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Moderate riskFDA DeviceClass II

Cardinal Health CliniClean Pericare Wipes recalled for potential lubricant contamination in surgical kits

CliniClean Pericare Wipes included in certain Cardinal Health surgical catheter trays may contain residual lubricant from manufacturing. If used on a patient, these wipes could cause localized skin irritation, redness, or mild inflammation.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Check your surgical kits against the affected lot numbers listed in the recall notice
  2. Do not use affected wipes on patients
  3. Contact your Cardinal Health representative for replacement wipes or kits
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults

This recall covers 12 products — see all of them.

Details

Units affected
956 units
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Classification
Class II
Recall number
Z-3102-2026

In the FDA's words

Description
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 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. 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 Distribution: US Nationwide distribution. Affected quantity: 956 units
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.

12 products in this recall

Cardinal Health catheter trays recalled for possible contamination

Cardinal Health is recalling 12 procedure kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes. The wipes may be contaminated with a lubricant used during manufacturing. If a contaminated wipe is used on a patient, it may cause localized skin irritation, redness, or mild inflammation. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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