{"url_path":"/fda/device/recalls/Z-3101-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT, BLO ROBOTIC GYN          , Catalog Number: PBCGRGB28;   2) KIT ,  GYN MAJOR  BARNES JEWIS, Catalog Number: PBVMLP22G;   3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D;   4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH;   5) KIT, GYN L…","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-3101-2026%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":372,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3101-2026\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, BLO ROBOTIC GYN          , Catalog Number: PBCGRGB28;   2) KIT ,  GYN MAJOR  BARNES JEWIS, Catalog Number: PBVMLP22G;   3) KIT, GYN OPERATIVE LAPAROSCOPY, Catalog Number: PBVM0722D;   4) KIT,MAJOR VAGINAL,PRESBYTERIAN, Catalog Number: PBV2MJMVH;   5) KIT, GYN LAPAROSCOPY          , Catalog Number: PBV2MJMVH;   6) KIT, GYN LAPAROSCOPY          , Catalog Number: PB43LSEJG;   7) GYNE ROBOTIC PACK CMC         , Catalog Number: SMACGGRACE;   8) LH GYN ROBOTICS PK            , Catalog Number: SMAOCGYLHL;   9) DAVINCI PACK WOMENS           , Catalog Number: SMAVPDWTMC;   10) PK GYN ROBOTICS OD            , Catalog Number: SMA4JGRODB;   11) PK LAPAROSCOPY GYN OD         , Catalog Number: SMA4JLGODA\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) PBCGRGB28, UDI-DI: 10198956432567(each), 50198956432565(case), Lot Number: GKU1823                       ; 2) PBVMLP22G, UDI-DI: 10198956123854(each), 50198956123852(case), Lot Number: NGKU2052                      ; 3) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856                      ; 4) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957                      ; 5) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0856                      ; 6) PBVM0722D, UDI-DI: 10198956124134(each), 50198956124132(case), Lot Number: NGKU0957                      ; 7) PBV2MJMVH, UDI-DI: 10198956285248(each), 50198956285246(case), Lot Number: NGKV3390                      ; 8) PB13GYAJD, UDI-DI: 10198956125193(each), 50198956125191(case), Lot Number: NGKV3390                      ; 9) PB43LSEJG, UDI-DI: 10198956200999(each), 50198956200997(case), Lot Number: NGKW2883                      ; 10) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU0856                      ; 11) SMACGGRACE, UDI-DI: 10197106820506(each), 50197106820504(case), Lot Number: NGKU2052                      ; 12) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW0682                      ; 13) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 14) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 15) SMAOCGYLHL, UDI-DI: 10198956257214(each), 50198956257212(case), Lot Number: NGKW3769                      ; 16) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823                       ; 17) SMAVPDWTMC, UDI-DI: 10197106678053(each), 50197106678051(case), Lot Number: GKU1823                       ; 18) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129                      ; 19) SMA4JGRODB, UDI-DI: 10197106670545(each), 50197106670543(case), Lot Number: NGKU0129                      ; 20) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129                      ; 21) SMA4JLGODA, UDI-DI: 10197106674949(each), 50197106674947(case), Lot Number: NGKU0129\n\n## Distribution\nUS Nationwide distribution."}