Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in no
Summary
The FDA issued a Class I for Walnut Wearable Smart Thermometer, intended for continuous chest temperature mon by BearCare, Inc.. Reason: There have been reports of skin burns to children wearing the device..
Details
Source
Device Recall
External ID
Z-1633-2023
Action Date
2023-06-14
Status
Terminated
Category
device
Product Description
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
Lot/Code Info: Lot Number 20221115W002
Quantity Affected: 1818 units
Reason for Recall
There have been reports of skin burns to children wearing the device.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-10
Company
Hauppauge, NY
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 139 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 (BearCare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BearCare, Inc. have FDA actions?
This is the only FDA action we have on record for BearCare, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1633-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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