BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
This recall is currently active, issued May 30, 2025. It was issued by Civco Medical Instruments Co. Inc..
- Recall Initiated
- May 1, 2025
- Posted
- May 30, 2025
- Recall Number
- Z-1892-2025
- Quantity
- 506 boxes
- Firm Location
- Kalona, IA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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
Root Cause
Process design
Action Taken
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.