Cardinal Health 200, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ; 2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II 170032 ; 3) SMA4FTLSCA, Catalog Number: TLH PACK
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
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →