BEUDAMED
    FDA Recall Terminated

    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

    Recall: Z-0454-2021 · Initiated September 16, 2020

    Recall

    Recall Number
    Z-0454-2021
    Event Number
    86522
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KXG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 16, 2020
    Terminated
    June 1, 2021
    Address
    1600 W Merit Pkwy South, Jordan, UT, 84095-2416

    Description

    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

    Reason

    The flocked tip of the 100mm swab may break off in the nasophyaryngeal cavity during sample collection. This could result in soft tissue injury of the nasophyaryngeal cavity or a delay in treatment.

    Action

    The firm sent an recall notification on September 16, 2020 to all affected consignees. In addition to informing consignees about the correction, the firm requested consignees take the following action: 1. Please refer to the attached instructions and/or linked instructional video when collecting samples with nasopharyngeal swabs. 2. Ensure that applicable personnel within your organization are made aware of this notice. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them. 4. If you have any questions or concerns regarding this communication or the products addressed, please contact your Merit Sales Representative or Merit Customer Service at (801) 208-4381.

    Distribution

    Worldwide distribution. US Nationwide, Australia, Canada, Colombia, Ghana, Ireland, Jamaica, Kenya, Panama, Qatar, Trinidad and Tobago.

    Quantity

    3,385,442 units