Civco Infiniti Needle Guide Bracket Recalled for Leak Testing Failure
Civco Medical Instruments is recalling Infiniti Needle Guide Brackets because a cover failed leak testing during validation of new needle guides.
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: The recall is classified as FDA Class II, and the source text describes a failure during validation testing without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Civco Medical Instruments Co. Inc. is recalling 177 boxes of CIVCO Infiniti Needle Guide Brackets. These products are used by physicians to perform needle-guided or catheter procedures with diagnostic ultrasound transducers.
The recall was initiated because a cover failed leak testing during validation testing of new needle guides from a replacement tool. The affected items include various biopsy starter kits and brackets for use with Esaote, Zonare, and BK Medical transducers.
The products were distributed worldwide, including in the United States and numerous international countries. No specific instructions for consumers are provided in the source text, but the recall is limited to the specific lot numbers and item codes listed in the agency record.
The recalled product
- Product
- CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter)…
- Manufacturer
- Civco Medical Instruments Co. Inc.
- Hazard
- Affected units
- 177
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)
- M664690
- M897110
- M119380
- M605540
- M706720
- M570610
- M543670
- M851530
- M983170
- M358570. M358570
- M427660. M526300
- M526300
- M734570
- M912740
- M103030
- A010473
- M771190
- M427390
- M293590
- M427370
Distribution
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