BEUDAMED
    FDA Recall 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 · Initiated February 1, 2018

    Recall

    Recall Number
    Z-2948-2018
    Event Number
    80702
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 1, 2018
    Terminated
    October 5, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    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.

    Action

    The firm, Medline Industries, Inc., sent an "URGENT RECALL IMMEDIATE ACTION REQUIRED" letter dated February 1, 2018 to their consignees with the required actions to be followed; 1. Immediately check your stock for item number EMZ10051240 and the affected lot number, 3131591, and quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacement(s). 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc. Should you have any questions, contact the Recall Coordinator at 1-866-359-1704.

    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