The Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROW Catheter is being recalled because the device’s label 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.
The multiple-lumen catheter is inserted in a large vein to administer drug therapy.
If a patient with a known or unknown allergy/sensitivity to chlorhexidine or silver sulfadiazine/sulfa drug is exposed to this product, there is the potential for an allergic reaction such as a delayed rash, hives or potentially an immediate Type 1, IgE mediated anaphylaxis (loss of blood pressure, bronchospasm and vascular collapse). This product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Arrow International, Inc. (subsidiary of Teleflex, Inc.) sent its distributors an Urgent Field Correction Action letter. In the letter, the firm asked their distributors to quarantine any affected inventory and relay the information to their Arrow sales representatives. The Arrow sales representative will place a new label on each kit within their inventory.
See the FDA recall