BEUDAMED
    FDA Enforcement Class II Ongoing

    PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.

    Recall: Z-0114-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0114-2026
    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 with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.

    Reason

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

    Code Info

    REF: 332077; Product Code: CE17TBFC; UDI-DI (Primary): 4046964177187; UDI-DI (Unit of Use): 4046964177170; Lot Number: 0062022053. Expiration Date: 10/16/2024

    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

    0 units