FDA-Device2024-12-11Class II
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Wilson-Cook Medical Inc.
Hazard
Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
Sold states
Distribution was OUS only to Argentina, Brazil, and Israel.
Affected count
46 devices
Manufactured in
4900 Bethania Station Rd, Winston Salem, NC, United States
Products
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2025Don't want to check this manually?
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