BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A

    Recall: Z-2633-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2633-2024
    Event ID
    94582
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 4, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    August 28, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Code Info

    DYNDA1431A, Lot Number 2020012890

    Distribution

    Worldwide distribution.

    Quantity

    1,679,067 units in total