BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990

    Recall: Z-1079-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1079-2020
    Event ID
    84530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 11, 2019
    Classification Date
    February 5, 2020
    Termination Date
    September 4, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Code Info

    Product-Lot Code: GR100150ST GRADUATED PITCHER STERILE 1000 CC 2018121090 GR1200ST STERILE 1200CC PITCHER KIT 2019031990

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    N/A