FDA-Device2023-06-28Class II
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
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
14,877 units
Manufactured in
4900 Bethania Station Rd, Winston Salem, NC, United States
Products
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2023Don't want to check this manually?
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