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
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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Model numbers and lot numbers: UDI-DI 00841436111058; Lot Numbers A228675, A228676, A233854, A268115, A268237, A272509, A277538, A280341. Part Number 667-151. Quantity: 18 units. Distribution: OH, PA, WA in the United States and China. Manufacturer: Civco Medical Instruments Co.
An error in inspection and programming of the eTRAX needle sensor may cause the needle tip position to be incorrectly identified on the user interface. This could lead to improper needle guidance during procedures.
No injuries or incidents have been reported.
1 Stop using the product. 2 Contact Civco Medical Instruments Co. Inc. or your healthcare provider for instructions. 3 Review the recall notice for additional steps and potential refunds or replacements. 4 If you are a facility, segregate affected devices and document the recall actions.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1733-2026. Manufacturer: Civco Medical Instruments Co. Inc. Address and phone not listed in this notice.
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