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

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

Code information: Product code MAD100, Batch/Lot numbers 160105, 160137, 160302, 160321, 160402, 160435, 160506, 160523, 160609, 160620, 160707, 160802, 160813; Product code MAD100OS, Batch/Lot numbers 160322, 160524, 160630; Product code MAD110, Batch/Lot numbers 160217, 160507; Product code MAD110OS, Batch/Lot numbers 160240, 160312; Product code MAD130, Batch/Lot numbers 160107, 160138, 160517; Product code MAD130OS, Batch/Lot numbers 160436, 160803; Product code MAD140, Batch/Lot numbers 160125, 160218, 160437, 160610, 160801; Product code MAD140OS, Batch/Lot numbers 160226, 160438, 160727; Product code MAD300, Batch/Lot numbers 160108, 160117, 160126, 160145, 160146, 160200, 160219, 160225, 160231, 160300, 160313, 160327, 160400, 160409, 160422, 160432, 160440, 160500, 160518, 160602, 160611, 160621, 160631, 160701, 160708, 160718, 160728, 160800, 160804, 160814, 160816, 160823; Product code MAD300B, Batch/Lot number 160410.

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