BEUDAMED
    FDA Enforcement Class I Terminated

    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.

    Recall: Z-1691-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1691-2013
    Event ID
    65420
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    July 16, 2013
    Termination Date
    April 21, 2015
    Address
    325 Paramount Drive, N/A, Raynham, MA, 02767, United States

    Description

    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.

    Reason

    Miscalibrated Fill Level Sensor may affect dosing level

    Code Info

    All serial numbers

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Belgium, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, Portugal, Greece, Egypt, Switzerland, and Turkey.

    Quantity

    5 US and and 360 OUS