BEUDAMED
    FDA Enforcement Class II Ongoing

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

    Recall: Z-1911-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1911-2023
    Event ID
    92301
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 21, 2023
    Initiation Date
    April 22, 2023
    Classification Date
    June 14, 2023
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

    Reason

    There is a potential that valve assemblies will not open. preventing fluid from draining.

    Code Info

    Lot # I2533611, I2546597, I2559292, I2548163 & I2578001; UDI-DI: 00884450394908

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and the countries of France, United Kingdom, Mexico.

    Quantity

    670 units