BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

    Recall: Z-2755-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2755-2024
    Event ID
    94581
    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 procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) PORT DRESSING CHANGE TRAY, Pack Number DT18415; 4) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512

    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

    CIT6715, Lot Number 2023011090; CIT6920, Lot Number 2021081890; DT18415 , Lot Number 22OBA722 ; DT18415 , Lot Number 22JBQ737 ; DT18415 , Lot Number 23BBE570 ; DT18415 , Lot Number 23DBS680 ; DT18415 , Lot Number 23EBS516 ; DT18415 , Lot Number 23HBN856 ; DT18415 , Lot Number 23JBV086 ; DT18415 , Lot Number 21BBF570 ; DT18415 , Lot Number 21CBO659 ; DT18415 , Lot Number 24CBM583 ; DYNDH1512, Lot Number 2021120690

    Distribution

    Worldwide