BEUDAMED
    FDA Recall Terminated

    Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

    Recall: Z-2770-2011 · Initiated June 9, 2011

    Recall

    Recall Number
    Z-2770-2011
    Event Number
    59003
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 9, 2011
    Posted
    July 11, 2011
    Terminated
    April 5, 2012
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

    Description

    Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Langston dual lumen catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

    Reason

    Vascular Solutions, Inc investigation of a recent Device Experience Report has made them aware of a potential problem with their 7F Langston dual lumen pigtail catheter (Model 5515) with lot number 548264. Recently it was reported that pouches containing Langston catheters (Model 5515) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier

    Action

    Vascular Solutions, Inc. sent an "URGENT MEDICAL DEVICE FIELD ACTION- LOT SPECIFIC" letter dated June 7, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructed customers to check their inventory for the affected product and provided information on how to examine the product. Customers are to complete and return a Field Action Customer Inventory Form via fax at 763-656-4250 or e-mail at www.vascularsolutions.com. VSI Customer Service will contact customers to set up return shipment of affected product. All affected product will be replaced upon receipt of the shipped product. Customers should contact their local Sales Representative for questions concerning this recall.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of CA, FL, IL, MA, MI, MO, NM, NC, OK, and WA and the countries of Austria and Canada.

    Quantity

    23 (5 pack) boxes