Civco Medical Instruments recalled 2 eTRAX Needle System Starter Kit 12G units for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The defect can cause the needle tip position to be incorrectly identified on the user interface. Stop using the device immediately and follow the recall instructions from Civco or your healthcare provider.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Civco Medical Instruments Co. Inc. or your healthcare provider for instructions
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The eTRAX Needle System Starter Kit 12G is used with Aurora Trackers in procedures requiring precise needle guidance. The kit is designed for clinicians in specialty settings.
A sensor error can cause incorrect needle tip position readings on the user interface, potentially affecting procedural accuracy and patient safety.
This recall is not presented as part of a broader industry pattern in the notice.
Clinicians may rely on needle tip position data displayed by the interface. Misidentification could lead to inaccurate needle placement or additional procedural risk.
Identifiers appear on the device label and packaging. The FDA recall page lists the official recall details.
Remedies are under manufacturer guidance. Process timelines often range from 4-6 weeks for refunds or replacements.
Keep recall notice, device labels showing Part Number 667-149, UDI-DI 00841436111034, Lot A228672, and all correspondence with Civco for records.
Part Number: 667-149. UDI-DI: 00841436111034. Lot Number: A228672. Quantity recalled: 2 units. Sold to healthcare providers in OH, PA, WA and China. Recall date: 2026-03-02. Status: ACTIVE.
No injuries or incidents have been reported.
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Five Civco Medical Instruments eTRAX Needle Sensor 12G units for Aurora Trackers are recalled in the United States. The recall cites an inspection and programming error that could misidentify the needle tip position on the user interface. Healthcare providers should stop using the device immediately and follow recall instructions.