BEUDAMED
    FDA Recall 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 · Initiated January 25, 2016

    Recall

    Recall Number
    Z-0813-2016
    Event Number
    73224
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    January 25, 2016
    Posted
    February 16, 2016
    Terminated
    October 24, 2016
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    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.

    Action

    LivaNova sent an Urgent Safety Alert dated January 25, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advice on action to be taken: "Remove and discard the IFU included within the case packaging for the product. "A copy of the correct IFU (Part Number 435085202, Revision B) is attached with this letter "Print copies of the IFU and place with the product. For questions regarding this notice, please contact Customer Service at 1-800-650-2623 (Monday to Friday BAM to 5PM MT) or e-mail [email protected]. We sincerely apologize for this inconvenience and thank you in advance for your support

    Distribution

    US Distribution to CA., and Internationally to Canada.

    Quantity

    60