Medical device manufacturer, Baxter Healthcare Corporation, has issued a medical device safety alert concerning its EXACTAMIX EVA Bags. The affected devices are identified as following:
The manufacturer is issuing a voluntary product recall for the affected lot numbers of the EXACTAMIX Empty EVA Bags due to the potential ability to leak once used for compounding.
The EXACTAMIX Empty EVA Bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.
An undetected leak in the compounded intravenous IV solution bag may allow for microbial contamination of the solution which may lead to a bloodstream infection or an air embolism caused by air entering the fluid path. The manufacturer has not received any reports of adverse event or patient injury associated with this issue for leaks in Hong Kong.
Affected users should locate and remove all affected product lots from their facility. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong and the affected lots were distributed between 30 Jan 2018 and 30 Apr 2018.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 3 October 2018