BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    Recall: Z-0889-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0889-2017
    Event ID
    75301
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    October 4, 2016
    Classification Date
    December 22, 2016
    Termination Date
    August 8, 2018
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    Reason

    Product sterility is compromised due to breach of the sterile barrier

    Code Info

    Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX

    Distribution

    Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom

    Quantity

    1,293,169 systems