Events

Recall of ProcedurePak (surgical procedure packs)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Molnlycke Health Care 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-2014-RN-00768-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00768-1
  • 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
    Molnlycke health care has identified that the sterile tubing supplied in certain procedurepak trays, may not have received an adequate sterilization dosage. this may lead to a compromise in sterility of one of the components in these trays.
  • Action
    Molnlycke is requesting their customers to identify and isolate all affected unused product at their facility. Molnlycke Health Care will arrange for collection and replacement of the product.

Device

ProcedurePak (surgical procedure packs)
  • Model / Serial
    ProcedurePak (surgical procedure packs)Product Codes: 97032966-02, 97032967-01, 97034172-01, 97042192-00 & 97042192-01Multiple batch numbers affectedARTG Numbers: 215992, 215993, 216000 & 216001
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd