BEUDAMED
    FDA Enforcement Class II Terminated

    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

    Recall: Z-1186-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1186-2016
    Event ID
    73352
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    August 15, 2012
    Classification Date
    March 17, 2016
    Termination Date
    May 26, 2017
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503, United States

    Description

    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259

    Reason

    On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water.

    Code Info

    All Serial Numbers for Item Number 16-02-81, 16-02-82, 16-02-85;

    Distribution

    Worldwide Distribution - US Nationwide, VA/govt/military

    Quantity

    1125 units