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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The eTRAX Needle System Starter Kit is a medical device used with Aurora Trackers for needle guidance during procedures.
An error in inspection and programming of the needle sensor can cause the needle tip position to be misidentified on the user interface, potentially affecting accuracy during procedures.
This recall is not stated as part of a broader industry pattern in the notice.
Immediate cessation of use is required. The impact is procedural disruption and potential patient safety risk if the device is used.
Find UDI-DI on the device label or packaging. Lot numbers are printed on the product packaging or label.
Refunds or replacements are determined by Civco and may take weeks. Expect 4-6 weeks for processing.
Keep photos of the label, UDI-DI, lot numbers, and recall notices. Save email threads and recall notices.
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.
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 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.
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.