Cardinal Health Recalls ChemoPlus Chemo Prep and Admin Kits
Cardinal Health is recalling ChemoPlus Chemo Prep & Admin Kits because the included gowns may have defects like 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. The hazard involves physical defects in protective gowns (rips, holes, foreign material) which pose a risk of exposure to hazardous drugs or contamination, but no specific injuries or illnesses are reported in the source text, fitting the criteria for moderate severity.
Plain-English summary
Cardinal Health 200, LLC is recalling 137,346 units of the ChemoPlus Chemo Prep & Admin Kit, model CT4025. The recall is limited to Lot 923184X. The product was 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 protective barrier intended for use during chemotherapy preparation and administration.
Healthcare facilities and consumers who have this specific lot of the ChemoPlus Chemo Prep & Admin Kit should stop using the product and contact Cardinal Health for instructions on return or replacement.
The recalled product
- Product
- ChemoPlus" Chemo Prep & Admin Kit, CT4025
- 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: 923184X
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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