Class IIDeviceOngoing

Cardinal Health 200, LLC

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 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-3102-2026
Event ID: 99553
Recall initiated: Jul 29, 2026
Classified: Sep 3, 2026
Reported: Sep 9, 2026
Quantity: 956 units
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waukegan, IL, United States
Lot / code info: 1) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU3049 ; 2) PB41RHRM3, UDI-DI: 10198956294219(each), 50198956294217(case), Lot Number: NGKU4043 ; 3) PB41RHRM4, UDI-DI: 10197106968413(each), 50197106968411(case), Lot Number: NGKU4716 ; 4) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 5) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0856 ; 6) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU0957 ; 7) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 8) PLVMCS22G, UDI-DI: 10198956198890(each), 50198956198898(case), Lot Number: NGKU2052 ; 9) PL22CSMMI, UDI-DI: 10195594952600(each), 50195594952608(case), Lot Number: NGKU0129 ; 10) PL22CSM13, UDI-DI: 10198956457553(each), 50198956457551(case), Lot Number: NGKU0129 ; 11) PL57CS60N, UDI-DI: 10197106889848(each), 50197106889846(case), Lot Number: NGKU2052 ; 12) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: NGKU4716 ; 13) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: NGKU4716 ; 14) SMAHBCSECB, UDI-DI: 10197106958926(each), 50197106958924(case), Lot Number: 20251217 ; 15) SMAHBCSEC3, UDI-DI: 10198956267183(each), 50198956267181(case), Lot Number: NGKU2887