BEUDAMED
    FDA Recall Terminated

    Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.

    Recall: Z-0030-2007 · Initiated June 20, 2006

    Recall

    Recall Number
    Z-0030-2007
    Event Number
    35959
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    NVM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2006
    Posted
    October 12, 2006
    Terminated
    October 16, 2006
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart.

    Reason

    The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.

    Action

    Recall letter was sent to customers on 6/20/2006 by US mail.

    Distribution

    Medical facilities located in MD, IL, MO, MA and United Kingdom, for a total of 5.

    Quantity

    11 units