| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01494-1 |
| Product Name/Description |
ARROW OnControl System Trays
ARROW OnControl Bone Lesion Biopsy System Tray
ARROW OnControl Bone Marrow Biopsy System Tray
ARROW OnControl System Sterile Procedure Tray
Catalogue Numbers: 9403-EU-006, 9408-EU-006, 9411-EU-006, 9462-EU-001, 9463-EU-001, 9464-EU-001, 9466-EU-001
Multiple Batch Numbers
ARTG Number: 264374 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. Because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the OnControl system, cannot be guaranteed. If sterility of the drape is compromised, there is the potential for infection to occur. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.
This action has been closed out on 25/09/2018 |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |