BEUDAMED
    FDA Recall Terminated

    Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.

    Recall: Z-0541-06 · Initiated December 20, 2005

    Recall

    Recall Number
    Z-0541-06
    Event Number
    34518
    Firm
    Bard Access Systems, Inc
    FEI Number
    3006260740
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2005
    Posted
    March 16, 2006
    Terminated
    August 11, 2009
    Address
    5425 Amelia Earhart Dr, Salt Lake City, UT, 84116-3713

    Description

    Groshong NXT ClearVue 4 Fr Single-Lumen PICC, Bard Access Systems, Inc.

    Reason

    Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions.

    Action

    Consignees were notified by letter on 12/20/2005.

    Distribution

    Nationwide, including VA facilities in CA, FL and IL. No foreign or military distribution.

    Quantity

    567 units