FDAHealthMarch 2, 2026
Civco Medical Instruments Co. Inc. — eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
⚠️ There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Is this relevant to me?
- Geography
- US, OH, PA, WA
- Source agency
- FDA
- Category
- Health
- Published
- March 2, 2026
US States: OH, PA, WA. China.
What's affected?
- Product
- eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- Lot code
- A233347
Additional details
UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.
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