BEUDAMED
    FDA Enforcement Class II Terminated

    STOCKERT Heater-Cooler System 3T, 120V/60 Hz

    Recall: Z-2775-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2775-2017
    Event ID
    77717
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 2, 2017
    Initiation Date
    June 30, 2017
    Classification Date
    July 27, 2017
    Termination Date
    October 10, 2023
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    STOCKERT Heater-Cooler System 3T, 120V/60 Hz

    Reason

    Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.

    Code Info

    Item No. 16-02-85; Serial No. 16S10958-16S16847

    Distribution

    "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY. Foreign: AL, AE, AR, AT, AU, AZ, BD, BE, BG, BH, BR, BY, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, ET, FI, FR, GB, GE, GR, GY, HK, HR, HU, IE, ID, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LT, LU, LV, LY, MA, MC, MK, MN, MT, MU, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PR, PS, PT, QA, RE, RO, RS, RU, SA, SE, SG, SK, SV, SY, TH, TN, TR, TT, TW, UA, VN, & ZA."

    Quantity

    7,546 units