B. Braun’s recall is a correction, not a product removal, affecting the battery pack for its Infusomat Space large-volume pump. It affects both wireless and non-wireless batteries, model numbers 8713051U and 8713052U.
According to an FDA notice, the company recalled the infusion pump system due to faulty occlusion alarms. On certain models, an occlusion alarm may sound when no occlusion exists, causing the pump to stop the delivery of medications. That includes high-risk medications like vasopressors.
Interruption to high-risk medication delivery could lead to hemodynamic instability requiring medical intervention to prevent impairment to body structures or body functions. In some cases, this could lead to life-threatening circumstances or death.
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