| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00421-1 |
| Product Name/Description |
Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)
Product Code: AHK6021
Batch numbers: S60P3 & S67P2
Exempt from registration in the ARTG under Schedule 5A of the Regulations. |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Baxter Healthcare is issuing a recall as a result of a complaint received indicating that the labelling of this product contains an error. Underneath the “Potassium 10 mmol” type on the main label, there is bracketed text that states “Potassium Chloride 0.075%”. The figure of 0.075% is incorrect. The correct figure should be 0.15%. |
| Recall Action |
Recall |
| Recall Action Instructions |
Hospitals are requested to remove all units from affected lots. The affected product should be returned by contacting Baxter Healthcare Customer Service. Baxter is requesting prescribers to monitor patients infused with the affected product for any irregularity in electrolyte levels. |
| Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |