Recall -- Firm Press Release
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Vascular Solutions Zerusa Ltd. Issues Recall of Guardian™ II and Guardian™ II NC Hemostasis Valves
FOR IMMEDIATE RELEASE - March 15, 2013 - MINNEAPOLIS, Minnesota - On February 28, 2013, Vascular Solutions Zerusa Ltd., a subsidiary of Vascular Solutions, Inc., 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."
Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at firstname.lastname@example.org. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.html
(form available to fax or mail), or
- Call FDA 1-800-FDA-1088
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company's product line consists of more than 70 products and services in three categories:
catheter products, hemostat products and vein products. Vascular Solutions delivers its products and services to interventional cardiologists, interventional radiologists, electrophysiologists and vein specialists through its direct U.S. sales force and international independent distributor network.
Vascular Solutions Zerusa, Ltd. is a wholly-owned subsidiary of Vascular Solutions, Inc. located in Galway, Ireland engaged in the manufacture and distribution of the Guardian hemostasis valves which was formed in January 2011 when Vascular Solutions acquired the Guardian hemostasis valve assets from Zerusa Limited.
For further information, connect to www.vasc.com .