FDAFDA recall Z-3098-2026 · Sep 9, 2026

Cardinal Health 200, LLC: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) recall

Recall found

Product

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

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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
Quantity: 2448 units
Distribution: US Nationwide distribution.
Recalling firm: Cardinal Health 200, LLC, Waukegan, IL
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-29

Source: openFDA enforcement record Z-3098-2026 · search recall number Z-3098-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.