#Aptalis flutter device manuals
#Aptalis flutter device pdf

Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.ĥ10(K)s with Product Code = BYI and Original Applicant = BRADSTREET CLINICAL RESEARCH ASSOC., INC. View online (3 pages) or download PDF (59 KB) Aptalis Flutter Mucus Clearance Device Instructions for use Flutter Mucus Clearance Device PDF manual. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. in the countries of: Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.ġ A record in this database is created when a firm initiates a correction or removal action. Worldwide Distribution - US Nationwide in the states of OH, NM, CO, NC, IL, MD, LA, MN, NJ, SC, AL, VA, MI, MA, and CA. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 90. The letter identified the affected product, problem and actions to be taken. Aptalis Axcan Scandipharm Flutter Mucus Clearance Device is shaped like a pipe with a hardened plastic mouthpiece at one end, a plastic protective, perforated cover at the other end, and a high-density stainlesssteel ball resting in a plastic circular cone on the inside. The affected products has lot numbers S46 and S47.Ĭustomer notification that the device may be difficult to open or close.Īptalis Pharmatech distributed a customer notification letter on November 13, 2014.

#Aptalis flutter device manuals

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 Flutter Mucus Clearance Device Manuals & User Guides User Manuals, Guides and Specifications for your Aptalis Flutter Mucus Clearance Device Medical Equipment. Percussor, powered-electric - Product Code BYIįLUTTER Percussor respiratory device, packaged one unit per clear plastic package. These devices are the Positive Expiratory Pressure, the High Frequency Chest Wall Oscillation, the Oral High Frequency Oscillation, the Intrapulmonary Percussive Ventilation, the Incentive Spirometry the Flutter and the Acapella and the Cornet.