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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00927-1
Product Name/Description	B. Braun Infusomat Space Infusion System (infusion pump) Model Numbers: 8713050, 8713050-99, 8713050, 8713060U, 8713060U-99 with software version G03, G02 or older Affected pumps were distributed from 6 November 2008 to 29 December 2011
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/09/2012
Responsible Entity	B Braun Australia Pty Ltd
Reason/Issue	This is an expansion of a previous recall, initiated by B. Braun in January 2012 due to the potential for breakage of the anti free flow clip located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, specially of narrow therapeutic range drugs, can cause life-threatening effects and injuries. This recall action was not notified to the TGA before it was initiated by B. Braun.
Recall Action	Recall for Product Correction
Recall Action Instructions	The sponsor will be providing a software and hardware update to mitigate the issue.
Contact Information	02 9629 0200 - B. Braun