BEUDAMED
    FDA Recall 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 · Initiated April 20, 2015

    Recall

    Recall Number
    Z-1720-2015
    Event Number
    71112
    Firm
    Compass Health Brands
    FEI Number
    3005182235
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    April 20, 2015
    Posted
    June 6, 2015
    Terminated
    October 25, 2016
    Address
    21973 Commerce Pkwy, Strongsville, OH, 44149-5558

    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.

    Action

    Compass Health sent an Urgent Recall Field Correction letters dated April 20, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Ensure all affected personnel are fully informed of this notice. Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. Advise your customers regarding the proper care and storage of the nebulizers. Your customers should discard their NEB-ROS User Manual and immediately download the latest versions HERE. If they are unable to download the most recent version, hard copies can be provided. Please contact Roscoe Medical Customer Support at (800) 376-7263 Monday - Friday 8:00 am EST - 5:00 pm EST. Complete and return the attached Recall Field Correction Response Form to Roscoe Medical within fifteen (15) days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Roscoe Medical via fax number (440) 572-4261 or via email at [email protected].

    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