{"url_path":"/fda/device/recalls/Z-3095-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT, GYN ROBOTIC GSAM         , Catalog Number: PBCCGRSGD;   2) KIT, GYN ROBOT ACCESSORY      , Catalog Number: PB35GYBJC;   3) KIT, PRIMARY RESECTION        , Catalog Number: PGVMOTBB19;   4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26;   5) KIT, LIVE…","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-3095-2026%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":545,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3095-2026\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, GYN ROBOTIC GSAM         , Catalog Number: PBCCGRSGD;   2) KIT, GYN ROBOT ACCESSORY      , Catalog Number: PB35GYBJC;   3) KIT, PRIMARY RESECTION        , Catalog Number: PGVMOTBB19;   4) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26;   5) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGVM07C26;   6) KIT, LIVER TRANSPLANT SUPPORT , Catalog Number: PGV2LTNHN;   7) KIT,UMMC GENERAL MAJOR TRANSPL, Catalog Number: PG15OT92A;   8) KIT,MAJOR LITHOTOMY NEW HAN   , Catalog Number: PG23MLNLD;   9) KIT, GENDER CARE              , Catalog Number: PG29GCPCK;   10) KIT, GENDER CARE              , Catalog Number: PG29GCPC3;   11) KIT, MUH LIVER                , Catalog Number: PG33LVMNC;   12) KIT, MIS HERNIA               , Catalog Number: PG35HPBJK;   13) KIT, GENERAL MAJOR            , Catalog Number: PG43MJEJD;   14) KIT, OPEN THORACOTOMY CMC     , Catalog Number: PVCGOTACF;   15) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYB;   16) KIT, MER THORACOTOMY ABDOMINAL, Catalog Number: PVX4TAMYC;   17) KIT, HEART II                 , Catalog Number: PV23HEVAE;   18) KIT, FLAP ACCESSORY           , Catalog Number: PW35FABJE;   19) HMC ROBOTIC PACK              , Catalog Number: SBA23RBHNG;   20) HMC ROBOTIC PACK              , Catalog Number: SBA23RBHNH\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) PBCCGRSGD, UDI-DI: 10197106840085(each), 50197106840083(case), Lot Number: NGKU0957                      ; 2) PB35GYBJC, UDI-DI: 10197106375723(each), 50197106375721(case), Lot Number: NGKU2052                      ; 3) PGVMOTBB19, UDI-DI: 10198956264113(each), 50198956264111(case), Lot Number: NGKT2394                      ; 4) PGVM07C26, UDI-DI: 10198956264434(each), 50198956264432(case), Lot Number: NGKT2394                      ; 5) PGVM07C27, UDI-DI: 10198956292895(each), 50198956292893(case), Lot Number: NGKT2394                      ; 6) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV2390                      ; 7) PGV2LTNHN, UDI-DI: 10198956292499(each), 50198956292497(case), Lot Number: NGKV3390                      ; 8) PG15OT92A, UDI-DI: 10197106475041(each), 50197106475049(case), Lot Number: NGKW2883                      ; 9) PG23MLNLD, UDI-DI: 10198956432024(each), 50198956432022(case), Lot Number: NGKU3969                      ; 10) PG29GCPCK, UDI-DI: 10198956299207(each), 50198956299205(case), Lot Number: NGKU4716                      ; 11) PG29GCPC3, UDI-DI: 10198956532496(each), 50198956532494(case), Lot Number: NGKU4716                      ; 12) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994                      ; 13) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994                      ; 14) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994                      ; 15) PG33LVMNC, UDI-DI: 10198956188358(each), 50198956188356(case), Lot Number: NGKU1994                      ; 16) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0856                      ; 17) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957                      ; 18) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU0957                      ; 19) PG35HPBJK, UDI-DI: 10198956124110(each), 50198956124118(case), Lot Number: NGKU2052                      ; 20) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883                      ; 21) PG43MJEJD, UDI-DI: 10197106594261(each), 50197106594269(case), Lot Number: NGKW2883                      ; 22) PVCGOTACF, UDI-DI: 10195594816469(each), 50195594816467(case), Lot Number: NGKV3487                      ; 23) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716                      ; 24) PVX4TAMYB, UDI-DI: 10197106892404(each), 50197106892402(case), Lot Number: NGKU4716                      ; 25) PVX4TAMYC, UDI-DI: 10198956329379(each), 50198956329377(case), Lot Number: NGKU4716                      ; 26) PV23HEVAE, UDI-DI: 10198956062160(each), 50198956062168(case), Lot Number: NGKT2391                      ; 27) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394                      ; 28) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394                      ; 29) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394                      ; 30) PW35FABJE, UDI-DI: 10198956142282(each), 50198956142280(case), Lot Number: NGKT2394                      ; 31) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: NGKU0129                      ; 32) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: NGKU0129\n\n## Distribution\nUS Nationwide distribution."}