BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

    Recall: Z-2989-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-2989-2024
    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: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026

    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

    DYNJRA9026 , Lot Number 22EBN191 ; DYNJRA9026 , Lot Number 22LBC356 ; DYNJRA9026 , Lot Number 23ABN403 ; DYNJRA9026 , Lot Number 23CBP475 ; DYNJRA9026 , Lot Number 23DBG934 ; DYNJRA9026 , Lot Number 23EBH050 ; DYNJRA9026 , Lot Number 23JBS641 ; DYNJRA9026 , Lot Number 23KBJ179 ; DYNJRA9026 , Lot Number 23LBU686 ; DYNJRA9026 , Lot Number 19ADC324 ; DYNJRA9026 , Lot Number 19ADD208 ; DYNJRA9026 , Lot Number 19LDA087 ; DYNJRA9026 , Lot Number 19LDB132 ; DYNJRA9026 , Lot Number 20ADC808 ; DYNJRA9026 , Lot Number 20BDA346 ; DYNJRA9026 , Lot Number 20BDB555 ; DYNJRA9026 , Lot Number 20CDB731 ; DYNJRA9026 , Lot Number 20EDC526 ; DYNJRA9026 , Lot Number 20GDA908 ; DYNJRA9026 , Lot Number 20IDA046 ; DYNJRA9026 , Lot Number 20IDA621 ; DYNJRA9026 , Lot Number 20LDB113 ; DYNJRA9026 , Lot Number 20LDB323 ; DYNJRA9026 , Lot Number 21BDA498 ; DYNJRA9026 , Lot Number 21DDA458 ; DYNJRA9026 , Lot Number 21DDA663 ; DYNJRA9026 , Lot Number 21HDC456 ; DYNJRA9026 , Lot Number 21JDB091 ; DYNJRA9026 , Lot Number 21KDC632 ; DYNJRA9026 , Lot Number 21LDA581 ; DYNJRA9026 , Lot Number 21LDB014 ; DYNJRA9026 , Lot Number 22BDA209 ; DYNJRA9026 , Lot Number 22BDC191 ; DYNJRA9026 , Lot Number 22CDA655 ; DYNJRA9026 , Lot Number 22CDC010 ; DYNJRA9026 , Lot Number 22ILB005 ; DYNJRA9026 , Lot Number 22KLA115

    Distribution

    Worldwide distribution.