BEUDAMED
    FDA Recall Terminated

    PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT

    Recall: Z-1796-2020 · Initiated March 11, 2020

    Recall

    Recall Number
    Z-1796-2020
    Event Number
    85292
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DXC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2020
    Terminated
    March 2, 2022
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT

    Reason

    During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.

    Action

    On 03/11/2020, Urgent Product Recall Notices were mailed via second day service. The recalling firm requests that customers immediately stop using, quarantine, and return the affected lots. Further, they requested that customers make personnel within their organization aware of this field action. If the product was further distributed to other facilities, institutions, or manufacturers, customers were asked to ensure this notice was immediately shared with them and note the quantity distributed on the customer response form. Customers with additional questions were encouraged to call 801-208-4381.

    Distribution

    U.S.: NV, IL, VA, PA, CA, AR, MA, GA, OH, NJ, TX, FL, NC, SC, MI, NH, CO, AL, MN, KS, NM, AZ, ID, MD, NY, OR, DC, DE, MO, IN, WI, IA, TN. O.U.S.: Switzerland, Hong Kong, Spain, Portugal, Canada, Singapore, United Arab Emirates, Mexico, United Kingdom, France, Japan, Germany, Italy

    Quantity

    1932