BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

    Recall: Z-0882-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0882-2022
    Event ID
    89672
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 4, 2022
    Classification Date
    April 6, 2022
    Address
    22100 Bothell Everett Hwy, Bothell, WA, 98021-8431, United States

    Description

    Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only FOR USE WITH HEARSTART DEFIBRILLATORS

    Reason

    There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.

    Code Info

    ALL LOTS

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam.

    Quantity

    331,712 UNITS