Baxter is recalling its 50mm 0.2 micron filter used to filter water-based intravenous solutions due to the presence of particulate mater and the potential absence of filter layers.
The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The recalled devices are designed for use in hospital pharmacies to filter bacteria and other microscopic matter during the preparation of water-based solutions used for IV administration sets. The filter is designed to attach to Baxter’s standard pharmacy pump tube.
