BEUDAMED
    FDA Recall Open, Classified

    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

    Recall: Z-1052-2026 · Initiated November 26, 2025

    Recall

    Recall Number
    Z-1052-2026
    Event Number
    98154
    FEI Number
    1417592
    Product Code
    OGR
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 26, 2025
    Posted
    January 12, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.

    Reason

    Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

    Action

    Medline issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/26/2025 via email and USPS first class mail. The notice explained the issue potential risk to the patient, and referred the consignee to the attached B Braun notice for further instructions. The B Braun notice provide "Interim Measures for Users" to provide for the continued use of the product. For questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    96 units