BEUDAMED
    FDA Enforcement Class II Terminated

    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Recall: Z-2534-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2534-2015
    Event ID
    71893
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    August 6, 2015
    Classification Date
    September 1, 2015
    Termination Date
    June 29, 2017
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Reason

    Sterility may be compromised

    Code Info

    Lot Numbers: 1504700138

    Distribution

    US Nationwide Distribution

    Quantity

    171 kits