Class 2 Device Recall BX2 Needle Guide

• Date Initiated by Firm: May 01, 2025
• Date Posted: May 30, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1892-2025
• Recall Event ID: 96814
• 510(K)Number: K093713
• Product Classification: Transducer, ultrasonic, diagnostic - Product Code ITX
• Product: BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
• Code Information: UDI-DI: 00841436120050; Lot Numbers: A174424, A176855, A177208, A182744, A184023, A185336, A185337, A186904, A189734, A190489, A193623, A194755, A198716, A198795, A199940, A200430, A202208, A203169, A203201, A203520, A205457, A207901, A208740, A211619, A212291, A213027, A215531, A216885, A217412, A220102, A221365, A221925, A225145, A226800, A228446, A228778, A229092, A229898, A230045, A230054, A230549, A230581, A231101, A231810, A232903, A233075, A233535, A236538, A238767, A239339, A239355, A240873, A240931, A241445, A242018, A242161, A243263, A243264, A245342, A245527, A246173, A248520, A248572, A250325, A252513, A252842, A254080, A254081, A254900, A254955, A255332, A257534, A258150, A258926, A260607
• FEI Number: 1937223
• Recalling Firm/ Manufacturer: Civco Medical Instruments Co. Inc.; 102 1st St S; Kalona IA 52247-9589
• For Additional Information Contact: Jim Leong; 319-248-6502
• Manufacturer 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.
• FDA Determined 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 be sent via email to distorder@civco.com. Type of Action by the Company: This notice is being communicated to all customers who have purchased a BX2 Needle Guide from affected lots. CIVCO requests you provide this notification to the appropriate personnel within your facility. If the affected product was distributed outside of your organization, please notify those locations down to the medical facility level. PLEASE SEND COMPLETED RESPONSE FORM to email to distorder@civco.com. If you have any questions, call 319-248-6502 or email: James.Leong@civco.com.
• Quantity in Commerce: 506 boxes
• Distribution: OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ITX