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U.S. Department of Health and Human Services

Class 2 Device Recall FLUTTER

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  Class 2 Device Recall FLUTTER see related information
Date Initiated by Firm November 13, 2014
Date Posted January 22, 2015
Recall Status1 Terminated 3 on July 11, 2015
Recall Number Z-1006-2015
Recall Event ID 70007
510(K)Number K946083  
Product Classification Percussor, powered-electric - Product Code BYI
Product 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.
Code Information The affected products has lot numbers S46 and S47.
Recalling Firm/
Manufacturer		 Aptalis Pharmatech Inc.
845 Center Dr
Vandalia OH 45377-3129
For Additional Information Contact
937-898-9669
Manufacturer Reason
for Recall		 Customer notification that the device may be difficult to open or close.
FDA Determined
Cause 2		 Process control
Action Aptalis Pharmatech distributed a customer notification letter on November 13, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to forward complaints to Aptalis Pharmatech Customer Service department at 908-927-9600.
Quantity in Commerce Approximately 49,000 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BYI and Original Applicant = BRADSTREET CLINICAL RESEARCH ASSOC., INC.
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