FDA-Device2026-09-09Class IIPROCESSING DEFECT

Cardinal Health BD Urinary Catheter Trays recalled for contaminated pericare wipes

OTHERNationwide distributionMedical devices

What this means

Cardinal Health BD Urinary Catheter Trays 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 if you have urinary catheter trays with Catalog Numbers PEVMETBJX or PEVMETB37, Lot Number NGKT2394
  • Do not use the CliniClean Pericare Wipes included in affected trays
  • Contact your Cardinal Health or BD representative for replacement wipes or trays
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
61 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, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3100-2026

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