BEUDAMED
    FDA Enforcement Class II Terminated

    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.

    Recall: Z-1557-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1557-2015
    Event ID
    70753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vital Signs Colorado Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    April 30, 2015
    Termination Date
    October 7, 2015
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909, United States

    Description

    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.

    Reason

    Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.

    Code Info

    Catalog Number 3960

    Distribution

    Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.

    Quantity

    399