FDA-Device2023-06-28Class II
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Wilson-Cook Medical Inc.
Hazard
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.
Sold states
US Nationwide - Worldwide Distribution
Affected count
63,830 units
Manufactured in
4900 Bethania Station Rd, Winston Salem, NC, United States
Products
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1978-2023Don't want to check this manually?
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