Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes
Cardinal Health is recalling specific 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 956 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The affected products include various kits for robotic hysterectomy and C-section procedures, distributed nationwide in the United States.
The recall was initiated because the CliniClean Pericare Wipes within these trays 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 check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If you have these products, stop using them and contact Cardinal Health for instructions on return or disposal.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 956
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) PB41RHRM3
- UDI-DI: 10198956294219(each)
- 50198956294217(case)
- Lot Number: NGKU3049
- 2) PB41RHRM3
- Lot Number: NGKU4043
- 3) PB41RHRM4
- UDI-DI: 10197106968413(each)
- 50197106968411(case)
- Lot Number: NGKU4716
- 4) PLVMCS22G
- UDI-DI: 10198956198890(each)
- 50198956198898(case)
- Lot Number: NGKU0957
- 5) PLVMCS22G
- Lot Number: NGKU0856
- 6) PLVMCS22G
- 7) PLVMCS22G
- Lot Number: NGKU2052
- 8) PLVMCS22G
Distribution
Distributed nationwide across the United States.
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