BEUDAMED
    FDA Enforcement Class II Ongoing

    DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

    Recall: Z-0984-2025 · Reported January 29, 2025

    Enforcement

    Recall Number
    Z-0984-2025
    Event ID
    96015
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Perfusion Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2025
    Initiation Date
    December 12, 2024
    Classification Date
    January 17, 2025
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States

    Description

    DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)

    Reason

    Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

    Code Info

    Model 77008 UDI-DI: 20763000091105, Lot Numbers: 2024010723, 202404C049; Model 77014 UDI-DI: 20763000091136, Lot Number: 2023121097

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    745 units