BEUDAMED
    FDA Recall Terminated

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    Recall: Z-0410-2009 · Initiated September 19, 2008

    Recall

    Recall Number
    Z-0410-2009
    Event Number
    50081
    Firm
    Covidien
    FEI Number
    1317749
    Product Code
    NYU
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 19, 2008
    Posted
    December 4, 2008
    Terminated
    December 4, 2008
    Address
    5439 State Route 40, Argyle, NY, 12809-3830

    Description

    PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.

    Reason

    Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used.

    Action

    Starting on 9/19/08, Covidien Sales Representatives visited each of the hospitals that received the catheters, informed the staff that the Venetrac insertion stylets were too short, and placed pink corrective sticker labels on any unused product. Should you require additional information, please contact [email protected] or 508-216-8532.

    Distribution

    Nationwide distribution including states of OH, WI, LA, TX, UT, CA, OR, and WA.

    Quantity

    82 units