BEUDAMED
    FDA Recall Terminated

    Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.

    Recall: Z-1546-2020 · Initiated February 10, 2020

    Recall

    Recall Number
    Z-1546-2020
    Event Number
    85022
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    February 10, 2020
    Terminated
    February 13, 2023
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153.

    Reason

    Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

    Action

    Medline notified customers on February 18, 2020 via "Urgent Recall Immediate Action required" letter. The consignees were instructed to complete the response form and return the product. The recall letter identified the affected product and lot numbers. Reason for the correction was also noted in the recall letter.

    Distribution

    US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.

    Quantity

    3,690 units