Recall Z-0581-2019 ยท GEX Powered Laser Surgical Instrument
Leoni Fiber Optics GmbH
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, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have be
| Date | Oct 17, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | The firm, LEONI, notified its distributor of the product issue on 10/16/18 via phone call and a subsequent "URGENT: MEDICAL DEVICE RECALL" letter. The distributor was informed of the product issue, and asked to disseminate recall information to customers. Actions to be taken by the Customer/User: End users should discontinue usage of the product. Product should be immediately quarantined. The Distributor should complete the acknowledgement of receipt form, to arrange for replacement and or credit to their account. A Leoni Customer Service Representative shall contact you with a Return mater |
| Distribution | US Distribution to the state of: Ohio. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050738 | FT FIBER OPTIC DELIVERY SYSTEMS Fibertech GmbH, Jun 2, 2005 |