BEUDAMED
    FDA Recall Completed

    Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

    Recall: Z-2036-2019 · Initiated April 30, 2019

    Recall

    Recall Number
    Z-2036-2019
    Event Number
    82927
    Firm
    Cardinal Health
    FEI Number
    3014524790
    Product Code
    FMI
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    April 30, 2019
    Address
    200 LLC 15 Hampshire St, Bldg 5, Mansfield, MA, 02048-1113

    Description

    Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011

    Reason

    Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

    Action

    Cardinal Health issued notification letter by mail on 4/30/19 advising product defect, health risk and action to take: 1. INSPECT inventory for the affected 2. SEGREGATE and QUARANTINE all on-hand product; 3. RETURN acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product quarantined or discarded. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST. Questions contact Cardinal Health at 800-292-9332

    Distribution

    Nationwide Foreign: AU, BE, CA, DK, FI, GB, IE, NL