Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device with compromised sterility, which poses a significant risk of infection. This aligns with the rubric for 'Severe' severity, which includes significant injury reports or high-risk medical device defects.
Plain-English summary
Leoni Fiber Optics GmbH is recalling specific sterile laser fiber assemblies intended for use in laser surgical procedures. The affected products are packaged in Smartscope single-box packaging and were distributed to the state of Ohio. The recall is due to a potential broken package seal, which compromises the sterility of the device.
The source text notes that a percentage of the products shipped in this packaging may exhibit a broken seal. Two reports of compromised sterility have been identified, but all products in this specific packaging are considered at risk. Using a device with a compromised seal could increase the risk of infection for the patient.
Consumers and healthcare facilities should stop using the affected laser fiber assemblies immediately. The recalling firm is Leoni Fiber Optics GmbH. The product is identified by the code 096975 00816901020326.
The recalled product
- Product
- Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label 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)
- 096975 00816901020326
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 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
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