Events

Recall of ULTRA Fabric Reinforced Surgical Gown, X- Large; MICROCOOL Breathable Gown, with SECURE-FIT, with Towel, X-Large

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kimberly Clark Aust 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-2012-RN-00685-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00685-3
  • 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
    Investigation identified variability occurring during the gown folding process which increased the thickness or height of the folded gown prior to packaging. the increased height of the folded gowns may cause the package seal to be compromised.
  • Action
    Quarantine and return affected devices to Kimberly Clark.

Device

ULTRA Fabric Reinforced Surgical Gown, X- Large; MICROCOOL Breathable Gown, with SECURE-FIT, with...
  • Model / Serial
    ULTRA Fabric Reinforced Surgical Gown, X- Large; MICROCOOL Breathable Gown, with SECURE-FIT, with Towel, X-LargeULTRA Fabric Reinforced Surgical GownProduct Code: 95221All lot numbers beginning with:AH9284*** to AH9356***AH0007*** to AH0356***AH1008*** to AH1364***AH2006*** to AH2146***MICROCOOL Breathable GownProduct Code: 92321All lot numbers beginning with: AH9303*** to AH9362***AH0016*** to AH0356***AH1020*** to AH1364*** AH2009*** to AH2132***ARTG: 139475
  • Manufacturer
    Kimberly Clark Aust Pty Ltd

Manufacturer

Kimberly Clark Aust Pty Ltd