Events

Recall of Device Recall LMA

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

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
    70258
  • Event Risk Class
    Class 2
  • Event Number
    Z-1085-2015
  • Event Initiated Date
    2015-01-13
  • Event Date Posted
    2015-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132646
  • 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
    Airway, oropharyngeal, anesthesiology - Product Code CAE
  • Reason
    The labelling of units from the affected lot indicates that it contains a size 5 lma supreme (new cuff), but may contain a size 4 lma supreme (new cuff).
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letter dated January 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products and to return it to Teleflex Medical. Customers were asked to complete the enclosed Recall Acknowledgement Form via fax even if they do not have the affected product in stock. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall LMA
  • Model / Serial
    Catalog No(s): 175050, Lot no. HMAUGK
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - U.S Nationwide in the states of: AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA & WA and the country of Canada.
  • Product Description
    LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, || Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA