BEUDAMED
    FDA Enforcement Class II Terminated

    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

    Recall: Z-1715-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1715-2020
    Event ID
    84681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    January 7, 2020
    Classification Date
    April 15, 2020
    Termination Date
    December 14, 2020
    Address
    10 Bowman Dr, Keene, NH, 03431-5043, United States

    Description

    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes

    Reason

    Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

    Code Info

    Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747

    Distribution

    USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

    Quantity

    720,100 total devices