Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Ex recall: Sterility Concern
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser…
Why was Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Ex 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
096876 00816901020289
- Product
- Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser…
- Recalling firm
- Leoni Fiber Optics GmbH
- Quantity
- N/A
- Distribution
- US Distribution to the state of: Ohio.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)