Symbios Medical Initiates Class 1 Recall for GOPump Infusion Pump KitsMarch 22, 2013
March 22, 2013
Symbios Medical Products, a trusted leader in medical innovations has recalled their GOPump infusion pump kit. The United States Food and Drug Administration (FDA) classified the recall as Class 1 which indicates that there is a reasonable risk of serious adverse event or death with the use of the equipment.
The affected infusion pump kits were found to be defective since the flow restrictor bead in the pump’s mechanism has a tendency to become displaced from its fitting. This may let the anesthetic contents to be dispersed at a higher rate than needed.
The recall affects the disposable pump kits with part number 510076. The kit part number and lot number may be found on the outer kit box labeling. If the pump has been removed from the outer kit box, the pump part and lot number may be found on the sterile barrier packaging. If the pump has been removed from the sterile barrier packaging, the pump lot number is the first eight digits of the serial number label, found on the base of the pump. These products were distributed between September 10, 2012 and February 11, 2013.
To know more details about this recall, visit http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm344311.htm
Improved infusion pump safety will lead to more effective patient care and reduced medication errors. To achieve these goals, it is essential to use infusion pump systems that are properly-serviced and in good working condition. AIV offers parts and services for most leading infusion pumps. Browse through AIV’s replacement parts and repair services at www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.
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