BEUDAMED
    FDA Recall Terminated

    RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.

    Recall: Z-0320-2007 · Initiated May 25, 2006

    Recall

    Recall Number
    Z-0320-2007
    Event Number
    36854
    Firm
    Rymed Technologies, Inc.
    FEI Number
    3005951712
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 25, 2006
    Posted
    December 30, 2006
    Terminated
    March 26, 2007
    Address
    6000 W. William Cannon Drive, Bldg. B Suite 300, Austin, TX, 78749

    Description

    RYM-5000 InVision-Plus NEUTRAL I.V. Connector, packaged 200 units per box, 5 boxes per case (1000 units/case); labeled as Sterile-Nonpyrogenic; assembled in Mexico for Rymed Technologies, Inc., Austin, TX.

    Reason

    Weld failures on IV connector (area of female luer and spike body)

    Action

    Consignees were notified by e-mail and/or phone on 05/25/06 regarding the recall. Distributors were asked to return product.

    Distribution

    Nationwide Recall

    Quantity

    16,000 units.