Drug recall
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a…
FDA recall event 70007 · Class II · Aptalis Pharmatech Inc.
Key facts
| Event ID | 70007 |
|---|---|
| Recall numbers | Z-1006-2015 |
| Recalling firm | Aptalis Pharmatech Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customer notification that the device may be difficult to open or close. |
| Initiation date | Nov 13, 2014 |
| Report date | Jan 28, 2015 |
| Termination date | Jul 11, 2015 |
| City | Vandalia |
| State | OH |
| Country | United States |
| FEI number | 1525864 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: