| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00153-1 |
| Product Name/Description |
Single Use Instruments including Scissors, Forceps, and Suckers
Multiple Products
All Lots
ARTG Numbers: 296281, 296277, 296279, 296278, 296276, 296280, 296240, 296260, 296315 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Thermo Fisher Scientific received a labelling concern that a sterile instrument used during surgical procedures was not labelled as a single use instrument and that there could be the possibility of reuse.
The devices affected are manufactured as single use instruments, and are safe for use as single use instruments.
When used as single use instruments the devices do not pose a risk to human health and are safe to use within the scope of their ARTG inclusion. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Thermo Fisher Scientific is advising users to keep the notification in a prominent position.
The manufacturer is currently working with their notified body on a scope extension but due to the time required to complete this, a resolution may not be achieved for 6 to 12 months.
This action has been closed out on the 12/11/2018. |
| Contact Information |
03 9757 4300 - Customer Serice Support |