BEUDAMED
    FDA Recall Terminated

    Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA

    Recall: Z-2580-2010 · Initiated May 20, 2010

    Recall

    Recall Number
    Z-2580-2010
    Event Number
    56046
    Firm
    Cardima Inc
    FEI Number
    1000150772
    Product Code
    OCL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 20, 2010
    Posted
    September 27, 2010
    Terminated
    March 23, 2011
    Address
    47266 Benicia St, Fremont, CA, 94538-1372

    Description

    Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA

    Reason

    Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.

    Action

    Cardima issued a Product Recall Notification dated May 18, 2010 to customers, identifying the affected product, the sterility issue, and the actions to be taken by the customer. Custormers are to quarantine and return the affected product to the firm. The firm will replace returned product as soon as it becomes available. Cardima Customer Service can be contacted at 800 354-0102.

    Distribution

    Worldwide Distribution to Distributors in USA (Pittsburgh, PA) and the countries of Ireland and Belgium, and customers in the states of CA, OH, MI, MO, AND WA, and the countries of Ireland and the Netherlands.

    Quantity

    28 units