Summary
The FDA issued a Class I for Cub 2 Enclosed Bed Canopy System by Sensory Medical Inc. Reason: Due potential misuse of the product, firm is updating warnings and precautions booklet for products distributed before December 16, 2021..
Details
Source
Device Recall
External ID
Z-0918-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
Cub 2 Enclosed Bed Canopy System
Lot/Code Info: Model/Product Code - Cub2 UDI Code: None Serial Numbers: All device manufactured/distributed prior to 12/16/2021.
Quantity Affected: 225 devices
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-14
Company
Lakewood, CO
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Sensory Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sensory Medical Inc have FDA actions?
This is the only FDA action we have on record for Sensory Medical Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0918-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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