Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter
MedSun: Newsletter #64, September 2011

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. The affected products were manufactured between April 14, 2011 and May 9, 2011. See Customers should check their stock, cease use and distribution, and quarantine all affected product.

Additional Information:

FDA MedWatch Safety Alert. Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter. August 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266526.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun