BEUDAMED
    FDA Enforcement Class II Terminated

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    Recall: Z-2427-2021 · Reported September 15, 2021

    Enforcement

    Recall Number
    Z-2427-2021
    Event ID
    88361
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 15, 2021
    Initiation Date
    July 16, 2021
    Classification Date
    September 3, 2021
    Termination Date
    May 12, 2023
    Address
    22100 Bothell Everett Hwy, N/A, Bothell, WA, 98021-8431, United States

    Description

    Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator

    Reason

    Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient

    Code Info

    Lot Y111220-01

    Distribution

    Worldwide distribution. US Nationwide, Australia, Austria, Bolivia, Canada, Chile, China, Denmark, France, French Polynesia, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Republic of Korea, Malta, Martinique, Mexico, Monaco, Netherlands, Norway, Poland, Spain, Switzerland, Taiwan, United Kingdom, and Uruguay

    Quantity

    19,840 units