Skip to content
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.

Field note

Send feedback

We'll only use this to respond to your feedback.