BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725

    Recall: Z-2189-2023 · Reported July 26, 2023

    Enforcement

    Recall Number
    Z-2189-2023
    Event ID
    92466
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2023
    Initiation Date
    May 18, 2023
    Classification Date
    July 20, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725

    Reason

    Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    Code Info

    all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840214P, UDI/DI (EA) 10193489443196, UDI/DI (CS) 40193489443197; b) Model Number DYNJ82725, UDI/DI (EA) 10195327207380, UDI/DI (CS) 40195327207381

    Distribution

    Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

    Quantity

    316 units