BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

    Recall: Z-2006-2025 · Reported July 2, 2025

    Enforcement

    Recall Number
    Z-2006-2025
    Event ID
    96865
    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
    July 2, 2025
    Initiation Date
    May 21, 2025
    Classification Date
    June 23, 2025
    Address
    9450 S State St, Sandy, UT, 84070-3213, United States

    Description

    REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly

    Reason

    Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

    Code Info

    Lot# 4282308/UDI: 382903819232

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Belgium, Canada, Chile, Colombia, Guatemala, Japan, New Zealand, Panama, Philippines, Singapore, Vietnam.

    Quantity

    50 units