Events

Recall of PSV Sets (Scalp Vein), Hard, 27Gx 3/4" ISO CE

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Nipro 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-2013-RN-00302-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00302-1
  • 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
    Crack in luer connector on nipro blood collection sets, resulting in small blood leak.
  • Action
    Nipro is recalling the device from the single wholesaler to whom it had been supplied. The recalled device has not been supplied by the wholesaler to third parties, e.g. hospitals.

Device

PSV Sets (Scalp Vein), Hard, 27Gx 3/4" ISO CE
  • Model / Serial
    PSV Sets (Scalp Vein), Hard, 27Gx 3/4" ISO CEModel Number: C-PSV-2719HD-ECEBatch Number: 12H31HARTG Number: 121677
  • Manufacturer
    Nipro Australia Pty Ltd

Manufacturer

Nipro Australia Pty Ltd