BEUDAMED
    FDA Recall Terminated

    Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

    Recall: Z-2313-2009 · Initiated July 1, 2009

    Recall

    Recall Number
    Z-2313-2009
    Event Number
    52989
    Firm
    Penumbra Inc.
    FEI Number
    3005168196
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    July 1, 2009
    Posted
    September 24, 2009
    Terminated
    November 30, 2010
    Address
    1351 Harbor Bay Pkwy, Alameda, CA, 94502-6541

    Description

    Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

    Reason

    Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'

    Action

    Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.

    Distribution

    CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.

    Quantity

    37 units