BEUDAMED
    FDA Enforcement Class III Terminated

    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

    Recall: Z-0745-2022 · Reported March 16, 2022

    Enforcement

    Recall Number
    Z-0745-2022
    Event ID
    89536
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 16, 2022
    Initiation Date
    January 13, 2022
    Classification Date
    March 10, 2022
    Termination Date
    May 19, 2023
    Address
    11811 Willows Rd Ne, N/A, Redmond, WA, 98052-2003, United States

    Description

    HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak

    Reason

    Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.

    Code Info

    GTIN/UDI: 05060167120695, Serial Number: 20D00009694

    Distribution

    U.S.: AK

    Quantity

    1