device · product 1 of 1
Cub 2 Enclosed Bed Canopy System
- Recall number
- Z-0918-2022
- Initiated
- March 14, 2022
- Classification
- Class I
- Status
- Ongoing
- Recalling firm
- Sensory Medical Inc
- Quantity
- 225 devices
App-derived interpretation
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Official device-enrichment evidence · Sourced
Labeling Change Control
Inspect official wording and provenance
Reason for recall
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Code information
Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.
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