Events

Recall of ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia 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-2018-RN-00131-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00131-1
  • 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
    During routine testing, it was found that bioburden levels of the manufacturing process were higher than internal acceptable rates and as such the sterility of the products cannot be confirmed. to date there have been no reports of any adverse events or serious injuries.
  • Action
    Stryker is advising customers immediately quarantine the product and return it back to Stryker. A Stryker representative can help facilitate this return where necessary.

Device

ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP
  • Model / Serial
    ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIPItem Numbers: 0306573000, 0210114100Affected Lot Numbers: 17282012, 17283012 ARTG Numbers: 139627, 141176
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA