Events

Recall of Multi Lumen and Pressure Injectable Central Venous Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mayo Healthcare 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-2014-RN-00613-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00613-1
  • 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
    There is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvc). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. misprinted labelling can cause user dissatisfaction with flow rates (ml/hr) in the case the lumen would be expected to perform as labelled for high volume gravity infused (the mismarked 16ga lumen) since in reality this is an 18ga lumen and gravity flow is approximately half (1/2) the expected flow rate in ml/hr for a 16ga lumen. this could result in a worst case scenario clinical intervention to use a pressure bag or pump to achieve adequate flow rates. the colour coding of all hubs is correct and corresponds to the arrow system.
  • Action
    Mayo Healthcare Pty Ltd is advising their customers to be aware of the incorrect labelling.

Device

Multi Lumen and Pressure Injectable Central Venous Catheters
  • Model / Serial
    Multi Lumen and Pressure Injectable Central Venous CathetersAffected Lot Numbers: 71F14A0329, RF1082062, 71F13H0637, ZF3063390, 71F14C0868, ZF1124891, ZF3051182, 71F13K0810, 71F13J1589, 71F14C0173, ZF2052625, 71F13H0972, 71F13K1389, 71F13K1796, 71F13K0429, ZF2111681, 71F13H1291, 71F13L0166, 71F14A0120, 71F13K1808, 71F14A1404, 71F13K0325, 71F13L1212, 71F14B0386, ZF3052590, RF0127942, 71F13K1625, ZF2123457, 71F14B0029, RF1069981, RF0087867, ZF3040526, 71F14B0377 ARTG Number: 142543
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd