| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01159-1 |
| Product Name/Description |
Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)
Systems affected - Ocean, Oasis
Product Codes: 2050-300, 3650-100
Lot/Serial Numbers: 10883118, 10891209, 10899344, 10883101, 10891238, 10906323
ARTG Number: 126675 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Atrium Medical has become aware that the force required to detach the tubing from the drain may be lower than Atrium Medical's product specifications. The manufacturer has received reports for leaking of blood or disconnection of the drain at the connection point of the ATS access line and the chest drain. The leaks or disconnection occurred following usage of the drain in excess of 2 days and typically were related to movement of the patient within the institution. |
| Recall Action |
Recall |
| Recall Action Instructions |
Atrium Medical is advising their customers to quarantine affected products and use an appropriate substitute device. If an adequate substitute is not available customers are advised to review the substitution list and contact Atrium for assistance in obtaining the substitute device.
It is further advised that in the event of an emergency situation the affected devices can continue to be used provided work around instructions are followed. |
| Contact Information |
1800 605 824 - Atrium Customer Service |