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BX2 Needle Guide, Part Number 644-094, tool for performing… recallZ-1892-2025 · Civco Medical Instruments Co. Inc. · initiated May 1, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Civco Medical Instruments Co. Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process design

What the company is doing

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 [email protected]. 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 [email protected]. If you have any questions, call 319-248-6502 or email: [email protected].

Recall details

Recall number
Z-1892-2025
Status
Open, Classified
Initiated by the company
May 1, 2025
Posted by the FDA
May 30, 2025
Recalling firm
Civco Medical Instruments Co. Inc.
Quantity
506 boxes
Product code
ITX
FDA submissions
K093713
Distribution
OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and Denmark

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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