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Z-1720-2015 Class II Terminated

Recalled by Compass Health Brands — Strongsville, OH

FDA device recall Z-1720-2015 was initiated by Compass Health Brands on April 20, 2015 and is designated Class II. 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… The recall status is terminated (terminated October 25, 2016). Affected quantity: 219,353 Manuals.

Recall Details

Product Type: Devices
Report Date: June 17, 2015
Initiation Date: April 20, 2015
Termination Date: October 25, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 219,353 Manuals

Product 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 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.

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.

Code Information

Models AG-MNEB and DS-NEB