BEUDAMED
    FDA Recall Terminated

    1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720

    Recall: Z-1690-2016 · Initiated March 18, 2016

    Recall

    Recall Number
    Z-1690-2016
    Event Number
    73691
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 18, 2016
    Posted
    May 18, 2016
    Terminated
    July 19, 2017
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    1) 24 G x 0.75 in. BD Angiocath" Autoguard" shielded IV catheter (0.7 mm x 19 mm) made of FEP polymer catalog number 381700 2) 24 G x 0.56 in. BD Angiocath-N" Autoguard" shielded IV catheter (0.7 mm x 14 mm) made of FEP polymer catalog number 381720

    Reason

    The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.

    Action

    BD isssued an urgent voluntary product recall lettter/recall response card on 3/18/2016.

    Distribution

    Nationwide

    Quantity

    1,305,150 units