BEUDAMED
    FDA Recall Terminated

    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.

    Recall: Z-1690-2013 · Initiated June 7, 2013

    Recall

    Recall Number
    Z-1690-2013
    Event Number
    65420
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 7, 2013
    Posted
    July 16, 2013
    Terminated
    April 21, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.

    Reason

    Miscalibrated Fill Level Sensor may affect dosing level

    Action

    Codman issued a Medical Device Correction Notification to Medical Facilities dated June 7, 2013 via FedX to inform them of the potential problem and a Worksheet (instructions) to Identify Pumps with Miscalibrated FLS during each patient's next scheduled refill session or sooner if patient is symptomatic. If a pump is identified as having a miscalibrated FLS, notify Codman Neuro using the same worksheet. In addition a sample letter was provided to Physi cans to provide to patients on the system. Follow the recommendations for managing patients who are identified as having a pump with a miscalibrated FLS. For additional information,contact your Codman Neuro representative, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to Codman Neuro at 1-866-491-0974, Option 2.

    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

    2 units US and 735 OUS