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Symbios Medical Products, LLC recalls Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following ki
Recalled June 12, 2013 · FDA recall Z-1460-2013 · Symbios Medical Products
Hazard
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the · FDA Class I
Units
33,543 all kits
Sold at
US Nationwide distribution.
Description
Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the
Product
Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self contained infusion system.
Manufacturer(s)
Symbios Medical Products, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →