FDA recall Z-1892-2025

Civco Medical Instruments Co. Inc. · Class II · device

Product

BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers

Reason for recall

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.

Distribution

OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

Key facts

Status: Ongoing
Initiation date: 2025-05-01
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Kalona, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2025