FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor
FDA device recall Z-1006-2015 · posted 2015-01-22 · Terminated
Recall details
- Recalling firm
- Aptalis Pharmatech Inc.
- Reason for recall
- Customer notification that the device may be difficult to open or close.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BYI
- Quantity affected
- 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
- Date initiated
- 2014-11-13
- Date posted
- 2015-01-22
- Date terminated
- 2015-07-11
- Location
- Vandalia, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLUTTER(R) (K946083) | Bradstreet Clinical Research Assoc., Inc. | 1995-03-13 |