Baxter International Inc. announced a voluntary recall of four lots of intravenous solutions to the hospital/user level due to the presence of particulate matter identified as cellulosic fibers and/or plastics. Baxter reports it 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.
The company says an investigation is underway to determine root cause.
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, and the patient’s underlying medical condition. There have been no reported adverse events associated with this issue to date, Baxter reports.
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.
This recall is being conducted with the knowledge of the FDA.
Source: FDA and Baxter