BEUDAMED
    FDA Enforcement Class II Ongoing

    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    Recall: Z-1381-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1381-2024
    Event ID
    94030
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medivance Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2024
    Initiation Date
    February 16, 2024
    Classification Date
    March 26, 2024
    Address
    321 S Taylor Ave Unit 200, N/A, Louisville, CO, 80027-3600, United States

    Description

    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C

    Reason

    Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.

    Code Info

    REF/UDI-DI/Lot(Expiration Date): 31802/00801741132131/NGGX5390(31Oct2024), NGGX1179(31Oct2024), NGGX1156(31Oct2024), NGHP2415(28Feb2025), NGHP2411(28Feb2025), NGHT1139(31May2025), NGHTY603(31May2025), NGHV4383(31Jul2025), NGHW1507(31Aug2025); 3180202/10801741132138/NGGZ2622(31Dec2024), NGGV1829(31Aug2024), NGGW3254(30Sep2024), NGHQ2940(31Mar2025); 31802C/00801741223457/NGGV1784(31Aug2024)

    Distribution

    Worldwide - US Nationwide distribution including in the states of IL, AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Australia, Singapore, South Korea, Taiwan, Japan, China, Thailand.

    Quantity

    1,654