BEUDAMED
    FDA Enforcement Class II Ongoing

    Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100

    Recall: Z-2100-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2100-2020
    Event ID
    84656
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cardinal Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    December 26, 2019
    Classification Date
    May 22, 2020
    Address
    7000 Cardinal Pl, N/A, Dublin, OH, 43017-1091, United States

    Description

    Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100

    Reason

    The feeding spike sets may leak at the interface of the tube and spike connector.

    Code Info

    All

    Distribution

    Worldwide distribution.

    Quantity

    114,731, 290 total units