BEUDAMED
    FDA Enforcement Class II Terminated

    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿

    Recall: Z-0271-2018 · Reported December 27, 2017

    Enforcement

    Recall Number
    Z-0271-2018
    Event ID
    78664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 27, 2017
    Initiation Date
    October 16, 2017
    Classification Date
    December 20, 2017
    Termination Date
    June 24, 2020
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿

    Reason

    Hydrogel peeling from the pads.

    Code Info

    Product Code: 31705 Lot # NGBS1063

    Distribution

    US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY

    Quantity

    24