FDA-Device2015-01-28Class II
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.
Aptalis Pharmatech Inc.
Hazard
Customer notification that the device may be difficult to open or close.
Sold states
Worldwide Distribution - US Nationwide in the states of OH, NM, CO, NC, IL, MD, LA, MN, NJ, SC, AL, VA, MI, MA, and CA. in the countries of: Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.
Affected count
Approximately 49,000 units
Manufactured in
845 Center Dr, N/A, Vandalia, OH, United States
Products
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1006-2015Don't want to check this manually?
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