BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagno
Summary
The FDA issued a Class II for BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or cat by Civco Medical Instruments Co. Inc.. 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 tran.
Details
Source
Device Recall
External ID
Z-1892-2025
Action Date
2025-06-11
Status
Ongoing
Category
device
Product Description
BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
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
Quantity Affected: 506 boxes
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-01
Company
Kalona, IA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Civco Medical Instruments Co. Inc. has 16 FDA actions in our database, including 13 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Civco Medical Instruments Co. Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Civco Medical Instruments Co. Inc. have FDA actions?
Civco Medical Instruments Co. Inc. has 16 FDA actions in our database, including 13 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1892-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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