BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0419-2018 · Initiated July 21, 2017

    Recall

    Recall Number
    Z-0419-2018
    Event Number
    78886
    Firm
    Stryker Medical Division of Stryker Corporation
    FEI Number
    1831750
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 21, 2017
    Terminated
    March 22, 2018
    Address
    3800 E Centre Ave, Portage, MI, 49002-5826

    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).

    Action

    Stryker notified customers of the recall by sending Customer Notification and Business Reply Forms, dated July 21, 2017.

    Distribution

    U.S.

    Quantity

    11160