CIVCO Needle Guide Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 3 boxes of Needle Guide Brackets because some units lack required product labeling. The recall covers specific lot numbers and inventory without labels.
What this means for you
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to missing labeling, which fits the criteria for moderate severity involving minor labeling errors or voluntary precautionary actions without reported harm.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 3 boxes of CIVCO Needle Guide Brackets, REF 674-057-10. These are reusable, non-sterile brackets used with FUJIFILM SonoSite, Inc. L25 series transducers. The recall was initiated on November 2, 2018, and was classified as Class II by the FDA. The recall was terminated on November 20, 2020.
The reason for the recall is that some brackets in inventory no longer have the product labeling. The affected units include boxes with lot numbers between A000012-A050663, M000880-M995980, and P022503, as well as all brackets in inventory that no longer have the product labeling. The firm notified customers via letter.
The product was distributed to Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, China, Colombia, Croatia, Cyprus, Denmark, Estonia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad/Tobago, Turkey, Ukraine, United Arab Emirates, and the United Kingdom. Users should check their inventory for these specific lot numbers or missing labels and stop using affected units.
The recalled product
- Product
- CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Hazard
- Affected units
- 3
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 (4)
- Boxes with lot numbers between A000012-A050663
- M000880-M995980
- and P022503
- and all brackets in inventory that no longer have the product labeling.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by CIVCO Medical Instruments Co., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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