BEUDAMED
    FDA Recall Terminated

    PET Infusion Pump

    Recall: Z-0400-2017 · Initiated September 30, 2016

    Recall

    Recall Number
    Z-0400-2017
    Event Number
    75387
    Firm
    Bayer Healthcare
    FEI Number
    2520313
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 30, 2016
    Posted
    November 11, 2016
    Terminated
    March 24, 2017
    Address
    1 Bayer Dr, Indianola, PA, 15051-9702

    Description

    PET Infusion Pump

    Reason

    The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.

    Action

    Bayer mailed an Urgent Medical Device Customer Notification letter to the affected consignees on September 30, 2016 asking that they review their current SAS inventory and determine if you have any product that is more than one year past its manufacturing date, Quarantine unused units and call Bayer Customer Care line to receive a Return Goods Authorization (RGA) number for the product's return.

    Distribution

    Distributed Nationwide and internationally to : Taiwan, Ukraine, Turkey, Thailand, Slovania, Singapore, Sweden, Saudi Arabia, Serbia, Romania, Qatar, Portugal, Poland, Panama, Oman, Norway, The Netherlands, Mexico, Malta, Morraco, Libyan, Lithuania, Lebanon, Kuwait, Italy, Israel, Hungray, United Kingdom, France, Finland, Spain, Denmark, Germany, Czech Republic, Chile, Switzerland, Belguim, Bosnia, Austria, Australia,

    Quantity

    165,127 (79,714 units in U.S.)