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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00153-1
Product Name/Description	Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump) Colleague P1.7 CXE Single Channel Pump Product Code: 2M91617 Colleague P1.7 CXE Triple Channel Pump Product Code: 2M91637 ARTG Number: 177494
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/02/2016
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	Baxter Healthcare has identified that the incorrect version of the operator manual was supplied with the delivery of some machines. The manuals are missing the addendum with instructions regarding the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed. If the administration set of the primary infusion has a closed clamp, it may lead to air embolism or delay of therapy for the primary infusion.
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter Healthcare is providing users with the correct user manual. This action has been closed-out on 15/02/2017.
Contact Information	02 8845 1669 - Baxter