FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination

OTHERNationwide distributionMedical devices

What this means

Presource Packs containing CliniClean Pericare Wipes in BD Urinary Catheter Trays may contain manufacturing lubricant residue on the wipes. If used on a patient, the contaminated wipes could cause localized skin irritation, redness, or mild inflammation.

  • Check your urinary catheter trays for the affected catalog numbers: KIT BLO LAVH, KIT UMMC AB HYST II 170032, or TLH PACK.
  • Do not use the wipes if your product matches one of the affected lot numbers: GKU1823 or NGKW2883.
  • Contact Cardinal Health or your supplier for instructions on returning or replacing the affected packs.
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
175 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) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3103-2026

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