FDA Announces the Recall of Several Defective Medical Products

June 17, 2013 |
FDA Announces the Recall of Several Defective Medical Products

June 17, 2013

The U.S. Food and Drug Administration (FDA) recently announced a voluntary recall of Symbios Medical Products’ GOBlock and GOPump Rapid Recovery System kits. The recall was initiated after the devices were deemed Defective Medical Products that could cause serious harm to patients who use them.

The products are used in the administration and delivery of medications into the patient’s body through a timed pump. The affected products were manufactured before July 2012 and were distributed to patients form April 1, 2011 to April 30, 2013.

According to an FDA Press Release, the recall was initiated after the company received five reports from patients claiming the devices had an excessively high flow rate for medications being administered to patients. Such a high flow rate could result in a patient experiencing adverse health effects, including:

  • toxic levels of medication in the bloodstream
  • seizures
  • heart dysrhythmia
  • death

While no fatalities have been reported as a result of the defects, two patients suffered serious injuries due to use of the products.

Those who are using or are in possession of the affected products have been instructed to contact the manufacturer via telephone to discuss any questions or concerns.

The Bloomfield Hills Personal Injury Lawyers with Michigan Injury Lawyers acknowledge the dangers posed through the use of a defective medical device. The firm may be able to help if such a product has harmed you or a loved one.