Recall Z-1461-2022
Touch US Llc · initiated June 21, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Codes / lots: UDI-DI (GTIN): 00195893740581
Reason for recall
Device was marketed without FDA 510(k) clearance or a PMA.
FDA-determined cause: No Marketing Application
Action taken
On June 21, 2022, the firm communicated the recall to customers who purchased the product through the company's website. The firm is also making an effort to recall the product that was sold through Amazon Marketplace. Customers should return any affected product to eTouch US LLC. The firm will provide a full refund of the original purchase cost to the customer when the recalled device is received from the customer. If you have any questions, please contact the firm Monday thru Friday, 9AM - 5PM Eastern Time: Support Team: 888-670-9070 Email: Support@etouchus.com
Details
- Recall number
- Z-1461-2022
- Initiated
- June 21, 2022
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 149
- Distribution
- US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
- Recalling firm
- Touch US Llc, Paramus, NJ