FDA-Device2020-01-15Class II
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Abbott Medical
Hazard
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Sold states
Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay
Affected count
814 devices
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0783-2020Don't want to check this manually?
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