BEUDAMED
    FDA Enforcement Class II Terminated

    MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

    Recall: Z-0419-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0419-2018
    Event ID
    78886
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Medical Division of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    July 21, 2017
    Classification Date
    January 27, 2018
    Termination Date
    March 22, 2018
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826, United States

    Description

    MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM

    Reason

    It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).

    Code Info

    LOT #(s): 1640002, 1645003

    Distribution

    U.S.

    Quantity

    11160