Z-1720-2015Class II

Roscoe Mini Neb Compressor User Manual for the NEB-ROS

Name: Z-1720-2015 Roscoe Mini Neb Compressor User Manual for the NEB-ROS
Creator: Compass Health Brands
Published: 2015-04-20
License: https://open.fda.gov/license/

Compass Health Brands (Distribution Center) / initiated 2015-04-20 / Terminated

FDA source

Compass Health Brands began a recall of 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 on 2015-04-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1720-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Posted: 2015-06-06
Terminated: 2016-10-25
Recalling firm: Compass Health Brands (Distribution Center)
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.
Product code: CAF Nebulizer (Direct Patient Interface)
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.
FDA 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. 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].
Quantity in commerce: 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, Costa Rica, Dominican Republic, Ecuador, France, Hong Kong, India, Norway, Spain, Trinidad and Tobago & United Kingdom.
Product codes and lots: Models AG-MNEB and DS-NEB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1720-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1720-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-05

Product code CAF

K031413Class IIVigormist Compressor NebulizerVega Technologies, Inc. / cleared 2003-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)