Z-0918-2022 Class I Ongoing
FDA device recall Z-0918-2022 was initiated by Sensory Medical Inc on March 14, 2022 and is designated Class I. Reason for recall: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021. The recall status is ongoing. Affected quantity: 225 devices.
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.