BEUDAMED
    FDA Recall Terminated

    ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.

    Recall: Z-2721-2011 · Initiated May 2, 2011

    Recall

    Recall Number
    Z-2721-2011
    Event Number
    58971
    Firm
    Cincinnati Sub-Zero Products Inc
    FEI Number
    1516825
    Product Code
    DWJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 2, 2011
    Posted
    July 1, 2011
    Terminated
    March 7, 2013
    Address
    12011 Mosteller Rd, Cincinnati, OH, 45241

    Description

    ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is intended to provide temperature-controlled warm water flow to a blood heat exchanger in order to maintain a patient's blood temperature. It can be used during extracorporeal circulation procedures. It is intended to use with commercially available heat exchangers.

    Reason

    The probe jack contacts (terminals) on certain of the firm's ECMO Heater devices are located too close to the solid state relay contacts (terminals) which can lead to the terminals coming into contact with each other. If this situation occurs, the service technician, user, and/or patient could be exposed to electric shock during servicing and/or use.

    Action

    Cincinnati Sub-Zero Products Inc issued an "Urgeant Medical Device Field Action" letter on May 2, 2011 to all affected customers. The letter includes; description of product and problem, affected lots and instructs customers to discontinue its use. The product is to be returned to the Service Department for an update and the customer is instructed to complete and mail Field Action Form. For additional contact the firm at 1-800-989-7373 or (513) 772-8810.

    Distribution

    Worldwide Distribution and countries of The Netherlands, Kuwait, India, Saudi Arabia, Taiwan and Australia. (USA) Nationwide including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MIN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, and WI.

    Quantity

    212 units - U. S. distribution & 44 units foreign distribution