BEUDAMED
    FDA Enforcement Class I Terminated

    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

    Recall: Z-1798-2021 · Reported June 16, 2021

    Enforcement

    Recall Number
    Z-1798-2021
    Event ID
    87945
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 16, 2021
    Initiation Date
    May 17, 2021
    Classification Date
    June 10, 2021
    Termination Date
    October 11, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

    Reason

    Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.

    Code Info

    a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096

    Distribution

    Worldwide distribution - US Nationwide and the countries of UK, Spain.

    Quantity

    1,432,200 units