The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0576-2019·Announced 2018-12-19

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.

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, 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.

See all 15 products in this recall →

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