NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered dir
FDA device recall Z-2781-2015 · posted 2015-09-17 · Terminated
Recall details
- Recalling firm
- Salter Labs
- Reason for recall
- The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- CAF
- Quantity affected
- 8,975
- Distribution
- Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
- Date initiated
- 2015-08-04
- Date posted
- 2015-09-17
- Date terminated
- 2016-05-06
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALTERLABS 8660 SERIES NEBULIZER (K962879) | Salter Labs | 1996-10-22 |
| SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) (K961476) | Salter Labs | 1996-07-16 |