Original Date Issued: January 26, 2010

Date updated: August 26, 2010

Audience: Healthcare Practitioners and Patients/Caregivers

Medical Specialties: Multiple, including Interventional Radiologists, Oncologists, Infusion Nurses

Other documents associated with this issue can be found at: Safety/AlertsandNotices/ucm198719.htm

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This document reflects FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices. The nature, magnitude and possible public health impact of this situation are not yet clear.