Recall Z-1720-2015 ยท CAF Nebulizer (Direct Patient Interface)
Compass Health Brands
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.
| Date | Jun 6, 2015 (initiated Apr 20, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 |
| Quantity | 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031413 | VIGORMIST COMPRESSOR NEBULIZER Vega Technologies, Inc., Oct 7, 2003 |