Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use
MedSun: Newsletter #58, March 2011

FDA MedWatch Safety Alert

Introducer tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, while introducer tip material may enter into the bloodstream, causing blood clots (thrombosis). Merit Medical Systems, Inc. is advising customers to immediately discontinue use of any affected product, examine their inventory, and quarantine all affected product.

Additional Information:

FDA MedWatch Safety Alert. Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use. February 4, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242343.htm


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