BEUDAMED
    FDA Recall Terminated

    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.

    Recall: Z-1572-2014 · Initiated November 10, 2015

    Recall

    Recall Number
    Z-1572-2014
    Event Number
    67921
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 10, 2015
    Posted
    May 9, 2014
    Terminated
    November 10, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 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.

    Reason

    A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

    Action

    Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at [email protected] We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to

    Distribution

    Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

    Quantity

    34