Vascular Solutions, Inc. Issues Recall of Twin-Pass® Dual Access Catheters
Healthcare facilities that have the affected Twin-Pass dual access catheters should remove the products from their inventory and return them to Vascular Solutions.
The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.
The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. A total of 15,896 devices have been manufactured, with 5,784 distributed in the United States and currently unexpired. The condition that led to the recall may affect approximately 9.2% of recalled devices.
Vascular Solutions, Inc. voluntarily initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products.
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, a 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 customerservice@vasc.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program:
-
Online at
http://www.fda.gov/medwatch/report.htm
(form available to fax (1-800-FDA-0178) or mail), or - Call FDA 1-800-FDA-1088 to request a reporting form
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 has launched more than 100 products that
are sold to interventional cardiologists, interventional radiologists,
electrophysiologists, and vein specialists through its direct U.S. sales
force and international independent distributor network.
For further information, connect to
www.vasc.com.
###