BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137

    Recall: Z-2988-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-2988-2024
    Event ID
    94583
    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 18, 2024
    Initiation Date
    April 8, 2024
    Classification Date
    September 6, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B; 2) PERIPHERAL NERVE BLOCK, Pack Number PAIN0137

    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

    DYNJRA0377B, Lot Number 19DDB791 ; DYNJRA0377B, Lot Number 21KDA359 ; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243; PAIN0137, Lot Number 21CLA312; PAIN0137, Lot Number 21ALA608; PAIN0137, Lot Number 20LLA425; PAIN0137, Lot Number 20JLA143; PAIN0137, Lot Number 20HLA191; PAIN0137, Lot Number 20GLA104; PAIN0137, Lot Number 20CLA627; PAIN0137, Lot Number 20BLA634; PAIN0137, Lot Number 20ALA243

    Distribution

    Worldwide distribution.