BEUDAMED
    FDA Recall Terminated

    XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

    Recall: Z-0968-2012 · Initiated November 16, 2011

    Recall

    Recall Number
    Z-0968-2012
    Event Number
    60987
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    MWS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 16, 2011
    Posted
    February 6, 2012
    Terminated
    January 10, 2014
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    XPOSE 4 Access Device (XP-4000) XPOSE 3 Access Device (XP-3000) positioners. Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.

    Reason

    There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners.

    Action

    Maquet sent an Urgent Device Removal Immediate Action Required letter dated November 16, 2011 and a Field Action Response forms via Federal Express to to affected customers. The letter identifies the problem, product. risk factors and actions to be taken. Customers were instructed to examine their stocks immediately to determine if they have any of the recalled product. If so, discontinue dispensing (distributing) the lot and complete the Field Action Response form attached to complete and fax the attached Field Action Response form. In addition, it provides instructions for how to return the recalled product to MAQUET. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271. If you have any additional questions, contact your local MAQUET Cardiovascul'ar sales representative or Customer Service at 1-888-880-2874 (6AM -5PM PST).

    Distribution

    Worldwide Distribution - USA Nationwide

    Quantity

    9436 unit total (US AND WORLDWIDE)