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U.S. Department of Health and Human Services

Class 2 Device Recall NEBROS, Roscoe Mini Neb Compressor

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  Class 2 Device Recall NEBROS, Roscoe Mini Neb Compressor see related information
Date Initiated by Firm April 20, 2015
Date Posted June 06, 2015
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-1720-2015
Recall Event ID 71112
510(K)Number K031413  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product 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.
Code Information Models AG-MNEB and DS-NEB
Recalling Firm/
Manufacturer		 Compass Health Brands
21973 Commerce Pkwy
Strongsville OH 44149-5558
For Additional Information Contact Roscoe Medical Customer Support
800-376-7263
Manufacturer 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.
FDA Determined
Cause 2		 Use error
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 corporate@roscoemedical.com.
Quantity in Commerce 219,353 Manuals
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAF and Original Applicant = VEGA TECHNOLOGIES, INC.
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