BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1557-2015 · Initiated March 13, 2015

    Recall

    Recall Number
    Z-1557-2015
    Event Number
    70753
    Firm
    Vital Signs Colorado Inc.
    FEI Number
    1718887
    Product Code
    BSR
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 13, 2015
    Posted
    April 30, 2015
    Terminated
    October 7, 2015
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909

    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.

    Action

    Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).

    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