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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: The affected products has lot numbers S46 and S47.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aptalis Pharmatech Inc.
- Reason for Recall:
- Customer notification that the device may be difficult to open or close.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
The affected products has lot numbers S46 and S47.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1006-2015