BEUDAMED
    FDA Enforcement Class II Terminated

    Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

    Recall: Z-2549-2019 · Reported October 2, 2019

    Enforcement

    Recall Number
    Z-2549-2019
    Event ID
    83681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 2, 2019
    Initiation Date
    August 8, 2018
    Classification Date
    September 20, 2019
    Termination Date
    April 29, 2021
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States

    Description

    Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758

    Reason

    The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.

    Code Info

    Model# M5072A; Lots #s Y070115-04 - Y011118-07;

    Distribution

    US: AK, AL,AR,AZ,CA,CO,CT,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV, WY, Argentina, Aruba, Australia, Austria, Belgium, Bolivia, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Egypt, El Salvador, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Malta, Martinique, Mauritius, Mexico, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Panama, Paraguay, Peru, Philippines, Poland, Puerto Rico, R¿union, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Viet Nam,

    Quantity

    181,894 Infant/Child SMART Pads Pads