BEUDAMED
    FDA Enforcement Class II Terminated

    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

    Recall: Z-1460-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1460-2018
    Event ID
    79713
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 25, 2018
    Initiation Date
    March 22, 2018
    Classification Date
    April 19, 2018
    Termination Date
    May 13, 2020
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.

    Reason

    Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.

    Code Info

    All lots

    Distribution

    Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.

    Quantity

    132