FDAClass IIApril 8, 2026

eTRAX Needle System Starter Kit recall

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Why was eTRAX Needle System Starter Kit recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00841436111065; Lot Number: A233347, A228677, A268116, A268238, A272513, A279457, A280388 , A281840

Product
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Recalling firm
Civco Medical Instruments Co. Inc.
Quantity
20 units
Distribution
US States: OH, PA, WA. China.
Recall date
April 8, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls