Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter Recalled due to Unlabeled Drug Ingredient

Nursing and Critical Care Medicine personnel are informed by the FDA that Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter is recalled because, due to an unlabeled drug ingredient it may cause allergic reaction which can lead to serious adverse events, including death.

Background of Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter

Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter, by Arrow International, Inc., is used to administer drug therapy inserted in a large vein.

FDA Alert on Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter

FDA’s reason for the recall is that the device contains unlabeled chlorhexidine and silver sulfadiazine. If a patient with an allergy to the above drug ingredients is exposed to this product this may cause allergic reaction which may lead to severe adverse events, including death.

The product manufacture dates are from June 28, 2010 to March 4, 2012 and distribution dates from December 9, 2010 to February 29, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter

“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.”

Contacting the FDA to report cases with Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter

In case of detection of adverse events or side effects related to the use of Arrow International, Inc. Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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