BEUDAMED
    FDA Recall Terminated

    Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.

    Recall: Z-2455-2008 · Initiated August 11, 2008

    Recall

    Recall Number
    Z-2455-2008
    Event Number
    49140
    Firm
    Vital Signs Colorado Inc.
    FEI Number
    1718887
    Product Code
    BSR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 11, 2008
    Posted
    September 21, 2008
    Terminated
    January 10, 2011
    Address
    11039 East Lansing Circle, Englewood, CO, 80112-5909

    Description

    Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.

    Reason

    Light protector may detach from lighted stylet during intubation.

    Action

    Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.

    Distribution

    Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.

    Quantity

    73 pieces