BEUDAMED
    FDA Recall Terminated

    ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242

    Recall: Z-0390-2007 · Initiated December 5, 2006

    Recall

    Recall Number
    Z-0390-2007
    Event Number
    37019
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    DTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2006
    Posted
    February 1, 2007
    Terminated
    July 24, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242

    Reason

    Specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch

    Action

    On December 5, 2006, the firm began notifying all affected customers, affiliates and distributors of the recall via letter. The letter advises that the firm has voluntarily recalled specific lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat .096' Rotating Hemostatic Valve (RHV) due to a potentially incomplete seal in the pouch. The letter advises Abbott Vascular will be replacing all returned product and that appropriate corrective actions will be implemented.

    Distribution

    Worldwide, including USA, Canada, Germany, Italy, Greece, New Zealand, Netherlands, France, Japan, Spain, and Bulgaria.

    Quantity

    6090751 - 791 devices, 6090752 - 656 devices, 6091151 - 381 devices, 6091152 - 132 devices