Device recall
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: PVCGBOB10; 5) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 6) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB12; 7) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB17; 8) KIT, OPEN HEART CON , Catalog Number: PVCGOHCOH; 9) KIT,OPEN HEART ADULT MDST , Catalog Number: PVCGOHCPA; 10) KIT, CABG , Catalog Number: PVHDCBAGK; 11) KIT, ORP CABG , Catalog Number: PVHDCGVCP; 12) KIT, ORP CABG , Catalog Number: PVHDCGV40; 13) KIT, VALVE , Catalog Number: PVHDVAAGH; 14) KIT, ORP VALVE , Catalog Number: PVHDVPVCQ; 15) KIT, ORP VALVE , Catalog Number: PVHDVPV43; 16) KIT, MAJOR CARDIAC , Catalog Number: PVOCMGJ36; 17) KIT, OPEN HEART DH , Catalog Number: PVOCOHNHE; 18) KIT, OPEN HEART , Catalog Number: PVOCOH12O; 19) KIT, CAROTID ENDARTERECTOMY , Catalog Number: PVVMCV07E; 20) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP22R; 21) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP245; 22) KIT, THORACIC BARNES JEWISH , Catalog Number: PVVMTH22J; 23) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO22R; 24) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO241; 25) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO242; 26) KIT, THORACIC , Catalog Number: PVVXTHLCG; 27) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10R; 28) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10S; 29) KIT, MAJOR VASC, PRESBYTERIAN , Catalog Number: PVV2MJ01M; 30) KIT, CARDIAC VALVE , Catalog Number: PVV207962; 31) KIT, CARDIAC VALVE , Catalog Number: PVV207963; 32) KIT, CARDIAC VALVE , Catalog Number: PVV207964; 33) KIT, CARDIAC CABG , Catalog Number: PVV293340; 34) KIT, CARDIAC CABG , Catalog Number: PVV293362; 35) KIT, CARDIAC CABG , Catalog Number: PVV293363; 36) KIT, PUH CARDIAC CABG , Catalog Number: PVX4CAP14; 37) KIT, PUH CARDIAC , Catalog Number: PVX4CRPR7; 38) KIT, EAS THORACIC ABDOMINAL , Catalog Number: PVX4THEAA; 39) KIT, CV , Catalog Number: PV15CGSPF; 40) KIT, CV , Catalog Number: PV15CGSPG; 41) KIT,MAJOR VASCULAR , Catalog Number: PV15MJSPD; 42) KIT, OPEN HEART SET UP , Catalog Number: PV24OHN29; 43) KIT, OPEN HEART , Catalog Number: PV29OHMME; 44) KIT, OPEN HEART , Catalog Number: PV3LOHSGJ; 45) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMYB; 46) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMY3; 47) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR47; 48) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR48; 49) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR49; 50) KIT, OPEN HEART , Catalog Number: PV40OHJUD; 51) KIT, MODULE OPEN HEART , Catalog Number: PV60OH15F; 52) CV W AUX PACK 2 OF 2 CMC , Catalog Number: SCVCGPAACD; 53) THORACIC ROBOTIC PACK CMC , Catalog Number: SCVCGTRACI; 54) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG17; 55) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG18; 56) CV PACK 2 OF 2 SHER , Catalog Number: SCVCGVCS16
- Recall number
- Z-3098-2026
- 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
- OEZ
- Device type
- Cardiovascular Procedure Kit
- 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
- 2448 units
- 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), Lot Number: NGKW2687 ; 18) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 19) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 20) PVHDCGV40, UDI-DI: 10198956326941(each), 50198956326949(case), Lot Number: NGKV2393 ; 21) PVHDVAAGH, UDI-DI: 10197106946459(each), 50197106946457(case), Lot Number: NGKT2391 ; 22) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 23) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 24) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 25) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 26) PVHDVPV43, UDI-DI: 10198956354838(each), 50198956354836(case), Lot Number: NGKW2687 ; 27) PVOCMGJ36, UDI-DI: 10198956248663(each), 50198956248661(case), Lot Number: NGKT2391 ; 28) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 29) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 30) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2455 ; 31) PVOCOH12O, UDI-DI: 10198956202054(each), 50198956202052(case), Lot Number: NGKT2391 ; 32) PVVMCV07E, UDI-DI: 10198956179615(each), 50198956179613(case), Lot Number: NGKT2394 ; 33) PVVMFP22R, UDI-DI: 10198956179653(each), 50198956179651(case), Lot Number: NGKT2394 ; 34) PVVMFP245, UDI-DI: 10198956249141(each), 50198956249149(case), Lot Number: NGKT2394 ; 35) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 36) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0957 ; 37) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 38) PVVMTO22R, UDI-DI: 10198956161016(each), 50198956161014(case), Lot Number: NGKT2394 ; 39) PVVMTO241, UDI-DI: 10198956221741(each), 50198956221749(case), Lot Number: NGKT2394 ; 40) PVVMTO242, UDI-DI: 10198956300521(each), 50198956300529(case), Lot Number: NGKT2394 ; 41) PVVXTHLCG, UDI-DI: 10198956170759(each), 50198956170757(case), Lot Number: NGKT1789 ; 42) PVV2CC10R, UDI-DI: 10198956285262(each), 50198956285260(case), Lot Number: NGKV3390 ; 43) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV3390 ; 44) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV2390 ; 45) PVV2MJ01M, UDI-DI: 10198956285224(each), 50198956285222(case), Lot Number: NGKV3390 ; 46) PVV207962, UDI-DI: 10198956212503(each), 50198956212501(case), Lot Number: NGKT2391 ; 47) PVV207963, UDI-DI: 10198956244245(each), 50198956244243(case), Lot Number: NGKT2455 ; 48) PVV207964, UDI-DI: 10198956255142(each), 50198956255140(case), Lot Number: NGKT2391 ; 49) PVV293340, UDI-DI: 10198956218451(each), 50198956218459(case), Lot Number: NGKT2391 ; 50) PVV293362, UDI-DI: 10198956240605(each), 50198956240603(case), Lot Number: NGKT2391 ; 51) PVV293363, UDI-DI: 10198956248007(each), 50198956248005(case), Lot Number: NGKT2391 ; 52) PVX4CAP14, UDI-DI: 10198956258921(each), 50198956258929(case), Lot Number: NGKU1994 ; 53) PVX4CRPR7, UDI-DI: 10198956244894(each), 50198956244892(case), Lot Number: NGKU1994 ; 54) PVX4THEAA, UDI-DI: 10197106795033(each), 50197106795031(case), Lot Number: NGKU4043 ; 55) PVX4THEAA, UDI-DI: 10197106795033(each), 50197106795031(case), Lot Number: NGKU4716 ; 56) PV15CGSPF, UDI-DI: 10197106847046(each), 50197106847044(case), Lot Number: NGKU0977 ; 57) PV15CGSPF, UDI-DI: 10197106847046(each), 50197106847044(case), Lot Number: NGKU0951 ; 58) PV15CGSPG, UDI-DI: 10198956324992(each), 50198956324990(case), Lot Number: NGKT3319 ; 59) PV15CGSPG, UDI-DI: 10198956324992(each), 50198956324990(case), Lot Number: NGKU0951 ; 60) PV15MJSPD, UDI-DI: 10197106847190(each), 50197106847198(case), Lot Number: NGKT3319 ; 61) PV15MJSPD, UDI-DI: 10197106847190(each), 50197106847198(case), Lot Number: NGKU0977 ; 62) PV24OHN29, UDI-DI: 10198956266315(each), 50198956266313(case), Lot Number: NGKU0977 ; 63) PV29OHMME, UDI-DI: 10198956042827(each), 50198956042825(case), Lot Number: NGKT3319 ; 64) PV29OHMME, UDI-DI: 10198956042827(each), 50198956042825(case), Lot Number: NGKU0977 ; 65) PV3LOHSGJ, UDI-DI: 10198956127968(each), 50198956127966(case), Lot Number: NGKU1994 ; 66) PV33TCMYB, UDI-DI: 10197106892442(each), 50197106892440(case), Lot Number: NGKU4716 ; 67) PV33TCMY3, UDI-DI: 10198956263994(each), 50198956263992(case), Lot Number: NGKU2887 ; 68) PV40OHAR47, UDI-DI: 10198956247086(each), 50198956247084(case), Lot Number: NGKT2391 ; 69) PV40OHAR48, UDI-DI: 10198956249165(each), 50198956249163(case), Lot Number: NGKT2391 ; 70) PV40OHAR48, UDI-DI: 10198956249165(each), 50198956249163(case), Lot Number: NGKT2455 ; 71) PV40OHAR49, UDI-DI: 10198956257924(each), 50198956257922(case), Lot Number: NGKT2391 ; 72) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2455 ; 73) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2391 ; 74) PV40OHJUD, UDI-DI: 10197106874844(each), 50197106874842(case), Lot Number: NGKT2455 ; 75) PV60OH15F, UDI-DI: 10197106634905(each), 50197106634903(case), Lot Number: NGKT2391 ; 76) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKU0977 ; 77) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKU0951 ; 78) SCVCGPAACD, UDI-DI: 10197106748169(each), 50197106748167(case), Lot Number: NGKT3319 ; 79) SCVCGTRACI, UDI-DI: 10197106453735(each), 50197106453733(case), Lot Number: N/A ; 80) SCVCGVCG17, UDI-DI: NGKU0957 (each), 10198956229624(case), Lot Number: 50198956229622; 81) SCVCGVCG18, UDI-DI: NGKU0856 (each), 10198956230651(case), Lot Number: 50198956230659; 82) SCVCGVCS16, UDI-DI: 10198956408548(each), 50198956408546(case), Lot Number: N/A ; 83) SCVCGVCS16, UDI-DI: 10198956408548(each), 50198956408546(case), Lot Number: NGKV5078
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States