BEUDAMED
    FDA Recall Terminated

    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

    Recall: Z-1733-2019 · Initiated February 11, 2019

    Recall

    Recall Number
    Z-1733-2019
    Event Number
    82503
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 11, 2019
    Terminated
    June 23, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

    Reason

    Incorrect needle length and gage.

    Action

    On 2/11/2019 the firm sent notifications of the recall with the following instructions: " 1.Locate and determine the number of affected products in your possession 2.Complete the attached Response Form within 10 days and return it to [email protected], even if you do not have any of the affected product in your possession. 3.Return affected product to Smiths Medical utilizing the pre-paid shipping labels included with this notice include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit or replacement. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at [email protected]."

    Distribution

    US Nationwide Distribution - AZ, CA, FL, GA, IL, IN, MA, MN, MO, MS, NJ, NY, PA, RI, SC, TN, TX, VA, and WA.

    Quantity

    109000 (96,000 USA)