BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

    Recall: Z-0570-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0570-2022
    Event ID
    89327
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 16, 2022
    Initiation Date
    January 7, 2022
    Classification Date
    February 8, 2022
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449

    Reason

    Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.

    Code Info

    All lot numbers within expiry

    Distribution

    Worldwide

    Quantity

    23,940 units