{"url_path":"/fda/device/recalls/Z-2041-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. FOLEY CARE KIT, Medline Kit SKU UROT1044;   2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770;   3. IV START KIT, Medline Kit SKU DYNDV2520;   4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255;   5. ON/OFF TRAY, Medline Kit SKU DYNDC2969;  …","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-16","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Medline Industries, LP"},"word_count":315,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2041-2026\n\n**Recalling firm:** Medline Industries, LP\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-16\n**Report date:** 2026-05-06\n\n## Product\nMedline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. FOLEY CARE KIT, Medline Kit SKU UROT1044;   2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770;   3. IV START KIT, Medline Kit SKU DYNDV2520;   4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255;   5. ON/OFF TRAY, Medline Kit SKU DYNDC2969;   6. IV START KIT, Medline Kit SKU DYNDV2520;   7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770;   8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255;   9. ON/OFF TRAY, Medline Kit SKU DYNDC2969;   10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.\n\n## Reason\nMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.\n\n## Affected lots\nMedline Kit SKU UROT1044:  UDI/DI each 10889942873890, UDI/DI case 40889942873891, Lot Number: 26BBC230;  Medline Kit SKU IV8770:  UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2025101090;  Medline Kit SKU DYNDV2520:  UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2025112090;  Medline Kit SKU ART255:  UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2025111890;  Medline Kit SKU DYNDC2969:  UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2025120190;  Medline Kit SKU DYNDV2520:  UDI/DI each 10653160384045, UDI/DI case 00653160384048, Lot Number: 2026010290;  Medline Kit SKU IV8770:  UDI/DI each 10653160382638, UDI/DI case 00653160382631, Lot Number: 2026010790;  Medline Kit SKU ART255:  UDI/DI each 10653160367598, UDI/DI case 00653160367591, Lot Number: 2026012090;  Medline Kit SKU DYNDC2969:  UDI/DI each 10653160376071, UDI/DI case 00653160376074, Lot Number: 2026012390;  Medline Kit SKU EBSI1364A:  UDI/DI each 10653160363163, UDI/DI case 00653160363166, Lot Number: 2026010690.\n\n## Distribution\nUS Nationwide distribution."}