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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00124-1
Product Name/Description	Spectra Optia Apheresis machine ARTG Number: 130529
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/02/2014
Responsible Entity	Terumo BCT Australia Pty Ltd
Reason/Issue	Terumo BCThas identified that pinhole leaks may occur due to stresses on the channel weld, particularly during long procedures on Spectra Optia. If leaks occur during use the procedure must be discontinued. Terumo BCT has received reports relating to leaks in the channel of the tubing set of the Spectra Optia. These leaks have many different causes, including operator misloading. A very specific type of channel leak, a 'pinhole' leak at a specific location reported by customers primarily during long MNC procedures have been identified.
Recall Action	Recall for Product Correction
Recall Action Instructions	Terumo BCT is installing a modified filler at the next scheduled preventative maintenance to mitigate the risk of leakage. The device can continue to be used while awaiting the replacement filler. Users should be aware of the potential for leakage and cease any procedure if leakage is observed.
Contact Information	02 9429 3600 - Terumo BCT Australia Customer Service