Baxter International Inc. is voluntarily recalling four lots of intravenous solutions to the hospital and user level. These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient, Baxter said in a news release.
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 patient’s underlying medical condition and the presence of a right-to-left cardiac shunt. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening. There have been no reported adverse events associated with this issue to date, and an investigation is underway to determine root cause, according to the news release.
Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes, for use as a priming solution in hemodialysis procedures, and may be used as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction and prevention of cardiac arrhythmias. The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014.
Baxter has notified customers, who are being directed not to use products from the recalled lots. Recalled products should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1.888.229.0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.