Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall - Contains Unlabeled Drug Ingredient
MedSun: Newsletter #75, August 2012

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter. The device's labeling erroneously states that the product "contains no medication," however; the device contains chlorhexidine and silver sulfadiazine. Additionally, the product’s label is missing the appropriate chlorhexidine contraindication. This product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine.

Additional Information:

FDA MedWatch Safety Alert. Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient. July 30, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm313721.htm


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