Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate
MedSun: Newsletter #58, March 2011

FDA MedWatch Safety Alert

Components of the Arstasis One Access System may fracture and/or separate during use, which may result in patient harm. These products were distributed from May 14, 2010 through October 13, 2010. Customers should work with their local Arstasis territory manager to ensure product replacement.

Additional Information:

FDA MedWatch Safety Alert. Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate. February 9, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242811.htm