BEUDAMED
    FDA Enforcement Class II Ongoing

    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

    Recall: Z-2222-2024 · Reported July 3, 2024

    Enforcement

    Recall Number
    Z-2222-2024
    Event ID
    94696
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2024
    Initiation Date
    May 15, 2024
    Classification Date
    June 27, 2024
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

    Reason

    Product labels state the incorrect expiration dates that extends beyond their true expiration date

    Code Info

    UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530

    Distribution

    MA Foreign: Spain, and Netherlands

    Quantity

    15 units