Cardinal Health Recalls Presource Packs with Potentially Contaminated Wipes
Cardinal Health 200, LLC is recalling 846 Presource Packs containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant, posing a risk of localized skin irritation.
What this means for you
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 potential localized skin effects (irritation, erythema, mild inflammation) without reports of hospitalization or serious injury, fitting the Moderate severity criteria for low-risk contamination or minor labeling/quality errors.
Plain-English summary
Cardinal Health 200, LLC is recalling 846 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The recall involves specific kits, including GYN Robotic, Liver Transplant Support, and General Major kits, distributed nationwide in the United States.
The recall is due to the potential presence of a lubricant used during the manufacturing process on the CliniClean Pericare Wipes. 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 recall notice. Affected products should be removed from use and returned to Cardinal Health 200, LLC for credit or replacement.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC GSAM , Catalog Number: PBCCGRSGD; 2) KIT, GYN ROBOT ACCESSORY , Catalog Number: PB35GYBJC; 3) KIT, PRIMARY RESECTION , Catalog Number: PGVMOTBB19;
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 846
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) PBCCGRSGD
- UDI-DI: 10197106840085(each)
- 50197106840083(case)
- Lot Number: NGKU0957
- 2) PB35GYBJC
- UDI-DI: 10197106375723(each)
- 50197106375721(case)
- Lot Number: NGKU2052
- 3) PGVMOTBB19
- UDI-DI: 10198956264113(each)
- 50198956264111(case)
- Lot Number: NGKT2394
- 4) PGVM07C26
- UDI-DI: 10198956264434(each)
- 50198956264432(case)
- 5) PGVM07C27
- UDI-DI: 10198956292895(each)
- 50198956292893(case)
- 6) PGV2LTNHN
- UDI-DI: 10198956292499(each)
Distribution
Distributed nationwide across the United States.
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