BEUDAMED
    FDA Recall 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 · Initiated October 4, 2016

    Recall

    Recall Number
    Z-0889-2017
    Event Number
    75301
    Firm
    Medtronic
    FEI Number
    1219930
    Product Code
    FEI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 4, 2016
    Terminated
    August 8, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    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

    Action

    Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked. Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878.

    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