St. Luke’s Health System OVERVIEW Every day defective product alerts are sent to health systems from manufacturers, distributors, and the Food and Drug Administration “FDA”. A small subset of these notices are regarding recalls or other issues describing product problems that, if left unresolved, are likely to result in patient or user death, severe injuries and/or permanent health problems or other significant adverse consequences. We call this type of product alert a critical product alert. Examples of critical product alerts include: when a surgical item will break off into a patient, a life supporting device will stop working, or a defibrillator failure. critical product alerts have increased in volume for the past three years. In 2016, St. Luke’s Health System (SLHS) addresse

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