Device product
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.
Z-2781-2015
Product summary
- Firm
- Salter Labs
- Event
- Event 71909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,975
- Official record key
device-enforcement:Z-2781-2015
Official wording
Reason: The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.
Code information: Lot Numbers 042015 through 070615A Series 8660, 8960, 8961, 8966, 8984. Nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7), Inspiratory valve cap (part number 600116).
Distribution pattern: Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.
Derived failure modes
-
Unknown
The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.