Medical device manufacturer, Baxter Healthcare, has issued a field safety notice (FSN) concerning its BURETROL Solution Set with 150ml INTERLINK Burette. The affected product code is 2C7564 with the lot numbers DR13E06019, DR13J24021, DR13J24039 and DR13L11016. The affected products were distributed to customers between 14 March 2014 and 30 June 2014.
According to the manufacturer, the voluntary recall was issued due to complaints of separation between the burette chamber and the drip chamber. The root cause for this issue has been identified and resolved.
If the separation is not detected before connection with the administration set, there is a risk of contamination of the sterile fluid path which could lead to blood stream infection or sepsis and may be life-threatening. Additionally, air may be aspirated into the vascular system, causing venous air embolism, which while is improbable may be life-threatening. There have been no adverse events reported for this issue.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 July 2014