BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0898-2017 · Initiated October 27, 2016

    Recall

    Recall Number
    Z-0898-2017
    Event Number
    75554
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    CCQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 27, 2016
    Posted
    November 9, 2016
    Terminated
    September 25, 2020
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    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

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

    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 [email protected]. 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 dated November 22, 2016, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to continue to return affected product for a full refund per the procedure set forth in the letter of October 27, 2016. Some customers have indicated that, due to medical necessity, they plan to continue using the affected lots rather than return them. Teleflex is advising all such customers to follow the supplemental instructions for Use included as Attachment B. These supplemental instructions allow non-destructive testing of each unit prior to the procedure to determine if it is defective. Institutions that intend to continue using affected lots with this supplemental testing, please send the acknowledgment form to [email protected] with their name and contact information and the lots that they will continue to use, or call 866-246-6990. Customers with questions should contact their local sales representative or Customer Service at 1-866-246-6990.

    Distribution

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

    Quantity

    2,674,650 units in total