Recall Z-3102-2026— Cardinal Health 200, LLC

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..

Recalling firm

Cardinal Health 200, LLC

Classification

Class II

Status

Ongoing

Initiated

2026-07-29

Firm location

Waukegan, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.