Symbios GOPump and GOBlock Kits: Class I Recall
MedSun: Newsletter #86, July 2013

FDA MedWatch Safety Alert

FDA and Symbios are informing the public of a recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication.

Additional Information:

Symbios GOPump and GOBlock Kits: Class I Recall. FDA MedWatch Safety Alert. June 12, 2013
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm356516.htm


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