- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Affected products (lot / model / serial)
- 1) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390 ; 2) PG36RPEAB, UDI-DI: 10198956225091(each), 50198956225099(case), Lot Number: NGKU2052 ; 3) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487 ; 4) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487
- Units affected
- 115 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Waukegan, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3097-2026
- Recall initiated
- July 29, 2026
- FDA classification date
- September 3, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99553
- Last updated on HTM Vibe
- September 15, 2026