The FDA is alerting healthcare providers about a potential high-risk issue with certain Baxter Healthcare Solution Sets with Duo-Vent Spikes.
Baxter has issued a recall for several lots of these products after identifying a risk that some products were incorrectly assembled with inverted side clamps, according to an Dec. 31 agency news release.
If the solution sets are used with an infusion clamp, medication may not be delivered properly and blood could backflow into the system, posing serious health risks, particularly for critically ill patients or neonates.
Baxter has sent an urgent recall notice to affected healthcare facilities, instructing them to immediately check stock for affected lot numbers and discontinue use of the products.
The agency said no injuries related to the issue have been reported but that it is monitoring the situation.