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Wilson-Cook Medical Inc. recalls HEMO-10 Hemospray Endoscopic Hemostat
Recalled April 29, 2020 · FDA recall Z-1746-2020 · Wilson-Cook Medical
Hazard
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. · FDA Class II
Units
89,423 devices total
Sold at
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
Description
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.
Product
HEMO-10 Hemospray Endoscopic Hemostat
Manufacturer(s)
Wilson-Cook Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →