BEUDAMED
    FDA Recall Terminated

    HEMO-10 Hemospray Endoscopic Hemostat

    Recall: Z-1746-2020 · Initiated February 4, 2020

    Recall

    Recall Number
    Z-1746-2020
    Event Number
    84822
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    QAU
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 4, 2020
    Terminated
    January 15, 2021
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    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.

    Action

    Cook Medical notified customers initially via "URGENT: MEDICAL DEVICE RECALL" letters sent on about 02/04/2020 and 02/25/2020. The letters contained the same information and informed customers that Cook Medical has received complaints that the handle and/or activation knob on Hemospray Endoscopic 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. Instructions to customers included to examine inventory for affected devices, cease use of them and quarantine them, return affected devices immediately to Cook Medical, and complete and return the Acknowledgement and Receipt Form. Additionally customers were instructed to inform appropriate personnel and customers, if further distributed, of the recall down to the user level. Questions or concerns can be directed to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

    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