BEUDAMED
    FDA Enforcement Class II Terminated

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    Recall: Z-1241-2019 · Reported May 8, 2019

    Enforcement

    Recall Number
    Z-1241-2019
    Event ID
    82450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Medical Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 8, 2019
    Initiation Date
    November 8, 2017
    Classification Date
    April 26, 2019
    Termination Date
    September 2, 2020
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

    Reason

    Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.

    Code Info

    Catalog Number / lot number a) Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602 b) Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603 c) Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604 d) Intrepid ArcticGel Universal Pad, 31700I / NGAXY601 e) ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040 f) ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021 g) ArcticGel X-Small Pad, 31703 / h) ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519 i) ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513 j) ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515 k) ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521 m) ArcticGel Large Pad Kit, 31709 / n) ArcticGel Large Pad Kit, 2-pack, 3170902 / o) ArcticGel Small Universal Pad Kit, 31810 / NGBP1534 p) ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712 r) ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Argentina, Australia, Canada, Saudi Arabia, South Korea, Singapore, Thailand, and Chile

    Quantity

    7526 units