BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    Recall: Z-0351-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0351-2024
    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 Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    Reason

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

    Code Info

    UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI: 07613203011853, Catalog # 20062E; UDI-DI: 10885403226120, Catalog # 70000N-07; UDI-DI: 10885403236112, Catalog # ME1224; UDI-DI: 10885403229756, Catalog # 20350ET; UDI-DI: 10885403240997, Catalog # 70001B-07T. All lots, thru expiration date October 16, 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