BEUDAMED
    FDA Enforcement Class II Terminated

    Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.

    Recall: Z-0813-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0813-2016
    Event ID
    73224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    January 25, 2016
    Classification Date
    February 16, 2016
    Termination Date
    October 24, 2016
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503, United States

    Description

    Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.

    Reason

    Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case.

    Code Info

    lot - 1529300018

    Distribution

    US Distribution to CA., and Internationally to Canada.

    Quantity

    60