ICU Medical Recalls Aminosyn II

ICU Medical has recalled one lot (2,112 units) of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. The company says it became aware of the issue while inspecting retention samples, according to a recall notice.

The notice says that administration of a product containing particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death.

ICU Medical acquired the product from Hospira and it is labeled accordingly (lot # 4989094; expiry 4/1/2022). Aminosyn II is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate.