BEUDAMED
    FDA Recall Terminated

    Medtronic Midas Rex Legend High Speed Pneumatic System

    Recall: Z-0278-05 · Initiated November 11, 2004

    Recall

    Recall Number
    Z-0278-05
    Event Number
    30509
    Firm
    Power Surgical Solutions
    FEI Number
    1625507
    Product Code
    HBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2004
    Posted
    December 4, 2004
    Terminated
    September 20, 2005
    Address
    4620 N Beach St, Fort Worth, TX, 76137-3219

    Description

    Medtronic Midas Rex Legend High Speed Pneumatic System

    Reason

    Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.

    Action

    The firm initiated the recall via letter on November 11, 2004.

    Distribution

    Nationwide and to the following foreign countries; Australia; Japan; Canada, China; Netherlands; Columbia; Mexico; Argentina; Sweden; Poland; Spain; Germany; Great Britan; Chile; Switzerland; Venezuela

    Quantity

    1432 units