BEUDAMED
    FDA Recall Open, Classified

    Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

    Recall: Z-1397-2025 · Initiated February 17, 2025

    Recall

    Recall Number
    Z-1397-2025
    Event Number
    96293
    Firm
    B Braun Medical Inc
    FEI Number
    2521402
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 17, 2025
    Posted
    March 19, 2025
    Address
    824 12th Ave, Bethlehem, PA, 18018-3524

    Description

    Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.

    Reason

    Increased risk for valve housing detachment causing leakage.

    Action

    An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417.

    Distribution

    Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.

    Quantity

    28,200 units