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FDA (Device enforcement)Recalled 2026-07-29class ii

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

Is my product affected?

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 SE

  • UPC 10198956294219
  • UPC 50198956294217
  • UPC 10197106968413
  • UPC 50197106968411
  • UPC 10198956198890
  • UPC 50198956198898
  • UPC 10195594952600
  • UPC 50195594952608
  • UPC 10198956457553
  • UPC 50198956457551
  • UPC 10197106889848
  • UPC 50197106889846
  • UPC 10197106958926
  • UPC 50197106958924
  • UPC 10198956267183
  • UPC 50198956267181

Check against the official notice below — it lists the full affected range.

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.

Details from the source

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. Distribution: US Nationwide distribution. Quantity: 956 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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