BEUDAMED
    FDA Recall Terminated

    7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.

    Recall: Z-1452-06 · Initiated August 4, 2006

    Recall

    Recall Number
    Z-1452-06
    Event Number
    36087
    Firm
    CryoCath Technologies Inc. 16771 Chemin Ste-Marie Kirkland Canada
    FEI Number
    3002648230
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2006
    Posted
    August 29, 2006
    Terminated
    January 16, 2007

    Description

    7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.

    Reason

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

    Action

    Consignees were notified by letter on 08/04/2006.

    Distribution

    Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.

    Quantity

    34 units