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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00385-1
Product Name/Description	Prismaflex Control Unit (with software versions prior to 8.10) Prismaflex 4.11 Product Code: 113082 Prismaflex 6.10 ROW Product Code: 114489 Prismaflex 7.XX ROW Product Code: 114870 All Serial Numbers ARTG Number: 142047
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/04/2017
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	Baxter Healthcare has received reports of device operators failing to adhere to the Instructions For Use (IFU) pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. These steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. If not followed, severe blood loss may occur with a potentially fatal outcome.
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter will be installing a free software upgrade at the users' facility. In the interim, Baxter is advising users that they may continue to use the affected units by following the instructions provided in the Prismaflex Operator’s Manual and the on-screen instructions when unloading the disposable set. Specifically, users should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	07 3244 2651 - Baxter Healthcare