Recall of Kimguard Container Filters 7.5in (19cm) round & 9x9in (23x23cm) square (Used for wrapping medical devices prior to sterilisation)

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-2013-RN-00244-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-21
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • 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
    These products may have thin areas which could potentially compromise the ability of the filter to maintain a sterile barrier.
  • Action
    Customers are requested to inspect their stock and quarantine any affected lots. Kimberly Clark Australia will arrange for the return of all affected units.

Device

  • Model / Serial
    Kimguard Container Filters 7.5in (19cm) round & 9x9in (23x23cm) square (Used for wrapping medical devices prior to sterilisation)Product code: 68507Lot numbers: MF1284XXX, MF1287XXX, MF1294XXX, MF1316XXX, MF2012XXX, MF2055XXX, MF2086XXX, MF2098XXX, MF2115XXX, MF2146XXX, MF2178XXX, MF2188XXX, MF2196XXX, MF2210XXX, MF2228XXX, MF2243XXX, MF2264XXX, MF2271XXX, MF2285XXX,MF2328XXX, MF2338XXXProduct code: 68509Lot numbers: MF1279XXX, MF1287XXX, MF1288XXXARTG Number: 127021
  • Manufacturer

Manufacturer