BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT

    Recall: Z-1061-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1061-2020
    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- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Code Info

    BSICVC1005A CVC DRESSING CHANGE KIT NICU 2018103090 BSIPICC1002A PICC DRESSING CHANGE KIT NICU 2019021390 BSIPICC1003A PICC DRESSING CHANGE KIT 2019041690, 2019030190

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    N/A