BEUDAMED
    FDA Recall Terminated

    Endoscopic Introducer/Extractor

    Recall: Z-2538-2017 · Initiated April 25, 2017

    Recall

    Recall Number
    Z-2538-2017
    Event Number
    77217
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 25, 2017
    Terminated
    March 26, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Endoscopic Introducer/Extractor

    Reason

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

    Action

    On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.

    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