BEUDAMED
    FDA Enforcement Class II Ongoing

    SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

    Recall: Z-0797-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0797-2022
    Event ID
    89553
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2022
    Initiation Date
    January 20, 2022
    Classification Date
    March 16, 2022
    Address
    1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States

    Description

    SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT

    Reason

    Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

    Code Info

    Catalog Number: 4306CSP Lot Numbers/UDI (GTIN, DI + PI): 0001410708 (01)10885403107795(17)220331(10)0001410708 0001411191 (01)10885403107795(17)220331(10)0001411191 0001412491 (01)10885403107795(17)220331(10)0001412491 0001413309 (01)10885403107795(17)220331(10)0001413309 0001416352 (01)10885403107795(17)220430(10)0001416352 0001417049 (01)10885403107795(17)220430(10)0001417049 0001420356 (01)10885403107795(17)220430(10)0001420356 0001421923 (01)10885403107795(17)220630(10)0001421923 0001422376 (01)10885403107795(17)220630(10)0001422376 0001425371 (01)10885403107795(17)220630(10)0001425371 0001426677 (01)10885403107795(17)220630(10)0001426677 0001429128 (01)10885403107795(17)220630(10)0001429128 0001432172 (01)10885403107795(17)220630(10)0001432172 0001433264 (01)10885403107795(17)220831(10)0001433264 0001433845 (01)10885403107795(17)220930(10)0001433845 0001437662 (01)10885403107795(17)221031(10)0001437662

    Distribution

    U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.

    Quantity

    15,650 devices