BEUDAMED
    FDA Enforcement Class II Terminated

    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.

    Recall: Z-2948-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2948-2018
    Event ID
    80702
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    February 1, 2018
    Classification Date
    August 29, 2018
    Termination Date
    October 5, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only.

    Reason

    Packaged with an incorrect overwrap.

    Code Info

    Lot # 3131591

    Distribution

    US Nationwide Distribution to states of: CA, CT, DE, FL, GA, IN, LA, MA, MD, MN, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA and WV

    Quantity

    90,870 units