Cub 2 Enclosed Bed Canopy System

Company

Sensory Medical Inc

Recall Initiated

March 14, 2022

Recall Number

Z-0918-2022

Quantity

225 devices

Firm Location

Lakewood, CO

Reason for Recall

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

Lot / Code Info

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

Root Cause

Labeling Change Control

Action Taken

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 First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future.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