Recall Z-1461-2022 ยท NBW System, Test, Blood Glucose, Over The Counter
Touch US Llc
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
| Date | Jun 21, 2022 |
| Status | Open, Classified |
| Reason | Device was marketed without FDA 510(k) clearance or a PMA. |
| Root cause | No Marketing Application |
| Action | 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.