T-piece Nebulizer with in-line connectors recalled over sterility concerns

Recall date

January 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Salter Labs recalls T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device d…

Recall number

Z-0796-2016

FDA classification

Class II

Brand / firm

Salter Labs

Sold / distributed

Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.

Why it was recalled

Reports that the T-piece does not fit on the nebulizer.

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

What was recalled

T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.