Civco Medical Instruments recalled 10 eTRAX Needle Sensor 16G units for Aurora Trackers. An inspection and programming error could cause the needle tip position to be misidentified on the user interface. Stop using the device immediately and contact Civco for instructions.
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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- Part Number: 667-158 - Product: eTRAX Needle Sensor - 16G for Aurora Trackers - UDI-DI: 00841436111096 - Lot Numbers: A276636, A282454 - Distribution: Ohio, Pennsylvania, Washington, and China - Recall Date: 2026-03-02 - Manufacturer: Civco Medical Instruments - Units Recalled: 10 - Status: Active (FDA recall page referenced)
There was an error in inspection and programming of the eTRAX needle sensor. The defect could cause the needle tip position to be incorrectly identified on the user interface.
No injuries or incidents have been reported.
1) Stop using the product. 2) Follow the recall instructions provided by Civco Medical Instruments or your healthcare provider. 3) Contact Civco Medical Instruments Co. for instructions on remediation. 4) Do not dispose of the device until directed. 5) For refunds or replacements, follow the manufacturer’s recall guidance and contact information.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1737-2026
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