Recall Z-1454-2013— Symbios Medical Products, LLC

Class I FDA medical device recall by Symbios Medical Products, LLC, initiated 2013-05-10, terminated 2014-03-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump Rapid Recovery System is a local pain mangagement system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered via tubing to the surgical site at a very slow rate. Reason: 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.

Recalling firm

Symbios Medical Products, LLC

Classification

Class I

Status

Terminated

Initiated

2013-05-10

Terminated

2014-03-07

Firm location

Indianapolis, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.