Symbios GoPump Recall Issued for Disposable Dual Infusion Pump Kits

A recall has been issued for Symbios GoPump dual infusion pump kits due to a faulty flow restrictor bead, which could allow increased amounts of fluid to travel into the body, posing a risk for severe health consequences and even death.  

The Symbios GOPump Elastomeric Infusion Pump Kit recall was announced by the FDA on March 18, after it was discovered that the flow rate bead can dislodge from its fitting and possibly allow solutions to run through a patient’s body at higher rates than intended.

The recall has been classified as Class I by the FDA, meaning that there is a reasonable probability that the use of this product will cause severe health consequences or death.

The recalled Infusion Pumps are disposable, self contained infusion systems that use an inflatable elastomeric reservoir to mechanically provide prescribed solutions at a pre-set rate to control pain management following surgery. The pumps have a liquid flow rate labeled at 2mL/hr per elastomer.

A full list of recalled GOPump Dual Infusion Kits has been provided on the FDA.gov website.

The recalled infusion pumps were manufactured under Symbios Medical Products, LLC, of Indianapolis, Indiana and distributed by B. Braun Medical Inc., of Allentown Pennsylvania from September 10, 2012 through February 11, 2013.

On February 25, Symbios Medical Products sent out an “URGENT MEDICAL DEVICE RECALL” notification letter indicating that the recalled products should be segregated and returned to the manufacturer.

The recalled infusion pumps were manufactured under Symbios Medical Products, LLC, of Indianapolis, Indiana and distributed by B. Braun Medical Inc., of Allentown Pennsylvania from September 10, 2012 through February 11, 2013.

Consumers should stop using the infusion pumps and verify the recall status of the product and follow the precautionary steps outlined by the “URGENT MEDICAL DEVICE RECALL”. For all other inquiry consumers may call 1-800-332-1088 or find more information online at www.fda.gov/MedWatch/report.htm