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

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

  • Check your stock for affected lot number NGKV3390 (Catalog Number PBOCGLN17).
  • Do not use the contaminated wipes on patients.
  • Contact your Cardinal Health supplier or the FDA for instructions on return or replacement.
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
36 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,GYN LAPAROSCOPY DH , Catalog Number: PBOCGLN17

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3094-2026

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