Symbios Medical Products last week recalled all of its GoPump rapid recovery systems and GOBlock kits manufactured with flow control components assembled prior to July 2012, according to the FDA.

These products were found to potentially cause excessively high flow rates, the agency reported. Due to the rapid influx of medication, particularly in patients with low body mass or advanced age, patient toxicity and serious injury including seizure, dysrhythmia and death can result, the FDA noted.

To date the company has reported 5 complaints about the pumps, 2 of which involved serious consequences. No patient deaths have been reported thus far.

The recall affects all 50 U.S. states and the District of Columbia. Products subject to this recall were distributed between April 1st, 2011, and April 30th, 2013.

The root cause is understood and processes have been put in place to address the issue, Symbios told regulators. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers.
Symbios is working to secure all affected product and have it returned, and immediately began recall action upon knowledge of the product related issues, according to the report.