Device recall
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO MAJOR SPINE , Catalog Number: POV2SCCPP; 2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI
- Recall number
- Z-3105-2026
- Event id
- 99553
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Report date
- Sep 9, 2026
- Posted
- Sep 3, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Sep 3, 2026
- Product code
- OJH
- Device type
- Orthopedic Tray
- Reason
- 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.
- Root cause
- Process change control
- Quantity
- 44 units
- Code info
- 1) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390 ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States