FDA-Device2013-06-12Class I

Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery

Symbios Medical Products, LLC
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

Sold states
US Nationwide distribution.
Affected count
33, 543 for all kits
Manufactured in
7301 Georgetown Rd., Suite 150, Indianapolis, IN, United States
Products
Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 510491, Disposable Single Infusion Pump for drug delivery

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2013

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