BEUDAMED
    FDA Recall Terminated

    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Recall: Z-2528-2015 · Initiated August 6, 2015

    Recall

    Recall Number
    Z-2528-2015
    Event Number
    71893
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 6, 2015
    Posted
    September 1, 2015
    Terminated
    June 29, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

    Reason

    Sterility may be compromised

    Action

    Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878

    Distribution

    US Nationwide Distribution

    Quantity

    116 kits