BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number DYNDC3274; 7) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A

    Recall: Z-2766-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2766-2024
    Event ID
    94585
    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

    Centurion procedure kits labeled as: 1) BIOPSY KIT, Pack Number DYNDA1466A; 2) BIOPSY SKIN/LACERATION TRAY, Pack Number SUT20455; 3) CHEST TUBE INSERTION TRAY, Pack Number CHT560; 4) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 5) PERITONSILLAR ABSCESS TRAY, Pack Number MNS3560; 6) PRE POST DIALYSIS, Pack Number DYNDC3274; 7) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A

    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

    DYNDA1466A, Lot Number 2022040190; SUT20455, Lot Number 2022040190; CHT560, Lot Number 2021092290; MNS4815, Lot Number 2022040190; MNS3560, Lot Number 2021021790; MNS3560, Lot Number 2021092290; MNS3560, Lot Number 2021092890; MNS3560, Lot Number 2022040190; MNS3560, Lot Number 2022071490; MNS3560, Lot Number 2023121290; DYNDC3274, Lot Number 2023121290; DYNDC2859A, Lot Number 2021092290

    Distribution

    worldwide