BEUDAMED
    FDA Recall Terminated

    Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.

    Recall: Z-2057-2008 · Initiated May 8, 2008

    Recall

    Recall Number
    Z-2057-2008
    Event Number
    48169
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    HCG
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    May 8, 2008
    Posted
    September 16, 2008
    Terminated
    October 21, 2008
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.

    Reason

    The product length is declared incorrectly in mm when the unit of measurement should be cm.

    Action

    Consignees were notified via recall letter dated 5/9/08 that the firm would replace product on hand. Distributors were requested to notify their customers of the recall. If you have questions, contact Customer Relations Department at 800-346-2686.

    Distribution

    Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.

    Quantity

    1183