BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY CVI4395A NICU PICC INSERTION KIT CVI4395A NICU PICC INSERTION KIT CVI4565 NEONATAL PICC TRAY

    Recall: Z-1044-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1044-2020
    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 Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY CVI4395A NICU PICC INSERTION KIT CVI4395A NICU PICC INSERTION KIT CVI4565 NEONATAL PICC TRAY

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Code Info

    Kit Code Product Lot Number CVI2310 NEONATAL PICC INSERTION TRAY 2018122190 CVI2550 NEONATAL PICC INSERTION TRAY 2019061190 CVI2550 NEONATAL PICC INSERTION TRAY 2019020190 CVI2550 NEONATAL PICC INSERTION TRAY 2019010490 CVI2550 NEONATAL PICC INSERTION TRAY 2018101190

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    957