[pending] BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures wi
Pending LLM rewrite. Source: FDA_DEVICE Z-1892-2025.
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
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
The recalled product
- Product
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
- 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 (20)
- UDI-DI: 00841436120050
- Lot Numbers: A174424
- A176855
- A177208
- A182744
- A184023
- A185336
- A185337
- A186904
- A189734
- A190489
- A193623
- A194755
- A198716
- A198795
- A199940
- A200430
- A202208
- A203169
- A203201
Distribution
Distribution scope not specified by the agency.
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