The FDA has issued a Class I recall for the Arrow multi-lumen venous catheterization set with a blue FlexTip ARROWg+ard catheter. These catheters are used to administer drug therapy after being inserted into a large vein. The label of the product incorrectly states that the catheter “contains no medication.”
The catheterization sets actually contain silver sulfadiazine as well as chlorhexidine. If a patient with an allergy or sensitivity, known or unknown, to either substance is exposed, they risk the possibility of adverse health consequences or even death. An allergic reaction to either can present as a delayed rash or hives or more immediately as Type 1, IgE mediated anaphylaxis. Such anaphylaxis manifests as loss of blood pressure, broncospasm, and vascular collapse.
Arrow sent out a letter on May 3rd, 2012 to all distributors of the sets urging them to quarantine the entirety of the designated product supply. The distributors were then to alert their Arrow sales representatives to replace the labels in order to properly warn potential patients.