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.
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 Sensor is a component used with Aurora Trackers in medical settings. It is subject to regulatory oversight as a medical device.
A defect from inspection and programming could misrepresent needle tip position on the user interface, potentially affecting clinical decisions.
This recall is not described as part of a broader industry pattern.
Patients may experience incorrect readings that could impact treatment decisions. The immediate risk is mitigated by stopping use and following recall instructions.
Labeling on the device and packaging; FDA recall page linked in the article
Not specified by the recall
Keep recall notice, packaging, serial numbers, and correspondence with Civco for records
Part Number: 667-156. UDI-DI: 00841436111072. Lot Number: A276634. Quantity: 5 units. Distribution: OH, PA, WA. Country of origin: China. Manufacturer: Civco Medical Instruments Co.
No injuries or incidents have been reported.
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