BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    Recall: Z-1747-2014 · Reported June 18, 2014

    Enforcement

    Recall Number
    Z-1747-2014
    Event ID
    68279
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NEO METRICS, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2014
    Initiation Date
    March 31, 2014
    Classification Date
    June 10, 2014
    Termination Date
    January 16, 2015
    Address
    2605 Fernbrook Ln N Ste J, N/A, Plymouth, MN, 55447-4756, United States

    Description

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    Reason

    Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

    Code Info

    MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899

    Distribution

    Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.

    Quantity

    1256 boxes ( 2 wires/box)