CIVCO Biopsy Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 73 boxes of Biopsy Brackets because some units lack required product labeling.
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 due to missing product labeling, which is a documentation and labeling issue rather than a direct physical hazard or contamination risk.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 73 boxes of CIVCO Biopsy Bracket, REF P03122-07. These are reusable, non-sterile, single-angle brackets designed for use with SonoSite L25 series transducers. The recall was initiated on November 2, 2018, and 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 any brackets in inventory that are missing their product labels.
The affected products were 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. The FDA classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Category
- Medical Device — Biopsy Bracket
- Hazard
- Affected units
- 73
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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