BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05

    Recall: Z-2463-2021 · Reported September 22, 2021

    Enforcement

    Recall Number
    Z-2463-2021
    Event ID
    88203
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CAREFUSION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 22, 2021
    Initiation Date
    August 2, 2021
    Classification Date
    September 13, 2021
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05

    Reason

    Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.

    Code Info

    Lots: 20025968 20026013 20035834 20035835 20026132 20026133 20085151

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.

    Quantity

    24,360