FDA-Device2026-09-09Class IIPROCESSING DEFECT
Cardinal Health CliniClean Pericare Wipes recalled for potential lubricant contamination in surgical kits
What this means
CliniClean Pericare Wipes included in certain Cardinal Health surgical catheter trays may contain residual lubricant from manufacturing. If used on a patient, these wipes could cause localized skin irritation, redness, or mild inflammation.
- Check your surgical kits against the affected lot numbers listed in the recall notice
- Do not use affected wipes on patients
- Contact your Cardinal Health representative for replacement wipes or kits
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
956 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, ROBOTIC HYST , Catalog Number: PB41RHRM3; 2) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM4; 3) KIT, C SECTION , Catalog Number: PLVMCS22G; 4) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 5) KIT, C SECTION MARTIN , Catalog Number: PL22CSMMI; 6) KIT, C SECTION OREGON HEALTH , Catalog Number: PL57CS60N; 7) C SECTION PACK , Catalog Number: SMAHBCSECB; 8) C SECTION PACK , Catalog Number: SMAHBCSEC3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3102-2026More Cardinal Health recalls
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for potential lubricant contamination
- FDA-Device2026-09-09Cardinal Health CliniClean Pericare Wipes in BD urinary catheter trays recalled for potential lubricant contamination
- FDA-Device2026-09-09Cardinal Health CliniClean Pericare Wipes in BD Urinary Catheter Trays recalled for lubricant contamination
- FDA-Device2026-09-09Cardinal Health Presource Packs with CliniClean Pericare Wipes recalled for manufacturing lubricant contamination
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