Civco Medical Instruments Co. Inc.: Device Recall
Recall #Z-1892-2025 · 05/01/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1892-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Civco Medical Instruments Co. Inc.
- Status
- Ongoing
- Date Initiated
- 05/01/2025
- Location
- Kalona, IA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 506 boxes
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.
Product Description
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
Distribution Pattern
OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.