FDA-Device2025-05-28Class II
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
Hazard
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Sold states
Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Affected count
89 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2025Don't want to check this manually?
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