Recall StatusTerminated
Date Initiated2015-04-20
Date Terminated2016-10-25
Product Quantity219,353 Manuals
Reason for Recall
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.
Firm 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 Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.