Vascular Solutions has announced an immediate recall for its Guardian II hemostasis valves, a product used in catheterization procedures.
Specific lots of the products have been recalled because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.
The recalled products bear lot numbers 8210 and 8211 and were distributed from April 2015 to February 2016.
A total of 26,550 devices have been manufactured, with about 5,300 distributed in the United States.
Healthcare facilities that have the affected Guardian II hemostasis valves should remove the products from their inventory and return them to Vascular Solutions.
Customers with questions about this recall can contact Vascular Solutions by phone at (888) 240-6001 or by email at email@example.com.