BEUDAMED
    FDA Recall Terminated

    STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

    Recall: Z-0682-2017 · Initiated August 1, 2014

    Recall

    Recall Number
    Z-0682-2017
    Event Number
    75573
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 1, 2014
    Posted
    December 1, 2016
    Terminated
    April 20, 2017
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

    Reason

    On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).

    Action

    Sorin Group sent an Important Information letter dated August 1, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by then consignee. Consignees were instructed to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU). Consignees with questions were instructed to call 303-467-6527 or 303-467-6503. For questions regarding this recall call 281-228-7260.

    Distribution

    Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.

    Quantity

    1,618 units in the US; 129 units outside of US