BEUDAMED
    FDA Enforcement Class II Ongoing

    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    Recall: Z-0038-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0038-2025
    Event ID
    95273
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    3M Company - Health Care Business
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 16, 2024
    Initiation Date
    August 14, 2024
    Classification Date
    October 9, 2024
    Address
    3m Center 2510 Conway Ave, Bldg 275-5w-06, Saint Paul, MN, 55144-0001, United States

    Description

    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    Reason

    Contamination with foreign substance matter

    Code Info

    UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

    Distribution

    International distribution to the country of South Korea.

    Quantity

    10,000 units