BEUDAMED
    FDA Enforcement Class II Ongoing

    Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 6) VANTEX 7FR 3L 16CM CVC BUNDLE US, Pack Number ECVC8050

    Recall: Z-2773-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2773-2024
    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 packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 6) VANTEX 7FR 3L 16CM CVC BUNDLE US, Pack Number ECVC8050

    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

    SPEC4380, Lot Number 2023092590; CIT6325, Lot Number 2023082990; CIT6785A, Lot Number 2022120190; CIT6785A, Lot Number 2023021790; CIT6785A, Lot Number 2023041290; CIT6785A, Lot Number 2023092590; PT215, Lot Number 2023082990; MNS9580, Lot Number 2023082990; ECVC8050, Lot Number 2023082990

    Distribution

    worldwide