BEUDAMED
    FDA Recall Terminated

    HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.

    Recall: Z-0211-2008 · Initiated August 22, 2007

    Recall

    Recall Number
    Z-0211-2008
    Event Number
    45426
    FEI Number
    3005747797
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    August 22, 2007
    Posted
    December 28, 2007
    Terminated
    August 13, 2012
    Address
    4024 Stirrup Creek Dr, Teleflex Creek Dr, Durham, NC, 27703-9000

    Description

    HUDSON RCI, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Teleflex Medical, Research Triangle Park, NC 27709.

    Reason

    Decreased in flow output; through the nebulizer -(when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient)

    Action

    Customers were notified by an Urgent Medical Device Recall letter on/about 08/22/2007. They were instructed to return the affected products to Teleflex Medical or acknowledge that the products no longer exist. In addition, each were instructed to forward the letter if they have further distributed into institutional settings or to homecare patients and retrieve relevant product from those locations. This recall is to the consumer/user level via sub-recall from distributors or direct accounts as per the Recalling firm.

    Distribution

    Worldwide: USA, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, France, Germany, Guatemala, India, Mexico, Panama, Peru, Philippines, South Korea, Thailand, United Arab Emirates, and The United Kingdom.

    Quantity

    215,656 units