The Australia Therapeutic Goods Administration (TGA) has issued a medical device safety alert concerning 15L Cycler Drainage Bag manufactured by Baxter Healthcare. The affected product code is R5C4145P.
Baxter has identified an issue with the Roberts Clamp (large clamp on the drainage bag) that is used to close the drain tube on the 15L Cycler Drainage Bag. The large clamp may not fully close the 15L Cycler Drainage Bag drain tube after filling and may result in leakage from the drain tube.
The manufacturer is advising users of the potential issue with the clamps and to take extra care to ensure the clamp on the drain tube is closed.
According to the local supplier, the affected products were not distributed in Hong Kong.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-01096-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 November 2013