BEUDAMED
    FDA Enforcement Class II Terminated

    Alcon Custom Pak

    Recall: Z-0053-2018 · Reported November 8, 2017

    Enforcement

    Recall Number
    Z-0053-2018
    Event ID
    77965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2017
    Initiation Date
    August 8, 2017
    Classification Date
    October 27, 2017
    Termination Date
    August 5, 2019
    Address
    9965 Buffalo Speedway, N/A, Houston, TX, 77054-1309, United States

    Description

    Alcon Custom Pak

    Reason

    Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

    Code Info

    2033459H, 2034186H, 2034491H

    Distribution

    States in the US - WI, NY, MO

    Quantity

    33 units