BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

    Recall: Z-0400-2024 · Reported December 6, 2023

    Enforcement

    Recall Number
    Z-0400-2024
    Event ID
    93276
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson Infusion Therapy Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2023
    Initiation Date
    October 4, 2023
    Classification Date
    November 24, 2023
    Address
    9450 S State St, Sandy, UT, 84070-3213, United States

    Description

    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533

    Reason

    Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site.

    Code Info

    UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31

    Distribution

    US Nationwide distribution in the states of CA, NC, MI, WA, CO, FL, NJ, NM, IL, KY, TN, OH, TX, IN, LA, IA, MS, MO, NE, MD, NY, PA, GA, VA, ME, SC, RI, MA, PR.

    Quantity

    528,000