| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00707-1 |
| Product Name/Description |
Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device
Batch Numbers: 1606018 and 1607019
ARTG Number: 221756 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Device Consulting has received three reports of the fibre sliding inside the sheath when the pullback device was being used. To date, no injuries have been reported. It has been determined by the manufacturer that when a pullback device is in use, the fibre can slide inside the sheath because the Tuohy Borst adaptor does not grip the fibre firmly due to a faulty o-ring. Should this occur during a procedure on a patient, surgical intervention would be required to remove the section of sheath that had separated. |
| Recall Action |
Recall |
| Recall Action Instructions |
Device Consulting will be replacing all units from the affected batches at facilities which use pullback devices. In the interim, TXMF600BFS fibres can continue to be used until the replacement is received provided that users pullback manually by pulling the sheath.
This action was closed out on the 11/09/2018 |
| Contact Information |
03 9998 2020 - Device Consulting |