{"url_path":"/fda/device/recalls/Z-2045-2026","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. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE …","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-2045-2026%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":442,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2045-2026\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. LVAD DRIVELINE KIT (Centurion),  Medline Kit SKU DT17360 (Centurion);   2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;   3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;   4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;   5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;   6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;   7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;   8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;   9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;   10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;   11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.\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 DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090;  Medline Kit SKU IVS1975A:  UDI/DI each 10653160327936, UDI/DI case 00653160327939, Lot Number: 2025100890;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2025103190;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2025110590;  Medline Kit SKU DT17360:  UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025110790;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2025111990;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2025112490;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2025120990;  Medline Kit SKU DM100:  UDI/DI each 10653160280101, UDI/DI case 00653160280104, Lot Number: 2026010690;  Medline Kit SKU DT5565B:  UDI/DI each 00653160126938, UDI/DI case 10653160126935, Lot Number: 2026011390;  Medline Kit SKU EBSI1172B:  UDI/DI each 10193489195453, UDI/DI case 20193489195450, Lot Number: 2026011390;  Medline Kit SKU DT7340:  UDI/DI each 00653160091427, UDI/DI case 50653160091422, Lot Number: 2026021090;  Medline Kit SKU DM660:  UDI/DI each 10653160290667, UDI/DI case 00653160290660, Lot Number: 2026020690;  Medline Kit SKU DM810:  UDI/DI each 10653160304739, UDI/DI case 00653160304732, Lot Number: 2026020990;  Medline Kit SKU EBSI1171A:  UDI/DI each 10888277781276, UDI/DI case 40888277781277, Lot Number: 2026021290;  Medline Kit SKU EBSI1173A:  UDI/DI each 10888277781320, UDI/DI case 40888277781321, Lot Number: 2026021790;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2025121990;  Medline Kit SKU EBSI1365A:  UDI/DI each 10653160355724, UDI/DI case 00653160355727, Lot Number: 2026020990.\n\n## Distribution\nUS Nationwide distribution."}