![]() ![]() 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. PEP/RMT (Medimex GmbH), Flutter VRP1 (Aptalis Pharma US). ![]() 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. PDF The use of breathing exercises with positive-pressure devices during hospitalization. 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. These devices, which can be introduced to school-aged children, include the acapella (Smiths Medical, Dublin, OH) Flutter (Aptalis, Birmingham. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 90. INDICATIONS The FLUTTER ® provides positive expiratory pressure (PEP) therapy for patients with mucus-producing respiratory conditions, including: Atelectasis, Bronchitis, Bronchiectasis, Cystic Fibrosis, Chronic Obstructive Pulmonary Disease (COPD), Asthma or other conditions producing retained secretions. Customer reviews Customer reviews 3. The letter identified the affected product, problem and actions to be taken. Aptalis Pharma Us, Inc Ar5891493099 Flutter Mucus Clearance. 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. FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. displaced by the airflow (such as the FLUTTER, Aptalis Pharma Inc, Bridgewater. 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. Positive expiratory pressure devices, such as Acapella Choice. Percussor, powered-electric - Product Code BYIįLUTTER Percussor respiratory device, packaged one unit per clear plastic package.
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