BEUDAMED
    FDA Enforcement Class II Terminated

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    Recall: Z-0902-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0902-2013
    Event ID
    64383
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Salyer Prn Biomedical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    January 31, 2013
    Classification Date
    March 1, 2013
    Termination Date
    April 15, 2013
    Address
    1833 W Main St Ste 116, N/A, Mesa, AZ, 85201-6924, United States

    Description

    Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.

    Reason

    Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.

    Code Info

    Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.

    Distribution

    Distributed in the states of MA,CA, and WI.

    Quantity

    9 units