BEUDAMED
    FDA Enforcement Class II Ongoing

    BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.

    Recall: Z-0350-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0350-2024
    Event ID
    93266
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    October 11, 2023
    Classification Date
    November 17, 2023
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.

    Reason

    Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

    Code Info

    UDI-DI: 10885403240867, Catalog # 4030B-07T; UDI-DI: 07613203020855, Catalog # 42081E. All lots, thru expiration date July 31, 2026.

    Distribution

    Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.

    Quantity

    N/A