Class 1 Device Recall Cubby Bed

• Date Initiated by Firm: March 14, 2022
• Create Date: April 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0918-2022
• Recall Event ID: 89707
• Product Classification: Patient bed with canopy/restraints - Product Code OYS
• Product: Cub 2 Enclosed Bed Canopy System
• Code Information: Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.
• Recalling Firm/ Manufacturer: Sensory Medical Inc; 3333 S Wadsworth Blvd Unit D321; Lakewood CO 80227-5142
• For Additional Information Contact: Caleb Polley; 855-964-2664
• Manufacturer Reason for Recall: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
• FDA Determined Cause: Labeling Change Control
• 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 First, locate the old/outdated product/user manuals from wherever it has been placed/stored. Destroy and discard this outdated product/user manuals in such a fashion so that it cannot be used in the future.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 Hello@cubbybeds.com.
• Quantity in Commerce: 225 devices
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.