BEUDAMED
    FDA Enforcement Class II Terminated

    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

    Recall: Z-2166-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2166-2021
    Event ID
    88191
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 4, 2021
    Initiation Date
    June 10, 2021
    Classification Date
    July 29, 2021
    Termination Date
    May 15, 2024
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

    Reason

    Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

    Code Info

    Catalog Number: IN3130 UDI: 00884450440179; 00884450510155; Lot Numbers: H1862928; H1896261; H1923761; H1929106; H1939255; H1966485; H1978295; H2068264; H2073193; H2073247; H2077173; Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262; H1909581; H1923762; H1929107; H1978299; H2007415; H2031599; H2068265; H2073248; H2077175; H2084368; Catalog Number: IN3302 UDI: 00884450511305 Lot Numbers: H1896263; H1966489; Catalog Number: IN3802 UDI: 00884450511510 Lot Numbers: H18962650; H1939259; H1966490; H1973390; H1978305; H1993118; H2001426; H2007417; H2012534; H2031601; H2073198; H2073249; H2077176;

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.

    Quantity

    7,211 devices