BEUDAMED
    FDA Enforcement Class I Terminated

    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.

    Recall: Z-2066-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2066-2019
    Event ID
    82940
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    May 3, 2019
    Classification Date
    August 12, 2019
    Termination Date
    March 1, 2021
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartridge, which is the subject of this recall, and the recalled BD Alaris Pump Infusion Set (RES#82951) Product Usage: The Vyaire enFlow Disposable Cartridges contain a heating element that is used to help raise or maintain a patient's body temperature.

    Reason

    The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to serious adverse events for patients due to the incomplete occlusion caused by variation in tubing wall thickness.

    Code Info

    Lots 2018090690 2018101190 2018101590 2018121190 2019013190 2019030490 2019040190

    Distribution

    One distributor located in Illinois.

    Quantity

    4,680 kits