Symbios Medical Products has recalled 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 five complaints received, two 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, according to the company.
This recall affects the entire United States and 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 1, 2011 and April 30, 2013. Recall action was begun immediately upon the knowledge of the product related issues.
Consumers or using customer sites with questions may contact the company via telephone at 1-317-225-4447, ext. 25, between the hours of 8 a.m. and 4 p.m. EST. Customers may also contact the company via e-mail at email@example.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration (FDA) online at www.fda.gov/MedWatch/report.htm or download a reporting form at www.fda.gov/MedWatch/getforms.htm (form available to fax or mail); or call FDA 1-800-FDA-1088
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