{"url_path":"/fda/device/recalls/Z-3104-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT, ASLMC CRANIOTOMY         , Catalog Number: PNCGCNAUM;   2) KIT, ORP MAJOR SPINE          , Catalog Number: PNHDFSVCI;   3) KIT,ORP NEURO TRAUMA          , Catalog Number: PNHDOTVCQ;   4) KIT, CRANIOTOMY PRESBYTERIAN  , Catalog Number: PNV20101L;   5) KIT, LARGE…","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-3104-2026%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":305,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3104-2026\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, ASLMC CRANIOTOMY         , Catalog Number: PNCGCNAUM;   2) KIT, ORP MAJOR SPINE          , Catalog Number: PNHDFSVCI;   3) KIT,ORP NEURO TRAUMA          , Catalog Number: PNHDOTVCQ;   4) KIT, CRANIOTOMY PRESBYTERIAN  , Catalog Number: PNV20101L;   5) KIT, LARGE SPINE 143487       , Catalog Number: PNV20101L;   6) FUSION ACCESSORY PACK BRO     , Catalog Number: SNECGLFABB;   7) LH GENERAL NEURO SPINE PACK   , Catalog Number: SNEOCGSLHP;   8) LH GENERAL NEURO SPINE PACK   , Catalog Number: SNEOCGSL20\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) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2391                      ; 2) PNCGCNAUM, UDI-DI: 10197106894316(each), 50197106894314(case), Lot Number: NGKT2455                      ; 3) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022                      ; 4) PNHDFSVCI, UDI-DI: 10198956143470(each), 50198956143478(case), Lot Number: NGKU1022                      ; 5) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022                      ; 6) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022                      ; 7) PNHDOTVCQ, UDI-DI: 10198956143777(each), 50198956143775(case), Lot Number: NGKU1022                      ; 8) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV3390                      ; 9) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390                      ; 10) PNV20101L, UDI-DI: 10198956285217(each), 50198956285215(case), Lot Number: NGKV2390                      ; 11) PN15LSRMH, UDI-DI: 10198956341692(each), 50198956341690(case), Lot Number: NGKW3769                      ; 12) SNECGLFABB, UDI-DI: 10197106881675(each), 50197106881673(case), Lot Number: NGKU0856                      ; 13) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769                      ; 14) SNEOCGSLHP, UDI-DI: 10198956233430(each), 50198956233438(case), Lot Number: NGKW3769                      ; 15) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW0682                      ; 16) SNEOCGSL20, UDI-DI: 10198956305762(each), 50198956305760(case), Lot Number: NGKW3769\n\n## Distribution\nUS Nationwide distribution."}