BEUDAMED
    FDA Enforcement Class II Ongoing

    PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.

    Recall: Z-0119-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0119-2026
    Event ID
    97550
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B BRAUN MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2025
    Initiation Date
    September 18, 2025
    Classification Date
    October 9, 2025
    Address
    861 Marcon Blvd, Allentown, PA, 18109-9577, United States

    Description

    PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.

    Reason

    Potential for the lid of the catheter connector to be in the incorrect position.

    Code Info

    REF: 332097; Product Code: CE17TKFCS; UDI-DI (Primary): 04046955899470; UDI-DI (Unit of Use): 04046955899487; Lot Numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, 0062013052. Expiration Date: 07/31/2026.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.

    Quantity

    21,270 units