BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.

    Recall: Z-1895-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1895-2021
    Event ID
    87915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 23, 2021
    Initiation Date
    April 29, 2021
    Classification Date
    June 16, 2021
    Termination Date
    March 20, 2023
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.

    Reason

    Specific lots may have been manufactured with insufficient or incomplete welds.

    Code Info

    GTIN 00643169947436, Lot number 221387901, Use By 2022-12-16

    Distribution

    US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.

    Quantity

    7 tubing sets