{"url_path":"/fda/device/recalls/Z-3098-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — 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 B…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3098-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Cardinal Health 200, LLC"},"word_count":1333,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3098-2026\n\n**Recalling firm:** Cardinal Health 200, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-29\n**Report date:** 2026-09-09\n\n## Product\nPresource 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\n\n## Reason\nThe 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.\n\n## Affected lots\n1) 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\n\n## Distribution\nUS Nationwide distribution."}