FDAClass IApril 20, 2022

Cub 2 Enclosed Bed Canopy System recall

Cub 2 Enclosed Bed Canopy System

Why was Cub 2 Enclosed Bed Canopy System recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.

Product
Cub 2 Enclosed Bed Canopy System
Recalling firm
Sensory Medical Inc
Quantity
225 devices
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
Recall date
April 20, 2022
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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