CIVCO Sales Demo Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is limited to missing labeling on sales demo kits, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
CIVCO Medical Instruments Co., Inc. is voluntarily recalling 135 boxes of CIVCO Sales Demo Kits (REF DEMOGPGUIDE). The recall was initiated on November 2, 2018, and was terminated on November 20, 2020. The product is intended for use by CIVCO and customer sales representatives.
The recall was issued because some inventory brackets no longer have the product labeling. The affected items 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 affected products were distributed to sales representatives in the United States and foreign countries, including 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, which means the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
- Manufacturer
- CIVCO Medical Instruments Co., Inc.
- Category
- Medical Device — Sales Demo Kit
- Hazard
- Affected units
- 135
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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