Cardinal Health Recalls ChemoPlus Drug Spill Kits Due to Gown Defects
Cardinal Health is recalling ChemoPlus Drug 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, but the defects are cosmetic or minor quality issues (rips, stains) without reports of serious injury or hospitalization, fitting the Moderate criteria for minor defects.
Plain-English summary
Cardinal Health 200, LLC is recalling 137,346 units of the ChemoPlus Drug Spill Kit-INSTI (SKU DP5016K). The recall is due to quality control issues where the gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris.
The affected lots are 915019X, 915020X, 915021X, 915022X, 924422X, and 925174X. The products were distributed globally and nationwide in the United States.
This recall is classified as Class II by the FDA. Users should check their inventory for these specific lot numbers and contact Cardinal Health for further instructions.
The recalled product
- Product
- ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Spill Kits
- 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: 915019X 915020X 915021X 915022X 924422X 925174X
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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