BEUDAMED
    FDA Enforcement Class I Terminated

    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.

    Recall: Z-1461-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1461-2013
    Event ID
    65192
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Symbios Medical Products, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 10, 2013
    Classification Date
    June 6, 2013
    Termination Date
    March 7, 2014
    Address
    7301 Georgetown Rd., Suite 150, Indianapolis, IN, 46268, United States

    Description

    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.

    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

    Code Info

    Pump Part 510613 , Lot 11-100815 - Lot 12-10101060 found in: GoBlock Kit 510612, Lot 11-100817 to 13-101475

    Distribution

    US Nationwide distribution.

    Quantity

    33,543 all kits