{"url_path":"/fda/device/recalls/Z-3105-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT, CHONY ORTHO MAJOR SPINE  , Catalog Number: POV2SCCPP;   2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI","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-3105-2026%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":124,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3105-2026\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, CHONY ORTHO MAJOR SPINE  , Catalog Number: POV2SCCPP;   2) KIT,ORTHOPLASTIC MICROVASCULAR, Catalog Number: PWVMFFABLI\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) POV2SCCPP, UDI-DI: 10198956285200(each), 50198956285208(case), Lot Number: NGKV3390                      ; 2) PWVMFFABLI, UDI-DI: 10198956123915(each), 50198956123913(case), Lot Number: NGKT2394\n\n## Distribution\nUS Nationwide distribution."}