The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning MiniCap Extended Life Peritoneal Dialysis (PD) Transfer Set with Twist Clamp manufactured by Baxter Healthcare Ltd. The affected product code is R5C4482 and only lot number H12F18054 is affected.
The manufacturer 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.
The manufacturer advises hospitals and distributors 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 details, please refer to TGA websites:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00536-2
and
http://www.tga.gov.au/safety/alerts-device-minicap-extended-life-pd-140515.htm
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 May 2014