| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01172-1 |
| Product Name/Description |
Various Sage Oral Care Products
Multiple Product Codes and Lot Numbers
ARTG Numbers: 128439 and 135840 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex Medical Australia has been advised by the manufacturer Sage Products LLC that there is the potential for cross-contamination of specific oral care solutions manufactured by a third party supplier on equipment shared with non-pharmaceutical products. The affects all Oral Care products containing solutions manufactured by the third party supplier.
The affected products were distributed between July 2015 and August 2017. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Discontinue use and/or further distribution of the affected lots.
2. Immediately quarantine any affected stock and complete the supplied acknowledgement form and email to austcs@teleflex.com
3. Destroy or dispose of affected product and provide records to Teleflex on the supplied acknowledgment form.
4. Complete the supplied recall acknowledgement form and return it to Teleflex. This form must be completed even if you no longer have affected product.
This action has been closed out on 7/09/2018. |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |