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Laser Fiber Assy-Single Use-LF… recallZ-0579-2019 · Leoni Fiber Optics GmbH · initiated Oct 17, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Leoni Fiber Optics GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Packaging

What the company is doing

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 material Authorization. If a replacement order is needed please inform customer service at the time of RMA issuance. - Discontinue usage if packaging irregularities exist - Return RMA units to Leoni Fiber Optics Inc. - Inform Customer Service if replacement product is required. - Complete acknowledge form and return back to Leoni Fiber Optics Inc. Attention Roger West, LFOI Quality Manager, [email protected] If you have any questions, please contact Quality Manager at 757-258-4805 or Email: [email protected].

Recall details

Recall number
Z-0579-2019
Status
Terminated
Initiated by the company
Oct 17, 2018
Recalling firm
Leoni Fiber Optics GmbH
Product code
GEX
FDA submissions
K050738
Distribution
US Distribution to the state of: Ohio.

Product description

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 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 been cleared.

Code information (models, lots, serial numbers)

096876 00816901020289

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K050738 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 81519).

Sources and updates

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