a broken package seal, which compromises the sterility of the device.
The source text notes that there have been two reports of compromised sterility. Because all products packaged in SmartScope single-box packaging are at risk of a compromised product seal, the entire distribution is affected. Broken seal pouches could increase the risk of infection if the devices are used in laser surgical procedures.
The affected products were distributed to the state of Ohio. The devices are intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in soft tissue applications. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-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)
- 096875 00816901020272
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
Same manufacturer · Leoni Fiber Optics GmbH
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 Broken Seals
FDA (Devices) · 2018-12-19
- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
FDA (Devices) · 2018-12-19
- SevereLeoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
FDA (Devices) · 2018-12-19
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