FDA-Device2017-11-15Class II
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced
Sorin Group USA, Inc.
Hazard
A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Sold states
Worldwide Distribution - US (nationwide) Internationally to France and Spain
Affected count
40 units
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0076-2018Don't want to check this manually?
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