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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00536-1
Product Name/Description	CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long) CAPD Solution Transfer Set with Locking Connector Product code: 5C4160 Minicap Extended Life PD Transfer Set with Twist Clamp Product code: 5C4482, R5C4482 Extra Short product code: 5C4483, R5C4483 Extra Long product code: R5C4484 ARTG Number: 167416
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/06/2013
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	Baxter is providing additional information regarding correct device use and additional warnings to end users. The improper use of peritoneal dialysis (PD) transfer sets could result in contamination leading to infection or peritonitis. There is also the potential of thyroid dysfunction following iodine exposure in children and infants. The current IFU does not list this as a warning.
Recall Action	Recall for Product Correction
Recall Action Instructions	Baxter is providing additional information regarding correct device use and additional warnings to end users. This action has been closed-out on 01/02/2016.
Contact Information	02 9848 1111 - Baxter Healthcare