Cardinal Health Recalls Surgical Kits with Potentially Contaminated Wipes
Cardinal Health is recalling 645 surgical kits 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 the hazard as causing localized skin effects like irritation and mild inflammation, which aligns with the rubric for moderate severity involving low-risk contamination or reversible adverse health consequences.
Plain-English summary
Cardinal Health 200, LLC is recalling 645 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The affected products include various surgical kits such as Craniotomy, Major Spine, and Neuro Trauma packs, 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 stop using these products immediately and contact Cardinal Health for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM; 2) KIT, ORP MAJOR SPINE , Catalog Number: PNHDFSVCI; 3) KIT,ORP NEURO TRAUMA , Catalog Number: PNHDOTVCQ…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 645
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) PNCGCNAUM
- UDI-DI: 10197106894316(each)
- 50197106894314(case)
- Lot Number: NGKT2391
- 2) PNCGCNAUM
- Lot Number: NGKT2455
- 3) PNHDFSVCI
- UDI-DI: 10198956143470(each)
- 50198956143478(case)
- Lot Number: NGKU1022
- 4) PNHDFSVCI
- 5) PNHDOTVCQ
- UDI-DI: 10198956143777(each)
- 50198956143775(case)
- 6) PNHDOTVCQ
- 7) PNHDOTVCQ
- 8) PNV20101L
- UDI-DI: 10198956285217(each)
- 50198956285215(case)
- Lot Number: NGKV3390
Distribution
Distributed nationwide across the United States.
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