BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0745-2022 · Initiated January 13, 2022

    Recall

    Recall Number
    Z-0745-2022
    Event Number
    89536
    Firm
    Physio-Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 13, 2022
    Terminated
    May 19, 2023
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    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.

    Action

    On 01/13/2022, Stryker telephoned the customer and informed them of the correction. The telephone call was followed up with a correction notice, mailed to the customer on 01/17/22, that informed the customer to contact Customer Service at 1 800 787 9537, option 2, 8:00 A.M. to 7:00 P.M. (Eastern Time), Monday - Friday or by email at [email protected] if they had questions or concerns.

    Distribution

    U.S.: AK

    Quantity

    1