BEUDAMED
    FDA Recall 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 · Initiated May 17, 2021

    Recall

    Recall Number
    Z-1798-2021
    Event Number
    87945
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    MEG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 17, 2021
    Posted
    June 10, 2021
    Terminated
    October 11, 2023
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    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.

    Action

    The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: [email protected] The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.

    Distribution

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

    Quantity

    1,432,200 units