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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