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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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.
An inspection and programming error in the eTRAX needle sensor could cause the needle tip position to be incorrectly identified on the user interface, potentially affecting device operation.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by Civco Medical Instruments Co. Inc. 3. Contact Civco Medical Instruments Co. Inc. or your healthcare provider for instructions. 4. Refunds or replacements, if available, will be handled per the manufacturer’s recall guidance. Refer to the FDA recall page for details.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1735-2026. Manufacturer contact details are not listed in the provided information.
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