| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00713-1 |
| Product Name/Description |
Various Terumo Introducer Kits
Glide Shealth Slender
Radifocus Introducer II (Femoral)
Radifocus Introducer II M Coat (Transradial)
Multiple Product Codes and Lot Numbers
ARTG Number: 126256 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Terumo has identified an issue where a potential loss of package integrity may compromise the sterility of the Introducer Kits. An incomplete seal in the kit's peel pouch was observed during a routine internal inspection by Terumo. Terumo has not received any customer complaints or reported patient injuries as a result of this issue. The potential incidence rate is estimated to be less than 0.02%. |
| Recall Action |
Recall |
| Recall Action Instructions |
Terumo is advising users to quarantine and destroy all product from the affected lots. Terumo will provide credit for destroyed product within the affected lots.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 837 866 - Terumo Australia Customer Service |