Recall Z-1461-2022— Touch US Llc
Class II · Ongoing
Class II FDA medical device recall by Touch US Llc, initiated 2022-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.. Reason: Device was marketed without FDA 510(k) clearance or a PMA..
- Recalling firm
- Touch US Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-21
- Firm location
- Paramus, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.