Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall
MedSun: Newsletter #60, May 2011

FDA MedWatch Safety Alert

There is a possibility that small particles (debris) may be found inside the catheter. This foreign debris can potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs. This could lead to a decreased blood supply to these structures which can result in serious injury and /or death.

Additional Information:

FDA MedWatch Safety Alert. Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall. April 1, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249387.htm


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