BEUDAMED
    FDA Enforcement Class II Terminated

    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

    Recall: Z-2251-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2251-2013
    Event ID
    66060
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 25, 2013
    Initiation Date
    August 12, 2013
    Classification Date
    September 18, 2013
    Termination Date
    June 16, 2014
    Address
    87 Venture Drive, N/A, Dover, NH, 03820-5914, United States

    Description

    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

    Reason

    Microbore tubing disconnecting from male luers on the extension sets.

    Code Info

    1203117, 1206030, 1212111, 1304133, 130516

    Distribution

    Nationwide Distribution (US), including the states of NY, MN, NJ, PA, FL, MD, and VA.

    Quantity

    13100