The U.S. Food and Drug Administration recently issued a Class I recall for a catheter marketed by Arrow International, Medical News reported.
The company is a subsidiary of Teleflex, which primarily designs, develops, manufactures and supplies single-use medical devices used by hospitals and healthcare providers for common diagnostic and therapeutic procedures in critical care and surgical applications.
The FDA stated that the Multi-Lumen Venous Catheterization Set with Blue FlexTip ARROWg+ard Catheter contains chlorhexidine and silver sulfadiazine, which are not included on the product's label. People who are allergic or sensitive to chlorhexidine and silver sulfadiazine and are exposed to the product could break out in a rash or hives, or endure anaphylaxis.
On May 3, 2012, Arrow International asked their distributors to quarantine the affected products so a proper label could be issued to them. The most recent announcement by the FDA moved the recall notice up to Class I status. This means that such products have a reasonable risk of causing adverse health complications or death upon use.
The affected products were manufactured from June 28, 2010, to March 4, 2012. They were distributed from December 9, 2010, to February 29, 2012.