BEUDAMED
    FDA Enforcement Class II Terminated

    MiniCap Extended Life PD Transfer Set

    Recall: Z-0768-2021 · Reported January 13, 2021

    Enforcement

    Recall Number
    Z-0768-2021
    Event ID
    86883
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2021
    Initiation Date
    November 10, 2020
    Classification Date
    January 4, 2021
    Termination Date
    March 24, 2023
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    MiniCap Extended Life PD Transfer Set

    Reason

    Potential for no-flow and leaks under the twist clamp.

    Code Info

    Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025

    Distribution

    Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia

    Quantity

    72,771 units