Events

Recall of Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & Trays Femoral Artery Pressure Monitoring Catheter Sets & Trays Radial Artery Pressure Monitoring Catheter Sets & Trays

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook 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-2016-RN-00052-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-01-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00052-1
  • 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
    Certain central venous catheters and pressure monitoring sets are being recalled due to an issue being identified with a manufacturing process that could result in the potential for catheter tip fracture and/or separation. potential adverse events that may occur as a result of catheter tip fracture and or separation may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. there have been no reports of illness or injury associated with this issue.
  • Action
    The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor.

Device

Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & T...
  • Model / Serial
    Central Venous Catheter and Pressure Monitoring SetsSingle Lumen Central Venous Catheter Sets & TraysFemoral Artery Pressure Monitoring Catheter Sets & TraysRadial Artery Pressure Monitoring Catheter Sets & TraysReference Part Numbers (RPN): C-NPMS-501J-15, C-PMS-301-FA, C-PMS-301J-FA, C-PMS-301J-PED, C-PMS-301-RA, C-PMS-400-RA, C-PMS-401-FA and C-PMS-401J-FAMultiple Lot Numbers affectedARTG Numbers: 154878 and 156190
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd