Civco Medical Instruments recalled 20 eTRAX Needle System Starter Kit 18G for Aurora Trackers. An error in inspection and programming of the needle sensor can cause needle tip position to be misidentified on the user interface. Healthcare providers and facilities should stop using the device immediately and follow the recall instructions from the manufacturer.
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 18G is used with Aurora Trackers for needle-based procedures. It is a Class II medical device in the recall.
An error in inspection and programming of the needle sensor may cause the needle tip position to be misidentified on the user interface, potentially affecting procedure accuracy.
This recall is not described as part of a broader industry pattern.
20 units across OH, PA, WA and China are affected. Immediate stop-use is required. Providers should follow recall instructions to determine replacement or refund actions.
Identify labels on the device and packaging for UDI-DI and lot numbers.
No processing timeline is provided in the recall notice.
Save recall notice, packaging, serial/lot numbers, photos of labels, and all correspondence with Civco or providers.
Model numbers and identifiers include UDI-DI 00841436111065; Lot numbers A233347, A228677, A268116, A268238, A272513, A279457, A280388, A281840. Part Number 667-152. Distribution: Ohio, Pennsylvania, and Washington in the United States, plus China. Quantity: 20 units.
No injuries or incidents have been reported.
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Civco Medical Instruments recalled 10 eTRAX Needle Sensor 16G units for Aurora Trackers. An inspection and programming error 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 2 eTRAX Needle System Starter Kit 12G units for Aurora Trackers sold to healthcare providers in Ohio, Pennsylvania and Washington. The defect can cause the needle tip position to be incorrectly identified on the user interface. Stop using the device immediately and follow the recall instructions from Civco or your healthcare provider.
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.