BEUDAMED
    FDA Recall Terminated

    Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.

    Recall: Z-0437-05 · Initiated January 12, 2005

    Recall

    Recall Number
    Z-0437-05
    Event Number
    30903
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    NIQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2005
    Posted
    January 26, 2005
    Terminated
    February 9, 2005
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.

    Reason

    Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.

    Action

    A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005.

    Distribution

    Distributed throughout the United States.

    Quantity

    300