{"url_path":"/fda/device/recalls/Z-2043-2026","section_key":"summary","section_title":"DEVICE Recall: Medline Industries, LP — Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E;   2. IV SECUREMENT KIT (Centurion),  Medline Kit SKU IVS1700;   3. IV START KIT (Centurion),  Medline Kit SKU IV8675;   4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSS…","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-2043-2026%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":359,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2043-2026\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 or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:    1. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E;   2. IV SECUREMENT KIT (Centurion),  Medline Kit SKU IVS1700;   3. IV START KIT (Centurion),  Medline Kit SKU IV8675;   4. NEONATAL IV SECUREMENT KIT W/SHIELD(Centurion), Medline Kit SKU IVSSTK12;   5. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940;   6. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775;   7. NEONATAL IV SECUREMENT KIT W/SHIELD, Medline Kit SKU IVSSTK12;   8. IV SECUREMENT KIT (Centurion), Medline Kit SKU IVS1700;   9. IV START KIT, Medline Kit SKU IV8675;   10. NEONATAL IV START KIT (Centurion), Medline Kit SKU IV8310E;   11. IV START & SECUREMENT KIT (Centurion), Medline Kit SKU IV6940;   12. IV START KIT WITHOUT TUBING, Medline Kit SKU IV8775.\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 IV8310E:  UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2025102390;  Medline Kit SKU IVS1700:  UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2025102390;  Medline Kit SKU IV8675:  UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2025110790;  Medline Kit SKU IVSSTK12:  UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025111890;  Medline Kit SKU IV6940:  UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2025112690;  Medline Kit SKU IV8775:  UDI/DI each 10888277732537, UDI/DI case 20888277732534, Lot Number: 2025120190;  Medline Kit SKU IVSSTK12:  UDI/DI each 10653160322511, UDI/DI case 00653160322514, Lot Number: 2025122690;  Medline Kit SKU IVS1700:  UDI/DI each 10653160259213, UDI/DI case 00653160259216, Lot Number: 2026010590;  Medline Kit SKU IV8675:  UDI/DI each 10653160319160, UDI/DI case 00653160319163, Lot Number: 2026010990;  Medline Kit SKU IV8310E:  UDI/DI each 10653160293798, UDI/DI case 00653160293791, Lot Number: 2026011990;  Medline Kit SKU IV6940:  UDI/DI each 00653160194210, UDI/DI case 10653160194217, Lot Number: 2026012990.\n\n## Distribution\nUS Nationwide distribution."}