Recall Z-0898-2017— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2016-10-27, terminated 2020-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-27
- Terminated
- 2020-09-25
- Firm location
- Research Triangle Park, NC, United States
Product description
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 for recall
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Data sourced from openFDA. This site is unofficial and independent of the FDA.