Recall Z-1892-2025 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Co. Inc.
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
| Date | May 30, 2025 (initiated May 1, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/1/25 was sent to customers. Actions to be taken by the Customer/User: CIVCO requests that you check your inventory for any BX2 Needle Guides and complete the supplied response letter for the appropriate action. Please contact your distribution partner to return any existing inventory or report its destruction by completing the attached response form. Please complete the enclosed response form even if you do not have any BX2 Needle Guides remaining in your inventory to assist in our reconciliation process. Response forms can also b |
| Quantity | 506 boxes |
| Distribution | OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM Civco Medical Instruments, Jan 19, 2010 |