Events

Recall of Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical Europe Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79643
  • Event Risk Class
    Class 2
  • Event Number
    Z-1628-2018
  • Event Initiated Date
    2018-03-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162883
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Applicator (laryngo-tracheal), topical anesthesia - Product Code CCT
  • 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 recalls@teleflex.com. 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 recalls@teleflex.com. This will allow us to document your receipt of this letter."

Device

Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM)
  • Model / Serial
    Lot Number 161212
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TX
  • Product 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
  • Manufacturer
    Teleflex Medical Europe Ltd

Manufacturer

Teleflex Medical Europe Ltd
  • Manufacturer Address
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA