Z-0918-2022 Class I Ongoing

Recalled by Sensory Medical Inc — Lakewood, CO

Recall Details

Product Type
Devices
Report Date
April 20, 2022
Initiation Date
March 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
225 devices

Product Description

Cub 2 Enclosed Bed Canopy System

Reason for Recall

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

Distribution Pattern

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

Code Information

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