Vascular Solutions Zerusa, Ltd recently initiated a nationwide recall of Guardian™ II and Guardian™ II NC hemostasis valves. Vascular Solutions Zerusa, Ltd. recently initiated a nationwide recall of Guardian™ II and Guardian™ II NC hemostasis valves used in catheterization procedures due to a risk of air leakage.
Specific lots of the products have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death, the company announced in its recall notice posted by the U.S. Food and Drug Administration (FDA) on March 15. The company has provided a list of the affected Guardian™ II and Guardian™ II NC valves to healthcare facilities and advised the facilities to remove these products from their inventory and return them to Vascular Solutions.
The FDA categorized this recall as a Class I—its most serious recall classification
The FDA categorized this recall as a Class I—its most serious recall classification—which is defined as a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled products were manufactured between February 2012 and February 2013 and distributed from February 2012 to February 2013. Adverse reactions or quality problems with the product may be reported to the FDA online, by mail, or by fax.