IV fluids recalled over possible contamination—patients face risk of vascular complications
B. Braun Medical, a global medtech company, is recalling two lots of an intravenous (IV) electrolyte solution due to an increased risk of the product containing particulate matter. If present, this particulate matter could lead to pulmonary emboli, occlusions or other significant vascular complications.
This recall includes two specific lots of 1-liter bags of B. Braun Medical’s Lactated Ringer’s Injections, E7500. The two lots, J4P756 and J4S843, were distributed from 2024 to 2025 throughout the United States. Each lot expires in May 2027.
No other lots should be impacted by this issue.
Lactated Ringer’s Injections are indicated for adult and pediatric patients as a source of water and electrolytes. The particulate matter at the heart of this recall contains cellulose, stearates and extremely low levels of inorganic materials such as copper. According to the recall, there is a “reasonable probability” of this particulate matter causing pulmonary emboli, occlusions of other blood vessels and/or phlebitis.
“B. Braun has not received any reports of adverse events related to this recall to date,” the company wrote. “If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death.”
The U.S. Food and Drug Administration posted B. Braun Medical’s recall as a public service. Read the full announcement here.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.