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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00329-1
Product Name/Description	Baxter Irrigation solutions 1.5% Glycine Irrigation Code: AHB7316 Batch: S63S1 Expiry: 30/09/2015 0.9% Sodium Chloride for Irrigation Code: AHB7616 Batch: S66P2 Expiry: 30/11/2015 0.9% Sodium Chloride for Irrigation Code: AHB7616 Batch: S71N8 Expiry: 31/03/2016 1.5% Glycine Irrigation Solution Code: AHB7317 Batch: S74P6 Expiry: 31/05/2016 0.9% Sodium Chloride for Irrigation Code: AHB7127 Batch: S82F6 Expiry: 31/10/2016 ARTG number: 155928
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	10/04/2015
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	An investigation into an adverse event report concerning a 6L renal dialysis solution that affected a single patient revealed the solution had been diluted. Baxter Healthcare is recalling the Irrigation Solutions listed above as further investigations revealed that these products were also potentially diluted with water for injection.
Recall Action	Recall
Recall Action Instructions	Customers are advised to locate and remove affected product from potential use. The TGA has published a web statement regarding this recall which is available at https://www.tga.gov.au/alert/dianeal-peritoneal-dialysis-solution-and-various-irrigation-solutions
Contact Information	1300 789 646 - Baxter Healthcare Customer Service