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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00889-1
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: 177497
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/08/2013
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	An omission has been identified in Chapter 4 (Operating Instructions - Secondary Infusions) of the current revision of the Operator's Manual for the Colleague product codes 2M91617 and 2M91637. The Operator's Manual should also instruct the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter is providing additional information to be included in the Operator's Manual instructing users to reopen the regulating clamp after a secondary infusion has completed. Customers are requested to ensure that this information is communicated to all appropriate clinical staff and to retain the letter with the Operator's Manual. This action has been closed-out on 12/04/2016.
Contact Information	02 8845 1547 - Baxter Healthcare