BEUDAMED
    FDA Recall Terminated

    Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx

    Recall: Z-0555-05 · Initiated November 18, 2004

    Recall

    Recall Number
    Z-0555-05
    Event Number
    30826
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    NIQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 18, 2004
    Posted
    February 18, 2005
    Terminated
    November 19, 2008
    Address
    14201 NW 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx

    Reason

    Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

    Action

    The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product.

    Distribution

    Distributed nation wide.

    Quantity

    80297 units