BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.

    Recall: Z-1877-2021 · Reported June 23, 2021

    Enforcement

    Recall Number
    Z-1877-2021
    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 HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx.

    Reason

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

    Code Info

    GTIN 00763000314231, Lot numbers 220911913, Use By 2022-03-13; and 221249923, Use By 2022-10-01

    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

    18 tubing packs