FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health CliniClean Pericare Wipes in BD urinary catheter trays recalled for manufacturing lubricant contamination

Nationwide distributionMedical devices

What this means

CliniClean Pericare Wipes included in certain BD urinary catheter trays may contain residual manufacturing lubricant. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

  • Check if you have Cardinal Health Presource Packs with CliniClean Pericare Wipes (Catalog Number PWV2MF01D, Lot NGKV3390).
  • Do not use affected wipes on patients.
  • Contact your supplier or Cardinal Health for instructions on replacement or return.
The agency's original wording
Hazard

The Urinary Catheter Trays contain CliniClean Pericare Wipes which 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. These may include irritation, erythema, or mild inflammation.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
60 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3099-2026

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