BEUDAMED
    FDA Recall Terminated

    ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures

    Recall: Z-0744-2016 · Initiated December 21, 2015

    Recall

    Recall Number
    Z-0744-2016
    Event Number
    72913
    Firm
    Acist Medical Systems
    FEI Number
    3001726808
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    December 21, 2015
    Posted
    February 2, 2016
    Terminated
    July 22, 2016
    Address
    7905 Fuller Rd, Eden Prairie, MN, 55344-2137

    Description

    ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). To be used for the controlled infusion of radiopaque contrast media for angiographic procedures

    Reason

    Reports related to ingress of air into the manifold.

    Action

    Acist sent an Urgent Medical Device Recall letter dated December 21, 2015, via e-mail to all affected consignees. The letter was addressed to Distribution Partner or Cardiac Cath Lab / Material Manager in the USA. In Europe, the letter was addresses to Purchasing Department. The letter described the problem and the product involved in the recall. Advised consignees to return affected units and to complete and return the Medical Device Recall Form. Distributors were further advised to send the recall letter to their customers. For questions or concerns, contact in US, ACIST Customer Service 1-888-670-7701 or your ACIST Sales Representative. Europe Direct contact ACIST Europe Customer Service +44 (0) 845 548 12 80 or contact your ACIST Sales Representative, Europe Indirect contact ACIST Europe Customer Service +31 45 750 70 25 or contact your Distributor. Distributors contact: ACIST Europe BV, Office: +31 (0)45 750 7015, Mobile: +31 (0)6 233 648 46.

    Distribution

    Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.

    Quantity

    48,614 cartons or 486,140 units