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Roscoe Mini Neb Compressor User Manual for the NEB-ROS recallZ-1720-2015 · Compass Health Brands · initiated Apr 20, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Compass Health Brands or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Use error

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1720-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 20, 2015
Posted by the FDA
Jun 6, 2015
Recalling firm
Compass Health Brands
Quantity
219,353 Manuals
Product code
CAF
FDA submissions
K031413
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.

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.

Code information (models, lots, serial numbers)

Models AG-MNEB and DS-NEB

Other devices under the same FDA submission

7 devices cleared under K031413 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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