BEUDAMED
    FDA Recall Terminated

    Medline Prefilled 350 ml Sterile

    Recall: Z-0718-2019 · Initiated September 5, 2017

    Recall

    Recall Number
    Z-0718-2019
    Event Number
    81021
    Firm
    Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
    FEI Number
    1417519
    Product Code
    CAF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 5, 2017
    Posted
    February 4, 2019
    Terminated
    April 16, 2024
    Address
    330 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3107

    Description

    Medline Prefilled 350 ml Sterile

    Reason

    Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

    Action

    Firm sent recall notification letters to customers on 9/5/2017.

    Distribution

    Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

    Quantity

    235,560