BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

    Recall: Z-1460-2025 · Reported April 2, 2025

    Enforcement

    Recall Number
    Z-1460-2025
    Event ID
    96368
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 2, 2025
    Initiation Date
    February 6, 2025
    Classification Date
    March 26, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

    Reason

    Devices may have higher than expected amounts of bacterial endotoxin.

    Code Info

    401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528;

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.

    Quantity

    74 units