| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00357-1 |
| Product Name/Description |
Portex Thoracic Catheter and Connecting Tube
Thoracic Catheter 28Fangled Soft, Adult Connector, 10/CA
Model Number: 200/812/280
Multiple Lot Numbers
ARTG Number: 145749
Smiths Medical Australasia - Portex Thoracic Catheter - Drain, thoracic |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Smiths Medical became aware of a potential breach in the seal of the package on certain packaging lots. These packages were used in the manufacturing of certain Portex Thoracic Catheters and Connecting Tubes, compromising the sterility of the devices.
Smiths Medical has not received any reports of serious injury relating to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Smiths Medical is advising customers to quarantine all stock of the affected units. Upon receipt of a completed Response Form provided with the Customer Letter, a Smiths Customer Service Representative will contact users with a Return Material Authorisation Number to facilitate the return of the product and issue a credit.
This action has been closed out on 11/07/2019 |
| Contact Information |
1800 654 949 - Smiths Medical Customer Service Department |