Events

Recall of Pennine Healthcare Ryles Tubes (used for enteral feeding)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bosco Medical Australia.

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-01156-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01156-1
  • 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
    Bosco medical australia pty ltd have been notified by the manufacturer that there is a possibility that a tube could have the print graduations running the wrong way, i.E. they decrease with distance from the tip of the tube, when the correct orientation is that the numbers increase with distance from the tip of the tube. there is the potential for misplacement of the tubes if the print graduations are used as the sole means for confirming the placement of the ryles tube.
  • Action
    Bosco Medical is advising users to inspect the graduations of the tubes prior to insertion. If affected product is found, replace with unaffected product and contact Bosco for credit or replacement.

Device

Pennine Healthcare Ryles Tubes (used for enteral feeding)
  • Model / Serial
    Pennine Healthcare Ryles Tubes (used for enteral feeding)Multiple products affected Product Codes: RT-2008/L, RT-2010/L, RT-2012/L, RT-2014/L, RT-2016/L, RT-2018/L, RT-2314, RT-2316All Lot Numbers affectedARTG Number: 144359
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia