Baxter International Inc. is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate matter. Baxter said it was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to particulate matter. In each case, the issue was discovered prior to patient administration and there have been no adverse events associated with these incidents reported to Baxter to date.
According to a press release, leaking containers could result in contamination of the solution. If not detected, this could lead to a bloodstream infection, worsened patient condition or other serious adverse health consequences. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
A subsequent investigation identified the root cause as a mechanical issue that affected one machine during a single shift. The mechanical issue has since been remedied.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at email@example.com.