BEUDAMED
    FDA Enforcement Class II Ongoing

    LIFEPAK 35 ECG cable REF 11111-000041

    Recall: Z-1102-2025 · Reported February 12, 2025

    Enforcement

    Recall Number
    Z-1102-2025
    Event ID
    96048
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2025
    Initiation Date
    January 21, 2025
    Classification Date
    February 5, 2025
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003, United States

    Description

    LIFEPAK 35 ECG cable REF 11111-000041

    Reason

    Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

    Code Info

    Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224

    Distribution

    U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.

    Quantity

    245 units