Events

Recall of Leongatha Delivery Pack containing umbilical clamps

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-2016-RN-01043-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01043-1
  • 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 become aware of situations where the umbilical clamp included in the procedurepak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. if the clamp is used incorrectly i.E. both hooks in the clamp are not engaged, the clamp may reopen. if the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.The ifu will be improved to include further instruction to ensure correct usage of the clamps.
  • Action
    Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage: - Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks. - Place the (thick) umbilical cord towards the ring end. - Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017.

Device

Leongatha Delivery Pack containing umbilical clamps
  • Model / Serial
    Leongatha Delivery Pack containing umbilical clampsProduct number: 97047649-01Umbilical clamps ref.: IFKR21 and 2305123-00All batches are affectedARTG Number: 133562
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd