BEUDAMED
    FDA Enforcement Class II Ongoing

    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,

    Recall: Z-1124-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1124-2023
    Event ID
    91483
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 22, 2023
    Initiation Date
    December 7, 2022
    Classification Date
    February 10, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,

    Reason

    The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

    Code Info

    a) Reorder Number DT21400, GTIN 40653160318225 Lot # 22HMH962; b) Reorder Number DT22255, GTIN 40653160328644 Lot # 22HMH427; c) Reorder Number DYNDC1022GB, GTIN 40195327038701 Lot # 22GBY236

    Distribution

    Nationwide

    Quantity

    1588 units