BEUDAMED
    FDA Enforcement Class II Ongoing

    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

    Recall: Z-0582-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0582-2025
    Event ID
    95755
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 11, 2024
    Initiation Date
    October 31, 2024
    Classification Date
    December 2, 2024
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203, United States

    Description

    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

    Reason

    Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

    Code Info

    UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.

    Distribution

    Distribution was OUS only to Argentina, Brazil, and Israel.

    Quantity

    46 devices