BEUDAMED
    FDA Enforcement Class II Terminated

    EVLP Convenience Pack/Kit

    Recall: Z-0358-2022 · Reported December 22, 2021

    Enforcement

    Recall Number
    Z-0358-2022
    Event ID
    88963
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 22, 2021
    Initiation Date
    October 27, 2021
    Classification Date
    December 10, 2021
    Termination Date
    April 5, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    EVLP Convenience Pack/Kit

    Reason

    NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.

    Code Info

    Model #: DYNJ901205C Lot #: 19HBE998 UDI: GTIN (01)40889942580607 EXP (17)2021-01-31 LOT (10)19HBE998

    Distribution

    US Nationwide distribution.

    Quantity

    28