Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1720-2015

April 20, 2015

Class II

Product summary

Firm
Compass Health Brands
Event
Event 71112
Status
Terminated
Classification
Class II
Quantity
219,353 Manuals
Official record key
device-enforcement:Z-1720-2015

Official wording

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 information: Models AG-MNEB and DS-NEB

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.