BEUDAMED
    FDA Enforcement Class I Terminated

    MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    Recall: Z-2296-2013 · Reported October 9, 2013

    Enforcement

    Recall Number
    Z-2296-2013
    Event ID
    65821
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2013
    Initiation Date
    August 13, 2013
    Classification Date
    September 30, 2013
    Termination Date
    September 11, 2014
    Address
    325 Paramount Drive, Raynham, MA, 02767, United States

    Description

    MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.

    Reason

    Drug flow rates exceeding programmed flow rates.

    Code Info

    OUS: Per recall strategy

    Distribution

    Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.

    Quantity

    OUS: 2168 units