BEUDAMED
    FDA Enforcement Class II Terminated

    HEMO-10 Hemospray Endoscopic Hemostat

    Recall: Z-1746-2020 · Reported April 29, 2020

    Enforcement

    Recall Number
    Z-1746-2020
    Event ID
    84822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wilson-Cook Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2020
    Initiation Date
    February 4, 2020
    Classification Date
    April 17, 2020
    Termination Date
    January 15, 2021
    Address
    4900 Bethania Station Rd, N/A, Winston Salem, NC, 27105-1203, United States

    Description

    HEMO-10 Hemospray Endoscopic Hemostat

    Reason

    Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.

    Code Info

    All Lot numbers manufactured 01/16/2017 - 01/15/2020 of both the following: HEMO-7 Order Number G56572 HEMO-10 Order Number G21049

    Distribution

    Nationwide distribution. International distribution to Bahrain, Belarus, Canary Islands, Gibraltar, Guadeloupe, Guernsey, Iraq, Israel, Jersey, Jordan, Kuwait, Lebanon, Martinique, Monaco, Morocco, Oman, Pakistan, Qatar, Reunion, Saudi Arabia, Tunisia, United Arab Emirates, Unites States, Canada, Netherlands Antilles, Chile, Egypt, Japan, Mexico, Peru, Puerto Rico, Trinidad and Tobago, Australia, Brunei Dassalarum, Hong Kong, Korea, Myanmar, Macau, Malaysia, New Zealand, Philippines, Singapore, Thailand, Vietnam, Argentina, Brazil, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Iceland, Italy, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia

    Quantity

    89,423 devices total