BEUDAMED
    FDA Recall Terminated

    4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

    Recall: Z-0127-2016 · Initiated September 18, 2015

    Recall

    Recall Number
    Z-0127-2016
    Event Number
    72244
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 18, 2015
    Posted
    October 15, 2015
    Terminated
    June 25, 2020
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

    Reason

    Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.

    Action

    An urgent medical device notification, dated September 22, 2015, was sent to direct accounts to alert them about the issue, the potential risks, and provide instructions for returning the completed response form and affected devices.

    Distribution

    Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.

    Quantity

    31590