BEUDAMED
    FDA Recall Terminated

    Newport HT50 All Purpose Ventilator

    Recall: Z-1375-05 · Initiated October 29, 2005

    Recall

    Recall Number
    Z-1375-05
    Event Number
    31282
    Firm
    Newport Medical Instruments Inc
    FEI Number
    2023050
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2005
    Posted
    August 17, 2005
    Terminated
    August 2, 2012
    Address
    1620 Sunflower Ave., Costa Mesa, CA, 92626

    Description

    Newport HT50 All Purpose Ventilator

    Reason

    Lack of alarm prior to shutdown.

    Action

    Notice of Field Correction was sent to consignees dated 10/29/2004. A second notice was sent 12/20/04 announcing that materials for conducting an upgrade were being sent which included a manual insert and brochure regarding the battery. Also request was made to return products as they are available. Notice was sent 12/20/04 that field correction kits were available for order. Recall is ongoing.

    Distribution

    Nationwide and Argentina, Australia, Bangledesh, Belgium, Bolivia, Brazil, Bulgria, Canada, Chile, Hong Kong, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Liechtenstein, Lithuania, Malaysia, Mexico, Netherlands, New Caldonia, Paraguay, Philipines, Poland, Portugal, Quatar, Republic of South Africa, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Sri Lanka, Sultanate of Oman, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Yemen Republic.

    Quantity

    3654