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Arrow International, Inc. (ARRO) Multi-Lumen Venous Catheterization Set With Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient


7/31/2012 8:42:07 AM

AUDIENCE: Nursing, Critical Care Medicine

ISSUE: 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.

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 presenting as a delayed rash, hives or potentially an immediate Type 1, IgE mediated anaphylaxis (loss of blood pressure, bronchospasm and vascular collapse). The product may cause serious adverse health consequences, including death, if used in a patient who is allergic to either chlorhexidine or silver sulfadiazine.


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