Teleflex Medical recalls Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code…

Recall date

October 27, 2016

Source

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

Recall number

Z-0898-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

Why it was recalled

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

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

What was recalled

Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes