FDA Device recall Z-2045-2026
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), M…
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), M… by Medline Industries, citing medline 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 We….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2045-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-16 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
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 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.
Reason
Medline 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.
Identifiers
| code_info | Medline Kit SKU DT17360: UDI/DI each 10653160264965, UDI/DI case 00653160264968, Lot Number: 2025101090; Medline Kit…Medline 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 e |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2045-2026%22
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