Cardinal Health Recalls Kendall Spill Kits Due to Gown Defects
Cardinal Health is recalling Kendall Spill Kits because the included gowns may have rips, holes, or foreign material.
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 quality issue that could compromise product function, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling 137,346 units of Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K. The recall affects lots 916197X, 916881X, 919683X, 920354X, 924620X, 928728X, and 931205X. The products were distributed globally and nationwide in the United States.
The recall was initiated because the gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris. These defects may compromise the integrity of the spill containment equipment.
Consumers and healthcare facilities should stop using the affected spill kits and contact Cardinal Health 200, LLC for instructions on returning the products or obtaining replacements.
The recalled product
- Product
- Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Spill Control
- Affected units
- 137,346
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)
- Lots: 916197X 916881X 919683X 920354X 924620X 928728X 931205X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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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