Cardinal Health Recalls Urinary Catheter Trays with Contaminated Wipes
Cardinal Health is recalling 115 units of urinary catheter trays containing CliniClean Pericare Wipes that may be contaminated with 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, which aligns with the criteria for moderate severity involving low-risk contamination or minor labeling/quality errors without reports of serious injury.
Plain-English summary
Cardinal Health 200, LLC is recalling 115 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The affected products include specific kits for robotics and video thoracoscopy, identified by catalog numbers PGOCRDNHD, PG36RPEAB, and PVCGVTACF. The recall covers units distributed nationwide in the United States.
The recall was initiated because the CliniClean Pericare Wipes within 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, including irritation, erythema, or mild inflammation.
Healthcare facilities and consumers should stop using the affected products and contact Cardinal Health for further instructions or a refund.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 115
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 (13)
- 1) PGOCRDNHD
- UDI-DI: 10198956057012(each)
- 50198956057010(case)
- Lot Number: NGKV3390
- 2) PG36RPEAB
- UDI-DI: 10198956225091(each)
- 50198956225099(case)
- Lot Number: NGKU2052
- 3) PVCGVTACF
- UDI-DI: 10195594816568(each)
- 50195594816566(case)
- Lot Number: NGKV3487
- 4) PVCGVTACF
Distribution
Distributed nationwide across the United States.
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