July 31, 2012
Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter: Class I Recall – Contains Unlabeled Drug Ingredient
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.
BACKGROUND: The multiple-lumen catheter is inserted in a large vein to administer drug therapy.
RECOMMENDATION: On May 3, 2012, the firm 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 would place new labels on each kit within their inventory.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Recall Notice, at: