BEUDAMED
    FDA Enforcement Class II Ongoing

    Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595

    Recall: Z-1118-2023 · Reported February 22, 2023

    Enforcement

    Recall Number
    Z-1118-2023
    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) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Number MNS12595

    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 DYNDA2524, GTIN 40193489361415, Lot # 22HME893 b) Reorder Number DT22705A, GTIN 40653160993224, Lot # 22HMC897 c) Reorder Number IV8635D, GTIN 40653160990261, Lot# 22HMH318 d) Reorder Number MNS12595, GTIN 40653160991015, Lot # 22HMD598

    Distribution

    Nationwide

    Quantity

    630 units