BEUDAMED
    FDA Enforcement Class II Terminated

    Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

    Recall: Z-2081-2015 · Reported July 22, 2015

    Enforcement

    Recall Number
    Z-2081-2015
    Event ID
    71593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 22, 2015
    Initiation Date
    June 15, 2015
    Classification Date
    July 15, 2015
    Termination Date
    July 25, 2018
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.

    Reason

    Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.

    Code Info

    Product code 16-02-95 Serial number 16S12004-16S15385

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.

    Quantity

    131