FDA-Device2022-04-20Class I
Cub 2 Enclosed Bed Canopy System
Sensory Medical Inc
Hazard
Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021.
Sold states
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
Affected count
225 devices
Manufactured in
3333 S Wadsworth Blvd Unit D321, N/A, Lakewood, CO, United States
Products
Cub 2 Enclosed Bed Canopy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2022Don't want to check this manually?
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