BEUDAMED
    FDA Enforcement Class II Ongoing

    Craftmatic Model 1 Base for Dual Bed Configurations

    Recall: Z-1499-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1499-2022
    Event ID
    89765
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Craftmatic Industries, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2022
    Initiation Date
    March 24, 2017
    Classification Date
    August 4, 2022
    Address
    3580 Gateway Dr, N/A, Pompano Beach, FL, 33069-4847, United States

    Description

    Craftmatic Model 1 Base for Dual Bed Configurations

    Reason

    A potential for dual-configured beds to separate or slip away from one another.

    Code Info

    4AM663, 4AM669, 4AR391, 4AR445, 4AR797, 4AR790, 4AR795

    Distribution

    US Nationwide distribution - product was not distributed outside of the United States

    Quantity

    N/A