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Aptalis Pharmatech Inc. recalls FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a per
Recalled January 28, 2015 · FDA recall Z-1006-2015 · Aptalis Pharmatech
Hazard
Customer notification that the device may be difficult to open or close. · FDA Class II
Units
Approximately 49,000 units
Sold at
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.
Description
Customer notification that the device may be difficult to open or close.
Product
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.
Manufacturer(s)
Aptalis Pharmatech Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →