Wilson-Cook Medical Inc. recalls HEMO-10 Hemospray Endoscopic Hemostat

Recall date

February 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1746-2020

FDA classification

Class II

Brand / firm

Wilson-Cook Medical Inc.

Sold / distributed

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, N…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HEMO-10 Hemospray Endoscopic Hemostat