Class IIDeviceOngoing

Cardinal Health 200, LLC

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF

Reason for recall

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.

Details

Recall number: Z-3097-2026
Event ID: 99553
Recall initiated: Jul 29, 2026
Classified: Sep 3, 2026
Reported: Sep 9, 2026
Quantity: 115 units
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waukegan, IL, United States
Lot / code info: 1) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390 ; 2) PG36RPEAB, UDI-DI: 10198956225091(each), 50198956225099(case), Lot Number: NGKU2052 ; 3) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487 ; 4) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487