Z-1461-2022 Class II Ongoing
FDA device recall Z-1461-2022 was initiated by Touch US Llc on June 21, 2022 and is designated Class II. Reason for recall: Device was marketed without FDA 510(k) clearance or a PMA. The recall status is ongoing. Affected quantity: 149.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- June 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 149
Product Description
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Reason for Recall
Device was marketed without FDA 510(k) clearance or a PMA.
Distribution Pattern
US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Code Information
UDI-DI (GTIN): 00195893740581