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. Nu-Hope: 7658-FV-C, Nu-Hope - 7658-FV-C - Nu-Flex Mid-Size Convex Urine Pouch with Flutter Valve 1 Opening, Pre-Cut, Nu-Flex Mid-Size Convex Urine Pouch. 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 FLUTTER DEVICE FOR FREE
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. Database contains 1 Aptalis Flutter Mucus Clearance Device Manuals (available for free online viewing or downloading in PDF): Instructions for use. 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.
Percussor, powered-electric - Product Code BYIįLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Respiratory equipment includes samples taken from patients nebulizers and airways clearance device (FLUTTER, Aptalis). To get the current version of the Flutter SDK, including its framework, engine, and tools: flutter -version flutter commands The following table shows which commands you can use with the flutter tool: For additional help on any of the commands, enter flutter help
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