FDA-Device2025-06-11Class II
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Hazard
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.
Sold states
OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
Affected count
506 boxes
Manufactured in
102 1st St S, N/A, Kalona, IA, United States
Products
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2025More Civco Medical Instruments Co. Inc. recalls
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for inaccurate needle position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 18G recalled for incorrect position display
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle tip position display
- FDA-Device2026-04-08Civco eTRAX Needle Sensor 14G recalled for incorrect needle tip positioning
- FDA-Device2026-04-08Civco eTRAX Needle System Starter Kit recalled for incorrect needle position display
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