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. 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. By device type, the market can be segmented into intrapulmonary percussive ventilation, high-frequency chest wall oscillation, flutter mucus clearance. 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. Respiratory equipment includes samples taken from patients nebulizers and airways clearance device (FLUTTER, Aptalis). 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.
The letter identified the affected product, problem and actions to be taken.
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. When you exhale into the flutter valve against backpressure, the ball. The device is triangular-shaped with a fluttering steel ball inside. It’s the most common type of oscillatory PEP therapy and is commonly used in patients with cystic fibrosis. 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. A flutter valve is a small, handheld device that is used to help clear mucus from the lungs. Percussor, powered-electric - Product Code BYIįLUTTER Percussor respiratory device, packaged one unit per clear plastic package.
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