FDA-Device2016-12-28Class II
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
Teleflex Medical
Hazard
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Sold states
Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Affected count
2,674,650 units in total
Manufactured in
2917 Weck Dr, N/A, Research Triangle Park, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0898-2017Don't want to check this manually?
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