Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00536-2 |
Product Name/Description |
MiniCap Extended Life PD Transfer Set with Twist Clamp (Peritoneal dialysis tubing set)
Product Code: R5C4482
Lot Number: H12F18054
ARTG Number: 131578 |
Recall Action Level |
Consumer |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
13/05/2014 |
Responsible Entity |
|
Reason/Issue |
Baxter has received complaints reporting connection issues between the PD transfer set catheter connector and an adapter with this lot number. Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis. |
Recall Action |
Recall |
Recall Action Instructions |
Hospitals and distributors are asked to locate and return all the affected products at their facility. Health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. For more details, please see http://www.tga.gov.au/safety/alerts-device-minicap-extended-life-pd-140515.htm .This action has been closed-out on 29/01/2016. |
Contact Information |
1300 789 646 - Baxter Healthcare Customer Service |