BEUDAMED
    FDA Recall Terminated

    7 cm Catheter Reservoir with 10 cm extension

    Recall: Z-0366-06 · Initiated March 24, 2005

    Recall

    Recall Number
    Z-0366-06
    Event Number
    32533
    Firm
    Vygon Neuro
    FEI Number
    2518608
    Product Code
    HCA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2005
    Posted
    January 10, 2006
    Terminated
    January 10, 2006
    Address
    2495 General Armistead Ave, Norristown, PA, 19403-3685

    Description

    7 cm Catheter Reservoir with 10 cm extension

    Reason

    stylet in package is shorter than that claimed on the label

    Action

    The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.

    Distribution

    The product was shipped to a hospital in CA and a distributor in Germany.

    Quantity

    11 units