BEUDAMED
    FDA Recall Open, Classified

    REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly

    Recall: Z-2005-2025 · Initiated May 21, 2025

    Recall

    Recall Number
    Z-2005-2025
    Event Number
    96865
    Firm
    Becton Dickinson Infusion Therapy Systems, Inc.
    FEI Number
    1710034
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    May 21, 2025
    Posted
    June 23, 2025
    Address
    9450 S State St, Sandy, UT, 84070-3213

    Description

    REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 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.

    Action

    On May 21, 2025, Becton Dickinson Infusion Therapy (BD) issued a "Urgent: Medical Device Recall" Notification to affected consignees FedEx and E-Mail. BD asked consignees to take the following actions: 1. Immediately review your inventory for product listed in the above table. Cease use and destroy any unused affected devices. 2. For devices that have deployed and are currently in use or if an impacted device was previously used, no additional follow-up activities are required for patients that have completed therapy. 3. Share and post this Product Recall letter within your facility network and forward to any customers you may have distributed the product to ensure awareness. Ensure the contents of this Product Recall are read and understood by those within your organization. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification.

    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