BEUDAMED
    FDA Recall Terminated

    16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard

    Recall: Z-0284-06 · Initiated March 25, 2005

    Recall

    Recall Number
    Z-0284-06
    Event Number
    31670
    Firm
    Becton Dickinson Medical Systems
    FEI Number
    1710034
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 25, 2005
    Posted
    December 15, 2005
    Terminated
    August 8, 2011
    Address
    9450 S State St, Sandy, UT, 84070-3213

    Description

    16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte Autoguard

    Reason

    Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

    Action

    Consignees were notified via telephone and fax letter, beginning 04/25/2005.

    Distribution

    AL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.

    Quantity

    435 units