Vascular Solutions Zerusa, a subsidiary of Vascular Solutions, is recalling the Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. 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 FDA is classifying this as a Class I recall. FDA defines Class I recalls 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.”
Healthcare facilities that have the affected Guardian II and Guardian II NC hemostasis valves should remove the products from their inventory and return them to Minneapolis-based Vascular Solutions. The recalled products were manufactured from February 2012 to February 2013 and distributed in the same period.
The recalled products are specific lots of Model Numbers 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products.
Galway, Ireland-based Vascular Solutions Zerusa initiated the recall on Feb. 28, 2013, through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Vascular Solutions notified its customers of the specific lots subject to the recall and included instructions on how to return the affected products. No injuries have been reported in association with this issue.