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
Reported: December 28, 2016 Initiated: October 27, 2016 #Z-0898-2017
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.
Details
- Recalling Firm
- Teleflex Medical
- Units Affected
- 2,674,650 units in total
- Distribution
- Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product 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. Recalled by Teleflex Medical. Units affected: 2,674,650 units in total.
Why was this product recalled? ▼
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2016. Severity: Moderate. Recall number: Z-0898-2017.
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