BEUDAMED
    FDA Enforcement Class II Terminated

    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    Recall: Z-0644-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0644-2014
    Event ID
    67034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 15, 2014
    Initiation Date
    July 10, 2013
    Classification Date
    January 8, 2014
    Termination Date
    September 15, 2021
    Address
    10 Bowman Dr, Keene, NH, 03431-5043, United States

    Description

    Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.

    Reason

    Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringes

    Code Info

    Lot Numbers: 2330832, 2336493, 2348708, 2353094, 2357319

    Distribution

    Worldwide Distribution: US (nationwide) including states of: AZ, CA, FL, IL, LA, MO, MS, NH, NY, OH, PA, TN, TX, VA, WI, and WV; and countries of: Canada, Italy and Spain.

    Quantity

    506925