BEUDAMED
    FDA Recall Terminated

    Alcon Custom Pak

    Recall: Z-0053-2018 · Initiated August 8, 2017

    Recall

    Recall Number
    Z-0053-2018
    Event Number
    77965
    Firm
    Alcon Research, LTD. 9965 Buffalo Speedway
    FEI Number
    1000117501
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 8, 2017
    Posted
    August 25, 2017
    Terminated
    August 5, 2019
    Address
    Houston, TX, 77054-1309

    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.

    Action

    The medical user was sent a customer recall notification letter on 8/7/17. The medical user is requested to return the unused, affected Custom Paks to Alcon. Upon receipt and verification, Alcon will destroy the affected sponges in a controlled manner via physical destruction.

    Distribution

    States in the US - WI, NY, MO

    Quantity

    33 units