BEUDAMED
    FDA Recall Open, Classified

    BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424

    Recall: Z-1239-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1239-2023
    Event Number
    91495
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    FMF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 1, 2023
    Posted
    March 10, 2023
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424

    Reason

    Nonsterile syringe potentially exposing the patient to pathogenic microorganisms and a risk of local infection.

    Action

    BD issued Urgent Medical Device Recall Letter to US Distributors/Wholesalers and Customer notification template on 2/1/23 via Federal Express (FedEx) and/or email, when available. OUS letters issued . Letter states reason for recall, health risk and action to take: 1. Immediately inspect your inventory for the specific catalog and lot number listed above. Destroy all affected products subject to the recall following your institution's process of destruction. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a customer letter to all customers to advise them of this field action notification on BD's behalf. An example of a customer communication is attached for your reference. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product credit, if required Credit will be provided for all destroyed product following receipt of the completed Distributor Response Form. Contact: North American Regional Complaint Center Phone: 1-844-88D-LIFE (1-844-823-5433) Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: [email protected]

    Distribution

    Worldwide distribution - US Nationwide and the countries of Chile, Colombia, Dominican Republic, Bahamas, Panama, Peru, Mexico, El Salvador, Mexico, Malaysia, Philippines, Vietnam, Hong Kong, Taiwan, Thailand, Canada.

    Quantity

    1,921,000 units