BEUDAMED
    FDA Enforcement Class II Ongoing

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    Recall: Z-0838-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0838-2025
    Event ID
    95971
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NOA Medical Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    November 5, 2024
    Classification Date
    January 10, 2025
    Address
    801 Terry Ln, Washington, MO, 63090-3543, United States

    Description

    NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX

    Reason

    Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.

    Code Info

    UDI/DI 00817492012745, Serial Numbers: 2038043534, 2038042756, 2038042755, 2038042750, 2038042751, 2038042752, 2038042753, 2038042754, 2038042757, 2038042244, 2038041722, 2038038738, 2038038750, 2038038749, 2038038748, 2038038747, 2038038746, 2038038745, 2038038744, 2038038758, 2038038757, 2038038756, 2038038754, 2038038753, 2038038752, 2038038755, 2038038743, 2038038742, 2038038737, 2038038751, 2038038739, 2038038740, 2038038741, 2038038766.

    Distribution

    US: GA, MI. MA, CA

    Quantity

    34 units