FDA recall Z-0918-2022

Sensory Medical Inc · Class I · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2022-03-14
Report date
2022-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lakewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0918-2022