Cardinal Health Recalls Urinary Catheter Trays with Potentially Contaminated Wipes
Cardinal Health is recalling 2,448 urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.
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 explicitly states that the potential harm is limited to localized skin effects (irritation, erythema, mild inflammation) and does not report any hospitalizations or serious injuries, fitting the Moderate criteria for low-risk contamination.
Plain-English summary
Cardinal Health 200, LLC is recalling 2,448 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The recall covers 56 specific catalog numbers, including kits for open heart, cardiac, and thoracic procedures, distributed nationwide in the United States.
The recall was initiated because the CliniClean Pericare Wipes included in these trays may be contaminated with a lubricant used during the manufacturing process. The source text does not report any illnesses or injuries associated with this contamination.
If a contaminated wipe is used on a patient, localized skin effects may occur. These potential effects include irritation, erythema (redness), or mild inflammation. Healthcare facilities and consumers should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice and stop using the affected products.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,448
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 (20)
- 1) PCVNCG540
- UDI-DI: 10198956230057(each)
- 50198956230055(case)
- Lot Number: NGKT3319
- 2) PCVNCG542
- UDI-DI: 10198956312463(each)
- 50198956312461(case)
- Lot Number: NGKU0951
- 3) PCVNCG55I
- UDI-DI: 10197106283059(each)
- 50197106283057(case)
- Lot Number: NGKU0977
- 4) PVCGBOB10
- UDI-DI: 10198956219885(each)
- 50198956219883(case)
- Lot Number: NGKT2391
- 5) PVCGBOB11
- UDI-DI: 10198956220676(each)
- 50198956220674(case)
- 6) PVCGBOB12
Distribution
Distributed nationwide across the United States.
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