The U.S. Food and Drug Administration (FDA) issued a Class I Recall of a catheter because the product is mislabeled and its use in some patients could cause death. The recall is directed to nurses and those in critical care medicine.The device is the Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter made by Arrow International, Inc.
Incorrect Label Related to Death Risk
According to the recall, the label incorrectly states that the catheter contains no medication. In fact, however, it contains both chlorhexidine and silver sulfadiazine. The label also has left off the contraindication (warning when it should not be used) for chlorhexidine.Should a patient be treated using the catheter and be allergic to either drug ingredient, he or she may have a delayed rash or hives or potentially an immediate severe allergic reaction that could cause a drop in blood pressure, bronchospasm (severe constriction of airways in the lungs) and collapse of the veins. This could cause the patient to die.The catheter is inserted into a large vein to deliver drugs to the patient.Arrow sent its distributors an urgent message, asking them to isolate the specified catheters and give the information to Arrow Sales Representatives. The representative would put new labels on every kit they intended to sell.A Class I recall is the most serious kind of recall. It is used for cases when using the recalled product can lead to serious health consequences or death.
Source: FDA – http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm313721.htm
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