BEUDAMED
    FDA Recall Terminated

    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.

    Recall: Z-1149-2014 · Initiated February 19, 2014

    Recall

    Recall Number
    Z-1149-2014
    Event Number
    67562
    Firm
    Medefil Incorporated
    FEI Number
    3001677091
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 19, 2014
    Posted
    March 6, 2014
    Terminated
    September 5, 2017
    Address
    250 Windy Point Dr, Glendale Heights, IL, 60139-3805

    Description

    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.

    Reason

    The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 ( Heparin I.V. Flush Syringe 100 units/mL; 5 mL fill in 12 mL Syringe) whereas this product is actually Product No. MIH-3333 (Heparin I.V. Flush Syringe 100 units/mL; 3 mL fill in 12 mL Syringe).

    Action

    URGENT MEDICAL DEVICE CORRECTION letters dated February 19, 2014 were sent to all direct accounts. The letters included instructions to: quarantine the recalled products; and,complete and return the attached customer response form (via Fax to 630-681-9100 or via mail to Medefil Inc., 250 Windy Point Drive, Glendale Heights, IL 60139) so that the correct number of replacement labels can be sent from Medefil.

    Distribution

    USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TX, UT, and WI, and the country of Canada.

    Quantity

    1,608 Master Cartons