BEUDAMED
    FDA Recall Terminated

    Pentalumen TD Thermodilution Catheter, Sterile

    Recall: Z-0305-04 · Initiated November 19, 2003

    Recall

    Recall Number
    Z-0305-04
    Event Number
    27788
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    DYG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 19, 2003
    Posted
    July 20, 2004
    Terminated
    April 14, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Pentalumen TD Thermodilution Catheter, Sterile

    Reason

    Thermodilution catheters have a potential for ruptured lumens within the catheter.

    Action

    Consignees were notified by letter on 11/19/2003.

    Distribution

    AR,AZ, CA, FL, LA, MA, NC, OR, PA, TN, TX, UT, VA, WA. VA facilities in AR,AZ,FL and NC. No military or foreign distribution.

    Quantity

    495 units