Recall Z-0898-2017 ยท CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Teleflex Medical
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
| Date | Nov 9, 2016 (initiated Oct 27, 2016) |
| Status | Terminated |
| Reason | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| Root cause | Process control |
| Action | Teleflex sent an Urgent Medical Device Recall Notification letter on/about October 27, 2016. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine affected products. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to Teleflex Customer Service or email to recalls@teleflex.com. For questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990. Teleflex sent an Amended Urgent Medical Device Recall Notification letter date |
| Quantity | 2,674,650 units in total |
| Distribution | Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.