Cardinal Health Recalls Kendall Blue Isolation Gowns Due to Defects
Cardinal Health is recalling Kendall Blue Isolation Gowns due to potential rips, holes, or foreign material that may compromise barrier protection.
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, and the defects (rips, holes, foreign material) represent a risk of reduced barrier protection without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Cardinal Health 200, LLC is recalling Kendall Blue Isolation Gowns (SKU CT5000) because of a potential for rips, holes, tears, incomplete or open seams, staining, or foreign material. These defects may compromise the gown's ability to provide minimal barrier protection against microorganisms, body fluids, and particulate material.
The recall affects 29,810,665 units distributed globally, including the United States (nationwide) and several international markets. The affected lot numbers range from 1901XXK to 2010XXK.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 29,810,665
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 (1)
- All lot numbers from 1901XXK to 2010XXK
Distribution
Part of a larger recall action
This product is one of 13 recalled by Cardinal Health 200, LLC 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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