BEUDAMED
    FDA Recall Terminated

    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.

    Recall: Z-1649-2016 · Initiated April 1, 2016

    Recall

    Recall Number
    Z-1649-2016
    Event Number
    73669
    Firm
    Medtronic
    FEI Number
    1219930
    Product Code
    LZH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 1, 2016
    Terminated
    May 18, 2018
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital and acute care settings.

    Reason

    Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm

    Action

    Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878.

    Distribution

    Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.

    Quantity

    145 units