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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01106-1
Product Name/Description	Arceole C3F8 and SF6 Lot Number: 15052502 Product Codes: AS-C3F8 and AS-SF6. ARTG Number: 233561
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	11/11/2015
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	There is a possibility that 2 units of C3F8 (lot 15052502) have been incorrectly packaged in SF6 boxes. The product codes for these items are AS-C3F8 and AS-SF6 respectively. However, the box label, the blister label, the patient labels and the canister would be properly labelled as C3F8. There is a remote risk that the user may not identify the mislabelling before use, and incorrectly use the C3F8 gas at a concentration usually used for the SF6, which would be a maximum of 20% instead of 12%.
Recall Action	Recall
Recall Action Instructions	Sponsor to notify potentially affected customers. Customers to inspect and return affected sotck. Sponsor to replace affected stock. This action has been closed-out on 24/08/2016.
Contact Information	TBC