News & Press: Patient Safety

5/17 - Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits

Friday, May 17, 2013  
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Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. To date, there have been 5 complaints received, 2 of which involved serious consequences. There have been no patient deaths reported. The root cause is understood and processes have been put in place to address the issue.

This recall affects only the fifty (50) United States plus the District of Columbia. 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. Products subject to this recall were distributed between April 1st, 2011 and April 30th, 2013. Recall action was begun immediately upon the knowledge of the product related issues.

For a complete list of affected products, click HERE.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 5/17/2013)

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