BEUDAMED
    FDA Recall Terminated

    Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

    Recall: Z-1494-2014 · Initiated March 24, 2014

    Recall

    Recall Number
    Z-1494-2014
    Event Number
    67831
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    March 24, 2014
    Posted
    April 24, 2014
    Terminated
    September 21, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

    Reason

    Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

    Action

    A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "

    Distribution

    Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca

    Quantity

    789