BEUDAMED
    FDA Recall Terminated

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    Recall: Z-0132-2015 · Initiated August 13, 2014

    Recall

    Recall Number
    Z-0132-2015
    Event Number
    69101
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    August 13, 2014
    Posted
    October 24, 2014
    Terminated
    March 30, 2016
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.

    Reason

    An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.

    Action

    Maquet Inc. issued Recall letters/Acknowledgement forms dated via Fed-Ex on 8/13/2014.

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, FINLAND, FRANCE, GREECE, HONG KONG, INDICA, INDONESIA, ISRAEL, ITALY, JAPAN, MEXICO, MALAYSIA, NETHERLANDS, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND VIETNAM.

    Quantity

    16,532 units (19,270 units international)