Aptalis Flutter Percussor Respiratory Device Recalled for Packaging Defect
Aptalis Pharmatech Inc. is recalling approximately 49,000 Flutter Percussor respiratory devices because the packaging may be difficult to open or close.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging issue (difficulty opening/closing) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging-only problems.
Plain-English summary
Aptalis Pharmatech Inc. is recalling approximately 49,000 units of the FLUTTER Percussor respiratory device. The recall is due to a customer notification that the device may be difficult to open or close. The affected products are packaged one unit per clear plastic package and have lot numbers S46 and S47.
The FLUTTER Percussor is intended to be used as a mucus clearance device for patients with mucus-producing respiratory conditions such as atelectasis, bronchitis, bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease (COPD), and asthma. The affected units were distributed worldwide, including in the United States and in Canada, Australia, Argentina, Guatemala, Serbia, Chile, and Finland.
Consumers should stop using the affected devices and contact Aptalis Pharmatech Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- 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…
- Manufacturer
- Aptalis Pharmatech Inc.
- Hazard
- Affected units
- 49,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- The affected products has lot numbers S46 and S47.
Distribution
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