BEUDAMED
    FDA Recall Open, Classified

    Cub 2 Enclosed Bed Canopy System

    Recall: Z-0918-2022 · Initiated March 14, 2022

    Recall

    Recall Number
    Z-0918-2022
    Event Number
    89707
    Firm
    Sensory Medical Inc
    FEI Number
    3020824629
    Product Code
    OYS
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    March 14, 2022
    Address
    3333 S Wadsworth Blvd, Unit D321, Lakewood, CO, 80227-5142

    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.

    Action

    On 03/14/2022, the firm, CUBBY, initiated calling its customers to inform them of an "URGENT-VOLUNTARY MEDICAL DEVICE CORRECTION" associated with Cubby Beds distributed between 02/24/2020 thru 12/16/2021 and the potential for the risk of misuse and possible entrapment. Between 03/15-16/2022, the firm mailed an URGENT VOLUNTARY MEDICAL DEVICE CORRECTION" Letter along with the updated Warnings & Precautions Booklet and new Product/User manuals. The Customer Notification Letter instructed customers to: 1. Identify/Locate Affected Product. Check their records and make sure that it is in fact a unit impacted by this voluntary medical device correction. 2. Add/Secure the Warning & Precautions Booklet to the Cubby Bed. 3. Locate, Remove, Destroy, and Update/Replace the Old Cubby Bed Product/User Manuals. First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future. Next, locate the updated product/user manuals that were provided with this Voluntary Medical Device Correction. Place and/or store these product/user manuals in an area close to/near the bed so they are readily available for use as needed. Ensure that anyone who provides patient care understands the content of these product/user manuals and knows where to find/locate them when needed. 5. Ensure Completion of All Steps & Completion of the Hardcopy or Online Verification Form. Double check and verify that all the steps outlined within the Steps for Voluntary Medical Device Correction have been properly completed/addressed. Should you have any questions or concerns about this correspondence, please contact, John Sawyer, Vice-President, Quality Assurance and Regulatory Affairs at (855) 964-2664 or email at [email protected].

    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