BEUDAMED
    FDA Enforcement Class II Ongoing

    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; 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.

    Recall: Z-2041-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2041-2026
    Event ID
    98692
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 6, 2026
    Initiation Date
    March 16, 2026
    Classification Date
    April 30, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    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; 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.

    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.

    Code Info

    Medline 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.

    Distribution

    US Nationwide distribution.

    Quantity

    40845 kits