BEUDAMED
    FDA Recall Terminated

    Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.

    Recall: Z-1341-2011 · Initiated December 3, 2010

    Recall

    Recall Number
    Z-1341-2011
    Event Number
    57454
    Firm
    Abbott Point Of Care Inc.
    FEI Number
    2245578
    Product Code
    JBP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 3, 2010
    Posted
    February 16, 2011
    Terminated
    July 16, 2013
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    Celite ACT Cartridge Cartridge is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery organ transplantation and dialysis.

    Reason

    Celite ACT cartridges have increased numbers of values outside the accepted allowable error.

    Action

    On behalf of Abbott, Genco Pharmaceutical Services sent an "URGENT RECALL NOTICE" dated November 2010, on December 3, 2010 via Fedex to all consignees/customers. Abbott sent out notification packages to foreign consignees/customers on December 3, 2010. The notice described the product, problem and action to be taken by customers. The firm recommended that customers use cartridges within 12 hours of removal from refrigerated storage based on the instructions provided with the product. The customers were instructed to complete and return the Business Reply cards to acknowledge receipt of the communication and provide the letter to any customers that have recieved the product. If you have any additional questions, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care Representative. On February 27, 2012 Abbott sent an Important Product Information letter via Fed Ex to inform customers that i-Stat Celite ACT cartridges manufactured from the beginning of 2012 can now be stored for two weeks at room temperature as indicated on the cartridge box. Foreign consignees were notified on 2/28/2012. Users are instructed to complete business reply cards to acknowledge receipt of the communication and provide the letter to any customers that have received the product. Any additional questions can be answered by contacting 8003668020 option 1.

    Distribution

    Worldwide distribution.

    Quantity

    1164275 cartridges