BEUDAMED
    FDA Recall Terminated

    Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code:80-1190 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.

    Recall: Z-0708-2012 · Initiated October 25, 2011

    Recall

    Recall Number
    Z-0708-2012
    Event Number
    60362
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    GWM
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    October 25, 2011
    Posted
    January 11, 2012
    Terminated
    May 29, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Screw Product Code:80-1190 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.

    Reason

    Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.

    Action

    Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.

    Quantity

    2827 units