BEUDAMED
    FDA Enforcement Class II Ongoing

    LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

    Recall: Z-0796-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0796-2022
    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

    LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL

    Reason

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

    Code Info

    Catalog Number: 4306C Lot Numbers/UDI (GTIN, DI + PI): 0001410709 (01)10885403057069(17)220331(10)0001410709 0001411249 (01)10885403057069(17)220331(10)0001411249 0001412995 (01)10885403057069(17)220331(10)0001412995 0001414260 (01)10885403057069(17)220331(10)0001414260 0001414360 (01)10885403057069(17)220430(10)0001414360 0001415852 (01)10885403057069(17)220331(10)0001415852 0001417193 (01)10885403057069(17)220430(10)0001417193 0001415027 (01)10885403057069(17)220430(10)0001415027 0001419336 (01)10885403057069(17)220430(10)0001419336 0001422223 (01)10885403057069(17)220630(10)0001422223 0001425520 (01)10885403057069(17)220630(10)0001425520 0001426674 (01)10885403057069(17)220630(10)0001426674 0001428621 (01)10885403057069(17)220630(10)0001428621 0001429518 (01)10885403057069(17)220630(10)0001429518 0001430118 (01)10885403057069(17)220630(10)0001430118 0001433265 (01)10885403057069(17)220831(10)0001433265 0001433844 (01)10885403057069(17)220930(10)0001433844 0001434817 (01)10885403057069(17)220930(10)0001434817 0001438147 (01)10885403057069(17)221031(10)0001438147

    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

    29,870 devices