BX2 Needle Guide may develop transducer cover breach during attachment
Civco Medical Instruments is recalling BX2 Needle Guide, Part Number 644-094, because tight tolerance during attachment to the transducer can cause a pinhole breach in the transducer cover.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—a pinhole breach in the transducer cover—is a design/manufacturing defect that could affect device function, but the source text contains no reports of harm or hospitalization, making it a moderate-severity precautionary recall.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling the BX2 Needle Guide, Part Number 644-094, a tool used for performing needle-guided or catheter procedures with diagnostic ultrasound transducers. The recall affects 506 boxes with 68 lot numbers (A174424 through A260607).
The needle guide can cause a pinhole breach in the transducer cover when the guide is attached due to the tight tolerance and fit between the components during latching.
The affected product was distributed outside the United States to Japan, Taiwan, France, Georgia, Germany, and Denmark. The UDI-DI is 00841436120050.
Users with affected lot numbers should contact Civco Medical Instruments Co. Inc. for instructions on product return or replacement.
The recalled product
- Product
- BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Affected units
- 506
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 00841436120050
- Lot Numbers: A174424
- A176855
- A177208
- A182744
- A184023
- A185336
- A185337
- A186904
- A189734
- A190489
- A193623
- A194755
- A198716
- A198795
- A199940
- A200430
- A202208
- A203169
- A203201
Distribution
Distribution scope not specified by the agency.
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