BEUDAMED
    FDA Enforcement Class II Terminated

    NEONATAL IV ACCESS SET

    Recall: Z-1090-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1090-2018
    Event ID
    79329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    October 23, 2017
    Classification Date
    March 17, 2018
    Termination Date
    June 21, 2018
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    NEONATAL IV ACCESS SET

    Reason

    Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

    Code Info

    IV4690 Lot codes: 2015111690 2016012590 2016040490 2016082990 2016111490 2017010990 2017013090 2017052990 2017080790

    Distribution

    Nationally

    Quantity

    N/A