Events

Recall of Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(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-2015-RN-00712-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00712-1
  • 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
    Following notification from component supplier, convatec ltd concerning the 3m suction tube contained in some procedure packs, mölnlycke is issuing this recall for product correction notice for packs containing this suction tubing. convatec conducted an internal assessment of product complaints that they had received and has identified that the suction tubes are not meeting their manufacturer's specifications. specifically, the connector part for application to the suction devices in the lots affected by the recall, has failed to meet its required reliability. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Action
    Customers are advised to isolate all affected, unused packs at their facility and contact Mölnlycke representative for alternative single packed sterile suction tubing. At the point of use, it is recommended that the users remove the ConvaTec 3m Suction Tube and dispose of the product, replacing it with a single packed sterile version. If customers or users have any issues with the above recommendation, please send the affected packs back to Mölnlycke for a full refund. This action has been closed-out on 15/08/2016.

Device

Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure pa...
  • Model / Serial
    Waratah Private General Packs and Waratah Private Knee/Shoulder Arthro Pack(Surgical procedure packs)Waratah Private General PackCatalogue number (SKU) : 97035035-05Batch numbers: 15030983, 15038366, 15077945, 15100388Waratah Private Knee/Shoulder Arthro PackCatalogue number (SKU): 97067575-00Batch number: 15035436ARTG Number: 133565
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd