BEUDAMED
    FDA Enforcement Class II Ongoing

    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 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.

    Recall: Z-2043-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2043-2026
    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 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.

    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 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.

    Distribution

    US Nationwide distribution.

    Quantity

    28550 kits