Recall Z-2781-2015 ยท CAF Nebulizer (Direct Patient Interface)
Salter Labs
NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.
| Date | Sep 17, 2015 (initiated Aug 4, 2015) |
| Status | Terminated |
| Reason | The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. |
| Root cause | Component change control |
| Action | Salter Labs sent a Medical Device Recall letter dated July 24 2015. The letter identified the affected product, problem and actions to be taken. The letter states that all affected product can be returned to Salter Labs for replacement at no charge with product specifically inspected for a tighter fit on the inspiratory valve cap. Customers were instructed to complete and return the Return Response Form as soon as possible. For any questions contact Salter Labs Customer Support at 800-421-0024 or the local Salter Labs representative. |
| Quantity | 8,975 |
| Distribution | Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland. |
| FDA record | Open on fda.gov |