BEUDAMED
    FDA Recall Terminated

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Recall: Z-1628-2018 · Initiated March 19, 2018

    Recall

    Recall Number
    Z-1628-2018
    Event Number
    79643
    Firm
    Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland
    FEI Number
    3007134520
    Product Code
    CCT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 19, 2018
    Terminated
    August 27, 2019

    Description

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 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

    The recall notice was disseminated by letter on 03/19/2018. The letter stated the following: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number 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."

    Distribution

    TX

    Quantity

    25 units