BEUDAMED
    FDA Enforcement Class II Terminated

    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

    Recall: Z-1121-2015 · Reported February 25, 2015

    Enforcement

    Recall Number
    Z-1121-2015
    Event ID
    69782
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pulsion Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2015
    Initiation Date
    November 4, 2014
    Classification Date
    February 17, 2015
    Termination Date
    October 2, 2015
    Address
    3781 Attucks Dr, Powell, OH, 43065-6080, United States

    Description

    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

    Reason

    Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

    Code Info

    Model Number PV8810US; Lot # 14AK20 and 14EK20

    Distribution

    US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.

    Quantity

    90 units