The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning AFX Introducer System [Model. no.: S17-45; Lot no.: 1079840, 1079843, 1079844, 1079845], manufactured by Endologix Inc.
According to the FDA, the AFX Introducer System is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss. This product was recalled due to reports of the dilator breaking during procedures. Use of this recalled product may cause serious adverse health consequences, including death.
For details, please visit the following FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm357563.htm
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm357544.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 June 2013