[pending] eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Pending LLM rewrite. Source: FDA_DEVICE Z-1734-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Category
- Medical Device — Devices
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 (9)
- UDI-DI: 00841436111065
- Lot Number: A233347
- A228677
- A268116
- A268238
- A272513
- A279457
- A280388
- A281840
Distribution
Distributed in 3 states:
- OH
- PA
- WA
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