B. Braun Recalls Safety Infusion System
February 1, 2011
B. Braun Medical is recalling certain models of its Outlook 400ES safety infusion system after discovering a software problem. Systems upgraded with Motorola compact flash hardware and supporting software and used in networks that utilize Temporal Key Integrity Protocol authentication can develop memory leaks, which may cause the infusion system to shut down and cease treatment. The FDA is classifying the recall as Class I.