BEUDAMED
    FDA Recall Terminated

    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Recall: Z-3212-2017 · Initiated July 5, 2017

    Recall

    Recall Number
    Z-3212-2017
    Event Number
    77980
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    CCT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 5, 2017
    Posted
    August 25, 2017
    Terminated
    November 20, 2018
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Reason

    Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

    Action

    Teleflex sent an Urgent Medical Device Recall Notification letter on July 5, 2017, to all affected customers. The letter directed the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter." For questions regarding this recall call 866-246-6990.

    Distribution

    Nationwide distribution

    Quantity

    135,456 units