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Recall Observatory FDA recall evidence

Device product

Cub 2 Enclosed Bed Canopy System

Z-0918-2022

March 14, 2022

Class I

Product summary

Firm
Sensory Medical Inc
Event
Event 89707
Status
Ongoing
Classification
Class I
Quantity
225 devices
Official record key
device-enforcement:Z-0918-2022

Official wording

Reason: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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