BEUDAMED
    FDA Recall Terminated

    SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

    Recall: Z-0554-04 · Initiated May 23, 2003

    Recall

    Recall Number
    Z-0554-04
    Event Number
    26463
    Firm
    Scion Cardio-Vascular, Inc.
    FEI Number
    1000113395
    Product Code
    FGO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2003
    Posted
    February 27, 2004
    Terminated
    May 7, 2004
    Address
    14256 SW 119 Avenue, Miami, FL, 33186

    Description

    SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST

    Reason

    Possible difficulty for the user in opening the stone retrieval basket.

    Action

    The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003.

    Distribution

    Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.

    Quantity

    28