Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes
Cardinal Health is recalling 19 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
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 source text describes only mild, localized skin effects (irritation, erythema) without reports of hospitalization or significant injury, fitting the Moderate criteria for low-risk contamination.
Plain-English summary
Cardinal Health 200, LLC is recalling 19 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The specific product is the KIT, LUNG TX CIRCULATOR, Catalog Number OVC3507231, Lot Number NGKU0957. These products were distributed nationwide in the United States.
The recall was initiated because the CliniClean Pericare Wipes may be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, it may cause localized skin effects, including irritation, erythema, or mild inflammation.
Healthcare facilities and consumers should stop using the affected wipes and contact Cardinal Health for further instructions or a return.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 19
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 (4)
- 1) OVC3507231
- UDI-DI: 10198956232457(each)
- 50198956232455(case)
- Lot Number: NGKU0957
Distribution
Distributed nationwide across the United States.
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