BEUDAMED
    FDA Enforcement Class II Terminated

    Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.

    Recall: Z-0156-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0156-2013
    Event ID
    63379
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxa Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    October 3, 2012
    Classification Date
    October 25, 2012
    Termination Date
    February 15, 2013
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.

    Reason

    The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use.

    Code Info

    Repeater Pump model #s 095, 099, and 099R.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.

    Quantity

    N/A