BEUDAMED
    FDA Enforcement Class II Terminated

    Endoscopic Introducer/Extractor

    Recall: Z-2538-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2538-2017
    Event ID
    77217
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2017
    Initiation Date
    April 25, 2017
    Classification Date
    June 14, 2017
    Termination Date
    March 26, 2019
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    Description

    Endoscopic Introducer/Extractor

    Reason

    reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

    Code Info

    All lots Catalog numbers: J-EIE-051500

    Distribution

    The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

    Quantity

    46