BEUDAMED
    FDA Enforcement Class II Terminated

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    Recall: Z-1720-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1720-2015
    Event ID
    71112
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Compass Health Brands
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    April 20, 2015
    Classification Date
    June 5, 2015
    Termination Date
    October 25, 2016
    Address
    21973 Commerce Pkwy, N/A, Strongsville, OH, 44149-5558, United States

    Description

    Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.

    Reason

    Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and storing a Roscoe Medical Nebulizer to reduce user damage (wear & tear) to the power cord.

    Code Info

    Models AG-MNEB and DS-NEB

    Distribution

    Worldwide Distribution US nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and countries of:: Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Hong Kong, India, Norway, Spain, Trinidad and Tobago & United Kingdom.

    Quantity

    219,353 Manuals