The U.S. Food and Drug Administration (FDA) issued a safety communication last month to notify healthcare providers about a Class I recall of the Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves. According to the announcement, the devices were recalled due to a risk for serious injuries and death.
The Guardian II and Guardian II NC hemostasis valves are designed to reduce blood loss during catheterization procedures. According to the FDA, the problem with the devices is that air may be introduced, which can result in an air embolism.
The recalled includes Model Numbers 8210, 8211, 8215 and 8216. The firm sent an “Urgent Medical Device Recall” to all its customers who use the devices.
Berkowitz and Hanna LLC is warning healthcare providers about the recall and the potential risks associated with these devices. The product liability lawyers at the firm represent individuals who suffer serious injuries as a result of defective medical devices and other products.
If you or someone you love has suffered an injury due to a recalled or defective product, you may be entitled to compensation. To speak with an attorney in Connecticut, contact Berkowitz and Hanna LLC today.