BEUDAMED
    FDA Enforcement Class II Terminated

    Left Atrial Catheter Set

    Recall: Z-0965-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0965-2018
    Event ID
    79195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 13, 2017
    Classification Date
    March 9, 2018
    Termination Date
    October 23, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Left Atrial Catheter Set

    Reason

    Label does not state that the product is heparin-coated.

    Code Info

    Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS

    Distribution

    Nationally

    Quantity

    56