BEUDAMED
    FDA Enforcement Class II Ongoing

    COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

    Recall: Z-1784-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1784-2026
    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 Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108

    Reason

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

    Code Info

    Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260221(10)15133690X, Lot Number 15133690X; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)260314(10)15274382, Lot Number 15274382; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15435573, Lot Number 15435573; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270118(10)15445615, Lot Number 15445615; Reference Part Number C-CSRC-7.5D-40-STRANGE, UDI (01)00827002091085(17)270104(10)15501690, Lot Number 15501690.

    Distribution

    Worldwide distribution.

    Quantity

    49 units