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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 Atrium Australia - Pacific Rim Pty Limited
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