Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects
Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.
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, and the defects (rips, holes, foreign material) represent a potential failure of barrier protection without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Cardinal Health 200, LLC is recalling Kendall Blue L isolation gowns and lab coats (SKUs CT5100, CT5101) because of potential manufacturing defects. The recall covers approximately 29.8 million units distributed globally, including the United States and several international markets.
The affected products may contain rips, holes, tears, incomplete or open seams, staining, or foreign material. These defects could compromise the gowns' ability to provide minimal barrier protection against microorganisms and body fluids for healthcare patients and personnel.
Healthcare facilities and consumers should stop using the affected gowns and contact Cardinal Health for instructions on return or replacement. The recall includes all lot numbers from 1901XXK to 2010XXK.
The recalled product
- Product
- Gown Kendall Blue L, SKU CT5100, CT5101 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…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Isolation Gowns
- 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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