| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01156-1 |
| Product Name/Description |
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-2316
All Lot Numbers affected
ARTG Number: 144359 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on 27/03/2024 |
| Contact Information |
1800 026 726 - Bosco Medical Australia |