BEUDAMED
    FDA Enforcement Class II Terminated

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    Recall: Z-1974-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1974-2020
    Event ID
    85586
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Access Scientific LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 23, 2020
    Classification Date
    May 14, 2020
    Termination Date
    April 27, 2021
    Address
    3910 Sorrento Valley Blvd Ste 200, N/A, San Diego, CA, 92121-1419, United States

    Description

    BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.

    Reason

    Saline Flush Syringe compromised sterility due to holes in the packaging.

    Code Info

    LOTS: 257837, 259820, 261063, 261317, 262161, 263001, 263648, 264816, 265133, 267194, 267195, 267718, 269001, 269005, 269713, 270780, 270779

    Distribution

    US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA.

    Quantity

    7,395 units