Events

Recall of Per-Q-Cath PICCs

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard 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-2015-RN-00480-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00480-1
  • 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 an internal labelling review, bard identified that the product gauge size (ga) is incorrect on certain per-q-cath products. the product gauge (ga) size is provided in two locations: on the label and in some cases on the catheter hub. this issue has been identified as a conversion problem (french to gauge size). no adverse reaction reports or other indication of injuries or diseases have been reported relating to this problem.
  • Action
    Bard is providing the correct Gauge measurement to hospitals and healthcare professionals. This action has been closed-out on 04/08/2016.

Device

Per-Q-Cath PICCs

Manufacturer

Bard Australia Pty Ltd