BEUDAMED
    FDA Enforcement Class II Terminated

    Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.

    Recall: Z-2640-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2640-2020
    Event ID
    85870
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EHOB, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 29, 2020
    Initiation Date
    June 9, 2020
    Classification Date
    July 17, 2020
    Termination Date
    January 25, 2021
    Address
    250 N Belmont Ave, N/A, Indianapolis, IN, 46222-4265, United States

    Description

    Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve pressure at bony prominences while the unique venting holes allow for air circulation to keep patients cool, dry and comfortable.

    Reason

    QC inspection observed that a portion of the lot may have been contaminated with blood.

    Code Info

    Lot 93649FA

    Distribution

    US Nationwide distribution.

    Quantity

    173