Civco eTRAX 14G starter kit may misreport needle tip position
Civco is recalling the eTRAX Needle System Starter Kit 14G for Aurora trackers because an inspection and programming error may cause the needle tip position to be incorrectly identified.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 14G for Aurora Trackers, part number 667-150. About 6 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 is identified by part number 667-150.
Facilities can identify affected kits by the part number above, and may contact Civco Medical Instruments Co. Inc. for further information.
The recalled product
- Product
- eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Affected units
- 6
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: 00841436111041
- Lot Number: A228673
Distribution
Part of a larger recall action
This product is one of 8 recalled by Civco Medical Instruments Co. Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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