BEUDAMED
    FDA Enforcement Class II Ongoing

    COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

    Recall: Z-1786-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1786-2026
    Event ID
    98495
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cook Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 15, 2026
    Initiation Date
    March 5, 2026
    Classification Date
    April 6, 2026
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120, United States

    Description

    COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

    Reason

    Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

    Code Info

    Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335.

    Distribution

    Worldwide distribution.

    Quantity

    20 units