Summary
The FDA issued a Class II for etouchus, model no. ETM-G01. Noninvasive Blood glucose meter. by Touch US Llc. Reason: Device was marketed without FDA 510(k) clearance or a PMA..
Details
Source
Device Recall
External ID
Z-1461-2022
Action Date
2022-08-03
Status
Ongoing
Category
device
Product Description
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Lot/Code Info: UDI-DI (GTIN): 00195893740581
Quantity Affected: 149
Reason for Recall
Device was marketed without FDA 510(k) clearance or a PMA.
Distribution
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-21
Company
Paramus, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Touch US Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Touch US Llc have FDA actions?
This is the only FDA action we have on record for Touch US Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1461-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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