BEUDAMED
    FDA Enforcement Class II Terminated

    NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    Recall: Z-1182-2015 · Reported March 4, 2015

    Enforcement

    Recall Number
    Z-1182-2015
    Event ID
    70322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Navilyst Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2015
    Initiation Date
    January 9, 2015
    Classification Date
    February 25, 2015
    Termination Date
    March 10, 2017
    Address
    10 Glens Falls Technical Park, N/A, Glens Falls, NY, 12801, United States

    Description

    NAMIC Convenience Kit, HOPKINS LEFT HEART, UPN H749601836621, REF/Catalog No. 60183662, STERILE, Rx ONLY ---- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.

    Reason

    The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

    Code Info

    Lots 4406489, 4562012, 4638454, 4712616, 4771914, 4778741, 4782797.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

    Quantity

    11 units