Vascular Solutions Zerusa Ltd. Issues Recall of Guardian(TM) II and
Guardian(TM) II NC Hemostasis Valves
MINNEAPOLIS, March 15, 2013 (GLOBE NEWSWIRE) -- 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:
oOnline at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or
oCall 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.
CONTACT: Howard Root,
Chief Executive Officer
Vascular Solutions, Inc.
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