BEUDAMED
    FDA Recall Terminated

    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.

    Recall: Z-1093-2011 · Initiated November 30, 2010

    Recall

    Recall Number
    Z-1093-2011
    Event Number
    57405
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    KQG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 30, 2010
    Posted
    February 11, 2011
    Terminated
    August 22, 2012
    Address
    6-8 Olsen Avenue, Edison, NJ, 08820-2419

    Description

    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.

    Reason

    Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.

    Action

    ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail [email protected].

    Distribution

    Worldwide Distribution

    Quantity

    265 boxes (95 ACT Tubes per box)