Cub 2 Enclosed Bed Canopy System

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

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 First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future.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].