BEUDAMED
    FDA Enforcement Class II Ongoing

    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

    Recall: Z-1979-2023 · Reported June 28, 2023

    Enforcement

    Recall Number
    Z-1979-2023
    Event ID
    92345
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 28, 2023
    Initiation Date
    May 22, 2023
    Classification Date
    June 21, 2023
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203, United States

    Description

    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

    Reason

    There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

    Code Info

    UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    14,877 units