Vascular (VASC) Unit Recalls Guardian II, II NC Valves; FDA Rates as Class I

March 15, 2013 4:37 PM EDT Send to a Friend
On February 28, 2013, Vascular Solutions Zerusa Ltd., a subsidiary of Vascular Solutions, Inc. (Nasdaq: VASC), initiated a nationwide recall of 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.

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 Vascular Solutions.

The recalled products were manufactured from February 2012 to February 2013 and distributed from February 2012 to February 2013.

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.

Vascular Solutions Zerusa Ltd. initiated the recall on February 28, 2013 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Vascular Solutions, Inc. in turn 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.

The U.S. Food and Drug Administration (FDA) classified 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.


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