Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes
Cardinal Health is recalling 61 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, and the source text describes potential localized skin effects such as irritation and mild inflammation without reporting hospitalizations or severe injuries, fitting the Moderate severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 61 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The affected products are identified by Catalog Numbers PEVMETBJX and PEVMETB37, and are associated with Lot Number NGKT2394. The recall covers kits distributed nationwide in the United States.
The recall is being issued because the CliniClean Pericare Wipes contained in the trays may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These potential effects include irritation, erythema, or mild inflammation.
Healthcare facilities and consumers should stop using the affected products and contact Cardinal Health 200, LLC for further instructions on how to return or dispose of the items.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 61
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 (8)
- 1) PEVMETBJX
- UDI-DI: 10198956176041(each)
- 50198956176049(case)
- Lot Number: NGKT2394
- 2) PEVMETBJX
- 3) PEVMETB37
- UDI-DI: 10198956212039(each)
- 50198956212037(case)
Distribution
Distributed nationwide across the United States.
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