BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

    Recall: Z-1432-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1432-2026
    Event ID
    98319
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2026
    Initiation Date
    January 5, 2026
    Classification Date
    February 20, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214

    Reason

    Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

    Code Info

    1) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBS147; 2) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25CBJ329; 3) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 25ABU209; 4) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBJ364; 5) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 24DBB718; 6) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23JBV524; 7) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBU998; 8) POD14214, UDI-DI: 10889942819362(each), 40889942819363(case), Lot Number: 23IBF119

    Distribution

    Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.

    Quantity

    1640 units