Cardinal Health Recalls Presource Packs with Potentially Contaminated Wipes
Cardinal Health 200, LLC is recalling 1,398 Presource Packs containing CliniClean Pericare Wipes that may be contaminated with a manufacturing lubricant.
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 FDA classified this as a Class II recall, and the source text describes the potential harm as 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 1,398 units of Presource Packs containing CliniClean Pericare Wipes within BD Urinary Catheter Trays. The recall covers specific kits used for gynecological and robotic surgeries, including catalog numbers such as PBCGRGB28, PBVMLP22G, and PBVM0722D. The products were 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. 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 the affected products and check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28; 2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: PBVMLP22G; 3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D;
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,398
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) PBCGRGB28
- UDI-DI: 10198956432567(each)
- 50198956432565(case)
- Lot Number: GKU1823
- 2) PBVMLP22G
- UDI-DI: 10198956123854(each)
- 50198956123852(case)
- Lot Number: NGKU2052
- 3) PBVM0722D
- UDI-DI: 10198956124134(each)
- 50198956124132(case)
- Lot Number: NGKU0856
- 4) PBVM0722D
- Lot Number: NGKU0957
- 5) PBVM0722D
- 6) PBVM0722D
- 7) PBV2MJMVH
- UDI-DI: 10198956285248(each)
- 50198956285246(case)
- Lot Number: NGKV3390
Distribution
Distributed nationwide across the United States.
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