Civco eTRAX 12G starter kit may misreport needle tip position
Civco is recalling the eTRAX Needle System Starter Kit 12G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the displayed needle tip position may not match the actual position during a guided procedure, and no injuries are stated.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling the eTRAX Needle System Starter Kit 12G for Aurora Trackers, part number 667-149. Two units were distributed in Ohio, Pennsylvania and Washington, and to China. The FDA has classified this recall as Class II.
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.
Affected product carries UDI-DI 00841436111034 and lot A228672.
Facilities can identify affected kits by the part number, UDI and lot number above, and may contact Civco Medical Instruments Co. Inc. for further information.
The recalled product
- Product
- eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Hazard
- position-error
- navigation-error
- procedure-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00841436111034
- Lot Number: A228672
Distribution
Distributed in 3 states:
- OH
- PA
- WA
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