Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I; 4) KIT, BLO BASIC OPEN HEART , Catalog Number
Check against the official notice below — it lists the full affected range.
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.
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. Distribution: US Nationwide distribution. Quantity: 2448 units Lot/code info: 1) PCVNCG540, UDI-DI: 10198956230057(each), 50198956230055(case), Lot Number: NGKT3319 ; 2) PCVNCG542, UDI-DI: 10198956312463(each), 50198956312461(case), Lot Number: NGKU0951 ; 3) PCVNCG55I, UDI-DI: 10197106283059(each), 50197106283057(case), Lot Number: NGKU0977 ; 4) PVCGBOB10, UDI-DI: 10198956219885(each), 50198956219883(case), Lot Number: NGKT2391 ; 5) PVCGBOB11, UDI-DI: 10198956220676(each), 50198956220674(case), Lot Number: NGKT2391 ; 6) PVCGBOB12, UDI-DI: 10198956256477(each), 50198956256475(case), Lot Number: NGKT2391 ; 7) PVCGBOB17, UDI-DI: 10198956393387(each), 50198956393385(case), Lot Number: NGKT2391 ; 8) PVCGOHCOH, UDI-DI: 10198956022270(each), 50198956022278(case), Lot Number: NGKT2391 ; 9) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 10) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 11) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKU0951 ; 12) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 13) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 14) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 15) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 16) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 17) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lo
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.