{"url_path":"/fda/device/recalls/Z-3097-2026","section_key":"summary","section_title":"DEVICE Recall: Cardinal Health 200, LLC — Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:  1) KIT,ROBOTICS DH               , Catalog Number: PGOCRDNHD;   2) KIT, EAS ROBOTIC              , Catalog Number: PG36RPEAB;   3) KIT, VIDEO THORACOSCOPY CMC   , Catalog Number: PVCGVTACF","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-3097-2026%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":150,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3097-2026\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,ROBOTICS DH               , Catalog Number: PGOCRDNHD;   2) KIT, EAS ROBOTIC              , Catalog Number: PG36RPEAB;   3) KIT, VIDEO THORACOSCOPY CMC   , Catalog Number: PVCGVTACF\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) PGOCRDNHD, UDI-DI: 10198956057012(each), 50198956057010(case), Lot Number: NGKV3390                      ; 2) PG36RPEAB, UDI-DI: 10198956225091(each), 50198956225099(case), Lot Number: NGKU2052                      ; 3) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487                      ; 4) PVCGVTACF, UDI-DI: 10195594816568(each), 50195594816566(case), Lot Number: NGKV3487\n\n## Distribution\nUS Nationwide distribution."}