The particles could enter the bloodstream and cause potential blood vessel blockages, organ damage, and other serious complications, according to recalls posted Aug. 25 by the Food and Drug Administration (FDA).
Baxter warned that stainless steel particles could “lead to a life-threatening blood clot in the lungs” and “cause permanent organ damage or death.” Fiberglass particles could cause vein irritation, inflammation, allergic reactions, or blockages that injure tissue or organs. The company had received no reports of adverse events connected to either product as of Aug. 25.
The recalls cover one lot of 70 percent dextrose injection and one lot of anticoagulant sodium citrate solution. Both are packaged in Baxter’s Viaflex plastic containers and supplied to health care facilities.
The dextrose product provides calories and fluids for patients who cannot get enough nutrition by eating or through a feeding tube. Health care providers mix it with other IV ingredients to prepare nutrition solutions. The recalled product is a pharmacy bulk package and is not intended to be infused on its own.
The recall affects dextrose lot Y495066, with an expiration date of July 31, 2027. It was distributed to health care providers and distributors in Alabama, Georgia, and Tennessee from July 25 through July 28.
The recall said that health facilities should stop using the lot and return all remaining units. Home care providers that used it to prepare IV nutrition should contact affected patients and replace those solutions with ones made without the recalled product.
The sodium citrate solution is used during certain blood donations and medical treatments. It prevents blood from clotting as a machine separates and collects specific parts of the blood.
Although the solution is not injected directly from its container, it mixes with blood as it passes through the machine. Some of that blood is then returned to the person, creating a possible route for fiberglass particles to enter the bloodstream.
That recall covers lot Y493475, with an expiration date of Dec. 31, 2027. The product was distributed to one U.S. customer from July 2 through July 11. Baxter directed the customer to stop using it and return all affected units.
The recall announcements did not explain how the stainless steel or fiberglass entered the products. Baxter said it was emailing affected customers with instructions for identifying and returning the recalled lots.