BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

    Recall: Z-0512-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0512-2025
    Event ID
    95615
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 16, 2024
    Classification Date
    November 22, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644

    Reason

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

    Code Info

    Codes: 1) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case), Lot Numbers: 22GLA530, 23BLA921, 23DLA373, 23GLA522, 23ILA136, 23JLB217, 23KLA008; 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case), Lot Numbers: 21JLA366, 21JLA956, 21LLA271, 22CLA831, 22DLA301, 22DLB149, 22FLA103; 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case), Lot Numbers: 22FLA985, 23CLA104

    Distribution

    US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

    Quantity

    3006 units