Official recall notice
FDA Recall: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI
- Recall date
- 2026-09-09
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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
1) PBCGLVBLI, UDI-DI: 10198956055469(each), 50198956055467(case), Lot Number: GKU1823 ; 2) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 3) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 4) PB15HYFCY, UDI-DI: 10197106474877(each), 50197106474875(case), Lot Number: NGKW2883 ; 5) SMA4FTLSCA, UDI-DI: 10197106609880(each), 50197106609888(case), Lot Number: GKU1823