BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

    Recall: Z-1810-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1810-2025
    Event ID
    96821
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2025
    Initiation Date
    April 22, 2025
    Classification Date
    May 30, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

    Reason

    Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

    Code Info

    UDI-DI 10888277858060 (EA); 40888277858061 (CASE) KIT LOTS 24CBJ925 24DBT405 24FBO318

    Distribution

    US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.

    Quantity

    1853 total