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Small Particle Aerosol Generator Model SPAG-2 6000 Series
- Starting date:
- April 5, 2017
- Posting date:
- May 2, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63130
Reason
The Spag-2 Nebulizer may not deliver aerosolized particles within the specified size or distribution parameters. Potential health consequence includes failure of the particles to reach the lower area of the respiratory tract, resulting in inadequate dosing or limited treatment effectiveness. Patients with respiratory distress due to concomitant pulmonary conditions may be at greater health risk or require additional medical intervention.
Affected products
Small Particle Aerosol Generator Model SPAG-2 6000 Series
Lot or serial number
S/N: 337170600007
Model or catalog number
6002
Companies
- Manufacturer
-
Valeant Pharmaceuticals North America LLC
400 Somerset Corporate Blvd
Bridgewater
08807
New Jersey
UNITED STATES