Events

Recall of Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

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

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
    73366
  • Event Risk Class
    Class 2
  • Event Number
    Z-1236-2016
  • Event Initiated Date
    2016-02-10
  • Event Date Posted
    2016-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143969
  • 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
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • Reason
    Ambu, aura gain laryngeal mask, was found to have lack of sterility assurance. the firm discovered the problem during final quality control at manufacturing site. damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications.
  • Action
    Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.

Device

Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile
  • Model / Serial
    Catalog Number:408300000  Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914   Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075.   Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Please see attached consignee list
  • Product Description
    Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile || for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
  • Manufacturer
    Ambu Inc.

Manufacturer

Ambu Inc.
  • Manufacturer Address
    Ambu Inc., 6230 Old Dobbin Ln Ste 250, Columbia MD 21045-5955
  • Manufacturer Parent Company (2017)
    Vsri Holding Ii Aps
  • Source
    USFDA