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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00377-1
Product Name/Description Trima Accel Automated System (Apheresis unit)

Catalogue Number: 81000

All serial numbers affected

ARTG Number: 130529
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 29/04/2013
Responsible Entity Terumo BCT Australia Pty Ltd
Reason/Issue There is the potential risk for an air embolism if air is delivered to a donor if the donor is connected prior to completion of loading the tubing set when using the Trima Accel system.
Recall Action Recall for Product Correction
Recall Action Instructions Terumo BCT is implementing a safety enhancement in the Trima Accel system software version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. This new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line.
Contact Information 02 9429 3600 - Terumo BCT Australia