BEUDAMED
    FDA Enforcement Class I Ongoing

    Cub 2 Enclosed Bed Canopy System

    Recall: Z-0918-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0918-2022
    Event ID
    89707
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sensory Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 20, 2022
    Initiation Date
    March 14, 2022
    Classification Date
    April 14, 2022
    Address
    3333 S Wadsworth Blvd Unit D321, N/A, Lakewood, CO, 80227-5142, United States

    Description

    Cub 2 Enclosed Bed Canopy System

    Reason

    Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.

    Code Info

    Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.

    Distribution

    U.S. Nationwide distribution to states including: AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA. MD, MI, MN, MO. MS. NC, ND, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, and WI; and O.U.S Internationally to: Canada

    Quantity

    225 devices