FDA Issues Early Alert on Medline Fluid Delivery Set Safety Risk

The FDA has issued an early alert highlighting a potentially high-risk issue with certain lots of Medline’s fluid delivery sets that include incorrect drip chambers. These sets, which should feature a gray micro drip chamber, were mistakenly shipped with a white macro drip chamber, capable of delivering three times more fluid per drop than intended. This discrepancy increases the risk of over-administration, potentially causing severe complications such as edema, shortness of breath, elevated blood pressure, or even death. Medline alerted customers on December 16, requesting the removal of affected devices, and no injuries have been reported to date.

The FDA’s early alert, part of a new pilot program, was published on December 30—just 14 days after Medline’s communication. This initiative aims to improve the timeliness of recall communications for potentially high-risk products, bridging the gap while the agency gathers data to assign formal recall classifications. Since its inception late last year, the FDA has used this approach to address safety concerns with products from companies like Baxter, Fresenius Kabi, and Olympus.