Device recall
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
- Recall number
- Z-3100-2026
- 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
- OGR
- Device type
- Ear, Nose, And Throat Surgical 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
- 61 units
- Code info
- 1) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 2) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 3) PEVMETB37, UDI-DI: 10198956212039(each), 50198956212037(case), Lot Number: NGKT2394
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States