FDA Announces Recall of Defective Medical Devices
June 17, 2013
Symbios Medical Products has partnered with the U.S. Food and Drug Administration to initiate a voluntary recall of the company’s GOBlock™ and GOPump™ Rapid Recovery System kits. The recall is being implemented due to several reports that deem the device a Defective Medical Product that could cause serious harm to users.
The faulty devices were manufactured before July 2012, but were distributed to patients between April 1, 2011, and April 30, 2013. The pumps are used to administer medications to patients suffering from numerous conditions.
An FDA Press Release explains the problem with the devices was discovered when the company received five reports claiming the unit had an excessive flow rate for medications. Such a high flow rate could result in a patient suffering from a number of adverse health events, including:
- toxic medication levels,
- heart dysrhythmias,
- and even death.
While no reports of fatal events have been made, two patients claimed to have suffered serious injuries associated with the use of the defective products.
Those who are in possession of the affected products have been instructed to contact the manufacturer regarding any questions or concerns.
The Norfolk Personal Injury Lawyers with Lowell “The Hammer” Stanley acknowledge the risks associated with the use of a defective medical device. The firm may be able to help if you or a loved one has been hurt by such a product.