FDA-Device2022-06-15Class II
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Cook Incorporated
Hazard
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
106,033
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1240-2022Don't want to check this manually?
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