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

FDA device recall Z-1892-2025 · posted 2025-05-30 · Open, Classified

Recall details

Recalling firm

Civco Medical Instruments Co. Inc.

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.

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.

Root cause

Process design

Status

Open, Classified

Product code

ITX

Quantity affected

506 boxes

Distribution

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

Date initiated

2025-05-01

Date posted

2025-05-30

Location

Kalona, IA

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