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Cardinal Health 200, LLC: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST , Catalog Number: P

Medical DevicesSource: FDA (device) · Date: 2026-09-09

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cardinal Health 200, LLC
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 / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-07-29
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
Product quantity
956 units
Voluntary mandated
Voluntary: Firm initiated
City
Waukegan
State
IL
Country
United States
Event id
99553
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