Recall Z-1720-2015— Compass Health Brands
Class II · Terminated
Class II FDA medical device recall by Compass Health Brands, initiated 2015-04-20, terminated 2016-10-25. It names one FDA 510(k) clearance: K031413. 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.. 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..
- Recalling firm
- Compass Health Brands
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-20
- Terminated
- 2016-10-25
- Firm location
- Strongsville, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.