FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health Presource Packs with CliniClean wipes recalled for potential lubricant contamination

OTHERNationwide distributionMedical devices

What this means

Urinary catheter trays in certain Cardinal Health Presource Packs contain CliniClean Pericare Wipes that may have been contaminated with lubricant from manufacturing. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

  • Check if you have affected trays (Catalog Numbers POV2SCCPP or PWVMFFABLI, Lot Numbers NGKV3390 or NGKT2394)
  • Do not use the CliniClean Pericare Wipes from affected trays on patients
  • Contact Cardinal Health or your supplier 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
44 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, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3105-2026

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