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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01289-1
Product Name/Description	SANGOFIX IV Administration Set and HEIDELBERG EXTENSION TUBING SANGOFIX IV Administration Set Article code: 4050193 Batch number: 3H24278T34 ARTG Number: 137615 HEIDELBERG EXTENSION TUBING Article code: 4052197 Batch number: 3H21278A23 ARTG Number:139265
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/12/2013
Responsible Entity	B Braun Australia Pty Ltd
Reason/Issue	Following reports of leaking from the in-line Safsite injection site, initial investigations have identified that on disconnection of a luer connector used to access the injection site, a resealing issue may occur intermittently. This may result in fluid leaking from the valve.
Recall Action	Recall for Product Correction
Recall Action Instructions	As an interim corrective action, B.Braun is recommending that end users fit a stand-alone Safsite valve to the in-line injection site. The valve can be used for injection or infusion and does not need to be removed. Further notifications will be undertaken if any additional actions are required based on B. Braun's investigations.
Contact Information	1800 172 182 - B. Braun Customer Service