The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning GOPump Elastomeric Infusion PumpKit manufactured by Symbios Medical Products, LLC. The affected kits, with or without accessories, are all containing Dual GoPump, part number 510076. These kits were distributed between 10 September 2012 and 11 February 2013.
According to the manufacturer, the products are being recalled as the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death.
The manufacturer advises the affected users to immediately remove all affected GOPump kits from the inventory. For details, please visit the following FDA websites:
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 March 2013