Events

Recall of Resus-EZY Air Cushion Mask

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Schell Medical Corporation Pty 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
    RC-2016-RN-01169-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-09-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01169-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Schell medical is advising users of an issue regarding product expiry dates for air cushion masks that were purchased between july 2009 and july 2011. these older masks do not have the expiry date shown on the unit label. they do have a lot number, which also doubles as the manufacturing date. this date is shown in the ddmmyy format, e.G lot no. 240511 indicates the mask was manufactured on 24th may 2011. the life of the mask is 5 years, thus in this example this mask has expired and should be discarded.
  • Action
    Schell Medical is advising users to inspect stock and discard any remaining units of the affected lots. Product manufactured since July 2011 includes the expiry date on the label and is unaffected by this issue. This action has been closed-out on 12/05/2017.

Device

Resus-EZY Air Cushion Mask
  • Model / Serial
    Resus-EZY Air Cushion MaskCatalogue Number: HP-8400, HP-8401, HP-8402, HP-8403, HP-8404, HP-84505Multiple lot numbers affectedSupplied between July 2009 and July 2011ARTG Number: 143640
  • Manufacturer
    Schell Medical Corporation Pty Ltd

Manufacturer

Schell Medical Corporation Pty Ltd