Aptalis Pharmatech Inc. recalls FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percusso…

Recall date

November 13, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1006-2015

FDA classification

Class II

Brand / firm

Aptalis Pharmatech Inc.

Sold / distributed

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.

Why it was recalled

Customer notification that the device may be difficult to open or close.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.