BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-0076-2018 · Reported November 15, 2017

    Enforcement

    Recall Number
    Z-0076-2018
    Event ID
    78331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 15, 2017
    Initiation Date
    September 28, 2017
    Classification Date
    November 8, 2017
    Termination Date
    October 17, 2018
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    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

    Reason

    A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected.

    Code Info

    Lot: 181185; UDI: (01)10803622125812(240)200-200(17)200703(10)181185

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to France and Spain

    Quantity

    40 units