Recall Class: Class I
Date Recall Initiated: Feb. 27, 2013
Products: Guardian II and Guardian II NC Hemostasis Valves, Model Numbers 8210, 8211, 8215, 8216
A list of the recalled lot numbers is available from Vascular Solutions and has been provided to each facility that purchased the affected products.
The recalled products were manufactured and distributed from February 2012 to February 2013.
Use: The Guardian II and Guardian II NC hemostasis valves are intended to reduce blood loss during catheterization procedures.
Vascular Solutions, Inc.
6464 Sycamore Court North
Minneapolis, Minnesota 55369
Vascular Solutions Zerusa Ltd. (a subsidiary of Vascular Solutions, Inc.)
209 Business Innovation Centre
NUI Galway, Newcastle Road
Reason for Recall: The firm is recalling the product due to a risk that air may be introduced into the device which may lead to an air embolism. This product may cause serious adverse health consequences, including death.
Public Contact: Consumers with questions may contact the company by phone at 1-888-240-6001 Monday through Friday, 8:00 AM to 5:00 PM Central Time or by email at firstname.lastname@example.org.
FDA District: Minneapolis District Office
FDA Comments: On Feb. 28, 2013, Vascular Solutions sent an "Urgent Medical Device Recall" letter to its customers. The letter described the problem and the product involved in the recall. The firm advised its customers to immediately remove the recalled product from their inventory and secure it. The firm also requested customers complete and return the Vascular Solutions Inc. (VSI) Account Inventory Form.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.