Medical device recalls Moderate risk

Salter Labs recalls NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered di…

Recall date
August 4, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2781-2015
FDA classification
Class II
Brand / firm
Salter Labs
Sold / distributed
Worldwide Distribution - US Nationwide and in the countries of Greece, UK, Belgium, Australia, and Switerzland.

Why it was recalled

The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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