Baxter issues worldwide recall of IV solutions due to visible particulate matter

Baxter International Inc. is voluntarily recalling four lots of intravenous (IV) solutions as the products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. The injection of particulate foreign matter may result in both chronic and acute inflammatory and allergic responses that may be life threatening. Although, there have been no reported adverse events associated with this issue to date, an investigation is underway to determine the root cause.

The products being recalled are one lot of highly concentrated Potassium Chloride Injection 20mEq/50ml in a ViaFlex Container and three lots of 0.9% Sodium Chloride Injection. The recalled products are packaged in 50ml and 100ml containers and were distributed worldwide between February 2013 and June 2014. The IV solutions were recalled after four customers over a period of six months complained that they found bags that contained visible particulate matter.

If infused, adverse health consequences of particulate matter could vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patients underlying medical condition and the presence of a right-to-left cardiac shunt.