Events

Recall of Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners

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-01082-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01082-1
  • 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
    Mölnlycke health care has received a recall notification from ecolab-microtek medical regarding basin liners which are contained within procedurepak products. the supplier has identified that very low number of basin liners have small holes or cracks which if present may compromise sterility.
  • Action
    Molnlycke Healthcare is requesting their customers to isolate any product from the affected batches. Mölnlycke Health Care will arrange for the collection and replacement of the product. This action has been closed-out on 06/06/2016. This action has been closed-out on 06/06/2016.

Device

Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners
  • Model / Serial
    Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin LinersProcedurePak Trays:Maxillo Facial Pack Rev4, Cairns Base Maxillo Facial Pack Rev4, Cairns Base Limb Rev6SKU: 97006791-05, 97006791-07, 97008210-07Batch ID: 12073320, 12080223, 12168637Basin Liner Product Codes: 2302362-00 & 2309247-00ARTG Numbers: 213220 & 133564
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd