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U.S. Department of Health and Human Services

Class 2 Device Recall etouchus model no. ETMG01

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  Class 2 Device Recall etouchus model no. ETMG01 see related information
Date Initiated by Firm June 21, 2022
Create Date July 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1461-2022
Recall Event ID 90523
Product Classification System, test, blood glucose, over the counter - Product Code NBW
Product etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Code Information UDI-DI (GTIN): 00195893740581
Recalling Firm/
Manufacturer		 Touch US Llc
94 Lilac Ln
Paramus NJ 07652-5291
For Additional Information Contact Customer Service
888-670-9070
Manufacturer Reason
for Recall		 Device was marketed without FDA 510(k) clearance or a PMA.
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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