BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2045-2026 · Initiated March 16, 2026

    Recall

    Recall Number
    Z-2045-2026
    Event Number
    98692
    FEI Number
    1417592
    Product Code
    OXQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 16, 2026
    Posted
    April 30, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    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.

    Action

    Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/16/2026 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the affected product be quarantined pending additional labeling. Consignees were directed to respond to the notice via Website link: https://recalls.medline.com, and upon receipt of the submitted response form, the account will receive over-labels to place on affected inventory, with instructions for the user to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight. Distributors or those who have further distributed the product are directed to notify those receiving the affected kits, and to include the customers quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to the customers to affix to their affected product. For questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    17550 kits