Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects
Cardinal Health is recalling Chembloc Preparation and Administration 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, but the defects (rips, holes, debris) are quality control issues without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health 200, LLC is recalling 137,346 units of the CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K. The recall affects Lot 911609X, which was distributed globally and nationwide in the United States.
The recall was initiated because the gowns included in these kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris. These defects may compromise the integrity of the protective barrier intended for use during chemotherapy preparation and administration.
Healthcare facilities and consumers who have this specific product should stop using it and contact Cardinal Health for further instructions or a return.
The recalled product
- Product
- CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
- Manufacturer
- Cardinal Health 200, LLC
- 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)
- Lot: 911609X
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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