BEUDAMED
    FDA Enforcement Class II Ongoing

    SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT

    Recall: Z-0794-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0794-2022
    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 LUMBAR PUNCTURE TRAY ADULT

    Reason

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

    Code Info

    Catalog Number: 4301CSP Lot Numbers/UDI (GTIN, DI + PI): 0001411297 (01)10885403107771(17)220331(10)0001411297 0001412994 (01)10885403107771(17)220331(10)0001412994 0001412993 (01)10885403107771(17)220331(10)0001412993 0001413312 (01)10885403107771(17)220331(10)0001413312 0001413224 (01)10885403107771(17)220331(10)0001413224 0001415321 (01)10885403107771(17)220430(10)0001415321 0001416350 (01)10885403107771(17)220331(10)0001416350 0001416833 (01)10885403107771(17)220430(10)0001416833 0001417546 (01)10885403107771(17)220430(10)0001417546 0001418031 (01)10885403107771(17)220430(10)0001418031 0001418108 (01)10885403107771(17)220430(10)0001418108 0001418415 (01)10885403107771(17)220430(10)0001418415 0001420365 (01)10885403107771(17)220430(10)0001420365 0001421922 (01)10885403107771(17)220630(10)0001421922 0001422603 (01)10885403107771(17)220630(10)0001422603 0001422916 (01)10885403107771(17)220630(10)0001422916 0001423132 (01)10885403107771(17)220630(10)0001423132 0001424769 (01)10885403107771(17)220630(10)0001424769 0001425084 (01)10885403107771(17)220630(10)0001425084 0001426503 (01)10885403107771(17)220630(10)0001426503 0001426326 (01)10885403107771(17)220630(10)0001426326 0001427017 (01)10885403107771(17)220630(10)0001427017 0001427227 (01)10885403107771(17)220630(10)0001427227 0001427711 (01)10885403107771(17)220630(10)0001427711 0001428496 (01)10885403107771(17)220630(10)0001428496 0001429509 (01)10885403107771(17)220630(10)0001429509 0001430610 (01)10885403107771(17)220630(10)0001430610 0001430605 (01)10885403107771(17)220630(10)0001430605 0001431471 (01)10885403107771(17)220630(10)0001431471 0001432426 (01)10885403107771(17)220831(10)0001432426 0001432425 (01)10885403107771(17)220831(10)0001432425 0001433266 (01)10885403107771(17)220831(10)0001433266 0001434250 (01)10885403107771(17)220930(10)0001434250 0001437530 (01)10885403107771(17)221031(10)0001437530

    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

    49,760 devices