BEUDAMED
    FDA Enforcement Class I Terminated

    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.

    Recall: Z-0186-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0186-2018
    Event ID
    78303
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Physio-Control, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    December 20, 2017
    Initiation Date
    October 27, 2017
    Classification Date
    December 12, 2017
    Termination Date
    June 12, 2019
    Address
    11811 Willows Rd NE, N/A, Redmond, WA, 98052-2003, United States

    Description

    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.

    Reason

    The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

    Code Info

    713609, 717912, 713904, 718033, 715008, 719323

    Distribution

    Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.

    Quantity

    14,219 units in total