Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00568-1 |
Product Name/Description |
Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshell
Multiple product codes affected
ARTG Numbers: 131578, 167416 & 140714 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
22/05/2014 |
Responsible Entity |
|
Reason/Issue |
Baxter is adding a contraindication statement to address iodine allergy for Baxter’s peritoneal dialysis products which contain iodine (i.e. povidone iodine) or for which iodine use is recommended. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Baxter is updating the instructions for use to include additional contraindications for iodine sensitive patients. End users are being notified of the new contraindications. |
Contact Information |
02 9848 1111 - Baxter Healthcare |