BEUDAMED
    FDA Enforcement Class II Ongoing

    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

    Recall: Z-1950-2021 · Reported June 30, 2021

    Enforcement

    Recall Number
    Z-1950-2021
    Event ID
    87864
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    EHOB, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 30, 2021
    Initiation Date
    April 19, 2021
    Classification Date
    June 24, 2021
    Address
    250 N Belmont Ave, N/A, Indianapolis, IN, 46222-4265, United States

    Description

    Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort. Product Code: 1025ECP

    Reason

    Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates

    Code Info

    Lot Number: 105013A

    Distribution

    US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.

    Quantity

    70 units