Civco Medical Instruments recalled 6 units of the eTRAX Needle System Starter Kit 14G for Aurora Trackers distributed to medical facilities in Ohio, Pennsylvania and Washington. The recall stems from an inspection and programming error in the needle sensor. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall 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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The eTRAX Needle System Starter Kit 14G is used with Aurora Trackers for needle guidance in clinical settings. It is distributed to medical facilities and is part of Civco’s interventional tools.
A sensor inspection and programming error can misidentify the needle tip position on the user interface, potentially affecting procedural accuracy and safety.
This recall is not presented as part of a broader industry pattern in the notice.
The immediate impact is restricted access to six units. Clinicians must suspend use and verify device identifiers before any further action.
Check the FDA recall page linked in the notice for official guidance and instructions.
Remedy/recall timeline not specified in the notice.
Keep packaging, serial numbers, recall notification, and all communications for audit and potential insurance purposes.
Model numbers: Part Number 667-150. UDI-DI 00841436111041. Lot Number A228673. Sold to healthcare facilities in OH, PA and WA. Quantity recalled: 6 units. Country of origin: China. Price: Unknown.
No injuries or incidents have been reported.
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Civco Medical Instruments Co. is recalling 5 eTRAX Needle Sensor 14G units for Aurora Trackers. The recall cites a programming and inspection error that could cause the needle tip position to be misidentified on the user interface. Stop using the device immediately and contact Civco for instructions.
Civco Medical Instruments recalled 18 units of the eTRAX Needle System Starter Kit 16G for Aurora Trackers after an inspection and programming error could cause the needle tip position to be misidentified on the user interface. The defect could lead to incorrect needle guidance during a procedure. Healthcare providers and patients should stop using the device immediately and follow the recall ins
Civco Medical Instruments Co. recalled 21 eTRAX Needle Sensors for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The devices have an inspection and programming error that can cause the needle tip position to be misidentified on the user interface. Clinicians should stop using the devices immediately and follow recall instructions from Civco.