BEUDAMED
    FDA Recall Terminated

    STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz

    Recall: Z-2776-2017 · Initiated June 30, 2017

    Recall

    Recall Number
    Z-2776-2017
    Event Number
    77717
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 30, 2017
    Posted
    July 25, 2017
    Terminated
    October 10, 2023
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    STOCKERT Heater-Cooler System 3T, 200V/50 Hz/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.

    Action

    "Consignees were sent a recall notification, dated 06/30/2017, via mail. Instructions included a recommendation from LivaNova to use its oxygenators, or other oxygenators that are equipped with compatible heat exchangers, to ensure that the permeability rate is within the prescribed allowable limits (ALs). Depending on whether or not the oxygenator was from LivaNova, there were specific instructions to follow for each type and source. Consignees were also instructed to complete and return the Confirmation Form. If product was further distributed, the firm asks that further customers be notified of the recall and that customers contact the LivaNova Quality Assurance Team at [email protected]. Questions regarding the recall can be directed to 800-986-4702 or [email protected]. Any adverse reactions are to be reported to FDA's MedWatch Adverse Event Reporting program."

    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