BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1979-2023 · Initiated May 22, 2023

    Recall

    Recall Number
    Z-1979-2023
    Event Number
    92345
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    QAU
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 22, 2023
    Posted
    June 21, 2023
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    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.

    Action

    The firm notified their consignees by letter and email beginning on 05/22/2023. The notice explained the issue, risk, and requested the following: Complete and return the Acknowledgement Form, ensure the notification is shared with appropriate personnel, down to the user level or customers if devices were further distributed, report any adverse events.

    Distribution

    US Nationwide - Worldwide Distribution

    Quantity

    14,877 units